cyrilzakka/clinical-trials huggingface dataset:
Treatment of Pathological Gambling With Naltrexone Pharmacotherapy and Brief Intervention

The aim of this research is to explore the efficacy of the opiate antagonist, naltrexone as combined with CBT-intervention in the treatment of pathological gambling (PG). The study period is 2011-2014 during which one hundred Pathological Gamblers will be recruited to participate to this placebo-controlled double-blind trial.

All participants have to be able to read and understand the patient information sheet and sign the informed consent. All participants are free to stop being in the study whenever they wanted. The patients are not paid or reimbursed for participation.

The study periods is 21 weeks during which the participant's have 8 appointments with the researchers. During the meetings research data will be collected and the participant is having Controlled Behavioral Therapy (CBT) consulting from a trained therapist. At the study visits, the subjects are given written instructions for the proper use of naltrexone and advised to take 50 mg naltrexone approximately one hour before gambling or feeling urges to gamble (and to refrain from taking naltrexone at other times). In this study the maximal daily dose is 50mg of naltrexone. The medication is free for the subjects.

Eligibility Criteria:
Inclusion Criteria:

* pathological gambling (scores 5+ from SOGS-R and DSM-IV criteria)

Exclusion Criteria:

* acute hepatitis
* severe liver or kidney dysfunction
* suicide risk or severe depression or other untreated mental health problem
* participation to other gambling research at the same time
* the use of drugs (especially opiates)
* pregnancy
* prisoners
* retarded and mentally ill patients were also excluded
Lotrafilcon B Plano Cosmetic Contact Lenses Study

The purpose of this study is to gather long-term performance and safety data on AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses in subjects 12 years of age and older. AIR OPTIX™ COLORS plano contact lenses do not contain visual correction and are worn for cosmetic purposes only.

Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of their participation in the study, approximately 1 year.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject and/or parents/legally authorized representative must be able to understand and sign an approved informed consent form.
* Has never worn contact lenses before, with or without refractive error correction.
* Willing to wear cosmetic contact lenses and who have expressed interest in 1 to 3 color variants of lotrafilcon B plano cosmetic contact lenses.
* Willing to wear the study lenses at least 5 hours per day for at least 2 days a week during the study.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Pregnant and lactating women.
* Any use of systemic or ocular medications that would contraindicate contact lens wear.
* Other protocol-defined exclusion criteria may apply.
Effects of Insulin Resistance in Non-diabetic Acute Coronary Syndrome Patients

Effects of insulin resistance in non-diabetic acute coronary syndrome patients by the homeostasis model assessment index (HOMA2-IR)

Help patients know about insulin resistance. If this condition persists for a long time, it will reduce the ability to produce insulin, thereby leading to increased blood sugar levels, causing type 2 diabetes. Helping doctors have a more general view, in order to come up with a strategy more effective monitoring and treatment, preventing diabetes and cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Control group The researcher collected samples from healthy people over 18 years old who came for a health check and were concluded to have good health at the Health Examination Department of University of Medicine and Pharmacy Hospital, Ho Chi Minh City. Not falling within the exclusion criteria and agreeing to participate in the study were included in the study.
* Researchers -All patients diagnosed with Acute coronary syndrome who were over 18 years old, met the inclusion criteria and did not have exclusion criteria, and agreed to participate in the study were included in the study.

Exclusion Criteria:

* Control group

  * Patients \< 18 years old.
  * History of heart disease or stroke
  * Exclude diabetic subjects
  * Exclude subjects at high risk of insulin resistance
* Researchers

  * Have diabetes or have previously been diagnosed with diabetes.
  * Patients \< 18 years old.
  * The patient does not participate in follow-up examinations and does not follow up treatment at the medical facility.
  * The patient died before reaching the hospital.
  * Patients with severe medical diseases: cirrhosis, cancer, obstructive pulmonary disease chronic obstructive pulmonary disease, chronic heart failure, severe kidney failure.
Effects of Psyllium on Constipation in Schizo-phrenic: A Randomized Controlled Crossover Trial

Constipation in schizophrenia is an important issue in clinical care. Constipation needs psychiatric professionals concerning and providing intervention because it may cause ileus and lead to death. The cause of constipation in patients may be due to side effects of antipsychotic medication, sedentary lifestyle, insufficient water intake, fiber, etc. The study aims to increase fiber of the consumption of psyllium to assess the constipation effectiveness in schizophrenics. The study conducted a crossover research design. G-power was used to calculate the 22 subjects in each of the two groups. A total of 44 patients with constipation who were schizophrenics will participate in the study. Patients will use simple randomly to be divided into two groups based on their live ward for pre-testing. These two groups will receive either psyllium 3.5 g/day or 7 g/day for 4 weeks in a single-blind, crossover trial. The trial will stop 1week after the first phase and post-test. Then, two groups will exchange the dose for 4 weeks. Post-test will record after finishing this second phase trial. This study can understand the benefits of psyllium on schizophrenics with constipation symptoms and can give professional suggestions to patients with constipation in the future.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-V was diagnoses with schizophrenia inpatients.
2. Aged between 20 years and above.
3. Those who defecate less than 3 times a week, or those who have Bristol stool form scale between 1 and 2, or those who have constipation assessment scale (CAS) scores more than one point from questions 3 to 8; Or use PRN stool softeners (including oral and suppository) at least once a week.
4. Clear awareness and able to communicate in Chinese and Taiwanese.

Exclusion Criteria:

1. Patients with intestinal diseases such as colon cancer, irritable bowel syndrome and other organic intestinal diseases such as rectal bleeding, intestinal surgery, rectal prolapse and other medical history.
2. Cases with positive fecal occult blood test in the past six months, changes in stool thickness for one month, history of iron deficiency anemia, and unexplained weight loss for one month.
3. Those who are unable to cooperate due to obvious mental symptoms.
4. History of grain allergy, asthma.
A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures

The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.

The investigators hypothesize:

1. That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
2. PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has been diagnosed with a 5th metatarsal delayed or non-union.
2. Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
3. Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

1. Subject has synovial pseudarthrosis.
2. Subject has a fracture gap of larger than 5mm as measured on CT Scan.
3. Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
4. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
5. Subject has an implanted unipolar pacemaker.
6. Subjects who have previous malignant or connective tissue disorder.
7. Subjects who use medication such as steroids or anticoagulants.
8. Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy

The purpose of this study is to establish whether new techniques that may make polyps (adenomas) stand out better from the background help increase the number of polyps visible at sigmoidoscopy (telescope test to look inside large bowel) compared to looking with standard sigmoidoscopy alone.

Colorectal cancer is the second commonest cause of cancer death. In majority of cases it is preceeded by a precancerous lesion called an adenoma (commonly known as polyp). Detection and removal of adenomas has been shown to reduce the death rate from colorectal cancer. Despite of meticulous examination "a miss rate" for adenomas at colonoscopy ranges from 6-15% in back-to-back colonoscopy studies. The nature of the polyps, which as well as being pedunculated (cherry like) can also be flat, which makes it difficult to see and detect and may add to the"miss rate".

The factors that affect whether an endoscopist sees a polyp are not well studied. Polyp detection rates vary widely, even amongst experts. Techniques that highlight lesions advanced in recent years. Chromoendoscopy, spraying dye on the bowel lining, has been shown to help pick up more precancerous polyps in one of three studies in normal patients. Autofluorescence endoscopy (AFI) and narrow band imaging (NBI) use light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.

Patients with familial adenomatous polyposis (FAP) have many hundreds of bowel polyps due to a genetic defect and are at very high risk of colorectal cancer. Many of them have the majority of the large bowel removed with only lowest part of the large bowel, the rectum, left and joined to the small bowel. The remaining rectum can still have up to 50 polyps and is regularly surveilled with sigmoidoscopy to see if any large polyps have grown so they can be removed before they turn into cancer. Some of these polyps are small and flat.

