louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01779232: Danazol Treatment in Endometriosis Women Before IVF
Official title: Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometriosis
Ovarian Cysts
Infertility
Keywords: endometriosis
ivf
ovarian reserve
danazol
Lead sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor class: NETWORK
First posted: 2013-01-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pre-treatment with danazol for at least 4 months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.

Detailed description: Endometriosis is a chronic benign disease defined by the presence of endometrial tissue outside the uterine cavity, affecting women in their reproductive age. This disease is clinically characterized by infertility pelvic pain and the presence of ovarian cysts, endometriomas, and affects the about 10% of women. Women with endometriosis when undergo IVF show lower pregnancy rate than general population, and a reduced ovarian reserve, due to the diseases and often to ovarian surgery. The aim of this study is to evaluate if a pre-treatment with danazol, an anti-estrogenic agent, may improve the otcome of IVF cycles in these women

Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian endometriotic cysts infertility

Exclusion Criteria:

- age more than 40 years systemic disease antimulleran hormone (AMH)\<1 and FSH\>20

Primary outcomes:
measure: pregnancy rate
timeFrame: 12 months
Secondary outcomes:
measure: implantation rate
timeFrame: 12 months
Other outcomes:
measure: number of mature oocyte collected
timeFrame: 12 months
Locations:
city: Rome
country: Italy
facility: CERM
Study officials:
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
name: Marco Sbracia, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03488732: Valvular Heart Disease Registry
Official title: Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valvular Heart Disease
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing transcatheter valvular interventions

Brief summary: Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.


Eligibility criteria: Inclusion Criteria:

- Severe valvular defect planned for valvular intervention

Exclusion Criteria:

- No informed consent

Primary outcomes:
measure: All-cause mortality
timeFrame: 10 years
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 10 years
measure: NYHA status
timeFrame: 10 years
measure: Grade of mitral regurgitation
timeFrame: 10 years
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik für Innere Medizin I
Study officials:
References:
Clinical trial NCT03618732: A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient
Official title: A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
upper limb
motor control
function
bilateral movement
virtual reality
Lead sponsor: Shatin Hospital
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 93
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: stratified, single-blinded, intervention and controlled study
Primary purpose: TREATMENT

Brief summary: This study aims at investigating whether bilateral movement-based training with computer games could augment motor function of paretic upper limb and improve quality of life in sub-acute stroke patients.


Eligibility criteria: Inclusion Criteria:

* Age between 45-85
* Diagnosis of ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography 1 week to 6 months after the onset of current stroke
* Scoring \> 6 of 10 of Abbreviated Mental Test
* Ability of the paretic hand to hold the game controller (minimal control)
* Able to give informed consent of the study
* Can understand instructions given by English or Cantonese

Exclusion Criteria:

* Any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment
* Having cardiac pacemaker
* Receptive dysphasia
* Undergoing drug studies or other clinical trials

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks
timeFrame: Change from baseline to 4 weeks
measure: Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followup
timeFrame: Change from baseline to 12 weeks (4 weeks after training ended)
Secondary outcomes:
measure: Action Research Arm Test (ARAT) baseline to 4 weeks
timeFrame: Change from baseline to 4 weeks
measure: Action Research Arm Test (ARAT) baseline to 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Action Research Arm Test (ARAT) baseline to followup
timeFrame: Change from baseline to 12 weeks (4 weeks after training ended)
measure: Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks
timeFrame: Change from baseline to 4 weeks
measure: Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks
timeFrame: Change from baseline to 8 weeks
measure: Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup
timeFrame: Change from baseline to 12 weeks (4 weeks after training ended)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02261532: A Phase I Study of TAS-102 in Solid Tumors
Official title: A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.

Detailed description: This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.

Eligibility criteria: Inclusion Criteria:

* 1. Has provided written informed consent prior to performance of any study procedure.
* 2. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
* 3. Is able to take medications orally.
* 4. Has adequate organ function (bone marrow, kidney and liver).
* 5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* 1. Has received TAS-102.
* 2. Has suffered serious complications.
* 3. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
* 4. Has had prior gastrectomy.
* 5. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.

Primary outcomes:
measure: Cmax (Maximum Plasma Concentration) of FTD
timeFrame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
timeFrame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
timeFrame: Multiple time points on Day 1 and Day 12 of Cycle 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Taiho Pharmaceutical Co., Ltd selected site
Study officials:
References:
citation: Wang X, Zhou J, Li Y, Ge Y, Zhou Y, Bai C, Shen L. Pharmacokinetics, Safety, and Preliminary Efficacy of Oral Trifluridine/Tipiracil in Chinese Patients with Solid Tumors: A Phase 1b, Open-Label Study. Clin Pharmacol. 2020 Apr 9;12:21-33. doi: 10.2147/CPAA.S232104. eCollection 2020.
Clinical trial NCT02470832: A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Patient Study
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers
* Ages 18 to 60 years, inclusive
* A body mass index (BMI) between 18 to 32 kg/m2, inclusive
* Agreement to comply with study restrictions

Exclusion Criteria:

* History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities
* Electrocardiogram (EGC) or vital signs abnormalities
* Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
* Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
* Pregnant or lactating
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Primary outcomes:
measure: Area under the plasma concentration-time curve from 0-t (AUC0-t)
timeFrame: Within 29 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Within 29 days
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: Within 29 days
Secondary outcomes:
measure: Change from baseline in QTcF
timeFrame: Up to 29 days
measure: Incidence of adverse events
timeFrame: Within 43 days
measure: Clinically significant changes from baseline in physical examination or laboratory parameters
timeFrame: Within 29 days
measure: Mean model parameters of RG1662 concentration vs. QTcF changes
timeFrame: Within 29 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06556732: Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease
Official title: Potential Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital on AF patients with structural heart disease. Eplerenone 25 mg daily will be given and searching for AF recurrence among study population.

Detailed description: This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital, on 100 patients with AF and structural heart disease. AF is confirmed by electrocardiography. The patients were divided into 2 groups:

Group A (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Group B (control group): 50 patients received amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Eligibility criteria: Inclusion Criteria:

* Patients with non-valvular AF who underwent cardioversion to sinus rhythm either medical, electrical or even spontaneously

Exclusion Criteria:

* Patients with rheumatic heart disease.
* Thyroid dysfunction.
* Wolf-Parkinson-White (WPW) syndrome.
* Renal impairment.
* Hyperkalemia.
* Acute coronary syndrome.
* Pregnancy.
* Left ventricular (LV) dysfunction with ejection fraction (EF) less than 40%.
* On current use of eplerenone.

Primary outcomes:
measure: AF recurrence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Heart Hospital
Study officials:
References:
Clinical trial NCT03448432: Prevalence Study of the Etiology of Pregnancy Anemia
Official title: Prevalence Study of the Etiologies of Pregnancy Anemias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Anemia
Keywords: Pregnancy Anemia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 700
Sex: FEMALE
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: Pregnant woman with anemia

Brief summary: Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.


Eligibility criteria: Inclusion Criteria:

* woman 18-years or older
* woman with a normal pregnancy
* anemia with accidental or symptomatic discovery, whatever the term of pregnancy
* non opposition collected

Exclusion Criteria:

* Refuse to participate
* Stopped pregnancy whatever the term
* Medical abortion of pregnancy

Primary outcomes:
measure: Prevalence of the etiologies of anemias occured during pregnancy
timeFrame: from date of inclusion until 6 weeks after delivery
Secondary outcomes:
measure: Study of obstetrical complications in women with anemia
timeFrame: from date of inclusion until delivery
measure: Study of the evolution of anemia during pregnancy and postpartum
timeFrame: from date of inclusion until 6 weeks after delivery
measure: Describe the etiological and therapeutic management of pregnancy anemias
timeFrame: from date of inclusion until 6 weeks after delivery
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT06645132: Understanding the Implementation of Cued Exercise Using Wearable Devices and a Custom Smartphone Application Following Bone Marrow Transplant.
Official title: Pilot Study to Understand the Feasibility of Implementing a Wearable Device Cueing System Following Bone Marrow Transplant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Cancer
Bone Marrow Transplant (BMT)
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a Fitbit), that would send personalized reminders to move during their post-transplant inpatient hospital stay to promote physical recovery and well-being.

Detailed description: Enrolled patients who have been diagnosed with a hematologic malignancy and are scheduled to undergo an allogeneic bone marrow transplant will use a custom-designed wearable device and smartphone application as a behavioral intervention to cue exercise. Participants will be asked to wear the wearable device for the duration of their post-transplant inpatient hospital stay.

Aim 1. To examine the potential efficacy of the wearable device + smartphone application to prompt alloBMT patients to move.

Aim 2. To receive participant feedback on their experience participating in the study.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosed with hematologic malignancy
* Scheduled to receive an alloBMT
* Physician consent to participate in the study

Exclusion Criteria:

• Inability to complete 15 minutes walking unassisted

Primary outcomes:
measure: Pilot evaluation of intervention efficacy
timeFrame: cumulative percent from day 1 through discharge from hospital, on average day 30
measure: Patient feedback from participation in the study
timeFrame: day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
References:
Clinical trial NCT01618032: Effects of Two Techniques of Mobilization in the Dorsiflexion on Patients With Chronic Ankle Instability
Official title: The Effects of Two Techniques of Mobilization in the Improvement of Dorsiflexion on Chronic Instability Ankles. A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Instability of Joint
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries. Passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. However, no studies have compared manipulative techniques of mobilization techniques in subjects with chronic ankle instability.

The aim of this study is to compare the effects of two mobilization techniques on ankle dorsiflexion in patients with chronic ankle instability.


Eligibility criteria: Inclusion Criteria:

* Subjects with chronic ankle instability

Exclusion Criteria:

* Acute or subacute ankle sprain.
* Recent lesions in lower extremities.

Primary outcomes:
measure: Pre-intervention ankle dorsiflexion
timeFrame: pre-intervention
measure: Inmediately post-intervention ankle dorsiflexion
timeFrame: inmediately post-intervention
measure: ten minutes post-intervention ankle dorsiflexion
timeFrame: ten minutes post-intervention
measure: 24 hr post-intervention ankle dorsiflexion
timeFrame: 24 hr post-intervention
measure: 48 hr post-intervention ankle dorsiflexion
timeFrame: 48 hr post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CEU San Pablo University
name: Ángel L Rodríguez-Fernández, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CEU San Pablo University
name: David Marrón-Gómez, PT, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT00177632: Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.
Official title: Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Weight Loss
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 66
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to examine the additional effect of either yoga or resistance exercise on weight loss weight combined with a standard behavioral weight loss intervention.


Eligibility criteria: Inclusion Criteria:

1. Female
2. 25-55 years of age
3. BMI = 25-35 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Participation in regular exercise (aerobic, yoga or resistance exercise) for \> 20 minutes per day on \> 2 days per week for the last 3 months. (This study is designed to recruit relatively sedentary adults.)
2. Currently being treated for psychological disorders/conditions and/or currently taking psychotropic medication.
3. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
4. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. However, pregnancy status will also be verified by the pregnancy test that is required for the baseline, 6 and 12 month DEXA).
5. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
6. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
7. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
8. History of myocardial infarction or valvular disease.
9. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Primary outcomes:
measure: weight loss
Secondary outcomes:
measure: fitness
measure: physical activity
measure: dietary intake
measure: mediators
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M Jakicic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: