cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease

Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson's disease in real world setting.

ABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan.

Participants will receive ABBV-951 as prescribed their physician and followed for 52 weeks.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with advanced Parkinson's disease (aPD).
* Prescribed ABBV-951 as physicians' decision according to the approved label for treatment of aPD.
* Given informed consent (or by her/his legal representative, if it's a requirement from the participating hospital/clinic) for participating this study.

Exclusion Criteria:

* Prior treatment with ABBV-951 for PD.
* Currently participating in interventional clinical trials.
French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal incontinence.

This study will provide additional data about safety and effectiveness of the usage of InterStim system in fecal incontinence environment and at the same time will confirm that results from clinical trials can be transposed to clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patient willing to sign the Data Release Form stating the non opposition to the study conduct;
* Patient able to understand information given by the investigator in terms of data collection and publication;
* At least 18 years old or older.
* Patient indicated to sacral neuromodulation testing with InterStim® system.

Exclusion Criteria:

* Replacement of an existing sacral neuromodulation system (implanted before inclusion period) without any evidence of benefits during a testing period.
* Patient unwilling to comply to data collection and publication rules.
Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair

The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.

Preoperative measurements, performed at baseline:

* Patient characteristics (age, BMI, smoking, obstetric history)
* Physical examination including POP-Q score. The genital hiatus (gh) at rest (as part of the POP-Q) will be used to assess the wideness of the vaginal introitus.
* Pelvic Floor Distress Inventory (PFDI-20) questionnaire and Patient Global Impression of Severity (PGI-S)
* Pelvic Floor Ultrasound 2DStudy measurements;
* Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-ir), Dutch Perineal Support Questionnaire (DPSQ), General Quality of Life (EQ-5D-5L), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)
* Patient and surgeons considerations with respect to level III repair;

Postoperative measurements:

* Regular physical check-up will be at 4-8 weeks after procedure.
* Physical examination including POP-Q score
* Patient Global Impression of Improvement score (PGI-I)
* Pelvic Floor Ultrasound 2D
* iMCQ, iPCQ, EQ-5D-5L questionnaire

Extra follow up:

* Physical check-up 12 \& 24 months after surgery:
* Physical examination including POP-Q score
* Pelvic Floor Ultrasound 2D
* PFDI-20, PGI-I, DPSQ, PISQ-ir, iMCQ, iPCQ, EQ-5D-5L questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. Female patient \>18 years of age
2. Complaints of pelvic organ prolapse
3. Indication for prolapse surgery (level I and/or level II repair)
4. Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm

Exclusion Criteria:

1. Unable to understand the Dutch language
2. Pregnancy at baseline or intendancy to become pregnant during the study period
3. Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)
4. Unwilling and / or incapable of giving informed consent
Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action

The objective of this study is to measure the energy value of pistachios in the human diet and study molecular mechanisms that may help explain the beneficial health effects of pistachios.

Previous studies have suggested that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. However, studies of pistachios are extremely limited. The aim of this study is to determine the energy value of pistachios in the human diet and to probe mechanisms by which pistachios impart health benefits. The metabolizable energy value of pistachio nuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of pistachios than simply calculating energy value based on Atwater factors. In addition to determining the energy value of pistachios, we will evaluate the effects of pistachio-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by pistachio consumption.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 65 years at beginning of study
* BMI between 20 and 38 kg/m2
* Fasting glucose \< 126 mg/dl
* Blood pressure \< 160/100 (controlled with certain medications)
* Fasting total blood cholesterol \< 280 mg/dl
* Fasting triglycerides \< 300 mg/dl

Exclusion Criteria:

* Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* History of bariatric or certain other surgeries related to weight control
* Smokers or other tobacco users (during 6 months prior to the start of the study)
* Antibiotic use during the intervention or for 3 weeks prior to any intervention period
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
* Known (self-reported) allergy or adverse reaction to pistachios or other nuts
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy

The study aims to predict the failure of High-flow Nasal Cannula oxygenation therapy by ultrasound evaluation of diaphragm and intercostal muscle contraction during the first 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* needing High-flow Nasal Cannula oxygenation therapy

Exclusion Criteria:

* received mechanical ventilation, including invasive or noninvasive ventilation within one month prior to enrollment
* history of neuromuscular disorders (e.g., myasthenia gravis, Guillain-Barre syndrome);
* immediate endotracheal intubation is required (life-threatening hypoxemia)
* extensive damage to the thoracic skin (e.g., burns) unable to undergo ultrasonography
* pregnancy
* attending physician deemed it inappropriate to participate in the trial.
Mbarara Acute Heart Failure Registry

This is a prospective cohort to describe clinical characteristics, predictors of poor outcomes both during hospitalization and at home, functional status, and quality of life among patients aged 13 years or more, consecutively admitted with acute decompensated heart failure at Mbarara Regional Referral Hospital.

This is a prospective observational cohort study to collect comprehensive data of heartfailure patients during and after hospitalization for acute heart failure at Mbarara Regional Referral Hospital (MRRH), Uganda. The investigators will collect sociodemographic, clinical, quality of life, functional status, and clinical cardiovascular disease measures during hospitalization and follow up for up to 1 year from the date of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with a confirmed clinical diagnosis of acute heartfailure aged 13 years or above at Mbarara Regional Referral Hospital, Uganda

Exclusion Criteria:

* Body swelling from kidney disease, liver disease or malnutrition.
* Acute kidney disease with no previous history/documentation of heart disease.
* History suggestive of chronic kidney disease with no previous history/documentation of heart disease.
* History suggestive of chronic liver disease with no previous history/documentation of heart disease.
Probiotics in Newly Recognized Type 1 Diabetes

They are major genera of bacteria that make up the colon flora in human, constitute intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal barrier and modulate local and systemic immune responses. Changes in gut microbiota can influence the immune system by increasing gut permeability, intestinal inflammation, and impaired oral tolerance in type 1 diabetes.Taken together, the data imply that bacteriotherapy may potentially be used as a tool to modulate the immune system for preventing islet destruction. Supplementation of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 improved blood glucose control in normoglycaemic pregnant women and reduced the frequency of gestational diabetes mellitus

Aim of the study:

The effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomized, double blind, placebo-controlled trial.

Primary end point:

Area under the curve (AUC) of c-peptide level during during fasting and at 30,60,90,120 min following the start of the meal

Intervention:

Included patients will be randomly assigned to receive a combination of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 (Probiotics Group ) or placebo (Placebo Group ) during six months.

The expected results:

Beneficial effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell function shown in the properly performed, methodologically accurate study would create a rationale for its routine use in patients with newly diagnosed type 1 diabetes.

Intervention:

At the 6-month follow-up visit will be evaluated adherence and occurrence of side effects of the study procedure. The outcome measures will be assessed at the beginning of the study, and at the 6 and 12-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes confirmed by clinical history and the presence of at least one positive autoantibody: anti-glutamic acid decarboxylase (anti-GAD), islet antigen 2 (IA2), islet cell antibody ( ICA)
* Fasting c-peptide level \>/= 0.4 ng/ml
* The diagnosis of diabetes during the last 60 days
* Consent to participate in the study

Exclusion Criteria:

* Antibiotic-therapy during last 4 weeks
* Taking of probiotics during last 2 weeks
* Intestinal infection during last 2 weeks
* Intestinal chronic diseases
Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia

A 48-week, open label, non comparative prospective trial in stable chronic human immunodeficiency virus-infected patients having achieved complete virological suppression for more than 24 weeks (human immunodeficiency virus-1 RNA \<50 c/ml) switching from an antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at screening, baseline, weeks 4, 12, 24, and 48.


Eligibility Criteria:
Inclusion Criteria:

* Human immunodeficiency virus-1-infected subjects with age ≥18 years old
* Hip or spine T-scores between \< -1.0 and \>-2.5 by dual-energy X-ray absorptiometry (in the previous 24 weeks)
* Stable antiretroviral treatment based on tenofovir and lamivudine or emtricitabine and boosted protease inhibitor for at least 24 weeks.
* Having plasma human immunodeficiency virus-1 RNA \<50 copies/mL for at least the previous 24 weeks, including at least two samples.

Exclusion Criteria:

* Pregnancy, breast-feeding status or plans for pregnancy in the short term
* Primary genotypic resistance mutations and/or previous virological failures to atazanavir or lamivudine/emtricitabine
* Chronic hepatitis B infection
* Patients with indication for therapy for the prevention of bone fractures
* 25-OH vitamin D deficiency (\< 10ng/mL)
* Hypogonadism (low total testosterone according to local reference range)
* Hypothyroidism (low T4 and increased thyroid stimulating hormone levels according to local reference ranges)
* Hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges)
* Having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more)
* Using anti-resorptive therapy (Calcium and vitamin D supplements are encouraged but not mandated)
* Body mass index lower than 19
The Application of Eye-Tracking Technology in Perioperative Management and Education

The goal of this observational study is to explore the value of eye-tracking technology in perioperative management and teaching. The study aims to understand how eye-tracking can help analyze the attention distribution of clinicians during perioperative procedures and optimize workflows for improved safety and teaching outcomes.

The main questions it seeks to answer are:

How does eye-tracking technology reveal the focus distribution patterns of experienced and novice clinicians in perioperative scenarios? Can visualizing expert clinicians' eye movement patterns improve the learning outcomes and operational skills of medical students?

Participants include anesthesiologists and medical students involved in perioperative management training. Eye-tracking data, such as fixation duration, fixation count, and heatmaps, will be collected during surgical and training scenarios. The study will analyze correlations between attention distribution and operational performance. This research will provide insights into optimizing perioperative safety and revolutionizing medical education using objective attention data.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologists, including senior physicians and junior doctors.
* Medical students undergoing perioperative management training.

Exclusion Criteria:

* Individuals with ophthalmological conditions that affect eye movement function.
* Participants who fail to complete the full experimental protocol.
Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium levels in primary hyperparathyroidism.

To conduct a double-blinded, placebo-controlled, randomized intervention study to investigate whether mineralocorticoid receptor (MR) antagonism, alone or in combination with cinacalcet, is an effective therapy for primary hyperparathyroidism (P-HPTH).

Hypothesis: MR antagonism, as a monotherapy or in combination with a calcimimetic, is a mechanism to lower parathyroid hormone (PTH) in primary hyperparathyroidism (P-HPTH).

Study Design: Sixty subjects with P-HPTH will be enrolled to randomly receive eplerenone (a potassium-sparing diuretic that directly blocks the MR), amiloride (a potassium-sparing diuretic that does not directly block the MR), or placebo for 4 weeks. Thereafter, all subjects will receive cinacalcet therapy (a calcimimetic that lowers PTH) in addition to their randomized intervention for an additional 2 weeks.

Anticipated Results: In this proof-of-concept study, eplerenone therapy will lower PTH, serum calcium, and markers of bone resorption in P-HPTH, when compared to placebo. The PTH response to amiloride will resemble that of placebo, suggesting that the eplerenone mediated reductions in PTH are specific to interactions with the MR. Combination therapy with eplerenone + cinacalcet will result in additive or synergistic reductions in PTH, when compared to placebo + cinacalcet or placebo + amiloride.

Implications: MR antagonism (alone or in combination with cinacalcet) may be a mechanism to lower PTH and calcium in P-HPTH, thereby identifying a new potential option in the limited medical therapies for P-HPTH.

Eligibility Criteria:
Inclusion Criteria:

* physician diagnosis of active P-HPTH (Serum calcium \> upper limit of reference range and serum PTH \> ULRR; or Serum Calcium \> ULRR AND serum PTH \> 30 pg/mL; or Serum Calcium within 0.2 mg/dL of the ULRR and PTH\>ULRR).
* negative pregnancy test in women aged 18-45

Exclusion Criteria:

* estimated glomerular filtration rate \< 60mL/min/1,73m2
* serum potassium \> 5.0 mmol/L
* age \<18 or \>80 years
* diabetes that is not well controlled (HbA1c\>8%)\\
* liver failure
* heart failure
* history of myocardial infarction or stroke
* active use of lithium
* active chronic inflammatory conditions (such as inflammatory bowel disease, rheumatoid arthritis, sarcoidosis)
* initiation within 3 months of bisphosphonates or cinacalcet
* need for imminent parathyroidectomy (within the next 6-8 weeks) as determined by their endocrinologist or surgeon
* absolute serum calcium \>13.0 mg/dL
* positive pregnancy test on any of the study visits for women ages 18-45.
Energy Expenditure & Activity During & After Exercise-Induced Weight Loss

This project is aimed at determining whether an exercise-based weight loss intervention causes a compensation in some component of energy expenditure such that the increase in measured energy expenditure is less than the added exercise. The study will compare two separate exercise interventions to determine if this is influenced by exercise intensity.

The primary aim of this proposed study is to determine how total daily activity thermogenesis (TDAT) and total daily energy expenditure (TDEE) are regulated in obese humans attempting to lose weight and maintain weight loss through exercise. Two exercise interventions will be compared; a structured aerobic exercise program and a walking program. exercise activity thermogenesis (EAT) will be verified, and non-exercise physical activity (NEAT), total daily activity thermogenesis (TDAT), and TDEE will be measured using state-of-the-art technologies. Subjects will be studied during a 6 month intervention period and then during a 6 month follow-up period. It is hypothesized that the walking program will have more favorable effects on TDAT and TDEE during both the intervention and follow-up periods. If the investigators hypotheses are correct, then data from the proposed study could be used to improve the effectiveness of exercise-based weight loss and weight loss maintenance programs.

Eligibility Criteria:
Inclusion Criteria

* Body mass index (BMI) 30-35.0 kg/m2
* Age 18-45 years
* Weight stable (\<2 kg weight fluctuation during previous 6 months)
* No regular exercise (\> 1 bout of exercise/wk or participation in any sporting activities \> 1 hr/wk)
* No self-report of acute or chronic disease (diabetes, heart diseases, and joint problems in particular)
* No current use of prescribed medications
* No plans to relocate within the next year
* No plans for extended travel (\> 1 week) within the next 6 months
* No tobacco use

For Females:

* No evidence of amenorrhea (Regular menstrual cycles of 21-35 days)
* Pre-menopausal status (self-report, to be confirmed during screening)
* Pregnancy or lactating within the past year
* No pregnancy or planned pregnancies; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control.

Exclusion Criteria:

* Claustrphobia;
* Any contraindication(s) to \> MRI, e.g. aneurysm, cochlear implant, cardiac pacemaker, or implantable cardiac defibrillator, artificial heart valve, metallic stents, any implantable devices or shunt, weight less than 300 lbs;
* Left Handed.
The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.

There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.

This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.

The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.

The results will be compiled from objective data and patient and physician interviews.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent.

Exclusion Criteria:

1. Hypersensitivity to benzodiazepines
2. Hypersensitivity to benzyl alcohol
3. Hypersensitivity to ketamine
4. Hypersensitivity to opiates
5. Pregnancy
6. Uncontrolled hypertension
7. Myocardial infarct in the last 6 months
8. CVA
9. Chronic pulmonary disease
10. Renal failure
11. Chronic liver disease (CHILD B or C)
12. Elevated ICP, cerebral hemorrhage or cranial SOL.
13. Hypovolemic shock
14. Glaucoma
15. Mental illness
16. Drug or alcohol addiction