cyrilzakka/clinical-trials huggingface dataset:
Water Intake Associated With Aerobic Exercise in Coronary

The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of effort and pain of individuals with autonomic alterations known as the coronary arteries remain poorly understood. In this sense, this study intends to investigate the influence of hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective perception of exertion and pain of coronary arteries submitted to aerobic exercise in the model of a cardiovascular rehabilitation session. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation sessions. Only in the second and the fourth session will the volunteers be instructed to ingest a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the first and the third sessions. The outcomes (autonomic modulation, cardiorespiratory variables and perceptions) will be evaluated before, during and after exercise. The results of this study will enable professionals working with this population to implement awareness strategies on the importance of fluid intake in cardiovascular rehabilitation programs.


Eligibility Criteria:
Inclusion Criteria:

* Men with coronary heart disease ischemia, over 45 years
* At least three months of cardiovascular rehabilitation

Exclusion Criteria:

* smokers, alcoholics
* Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)
* Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load
* myocardial ischemia and / or severe ventricular arrhythmias during the exercise test
Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study

This 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study investigate the potential of collecting robust, real-time clinical study measures of glucose levels using Abbott Freestyle Libre Continuous Glucose Monitoring devices associated with a smartphone application

The goal of this study is to characterize the performance of a Continuous Glucose Monitoring System in medical food studies. The Freestyle Libre Glucose Sensors will be used to follow subject's 8-day glucose trajectories over the course of a 5-week, double-blind, placebo-controlled, 2x2 crossover, medical-food experiment. The medical food has been designed to increase butyrate production and promote the health of the colonic mucin layer.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 75 years of age
* If female, must meet all the following criteria:
* Not pregnant or breastfeeding
* If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods \[male condom with spermicide, with or without cervical cap or diaphragm\], implants, injectable or oral contraceptives \[must have been using for at least the last 3 months\], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study
* Must be able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 \[HIPAA\] legislation as modified in 2013)
* Must be able to communicate with the investigator, and understand and comply with protocol requirements
* Must be able to wear a CG patch and perform a scan no less than once every 8 hours for the duration of the sensor periods.

Exclusion Criteria:

* Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study
* Subjects using a proton pump inhibitor must be on a stable dose that will be maintained throughout the study period
* Subjects who plan to travel outside the United States during the projected study period
* Subjects who have received an experimental drug within 30 days prior to study entry
* Subjects with known milk, peanut, or tree nut allergies
* Subjects who have been diagnosed with a sexually transmitted disease including, but not limited to, HIV, syphilis, herpes, gonorrhea, hepatitis A, hepatitis B, and hepatitis C
* History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy
* Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer

The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.

Cohorts of 3 will be treated each at different dose levels and images will be taken at 4 time points. For dosimetry estimates, there will be a 20-24 hr time point post-administration of 99mTc-GP for the first 3 patients. If the biodistribution and dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will eliminate that 4th scan for all other patients. Urine and blood samples will be collected at 5 time points, and an additional blood and urine sample will be collected for dosimetry analysis at 30\~60 min.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed stage I-IV breast cancer (tumor size

  * 2cm in imaging examinations) who are scheduled to start systemic therapy.
* Patients must have histological diagnosis of invasive breast cancer.
* Extent of disease will be determined by physical examination and conventional radiological studies.
* Must be age 18 or older.
* ECOG performance status 0-2.
* Patients with history of prior malignancies must be disease-free for at least 5 years of study entry.
* Normal hematological function: WBC \> 3000/ul, absolute neutrophil count \> 1500/ul, platelets \> 100,000/ul, and Hgb \> 10 gms (transfusion to achieve Hgb \> 10 gms is acceptable).
* Serum total bilirubin \< 1.5 mg/dl and SGPT \< 1.5 X normal.
* Adequate kidney function (creatinine \< 1.5 mg/dL).

Exclusion Criteria:

* Patients who received previous chemotherapy for the newly diagnosed breast cancer.
* No evidence of primary breast lesion (e.g. T0, Tx).
* Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
* Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
* Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.
Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer

The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis and esophagitis grade II or higher by the use of proton therapy compared to photon radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life, loco-regional control, survival and late radiation induced side effects.

Patients in this trial undergo primary radiochemotherapy for locally advanced NSCLC. As early and intermediate late effects of radiotherapy do not only hamper quality of life but can, in the case of radiation induced pneumonitis, be potentially lethal, a reduction of these side effects is desirable. Patients in this trial are 1:1 randomised to intensity modulated radiotherapy with photons or proton therapy. The primary aim of the study is to show a decrease of pneumonitis and or esophagitis grade 2 or higher by proton therapy. The observed incidence of both these side effects is 39% with photon therapy. The estimated incidence with proton therapy is around 12 %. Simultaneous chemotherapy will be applied to current clinical standards.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC (confirmed by cytology or histology) staged UICC IIIA or IIIB or UICC II if the patient declines surgery
* no distant metastases (M1)
* patient' age between 18 and 70 years
* Patient medically suited for primary radiochemotherapy with curative intent
* signed declaration of informed consent
* adequate compliance for treatment and clinical follow up
* adequate contraception during and after therapy if indicated

Exclusion Criteria:

* Participation in other interventional trial
* T1 or T2 N0 tumours that are candidates for stereotactic radiotherapy
* relevant neurological or psychiatric disorders that hinder treatment, follow-up or understanding of the procedures
* pregnant or breastfeeding women
* prior thoracic radiotherapy
* history of other malignancies during the last 5 years (exceptions can be made for tumours with excellent outcome)
* weight loss greater than 15% before therapy
* serological alterations (liver, kidney) prohibiting application of simultaneous chemotherapy
* respiratory motion of the tumour \> 10 mm (evaluated by 4D CT), also when methods for motion reduction (abdominal compression) are used
Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment OCT

The choroid, which is located between the retina and the sclera, is a connective tissue layer that is densely packed with blood vessels and is responsible for supplying oxygen and nutrients to the retina's periphery. One of the primary functions of the choroid is to support the metabolism of the retinal pigment epithelium (RPE). It is implicated in the pathogenesis of a variety of retinal disorders, including age-related macular degeneration, polypoidal choroidal vasculopathy, central serous chorioretinopathy, and high myopia-associated chorio retinal atrophies. Because choroidal alteration has a fundamental role in the development and progression of these diseases, choroidal thickness provides comprehensive information to physicians.

For the study of the choroid, researchers have used ultrasound, magnetic resonance imaging MRI, and Doppler laser, but these methods have limited utility due to a lack of resolution. Contrary to this, indocyanine green (ICG) angiography provides valuable clinical information but does not provide cross-sectional images of the choroid for in vivo research studies.

Optical coherence tomography (OCT) has gained in popularity in clinical and experimental ophthalmology over the last decade as a way to acquire detailed, three-dimensional images of the retina . Imaging the entire choroid, on the other hand, has proven to be more difficult due to the significant decline in signal strength beyond the RPE prompted by the pigment in the RPE and choroid and light scattering in the vasculature. The development of improved depth imaging (EDI) by Spaide et al. opened the door to quantitative choroid assessment. Choroid imaging is currently possible using one of two optical coherence tomography (OCT) techniques: (1) spectral-domain (SD) OCT utilizing standard light sources using EDI, and (2) swept-source (SS) OCT using a long wavelength light .A 1 m-band light source is used in SS-OCT, which penetrates deeper into the retino choroidal tissues and so optimizes the resolution. To better visualize retinal and choroidal changes, SS-OCT can concurrently display a focused image of both the retina and the choroid. This renders it an accurate technology for assessing choroidal thickness.

Such findings of choroidal thickness changes revealed that the choroid and choroidal thickness may be important attributes in the evaluation of ocular pathology. To properly understand the scientific value of these potential choroidal thickness variations, it would appear that comprehensive and systematic normative values for choroidal thickness are fundamental.


Eligibility Criteria:
Inclusion Criteria:

* Normal adult volunteers

Exclusion Criteria:

* Eyes with chorioretinal or vitreoretinal diseases
* History of intraocular surgery
* Glaucoma.
* Systemic diseases or conditions that could affect retinal or choroidal thickness,
* Pregnant women
Genomic Evolution of Metastasis in Gastric Cancer

The aim of this study is to track tumor evolution of regional and distant metastases in gastric cancer using the Next Generation Sequencing technologies.

Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Metastasis is the leading cause of death in gastric cancer patients, with median overall survival of less than 1 year. Currently, there is no effective treatment because the molecular mechanism of metastasis remains unclear. The aim of this study is to use advanced NGS technologies to dissect the genomic changes (genetic, epigenetic and transcriptional changes) of the primary tumor and associated metastatic sites of the same patients. With that, the investigators can reconstruct the clonal evolution from primary tumor to metastasis, identify key pathways governing metastasis development that can be targeted for future therapeutic development.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female patients aged 18 years and older
2. Histologically proven primary gastric adenocarcinoma and clinical evidence of metastasis (N1-3M1)
3. Biopsies can be taken at multiple sites
4. No known other concomitant cancer diagnosis
5. Signed informed consent

Exclusion Criteria:

1. Gastric adnocarcinoma cannot be confirmed primary
2. Unable to undergo biopsy or surgery
Safety, Tolerability, Efficacy and Pharmacodynamics of CAL02 in Severe Pneumonia Caused by Streptococcus Pneumoniae

The objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of standard of care antibiotic treatment.

Streptococcus pneumoniae is the most frequently identified pathogen of community-acquired bacterial pneumonia and its severe forms are associated with high morbidity and mortality, despite pneumococcal vaccines and medical treatment (antibiotic therapy, alone or in combination). Bacterial toxins, such as the pore-forming toxin (PFT) pneumolysin (from Streptococcus pneumoniae), are involved in the development of invasive disease and play a key role in severe and fatal complications. CAL02 offers a novel therapeutic approach by neutralising bacterial toxins, such as pneumolysin, which recognise specific microdomains on host cell membranes, called lipid rafts.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients ≥ 18 years and ≤ 80 years of age
* Body weight 40-140 kg
* Severe pneumonia caused by Streptococcus pneumoniae managed in an ICU
* CURB-65 score ≥ 3 in patients aged \> 65 and CURB-65 ≥ 2 in patients aged \< 65
* Streptococcus pneumoniae identification with the urine antigen test or any other proven documented identification method
* Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines

Exclusion Criteria:

* Patients with hospital-acquired-, health care-acquired- or ventilator- associated-pneumonia
* More than (i) 12 hours since diagnosis of severe CAPP and (ii) 24 hours or 60 hours since antibiotic treatment IV or per os, respectively, unless documented not to be active against S. pneumoniae, will have elapsed at the time of IMP administration
* APACHE II score \> 30 points
* SOFA score \> 12 points
* Inability to maintain a mean arterial pressure ≥ 50 mm Hg
* Known hypersensitivity to liposomal formulations
* Patients with severe neutropenia or lymphoma or current or anticipated chemotherapy
* End-stage neuromuscular disorders
* Patients who have long-term tracheostomy
* Current or recent participation in an investigational study
* Presence of other pneumococcal site infection
* Patients with known acquired immune deficiency syndrome (AIDS) with CD4 count \< 200 cells/mL
* Patients with known post-obstructive pneumonia (active primary lung cancer or another malignancy metastatic to the lungs)
* Patients with cystic fibrosis, Pneumocystis jiroveci pneumonia, or active tuberculosis
* Patients receiving immunosuppressant therapy
* Patients with a known liver function deficiency
* Splenectomised patients
* Patients who have experienced an allergic reaction to eggs
* Moribund clinical condition
* Nursing and pregnant women
* Women of child bearing potential not using an effective contraception.
Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder

The current study aims to evaluate the impact of long (\>5 days) and/or compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm.

The basis for this study is the diversity of clinical practices across Swedish regions. By categorizing clinics based on their practices with respect to long and/or compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides.

All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).

Data collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. The participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with BPD. The top quartile of participants will be compared with the bottom quartile.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatric clinic in Sweden authorized to administer compulsory care for adults. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).

Exclusion Criteria:

* No authorization to administer compulsory care for adults
To Evaluate the Safety and PK Characteristics in Healthy Volunteers

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria
Randomized Controlled Trial of Health Care to Elderly Patients.

To study the efficacy of multicomponent treatment and care for patients with acute illness or deterioration of a chronic disease at a nursing home in primary health care compared to traditional treatment at hospital.

Managers at St. Olavs University Hospital and the City of Trondheim local authority decided in 2001 to establish a reinforced department at a nursing home with a multicomponent approach to patient treatment.

In the study treatment at a nursing home will be compared with conventional treatment in ordinary hospital beds in medical, surgical and orthopedic departments at a hospital. Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique. Eligible participants will be hospitalized from their ordinary home and expected to return to home after treatment. When an eligible patient is identified and accepted for inclusion, randomization will be performed by the Clinical Research Department at the Faculty of Medicine.

Eligibility Criteria:
Inclusion Criteria:

* Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique.

Exclusion Criteria:

* Participating doctors at the hospital together with general practitioners shall develope exclusion criteria through Delphi technique.
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg positive hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
* Subjects with historical biopsies used for entry will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5). If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline.
* For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of ≥ 50 mL/min.

Exclusion Criteria:

* Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded.
* Subjects with clinically significant concomitant diseases will be excluded.
Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis

This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.

The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 60 years.
* Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.
* Negative pregnancy test at screening.
* Agreement to use reliable contraception throughout the study and for 30 days after its completion.
* Signed informed consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Diagnosed bacterial vaginosis.
* Chronic inflammatory or atrophic diseases of the female genital organs.
* History of malignant neoplasms.
* Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.