cyrilzakka/clinical-trials huggingface dataset:
Blame Rebalance fMRI Feedback Proof-of-concept

The investigators have shown that decoupling of brain networks when feeling guilty is the first potential functional neuroimaging biomarker of risk of major depression. It remains detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was found while people felt guilty during functional magnetic resonance imaging (fMRI) relative to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target for interventions to reduce the largely increased risk of recurrent episodes in people who have had one episode but are currently remitted. To our knowledge, however, there is no proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected and fed back to the participants after a short temporal delay in a real-time fMRI setting and whether coupling can be increased through neurofeedback training. This project aims at developing the first fMRI neurofeedback system to treat self-blame-selective neural decoupling and to test its feasibility in people with major depressive disorder currently remitted from symptoms.

Specific aim 1: Demonstrate that anterior temporal lobe (ATL)-septal/subgenual cingulate (SCSR) coupling for guilt can be increased through one session of neurofeedback in the group seeing visual feedback based on increasing correlations during the guilt condition compared with the group seeing visual feedback based on keeping correlations at the same level during the guilt condition.

Specific aim 2: Demonstrate that this increase in coupling is selective for guilt relative to indignation.

Specific aim 3: Demonstrate that mood is not negatively affected by neurofeedback.

Specific aim 4: Explore whether this short intervention decreases self-hate on the Interpersonal Guilt Questionnaire (Portuguese translation) and increases self-esteem on the Rosenberg scale (both show significant correlations with SCSR-ATL coupling across major depressive disorder and control groups in our Manchester study), or if these measures are not available, decreases negative affect on the Positive and Negative Affect Scale.

Eligibility Criteria:
Inclusion Criteria:

* past major depressive episode according to Diagnostic Statistical Manual (DSMIV) for at least 2 months, currently not fulfilling criteria for depression and remitted from symptoms for at least 2 months

Exclusion Criteria:

* suicidal thoughts
* other current DSM-IV axis-I disorders
* a history of atypical major depressive episodes (DSM-IV)
* Global Assessment of Functioning scores below 80 as a sign of incomplete remission or co-morbidity
* \>2 points on the suicidality item of the Hamilton Depression Scale
* prior criminal convictions
* history of violent behavior towards persons as determined by clinical interview
* positive past or current screening question for irritability on the mood disorders module
* antisocial personality as determined on personality interview using DSM-IV criteria
* borderline personality disorder as determined on personality interview using DSM-IV criteria according to the personality interview
* current self-harming behaviors
Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound.

The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 16 years
* Clinically suspected lower extremity DVT

Exclusion Criteria:

* Known chronic DVT
* Acute DVT confirmed by prior formal imaging
* Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.)
* Anticoagulation \>48 hours prior to imaging (formal or LCU)
Online Study of People Who Have Genetic Changes and Features of Autism: Simons Searchlight

Simons Searchlight is an observational, online, international research program for families with rare genetic variants that cause neurodevelopmental disorders and may be associated with autism. Simons Searchlight collects medical, behavioral, learning, and developmental information from people who have these rare genetic changes. The goal of this study is to improve the clinical care and treatment for these people. Simons Searchlight partners with families to collect data and distribute it to qualified researchers.

Simons Searchlight has expanded over the last several years to include additional gene changes and participation through remote formats, either online or by phone. This allows English and Spanish-speaking families from across the world to participate at times that are convenient to their schedule. Participants can donate blood, saliva, or both. These samples are then linked to medical, behavioral, learning, and developmental data in order to understand the effects of specific gene changes.

Information provided by participants will be stripped of any personal identifying information and made available to qualified scientists around the world.

The Simons Foundation, a New York-based private foundation, is committed to finding science-based solutions and working towards the development of targeted treatments to improve the lives of people who have genetic and developmental differences.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of any age with a genetic condition on our eligible list along with their biological family members. Current list can be found at: https://www.simonssearchlight.org/research/what-we-study/
* Must be fluent in English or a supported language. Current supported languages are Spanish, French, and Dutch, with more to come.
* Able to register and participate through our online platform, which can be accessed through any device able to connect to the internet.
* Able and willing to provide consent.

Exclusion Criteria:

-Some genetic changes that we study have regions or variants that are not eligible for our research. This is determined during our laboratory review that is completed by trained and certified genetic counselors. These specific ineligible regions or variants can change frequently.
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on \[CAMN107A2109\] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.


Eligibility Criteria:
Inclusion Criteria:

* Having participated in Novartis study CAMN107A2109, and
* Written signed and dated informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Impaired cardiac function,
* Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
* Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
* patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
* Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
* Patients unwilling or unable to comply with the protocol.

Other protocol -defined inclusion/exclusion criteria may apply
Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest

The aim of this study is to evaluate the prognostic value of the suppression ratio monitored by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient admitted to our intensive care unit after a cardiac arrest are included. The results of the suppression ratio will be collected in the 6 first hours of admission. We will evaluate the link between suppression ratio and cerebral performance category score collected at three months.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Cardiac arrest admitted to the ICU

Exclusion Criteria:

- Pregnancy
Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients

Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item

Exclusion Criteria:

* Secondary diagnosis of Bipolar I disorder
* Suicidal history
* Organic brain disease
* Dementia
* History of substance abuse
Zonisamide for Weight Reduction in Obese Adults

The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.

This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.

Eligibility Criteria:
Inclusion Criteria: Age 18-65 years; BMI 30-50

Exclusion Criteria:

Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)

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Treatment of Male Pattern Baldness With Botulinum Toxin

This proof of concept study seeks to demonstrate that Botulinum toxin injections are a safe and effective method for treating this form of hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male pattern baldness
* Norwood II-VI

Exclusion Criteria:

* Treatment with Botulinum toxins or other hair growth interventions with past year
Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids

The purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with a diagnosis of uterine fibroids at any time and at least 1 office visit during study time period
* At least 1 of the procedures of interest occurring between January 1, 2005 - December 31, 2011
* ≥ 18 years and \< 55 years of age at the index date

Exclusion Criteria:

* Patients with a diagnosis of gynecologic cancer (ovarian, uterine, cervical)
* First recorded diagnosis of uterine fibroids occurring beyond four weeks after the Index Date ONLY for patients who underwent endometrial ablation or hysterectomy
* Patients with a record of any procedures of interest occurring before January 1, 2005
Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus

Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. Alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids in order to decrease adverse drug reactions.

This study was conducted to evaluate the effect of quercetin on treatment of erosive -atrophic lesions of oral lichen planus (OLP).


Eligibility Criteria:
Inclusion Criteria:

* confirmation of clinical diagnosis of Atrophic and erosive lichen planus by histological examination
* two weeks wash out periods after the last treatment
* having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in VAS Score

Exclusion Criteria:

* confirmation of dysplasia and malignancy in histologic examination
* confirmation of lichenoid reaction in histologic examination
* pregnancy and breast feeding
* using fluorokinolon and cyclosporin which interact with quercetin
Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)

The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting.

The primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.

Robotic-assisted surgery is hypothesised to reduce time to functional recovery by 2 days compared with open surgery. With a power of 80% and alpha of 0.05, the sample size needed in each arm to test superiority is 35 patients. With an expected 25% drop-out rate, 47 patients will be randomized in each group, with a total of 94 patients to be randomized in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference.
* Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist.

Exclusion Criteria:

* Previous extensive surgery in the upper abdomen (for example open liver surgery)
* Pregnancy
* Intraoperative findings of dissemination (patient is then excluded after randomization)
* Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization).
* Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)
Hyperoxia During Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?

Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation.

Aim: The goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (CWRET) on a cycle ergometer compared to sham air.

Methods: We plan to include 25 Patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged \>18 years; stable condition \>3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. Patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two CWRET (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. Patients and assessors will be blinded. The difference endurance time of the CWRET with oxygen vs. sham air will be the primary outcome of this study.

Data will be summarized by means (SD) and medians (quartiles) for normal and non-normal distributions. Effects of treatment will be evaluated by mean differences with 95% confidence intervals, T-tests or Wilcoxon matched pair tests as appropriate. A p-value threshold of \<0.05 or a confidence interval not including zero will be considered as statistically significant. Analyses will be performed according to the intention to treat principle.


