cyrilzakka/clinical-trials huggingface dataset:
Within-subject Variability of Insulin Detemir in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese men or women
* Holding a Japanese pass-port and Japanese-born parents
* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body Mass Index (BMI) between 18 and 30 kg/m\^2, incl.
* Fasting blood glucose maximum 6 mmol/L

Exclusion Criteria:

* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
* Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
* Subject with history of alcohol or drug dependence
Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders

This study evaluates the risk for incident falls and fall-related injuries at the onset of neurocognitive disorders in older adults participating in the Canadian Longitudinal Study

Falls are frequent events in adults over age 65 (up to 30% each year in Canada). They are a major Canadian public health concern, which negatively impacts health and quality of life of fallers, and health care system. Neurocognitive disorders are strongly associated with falls and fall-related injuries.

Several clinical characteristics, identified previously as risk factors for falls in the older population and in older adults with neurocognitive disorders are selected in the Canadian Longitudinal Study On Aging. The performance criteria of different statistical models will be compared for the association of neurocognitive disorders with falls and fall-related injuries. Six linear statistical models (i.e., logistic regression, discriminant analysis, Bayes network algorithm, decision tree, random forest, boosted trees), Factor Mixture Models and two different artificial neural network (i.e., multilayer perceptron and the neuroevolution of augmenting topologies).

Eligibility Criteria:
Inclusion Criteria:

* People who are 65 years and over
* Men and women who live in Canada

Exclusion Criteria:

* People who do not live in Canada
* A fall resulting from acute medical event and/or an external factor
* Moderate to severe dementia
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics

A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.

Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism.

3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 35 kg/m2
* Capable of providing informed consent
* COVID-19 negative and/or asymptomatic

Exclusion Criteria:

* Subject who does not/will not eat animal protein sources.
* Body mass index \> 35.
* History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
* Use of insulin to control blood sugar level.
* Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
* Currently using prescription blood thinning medications.
* Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
* Unwilling to avoid using protein or amino-acid supplements during participation.
The Effect of Intraabdominal Saline Irrigation in Abdominal Hysterectomies

The objective of this prospective randomised clinic study is to investigate the effect of peritoneal cavity saline irrigation during abdominal hysterectomies on postoperative infectious morbidities and gastrointestinal disturbance. The participants will be randomised to either an irrigation of abdominal cavity or the control group after vaginal closure. Assignment to one of the two treatment groups will be determined using a computer generated random numbers. Primary outcome is the rate of postoperative infectious morbidities. Secondary outcome is the rate of gastrointestinal disturbances (nausea, vomiting), use of antiemetic drugs and pain score in the postoperative period. 100 patients in each treatment arm planned.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing hysterectomies for benign causes

Exclusion Criteria:

* patients who have diabetes mellitus patients undergoing hysterectomy for pelvic inflammatory disease or tuboovarian abscess
Study of Personalized Cancer Therapy to Determine Response and Toxicity

The purpose of this study is to learn more about personalized cancer therapy including response to treatment and side effects. Information about the tests and treatments a person received, or will receive, for their cancer will be collected from medical records to help the researchers determine whether or not patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor. Optional research tests may be performed on tissue, body cavity fluid, blood or urine provided, discarded biological samples taken during routine care that would normally be disposed of and not saved, or on blood samples collected for this study. These research tests will be used to create a "profile" of the collected specimens which will describe unique characteristics about the genes involved in a person's cancer. The tests will also help researchers look for biomarkers that may help predict how people respond to treatment.

This is a correlative study of personalized medicine with retrospective and prospective components. Patient medical records will be examined for results of molecular profiling obtained through standard of care testing to help understand, in a descriptive fashion, how well molecular testing might predict response to therapy. Patient outcome parameters including, but not limited to, tumor response, time to treatment failure, patient survival, and toxicity will be analyzed, as well as pharmacodynamic (PD) and pharmacokinetic (PK) data when available. This study will also include optional research-related testing of tissue, blood, or urine specimens via a variety of simple or advanced techniques such as molecular, proteomic, and metabolic analyses for biomarker discovery or for PK and PD parameters. These specimens will be obtained from clinical specimens archived by UCSD Health System Pathology or from specimens collected via an existing IRB-approved protocol, discarded specimens, or from specimens collected for this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Must be willing to provide informed consent, parent permission, or assent

Exclusion Criteria:

* Subjects unable to give informed consent, parent permission, or assent
Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers

The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active metabolite, safety, tolerability of AZD6140 following single administration in healthy male Japanese volunteers.

A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of oral AZD6140 after Single Dose in Healthy Japanese Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject aged between 20 to 45 years inclusive
* Body mass index (BMI=weight/height2) between 18.0 to 27.0 kg/m2 inclusive
* Body weight between 50.0 to 85.0 kg inclusive Provision of written informed consent

Exclusion Criteria:

* Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator, or positive results on screening tests for serum hepatitis B surface antigen and hepatitis C antibody, syphilis and human immu
* Supine blood pressure \> 150 mmHg systolic or \> 95 mmHg diastolic or supine pulse \> 90 beats per minute (after resting for 10 minutes) Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
* Personal or familial predisposition for thrombotic disorders Clinically significant medical history, including psychiatric disorders and severe allergies
Study on the Efficacy and Timing of ECMO Therapy in Children With Refractory Septic Shock

Severe sepsis and septic shock remain the leading causes of child mortality worldwide. Sepsis is a complex process that ultimately leads to circulation disorders, organ perfusion abnormalities, capillary leakage, tissue hypoxia, and organ failure. The difficulty of clinical treatment is microcirculation and mitochondrial dysfunction in septic shock. Once shock enters the stage of microcirculation failure, conventional treatment is ineffective. ECMO can effectively support the circulatory system and provide good oxygen delivery, but there are many controversies in clinical treatment. 1) whether ECMO can effectively improve the clinical prognosis of children with septic shock; 2) appropriate timing for ECMO intervention; 3) which key clinical factors affect the effect of ECMO treatment. This study intends to adopt a multi-center, prospective, non-randomized controlled trial design, and the main research hypothesis is whether ECMO treatment can improve the success of discharge survival of children with septic shock.

In this study, a variety of statistical analysis methods will be used to screen the clinical indicators and truncation values suitable for starting ECMO, and to construct a comprehensive prediction model, so as to determine the basis for the optimal timing of ECMO treatment in the future. The efficacy of ScVO2, lactic acid, and vasoactive inotrope score (VIS) on the ECMO treatment timing will also be evaluated. This study aims to evaluate and improve the clinical application of ECMO in the treatment of sepsis in children

Eligibility Criteria:
Inclusion Criteria:

• Children with septic shock and refractory septic shock admitted to the PICU of all the study centers

Exclusion Criteria:

* Fatal chromosomal abnormalities (e.g., trisomy 13 or 18)
* Uncontrolled bleeding
* Irreversible brain damage
* After allogeneic bone marrow transplantation
* Weight less than 2.5kg or severe malnutrition
Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug

The purpose of this study is evaluate the safety and tolerability parameters regarding the new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and multiple doses of the new drug.


Eligibility Criteria:
Inclusion Criteria:

* Male patient, aged between 18 and 50 years;
* Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and ≤ 30 kg/m2;
* Healthy men accordance with their historical and tests;
* Healthy subject with laboratory results within the normal range or within the parameters accepted by the clinical protocol
* Negative results for parasitological stool examination performed in the clinical study;
* Subject of research with laboratory results within the normal range for urinalysis collected before the first visit;
* Research subjects allocated in Group 6 with endoscopy within the normal range;

Exclusion Criteria:

* History of gastrointestinal disease, hepatic, renal, cardiovascular, pulmonary, neurologic, hematologic, diabetes or glaucoma;
* Evidence on clinical examination or physical or complement, organ dysfunction or any clinically significant deviation from normality;
* History of use of psychotropic drugs or excessive alcohol consumption (more than two units of alcohol per day, one unit being equivalent to one cup (200 mL) of brew or a dose (50) mL of distilled beverage) or having difficulty to abstain during the study;
* Use of any medication two (2) weeks prior to inclusion of the research subject in the study;
* Regular smokers or who quit less than one (1) year;
* History of food allergy or hyperreactivity to medications or foods;
* HIV positive for HIV;
* Being positive for Hepatitis B;
* Being positive for hepatitis C;
* Testing positive for Helicobacter pilorum;
* Using substances modulating hepatic microsomal activity within thirty (30) days prior to entry of the subject of research in the clinical study (date of signing the consent form);
* Having donated blood (blood volume higher than 500 mL) within four (4) months preceding the date of signing the consent form;
* Subject with a history of hypersensitivity to any component of the investigational product;
Safety of Different Forms of Creatine

This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.

This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and blood pressure reactivity and self-reported side effects.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy
* At least 6 months immediate prior history of resistance training including bench press and leg press or squat

Exclusion Criteria:

* A history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
* Use of prescription medication (birth control is allowed)
* Pregnant or nursing or plan to become pregnant during the next month
* Creatine or nitrate use in the last eight weeks
* History of smoking
* History of drinking (i.e., 12 drinks per week or more)
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, Nuprin, etc.), indomethacin (Indocin), naproxen (Aleve, Anaprox, Naprelan, Naprosyn), piroxicam (Feldene)
Validity of Turkish Version of PROMIS-29 Measure

This study will be carried out on 100 patients with chronic musculoskeletal disorders who applied to Acıbadem Maslak Hospital Orthopedics and Traumatology Department. Demographic information (age, education level, occupation, marital status) will be obtained from the patients, they will be asked whether they have a chronic musculoskeletal disease diagnosed by the doctor, and they will be asked to fill in the PROMIS 29 and SF-36 v2 questionnaires.

The PROMIS 29 questionnaire contains 4 questions from each of the seven contents of PROMIS (physical function, depression, anxiety, fatigue, sleep disorder, participation in social activities and pain interaction) and 1 question from the intensity of pain. Each item has 5 answer options (from 1 to 5), only pain intensity has 11 answer options (from 0 to 10). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20. SF-36 is the most widely used scale to assess general health status, and 36 items question 8 content (physical function, physical role, pain, general health, social function, energy / fitness, social function, emotional role, mental health). The Turkish translation of the PROMIS 29 questionnaire is presented in ANNEX-2.

The translation of the PROMIS 29 questionnaire into Turkish was made by Northwestern University according to the FACIT translation method. Its Turkish translation was obtained from Northwestern University by signing a license agreement for use in scientific research.

Participants will first be asked to sign the informed consent form electronically. PROMIS 29 and SF-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via an internet-based questionnaire platform.

The external validity of the PROMIS 29 questionnaire will be evaluated by its correlation with the SF-36 v2, a similar general health profile questionnaire.

To evaluate inter-rater test-retest reliability, both scales will be filled in by patients a second time between 7-14 days.


Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18,
* To be able to read and speak Turkish,
* To have a chronic musculoskeletal disease
* volunteering to participate in the study

Exclusion Criteria:

* To have serious medical conditions or complications (such as vision or hearing impairments) that may affect the participant's ability to respond to study questionnaires
Sensor Technology Assessments of Reproductive Target Study

The objective of this study was to better understand female reproductive health in the context of using wearable technology. Participants were provided and wore an Oura Ring, tracked their menstrual cycles, provided at-home ovulation test results, and had their cycles monitored via trans-vaginal ultrasounds. The study aimed to collect data from females with regular menstrual cycles.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women age 18-42 years
* Regular menstrual cycles every 25-32 days
* Own an iPhone or Android mobile device
* Agree to follow study protocol such as wearing the Oura Ring for the duration of the study, at-home ovulation testing, present for frequent ultrasounds

Exclusion Criteria:

* Non-English speaking
* Current use of hormonally active medications
* History of infertility
* History of recurrent pregnancy loss
* Current circadian disruptions
Japanese Phase 1 Study of BMS-844203 (CT322)

The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0-1

Exclusion Criteria:

* Subject has uncontrolled diabetes or hypertension
* Clinical significant bleeding diathesis or coagulopathy
* Thrombotic or embolic cerebrovascular accident
Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

The purpose of this study is to analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival.

Talc pleurodesis is the most popular method to control symptoms of recurrent malignant pleural effusion. The intrapleural talc delivery may be by videothoracoscopy and talc poudrage or talc slurry thought a chest tube and the best method is still controversial. Although the lung expansion is a key criteria for success of the procedure, its characteristics are poorly studied.

Patients were enrolled into two groups: videothoracoscopic talc poudrage (VT) and talc slurry through a chest tube (DT). Lung expansion was evaluated through chest CT scans obtained obtained in the first 7 days and 1, 3 and 6 months after pleurodesis. All examinations were revised by two independent observers. Clinical efficacy (considered as lack of new procedures during follow up), complications, drainage duration, hospital stay and quality of life (general and specific questionnaires) were also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Malignant pleural effusion confirmed by cytological analysis of pleural fluid and/or pleural biopsy;
* Recurrent pleural effusion with symptoms;
* Chest radiography with lung expansion after thoracocentesis;
* Karnofsky Performance Status \> 70;
* Written informed patient consent were obtained.

Exclusion Criteria:

* Hemorrhagic diathesis;
* Active infection;
* Cutaneous infiltration;
* Patients unable to understand the questionnaires;
* Age: \> 90 yo or \< 18 yo.
Where is the Initial Site of Biotransformation of Folates in Humans?

The aim of this study is to test the assumption that, in humans, folic acid, a dietary supplement is biotransformed (reduced and methylated) to the natural circulating plasma folate 6S-5Methyltetrahydrofolic acid (5-MTHF) in the intestinal mucosa.

Current thinking, based mainly on rodent studies, is that physiological doses of folic acid (pteroylmonoglutamic acid), like dietary vitamin folates, are biotransformed in the intestinal mucosa and transferred to the portal vein as the natural circulating plasma folate, 5-methyltetrahydrofolic acid (5-MTHF), before entering the liver and the wider systemic blood supply.

Study design:Open labelled study that samples portal and peripheral veins for labelled folate concentrations following oral ingestion with physiological doses of dietary supplements stable-isotope-labelled folic acid, or, the reduced folate, 5-formyltetrahydrofolic acid (5-FormylTHF). The study was performed in subjects with a Transjugular Intrahepatic Porto Systemic Shunt (TIPSS) in situ at the time of a routine annual patency check to allow blood samples to be taken from the portal vein. The aim of this study is to test the assumption that, in humans, folic acid is biotransformed (reduced and methylated) to 5-MTHF in the intestinal mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Stable, synthetic liver function without recent evidence of decompensation (defined as liver function inadequacy or active complications of portal hypertension)
* Abstinent from alcohol
* Free from malignant disease
* Normal gut permeability (as assessed by the lactulose/mannitol test)
* Patent TIPSS on their last surveillance

Exclusion Criteria:

* Taking Vitamin B supplements
* Taking Folic Acid supplementation
* Unable to provide informed consent
Faecal Microbiota Transplantation to Ameliorate Nintedanib-induced Diarrhea in Patients With Idiopathic Pulmonary Fibrosis

This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases:

1. First phase: faecal samples will be collected in patients diagnosed with Idiopathic pulmonary fibrosis treated with nintedanib.
2. Second phase: double-blind, randomised, clinical trial of autologous faecal microbiota transplantation (FMT) vs placebo in Idiopathic pulmonary fibrosis patients who will experience nintedanib-induced diarrhea within 8 weeks of baseline visit.

Follow-up visits will be scheduled at 1, 4 and 12 weeks after randomization. The main aim of the study is to assess the efficacy of FMT in ameliorating diarrhea experienced by patients with idiopathic pulmonary fibrosis treated with nintedanib.


Eligibility Criteria:
Inclusion Criteria:

Phase 1 (faecal samples collection)

* Patients aged ≥18 years when signing the informed consent;
* Diagnosis of IPF within 4 weeks based on 2018 ATS/ERS/JRS/ALAT Guidelines (2) as confirmed by the investigator based on chest HRCT scan and if available surgical lung biopsy;
* Patients already on antifibrotic therapy with nintedanib according to clinical practice.

Phase 2 (FMT procedure)

- Patients who develop diarrhea of grade 2 or 3 according to the Common Terminology Criteria (CTC) for Adverse Events (AE) version 5.0 (12) within 8 weeks of baseline visit.

Exclusion Criteria:

* Women of childbearing potential or pregnant;
* History of colorectal surgery or cutaneous stoma;
* Food allergies;
* Recent (\<6 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antibiotics, probiotics, proton pump inhibitors, immunosuppressants and/or metformin);
* Any documented active or suspected malignancy, except appropriately treated basal cell carcinoma of the skin, "under surveillance" prostate cancer or in situ carcinoma of uterine cervix;
* Decompensated heart failure or heart disease with ejection fraction lower than 30%, severe respiratory failure, psychiatric disorders, pregnancy or inability to provide informed consent.
* Fecal sample unable for FMT according to the opinion of the Investigators (e.g. positive for pathogens);
* (phase 2 only) Diarrhea from known causes (e.g. infectious gastroenteritis, Clostridium difficile infection, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis and/or biliary salt diarrhea).