louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01241032: Phase I Study to Investigate the Alcohol Interaction of DA8159
Official title: A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Alcohol on the Pharmacokinetics of Udenafil Tablet in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Erectile Dysfunction
Keywords: DA-8159
Udenafil
Alcohol
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2010-11-16
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Adult males aged 19 to 55 years at screening.
* Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
* Subjects with hypotension or hypertension.
* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Primary outcomes:
measure: Pharmacokinetics (AUC and Cmax)
timeFrame: 48 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809432: The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution
Official title: Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Heart Rate Variability
Keywords: Air pollution
Heart rate
Heart rate variability
Blood pressure
Face mask
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
First posted: 2008-12-17
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Exposure to air pollution is an important risk factor for cardiovascular morbidity and mortality, and is associated with increased blood pressure, reduced heart rate variability, endothelial dysfunction and myocardial ischaemia. The study objectives were to assess the potential cardiovascular benefits of reducing personal particulate air pollution exposure by wearing a facemask in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Current smokers
* Significant occupational exposure to air pollution
* Regular medication use (except oral contraceptive pill)
* Intercurrent illness

Primary outcomes:
measure: Ambulatory blood pressure
timeFrame: During 24 hour study period
Secondary outcomes:
measure: Heart rate
timeFrame: During 24 hour study period
measure: Heart rate variability
timeFrame: During 24 hour study period
measure: Personal air pollution exposure
timeFrame: During 2 hour city centre walk
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Medical Union College
Study officials:
affiliation: University of Edinburgh
name: Jeremy P Langrish, MB BCh MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.
Clinical trial NCT05806632: Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification
Official title: Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Local Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 108
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 stage IIB-IIIC breast cancer undergoing neoadjuvant chemotherapy (NACT), followed by breast surgery

Brief summary: Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints:

1. Complete pathological response rate to definitive breast surgery;
2. Rate of thromboembolic events.


Eligibility criteria: Inclusion Criteria:

* Patients with normal organ functions
* Cytologically/histologically proven breast cancer, stage IIB-IIIC
* Participants must not have prophylactic or therapeutic indications for anticoagulants.

Exclusion Criteria:

* Pregnacy
* Metastatic breast cancer
* Previous chemotherapy, hormone therapy, radiotherapy
* Previous malignancies or contralateral breast cancer

Primary outcomes:
measure: Pathological response rate
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT04428632: Oral Berotralstat Expanded Access Program
Official title: Expanded Access Program With Oral Berotralstat for the Prevention of Attacks in Patients With Hereditary Angioedema
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Hereditary Angioedema
HAE
Prophylaxis
Keywords: Berotralstat
BCX7353
Hereditary Angioedema
HAE
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-06-11
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

Detailed description: Physicians may request access to berotralstat for eligible participants with unmet medical need

Physicians can send email inquiries to access.us@inceptua.com or call 1-888-225-8677

Patients who may be interested should contact their physician about participation

Berotralstat (BCX7353) will be available through this expanded access program until it is commercially available

Eligibility criteria: Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for participation in this program:

1. At least 12 years of age
2. Able to provide written, informed consent or assent
3. Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial
4. Females must use acceptable effective contraception

Exclusion Criteria

Patients must meet none of the below exclusion criteria to be eligible for participation in this program:

1. Pregnancy or breast-feeding
2. Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety
3. Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02728232: Internal Iliac Artery Ligation and Abnormally Invasive Placenta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Percreta
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is set to detect the impact of bilateral internal iliac artery ligation on the amount of intra-operative blood loss during the hysterectomy procedure done for the management of abnormally invasive placenta


Eligibility criteria: Inclusion Criteria:

* females with pre-operative diagnosis of abnormally invasive placenta

Exclusion Criteria:

* refusal to get enrolled in the study

Primary outcomes:
measure: amount of intra-operative hemorrhage
timeFrame: 2-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Ahmed M Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232232: Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Atrial mechanical stunning and
atrial electrical remodeling
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether fish oils may be of benefit to patients with certain heart rhythm disturbances called atrial fibrillation and atrial flutter.

Atrial fibrillation and atrial flutter are two heart conditions that can be successfully treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in the case of atrial fibrillation). Ablation involves the application of high frequency energy waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a normal rhythm with the use of an electric current.

Fish oil supplements may be of benefit to patients with heart problems. Recent evidence suggests that fish oils may benefit those with rhythm disturbances.


Eligibility criteria: Inclusion Criteria:

* Chronic atrial flutter requiring radiofrequency ablation.
* Chronic atrial fibrillation requiring internal cardioversion.

Exclusion Criteria:

* Sinus rhythm.
* Pregnancy.
* Patients \> 80 years and \< 18 years of age

Primary outcomes:
measure: The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
measure: Adverse events related to fish oil ingestion.
timeFrame: 18 months
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Paul Sparks
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar S, Sutherland F, Wheeler M, Heck PM, Lee G, Teh AW, Garg ML, Morgan JG, Sparks PB. Effects of chronic omega-3 polyunsaturated fatty acid supplementation on human atrial mechanical function after reversion of atrial arrhythmias to sinus rhythm: reversal of tachycardia-mediated atrial cardiomyopathy with fish oils. Heart Rhythm. 2011 May;8(5):643-9. doi: 10.1016/j.hrthm.2011.01.014. Epub 2011 Jan 11.
Clinical trial NCT01136837: The Prognostic Significance of a Fragmented QRS Complex After Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fragmented QRS
Primary PCI
MACE
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who presented to the hospital within 12 hours of the onset of chest pain who were admitted to the coronary intensive care unit (ICU) with the diagnosis of acute STEMI and who were administered primary PCI. Having acute STEMI for the first time was stipulated for inclusion in the study.

