louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00819312: YAZ, Oral Contraceptive Registration in China
Official title: A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraceptives,
Oral Hormonal;
Contraceptive Methods;
Female
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 675
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.


Eligibility criteria: Inclusion Criteria:

* Healthy women between 18 and 45 requesting oral contraception.
* Smokers may not exceed 30 years of age.

Exclusion Criteria:

* The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.
* Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
* Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea
* Any disease or condition that may worsen under hormonal treatment
* Other contraceptive methods such as sterilization or IUD/IUS
* Substantial overweight (BMI \> 30 kg/m2).

Primary outcomes:
measure: The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
timeFrame: 13 cycles (1 cycle= 28 days)
Secondary outcomes:
measure: Bleeding pattern indices
timeFrame: 13 cycles
measure: Cycle control parameters
timeFrame: 13 cycles
measure: Adverse events
timeFrame: Whole study period
measure: Laboratory tests
timeFrame: Whole study period
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Wuhan
country: China
state: Hubei
city: Nanjing
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Yangzhou
country: China
state: Jiangsu
city: Shenyang
country: China
state: Liaoning
city: Jinan
country: China
state: Shandong
city: Xi An
country: China
state: Shanxi
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Hongkong
country: Hong Kong
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00876512: CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study
Official title: CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Keywords: thienopyridine resistance
stable effort angina
platelet activation
ADAMTS13
von Willebrand Factor
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kumamoto University Hospital, Kumamoto Chuo Hospital and Saisekai Kumamoto Hospital

Brief summary: Dual antiplatelet therapy with aspirin and thienopyridines decreases the rate of stent thrombosis in patients undergoing percutaneous coronary intervention (PCI). However, despite intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. The present study is designed in order to clarify the influence of CYP2C19 genetic polymorphism on the several biomarkers for platelet activation in Japanese patients treated with thienopyridines undergoing elective PCI.

Detailed description: We enrolled patients with stable effort angina who received dual-antiplatelet therapy with both aspirin (100mg) and clopidogrel (75mg). We performed PCI 12-24 hours after 300mg loading dose of clopidogrel, or at least 7 days of 75mg clopidogrel treatment after 300mg initial loading dose. We examined platelet adhesiveness, plasma biomarkers for platelet activation such as plasma VWF and ADAMTS13, CD40L, P-Selectin levels, and ADP-induced platelet aggregation using Light transmittance aggregometry (LTA) and VerifyNow P2Y12 assay system in those patients. We also analyzed the CYP2C19 genetic polymorphism to examine the influence of this genetic variation on the several biomarkers for platelet activation.

Eligibility criteria: Inclusion Criteria:

* The stable effort angina patients
* More than 20 years old
* Undergoing elective PCI treated with aspirin and clopidogrel

Exclusion Criteria:

* Patients treated with the following medical therapy (ie. Warfarin, Steroid, thrombolytic drug, Ticlopidine, Sarpogrelate hydrochloride or Cilostazol)
* Patients with the following diseases (deep vein thrombosis, atrial fibrillation, collagen disease, infection, liver or renal dysfunction, malignant diseases)

Primary outcomes:
measure: Platelet function tests
timeFrame: before, immediately after, 1, 2, and 28 days after elective PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
Study officials:
References:
Clinical trial NCT02952612: Active Surveillance of Papillary Thyroid Microcarcinoma
Official title: Active Surveillance of Papillary Thyroid Microcarcinoma (PTMC) in Catholic Medical Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer, Papillary
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational study enrolls patients who was diagnosed as papillary thyroid microcarcinoma by FNA (Fine needle aspiration) or CNA(Core needle aspiration) and who wish to be enrolled this study.

Brief summary: Papillary thyroid microcarcinoma are small thyroid cancer measuring 1cm or less. Most of this tumor are not palpable and are identified either through pathologic examination or from imaging modalities, such as CT scan or thyroid sono. Active surveillance of papillary microcarcinoma is to observe thyroid papillary cancer without immediate surgical approach. The purpose of this study is to understand more about the characteristics of papillary microcarcinoma, which has been known for "the cancer slowly progression"


Eligibility criteria: Inclusion Criteria:

1. \< 1 cm solitary nodule
2. Surrounded by ≥ 2 mm normal thyroid parenchyma
3. Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery
4. No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
5. No extrathyroidal extension
6. Clinically N0 and Clinically M0
7. ≥ 18 years
8. Combined severe comorbidities or Inoperable condition (optional)
9. No wish to surgery and Willingness to accept active surveillance
10. No history of radiotherapy on head and neck area
11. Accepted by the Board of Thyroid Cancer Meeting

Exclusion Criteria:

1. ≥ 1 cm nodule and multifocal nodules regardless of size
2. Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer)
3. Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
4. Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery
5. Extrathyroidal extension
6. Any of N1 or M1
7. Documented increase in size according to America Thyroid Association (ATA) guideline in a previously confirmed Papillary thyroid microcarcinoma
8. \< 18 years
9. Not willing to accept observational active surveillance approach

Primary outcomes:
measure: Progression of papillary thyroid microcarcinoma
timeFrame: 5 years after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seocho-Gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Dong-Jun Lim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04329312: Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis
Official title: Differential Diagnosis of Pulmonary Hypertension With Automated Image Analysis - a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Hypertension
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Institute for Lung Vascular Research
First posted: 2020-04-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Populations are recruited from the patients visiting the outpatient clinic for pulmonology of the Medical University of Graz.

Brief summary: The aim of the study is to determine relevant morphologic parameters of the lung vasculature for the differentiation between different groups of patients with pulmonary hypertension (PH) by thoracic computer tomography (CT). In this pilot study patients undergoing right heart catheterization will be investigated by thoracic CT and special software to determine morphologic readouts.

The investigators expect that using this non-invasive method, parameters relevant for the differentiation of the patients with PH can be determined.

Detailed description: Pulmonary hypertension (PH) is defined as an elevated mean pressure in the pulmonary artery above 20mmHg determined at right-heart catheterization. Depending on the presentation and pathogenesis, patients are classified according to five main groups. A correct classification is crucial, since it is essential for the available therapy options.

A promising non-invasive method to provide important hemodynamic and clinical Information is the fully-automatic analysis of thoracic computed tomography images. This method can yield a number of quantitative morphologic readouts of the lung vasculature and the parenchyma.

This study aims to identify quantitative markers from the fully-automatic image analysis, which allow a discrimination between the various PH patient groups.

Eligibility criteria: Inclusion Criteria:

* Patients with right-heart catheterization
* Clinical indication for thoracic CT

Exclusion Criteria:

* Pregnancy
* Decreased kidney function
* Intolerance to contrast material
* Other standard CT contraindications

Primary outcomes:
measure: Lung vessel morphology
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz, Division of Pulmonology
state: Steiermark
Study officials:
affiliation: Medical University of Graz
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06411912: A Study of NIDO-361 in Patients With SBMA
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NIDO-361 in Patients With Spinal and Bulbar Muscular Atrophy (SBMA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Spinal and Bulbar Muscular Atrophy
Kennedy's Disease
Lead sponsor: Nido Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to receive NIDO-361 or placebo at the recommended Phase 2 dose (RP2D) of 100 mg once daily. Patients will receive daily oral doses of NIDO-361 or placebo for 12 months.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of NIDO-361 in adult patients with Spinal and Bulbar Muscular Atrophy (SBMA).


Eligibility criteria: Inclusion Criteria:

* Ambulatory male
* Documented SBMA diagnosis confirmed by DNA genetic testing
* Able to complete six-minute walk test (6MWT)

Exclusion Criteria:

* Clinically significant cardiovascular, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurologic, immunologic, malignant, metabolic, psychiatric, or other condition that, in the opinion of the Investigator, precludes the participant's safe participation in the study or would interfere with the study assessments
* Inability to undergo MRI (mild sedation may be allowed)

Primary outcomes:
measure: Change from baseline in thigh and total lean muscle volume as assessed by whole-body MRI
timeFrame: Through study completion, an average of 1 year
measure: Number of patients with adverse events or serious adverse events. Number of patients discontinuing study and number of deaths. Number of mild, moderate, and severe adverse events.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Klinik for Nerve- og Muskelsygdomme & Copenhagen Neuromuscular Center
city: Milano
country: Italy
facility: IRCCS Istituto Neurologico Carlo Besta
city: Padova
country: Italy
facility: Azienda Ospedale Università di Padova
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: London
country: United Kingdom
facility: University of College London Hospital (UCLH)
Study officials:
References:
Clinical trial NCT03271112: Frailty Prevention in Elders From Reunion Island
Official title: Frailty Prevention in Elderly People From Reunion Island: Effects of Adaptated Exercises on Physical Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Physical Activity
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Institut de Recherche pour le Developpement
name: General Social Security Fund
First posted: 2017-09-01
Enrollment: 97
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilote study
Primary purpose: PREVENTION

Brief summary: In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty. Social welfare has developped exercise programs to promote physical activity especially for elderly with higher risk factors of frailty, including low incomes.

The study evaluates the potent benefit effect of such exercise program on physical performance and frailty improvement in seniors from Reunion Island. All seniors participate to a 12-weeks exercise program especially dedicated to this targeted population needs and ability.

Detailed description: Regular physical activity has been shown to slow down sarcopenia, and increase strengh in elders. Nevertheless, senior with low incomes do not usually have access to physical activity areas.

Social partners are in close relationship with these elders and could promote free exercise programs dedicated to elders classified as "GIR5-6" according to the French scale "AGIRR". The AGIRR scale takes into account several criteria allowing the evaluation of the level of autonomy. The level of autonomy is closely related to frailty and could be reversed since elders have not reach a dependant-state. The "GIR5-6" level means that elderly people are still not dependant but exhibit several frailty risk factors.

The level of frailty and the physical performance of the participants is assessed by standard geriatric evaluation before the 12-wks exercice program. The improvement of the physical performance is assessed after he 12-wks exercice program.

Eligibility criteria: Inclusion Criteria:

* Retired
* with an autonomy level corresponding to the "GIR 5-6" level of the French "AGIRR scale"
* informed consent

Exclusion Criteria:

* physical activity prohibited
* under guardianship

Primary outcomes:
measure: Physical performance improvement
timeFrame: Physical performance improvement from baseline to 12 wks
Secondary outcomes:
measure: Quality of life score
timeFrame: SF36 improvement from baseline to 12 wks
Other outcomes:
Locations:
city: Saint-joseph
country: Réunion
facility: Chu Reunion Island
Study officials:
affiliation: Centre Hpospitalier Universitaire de La REUNION
name: Jean-Marc EYCHENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05397912: Uterine Elastography: a Potential Predictor of Embryo Transfer Success
Official title: Uterine Elastography: a Potential Predictor of Embryo Transfer Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to one of our offices for an ultrasound the day prior to embryo transfer will be reviewed for inclusion. Patients will be undergoing euploid, single, frozen embryo transfer.

Brief summary: To determine if the mean elasticity value (measured in kilopascals, kPa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (FET) success and long term reproductive outcomes when measured the day prior to FET.


Eligibility criteria: Inclusion Criteria:

1. Female patients, 18yo-45yo, presenting for ultrasound the day prior to embryo transfer
2. Patients planning to undergo single embryo transfer (SET) of a euploid embryo by Preimplantation genetic testing for aneuploidy (PGT-A)
3. Uterine evaluation prior to transfer (saline sonogram or hysteroscopy) within 1 year
4. Egg recipients

Exclusion Criteria:

1. Gestational carriers
2. BMI \> 35
3. Diagnosis of a uterine anomaly
4. History of uterine surgery, excluding polypectomy, c-section, D\&C
5. Communicating hydrosalpinx
6. Transfer of an embryo of unknown ploidy status or embryos of undetermined safety
7. Surgically retrieved sperm
8. Embryos that were cryopreserved on day 7 of development
9. Poor quality embryos defined by modified Gardner grading criteria used in the embryology lab
10. Sonographically abnormal appearing uteri, including distortions from leiomyomas and thin endometrium

Primary outcomes:
measure: Sustained Implantation Rate
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
measure: Chemical Pregnancy
timeFrame: 8-10 days after embryo transfer
measure: Clinical Pregnancy
timeFrame: 2-4 weeks after embryo transfer
measure: Clinical Pregnancy Loss
timeFrame: 2-40 weeks after embryo transfer
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Marie Werner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00665912: Platelet-Rich and Concentrated Platelet-Poor Plasma to Reduce Air Leak Post-Lobectomy: A Randomized Controlled Trial
Official title: Platelet-Rich and Concentrated Platelet Poor Plasma to Reduce Air Leak Post Lobectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: University of Western Ontario, Canada
First posted: 2008-04-24
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak after lobectomy for lung tumours.


Eligibility criteria: Inclusion Criteria:

* Patients requiring a lobectomy

Exclusion Criteria:

* Pneumonectomy
* Sleeve lobectomy
* Determination of unresectability (prior to the initiation of lobectomy)
* Wedge resection alone

Primary outcomes:
measure: Duration of postoperative air leak
timeFrame: Every 4 hours of postop hospital stay, between 4-6 weeks postop
Secondary outcomes:
measure: Incidence of air leak, Prolonged air leak (> days), Complications
timeFrame: Every 4 hours of postop hospital stay, between 4-6 weeks postop
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario: Division of Thoracic Surgery
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Richard Inculet, MD, FRCSC, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Darrin Payne, MD
role: STUDY_CHAIR
affiliation: Western University, Canada
name: Dalilah Fortin, MD
role: STUDY_CHAIR
affiliation: Western University, Canada
name: Richard Malthaner, MD
role: STUDY_CHAIR
affiliation: Western University, Canada
name: Robert Humphrey, MD
role: STUDY_CHAIR
References: