louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00776230: Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Official title: Immunogenicity of a Commercial Batch of the Japanese Encephalitis Vaccine IC51 up to Twenty-four Months Post Filling. An Open-label, Multicenter, Phase 3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Detailed description: Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.

The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Eligibility criteria: Inclusion Criteria:

* Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.

Exclusion Criteria:

* History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

Primary outcomes:
measure: Primary: 1. Geometric Mean Titers (GMT) at Day 56
timeFrame: 56 days post 1st vaccination
Secondary outcomes:
measure: Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability
timeFrame: see above
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Zentrum für Reisemedizin
city: Berlin
country: Germany
facility: Berliner Zentrum Reise- und Tropenmedizin
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock
Study officials:
affiliation: Valneva Austria GmbH
name: Evelyn Hatzenbichler
role: STUDY_DIRECTOR
References:
Clinical trial NCT03815630: A Study of PD1 Combined With Dc-cik in the Treatment of Solid Tumors
Official title: Clinical Study on the Safety and Efficacy of Pd-1 Combined With Dc-cik in the Treatment of Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Solid Tumor
Lead sponsor: Allife Medical Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
name: Henan Provincial People's Hospital
name: Beijing Hospital
First posted: 2019-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a single center、single arm、open-label, to investigate the safety and efficacy of PD-1 and DC-CIK with anti-solid tumor


Eligibility criteria: Inclusion Criteria:

1. Previously receiving ≥ first-line regimen chemotherapy;
2. Age over 3 years old and less than 14 years old;
3. The expected survival period is more than 3 months;
4. ECOG≤2;
5. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg / dl;
6. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L;
7. There are measurable target lesions.

Exclusion Criteria:

1. Liver and kidney function:

   * Total bilirubin \> 2 x ULN (Gilbert syndrome \> 3 x ULN)
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN
   * Serum creatinine clearance \>60mL/min
2. Serological examination:

   * Absolute neutrophil count (ANC) \<0.75x109/L
   * Platelet count (PLT) \<50x109/L
3. Active hepatitis B (HBV-DNA \> 1000 copies / ml), hepatitis C, or uncontrolled infection;
4. The number of days of chemotherapy medication and the administration of hormones below 5mg is ≤3, and the number of days of withdrawal of hormones greater than 5mg is ≤5;
5. Active CNS disease (tumor cells in CSF);
6. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
7. creatinine \> 1.5 times the upper limit of normal or ALT / AST \> 3 times the upper limit of normal or bilirubin \> 2 times the upper limit of normal;
8. The New York Heart Association (NYHA) is classified as Level III or higher;
9. Uncontrolled diabetes;
10. With other uncontrolled diseases, the investigator believes that it is not suitable for joining;
11. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.

Primary outcomes:
measure: occurrence of treatment related adverse events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04830930: A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of CKD-381 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Keywords: CKD-381
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: TREATMENT

Brief summary: A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Detailed description: A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 50 aged in healthy adult
2. Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
3. Have negative result on Helicobacter Pylori antibody test

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.

Primary outcomes:
measure: Cmax
timeFrame: 0-24 hours
measure: AUClast
timeFrame: 0-24 hours
measure: Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: ksyu@snu.ac.kr
name: Kyungsang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04897230: Effects of Yoga on Heart Rate and Heart Rate Variability Responses to Stress
Official title: The Effects of Acute Yoga Practice on Heart Rate and Heart Rate Variability Responses to Mental Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Reactivity to Stress
Keywords: yoga, mental stress, cardiac autonomic function, stress response
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction: Yoga has been shown to reduce stress and have benefits for a number of stress-related disorders. However, the effects of an acute bout of yoga practice on cardiac autonomic response to and recovery from stress remain unclear. This study aimed to examine the effect of a single bout of yoga on heart rate (HR) and heart rate variability (HRV) response to and recovery from mental stress.

Materials and Methods: This study was conducted with a randomized, counterbalanced, crossover design. A total of 44 participants completed two sessions (yoga and video watching (VW)) in randomly assigned order. After each condition, participants underwent a Stroop task and mental arithmetic task. Electrocardiogram was measured and HR and HRV for resting, each condition, and the stress and recovery periods were analyzed.


Eligibility criteria: Inclusion Criteria:

* aged between 20 and 40 years old
* a body mass index (BMI) between 18.5 and 30
* being sedentary

Exclusion Criteria:

* Electrocardiogram (ECG) abnormalities (e.g., arrhythmia, atrioventricular blocks)
* history of cardiovascular disease, diabetes, or renal disease
* contraindications for exercise (e.g., orthopedic problems)
* involvement in any yoga practice
* being pregnant or nursing
* use of tobacco products or medications that may affect cardiovascular function

Primary outcomes:
measure: Heart Rate
timeFrame: up to 5 minutes
measure: Heart Rate Variability
timeFrame: up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00173030: Genetic Study of Atrial Fibrillation: Focusing on Renin-Angiotensin System and C-Reactive Protein Genes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Multi-locus and multi-gene studies of atrial fibrillation, focusing on renin-angiotensin system genes and C reactive protein gene


Eligibility criteria: Inclusion Criteria:

* Patients with atrial fibrillation

Exclusion Criteria:

* Patients with atrial fibrillation who are reluctant for the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jiunn-Lee Lin
role: STUDY_CHAIR
References:
Clinical trial NCT01219530: Follow Up of Gestational Carriers and Intended Parents
Official title: Follow Up of Gestational Carriers and Intended Parents
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Attitudes
Reactions
Psychopathology
Keywords: gestational carrier
intended parent
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients participating in the gestational carrier program, either as a gestation carrier or an intended parent.

Brief summary: To explore the attitudes and reactions of gestational carriers and intended parents though their medical, pregnancy and postpartum experiences.

Detailed description: This study will first evaluate whether there is any existing psychopathology in gestational carriers prior to their pregnancies. Second, the study will explore the gestational carriers' and intended parents' experiences including attachment with quantitative measurements. These measurements will be collected prospectively.

Eligibility criteria: None, other than being either a gestational carrier or intended parent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Andrea M Braverman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01327430: Phospholipid Absorption of a Milk Phospholipid
Official title: Effect of a Milk Phospholipid Supplementation on the Lipid Metabolism in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: glycerophosphates
sphingomyelins
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 15
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate parameters of the lipid metabolism in plasma and feces of healthy subjects after a dietary supplementation of different dosages of milk phospholipids.

Detailed description: To date the mechanisms for the intestinal absorption of glycerophosphates and sphingolipids are not completely investigated. It is assumed, that sphingolipids and sterols compete for intestinal absorption. In addition it is unclear, if a dietary phospholipid supplementation may influence the phospholipid concentration in plasma.

To evaluate the effect of a dietary phospholipid supplementation 15 healthy female subjects received over 10 days daily 3 g of milk phospholipids stirred in a dairy product. During the following 10 days the subjects were supplemented with daily 6 g milk phospholipid. Finally, the subjects received over 10 days 6 g of the milk phospholipid in a dairy product and 2 g of plant sterols serving a commercial product.

Eligibility criteria: Inclusion Criteria:

* female
* age: between 30 and 45 years

Exclusion Criteria:

* metabolic diseases
* arteriosclerosis
* pregnancy and breast feeding

Primary outcomes:
measure: Change in plasma phospholipid concentration
timeFrame: after 0, 10, 20, and 30 days
Secondary outcomes:
measure: Plasma lipids
timeFrame: after 0,10,20, and 30 days
measure: Fecal lipids
timeFrame: after 0,10,20, and 30 days
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University of Jena, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University, Department of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keller S, Malarski A, Reuther C, Kertscher R, Kiehntopf M, Jahreis G. Milk phospholipid and plant sterol-dependent modulation of plasma lipids in healthy volunteers. Eur J Nutr. 2013 Apr;52(3):1169-79. doi: 10.1007/s00394-012-0427-0. Epub 2012 Jul 27.
Clinical trial NCT01183130: Compliance Monitoring in Real Time During Opioid Substitution Treatment
Official title: Compliance Monitoring in Real Time During Opioid Substitution Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opiate Dependence
Keywords: opiate dependence
compliance monitoring
substitution treatment
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to examine whether electronic compliance monitoring in real time could offer some advantages compared to normal electronic monitoring in opioid substitution treatment. The investigators would also like know whether this method could enable the quick detection of possible problems in medication intakes and/or prevent the abuse or diversion of substitution medications.


Eligibility criteria: Inclusion Criteria:

* Opiate dependence
* Suboxone treatment
* Stable substitution medication dose

Exclusion Criteria:

* Chaotic situation in life

Primary outcomes:
measure: The effectiveness of treatment (Treatment Outcomes Profile TOP)
timeFrame: Every four weeks.
Secondary outcomes:
measure: Patients´opinions about the treatment.
timeFrame: Once when the study phase ends (after the 8 th study week).
Other outcomes:
Locations:
Study officials:
affiliation: Kuopio University Hospital, University of Eastern Finland
name: Ulrich Tacke, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02368730: Documentation of the Efficacy of Desmopressin Within the Context of Surgical Procedures
Official title: Documentation of the Efficacy of Desmopressin (MINIRIN Parenteral 4 Microgram/ml Solution for Injection) Within the Context of Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Dysfunction
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital doctors specialised in anaesthesia

Brief summary: In this non-interventional multicentre, prospective, observational cohort study, the efficacy of desmopressin is evaluated in patients with platelet dysfunction due to acetylsalicylic acid or cox-1-inhibitors within the context of surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Pre-, peri- or postoperative treatment with a standard dose of desmopressin as a result of platelet dysfunction (disturbance of blood platelet function) due to treatment with acetylsalicylic acid or cox-1-inhibitor.
* Decision on the therapy with MINIRIN parenteral 4 Microgram/ml solution for injection has already been made independently by the physician beforehand
* The patients (≥ 18 years) have been informed about the non-interventional study and have given their written consent for participation

Exclusion Criteria:

* Participation in a clinical trial
* Treatment with acetylsalicylic acid for cardiovascular indications

Primary outcomes:
measure: Change in platelet function pre- and post-administration of desmopressin
timeFrame: From baseline up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT00550225: Succinate Salt Version of GSK961081 for Healthy Volunteers
Official title: A Randomised, Double-blind, Dose Escalating Study in Healthy Volunteers to Assess the Safety, Tolerability, Extra Pulmonary Pharmacodynamics and Pharmacokinetics of Single Doses of GSK961081 (Succinate Salt)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: succinate
anti-muscarinic
b-agonist
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2007-10-29
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Salt Bridging study for GSK961081


Eligibility criteria: Inclusion Criteria:

* Healthy adult males or female aged between 18 and 50 years.
* Body mass index within the range 19-29.9 kilograms/metre2
* Forced Expiratory Volume in 1 second (FEV1) \>80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \> 0.7
* Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years.

Exclusion criteria:

* Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
* History of respiratory disease
* Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening \>450msec on an individual ECG or a PR interval outside the range 120-210 msec
* Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
* Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
* Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
* Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
* Infected with the Hepatitis B, Hepatitis C, or HIV virus
* Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation

Primary outcomes:
measure: FEV1 at intervals
timeFrame: during the 10 week study
measure: Cardiac monitoring at intervals
timeFrame: during the 10 week study
Secondary outcomes:
measure: Plasma concentrations of GSK961081 at intervals
timeFrame: during the 10 week study
measure: PK parameters at intervals
timeFrame: during the 10week study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: