cyrilzakka/clinical-trials huggingface dataset:
Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.

This study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. Male or female subjects aged between 19 and 60 years will participate in the study. The study design is an opne-label, randomized, multiple dose paraller study. The patients were randomly assigned to DWJ1230 or DWB2001. It is intended that a total of 60 subjects will be enrolled to ensure that at least 24 subjects will complete the study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic functional Diarrhea. (included Irritable Bowel Syndrome with perdominant diarrhea(IBS-D)).
* Male or Female subjects aged between 19 and 60 years at screening.
* Body Mass Index(BMI) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information.

Exclusion Criteria:

* No history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer.
* Identified or strongly suspected organic cause to diarrhea.
* Celiac disease or Intestinal malabsorption, Unspecified intestinal malabsorption.
* History of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product.
* Constipation, Iron deficiency anaemia, Hypocalcaemia, Osteoporosis.
* Known domestic, leisure or professional exposure to elemental impurities.
* Women who are breastfeeding or are planning to become pregnant during the study.
* Positive pregnancy test at screening.
* Presence of clinically significant physical, laboratory, vital signs, or ECG findings.
* Blood lead level \> 3.3 μg/dL(=33.0 μg/L) at screening.
* galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption.
* Receipt of any investigational agent or study drug within 4 weeks prior to screening.
* Patients with history of alcohol or drug abuse.
* Subjects who donated whole blood within 2 months, donated blood components within 1 month.
* Subjects who have participated and taken investigational drug within 1 month prior to study drug administration.
* Subjects who the investigator considers inappropriate for the study due to other reasons.
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency

This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

All subjects:

* In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values (except for values related to hepatic insufficiency).

Hepatic impaired subjects:

* A Child-Pugh Classification score clinically determined as Class A, Class B, or Class C.
* Absolute neutrophil count (ANC) \> 1000 cells/mm3
* Hemoglobin \> 9 mg/mL
* Platelet count \> 50,000/mm3 at screening and baseline
* Serum creatinine ≤ 2.0 x ULN
* Free of significant medical disorders unrelated to the subject's hepatic disorder

Exclusion Criteria:

All subjects:

* Significant illness, including infections, or hospitalization within 4 weeks prior to dosing (hospitalization is allowed for hepatic impaired subjects if related to liver disease). Invasive systemic fungal infections need to be fully resolved prior to study entry.
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug (everolimus) or drugs similar to the study drug (other mTOR inhibitors, e.g., rapamycin or temsirolimus).
* Active bleeding during the last 28 days prior to dosing, including variceal bleeding.
* Except for hepatic impairment, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study.
* Use of tobacco within 7 days prior to dosing or during the study.
* Consumption of alcohol within 3 days prior to dosing or during the study.
* Consumption of grapefruits, grapefruit juice, Sevilla oranges, starfruit or related foods within 7 days prior to dosing or during the study period.
* Use of any drugs known to affect CYP3A4 or PgP, including both inhibitors and inducers, within 7 days prior to dosing or during the study.

Hepatic impaired subjects:

* Symptoms or history of Grade 3 or 4 hepatic encephalopathy within 4 weeks of study entry.

Other protocol-defined inclusion/exclusion criteria may apply
Nitrocamptothecin in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer.

OBJECTIVES: I. Assess the toxicity and efficacy of nitrocamptothecin in patients with locally recurrent or metastatic breast cancer. II. Determine the duration of response and time to treatment failure in these patients with this treatment regimen. III. Correlate serum levels of nitrocamptothecin and its lactone metabolite with response and toxicity in these patients. IV. Correlate topoisomerase I and II levels with toxicity and response in these patients.

OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for 8 weeks. Patients achieving complete or partial response or stable disease continue therapy in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 8-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally recurrent or metastatic breast cancer not amenable to surgery or radiotherapy Measurable or evaluable disease No prior radiotherapy to only target lesion Disease progression after no more than 2 prior chemotherapy treatments for metastatic disease No active CNS metastasis Prior CNS metastasis allowed with no evidence of active disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Hemoglobin greater than 9.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be able to have daily fluid intake of at least 3 liters No concurrent active infection No other prior malignancy in past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan, topotecan, or other camptothecin analogues At least 3 weeks since prior chemotherapy Endocrine therapy: No concurrent corticosteroids to control CNS disease Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery
The Influence of Caffeine Supplementation on Specific Performance and Training Activities

The purpose of this study is to verify the effect of acute caffeine (CAF) and placebo (PLA) supplementation on physical capacity and discipline-specific exercise performance in athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Caffeine (CAF) is often proposed as an ergogenic agent, especially during high-intensity efforts. CAF supplementation may reduce effort-induced multi-faceted symptoms of fatigue and can improve psychomotor functions (like agility or decision-making processes), which is required during the intermittent high-intensity efforts in combat sports and speed-strength disciplines. Moreover, it is suggested that CAF treatment is associated with increased glycolytic activity during simulated or real training/competition bouts, which results in performance and physical capacity improvement.

However, there are hardly any data on the individual CAF-induced and dose-dependent changes in physical capacity and discipline-specific performance in combat sports and speed-strength disciplines. Therefore, the study aims to examine the effect of acute, different-dose CAF ingestion on physical capacity and discipline-specific performance in combat sports and speed-strength athletes, in a randomized, double-blind, placebo-controlled crossover trial.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate,
* a current medical clearance to practice sports,
* training experience: at least 2 years,
* minimum of 4 workout sessions (in the discipline covered by the study) a week.

Exclusion Criteria:

* current injury,
* any health-related contraindication,
* declared general feeling of being unwell,
* unwilling to follow the study protocol.
68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-RM2 PET/CT for detection of intermediate and high-risk prostate cancer prior to prostatectomy.

OUTLINE:

Patients receive 68Ga-RM2 intravenously (IV). Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.

After completion of study, patients are followed up at 24-48 hours and within 3-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma
* Planned prostatectomy with lymph node dissection
* Intermediate to high-risk disease (as determined by elevated PSA \[PSA \> 10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
* Able to provide written consent
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent)
* Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to the 68Ga-RM2 PET

Exclusion Criteria:

* Inability to lie still for the entire imaging time (approximately 30 minutes)
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.


Eligibility Criteria:
Key Inclusion Criteria:

* Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
* Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated LMP.
* Presence of MS.

Key Exclusion Criteria:

- Pregnancies will be excluded from this study if they are exposed to any known teratogens from the beginning of baseline through the end of the relevant exposure window.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
MINIject Global Long-Term Follow-up Study

The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient who received a MINIject glaucoma implant within a prior clinical study
* Patient continues to have MINIject implanted at the point of enrolment
* Patient must provide written informed consent to participate

Exclusion Criteria:

* Individuals under tutorship or trusteeship
* Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Active choroidal neovascularization (CNV)
* Active macular edema (ME)
* Rubeosis iridis/neovascular glaucoma.
* Proliferative diabetic retinopathy requiring vitrectomy.

Exclusion Criteria:

* wet Age-related macular degeneration
* pathologic myopia
* pseudoxanthoma elasticum
* diabetic macular edema
* retinal vein occlusion
* \< 18 years of age
* History of hypersensitivity to ranibizumab
* Use of any systemic anti-angiogenic drugs 3 months before inclusion
* Women of child-bearing potential and Pregnant or nursing (lactating) women.
* Active or suspected ocular infection
High-Load Blood Flow Restriction (BFR) Training May Decrease Anaerobic Fatigue in Distance Runners

This study investigates the effects of high-load BFR training on anaerobic performance and fatigue resistance in distance runners. To determine whether adding BFR to isokinetic resistance training improves anaerobic performance and 5-10 km running times in runners. Forty-two runners were randomized into BFR (n=21) and control (n=21) groups. Both groups followed an identical 8-week isokinetic training protocol twice weekly. The BFR group performed exercises with arterial occlusion pressure set to 80% of the measured occlusion pressure. Anaerobic performance was assessed via the Wingate test, and 5 km and 10 km running times were recorded before and after the intervention. Statistical analyses compared pre- and post-training performance within and between groups.

Blood flow restriction (BFR) training is increasingly used to enhance athletic performance, but its effects on anaerobic fatigue in distance runners remain unclear. This study investigates the effects of high-load BFR training on anaerobic performance and fatigue resistance in distance runners.To determine whether adding BFR to isokinetic resistance training improves anaerobic performance and 5-10 km running times in runners.

Forty-two runners were randomized into BFR (n=21) and control (n=21) groups. Both groups followed an identical 8-week isokinetic training protocol twice weekly. The BFR group performed exercises with arterial occlusion pressure set to 80% of the measured occlusion pressure. Anaerobic performance was assessed via the Wingate test, and 5 km and 10 km running times were recorded before and after the intervention. Statistical analyses compared pre- and post-training performance within and between groups.

Eligibility Criteria:
Inclusion Criteria:

* The absence of cardiovascular or musculoskeletal conditions,
* No recent resistance training,
* Running more than 20 kilometers per week.

Exclusion Criteria:

* Having a cardiovascular or musculoskeletal condition,
* Having done recent resistance training,
* Running less than 20 kilometers per week.
The Effect of Caffeine Reduction on Snoring and Quality of Life

Snoring is a problem for many people, often disturbing energy level, quality of sleep, and the relationship with a bed partner. Two observational studies that have indicated a relationship between the consumption of caffeine and snoring. The objective of this study will be to observe the degree of snoring and quality of sleep when caffeine intake is reduced over a period of four weeks. This will be a prospective, before-and-after study of a behavioral intervention.

This study will engage thirty adults who report snoring, drink two cups of coffee or more per day (or an equivalent amount of caffeine), and have a consistent bed partner who can report on snoring severity. Both subject and partner will be asked to fill out a diary each day. The subjects will record the type of caffeine consumed, time at which each beverage was ingested, the total minutes of physical exercise, any caffeine withdrawal symptoms, quality of sleep, and energy in the morning. The partner (reporter) will rate his or her own sleep quality and energy in the morning, as well as the snoring level of the subject. Beginning the second week of the study, the subject will reduce caffeine intake to half the baseline consumption, and on the third week, will eliminate caffeine altogether.

At the end of each week, the participants will be asked to mail their diaries in to the researchers and start a new series of entries. The study team will also call each week to answer any questions or concerns of the subject and reporter, and encourage continued reporting. When six weeks have elapsed following the completion of the last diary, the investigators will make a final call to the participants to record their current level of snoring, quality of sleep, and daily energy level.


Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years
* consume 16 ounces of coffee or 25 ounces of caffeinated soda or tea
* consistent bed partner willing to serve as reporter
* reported as a loud snorer (6 or more on 10 point scale) most days of an average week

Exclusion Criteria:

* pregnant
* diagnosed by doctor with sleep apnea, facial or airways defect
* any facial or airways surgery that has changed snoring pattern.
* upper airways infection that requires antibiotics, cough suppressants, etc. in the last month
* use any continuous positive airway pressure (CPAP) device or dental appliance
* bed partner hearing impairment or defects.
Psorcast Mobile Study

The purpose of this study is to understand variation in the symptoms of psoriasis and psoriatic arthritis using simple, scalable smartphone-based measurements. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

Psoriatic disease exhibits a spectrum of symptoms and can transition from psoriasis (PsO), largely affecting the skin, to psoriatic arthritis (PsA) involving widespread musculoskeletal inflammation. Early detection of the PsO-to-PsA transition and rapid administration of effective treatment is essential, as a delay in diagnosing PsA by as little as 6 months can lead to irreversible joint damage. This "ticking clock" paradigm drives the need for frequent monitoring and effective therapeutic intervention as early as possible to attenuate or possibly prevent disease progression. Using a suite of smartphone-based measurements in an app called Psorcast (psoriasis forecasts), we aim to aggregate weekly, symptom measurements from participants in a remote, longitudinal observational study to map the trajectories of treatment response and disease progression. In this study, we will explore measurements of psoriatic disease activity at least an order of magnitude more frequently (weekly vs. quarterly) than standard clinical practice or clinical trial designs. This study is not meant to provide a medical diagnosis, treatment, or medical advice. It is meant to provide a scalable, inexpensive, non-invasive and frequent measure and tracking of psoriasis and psoriatic arthritis for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 and older who consent to participate in the study
* Own a compatible iPhone or iPod Touch device running iOS 12.2 or above
* Be able to read and understand an official language of the country of participation

Exclusion Criteria:

* Age 17 years or younger
* Not a resident of the a country where the app is approved for use
* Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
* Not be able to read and understand an official language of the country of participation
Can ILR Reduce the Risk of Arm Lymphedema?

Breast cancer-related lymphedema (BCRL) is a debilitating, usually lifelong burden for breast cancer survivors. For the breast cancer patients receiving axillary lymph node dissection (ALND), the likelihood of BCRL is about 20%. Lymphatico-venous anastomosis (LVA) has been accepted as a method of treating extremity lymphedema. A few studies have mentioned the prophylactic effect of LVA on BCRL. However, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. Therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ILR) with LVA could have a clinically significant effect on the reduction of BCRL occurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with unilateral breast cancer
2. Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively

Exclusion Criteria:

1. Had received axillary lymph node dissection
2. Going to receive bilateral axillary lymph node dissections
3. Already have arm lymphedema
4. Allergy to the dye used intraoperatively