Brief summary: To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient who had undergone primary percutaneous coronary intervention (PCI).


Eligibility criteria: Inclusion Criteria:

* Patients with chest pain that continued longer than 30 minutes and with ≥ 2 mm ST elevation in ECG at least in two adjacent derivations were diagnosed with an acute STEMI. In all patients, at least two-fold increases were seen in serum CK-MB levels compared to normal values.Having acute STEMI for the first time was stipulated for inclusion in the study.

Exclusion Criteria:

* Subjects with known allergies to aspirin and clopidogrel, inadequate echocardiographic images, malignancy, a previous cerebrovascular event, renal dysfunction (creatine level \> 2.5 mg/dl), a previous MI, or a history of cardiogenic shock as well as those who refused to participate in the study were excluded.

Primary outcomes:
measure: Major Adverse Cardiac Events
Secondary outcomes:
measure: Q Wave and QRS distortion for predicting major adverse cardiac events
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Hastanesi
Study officials:
References:
citation: Ari H, Cetinkaya S, Ari S, Koca V, Bozat T. The prognostic significance of a fragmented QRS complex after primary percutaneous coronary intervention. Heart Vessels. 2012 Jan;27(1):20-8. doi: 10.1007/s00380-011-0121-9. Epub 2011 Feb 23.
Clinical trial NCT06721637: Effect of Core Stability Exercise Versus Whole Body Vibration in Improving Vitamin D Absorption in Women
Official title: Effect of Core Stability Exercise Versus Whole Body Vibration in Improving Vitamin D Absorption in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Absorption
Keywords: Core stability exercise
Whole body vibration
Vitamin D absorption
Women
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research was conducted at the Physical Therapy Department of Al-Zaytoonah University. Forty female patients who had vitamin D deficiency were enrolled in this study according to specific criteria: vitamin D concentration was preliminarily assessed based on the parathyroid hormone response so concentration of vitamin D and parathyroid hormone were measured pre- and post-two month's intervention. Vitamin D concentration was less than 12ng/ml and age between 20 and 50 years

Brief summary: This study was conducted to explore the influence of core stability exercise versus whole body vibration in improving vitamin D absorption in women.

Detailed description: This study was conducted to explore the influence of core stability exercise versus whole body vibration in improving vitamin D absorption in women.

Eligibility criteria: Inclusion Criteria:

* Vitamin D concentration was less than 12ng/ml and age between 20 and 50 years and Their BMI less than 30

Exclusion Criteria:

* Vitamin D concentration was greater than 20ng/ml, Their BMI greater than 30 and exhibited a history of significant medical diseases such as rheumatoid diseases, uncontrolled high blood pressure, serious heart or lung issues, chronic viral infections including herpes and hepatitis

Primary outcomes:
measure: vitamin D concentration
timeFrame: 8 weeks
measure: parathyroid hormone
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kerolous ishak shehata kelini
Study officials:
References:
Clinical trial NCT03638037: Correlation Between Maternal Vitamin D Level And Preterm Birth
Official title: Correlation Between Maternal Vitamin D Level And Preterm Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Birth
Preterm Labor
Vitamin D Deficiency
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 138
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with singelton pregnancy

Brief summary: Assessment of correlation between vitamin D level and prevalence of preterm births remains limited. The exact role of vitamin D in preterm birth has not yet been clearly defined ,where some studies showed vitamin D deficiency increased the risk of preterm birth while other studies found no correlation. In this study will try to continue research on this subject.


Eligibility criteria: Inclusion Criteria:

* Singleton gestation.
* Maternal age: 20-35 years.

Exclusion Criteria:

1. Multi fetal pregnancy.
2. Anatomical or genetic defect of the fetus.
3. Iatrogenic preterm delivery.
4. Maternal medical disorder e.g diabetes millets (D.M).
5. Antepartum hemorrhage.
6. Hypertensive disorders.
7. Polyhydromins or oligolydromins
8. Premature rupture of membranes ± Chorioamnionitis
9. Incompetent cervix.
10. Post IVF.
11. Uterine Fibroid or malformation.

Primary outcomes:
measure: proportion of patients with severe vitamin D deficiency
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, Maternity Hospital
Study officials:
References:
Clinical trial NCT02296437: Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression
Official title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2014-11-20
Enrollment: 40
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: Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.


Eligibility criteria: Inclusion Criteria:

1. Participants are aged 18-65 years.
2. Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
3. MADRS score of 20 or more.
4. Right handed
5. A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.

Exclusion Criteria:

1. DSM-V psychotic disorder.
2. Drug or alcohol abuse or dependence (preceding 6 months).
3. Inadequate response to ECT (current episode of depression).
4. Regular benzodiazepine medication
5. Rapid clinical response required, e.g., due to high suicide risk.
6. Clinically defined neurological disorder or insult.
7. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Pregnancy.

Primary outcomes:
measure: Montgomery and Asberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of New South Wales
state: New South Wales
Study officials:
References: