louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03062982: Food-Effect and Metabolism Study in Healthy Subjects
Official title: A Phase I, Open-label, 2-sequence, Cross-over, Pharmacokinetic (PK) Study to Evaluate the Effect of the Food and to Identify the Metabolism of Fluzoparib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.


Eligibility criteria: Inclusion Criteria:

* Able and willing to give written informed consent.
* Must be willing to comply with the requirements of the study.
* Willing to use a medically acceptable method (as defined by the Investigator) of birth control in the 6 months.
* Male or female aged 18-50 years.
* Weight more than 45kg, BMI within 18 and 28 kg/m2.
* No clinically significant abnormalities in physical examination and lab tests.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* No history of alcohol or drug abuse within the past year.
* Participation in any clinical trial of an experimental drug or device in the previous 3 months.
* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.

Primary outcomes:
measure: Pharmacokinetics - Cmax
timeFrame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h
measure: Pharmacokinetics-AUC
timeFrame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h
measure: Pharmacokinetics - Tmax (Hours)
timeFrame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h
measure: Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC
timeFrame: 0-96h post dose if availabel
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hosital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT01739582: An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Official title: An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hypogonadism
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety profile of Androxal in men with secondary hypogonadism.

Detailed description: This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Eligibility criteria: Inclusion Criteria:

• Successful completion of either ZA-301 or ZA-302

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Primary outcomes:
measure: Testosterone levels
timeFrame: 26 weeks
Secondary outcomes:
measure: Follicle Stimulating Hormone and Leutinizing Hormone
timeFrame: 26 weeks
measure: Diabetic Parameters
timeFrame: 26 weeks
measure: Change in weight and body mass index (BMI)
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00976482: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Official title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradyarrhythmia
Keywords: Cardiovascular
Pacemaker
Mortality
Physiologic pacing
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 1745
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: Patient implanted with permanent pacemaker accroding to guidelines.

Brief summary: The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.

Detailed description: The principal objective of the OPTI-MIND study is to collect data on two-year all-cause mortality in a general population implanted with a PM according to current clinical practice. Additionally, the study aims to stratify the outcome by both known patient-related risk factors and by physiologic pacing mode setting (a specifically defined PM programming). Stratification will be done for pre-specified classes of patients on the basis of their primary rhythm disease.

Eligibility criteria: Inclusion Criteria:

* Patients implanted with a current Boston Scientific pacemaker (all ALTRUA models) or any future commercially available Boston Scientific PM families according to international and local guidelines for pacemaker implantation;
* Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
* Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* Unable to be followed up by the participating centres for a period of two years;
* Current device implanted for more than 15 days;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
* Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. Each instance should be brought to the attention of the sponsor to determine eligibility.

Primary outcomes:
measure: Two-year All-cause Mortality
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Katholisches Krankenhaus, St.Johannes Hospital
Study officials:
affiliation: Az. Osp. S. orsola - Malpighi, Bologna, Italy
name: Mauro Biffi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06747182: Mobile Phone-based Smoking Cessation Program
Official title: Mobile Phone-based Smoking Cessation Program for Individuals With Cardiovascular Risk or Disease in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder (SUD)
Keywords: smoke cessation
cardiovascular diseases
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this online, randomized controlled trial (RCT), the participants will be randomized and allocated in 1:1 ratio to mobile phone-based intervention group or to the wait-list control group. Participants will receive a 12-week intervention with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 2000 smokers with willingness to make a quit attempt within a month from October 2022 to April 2023 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in November 2023. The trial results will be available by the end of 2023 .


Eligibility criteria: Inclusion Criteria:

* In this RCT, approximately 2,000 smokers (a smoker is defined as an individual who smoked 100 cigarettes in their lifetime, and currently smoke ≥ 5 cigarettes per day) who are willing to make a quit attempt within one month with CVDs diagnosis or risk.

Exclusion Criteria:

* patients unwilling to quit smoking

Primary outcomes:
measure: Continuous smoking abstinence
timeFrame: at week 26 after the quit date
Secondary outcomes:
measure: 7-day point prevalence smoking abstinence
timeFrame: week 1, 2, 3, 4, 8, 12, 16, 20 and 26
measure: self-reported continuous smoking abstinence
timeFrame: week 4, 8, 12, 16, 20 and 26 after the quit date
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
state: Zhejiang
Study officials:
References:
Clinical trial NCT00004382: Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperbilirubinemia
Keywords: hematologic disorders
hyperbilirubinemia
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Rockefeller University
First posted: 1999-10-19
Enrollment: 80
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece.

II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.

Detailed description: PROTOCOL OUTLINE: Patients are randomly assigned to a clinical group within 96 hours of birth. Patients are stratified by gestational age, clinical status, and age at treatment.

One group receives tin mesoporphyrin. Patients are crossed to phototherapy if the plasma bilirubin concentration reaches the treatment threshold.

The second group receives phototherapy with Special Blue fluorescent lamps for at least 24 hours. Patients receive a second phototherapy course if the plasma bilirubin concentration reaches the treatment threshold within 24 hours of the first course.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Premature infants of gestational age 210 to 251 days
* No blood group isoimmunization (direct Coombs' positive), e.g., rhesus or ABO
* No glucose-6-phosphate dehydrogenase deficiency

--Prior/Concurrent Therapy--

* No maternal phenobarbital in last month of pregnancy

--Patient Characteristics--

Renal: No congenital renal abnormality

Cardiovascular: No congenital heart abnormality

Pulmonary: No asphyxia requiring assisted ventilation at delivery

Other: No other major congenital abnormality, i.e.:

* Central nervous system
* Chromosomal
* Gastrointestinal

No evident or suspected congenital infection, i.e.:

* Cytomegalovirus
* Herpes
* Rubella
* Syphilis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rockefeller University
name: Attallah Kappas
role: STUDY_CHAIR
References:
Clinical trial NCT00921882: Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum?
Official title: Is it Possible to Screen for Type 2 Diabetes at Day 2 Gestational Diabetes Mellitus Postpartum?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Type 2 Diabetes
Keywords: Type 2 diabetes
Post-partum screening
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 51
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: Women with gestational diabetes mellitus who delivered.

Brief summary: Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.


Eligibility criteria: Inclusion Criteria:

* Dx of gestational diabetes treated with insulin
* To be in post-partum
* Delivery of a baby of at least 37 weeks of gestation
* Have signed the consent form

Exclusion Criteria:

* History of glucose intolerance of diabetes before the pregnancy
* Obstetrical pathology during pregnancy

Primary outcomes:
measure: Oral glucose tolerance test
timeFrame: 8 weeks post partum
Secondary outcomes:
measure: Acceptability of screening test
timeFrame: 8 weeks post partum
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493982: Evaluation of the Be Vape Free Curriculum of the Tobacco Prevention Toolkit
Official title: Evaluation of the Be Vape Free Curriculum of the Tobacco Prevention Toolkit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: E-cigarette Use
Keywords: youth
tobacco
education
health
prevention
vaping
e-cigarette
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-09
Enrollment: 10800
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. A set of lessons focused on e-cigarette/vaping prevention education specifically is called the Be Vape Free curriculum. The aims of this study are to determine: (1) whether the Be Vape Free curriculum is effective in increasing middle and high school students' resistance to using tobacco and in decreasing positive attitudes towards and intentions to use e-cigarettes; (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco; and (3) Examine heterogenous treatment effects identifying groups that benefit the most and those who do not benefit at all from the intervention.


Eligibility criteria: Inclusion Criteria:

Middle school and high school students receiving health education at schools participating in the study

Exclusion Criteria:

None

Primary outcomes:
measure: Change in e-cigarette use
timeFrame: Change from baseline to follow-up at approximately 156 weeks
measure: Change in intention to use of e-cigarettes scaled score as measured by investigator-originated survey
timeFrame: Change from baseline to follow-up at approximately 156 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Bonnie Halpern-Felsher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02930382: Assessment of Spontaneous Baroreflex Sensitivity in Carriers of Implantable Cardioverter Defibrillators: Association With Disorders of the Ventricular Heart Rate. Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years after myocardial infarction (MI) in primary prevention.

Left ventricular ejection fraction (LVEF) is proposed as the one tool predicting sudden cardiac death after MI.

Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after MI was predictor of sudden death.


Eligibility criteria: Inclusion Criteria:

* Patients implanted with an implantable cardioverter defibrillator for primary prevention of of cardiac sudden death, ischaemic cardiomyopathy
* Implantable cardioverter defibrillators implantation for at least 3 years
* Age ≥ 18 years

Exclusion Criteria:

* ventricular or atrial pacing ≥1%,
* atrial fibrillation history
* age under 18 years

Primary outcomes:
measure: spontaneous baroreflex sensitivity by the sequence method (mean slope)
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU DE Poitiers
Study officials:
References:
Clinical trial NCT03789682: CD155 in Bladder Cancer
Official title: Predictive Value of CD155 for Survival and Effectiveness of Chemotherapy in Patients With Muscle Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with non-metastatic muscle invasive bladder cancer underwent cystectomy in Fudan University Shanghai Cancer Center is included

Brief summary: This research is designed to investigate the prognostic and predictive value of CD155 in muscle invasive bladder cancer.


Eligibility criteria: Inclusion Criteria:

* patients with non-metastatic muscle invasive bladder cancer
* pathology confirmed urothelial carcinoma
* underwent cystectomy and pelvic lymph node dissection

Exclusion Criteria:

* not enough tissue for immunohistochemistry
* patients with a second neoplasm

Primary outcomes:
measure: Recurrence free survival
timeFrame: 2018.1.1-2023.12.31
Secondary outcomes:
measure: Overall survival
timeFrame: 2018.1.1-2028.1.1
measure: Benefit from neoadjuvant chemotherapy
timeFrame: 2018.1.1-2028.1.1
measure: Benefit from adjuvant chemotherapy
timeFrame: 2018.1.1-2028.1.1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT05926882: Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.
Official title: Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alopecia Areata
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alopecia areata (AA) is a disease characterized by hair cycle dysfunction and the presence of peribulbar and perifollicular mononuclear cell infiltrate.1 The majority of patients report the rapid onset of one or several well-defined, usually round, 1 to 4 cm areas of scalp hair loss. A common feature is the presence of "exclamation-mark" hairs that are broken and short hairs that taper proximally.

Commonly used treatment modalities are steroids (intra-lesional, topical or systemic), contact immunotherapy, anthraline, minoxidil, calcineurine inhibitors, topical retinoids, systemic immune modulating agents, photo-chemotherapy, dermatography wigs and hypnotherapy etc Apremilast is a newer drug. It is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), this may be effective treatment for a variety of inflammatory skin disorders such as alopecia areata.

Detailed description: Due to its increasing prevalence and lack of local data on its long term management, the investigators designed current study On Efficacy of Oral Apremilast in Alopecia areata in-order to evaluate its effectiveness.

Eligibility criteria: Inclusion Criteria:

* Either gender.
* Age 20-70 years.

Exclusion Criteria:

* Patients with history of connective tissue disorder, vasculitis, seropositive and seronegative arthritis
* Patients with history of psoriasis.
* Patients excluded from the study will be patients having history of previous treatments with some systemic agents

Primary outcomes:
measure: Efficacy of Oral Apremilast in the treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi
timeFrame: It will be assessed upto 12 weeks
Secondary outcomes:
measure: Mean difference of Salt score before and after the treatment
timeFrame: it will be assessed upto 12 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: JPMC
state: Sindh
Study officials:
affiliation: JPMC
name: Nazia Jabeen, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: JPMC
name: Khadija Asadullah, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: JPMC
name: Faiza Inam, FCPS
role: PRINCIPAL_INVESTIGATOR
References: