louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03531437: Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT
Official title: Comparison of Coagulation Profiles in Oral Contraceptive Pills Users Between 1.5 mg Estradiol/2.5 mg Nomegestrol Acetate (Zoely) and 15 mcg Ethinylestradiol/60 mcg Gestodene (Minidoz): A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Contraception
Hypercoagulability
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 112
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles

Detailed description: compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen

Eligibility criteria: Inclusion Criteria:

* Woman age 19-40 yr
* Normal uterus and both adnexae
* BMI \< 28.5 kg/m2
* Require contraception with COCs

Exclusion Criteria:

* Pregnancy
* Postartum period within 6 wk
* Smoking
* BP ≥ 140/90 mmHg
* Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR
* use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system
* Use contraceptive steroids within 3 months

Primary outcomes:
measure: D-dimer
timeFrame: 12 weeks
Secondary outcomes:
measure: fibrinogen
timeFrame: 12 weeks
measure: antithrombin III
timeFrame: 12 weeks
measure: to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01242137: Pharmacogenetic Effect on the Pharmacodynamics of Glibenclamide
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes type 2 patients treated with metformin and glibenclamide.

Brief summary: Glibenclamide is metabolized by the hepatic enzyme P450 CYP2C9 to less active form. Polymorphism of this enzyme demonstrated clinical significance when examined on other drugs from the sulfonylurea drug family, to whom Glibenclamide is included.

The investigators assumption is that patients with less active alleles of the enzyme may show lower dose requirements of the drug for glycemic control, when compared to patients homozygotes to wild-type alleles.


Eligibility criteria: Inclusion Criteria:

* Tx with metformin and glibenclamide

Exclusion Criteria:

* Tx which affecting the P450 2C9 action
* Renal failure

Primary outcomes:
measure: HbA1c
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yakov
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
References:
Clinical trial NCT01598337: The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency
Official title: The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Prince Sultan Cardiac Center, Adult Cardiology Department.
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG.

Detailed description: Coronary artery bypass graft (CABG) surgery is a commonly used revascularization strategy in patients with severe coronary artery disease. Saphenous vein grafts (SVGs) are the most frequently used conduits for this procedure. Unlike arterial grafts, SVGs are particularly susceptible to occlusive thrombosis during the first post-operative year, which exposes patients to increased risks of death, myocardial infarction, and repeat revascularization.

This study is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG. Patients will undergo planned cardiac Computed tomographic angiography (CTA) predischarge (at 1 week) and CTA/coronary angiography (CAG) at 6 months to 1 year follow-up. CTA at baseline (predischarge) and follow-up CTA/CAG at 6-12 months after CABG will be used to evaluate graft patency.

Eligibility criteria: Inclusion Criteria:

* All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups

Exclusion Criteria:

* Acute myocardial infarction (AMI) or cardiogenic shock
* Aortic dissection
* Mechanical valves.
* Contraindication to antiplatelets or aggrastat.
* Active bleeding or high risk of bleeding.
* History of hemorrhagic stroke any time.
* Recent history of embolic stroke or transient ischemic attack (TIA) less than 3 months.
* Active peptic ulcer disease (PUD).
* Liver derangement.
* Warfarin use.
* Heparin-induced thrombocytopenia (HIT) syndrome.
* Thrombocytopenia (platelet count \<100,000/mm3), disorders of platelet function

Primary outcomes:
measure: Venous graft patency
timeFrame: At one year
Secondary outcomes:
measure: Major cardiac events (MACE)
timeFrame: At one year
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
Study officials:
affiliation: Prince Sultan Cardiac Center (PSCC), Riyadh
name: Hussein S Al-Amri, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05429437: Assesment of Two Different Modalities of Maxillary Canine Retraction Assisted With Injectable Platelet Rich Fibrin
Official title: Assesment of Two Different Modalities of Maxillary Canine Retraction Assisted With Injectable Platelet Rich Fibrin: A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Effect of Platelet Rich Fibrin Tooth Movement
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 18
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The present prospective clinical study will be undertaken for assessment of two different modalities of maxillary canine retraction assisted with injectable platelet rich fibrin.


Eligibility criteria: Inclusion Criteria:

* An age range from 15-22 years.
* Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.
* All permanent teeth present, 3rd molars are excluded.
* Good oral and general health.
* No systemic disease/medication that could interfere with OTM. No previous orthodontic treatment.

Exclusion Criteria:

* Patient diagnosed to have an indication for non-extraction approach.
* Poor oral hygiene or periodontally compromised patient.
* Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.

Primary outcomes:
measure: assessment of acceleration of canine retraction
timeFrame: post interventional at 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar university
Study officials:
affiliation: Al-Azhar University
name: mohamed radwan, student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
citation: Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
Clinical trial NCT00121537: Study to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes
Official title: A Prospective Study to Determine the Utility of Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes With Regards to Lower Extremity Fasciotomy Wound Healing, Complications, Cost and Patient and Nursing Satisfaction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wounds
Compartment Syndromes
Keywords: wounds-open
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2005-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies.


Eligibility criteria: Inclusion Criteria:

* four compartment fasciotomies performed on one or both lower extremities
* subject and/or subject's legally authorized representative (next-of-kin) has voluntarily signed and dated informed consent.

