cyrilzakka/clinical-trials huggingface dataset:
Tracking Response to Antidepressants in Advance of Investigational Trials, Relapse Study

TRAIT-RS is an observational study to evaluate ongoing treatment response stability to standard of care antidepressant treatments (ADTs) among individuals who met criteria for Major Depressive Disorder (MDD) and completed the Tracking Response to Antidepressants in Advance of Investigational Trials (TRAIT) study (NCT04748276).


Eligibility Criteria:
Inclusion Criteria:

* Participant has completed the TRAIT study and, in the opinion of the investigator, would benefit from ongoing depression monitoring and/or ADT treatment.
* Participant has signed an ICF prior to any study-specific procedures being performed.
* Participant is male or female of age ≥ 18 years.
* Participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an ADT.

Exclusion Criteria:

* Participant is pregnant, breast-feeding, or planning to become pregnant.
* A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which, in the opinion of the investigator, may impact participant safety or study results.
* Participant has a history of any psychiatric condition other than MDD, which, in the opinion of the investigator, is primary or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
* Any participant who represents an acute suicidal risk in the opinion of the investigator.
* Moderate or severe substance use disorder within 90 days prior to screen according to DSM-5 criteria that, in the opinion of the investigator, could pose undue risk to the participant or compromise the study.
* Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
A Randomized Controlled Trial of Menopausal Tool/App for Women

The purpose of this study is about assessing the utilization of a mobile phone application (app), designed to improve the menopause experience of midlife women experiencing related symptoms and its association with menopause-related health care utilization


Eligibility Criteria:
For Patient Enrollment:

Inclusion Criteria:

* Women between the ages of 45 and 55
* English speaking (app only available in English)
* Able to provide informed consent
* Experiencing menopause symptoms, which will be assessed by a Menopause Rating Scale (MRS) survey score of ≥ 5
* Has an upcoming Mayo Clinic primary care appointment within 3 weeks of the enrollment and the MRS survey

Exclusion Criteria:

* Lack of willingness to engage with app
* Inability to provide informed consent
Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis

Intradialytic hypotension (IDH) is defined as less than the 5th percentile of SBP measurements and is associated with clinical symptoms, such as abdominal pain, nausea, vomiting, muscle cramps, restlessness, light-headedness, syncope, and anxiety. In adults There is no consensus definition of IDH, however, according to the Kidney Disease Outcomes Quality Initiative and European Best Practice Guidelines, IDH is defined as a decline in systolic blood pressure ≥20 mmHg or a decrease in a mean arterial pressure by 10 mmHg and associated with clinical events like abdominal pain, nausea, vomiting, muscle cramps, dizziness, fatigue, and restlessness.

IDH occurs in response to the reduction in blood volume (BV) during ultrafiltration (UF) and subsequent poor compensatory mechanisms due to abnormal cardiac function (left ventricular dysfunction, chamber remodeling, congenital heart diseases, and arrhythmias) or autonomic or baroreceptor failure. To maintain volume status, the body shifts fluid from the interstitial space to the intravascular space and increases heart rate, contractility, and vascular tone.

Plasma refilling, another essential factor in maintaining euvolemia, depends on oncotic, osmotic, and hydraulic gradients across vascular beds. If UF rates surpass plasma refilling rates, intravascular volume falls and hypotension results. Hematocrit levels, tissue hydration and arterial vasoconstriction all promote plasma refilling rates. Alterations in these factors during dialysis decrease the plasma refilling rate, resulting in hypotension.

Aim of The Work:

The aim of this study is to assess and evaluate the efficacy and safety of L Carnitine in the prevention of intradialytic hypotension in pediatric patients on regular hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6-18 years
* Patients on hemodialysis for 3 months or longer
* Patients on hemodialysis frequency 3 times weekly (with the same dialysate concentration and temperature)
* Patients who had two or more episodes of intradialytic hypotension during dialysis (less than the 5th percentile of SBP measurements and is associated with clinical symptoms) in the last 3 months.

Exclusion Criteria:

* Patients with life expectancy \< 3 months
* Patients with known hypersensitivity to L carnitine
* Patients received L carnitine in the previous 6 months
Lycopene in Preventing Prostate Cancer in Healthy Participants

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.

PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.

OBJECTIVES:

Primary

* Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.

Secondary

* Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.
* Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.

OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.

* Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
* Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
* Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.

PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy participants
* No existing prostate disease

PATIENT CHARACTERISTICS:

* Able to supply blood and urine samples
* Able to answer demographic and dietary recall questionnaires
* No hospital inpatients
* Not allergic to tomatoes or tomato products
* Not abusing alcohol or non-prescribed drugs
* No existing gastrointestinal disease or cancer

PRIOR CONCURRENT THERAPY:

* At least 2 weeks since prior lycopene (in supplement form)
* No concurrent participation in another clinical trial
Major Pelvic Hemorrhage in Complex Surgery

Hemorrhage is a challenging complication of pelvic surgery. In this study, the investigators aimed to analyze the causes, management, and outcomes of major pelvic hemorrhage in patients undergoing complex abdomino-pelvic surgery. Participants who had a major intraoperative pelvic hemorrhage during complex abdomino-pelvic surgery at 11 tertiary referral centers were included. Participant characteristics, causes of hemorrhage, management strategies, and outcomes including morbidity and mortality analyses were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had major pelvic bleeding during complex abdominopelvic surgery
* Patients operated in hospitals where over 225 colorectal cases were performed every year

Exclusion Criteria:

* Patients operated for palliative intent
Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety

This protocol will test the hypothesis that Acceptance and Commitment Therapy (ACT) is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Participants should expect their participation in the study to last 9-12 months.

The study's major theme is "to examine the efficacy of a brief Acceptance and Commitment Therapy (ACT) intervention in treating perinatal anxiety symptoms, as compared to a supportive control condition."

The perinatal and postpartum periods are known to be a vulnerable time for the development of mental health symptomatology, with approximately 7% of women developing postpartum depression in the first three months following childbirth. One known predictor of postpartum depression is perinatal anxiety and distress. The impact of postpartum depression extends beyond the mother, whose distress and daily functioning are affected, with adverse effects on infant development and care. The need for interventions and preventive interventions has been widely indicated for over two decades.

This protocol will describe two conditions, the effects of which will be contrasted to determine the efficacy of ACT in treating anxiety and depressive symptoms among perinatal women. The ACT condition will be compared to a supportive psychoeducation intervention. The effects of the intervention will be determined in terms of self-report measures (anxiety and depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews (depression, anxiety). The impact of trauma history and psychodiagnostic history will be examined as moderating factors and/or covariates in the examination of the intervention's efficacy.

This protocol will test the hypothesis that ACT is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Second, the investigators will examine the intergenerational impact of the intervention on the offspring via offspring birth outcomes, as reported in the electronic medical record. Finally, the investigators will explore mediators and moderators of the treatment outcomes. This work will advance the understanding of the impact of brief interventions on perinatal well-being and improve the ability to disseminate empirically supported interventions for pregnant mothers.

Eligibility Criteria:
Inclusion Criteria:

1. Adult women (ages 18-45) who are between 18-26 weeks pregnant
2. Fluency in English
3. Ability to give informed consent and comply with study procedures (including phone and internet access)
4. Elevated GAD-7 score (10+)
5. Women must be receiving prenatal care
6. Singleton pregnancy

Exclusion Criteria:

1. Prisoners
2. Inability to give informed consent and comply with study procedures
3. Past/current mania, past/current psychoses (assessed with Psychosis Screening Questionnaire)
4. No therapy appointments in last 60 days (not currently in psychotherapy).
Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery

The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip replacement


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Subjects undergoing elective total knee or hip replacement or a revision of at least one component of a total knee or hip replacement

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Known or suspected, acquired or bleeding or coagulation disorder in the subject or a first degree relative
* Active bleeding or at high risk for bleeding.
* Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days other than the elective knee/hip surgery
* Active hepatobiliary disease
* Hemoglobin \<9 g/dL
* Platelet count \<100,000/mm3
* Creatinine clearance \<30 mL/min
0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia

Chlorhexidine is a effective strategy in reducing ventilator associated pneumonia. However, it is unclear if prophylactic 0.12% chlorhexidine oral rinse can reduce the risk of non-ventilator hospital-acquired pneumonia among hospitalized patients.

Participants will be classified into three groups, applied twice a day by care givers. Oral colonization will be tested in the baseline, day-3, day-7, and at the discharge. Quantitation of colonization of the oral cavity by oral rinses and respiratory pathogens were measured.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients \> 20 years old without ventilator

Exclusion Criteria:

* known hypersensitivity to or intolerance of Chlorhexidine or Listerine
Magnesium Sulfate in Obese Preeclamptics

The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

Magnesium sulfate is generally given to patients to protect the mother against seizures in the case of preeclampsia. Different hospitals in the United States use different doses of magnesium sulfate. Participants will receive one of two accepted doses of magnesium sulfate for preeclampsia. The dose is usually 4g - 6g at the start, with another dose of 2-3 g every hour until 24 hours after delivery. Participants will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete. Participants will receive magnesium sulfate in the course of their normal clinical care whether or not they participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are ages 18-45
* 32-42 weeks' pregnant
* Prescribed magnesium sulfate for preeclampsia
* BMI ≥35 kg/m2

Exclusion Criteria:

* Pregnant women \< 32 weeks' pregnant
* Women who are on dialysis
Effect of Litramine on Fat Excretion

The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.


Eligibility Criteria:
Inclusion Criteria:

* BMI 20-30 kg/m2
* Accustomed to 3 main meals/day
* Commitment to avoid the use of other weight management products during study
* Females' agreement to use appropriate birth control methods during the active study period
* Self-reported regular bowel movement (1-2 times per day)
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

* Known sensitivity to the ingredients of the device
* Diabetes mellitus (type 1 or 2)
* History or clinical signs of endocrine disorders
* Clinically relevant excursions of safety parameter
* Current use of anti-depressants
* Presence of acute or chronic gastrointestinal disease
* Uncontrolled hypertension (more than 160/110 mm Hg)
* Stenosis in the gastrointestinal tract
* Bariatric surgery
* Abdominal surgery within the last 6 months prior to enrollment
* History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
* Other serious organ or systemic diseases such as cancer
* Any medication that could influence gastrointestinal functions
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment
* History of abuse of drugs, alcohol or medication
* Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation
Soccer Play in Children With Cerebral Palsy

1. To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function in children with cerebral palsy
2. To find out if the leisure activity (soccer) increase the quality of life, motor function, gait function etc..
3. Safety of soccer play in children with cerebral palsy

1. 1 hr of play once a week for 8 weeks of soccer program was done in the experimental group.
2. Both the experimental and control group were children with ambulatory cerebral palsy aged 5 to 12 years.
3. Several outcomes were measured before and after the program

   * pulmonary function test including FVC, FEV1
   * GMFM-88, PBS, walking test, muscle power sprint test, timed up and go, gait parameters
   * Child Health Questionnaire Parent Form 50 (CHQ-PF50)
   * KIDSCREEN
4. An accelerometer was worn before the program and during the program for a week (experimental group only)

Eligibility Criteria:
Inclusion Criteria:

* children with cerebral palsy
* GMFCS level I-II
* 5-12 years old

Exclusion Criteria:

* acute disease, less than 6 months from the surgery
* the behavioral or psychiatric problem that hinders group activity
* intellectual disability to do the questionnaire
* who do not participate in the class well (absent more than 3 times)
Adjunctive Study of AL-37807 Ophthalmic Suspension

The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma
* Ocular hypertension
* Must have been on Xalatan for at least 3 months
* VA not worse than 0.60
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age related
* Other protocol-defined exclusion criteria may apply
The Effects of Pentoxifylline on PAI-1 in an Obese Population

PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human subjects.

Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8.

Eligibility Criteria:
Inclusions: 1. A Body Mass Index of ≥ 30.0 2. Age 21 or older 3. Few or no medical problems 4. PAI-1 level ≥ 10 ng/dl

Exclusions: 1. Cigarette use 2. Present use of angiotensin converting enzyme (ACE) Inhibitors 3. Recent cerebral and/or retinal hemorrhage 4. Intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine 5. Presently on warfarin therapy 6. Pregnancy or breast-feeding 7. Recent surgery 8. Recent diagnosis/treatment for peptic ulcer
Randomised Trial of NBI for Adenoma Detection

Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors detect more patients with at least one pre-cancerous polyp (adenoma) than conventional colonoscopy using white light alone?

May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability.

Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce the death rate from colorectal cancer. However, despite meticulous examination there is a "miss rate" for adenomas at colonoscopy which ranges from 66-25% in back-to-back colonoscopy studies. The nature of the polyps which as well as being pedunculated (cherry like) can be flat or depressed making them difficult to see, which may contribute to the "miss rate".

The factors, which influence the endoscopist detection are not well studied. Polyp detection rates wary widely, even among experts. Techniques that highlight lesions have advanced in recent years. Chromoendoscopy, the current gold standard technique, relies on spraying dye on the bowel lining, has been shown to help pick up more pre-cancerous polyps in two of three studies; however it is not widely used as it is time consuming and requires extra equipment and training. Narrow band imaging (NBI) is a technique that relies in light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up adenomas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. Autofluorescence endoscopy uses short wavelength light and 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.

We aim to see if NBI is better than standard colonoscopy for detecting precancerous polyps. This is likely as it is similar to chromoendoscopy which is already shown to help. If a polyp is found we will use other types of endoscopy, particularly NBI with magnification and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous polyps.

May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability. No additional data collected.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age, patients in a high risk group for adenomas

Exclusion Criteria:

* patients with known colitis or polyposis, unable or unwilling to give informed consent