cyrilzakka/clinical-trials huggingface dataset:
Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting

This project will test 3 methods of dietary changes in a weight loss clinic. Participants will be randomized to one of 3 arms: low-carbohydrate diet, intermittent energy restriction, or Hunger Training. A maximum of 30 participants will be assigned to each arm. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic.

Adult obesity, a common condition in the United States, is a well-established risk factor for the development of chronic diseases, including diabetes, heart disease, hypertension, and many types of cancer. However, research has not determined what type of diet is best for reducing weight and achieving optimal health outcomes. In this randomized trial, participants seeking care at a weight loss clinic will be assigned to one of three diets: low-carbohydrate, intermittent energy restriction, or Hunger Training. On the low-carbohydrate diet, participants will be instructed to consume less than 30 grams of carbohydrates per day. The intermittent energy restriction protocol will require participants to choose 2 non-consecutive days per week in which they will consume 500-650 calories. Hunger Training is a relatively new approach that involves teaching people to monitor their hunger symptoms and blood glucose, and to eat only when blood glucose is below a certain level. To our knowledge, these weight loss modalities have not been compared in a single, clinical study. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic. The goal will be achieved though the successful completion of the following aims:

Aim 1: To determine the feasibility of recruiting, retaining and maintaining the adherence participants in a randomized clinical trial testing 3 weight loss modalities.

Aim 2: To examine and compare the effect of 3 weight loss modalities on changes in anthropometric measures and metabolic and cancer-related health markers.

Aim 3: To evaluate and compare patients' perceived satisfaction with each weight loss modality.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese as indicated by BMI \>27
* Age ≥ 18
* HbA1C \<8.0
* Fluent in English

Exclusion Criteria:

* Cognitive state that precludes informed consent or adherence to study protocols
* Pregnant, breast-feeding, or planning to become pregnant within 6 months
* A1C ≥ 8.0
* Taking an anti-obesity medication
* Insulin-dependence
* prior metabolic surgery
* current laparoscopic adjustable gastric band ("lap band") use
* Experience of substantial weight changes (±5 kg or ±10 lbs) in the past 3 months
A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients Undergoing Major Surgery

Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb

Eligibility Criteria:
Inclusion Criteria:

Paediatric patients scheduled for major orthopaedi or neurosurgical process under general anesthesia Arterial catheter necessary in the anesthetic protocol. BMI\<30 No opposition holders of parental authority and children.

Exclusion Criteria:

Hemoglobin disease Pretreatment with erytropoietin or iron
Mp-MRI in the Diagnosis of Liver Fibrosis After Liver Transplantation

It is an open label observation clinical trial, all participants are liver transplant patients. The investigators deem to make a better criteria for assessing liver fibrosis after liver transplantation. The point of the clinical trial is to evaluate the efficacy of multiparameter MRI in the diagnosis of liver fibrosis after liver transplantation.

We collected patients aged 18 to 85 who had undergone liver transplantation. At the same time, all patients underwent liver biopsy or ultrasonic transient elastography after MRI. People who were allergic to gadolinium contrast agent, serious cardiopulmonary disease and contraindications to MRI were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 -85 years
* Patients after liver transplantation
* Patients who are going to undergo liver biopsy or ultrasonic transient elastography
* Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

* Patients with tumor
* Patients who are allergic to gadolinium contrast agent
* Patients with contraindications to magnetic resonance imaging
* Patients with severe heart and lung diseases
* Patients who are not suitable for this study according to the researcher's judgment.
Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD

Adults who have attention deficit hyperactivity disorder (ADHD) suffer from significant occupational, academic and social problems, many of which are believed to be a result of problems with executive functioning. Executive functioning refers to a group of neuro-psychological functions which include sustained attention, working memory, verbal fluency, as well as motor and mental processing speed. Individuals with ADHD have been shown to have deficits in executive functioning independent of IQ, co-occurring psychiatric disorders, gender, and ADHD subtype. "Recollect" is an application (App) based working memory training video game where participants conduct 3-different adaptive working memory tasks. In each of these tasks participants are presented with a set of stimuli to be remembered while playing a simple platform game where they help navigate an astronaut across the screen and dodge obstacles. Recollect has been designed for all age groups to an interesting, fun and effective brain-training activity. The memory tasks included in the game have been independently shown to improve working memory in a manner that transfers to untrained tasks.

The purpose of this study is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult ADHD.

The primary objective is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult Attention Deficit Hyperactivity Disorder (ADHD).Consenting participants will be screened using the Mini International Neuropsychiatric Interview for DSM-5 (MINI) to confirm ADHD diagnosis. Participants will be asked to download either Recollect or Tetris on their own mobile device. Following a training/orientation session, they will be asked to spend 20 minutes per day at least 5 days per week playing Recollect or Tetris over a 4 week period. At Week 4, study staff will check the time log on the Recollect/Tetris App to confirm how much time was spent playing the game. Participants will be asked to complete two ADHD symptom severity scales, as well as App-based neurocognitive testing at baseline (Week 0) and endpoint (Week 4).

Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 18 and older who own a mobile device such as a Smartphone or tablet.
2. Current diagnosis of Adult ADHD, at any stage of treatment.
3. Comorbid psychiatric conditions will be allowed.
4. Medication or psychotherapy must have been stable (no dose changes) for 4 weeks prior to study participation.
5. Must be able to read, write and understand English.

Exclusion Criteria:

1. Participant does not own a Smartphone or tablet.
2. No dose changes during the 4 week study period.
3. No initiation of new psychological therapy or counselling during the 4 week study period.
Pharmacotherapy in Depression With Panic Spectrum

This research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft.

Researchers at the University of Pittsburgh Medical Center Health System are currently recruiting men and women, ages 18 to 60, to examine the effectiveness of the FDA-approved medication sertraline (Zoloft) for major depression.

Participants will be randomly assigned to one of two groups. Each group will begin and continue taking Zoloft at different doses. A physician will follow eligible participants weekly for approximately 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18-60;
* Current diagnosis of major depression, and a rating of ³15 on the HRS-D-25; - -Presence of significant, co-existing panic-agoraphobic spectrum symptoms,
* Absence of ongoing therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications
* Physically healthy,
* Female participants of childbearing potential must be practicing a medically acceptable form of double-barrier birth control or using oral contraceptives such as birth control pills, implants, or injections;

Exclusion Criteria:

* Females who are pregnant or breast-feeding;
* History of suicide attempt in the 6 months prior to entry, active suicidal ideation, or significant suicide risk;
* History of hypersensitivity to or current use of sertraline;
* Unstable or untreated medical conditions,
* Participants who do not wish to discontinue current, ineffective antidepressant treatment;
* Participants who have recently begun psychotherapy (less than 3 months prior to study entry);
* Diagnosis of current panic disorder, psychosis, substance or alcohol abuse, anorexia, bulimia, dissociative, bipolar disorder, or any other psychiatric or medical illness that would interfere with the best treatment strategy for the potential participant.
Dose-painting Radiation for LA-NSCLC

The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.

The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.

The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety.

Eligibility Criteria:
Inclusion Criteria:

1. The patient or the legal representative of the patient can sign a written informed consent, and can understand and agree to follow the research requirements;
2. The age at the time of signing the informed consent form is between 18 and 75 years old;
3. It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
4. Stage II-Ⅲ (AJCC 8th edition \[Rice et al., 2017\]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
5. Measurable lesions that meet the definition of RECISTv1.1;
6. ECOG physical status ≤ 2;
7. Survival expectancy ≥ 3 months;
8. Hemoglobin ≥100g/L, WBC≥4×109/L, platelet ≥100×109/L (or follow the standards of each center);
9. Liver function: ALT, AST\<1.5 times the upper limit of normal (ULN), total bilirubin\<1.5×ULN;
10. Renal function: serum creatinine \<1.5×ULN;
11. Pulmonary function: FEV1\>50%, the percentage of DLCO (lung diffusion function) measured value and predicted value\>80% mild to moderate lung function impairment.
12. The patient has good compliance with the treatment and follow-up.

Exclusion Criteria:

1. There is evidence of distant metastasis (M1, AJCC 8th edition \[Rice et al., 2017\]);
2. There is pleural effusion, pericardial effusion or ascites that is not clinically controlled and requires repeated drainage or medical intervention (within 2 weeks before randomization);
3. Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
4. Have received radiotherapy and surgical treatment;
5. There were other active malignant tumors ≤ 2 years before enrollment, except for the specific cancers under study in this study and locally recurring cancers that have been cured (eg, resected basal cell or squamous cell skin cancer, superficial Bladder cancer, carcinoma in situ of the cervix or breast);
6. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.;
7. Has suffered from other malignant tumors;
8. Subjects who have received other drug trials within the past month;
9. Pregnant or lactating women and women who refuse contraception during the treatment observation period;
10. People with a history of severe allergies or idiosyncratic physique;
11. Those with a history of severe lung or heart disease;
12. Refusal or inability to sign the informed consent to participate in the trial;
13. Drug or alcohol addicts;
14. Personality or mental illness, lack of capacity for civil conduct or limited capacity for civil conduct.
Incidence Of Hemidiaphragmatic Paralysis After Usg Guided Low Dose Interscalene Brachial Plexus Block

to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug followed by 24 hours continous infusion of drug

to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug followed by 24 hours continous infusion of drug. To see hemidiaphragmatic paralysis by seeing diaphragmatic excursion on M mode Usg subcostal approach, to see post operative pain, patient satisfaction score, complications if any

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years and belonging to ASA grade I, II, III, undergoing either, shoulder surgery, (rotator cuff repair, acromioplasty, hemiarthroplasty, and total shoulder replacement) or surgery for proximal humerus fracture will be recruited for the study.

Exclusion Criteria:

* a) Patient refusal for interscalene block b) Severe respiratory disease (FEV1/FVC \<0.7 and FEV1 \< 80% of predicted) c) Allergy to amide local anaesthetic drugs d) Chronic opioid therapy e) Patients who cannot understand how to operate PCA and VAS
Rapid Benzodiazepine Detoxification Using Flumazenil - 1

The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist, flumazenil, will reduce acute benzodiazepine withdrawal.


Eligibility Criteria:
Please contact site for information.
Standardized Management of Pregnancy Weight of Twin Pregnancy

There are few studies on the optimal value of pregnancy weight gain for twin pregnancy in China.At present, China has not put forward guidelines for the appropriate value of weight gain in twin pregnancy, and the lack of standards for weight gain during pregnancy in clinical application or disease prevention and control seriously restricts the health management of pregnant women.In order to effectively control a series of adverse consequences caused by improper weight gain of women during twin pregnancy, it is urgent to establish the appropriate value of weight gain during twin pregnancy, which will also fill the gap in this field in China.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Twin pregnancy
* pregnancy weeks ≤ 6 weeks

Exclusion Criteria:

* adverse pregnancy history
* kidney disease
HIV Prevention Among At-risk Latinos in the Heartland

This study is a randomized controlled trial that evaluates the efficacy of a network intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three mid sized Midwestern cities.

To benefit from early HIV diagnosis, the CDC suggests that groups at higher HIV risk get tested regularly. The study will evaluate the efficacy of an intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three midsized Midwestern cities. The intervention uses the relationships that permeate networks of LMSMT by training well-positioned members to encourage a collective response to the epidemic and to disseminate HIV testing and prevention messages and resources within the network. Thus, we will (a) recruit 36 friendship networks of LMSMT in Milwaukee, Cleveland, and Indianapolis (N ≈ 432); (b) test them for HIV and recommend that they test regularly; (c) invite key members of 18 randomly selected networks to a 4-session training to promote regular HIV testing and prevention in their networks; (d) conduct chart reviews to verify regular testing and PrEP visits and assess regular testing, PrEP visits, and risk behavior and mediators at 6, 12 and 18-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* Latinx men who have sex with men or transgender women 18 or more years of age.
* Lives in the Milwaukee, Cleveland or Indianapolis area.
* Can provide informed consent.
* Additional inclusion criteria for networks: 80% or more of the network is of Latinx descent.

Exclusion Criteria:

* Cis-gender female.
* Did not have sex with men or identify as homosexual or bisexual.
* Cannot provide consent.
Memantine and Post-mastectomy Neuropathic Pain

The aim of this study is to evaluate if memantine administered for four weeks starting two weeks before surgery induces a decrease in pain intensity at 3 months post-mastectomy.

This is a randomized, controlled, open-label study in patients undergoing mastectomy. Patients included in this trial will receive memantine or not. For patients in the "memantine" group, the treatment will be given in titration (maximum dose of 20 mg/day). Concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment. Whether it is the "memantine" group or the "usual care" group, visits will be scheduled under the usual following conditions of the participating center.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years,
* Patient with a diagnosis of breast cancer, programmed for mastectomy with or without axillary dissection and neoadjuvant chemotherapy,
* Patient able to understand and willing to follow the study protocol,
* Acceptance to give a written consent.

Exclusion Criteria:

* Patient with a contraindication to memantine administration (hypertension, severe cardiac or hepatic insufficiency, stroke),
* Patient with diabetes (type I and II),
* Patient with renal insufficiency,
* Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
* Patient treated with specific drugs (amantadine, ketamine, dextromethorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbituric, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine),
* Patient with alcohol addiction,
* Epileptic patient or history of epileptic seizure or convulsions,
* Pregnant or nursing woman,
* Patient with a cooperation and an understanding that does not allow for a strict compliance under the conditions set out in the protocol,
* Patient participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
* Patient benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),
High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Very Premature Infants: a Prospective Observational Study

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low SpO2.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 28+0 and 31+6 gestational weeks were enrolled in the study after obtaining parental informed consent.

Exclusion Criteria:

* Infants with congenital malformations, previable rupture of membranes, and acute intrauterine hypoxia.
Targeted Sensory Reinnervation (TSR) in Hand Amputation

If a person has to have a part of their body amputated, in this case their hand, the patient then lacks information about the missing limb, which in many cases leads to pain that severely restricts their quality of life and participation in everyday life.

This is usually phantom and/or neuroma pain. Phantom pain is usually caused by many different mechanisms and occurs in 80-90% of patients.

Pain caused by terminal neuromas affects 13-32% of amputees and manifests itself as residual limb pain.

A neuroma itself is a benign lump that can develop at the site of the defect after a nerve has been severed (neurectomy).

In some cases the impairment is so severe that prosthetic tolerance, functional independence and quality of life can be severely affected.

Numerous treatment options for these types of pain are far from satisfactory for many patients and remain a major challenge for both the clinician and the person affected.

It is often no longer possible for the patients to pursue a profession or hobby due to the pain as well as due to the pain medication required and its possible side effects.

Surgical intervention can therefore be considered for patients who do not (or no longer) respond to conservative pain treatment.

In recent years, many surgical approaches have been introduced to treat or prevent post-amputee pain.

One of these methods can make it possible to create an authentic feeling of the missing limb and thus reduce or eliminate phantom pain by means of targeted sensory reinnervation (TSR) of the lost body part.

Sensory reinnervation means that a nerve which enables a (sensory) perception associated with a sense is "redirected" to a new area of the body and can therefore fulfil at least part of its task again.

In this case, an authentic feeling of the lost body part.

The aim of this retrospective data-analysis is to evaluate data from patients with hand amputation (planned surgery or caused by accident/infection..) who have undergone TSR surgery to treat or prevent phantom and neuro-pain with regard to different parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients with amputations of the hand
* Patient with programmed hand amputation
* Patients with treatment-resistant pain
* Patients with treatment-resistant phantom- and neuroma pain
* Patients with performed TSR Surgery
* Aged at least 18 years
* Patient must be alive at the time of medical record review

Exclusion Criteria:

* Patients enrolled in another interventional clinical trial
* An injured skin area for reinnervation at the volar side of the forearm, as well as an injured median or ulnar nerve.