louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00196157: Line Versus Spot Ablation in Persistent Atrial Fibrillation
Official title: Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Detailed description: This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.

The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years
* symptomatic persistent (\> 7 days lasting) atrial fibrillation
* at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
* oral anticoagulation (\> 4 weeks prior to ablation)

Exclusion Criteria:

* moderate to severe valvular heart disease
* congenital heart disease
* LV-EF \< 35%
* reversible cause for atrial fibrillation (e.g., hyperthyreosis)
* prior left atrial ablation or Maze operation
* left atrial thrombus

Primary outcomes:
measure: Sinus rhythm in follow-up
timeFrame: Sinus rhythm in follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Claus Schmitt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Heidi Estner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01307657: Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
Official title: Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: clopidogrel
platelet
platelet function test
healthy
Platelet function tests
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether a high-fat meal affects the ability of platelet function tests to measure platelet inhibition by clopidogrel.

Detailed description: The purpose of this study is to determine the influence of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy people using platelet function assays. Twelve healthy adult subjects will be recruited to take part in this research study. After consent is obtained, subjects will be asked to present to the clinical research center after a 12 hour fast. A baseline blood sample will be drawn at 8 am, and subjects will then be administered a 600 mg dose of clopidogrel. At 12 noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Subjects will then be provided a standardized high-fat meal with an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment.

Eligibility criteria: Inclusion Criteria:

* 19 years of age or older
* healthy subjects
* deny taking medications that affect platelet function for at least 7 days prior to test

Exclusion Criteria:

* history of cardiovascular disease
* any risk factors for cardiovascular disease
* surgery in last 3 months
* history of anemia/thrombocytopenia
* pregnancy

Primary outcomes:
measure: Platelet inhibition
timeFrame: 3 time points over 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Julie Oestreich, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dobesh PP, Urban JF, Shurmur SW, Oestreich JH. Impact of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy subjects. Thromb J. 2015 Jan 23;13(1):3. doi: 10.1186/s12959-014-0033-x. eCollection 2015.
Clinical trial NCT00551057: Expression of Inflammatory Proteins in Pancreatic Cancer
Official title: Expression of Inflammatory Proteins in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cancer or chronic pancreatitis

Brief summary: The purpose of this trial is to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue.

Detailed description: Purpose: to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue

* Trial with surgical intervention

Eligibility criteria: Inclusion criteria:

* Patients with pancreatic cancer or chronic pancreatitis

Exclusion criteria:

* Patients with alpha 1-antitrypsin deficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich Department of Surgery
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Marc Schiesser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02932657: Perceived Impact of Art Therapy in Patients With Cystic Fibrosis and in Professional Interdisciplinary Teams Taking Care of Them.
Official title: Perceived Impact of Art Therapy in Patients With Cystic Fibrosis (Adolescents, Adults and Transplanted Not Transplanted) and in Professional Interdisciplinary Teams Taking Care of Them.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 23
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Will be included in this research project:

* Adolescents aged 13 to 18, followed by the cystic fibrosis Children center of Nantes that have benefited from art therapy session
* Non transplanted adult patients followed cystic fibrosis center of Foch and having already benefited from art therapy session
* The transplanted adult patients followed the transplantation center Foch and having already benefited from art therapy session

Brief summary: Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment.

Through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis aged adolescents 13 to 18 years, as part of their monitoring at cystic fibrosis center of Nantes
* Adults over 18 years nontransplanted in their follow at cystic fibrosis center/transplantation center of Foch
* More than 18 adult transplant as part of their monitoring at cystic fibrosis center/transplantation center Foch
* Professional interdisciplinary teams taking care of the cystic fibrosis children center of Nantes, cystic fibrosis center/transplantation center of Foch
* Agreeing to participate in research

Non Inclusion Criteria:

* Patient refusal of adolescent parents to participate in the study
* Professional refusal of teams to participate in the study

Primary outcomes:
measure: Patient responses to the effects of art therapy and music therapy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Nantes University Hospital
name: Valérie David, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04136457: Proteome Remodelling
Official title: Proteome Remodelling and Dynamics in Human Skeletal Muscle: Effect of Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skeletal Muscle Physiology
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the project is to investigate the proteome signature dynamics and remodelling in human skeletal muscle induced by exercise training


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* VO2max \> 55 mL/min/kgLM for men and \> 50 for women (only applicable for endurance and sprint training interventions)
* BMI \< 26

Exclusion Criteria:

* Chronic disease deemed by the medical doctor to pose a risk or to affect study outcomes
* smoking
* Use of prescription medicine deemed by the medical to affect study outcomes
* Pregnancy

Primary outcomes:
measure: Skeletal muscle proteome signature
timeFrame: Change from baseline at week 6 or 8 depending on the intervention
measure: Anabolic signaling
timeFrame: Change in anabolic signaling from rest to 1 hour following resistance exercise both at baseline and following 8 weeks of resistance training
Secondary outcomes:
measure: Skeletal muscle mitochondrial respiration
timeFrame: Change from baseline at week 6 following endurance and sprint training
measure: Maximal oxygen consumption
timeFrame: Change from baseline at week 6 following endurance and sprint training
measure: Body composition
timeFrame: Change from baseline at week 6 or 8 depending on the intervention
measure: Myonuclei
timeFrame: Change from baseline at week 8 following resistance training
measure: Satellite cells
timeFrame: Change from baseline at week 8 following resistance training
measure: Fiber size
timeFrame: Change from baseline at week 8 following resistance training
Other outcomes:
measure: Skeletal muscle mitochondrial supercomplexes
timeFrame: Change from baseline at week 6 following endurance and sprint training
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT03784157: Study Of The Metabolic Parameters Of Uterine Muscle Cells
Official title: Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Keywords: Hysterotomy
UTERINE MUSCLE CELLS
ISCHEMIA
COLD ISCHEMIA
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies

Brief summary: To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time.

Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.


Eligibility criteria: Inclusion criteria:

* - Adult patient
* Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies (fibroma, adenomyosis, genital prolapse,...) within the CMCO
* Patient consenting to the use of cells from her uterus for incineration for research purposes
* Patient giving her consent for the use of her medical data for the purposes of this research.
* Patient agreeing to participate in the study

Exclusion criteria:

* - Patient refusing to participate in the study
* Patient under the protection of justice
* Patient under guardianship or curatorship
* Suspicion of gynaecological malignant pathology
* Pregnant or breastfeeding woman
* Impossibility to give the subject informed information (difficulties in understanding the subject...)

Primary outcomes:
measure: Ischemia
timeFrame: 1 hour after sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie - CMCO
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Olivier GARBIN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05869357: Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
Official title: Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Safety Issues
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.

Detailed description: There are 106 healthy volunteers in this study. Upper left arm is divided into 2 parts (2x2 cm) which are A and B area. Upper right arm is divided into 2 parts (2x2 cm) which are C and D area. Four area (A, B, C, and D) are randomized to receive cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric, and cream base (Control group). Samples are applied 2 times/day for 6 days (Induction phase). Then, the volunteers will stop applying samples for 7 to 10 days (Free period). After that, Samples are applied 2 times/day for 3 days (Challenge phase). Erythema, melanin, humidity, transepidermal water loss, skin adverse reaction, and satisfaction are evaluated.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 60 years
* No skin diseases
* No allergy to sericin and turmeric
* No immunocompromised disease or using steroid for 2 weeks before participated in this study
* Willing to participate in this study

Exclusion Criteria:

* Uncontrolled disease, cancer, and heart disease
* Cannot follow the protocol
* Pregnancy and lactation
* Participated in other studies

Primary outcomes:
measure: Erythema index
timeFrame: 19 days
measure: Melanin index
timeFrame: 19 days
Secondary outcomes:
measure: Humidity index
timeFrame: 19 days
measure: Transepidermal water loss index
timeFrame: 19 days
measure: Skin reaction
timeFrame: 19 days
measure: Satisfaction of the volunteers
timeFrame: 19 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05310357: Chromosomal Instability in Ovarian Cancer
Official title: The Role of Chromosomal Instability in Monitoring the Course of Ovarian High-grade Serous Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
High-grade Serous Ovarian Carcinoma
Chromosomal Instability
Somatic Copy Number Distortion
Survival Outcomes
Minimal Residual Lesions
Progression-free Survival
Overall Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients confirmed of primary ovarian high grade serous carcinoma.

Brief summary: Chromosomal instability (CIN) refers to the ongoing genomic change, which involves the amplification or deletion of chromosome copy number or structure. The changes rang from point mutation to small-scale genomic change and even the change of whole chromosome number. It has been reported that the characteristics of genomic rearrangement can be used as a marker of clinical outcome of high-grade serous ovarian cancer, and specific genomic rearrangement are related to the poor prognosis. In noninvasive gene detection with low coverage, patients diagnosed with ovarian cancer have deteriorating progression-free and overall survivals regardless of the tumor stage when somatic copy number distortion (sCNA) exceeds the threshold in plasma. The detection rate of sCNA increased along with the tumor stage. We enrolled those as our target patients, who are diagnosed with high-grade serous ovarian cancer and willing to take part in. The CIN in peripheral cell-free DNA was observed before initial treatment, after primary debulking or staging surgeries, before recurrence and during the process of recurrence treatment. Our aim is to explore the application of CIN in peripheral tumor DNA in the detection of minimal residual lesions (MRD) after primary treatment and recurrence monitoring.


Eligibility criteria: Inclusion Criteria:

* Confirmed of primary ovarian high grade serous carcinoma (HGSC)
* Aged 18 years or older
* Acceptance of surgical treatment for HGSC
* With detailed follow-up outcomes

Exclusion Criteria:

* Not meeting all of the inclusion criteria
* Declining to anticipate the trial

Primary outcomes:
measure: Incidence of chromosomal instability (CIN)
timeFrame: One year
Secondary outcomes:
measure: Progression-free survival
timeFrame: One year
measure: Overall survival
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05459857: A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
Official title: A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Imperial Brands PLC
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes. The study investigates combustible and heated tobacco (HT) products in a cross-over design, including pharmacokinetic evaluation, subjective questionnaire assessments, as well as safety evaluation.

Subjects will perform a screening visit and a 5-day confinement period.


Eligibility criteria: Inclusion Criteria:

* Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
* Has a positive urine cotinine (\>500 ng/mL) at Screening
* Has an exhaled carbon monoxide \>10 ppm at Screening
* A female subject of childbearing potential must use contraception
* Male subject must use contraception

Exclusion Criteria:

* Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
* Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
* Has a fever (\>38.05°C) at Screening or check-in
* Has a history or presence of drug or alcohol abuse within 24 months of Check-in
* Pregnant or lactating females
* Has used any prescription smoking cessation treatments within 3 months prior to Check-in
* Is planning to quit smoking during the study or within the next 3 months

Primary outcomes:
measure: Nicotine Cmax
timeFrame: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
measure: Nicotine AUCt
timeFrame: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
Secondary outcomes:
measure: Urge to Smoke Pre-Use
timeFrame: 10 minutes prior to the start of the product use session
measure: Urge to Smoke Post-Use
timeFrame: At 240 min following the start of study product use
measure: Smoking Urges Emax
timeFrame: 10 minutes prior to the start of the product use session, and at 4, 8, 15, 45, 60, 210 and 240 minutes following the start of study product use
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Celerion
state: Nothern Ireland
Study officials:
References: