cyrilzakka/clinical-trials huggingface dataset:
Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone

The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.

The study terminated on 17-Jul-07 due to concerns about long-term cardiovascular safety of Avandia and slow patient enrollment. There were no specific safety issues raised within the trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with type diabetes mellitus (diagnosed via ADA criteria), newly diagnosed or treatment-naive (other than diet and exercise) and HbA1c range of 7 to 9%.
* 45-70 years of age.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).
Effects of Early Treadmill Training on Ambulatory Ability in Stroke Patients: Electromyographic and Kinematic Analyses

The purpose of this study is to explore an alternative approach that emphasizes task specificity and treadmill training for ambulation training of these patients.

Restoration of independent ambulatory ability is one of the most common functional goals of patients with hemiplegia after stroke. Ambulation training, therefore, is an important part of physical therapy intervention for these patients. Conventional neurologic physical therapy for ambulation training, based sorely on neurophysiology, prohibits early ambulation experience after stroke in attempt to avoid the development of abnormal gait patterns. Such an approach has been shown to be limited in helping these patients regain independent ambulatory ability.

Eligibility Criteria:
Inclusion Criteria:

* between 40 and 75 years old
* first stroke with R't side hemiplegia due to middle cerebral artery occlusion and received acute treatment at NTUH
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
* able to ambulate independently in parallel bars and having no independent ambulation ability outside parallel bars

Excursion criteria:

* having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
* having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases other than stroke
Phase I Study GX-G3 in Healthy Subjects

pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.

MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be examined for safety evaluation.

The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity will be evaluated to investigate antibody production.

Eligibility Criteria:
Inclusion Criteria:

Subjects may be entered in the study only if they meet all of the following criteria:

1. Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF);
2. Healthy male volunteers aged 20-45 years;
3. Have a body weight of 60-90 kg (inclusive), have a body mass index (BMI) equal to or greater than 19 and less than 27 kg/m2;
4. Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);

Exclusion Criteria:

Subjects presenting with any of the following will not be entered in to the study:

1. Have a history of or current evidence of disease;
2. Have percent of white blood cell (WBC) or neutrophil \> UNL;
3. Have count of platelet \< 100,000/mm3;
4. Have the longest length of spleen \> 16 cm measured by abdomen ultrasonography ;
5. Have MSSBP ≥ 140 mmHg or ≤ 90 mmHg and/or MSDBP ≥ 95 mmHg or ≤ 50 mmHg; (BP must be measured after resting for at least 3 minutes)
6. Have clinically significant arrhythmia by EKG/ECG;
7. Are positive for HBV, HCV, HIV;
8. Have a history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the investigator;
9. Have had any blood donation/ blood loss greater than 400 ml within 8 weeks prior to dosing;
10. Have participated in another clinical trial with investigational drugs within 8 weeks of screening period;
11. Any other conditions that are considered inappropriate or unsafe for subjects by the Investigator;
12. Are considered ineligible by the investigator due to physical findings or laboratory values at the screening assessments;
13. Have a history of G-CSF treatment;
Human Milk Nutrients and Infants' Health Outcomes in South China

The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.

Human milk components are beneficial to the growth and development of infants, such as phospholipids, gangliosides, sialic acids, choline, oligosaccharide and so on. However, studies on the associations between human milk components and infants' outcomes are limited. Therefore, this study is designed to investigate the relationship between Chinese human milk components and the growth and development of infants.

Eligibility Criteria:
Inclusion Criteria:

* age 4-5 years
* healthy children
* breastfeeding between 0 to 400 days of age
* human milk components in human milk being determined
* sign informed consent

Exclusion Criteria:

* children with severe chronic diseases, such as tumor, severe digestive diseases, kidney diseases
* gestational diabetes, hypertension and other metabolic diseases
* children with mental system diseases
* children with congenital and genetic diseases
* children with infectious diseases, eg, upper respiratory tract infection or diarrhea
* antibiotic or other drugs influencing intestinal flora being taken within 45 days
* Withdraw withdraw informed consent serious violation of the scheme no longer meet the research criteria because of health factors or accidents
Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)

There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2.

* Primary end point: comparison the rate of COVID-19 between PEP with HCQ and control group.
* Secondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment).
* Safety comparison: Safety verification by identifying major side effects in the HCQ group."


Eligibility Criteria:
Inclusion Criteria:

* A contact person from confirmed case of SARS-CoV-2 infection
* Medical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals
* Persons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc.

  * Subjects of study include both symptomatic and asymptomatic contacts.

Exclusion Criteria:

* Hypersensitivity to Chloroquine or Hydroxychloroquine
* Those who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc.
* Human immunodeficiency virus (HIV) infected person
* Patients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease)
* Patients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis)
* Arrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR≤30mL / min / 1.73m2
* A person who is positive in the COVID-19 screening PCR test before starting PEP
Growth Process and Development of the Musculoskeletal System in Young Gymnasts

assessment of the musculoskeletal system will be performed twice a year, for three years of young gymnasts.

Aims: To examine the changes in the anatomical and morphological features in the skeleton of young female artistic and rhythmic gymnasts and follow the risk of injuries during the period of pubertal growth.

Methods: 200 gymnasts (100 rhythmic and 100 artistic) will participate. Measurements will be performed at the beginning and the end of each year, for three years. Each gymnast will be examined for the following: asked about her menarche, assessed by a physician for Tanner stages, and will answer the Triad-specific self-report questionnaire. Anthropometric measurements (height, weight, BMI), muscle strength (using hand-held dynamometer), joint range of motion (using goniometer), scoliosis, and Beighton test for hypermobility will be assessed. In addition, the gymnasts will be scanned by using three different ultrasounds: Bone age for the skeletal age, SOS for the bone properties, and ultrasound tissue characterization for the tendon structure. The gymnasts will be asked about their physical training history, frequency, and training intensity. Each gymnast will be asked whether she had pain or injuries during the period she has been training, as well as a physical and injuries evaluation that will be conducted by a physician.

Once a month a telephone follow-up with the trainer regarding any pain or injuries in the last month will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* training at least 4 times per week,
* a minimum of 16 hours per week, at a competitive level.
* The gymnasts exercised fully three months before the beginning of the study
* have not been absent more than three days from training due to pain, discomfort, or injury.

Exclusion Criteria:

* present injury causing pain
* missing training.
Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

The main purpose of this project is to conduct a prospective cohort study in order to better understand the importance of insomnia symptoms in patients referred to interdisciplinary rehabilitation due to chronic pain. Moreover, this project will also raise awareness on how insomnia symptoms, alone, and in interplay with factors such as function, psychological distress, physical activity, and fatigue impact on patient's prognosis and work ability. Our aim is that this knowledge can be used to design new interventions and improve rehabilitation programs for this patient group.

Insomnia is a vast problem among patients with chronic musculoskeletal pain. Despite the close relation between pain and sleep, sleep quality has received little attention in rehabilitation programs for patients with pain. So far, there is a lack of studies investigating the association between insomnia and chronic pain in patients referred to interdisciplinary rehabilitation. Identifying subgroups of the population with higher burden of poor sleep will aid clinicians to tailor treatment and prevention strategies. Moreover, knowledge on how insomnia symptoms fluctuate throughout the rehabilitation program and how insomnia symptoms interact with factors such as mental distress, physical activity, and fatigue impact on patient's recovery (e.g., the prognosis of pain, quality of life, and work participation) can be used to develop and implement more successful rehabilitation programs.

This is a cohort study primarily designed to address sleep problems in patients referred for pain rehabilitation by using questionnaire data from the rehabilitation centers linked to registry data. This study will constitute both a cross-sectional survey among patients referred to rehabilitation before they participate in rehabilitation. In addition to questionnaires, administrative data and clinical data, these data will be linked to national health registries on prescriptions, health care use and sickness absence. Potential participants are patients referred to rehabilitation at five different Unicare rehabilitation centers in Norway (Unicare Helsefort, Unicare Coperio, Unicare Hokksund, Unicare Friskvern and Unicare Jeløy) due to long-term pain complaints.

Eligibility Criteria:
Inclusion Criteria:

* Take part in rehabilitation for long-term pain complaints at one of the five centers
* Consented to research

Exclusion Criteria:

* None
Study to Analyze the Aerobic Performance Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists

Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a sustained release beta alanine on the aerobic performance efficacy in recreational cyclist

Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).

The product to be consumed is beta alanine. Participants will consume the product for 30 days. They will have to take 4 intakes every three hours, being the first intake two hours after waking up.

The study subjects will have to make 2 visits to the laboratory. At the first and last visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male cyclists with more than two years of cycling experience.
* Perform tests without fatigue.
* Road bike training at least twice a week.

Exclusion Criteria:

* Participants with chronic illness.
* Have a long-term injury that prevents you from training in the previous month.
* Inability to understand informed consent.
* Have consumed beta alanine in the three years prior to the start of the study.
* Consumption of other supplements that may alter performance.
UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients

OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

Eligibility Criteria:
Inclusion Criteria:

* cancer patients with Infections

Exclusion Criteria:

* No Infections
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants

This first in-human (FIH) study of UB-313, an anti-calcitonin gene-related peptide based immunotherapeutic candidate, is designed to assess the safety, tolerability, and immunogenicity of 4 selected UB-313 dose regimens in healthy adults.

This is a single-site, randomized, double-blind, placebo-controlled, multidose regimen, FIH study of UB-313, an anti-CGRP peptide-based immunotherapy candidate. The double-blind period will include dose escalation and cohort staggering for up to 4 planned dose levels of UB-313 or placebo in 4 cohorts of healthy participants. All eligible participants will be enrolled in the study for up to 44 weeks, consisting of IM injections of UB-313 or placebo at Week 0 (Baseline, Day 1), Week 4, and Week 12. The End of Treatment (EoT) is defined as Week 16, followed by a follow-up period up to Week 44.

Eligibility Criteria:
Inclusion Criteria:

* Is a male or female aged 18 to 55 years old, inclusive, at time of informed consent.
* Has a body mass index between 18 and 30 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg.
* Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period.
* Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose.
* Other inclusion criteria apply

Exclusion Criteria:

* Has a history of clinically significant medical or psychiatric conditions, which in the opinion of the Investigator may compromise the participant's safety or the scientific value of the study, posing an unacceptable risk to the participant or interfere with the participant's ability to comply with study procedures or abide by study restrictions.
* Presents any concern by the Investigator regarding safe participation in the study or for any other reason (including contraindication to MRI) that the Investigator considers the participant inappropriate for participation in the study.
* Has a recent history (within the past year of Screening) of migraine headache.
* Has unsuitable skin characteristics for the dermal capsaicin challenge as determined by the Investigator.
* Has not demonstrated at least a 100% increase in dermal blood flow following capsaicin challenge as part of Screening procedures and measured through laser speckle contrast imaging.
* Other exclusion criteria apply
DOTATATE PET for Meningioma Radiation Planning

68Ga-DOTATATE-based radionuclides are a novel modality in the diagnosis and treatment of central nervous system meningioma. DOTATATE is a ligand for the SSTR (somatostatin receptor), which is expressed in meningioma but not in normal brain or bone. It is also more effective than MRI in delineating tumor, which is the current imaging standard for assessing meningioma. For radiation planning, it can help to reduce the risk of geometrical miss, identify area that require dose-escalation, and reduce dose to normal tissue. The purpose of the study is to compare the radiation therapy (RT) contouring and planning for meningioma with and without the use of 68Ga-DOTATATE-PET


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Able and willing to comply with the study procedures
* Intact meningioma requiring definitive radiation
* Post-operative meningioma requiring adjuvant radiation
* No prior radiation therapy or medical therapy directed at the tumour

Exclusion Criteria:

* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent
The Most Frequently Preferred Surgical Method In The Treatment Of Sacrococcygeal Pilonidal Disease

There is no consensus on which procedure is the ideal surgical method in the treatment of sacrococcygeal pilonidal disease (SPD). The study aimed to retrospectively screen the cases that had undergone surgical treatment for SPD in the last 15 years in four different tertiary Stage hospitals and analyze the most frequently used surgical treatment method and its results.

The researchers in our study will retrospectively scan the records of patients who have been operated on for SPD in the last 15 years at Health Sciences University Konya Health Practice and Research Center, Selçuk University Medical Faculty Hospital, Necmettin Erbakan University Medical Faculty Hospital, and Başkent University Medical Faculty Hospital General Surgery Clinics.

Demographic characteristics of the patients, type of anesthesia, duration of operation, duration of hospitalization, time to return to work or school, final healing time, follow-up time, and recurrence information will be transferred to the SPSS statistics program analyzed.

The researchers could not find any articles in the literature on the subject. Therefore, this study will contribute to the literature.

Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 14-80 who underwent surgery for pilonidal sinus

Exclusion Criteria:

* unregulated diabetes mellitus
* collagen tissue disease
* decompensated cardiovascular disease
* cases with missing follow-up information
Role of Serum Albumin and Total Protein in Survival of Cancer Cachectic Patients

Serum albumin can indicate the onset of cancer cachexia, provide information about a patient's nutritional status, and serve as a biomarker for the prognosis of patients with cancer cachexia. However, the relationship between serum albumin levels and mortality in patients with cancer cachexia remains unclear. We aimed to examine the association of albumin and total protein with 1-year mortality in patients with cancer cachexia

Cancer cachexia is defined as a multifactorial and multi-organ syndrome characterized by the loss of skeletal muscle mass (with or without loss of adipose tissue), which cannot be fully reversed by conventional nutritional support. In recent years, cancer cachexia has increasingly been seen as a systemic phenomenon that affects various organs, such as the liver and myocardial tissue. Cachexia is closely related to anorexia, inflammation, insulin resistance, and decreased protein levels, which can lead to progressive functional impairment, treatment-related complications, poor quality of life, and cancer-related death. Its pathophysiology is characterized by a negative protein and energy balance. However, there are no clear clinical guidelines to effectively combat the progressive tissue loss associated with cachexia. Cancer cachexia occurs mostly in advanced cancers, with more than half of patients with cancer having cachexia in the later stages, and \>10% of patients die with or from it.

Studies have shown that cachexia can be diagnosed when weight loss in the past 12 months is ≥5%, and the physiological variables of patients match at least threeof the following five criteria: decreased muscle strength,fatigue, anorexia, low fat-free mass index (FFMI), and abnormal blood profile. Albumin and total protein are two variables that reflect an individual's nutritional status and disease severity. Additionally, albumin can serve as an indicator of the inflammatory response and is considered a highly sensitive marker of a patient's nutritional status. Serum albumin and total protein can be used to define cancer cachexia and cancer-related malnutrition; patients with cachexia have lower total protein and albumin levels than those without cachexia.5 Serum albumin may serve as a prognostic factor for treatment outcomes and compliance in patients with advanced cancer.

Although a reduction in albumin and total protein levels are associated with the diagnosis of cancer related cachexia, no studies have shown that albumin and total protein can predict mortality in patients with cancer cachexia. Here, we describe a prospective non randomized study that will be conducted to explore the association between serum albumin and total protein levels and 1-year mortality in patients with cancer cachexia .

Eligibility Criteria:
Inclusion Criteria:

* patients who will accept to participate in our study with diagnosis of cancer cachexia

Exclusion Criteria:

* patients who not fulfill criteria of cance cachexia