Eligibility Criteria:
Inclusion Criteria:

* We will include male and female lung disease patients undergoing pulmonary rehabilitation: aged ≥ 18 years; stable condition \> 3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% during a 6-minute walking test (6MWT); informed consent as documented by signature.

Exclusion Criteria:

* Severe daytime resting hypoxemia (SpO2 \< 88% or partial pressure of oxygen (PaO2) \< 8 kPa); unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease; inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle; women who are pregnant or breast feeding; enrolment in another clinical trial with active treatment.
The Effect of Thoracic Mulligan Mobilization on Sub-acromial Impingement Syndrome

This study was conducted to investigate the effect of mulligan thoracic sustained natural apophyseal glide on patients diagnosed as sub acromial impingement syndrome and its effect on shoulder range of motion, pain, function and disability of affected shoulder joint and size of sub acromial space, Half of the patients will treated with traditional treatment and mulligan thoracic SNAGS technique, while the other half will treated with traditional treatment only.

Forty patients with sub-acromial impingement syndrome will participate in this study. Intervention for the both group consisted of 12 session (3 times per week ) for one month. Subjects will be divided randomly and allocated into two groups , study group will received supervised exercise and mulligan thoracic SNAGS technique and the control group will received supervised exercise (stretching and strengthening exercises). both group will assessed by x ray to measure sub-acromial space , visual analogue scale for pain , The Shoulder Pain and Disability Index for shoulder function and goniometer for shoulder flexion, abduction ,external and internal rotation range of motion before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred as sub-acromial impingement syndrome (stage 2) according to neer's classification.
2. Have +ve Neer's sign, +ve Hawkins and Kennedy test and +ve Empty and full can tests.
3. selected from both genders.
4. Aged from 25 to 40 years old.
5. Have restricted thoracic extension motion ( +ve occiput to wall test).

Exclusion Criteria:

1. History of shoulder adhesive capsulitis
2. Rotator cuff tendon tear/rupture (stage 3).
3. Shoulder dislocation, subluxation and fractures.
4. History of cervical, shoulder, upper back surgery.
5. Any spinal deformities such as scoliosis, kyphosis and rounded shoulder.
6. Diabetes mellitus.
7. Radiculopathy.
8. History of breast cancer.
9. Previous stroke or Shoulder hand syndrome.
10. Ligamentous Laxity.
Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence

The purpose of the study is to determine the genetic influence on short-, middle- and longterm effects of an inpatient lifestyle therapy program in overweight and obese children and adolescents.

In Germany, as in other countries, overweight and obesity affects a growing number of children and adolescents. Obesity-related diseases such as arterial hypertension, disorders of glucose and lipid metabolism and an increase in inflammation markers are associated with higher morbidity and mortality in early life, therefore effective therapy concepts are needed.

The aim of this study is to evaluate the effects of a 4-6 week inpatient obesity lifestyle therapy program over 10 years and the genetic influence on the short-, middle- and longterm outcome.

The lifestyle intervention consists of physical exercise, nutrition education and behaviour therapy based on the criterions developed by the German Obesity Group (degree of weight reduction, improvement of comorbidity and health behaviour, minimising of side effects).

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese children (BMI \>90th percentile for age and gender), who obtained an inpatient lifestyle intervention in the participating clinic.
* Children with written consent from their parents and the acceptance of a 10-year follow-up.

Exclusion Criteria:

* Children without written consent from their parents.
* Children with monogenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrome) or with secondary obesity.
Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia

The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-45 years old with iron deficiency anaemia
* haemoglobin level between 85 g/L and 105 g/L
* serum ferritin level \< 15 µg/L
* D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation
* Standard diet

Exclusion Criteria:

* - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
* Haemochromatosis or iron overload of secondary origin (blood transfusion),
* Long term treatment known to modify iron absorption,
* Gastro duodenal ulcer,
* Inflammatory bowel disease or any digestive disease which could modify iron absorption,
* Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase,
* Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
* Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.