Exclusion Criteria:

* inability to place wound VAC
* contraindications for wound VAC use
* pregnant females
* prisoners

Primary outcomes:
measure: Rate of wound healing
Secondary outcomes:
measure: Time to delayed primary wound closure
measure: Time to completion of secondary healing
measure: Patient satisfaction
measure: Nurse satisfaction
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: John G Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199537: Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer
Official title: Bone Loss in Men on Androgen Blockade as Adjuvant Therapy for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Bone Loss
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Lawson Health Research Institute Internal Review Fund
name: University of Western Ontario, Canada
First posted: 2005-09-20
Enrollment: 25
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with Prostate Cancer undergoing continued treatment with leuteinizing hormone-releasing hormone \[LHRH\] therapy

Brief summary: Patients with advanced prostate cancer undergoing adjuvant treatment with androgen blockade will be followed over a 1 year interval to assess the effects of this treatment on bone metabolism. It is expected that men undergoing androgen blockade will experience accelerated bone loss.


Eligibility criteria: Inclusion Criteria:

* Men
* Age of 40 years or greater
* Diagnosis of advanced prostate cancer (ie: prostate-specific antigen \[PSA\] less than 25 ug/L and undergoing continued treatment with leuteinizing hormone-releasing hormone \[LHRH\] therapy)
* Willing and able to consent

Exclusion Criteria:

* Metastatic disease to bone
* Medications affecting bone turnover (bisphosphonate, steroids, anticonvulsant)
* Renal failure (serum creatinine \> 200 umol/L)
* Co-morbidity factors affecting bone density (ie: Paget's, rheumatoid arthritis)
* Factors affecting ability to perform the bone density tests using femoral head measurements (ie: bilateral hip arthroplasty)
* Cancer other than skin, except when, in the investigators' opinion, it is determined to be appropriate and not adversely affect the outcome of the trial
* Gastrointestinal (GI) pathology (eg. malabsorption syndrome)
* Parathyroid disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
state: Ontario
Study officials:
affiliation: Urology, St. Joseph's Hospital, University of Western Ontario
name: Hassan Razvi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03259737: An Observational Study of Stroke Patients.
Official title: An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Care
Cerebrovascular Disorders
Hyperglycemia
Hypertension
Troponin
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \> 18 years, registered with a diagnosis of stroke during 2015 at Innlandet Hospital Trust Lillehammer.

Brief summary: The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.

Detailed description: There is in general a focus on misuse of health resources. An increasing amount of guidelines is produced to reduce the variation in treatment of patients with the same diagnosis. Many recommendations are weak but seems though to have considerable impact on in hospital care. The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent supplementary CT and MRI. The intention is to study these issues in a larger population including an evaluation of utility of the different examinations and evaluations.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and I64)
* Hospitalized between January 1 and December 31, 2015

Exclusion Criteria:

* Previous hospitalization with a diagnosis of stroke in 2015.
* Foreigners and patients from other regions of Norway.

Primary outcomes:
measure: Number of supplementary computer tomography and magnetic resonance imaging of the brain.
timeFrame: 3 months
measure: The number of blood sugar measurements
timeFrame: 72 hours after admission to hospital
Secondary outcomes:
measure: Troponin measurement,
timeFrame: 72 hours
measure: Number of blood pressure measurement
timeFrame: 72 hours
measure: Transfer to tertiary center
timeFrame: 72 hours
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Innlandet Hospital Trust Lillehammer
city: Lillehammer
country: Norway
facility: Ellen Bøhmer
Study officials:
affiliation: Sykehuset Innlandet HF
name: Ingebjørg Hartz
role: STUDY_DIRECTOR
References:
Clinical trial NCT03079037: Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3
Official title: Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's Disease (PD)

Brief summary: This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic PD
* DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.

Exclusion Criteria:

* Other significant neurological disorder
* History of dementia
* Prior history of stereotactic neurosurgery
* Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
* Pregnant women

Primary outcomes:
measure: Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michael C. Park, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03180437: Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
Official title: Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Immunotherapy
γδ T Cell
Pancreatic Cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2017-06-08
Enrollment: 62
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 study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.

Detailed description: Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the healthy donor will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.

Eligibility criteria: Inclusion Criteria:

1. age: \>18 years
2. participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation
3. will receive IRE, gd Tcells
4. life expectancy: more than 3 months
5. ability to understand the study protocol and a willingness to sign a written informed consent document
6. adequate liver and renal function were required
7. intolerant or refused to chemotherapy or to chemotherapy

Exclusion Criteria:

1. patients with other kinds of cancer
2. history of coagulation disorders or anemia
3. heart disease and diabetes
4. history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease
5. a performance status score of \>2

Primary outcomes:
measure: PFS
timeFrame: 2 years
measure: OS
timeFrame: 2 year
Secondary outcomes:
measure: Tumor size
timeFrame: 3 months
measure: CTC
timeFrame: 3 months
measure: CA 19-9
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biotherapy center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Biological treatment center in Fuda cancer hospital Guangzhou
name: Jibing Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin M, Zhang X, Liang S, Luo H, Alnaggar M, Liu A, Yin Z, Chen J, Niu L, Jiang Y. Irreversible electroporation plus allogenic Vgamma9Vdelta2 T cells enhances antitumor effect for locally advanced pancreatic cancer patients. Signal Transduct Target Ther. 2020 Oct 23;5(1):215. doi: 10.1038/s41392-020-00260-1.
Clinical trial NCT06936137: : EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
Official title: : EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Antipsychotic Induced Weight Gain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the goal of the study is to improve the quality of life of patients on antipsychotic medications and increase the rate of compliance to treatment.

Primary objective:

1.To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.

Secondary objective:

1. To determine the effect of probiotic supplementation on the psychological state of patients.


Eligibility criteria: Inclusion Criteria:

* Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤60.

With more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years.

Exclusion Criteria:

1. Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.
2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.

   -

Primary outcomes:
measure: To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university hospitals
state: Abbassia
Study officials:
References: