cyrilzakka/clinical-trials huggingface dataset:
Prunes for Gastrointestinal Function After Gynecologic Surgery

This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. Patients in the control arm will take 100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary objective is to determine the time to first bowel movement after surgery.

A major postoperative complaint among benign gynecological surgery patients is constipation. Improved management of constipation among these patients has the potential to both alleviate pain and for significant savings for health care systems. This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. The primary objective is to determine the time to first bowel movement after surgery. Secondary objectives are pain associated with first bowel movement, stool consistency using Bristol stool form scale, compliance and patient satisfaction. The study population includes women over the age of 18 undergoing benign gynecologic surgery with overnight stay. Patients in the control arm will take 100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. Follow-up phone calls will be made 3 and 5 days postoperatively to inquire about primary and secondary outcomes. Participants will be randomized to the treatment or control group at a 1:1 ratio and using randomization blocks of 6. Participant characteristics will be presented as means and standard deviations for continuous variables and counts and percentages for categorical variables. The primary and secondary outcomes will be assessed using two-sample t-tests.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients seen in the Gynecology or Urogynecology clinics at LAC+USC Medical Center who are planned for surgery requiring at least 24 hour stay
2. Age 18 or greater
3. Able to give informed consent
4. No contraindications to docusate or prune consumption

Exclusion Criteria:

1. Unable to give informed consent
2. Unwilling to follow protocol
3. Active malignancy
4. Emergency surgery
5. Diabetes mellitus
6. Inflammatory bowel disease, gastroparesis, or other bowel disorder
7. History of bowel resection or presence of colostomy
8. Dependence on regular laxative use prior to surgery
9. Baseline frequency of bowel movements less than weekly
10. Intraoperative enterotomy or any bowel surgery performed at the time of surgery
11. Patient unable to initiate oral intake on post op day 1 for any reason
12. Allergy to docusate or prunes
A Clinical Trial to Evaluate the Efficacy of a Men's Supplement in Supporting Testosterone, Improving Cognitive Function, Mood, and Sexual Function

This randomized, triple-blind, placebo-controlled, hybrid trial aims to evaluate the efficacy of a men's supplement designed to increase testosterone levels and improve energy, cognition, and sexual function. The study will involve 50 male participants, with assessments carried out at Baseline, Day 45, and Day 90 through questionnaires and blood tests.


Eligibility Criteria:
Inclusion Criteria:

* Male (biological at birth).
* Aged between 30-65.
* Generally healthy - do not live with any uncontrolled chronic disease such as diabetes or hypertension.
* Willing to provide blood draws during the study duration.
* Fitness/wellness enthusiast who has the same weekly exercise routine i.e. HIIT, strength training, or running \&amp;gt;3 times per week.
* Self-reported concerns with energy levels, mood, and libido and sexual performance/adequacy.
* Willing to avoid medications, supplements, or vitamins aimed at increasing testosterone levels for the duration of the study.

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone with known severe allergic reactions requiring the use of an Epi-Pen.
* Unwilling to follow the study protocol.
* Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g., eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder).
* Current substance abuse disorder.
* Any medical condition that is unstable or uncontrolled.
* Has introduced any new prescription medication or supplements within the past 12 weeks that influence testosterone production.
* History of testicular or prostate cancer.
* Previously has undergone a vasectomy.
* Currently undergoing hormone replacement therapy (HRT)
* Currently taking performance-enhancing drugs.
* Anyone taking prescription blood pressure, immunosuppressants, sleeping aids, anti-seizure, and/or thyroid medications.
* Living in New York, Rhode Island, Hawaii, or Alaska.
Vagal Nerve Stimulation for Post COVID Fatigue

The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.

Patients, after consenting, will perform questionnaires, have a blood samples taken, and undergo PET/CT scans of the brain. Patients will then be randomized to either receive vagal nerve stimulation, or continue standard clinical care. For those randomized to receive treatment, they will be given a device and asked to follow a specific regimen daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Presence of fatigue and post exertional malaise.
* Presence of headache
* Clinical diagnosis of post COVID syndrome.
* They have consented to participate in the study
* They have the ability to participate in all aspects of the study.

Exclusion Criteria:

* Pregnant.
* Prior adverse reaction to 14FDG.
* Active implantable medical device e.g. pacemaker, hearing aid implant
* Metallic device e.g. stent, orthopedic hardware in neck
* Using another electronic device at the same time e.g. TENS, mobile phone.
* Any other condition deemed exclusionary by the study principal investigator
Evaluation of Intraoperative Lagophthalmos Formula

This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. included 20 eyelids from 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula

This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. The study included 20 eyelids of 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula.

Preoperative MRD 1 (Margin-to-reflex distance 1) and levator function were measured, then intraoperative palpebral fissure opening was determined from formula: Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26× Levator function. Postoperative MRD 1 was measured after 1 day, 1week,1month, 3 months and 6 months .Success was defined as postoperative MRD 1 ≥ 3 mm and difference between both eyelids height ≤ 1 mm at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* simple congenital ptosis (any degree) with levator function of 4mm or more

Exclusion Criteria:

* levator function less than 4mm
* a history of previous ptosis surgery
* other accompanying congenital diseases, such as blepharophimosis, congenital fibrosis of the extraocular muscles, Marcus Gunn (jaw-winking) syndrome, double elevator palsy and congenital third nerve palsy
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion

The purpose of this study is to determine whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.


Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation (AF), AF persistence for \> 7 days but \< 1 year
* Total AF history \< 2 years
* Written informed consent of the patient
* Age ≥18 years
* Female patients are sterilised or postmenopausal or apply an adequate method for contraception (Pearl index \<1%) and have a negative pregnancy test (ß-HCG) and do not breastfeed/nurse.

Exclusion Criteria:

* Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks
* Myocardial infarction within the last 3 months
* Heart failure NYHA class III - IV
* Uncontrolled hypertension, defined as a systolic blood pressure \> 160 mm Hg and/or a diastolic blood pressure \> 95 mm Hg (anti-hypertensive treatment is allowed).
* Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics
* Instable angina pectoris
* Use of Digitalis
* Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before)
* Contraindication or hypersensitivity to ß-blockers
* Open heart surgery within the last 3 months
* Pregnancy
* Acute and reversible illnesses
* Acute and chronic infection
* Alcohol or drug abuse or a severe progressive extracardiac disease
* Untreated manifest and latent hyper- or hypothyroidism or \< 3 months peripheral euthyroidism (normal fT3)
* Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min)
* Patients with liver cirrhosis (Child-Pugh class C)
* Co-administration of strong CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin and Nephazodon)
* Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation)
* Serum potassium \> 5 mmol/l
* Patients unlikely to comply with the protocol
Serum miR-122 as a Real-time Detection Biomarker of Drug-induced Liver Injury by Chemotherapy

This is an open , multicenter, interventional clinical trial to conform the role of of miR-122 a real-time detection biomarker of drug-induced liver injury by chemotherapy.

The endorsed standard serum biomarkers, like ALT, AST, total bilirubin, are not tissue-specific, and cannot detect drug-induced liver injury (DILI) at a very early stage, thus unable to properly guide risk assessment and patient management. miR-122 is a liver-enriched miRNA. Many studies have demonstrated that miR-122 is a sensitive and specific biomarker when DILI occurred. However, there is a lack of a standard quantification method for miR-122 and confirmatory studies using a comprehensive list of drugs and patients. The investigators have developed the miRNA-derived Fragment Length Polymorphism (miRFLP) assay for the simultaneous quantification of multiple miRNAs.The methodology improves detection reliability by eliminating intra-assay variables. In this study, the investigators will investigate the role of miR-122 as a real-time detection biomarker of drug-induced liver injury utilizing the miRFLP assay. In addition, the investigators will try to identify the normal physiological range of miR-122 in healthy population and the relationship of miR-122 and hepatic failure in patients of intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

For all the participants:

* Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment.
* Patients with liver disease:hepatitis B，hepatitis C，cirrhosis, hepatic failure and so on.

For patients in chemotherapy group:

* Life expectancy at least 12 weeks
* 40 patients received epirubicin-containing chemotherapY
* 40 patients received paclitaxel-containing chemotherapy
* Patients received carboplatin-containing chemotherapy.
* Patients with congestive heart failure
* Unstable angina pectoris
* Previous history of myocardial infarction within 6 month prior to study entry
* Uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia.

Exclusion Criteria:

* Patients previously received chemotherapy
The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK

This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.

After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome.

In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing DMEK

Exclusion Criteria:

* no specific exclusion criteria
The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy

The purpose of this study is to determine differences in lower extremity landing biomechanics and real-world physical activity between individuals with patellar tendinopathy compared to individuals without patellar tendinopathy,and to determine the acute effects of an isometric loading intervention on lower extremity landing biomechanics in individuals with patellar tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

The investigators will recruit a convenience sample of participants who meet the following overall criteria:

1. Age 15 and post-pubertal (confirmed by Pubertal Development Scale Questionnaire) - 28 years
2. Actively participating within an organized sport setting (high school, collegiate, club, competitive intramural sports) in their respective team's weekly training and competitions, quantified by a Tegner Activity Level Scale of at least 5.

Exclusion Criteria:

The following exclusion criteria will be applied to all participants:

1. Any anterior knee pain with no patellar tendon abnormality on ultrasound assessment.
2. History of any knee joint surgery ever.
3. History of other (non-knee) lower extremity surgery in the last 1 year.
4. History of lower extremity injury in last 6 months (other than patellar tendinopathy).
5. An injection (corticosteroids, plasma-rich-protein, etc.) to the patellar tendon in the last 3 months.
6. Known history of osteoarthritis or current symptoms related to osteoarthritis (i.e. stiffness, swelling).
7. Participation in formal rehabilitation for patellar tendinopathy in prior 3 months
8. Known neurological disorders, including: stroke, multiple sclerosis, ALS, diabetic neuropathy, epilepsy, traumatic brain injury resulting in loss of consciousness, concussion within the last 6 months, cranial neural surgery, balance disorders.
9. Use of pacemaker or another implantable electronic device.
10. History of cardiac arrhythmia or any cardiac condition.
11. History of psychiatric disorder. \*
12. History of cancer in the brain or thigh musculature.
13. Pubertal Development Scale Score \< 12 (Stages 1-4)

    * Note: Rationale for exclusion of individuals with a history of psychiatric disorders is that these individuals may have taken or be taking pharmacological agents that could affect pain or neuromuscular control.
Venous Thromboembolism in DM1

The risk for venous thromboembolism (VTE) in DM1 and in other inherited myopathies, which can lead to chronic immobilization, are unknown. The purpose of this study is to evaluate incidence of VTE in cohort of patients presenting with DM1 with a comparison to a group of other inheritable myopathies and to a community-based population.

A cohort of more that 2,800 adult patients admitted to our Institutions between January 2000 and November 2014 with genetically proven myopathy will be retrospectively included.

Any information relative to their demographic and genetic characteristics, their muscular functional status and the occurrence of VTE will be collected.

Statistical analysis will be performed to estimate the incidence of venous thromboembolism in this population, to identify predictors of VTE, and to compare its incidence to a community-based population.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Genetically proven myopathy
* Admission in our institutions from January 2000 to November 2014

Exclusion Criteria:

* Patient refusal
Long-Term Outcome Following the Treatment of Pediatric Scoliosis

Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.

The investigators hypothesize that sagittal alignment and thoracic volumes will predict successful treatment outcomes as measured by improved pulmonary function and health-related quality of life in adolescent idiopathic scoliosis patients at a minimum 20-year follow-up. Significant focus has been placed on the coronal plane in order to determine treatment indications for scoliosis, but with new understanding about the important of sagittal balance and pulmonary function, the treatment indications should be broadened. Thus, the investigators propose the following study to explore parameters associated with a durable and acceptable outcome following scoliosis treatment, minimizing the need for further surgery and to optimizing quality of life and pulmonary health. Beyond the standard radiographs and Scoliosis Research Society (SRS) scores, this study undertakes a comprehensive assessment of health-related quality of life, chest asymmetry and body satisfaction scoring, sagittal plane parameters, and 3D modeling of the childhood and current spinothoracic deformity. Thus, the investigators research team is uniquely poised to determine broader treatment indications for scoliosis. The overarching goal of this research effort is to determine new parameters based on thoracic volume and sagittal plane alignment in addition to coronal deformity in order to determine the appropriate treatment threshold for surgical intervention in children with adolescent idiopathic scoliosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adolescent idiopathic scoliosis made before age 18
* Diagnosis of adolescent idiopathic scoliosis prior to 1994
* Treatment with bracing, observation, or surgery prior to age 18 and 1994
* Adequate radiographs/medical records available from time of diagnosis

Exclusion Criteria:

* Neuromuscular scoliosis
* Syrinx
* Inadequate radiographs/medical records available from time of diagnosis
Financial Incentives for Maintenance of Weight Loss

This study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.

Study participants will be obese volunteers recruited from a major community-based weight loss program (Weight Watchers), who have lost at least 5kg during the 4-6 months prior to enrolling in the study. Among these participants, the following will be assessed: 1. The effectiveness of a daily lottery-based financial incentive, relative to the control group, on weight loss and weight maintenance; 2. The effectiveness of a direct payment incentive, relative to the control group, on maintenance of weight loss; 3. Assess the comparative effectiveness of lottery-based and direct payment financial incentives on weight loss and maintenance; 4. The degree to which weight loss is maintained in the intervention groups relative to usual care during the 6 months following cessation of the intervention will also be determined.

During Phase I, incentives will be provided to some study participants (direct payment and lottery arm) for the first 6 months and subjects will be followed for 6 more months to examine effects following cessation of incentives.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 30-80
* BMI between 30 and 45 prior to starting Weight Watchers
* Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling
* Stable health

Exclusion Criteria:

* Substance abuse
* Bulimia nervosa or related behaviors
* Pregnancy or breast feeding
* Medical contraindications to counseling about diet, physical activity, or weight reduction
* Unstable mental illness
* Screen positive for pathological gambling on the basis of the 10 item DSM-IV criteria (excluded if meets 5 or more criteria)
* Individuals unable to read consent forms or fill out surveys in English
Melatonin for Prevention of Metabolic Side Effects of Olanzapine

The purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.

Atypical antipsychotics including olanzapine are associated with significant metabolic side effects. Animal studies have suggested that melatonin might prevent some of the olanzapine-associated side effects. Melatonin is safe and is widely used as a sleep-promoting complement, and is not associated with side effects seen with other used drugs such as metformin.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 year
* First episode schizophrenia (DSM-IV-TR)
* Ability to take medicine orally
* Eligible for starting olanzapine

Exclusion Criteria:

* Married women who are at reproductive age
* History of taking olanzapine in the recent 3 months
* History of allergy or intolerance to olanzapine
* History of significant head trauma ( causing loss of consciousness more than 5 minutes or neurological or cognitive sequels)
* Liver, kidney, cerebrovascular or cardiovascular disease
* Diabetes, metabolic syndrome
* Cancer
* Using antiepileptic (other than benzodiazepines for sleep) , antihypertensive, anticoagulant, anti-platelet drugs
* Using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil)
* Delirium
* Need for administration of other antipsychotics
* Substance abuse
A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.

The effects of Glucocorticoïds and Infliximab have never been compared in early RA using MRI as primary outcome measure. In the current study, we compare the effects of MTX alone or in combination with intravenous (IV) methylprednisolone (MP) pulse therapy or IFX on MRI-detected synovitis, bone edema and erosive changes in early RA patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[SJC\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[TJC\] ≥ 8 \[by the 68 joints count\]) and had not been treated with MTX before.
* Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[SJC\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[TJC\] ≥ 8 \[by the 68 joints count\]) and had not been treated with MTX before.

Exclusion Criteria:

* Exclusion criteria included past/current history of tuberculosis, congestive heart disease, past treatment with GC for more than 3 months (and not during the 4 weeks before inclusion), previous treatment with more than 2 DMARDs, MTX, IV MP pulse.