cyrilzakka/clinical-trials huggingface dataset:
Explaining Sedentary Behavior With Planning (the Revised HAPA Model)

This study would investigate the effects of forming action plans on a reduction of sedentary behaviors. Participants will be randomly assigned to either active control group (education on sedentary behaviors and physical activity) or the intervention group (forming action plans referring to replacing sedentary activities with physical activity. The effects of the intervention will be evaluated at the 2-month follow-up and at the 8-month follow-up.

The effects of three sessions (3 education sessions versus 3 education sessions+ forming plans to replace sedentary behavior with physical activity) will be investigated among participants from three age groups: adolescents (12-17 years old), adults (18-60 years old), and older adults (\>60 years old). Compared to education only, forming plans about how to replace time spent on sedentary activities with physical activity is expected to result in a significantly larger change (a reduction) of sedentary time at the follow-up. Accelerometers will be used to evaluate short-term and mid-term changes in total sedentary time and the relative proportion of time spent on sedentary behavior vs light-intensity and moderate-to-vigorous- intensity physical activity.

Additionally, the study will observe changes in if the cognitions included in the Health Action Process Approach model (HAPA), such risk perception, self-efficacy, outcome expectancies, intention, action control, as well as changes in behavioral habit, presence of sedentary behavior cues in physical environment, and physical activity behavior. The observations will be conducted three times, at the baseline (before the intervention), the 2-month follow up, and at the 8-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* not meeting physical activity guidelines proposed by the World Health Organization

Exclusion Criteria:

* any existing diseases with contraindications for moderate intensity physical activity, confirmed by patient's primary care physician or a specialist in cardiovascular diseases/endocrinology/rehabilitation medicine providing care for the patient during the recruitment and follow-ups
Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.

Primary objectives:

1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.
2. To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.

Secondary objectives:

1. To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass.
2. To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.

Eligibility Criteria:
Inclusion Criteria:

* CHD children who have associated PH risk factors and have accepted biventricular repair
* Pp/Ps \>= 0.75 (before surgery) or Pp/Ps \>= 0.5 (after surgery)

Exclusion Criteria:

* severe mitral stenosis
* obstructive drainage of pulmonary veins
* platelet count \< 50,000,000,000/L \& obvious bleeding
Effects of Milk Protein and Vitamin D on Children's Growth and Health

The purpose of D-pro is to investigate the combined and separate effects of milk protein and vitamin D on bone health, growth, muscle function, body composition and cardiometabolic health in 6-8-year-old children.

The D-pro study investigates the effects of high or medium intakes of milk protein, and vitamin D supplements or placebo, in healthy 6-8 year-old Danish children. The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to receive yoghurt products with either high or medium protein content (300g/day, 6 days/week) and to receive tablets with either vitamin D (20 μg/day) or placebo for 24 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention.

The primary outcome will be bone mineral density (BMD). The investigators will also measure effects on children's muscle function, cardiometabolic health, body composition, growth and growth factors, nutrient status, immune defence and risk of acute respiratory tract infections, as well as appetite hormones. The investigators will also assess potential sex-specific effects and the potential modifying effect of genotype.

Eligibility Criteria:
Inclusion Criteria:

Children must:

* Be 6-8 years of age at the start of the intervention
* Be healthy
* Have a frequent intake of milk and yoghurt products, corresponding to at least ¼ liter a day
* Like yoghurt and high protein yoghurt ("skyr")
* Be of white, Danish or European origin

Moreover:

* The family must not be planning a winter vacation south of a latitude of 50° North
* The child must speak and understand Danish in order to understand the study procedures
* At least one parent must read, speak and write Danish

Exclusion Criteria:

* Known or suspected allergy or intolerance to milk or milk components
* Chronic illness or disease that may affect study outcomes
* Chronic intake of medicine that may affect study outcomes
* Use of vitamin D-containing supplements \>3 days/week the 2 last months and use of any vitamin D-containing supplements the last 1 month before intervention start
* Concomitant participation in other studies involving dietary supplements or blood sampling
* Living in a household with another participating child
Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers

The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.


Eligibility Criteria:
Inclusion Criteria:

* 19 - 45 years of age at the time of screening
* Subjects weighing ≥55 and ≤90 kg with BMI between 18 and 27 kg/m2
* Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study

Exclusion Criteria:

* History of clinically significant hepatic, renal, neurologic, immunologic, respiratory, endocrine disease or hematologic•oncologic disease, cardiovascular, psychiatric disease
* History of disease or surgery of the gastrointestinal tract that could interfere with kinetics of the study drug. Simple hernia repair or appendectomy are excepted.
* History of clinically significant or relevant allergy/hypersensitivity
* Blood AST (SGOT), ALT (SGPT) \>1.5 of upper limit
* eGFR value of ≤90mL/min/1.73m2
* Systolic blood pressure of \<100 mmHg or \>160 mmHg
* Diastolic blood pressure of \<60 mmHg or \>100 mmHg
* Any abnormalities in 12-lead ECG at screening visit
* Subjects who showed positive result in drug abuse tests, or who has history of drug abuse within 60 days prior to the time of screening
* Subjects who took prescribed medications or oriental medicine within 14 days or over-the-counter (OTC) medications or vitamins within 7 days prior to the dose of the study drug (however, the subject can be included if other criteria are met according to the discretion of the investigator)
* Subjects who were administered any investigational products within 3 months from the first dose of the study drug
* Subjects who have donated whole blood (60 days) or partial blood (30 days), or received blood transfusion
* Subjects who have had alcohol consistently (\>21units/week, 1unit=10 g of pure alcohol) or who is not able to stop drinking alcohol throughout the study period
* Subjects who have smoked until 90 days prior to the study initiation or who are not able to stop smoking throughout the study period
* Subjects who are not able to stop taking grapefruit/caffeine from 3 days prior to the first dose of the study drug throughout the study period
* Subjects who plan for pregnancy during the study period or who are not able to use established contraceptive method
* Subject who judged not eligible for study participation by investigator
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life

Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and paclitaxel were eligible to this trial.
* Eastern Cooperative Oncology Group (ECOG) performance status less than 3.
* renal function (serum creatinine 1.25 times the upper limit of normal, glomerular filtration rate greater than 60 ml/min)
* liver function (AST/ ALT three times the upper limit of normal, bilirubin concentrations 1.25 the upper limit of normal)
* bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count greater than 100 x 109/l).

Exclusion Criteria:

* patients with more than 4 chemotherapies in medical history
* severe cardiac disease
Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis

Pediatric patients between 6months and 6years old will be included. They are scheduled for elective general or urologic surgery at a single tertiary medical center. Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The researcher will get the symptom score of the upper respiratory tract infection in the questionnaire. The degree of anesthesia induced atelectasis is measured using lung ultrasound. Pulmonary ultrasound is performed after endotracheal intubation and at the end of the operation dividing the patient's thorax into 12 regions. The investigator grades the degree of atelectasis at each region form 0 to 3 points. After the end of the operation, check whether the respiratory adverse effects occurred during emergence and recovery at the post anesthesia care unit.


Eligibility Criteria:
Inclusion Criteria:

* Age: Pediatric patients older than 6 months and younger than 6 years
* scheduled for elective pediatric general or urology surgery.

Exclusion Criteria:

* undergoing laparoscopic surgery
* pediatric patients with lower respiratory tract infection( pneumonia , bronchiolitis )
* patients with bronchopulmonary dysplasia history
* hemodynamic instability
Correlation Between Environmental Pollution and Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) refers to the abnormal glucose metabolism index of pregnant women during pregnancy. At present, about 15% of pregnant women will develop GDM in the second and third trimester, which seriously affects the health of the pregnant woman and the fetus. However, the etiology of GDM remains unclear. Various pollutants in the environment may have a potential impact on pregnant women and fetuses. For example, previous studies have shown that exposure to atmospheric pollutants nitric oxide and organochlorine pesticides are associated with GDM. At present, we plan to further investigate the correlation between environmental pollutants and GDM.


Eligibility Criteria:
Inclusion Criteria:

* Plan to complete OGTT and give birth in the research center
* First trimester
* Singleton pregnancy
* Without diabetes before pregnancy

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
* Fetus has a known deformity or genetic defects
* Incomplete clinical data
* Assisted reproductive
Genetic Predisposition Testing Program for Pancreatic Neuroendocrine Neoplasms

This is a prospective observational multi-center pilot study of germline testing for participants receiving care at University of California participating locations with a new or existing diagnosis of Pancreatic Neuroendocrine Neoplasms (PanNEN). This protocol is an extension of existing Genetic Testing Station efforts at University of California, San Francisco (UCSF)

PRIMARY OBJECTIVE:

I. To assess the frequency of germline mutations in patients with PanNEN.

SECONDARY OBJECTIVES:

I. To assess the rates of different types of germline mutations in patients PanNEN.

II. To assess the rates of different types of variants of uncertain significance in patients with PanNEN.

III. To estimate the rate of completion of genetic testing in patients who are offered prospective germline testing.

EXPLORATORY OBJECTIVES:

I. To examine attitudes of patients who have completed germline testing.

II. To explore reasons for declining germline testing.

III. In patients with repeat germline testing, compare the frequency of germline alteration between tests.

IV. Assess the relationship between germline pathogenic variants and somatic mutations in PanNEN.

OUTLINE:

Potential eligible participants will be identified via chart review and invited to consent to the study. Study participants who agree to prospective testing and have not had previous large panel germline testing will watch an informational video about germline testing and be offered testing with University of California, San Francisco's (UCSF) Expanded Hereditary Cancer Panel. Study participants who decline germline testing will be asked to answer a one-question Declination Survey. Results will be shared with participants and their providers per the standard of practice at each participating study site. All participants who decided to receive germline testing will be asked to complete a decision survey.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed PanNEN.

   a. The diagnostic biopsy may have been taken from any site (primary or metastatic).
2. New and existing PanNEN participants will be eligible (any grade, any stage, any age \> 18 years).
3. Participants willing and able to comply with the study procedures.

Exclusion Criteria:

1. Inability to provide informed consent.
2. For participants who have not had prior testing with a dedicated germline pane of at least 80 genes:

   1. Inability to speak/read a language supported by the germline testing station (GTS). The supported languages currently include English, Korean, Japanese, Vietnamese, Russian, Tagalog, Farsi, Spanish, Cantonese, Mandarin, and Arabic).
   2. Active hematologic malignancy.
   3. History of allogenic bone marrow transplant or stem cell transplant.
Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise

We evaluated the effect of two weeks of intensive supervised physical activity in serum fibroblast growth factor 21 (FGF21) levels.

Comparative and longitudinal study. Anthropometric and biochemical evaluation were done before, 1hr and 4hr after a bout of exercise and repeated after two weeks of daily supervised exercise. We studied sedentary young healthy women. A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks. The Department of Endocrinology and Metabolism at the INCMNSZ performed all biochemical laboratory measurements using standardized procedures.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Aged 18 to 35 years old,
* Body mass index (BMI) \<30 kg/m2
* Without contraindication for exercising

Exclusion Criteria:

* Metabolic syndrome
* Diabetes
* Dyslipidemia
* Hypertension
* Asthma
* Thyroid disease
* Treated with fibrates, beta agonists or blockers
* History or current arrhythmias, murmurs, cardiomegaly, or treatment for cardiovascular diseases -
* Contraindications for exercise testing were also considered as exclusion criteria (see references)
Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers

The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of the screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age ≥ 18 and ≤ 55 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding during the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological, or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant history of orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) considered relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (greater than 24 hours) (less than 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
* Participation in another trial with an investigational drug (less than 2 months prior to administration or expected during trial)
* Smoker (more than 10 cigarettes/day or more than 3 cigars/day or more than 3 pipes/day)
* Alcohol abuse (more than 60 g of ethanol per day)
* Drug abuse
* Blood donation or loss greater than 400 mL (less than 1 month prior to administration or expected during the trial)
* Clinically relevant laboratory abnormalities
A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne

This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.

This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
* Baseline IGA score of mild, moderate or severe
* Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit

Exclusion Criteria:

* Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
* Female subjects who are pregnant, nursing, or considering becoming pregnant
* Methemoglobin \> 2% at baseline
* Clinically significant anemia at baseline
* Use of topical or systemic medications to treat acne
* Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors
Micro-interventions Aiming to Optimize Expectations or Self-compassion to Improve Well-being/Reduce Stress and Their Differential Effects

The study's aim is to determine whether brief interventions (micro-interventions) aiming to optimize expectations or enhancing feelings of self-compassion are able to improve well-being/reduce perceived stress in comparison to an active control group in an online-study

In this study we use a pre-post-test design to compare the effects of the (classic) best possible self intervention vs. the best possible self intervention (including ways on how to reach the imagined best possible future) vs. a self-compassion intervention vs. an active control group. We are interested in the differential effects and examine several moderators.

Eligibility Criteria:
Inclusion Criteria:

* fluent in German language
* access to a computer/tablet/smartphone with audio output/headphones

Exclusion Criteria:

* not willing to take part in an online-intervention (duration: 60 minutes)
* no access to a computer/tablet/smartphone with audio output/headphones
Vitamin D Treatment to Patients Suffering From Chronic Pain and Vitamin D Hypovitaminosis

The objective of this study is to check whether vitamin D will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain.

Vitamin D is a complex nutrient that functions as a hormone to benefit numerous body tissues.

Vitamin D is naturally produced by skin exposed to ultraviolet B. Despite the fact that Israel is a sunny country, a majority of all patients, and particularly those with pain, have inadequate intake of vitamin D.

Vitamin D therapy is easy for patients to self administer, well tolerated, and very economical.

In this study, we'll check whether vitamin D will lead to a decrease in pain intensity in patients suffering from chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* men and women over 18, who suffer from chronic pain and hypovitaminosis D

Exclusion Criteria:

* patients that are treated with vitamin D
Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations

The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients (20-50)
* Good oral hygiene (plaque index 0 or 1 )
* Patient approving to participate in the study
* Absence of parafunctional habits and/or bruxism

Exclusion Criteria:

* Patients with known allergic or adverse reaction to the tested materials.
* Systematic disease that may affect participation.
* Xerostomic patients.
* Bad oral hygiene (plaque index 2 or 3 )
* Heavy smokers
* Patients undergoing or will start orthodontic treatment
* Patients with removable prothesis