We aim to see if using the new enhancement techniques we can detect more polyps in patients with FAP than with standard endoscopy.The patients will undergo flexible sigmoidoscopy as usual. This will then be repeated with the auto fluorescence feature of the endoscope activated, followed by a repeat with the narrow band feature activate. Then the lining of the bowel will be sprayed with blue dye (non-absorbed) and extra dye suctioned, the viewing process will be repeated the final time. This should take approx. 5 minutes. The videos from the procedures will be anonymised and randomised for viewing by another endoscopist.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Familial adenomatous polyposis who have had ileo-rectal anastomosis and had 20 or less adenomas at previous surveillance examination

Exclusion Criteria:

* poor bowel preparation, unable or unwilling to give informed consent, under 18 years of age,those with more than 20 adenoma
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The purpose of this study is to determine whether the medication pravastatin will ameliorate renal and cardiovascular disease over a 3-year period in children and young adults with autosomal dominant polycystic kidney disease (ADPKD).

Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease, affecting 1 in 400 to 1000 individuals and accounting for 4% of end-stage renal disease in the United States and 8-10% in Europe. The condition is characterized by progressive development of kidney cysts with kidney enlargement and associated loss of kidney function. High blood pressure and cardiovascular disease are common in patients with ADPKD. Although the condition is often thought to affect primarily adults, it is clear that the disease can be present in the fetus and young children.

This study was designed to determine if treatment with the medicine pravastatin can slow the progression of kidney and heart disease when initiated early in life in patients with ADPKD. The Investigators will assess differences between pravastatin and placebo study groups over the three-year study period with respect to: 1) total kidney volume as assessed by magnetic resonance imaging (MRI); 2) left ventricular mass index as assessed by MRI; 3) urinary albumin excretion; and 4) endothelial-dependent vasodilation as assessed by brachial ultrasound. A total of 110 subjects were enrolled in this research study. This study involved pediatric subjects because the Investigators believe that early intervention is critical if they are to decrease the morbidity and mortality associated with this condition. If pravastatin is shown to be effective in ameliorating progression of renal and cardiovascular disease in this study, routine management of people with this condition will be drastically altered.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-22 years
* Autosomal dominant polycystic kidney disease
* Normal kidney function

Exclusion Criteria:

* Abnormal kidney function
* Past allergic history to medications used in study
* Liver disease
* Muscle disease/dystrophy
* Pregnancy, planned pregnancy, or lactation within study period
* Inability to cooperate with or clinical contraindication for magnetic resonance imaging
The Feasibility of Florbetapir Quantitation in Europe

This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Readers have undergone Amyvid reader training
* Readers have not more than minimal experience with quantitation of amyloid PET scans

Exclusion Criteria:

* Readers have previously been trained to quantitate amyloid PET scans
Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula

Perianal fistulas are in the forefront (42 to 72, 4%) of morbid complication of Crohn's disease, affecting nearly one- third of patients and complicating abscesses in 35-48% of cases. The current treatment is based on the combination of drainage (proctologic and surgical), and biologics techniques, but the failure rate varies from 30 to 80%. Actually, innovative cell therapy procedures are validated by Cell-Easy with the use of allogenic mesenchymal stem cells for the immunomodulatory, anti-inflammatory, angiogenic and trophic properties (CellReady®) and represent a promising option in the treatment of perianal fistulas associated with Crohn's disease. This phase I/II study is designed to evaluate the treatment of complex perianal fistulas associated with Crohn's disease, after failure of conventional treatment by injection of allogeneic cultured adipose-derived stromal cell (AdMSC) into the fistula.

The injection of adipose stromal cells is currently evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischemia, osteoarthritis, systemic slerosis...). Immunoregulatory and anti-inflammatory properties of AdMSC's are responsible for accelerating healing and represents an innovative approach to treat perianal fistulas associated with Crohn's disease.

This phase I/II study is designed to evaluate the treatment of complex perianal fistulas associated with Crohn's disease, after failure of conventional treatment by injection of AdMSC (CellReady®) into the fistula.

Different doses of AdMSC will be tested for a dose escalation (5.10\*7 and 10.10\*7 cells) and injected in the in the wall of the fistula.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old,
* Patients who signed the informed consent,
* Patient affiliated to a social security system,
* Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological and/or radiological criteria for more than 3 months,
* Colonoscopy less than a year old without ulcer in the rectum,
* Presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports,
* Patient treated with a combined treatment (drainage on setons + anti-TNFα) and who failed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled

Exclusion Criteria:

* Refusal of the patient to participate in the study,
* Positive QuantiFERON test,
* Patient with transplanted organ,
* History of cancer in the last five years or lympho-proliferative disease,
* Persistent bacterial or viral infection,
* Patient with a contraindication to MRI,
* Known allergy to Gadolinium,
* Known allergy to Albumine,
* End-stage organ failure,
* Pregnant or breastfeeding women,
* Women of childbearing age without effective contraception throughout the duration of the study,
* Patient under judicial protection, under guardianship or curatorship.
* Patient previously treated with ALOFISEL®
Glaucoma Screening With Smartphone Ophthalmology

The purpose of this study is to assess the accuracy and reliability of smartphone ophthalmoscopy compared to slit-lamp biomicroscopy in glaucoma screening for potential community screening programs.


Eligibility Criteria:
Inclusion Criteria:

* ocular hypertension
* glaucoma

Exclusion Criteria:

* substantial media opacity
* refractive error outside the range from -10.00 to +5.00 diopters
Optimal Postoperative Pain Management After Lung Surgery (OPtriAL)

Adequate pain control after video-assisted thoracoscopic surgery (VATS) for lung resection is important to improve postoperative mobilisation, recovery, and to prevent pulmonary complications. So far, no consensus exists on optimal postoperative pain management after VATS anatomic lung resection.

Thoracic epidural analgesia (TEA) is the reference standard for postoperative pain management following VATS. Although the analgesic effect of TEA is clear, it is associated with patient immobilisation, bladder dysfunction and hypotension which may result in delayed recovery and longer hospitalisation. These disadvantages of TEA initiated the development of unilateral regional techniques for pain management. The most frequently used techniques are continuous paravertebral block (PVB) and single-shot intercostal nerve block (ICNB).

The investigators hypothesize that using either PVB or ICNB is non-inferior to TEA regarding postoperative pain and superior regarding quality of recovery (QoR). Signifying faster postoperative mobilisation, reduced morbidity and shorter hospitalisation, these techniques may therefore reduce health care costs and improve patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* Patients referred for anatomic lung resection (pneumonectomy, (bi)lobectomy or segmentectomy for either benign or malignant disease) with the intention of performing it by video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS)
* Patients should be able to provide informed consent and fill out questionnaires in Dutch language.

Exclusion Criteria:

* Patients with contra-indications for TEA or PVB (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis and mechanical spine obstruction) or allergic reactions to local anaesthetics will be excluded.
* Patients chronically using opioids for reasons not related to the operation will be excluded from the study since postoperative baseline opioid requirement will be higher and TEA remains the preferred technique for these patients.
* In case the lung surgeon estimates the operation to be performed through a thoracotomy instead of VATS/RATS
Changes in Speed, Endurance and Balance in Women Patients With Multiple Sclerosis After 4 & 8 Weeks of Aquatic Exercise Training

Background: It has been shown that adults with Multiple sclerosis (MS) have less leg strength than their peers, as well as impaired balance, which has led to an increased prevalence of falls in this population.The purpose of this study was to assess the effects of 8-weeks aquatic exercise training in balance, endurance and speed in women with MS.

Methods: In this semi-experimental study, 32 women with clinically-definite relapsing-remittent MS who were registered through the Isfahan MS association volunteered for this study. They randomly selected an aquatic exercise (n = 17) and control (n = 15) groups. Aquatic exercise group completed a 8-week aquatic exercise training program consisted of three sessions per week, each session lasting 45 to 60 minutes 50 to 75 percent of their maximum heart rate reserve on 20-25 degree centigrade's, whereas the control group was instructed to maintain their current lifestyle. The balance of angry was surveyed with using of Berg analyze, speed and endurance 6 minutes walking test before starting of exercise program and after 4 weeks and at the end of 8 weeks was analyzed. The obtained data's were analyzed using analysis of variance with repeated measures.


Eligibility Criteria:
Inclusion Criteria:

* All women diagnosis of clinically or laboratory supported MS, a minimum time of two years since the diagnosis was made, no relapse within the 4 weeks preceding baseline, ability to participate in regular exercise sessions.

Exclusion Criteria:

* Patients were excluded from the study if they had a relapse during the intervention period, and had a disease preventing their participation (e.g. cardiovascular, respiratory or skeletal diseases).