cyrilzakka/clinical-trials huggingface dataset:
Managing Recurrent Abdominal Pain

The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).

Recurrent Abdominal Pain (RAP) is one of many disorders in adults and children for which there is no identifiable organic or physiological cause, yet which is associated with illness behavior that has significant societal and personal costs. Although 10-15% of children have RAP, there is at present no accepted medical or behavioral treatment for it. We have conducted a series of studies that suggests that illness behavior is, at least in part, learned during childhood when parents model sick role behavior or respond to their children's somatic complaints in a way that encourages or reinforces sick role behavior. The goal of this project is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with RAP.

The study is a randomized clinical trial. Children with RAP are assigned to one of two treatment conditions: 1) a social learning and cognitive behavior therapy condition (SLCBT) or 2) an education and support condition (ES). The SLCBT protocol teaches parents and children cognitive-behavioral methods such as relaxation and coping for managing RAP pain and stress. Patients and parents in the ES condition receive educational information regarding nutrition and the gastrointestinal system. Both treatment arms consist of three sessions with a mental health professional, each one week apart.

Study families are recruited from physicians in the community and through community flyers and newsletters. Outcome measures are collected at baseline, end of treatment, and at follow-up evaluations conducted three, six and 12 months later. Measures are designed to assess: RAP symptoms, health care utilization, psychological symptoms, school absences, functional disabilities, and family stress).

Primary Hypothesis: Children in the SLCBT condition will exhibit a greater decrease in symptoms of RAP and related maladaptive behaviors and cognitions than children in a comparison condition.

Eligibility Criteria:
Inclusion Criteria:

* child experienced at least 3 episodes of abdominal pain over a 3-month period which affected his/her activities
* primary caregiver willing and able to complete questionnaires
* child aged 7-17
* child has lived with the primary caregiver full-time for at least the past 5 years and for at least half of his/her lifetime

Exclusion Criteria:

* positive physical or laboratory findings which would explain the child's abdominal pain
* chronic disease
* major surgery in past year
* developmental disabilities that require full-time special education or impair ability to respond
* inability to comprehend English
The Effectiveness of Reablement in Home Dwelling Adults

The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling adults is effective with regards to functional ability, health-related quality of life, coping, mental health and municipal costs.

Health promotion and prevention of functional decline among home dwelling adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and institution placement. In the coming years there will be a significant increase in number of persons in Norway that need interventions aiming at coping with everyday activities. Therefore there is a call for new models for early intervention and rehabilitation in order to give service to a larger amount of home living people. Reablement is a new and promising rehabilitation model which many Norwegian municipalities are implementing in order to meet current and future needs for municipal home-based services. However, very little research has been performed regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning, health-related quality of life, coping, mental health and economic municipal costs.

The study will be conducted in 44 municipalities in Norway. It is a quasi-experimental intervention trial, recruiting home-dwelling adults with an initial functional decline in daily activities. The intervention is intensive, multidisciplinary, home-based rehabilitation given by home-trainers, under supervision from an occupational therapist, nurse or a physiotherapist. The control intervention is standard home-based treatment and care.

A total of approximately 750 participants will be recruited, including approximately 100 participants the control group. The participants will be assessed at baseline, and at 10 weeks ,6-, and 12 months follow-up. Primary outcomes will be participation, activity, and municipal expenditures. Costs are generated by the working hours of the different professions. Hence, there will be a weekly registration of the working hours different health care professions spend in the private homes of the participants.

Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups from baseline to the end of intervention. The working hour data is panel data and will be analyzed accordingly; a random or a mixed effect regression model will be employed. Also, descriptive statistics and simpler tests will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Home-dwelling person
* Applicant of home-based services
* Above 18 years old
* Functional decline in at least one activity
* Able to understand written and oral Norwegian

Exclusion Criteria:

* Cognitive disability
* Terminal ill
* Being assessed as needing nursing home placement
* Being assessed as needing institution-based rehabilitation
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.

Thirty adults aged 30-75 y will be randomized to either 4 g/d of eicosapentaenoic acid or no drug for 12 weeks. Endothelial function will be measured at baseline and after 12 weeks. in a secondary aims, we will evaluate effects of eicosapentaenoic acid (EPA) on plasma levels of c-reactive protein, oxidized low-density lipoprotein cholesterol, and endothelin-1.

Eligibility Criteria:
Inclusion Criteria:

* Age 30+ years
* Hypertriglyceridemia (150-400 mg/dl)
* Statin use for at least six months at the time of screening
* Type 2 diabetes treated with diet and/or oral hypoglycemic agents diagnosed 1+ year
* Ability to provide informed consent and provide blood samples
* Willingness to abstain from fish oil, EPA, over the counter niacin, and other omega-3 fatty acid supplements during the study period (12 weeks)
* Ability to travel to the study site at Brigham and Women's Hospital for 3 study visits
* Reactive hyperemia index (RHI) of ≤ 2.0

Exclusion Criteria:

* Eating disorder or heavy drinkers
* Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification
* Pregnant or lactating women
* Statin use \<6 months at the time of screening
* Allergy to EPA, fish oil, or other omega-3 fatty acids
* Current use of insulin, cyclophosphamide, estrogen, fibrates, niacin, hormone replacement therapy, testosterone, oral contraceptives, growth hormones, insulin-like growth factor-1, and other systemic steroids.
* Inability to provide informed consent or blood samples
* History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
* Diagnosis of diabetes \< 1 year prior to enrollment
* Intention to move out of greater Boston area within one year
* Current use of omega-3 supplements, fish oil, or \>2 servings of fish per week
* Bleeding disorder or uncontrolled endocrine (i.e., thyroid) or metabolic disorders
* Treatment with blood thinning drugs (i.e. warfarin and clopidogrel)
* Major surgical operation 3 months before or after screening
* Organ transplantation
* Current participation in another trial or plan to do so during the study
* Inability to give informed consent or to travel to the study center at Brigham and Women's Hospital
* RHI of \>2.0
* Triglycerides \<150 mg/dl or \>400 mg/dl
* Body mass index of 40+ kg/m2
Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.

PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can produces increased pressure around the distal optic nerve,which is likely followed by venule compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly characterized by standard automated perimetry to measure peripheral visual field sensitivity.

Pupillometry is a promising approach for functional assessment in PTC because it is noninvasive, objective, performed quickly with minimal patient cooperation needed.

The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be examined.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects

1. Male or female patients, age between 18 and 80 years, inclusive
2. Informed written consent will be obtained from all participants.
3. Normal eye examination
4. Best-corrected visual acuity (BCVA) of 20/20
5. Normal color vision test (Ishihara/HRR)
6. Normal Spectral-Domain Optical Coherence Tomography (SD-OCT)
7. Normal 24-2 Humphrey visual field (SITA Standard) and:

   * Short duration (≤10 minutes)
   * Minimal fixation losses, False POS errors and False NEG errors (less than 33% for each one of reliability indices)

PTC patients

1. Male or female patients, age between 18 and 80 years, inclusive
2. Best-corrected visual acuity (BCVA) of at least 20/100 in worse eye
3. Optic disc edema
4. PTC diagnosis based on Modified Dandy Criteria ( lumbar puncture with opening pressure higher than or equal to 25 cm H2O, normal cerebrospinal fluid constituents, and unremarkable brain imaging results except typical for PTC

Exclusion Criteria:

Healthy subjects

1. History of past (last 3 months) or present ocular disease or ocular surgery
2. Use of any topical or systemic medications that could adversely influence pupillary reflex
3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
5. Visual media opacity including cloudy corneas.
6. Any condition preventing accurate measurement or examination of the pupil.

PTC patients

1. Any other neurologic or ophthalmic disease other than PTC
2. Use of any topical or systemic medications that could adversely influence pupillary reflex
3. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
4. Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
5. Visual media opacity including cloudy corneas.
6. Any condition preventing accurate measurement or examination of the pupil.
Infertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes

Infertile PCOS women with obesity were included into lifestyle change weight loss program prior to inclusion to IVF procedures. They attended group as well as individual workouts and they were advised on healthy eating.

The weight loss program will consist of dietary change and exercise program which will be performed 3 times weekly.

Eligibility Criteria:
Inclusion Criteria:

* BMI over 30 kg/m2
* PCOS
* Primary or secondary infertility
* normal partner's semen

Exclusion Criteria:

* Other identifiable causes of infertility
EUS-guided Combined Therapy Versus Beta Blocker Therapy in Primary Prophylaxis o GOV II and IGV I

The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.

