cyrilzakka/clinical-trials huggingface dataset:
Study of Fish Oil to Reduce ALT Levels in Adolescents

This trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased ALT.

Over the past two decades, pre-adult nonalcoholic fatty liver disease (NAFLD) has emerged from the relative obscurity to become the most common cause of liver disease in pediatric patients. Currently, over 17% of US children and adolescents have a BMI at or greater than the 95th percentile for age and gender and 20% of children in weight management programs are estimated to have NAFLD. Untreated NAFLD can lead to fibrosis and to established cirrhosis in children as young as 10. Fish oils are a rich source of omega-3-acid ethyl esters or n-3 long-chain polyunsaturated fatty acids, and increasing evidence suggest they may safely improve hepatic steatosis. Given the prevalence of obesity, of NAFLD, and the severe, progressive nature of this condition, effective treatment strategies are urgently needed. We plan to gather preliminary data on the efficacy and safety of fish oil supplements in reducing persistent elevation of ALT levels and hepatic steatosis on abdominal CT-scan among urban youth (BMI\>=95th percentile). This preliminary data will provide the necessary information to calculate the sample size for a phase 2 trial.

Eligibility Criteria:
Inclusion Criteria:

* BMI (kg/m2) at or above the 95th percentile for age and gender
* Weight below 400 pounds (less than 182 kilograms)
* Persistent elevation of ALT (41-90 UI/L at study screening)
* Presence of hepatic steatosis on abdominal CT-scan
* Able to give informed consent/assent

Exclusion Criteria:

* Type 2 diabetes mellitus
* Prior drug treatment for diabetes, insulin insensitivity, or weight loss medications six months before screening
* Use of prescription strength glucocorticoids within three months before screening
* History of syndrome or medical disorder associated with significant obesity
* Participation in a weight loss program within six months of screening resulting in 5% or more weight loss
* History of weight loss surgery
* Alcohol use more than twice weekly or more than 3 alcohol containing beverages within a 24-hour period in the past six months
* Known or suspected bleeding condition
* History of liver disease including prior liver biopsy with NASH type 2 or cirrhosis
* Former or present positive blood tests for Infectious hepatitis B or C, autoimmune hepatitis, Wilson disease, Alpha-1 anti-trypsin deficiency, Iron storage disease, or high TSH
* History of past or current pregnancy
* Use of illegal/illicit drugs
* Other conditions contraindicated or cause for caution in the use of fish oil
* Unable to comply with the protocol
* Any other serious disease determined by the study gastroenterologists and physician nutrition specialist as potential study risk for the patient
Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers

The goal of this project is to implement and evaluate a novel intervention for low-income families to reduce the burden of caregivers of a child with asthma.


Eligibility Criteria:
Inclusion criteria:

1. Must be age 18 or older
2. Able to speak and read English or Spanish
3. Have a smartphone or computer with active service
4. Care for a child with asthma between ages 5-12
5. Agree to participate

Exclusion criteria:

1. Age less than 18
2. Inability to speak and read English or Spanish
3. Does not have a smartphone or computer with active service
4. Child does not have asthma
5. Care for a child less than 5 or greater than 12
6. Decline to participate
7. Prisoners
Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal

The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure in comparison to the standard surgery for low rectal cancer. The investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.

Anastomotic leak represents the most frequent complication after rectal cancer surgery and a lateral covering ileostomy is usually performed to reduce its incidence. Other important consequences of rectal cancer surgery are alterations in bowel habits and function and a negative impact on quality of life. This prospective, randomized, multicenter and controlled trial compares post-operative complications, quality of life, faecal incontinence and recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis protected by a lateral ileostomy or with a two-staged Turnbull-Cutait colo-anal anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy established by rigid proctoscopy, with histological confirmation and candidates of colo-anal anastomosis;
* Patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical treatment;
* Patients who undergo an ultra-low anterior rectal resection with total mesorectal excision and nerve and sphincter-sparing with curative intention
* Any extension of the primary tumor (T 1-2-3-4) according to the TNM classification;
* Patients with or without lymph node metastasis (N - / +) and with or without resectable distant metastases;
* Patients clinically without fecal incontinence prior to the current illness and with a Wexner incontinence Score less than or equal to 5;
* Patients ASA I, II or III and adequate hematological, renal and hepatic function;
* Patients who signed informed consent.

Exclusion Criteria:

* Altered cognitive state(eg mental retardation or dementia) that prevents collaboration in the study or patients who can neither read nor write
* Fecal incontinence (Wexner equal to or greater than 6);
* Previous surgery or proctological, colonic and anorectal functional disease
* Diagnosis of synchronous colorectal or any other active neoplasm;
* Patients ASA IV, V;
* Pregnancy and lactation;
* Rejection of the patient to sign the consent form.
Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis

To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.

The study has now completed see Primary publication:

Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial.

Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R.

Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a confirmed diagnosis of multiple sclerosis and at randomisation have entered the secondary progressive stage. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least one point on the EDSS or clinical documentation of increasing disability.
* EDSS 4.0 - 6.5 inclusive
* Women of childbearing age will be required to use appropriate methods of contraception to avoid the unlikely teratogenic effects of simvastatin.
* Able to give written informed consent
* 18 - 65 years

Exclusion Criteria:

* Unable to give informed consent
* Primary progressive MS
* Those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 3 months of the screening visit. These patients may undergo a further screening visit once the 3 month window has expired and may be included if no steroid treatment has been administered in the intervening period.
* Patient is already taking or is anticipated to be taking a statin.
* Any medications that unfavourably interact with statins: fibrates, nicotinic acid, cyclosporine, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse.
* The use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the previous 6 months.
* The use of mitoxantrone if treated within the last 12 months.
* If the patient has ever been treated with alemtuzumab.
* If screening levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatine kinase (CK) are three times the upper limit of normal patients should be excluded.
* Patient unable to tolerate baseline scan or scan not of adequate quality for analysis (e.g. too much movement artefact).
* If a female patient is pregnant or breast feeding
Effects of Constipation Treatment in Chronic Kidney Disease: A Pilot Feasibility Trial

Constipation is one of the most prevalent gastrointestinal disorders in patients with chronic kidney disease (CKD) and has been associated with their adverse kidney and cardiovascular outcomes; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical and microbiological parameters in patients with CKD. The investigators aim to test the feasibility of delivering an intervention with constipation treatment and determine its effects on changes in clinical, biochemical, and microbiological parameters in patients with CKD and constipation.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients \>18 years old.
2. Patients able and willing to provide written informed consent and HIPAA authorization.
3. CKD stages G3-G5 without kidney replacement therapy with estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 creatinine equation.
4. Functional or opioid-induced constipation based on the Rome IV criteria.
5. Patients must refrain from taking any laxatives for at least one week prior to screening, although rescue with one bisacodyl 5 mg tablet will be allowed when a patient does not have a bowel movement for ≥3 consecutive days or when symptoms become intolerable.
6. A negative pregnancy test in female patients prior to enrolment, unless the patient is two years postmenopausal or has had a documented tubal ligation or hysterectomy.

Exclusion Criteria:

1. History of drug abuse, anorexia nervosa, or bulimia.
2. History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever).
3. Liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included).
4. Galactosemia.
5. Allergies to lactulose.
6. History of gastrointestinal surgery except appendectomy.
7. Use of antibiotics or immunosuppressants within 30 days prior to the enrollment in the study.
8. Use of pre- or probiotics within 30 days prior to enrollment in the study.
9. Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding.
10. Patients currently participating in another interventional study.
11. Major surgery within one month prior to enrollment in the study or planned surgery while the patient is in the study, other than dialysis vascular access surgery.
12. Patients who the investigator determine have a medical status that would preclude the patient's participation.
13. Patients on hemodialysis or peritoneal dialysis.
14. Patients with a functional kidney transplant.
15. Patients with past lactulose use.
Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.

In women undergoing laparoscopic ovarian cystectomy which is less harmfull on the ovarian reserve (electrocoagulation or suturing).

The aim of the present study was to determine which hemostatic procedure (hemostatic suture or electrocautery) may be less harmful after laparoscopic cystectomy, based on the longterm status of the ovarian reserve.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18- 45.
2. Regular menstrual cycle.
3. Unilateral ovarian cyst clinical \& us finding as endometriotic cyst.
4. C/O of pelvic pain.
5. No medications (oral pills \& hormonal drugs) in the past 3 monthes before enrollement.
6. No evidence of endocrine disorders (DM, Thyroid dysfunction,hyper prolactenemia, congenital adrenal hyperplesia, cushing's syndrome or adrenal insufficiency)
7. No previous adnexial surgery.
8. Pathology diagnosis of excised ovarian tissue (endometriotic cyst)
9. Appropriate medical condition for laparoscopic surgery.
10. Completely understand the process of the study with written consent.

Exclusion Criteria:

1. PCO according to Rotterdam criteria.
2. Pathological diagnosis of excised ovarian tissue as non endometriotic cyst.
3. Previous ovarian surgery.
4. Suspected ovarian malignancy.
5. Patient whose histopathology showed benign cyst apart from endometrioma.
6. Irregular menstrual cycles.
7. Post menopausal status.
8. Bilateral ovarian cyst.
9. AMH \< 0.5 ng/ml.
10. Premature ovarian failure in family.
Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain

Irritability was defined by Geoffrey Maitland as the vigor of activity to provoke symptoms, the severity of symptoms, and time for symptoms to subside. Irritability is deeply embedded in the physical therapy clinical decision-making process. However, the mechanisms contributing to irritability are unknown. Therefore, the purpose of this study is to characterize pain sensitivity and pain-related psychological factors by irritability level in individuals with shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* shoulder pain symptom intensity rated as 3/10 or higher in the past 24 hours
* attending physical therapy for shoulder pain

Exclusion Criteria:

* non-English speaking
* systemic medical conditions that affect sensation, such as uncontrolled diabetes
* history of shoulder surgery or fracture within the past 6 months
* history of a chronic pain condition, such as fibromyalgia
* blood clotting disorder, such as hemophilia
* contraindication to the application of ice (blood pressure \> 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* currently pregnant
A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention

The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in Veterans 65 years and older. This study will also examine the neuromuscular and cognitive attributes that contribute to clinically meaningful improvements in mobility; and determine whether a novel mode of cognitive training can enhance cognition among mobility limited primary care Veterans 65 years and older.

This study is a randomized control pilot study. All participants will receive rehabilitative exercise addressing mobility skills. In addition, one group will be will receive additional cognitive training. Randomization is stratified according to screening mobility and cognitive score.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-90
* History of fall in the past year OR difficulty or task modification with climbing one flight of stairs or walking ½ mile (6 blocks)
* Community Dwelling
* Ability to speak and understand English

Exclusion Criteria:

* Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer
* Major medical problem interfering with safe and successful testing (i.e. history of hip replacement with recurrent dislocation; uncontrolled hypertension, use of supplemental oxygen
* Myocardial infarction or major surgery in previous 3 months
* Planned major surgery (e.g. joint replacement)
* Baseline Short Physical Performance Battery Score \<4 or \>10
* Modified Mini Mental Status Examination score of ≤77 out of 100
* Inability to safely complete the 400 meter walk test
Treatment of Olecranon Fractures in the Elderly

Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.

Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment

Eligibility Criteria:
Inclusion Criteria:

* Displaced olecranon fracture (Mayo 2A and 2B).

Exclusion Criteria:

* Associated fractures in the coronoid process, radial head or distal humerus.
* Open fracture, Gustilo-Andersen 2 or 3
* Severe cardiopulmonary disease or other medical condition which contraindicates surgery.
* Previous injury to or other condition in the elbow with serious functional impairment
Distal Radius Fracture - Treatment Comparison

This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.


Eligibility Criteria:
Inclusion Criteria:

* Closed extra-articular distal radius fracture or a minimally displaced intra-articular fracture
* Fracture classified as an AO/OTA A2, A3, C1 or C2 with or without an ulnar styloid fracture
* Must be treated within the first 14 days of injury,
* Male or female greater than or equal to 65 years of age.
* Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
* Ability to understand and provide written authorization for use and disclosure of personal health information
* Fracture that can be treated closed with or without closed reduction

Exclusion Criteria:

* Concomitant contralateral or ipsilateral upper extremity fractures
* Ipsilateral ulna (excluding styloid) fracture
* Open fracture
* Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
* Unstable distal radioulnar joint after fracture fixation
* Fractures where the transverse fracture line is less than 10mm from the distal radius joint surface
* Artery or Nerve injury secondary to fracture
* History of alcoholism
* Currently on chemotherapy or radiation therapy
* Currently on worker's compensation
* Rheumatoid arthritis or other inflammatory arthropathies.
* History of chronic pain issues or psychiatric disorder that precludes reliable follow-up.
Synthesis of Glutathione From Low Birth Weight Newborn Babies

The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.The protocol is constituted of two steps. The objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. Objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. In this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.


Eligibility Criteria:
Inclusion Criteria (first step):

* Full term newborn babies
* Gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile
* Eutocic delivery

Inclusion Criteria (second step):

* Low birth weight newborn babies (gestational age \< 32 weeks of amenorrhea and/or weight of birth \< 1500 g and/or weight of birth \< third percentile for their gestational age)
* Full term newborn babies (gestational age \> 37 weeks of amenorrhea and weight of birth \> tenth percentile)

Exclusion criteria (first and second step):

* Mother diastolic blood pressure \> 90 mmHg during pregnancy,
* pH \< 7.2 at umbilical cord and/or difference in pH \< 0,02 between arterial pH and venous pH
* Dystocic delivery
* Bacterial or viral maternofoetal infection
* Foetal malformation
* Foetal disease
* Taking N-acetyl-cystein or vitamines and antioxidant minerals by the mother for the last 24 hours
Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis

Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).

AIMS:

1. Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
2. Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years)
* Diagnosis of ulcerative colitis (UC)
* Status post ileal pouch anal anastomosis IPAA (completed all stages)

Exclusion Criteria:

* Pediatric patients
* Indeterminate colitis
* Status post IPAA for familial adenomatous polyposis (FAP)
* BMI \> 30 kg/m2
* Pregnant
* Decompensated Cirrhosis
* Inability to provide informed consent