Gastric variceal bleeding is a severe condition associated with a high mortality. Bleeding from varices bleeding will be defined as the occurrence of hematemesis and/or melena requiring \>2 U of blood or a decrease of 2 gm/dl of hemoglobin if no blood transfusion is given, with the confirmed endocopic visualization of GOV II and IGV I.

The beta blocker therapy is an effective method for the prevention of the first esophageal variceal bleeding; however, the efficacy in preventing first gastric variceal bleeding is controversial.

The investigators aimed to compare the efficacy in preventing the first gastric variceal bleeding in patients with documented GOV II and IGV I.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Writeen informed consent provided.
* Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.
* Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)
* Patient preference for EUS-guided therapy.

Exclusion Criteria:

* Under 18 years old.
* Refuse to sign written informed consent.
* Pregnancy or nursing.
* Previous treatment of gastric varices.
* Non-cirrhotic portal hypertension
* Concurrent hepato-renal syndrome and/or multi-organ failure.
* Proven malignancy including hepatocellular carcinoma
* Platelet count less than 50,000/ml or International Normalized Rate (INR) \>2.
* Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
* Esophageal stricture.
* Uncontrolled coagulopathy.
Transmural Collaborative Care Model for CVRM and Medication Review for Patients Using Antipsychotics

Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient.

A transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.

It is well established that patients with severe mental illness and patients treated with atypical antipsychotics have excess metabolic dysfunction and are at an increased risk of cardiovascular disease. Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient. General practitioners experience barriers regarding knowledge, collaboration with psychiatrists, and patient compliance. To overcome these barriers a transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. TACTIC is a one-time transmural intervention comprising three steps: 1) an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting, 2) a multidisciplinary meeting with the patient to review his or her antipsychotic use and cardiovascular risk and to provide tailored treatment advice, and 3) a follow-up contact with the general practitioner to translate the treatment advice into an individualised action plan through shared decision making.

This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.

Eligibility Criteria:
Inclusion Criteria:

* using atypical antipsychotic medication for at least 3 months at baseline
* the atypical antipsychotic medication is prescribed by the general practitioner
* a 10-year cardiovascular risk of at least 5% (as measured with QRISK3 score) at baseline

Exclusion Criteria:

* diagnosis of dementia or organic psychosis
* diagnosis of cardiovascular disease (acute myocardial infarction, acute coronary syndrome, heart failure, ischemic stroke, transient ischemic attack, peripheral artery disease, aortic aneurysm or a revascularization procedure, i.e. percutaneous coronary intervention or coronary artery bypass grafting)
Effect of Smoking on Postprandial Gastric Emptying, Glucose Tolerance and Secretion of Gut and Pancreatic Hormones

The study aims to evaluate the effect of smoking on postprandial responses such as plasma glucose, secretion of gut - and pancreatic hormones and gastric emptying in healthy, heavy smoking men.

Epidemiological studies show that active smoking increases the risk of type 2 diabetes in a dose-dependent fashion. Smokers seem to be characterized by central obesity, increased inflammatory markers and oxidative stress, which may lead to insulin resistance and irregularities in glucose metabolism. The current study is a meal test study, in which the aim is to examine a number of variables during a liquid mixed meal test (including gastric emptying, glucose tolerance, gut and pancreatic hormone responses, gall bladder emptying, appetite and food intake) performed in healthy non-smoking subjects and in healthy smokers with or without concomitant cigarette smoking.

The investigators hypothesize that smoking-induced increases in circulating nicotine levels and simultaneous activation of nicotinic receptors in the gastrointestinal tract and in the autonomic nervous system would have detrimental effect on postprandial glucose metabolism and, thus, constitute an important link between smoking and the risk of type 2 diabetes. The current study will help to clarify this hypothesis and improve our general understanding of the association between smoking and gut hormone secretion, gastric emptying and glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Both groups

  * Caucasian ethnicity
  * Healthy males
  * Normal haemoglobin
  * Age above 18 years
  * Informed and written consent
  * BMI \>20 kg/m2

Smokers • Minimum 20 cigarettes pr. day for at least 1 year

Non-smokers

• No smoking on a regular basis

Exclusion Criteria:

* Both groups

  * Diabetes or prediabetes (fasting plasma glucose levels \>6.5 mM or HbA1c \>6.0%)
  * First- or second-degree relatives with diabetes
  * Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
  * Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
  * Hypo- or hyperphosphataemia
  * Nephropathy (serum creatinine \>150 µM and/or albuminuria
  * Treatment with medicine that cannot be paused for 12 hours
  * Hypo- or hypercalcaemia
  * Hypo- and hyperthyroidism
  * Treatment with oral anticoagulants
  * Active or recent malignant disease
  * Any treatment or condition requiring acute or sub-acute medical or surgical intervention
  * Any condition considered incompatible with participation by the investigators
Sleep Quality in Healthcare Personnel During COVID-19

Coronavirus disease 2019 (COVID-19), represents a medical and psychological challenge to healthcare workers to the limits that it affects their quality of sleep and their general health.


Eligibility Criteria:
Inclusion Criteria:

* All healthcare personnel actively working during the pandemic

Exclusion Criteria:

* non healthcare workers
Effects of Mindfulness Training on Emotion Regulation and Social Cognition.

The present study will investigate the effects of a mindfulness training on emotion regulation and social cognition, using several psychological, behavioral, psychophysiological and neuroimaging methods.

The aim of the present study is to evaluate the impact of a mindfulness intervention, particularly the mindfulness-based stress reduction (MBSR), on the capacities of emotion regulation and social cognition, in caring/helping professions which are vulnerable to stress. In the context of a longitudinal intervention study, a randomized controlled trial, the efficacy of the MBSR to increase the capacity for self-emotion regulation, empathic attunement, and compassion capacities will be measured. For doing this, several psychological, behavioral, psychophysiological and neuroimaging brain measurements will be used.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: Men or women
* Right-handed
* Normal or corrected-to-normal visión
* German as a first language
* No history of neurological or psychiatric problems, or use of controlled medication that might interfere with emotion or attention.
* No symptoms of claustrophobia
* Written informed consent form to participate in the study and neuro-imaging experiment.

Exclusion Criteria:

* Chemical dependence, including nicotine and alcohol
* Dementia or psychotic condition.
* Depression or use of antidepressants
* Pregnant or breast-feeding women
* Prior MBSR class or regularly practicing mindfulness meditation (or yoga) for three or more months.
* Non-controlled severe medical disease that might interfere with the performance of the study, such as neoplasias, cardiopathies, digestive pathologies, diabetes mellitus type I or type II
* Neoplasias in the central nervous system
* Tremor or dystonia in cephalic segment that hinders the performance of the MRI study (tremor equal to or higher than 3 in each corporal segment, according to the UPDRS scale)
* Fulfillment of any criterion of contraindication for the MRI exam (for instance, metallic implants, claustrophobia, pregnancy, use of pacemaker; intracranial aneurism clip; cochlear implants).
* Presence of odontological devices that might disturb the magnetic field or any sources of variation of the magnetic susceptibility
* Any other conditions the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered.
Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort " REPA ")

Recurrent respiratory papillomatosis (RRP) is a rare disease. However, it is the most common benign laryngeal tumor in children. To date, no epidemiological data are available in France. The aim of this study is to establish the epidemiology of juvenile PPR.

Recurrent respiratory papillomatosis (RRP) is characterized by the recurrent proliferation of multiple polypoid squamous tumors in the respiratory tract, linked to HPV infection. RRP is a rare disease. However, it is the most common benign laryngeal tumor in children.

There are currently no French national epidemiological data on this disease. The data collected by the reference centers will enable us to gain a better understanding of this pathology in terms of epidemiology, risk factors, genetic susceptibility and clinical manifestations, as well as to significantly study the efficacy of the various existing therapies and preventive measures, in order to establish a clear, standardized and optimal guideline.

Eligibility Criteria:
Inclusion Criteria:

* Patients with juvenile PRR (disease onset before age 18)
* Followed in the :

  * The MALO CRMR
  * One of the MALO network's CCMRs
  * One of the main correspondent centers

Exclusion Criteria:

* Patients objecting to the collection of their personal data
* Parents of minor patients objecting to the collection of their child's personal data