louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03417076: Absolute Bioavailability Study With Bexagliflozin
Official title: A Phase 1, Single Center, Open-label, Single Period, Non-randomized Study to Determine the Absolute Bioavailability of Bexagliflozin Tablets Following a Single Oral Dose Co-administered With an Intravenous Microtracer Dose of 14C-Bexagliflozin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Theracos
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.


Eligibility criteria: Inclusion Criteria:

* body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
* no nicotine and tobacco consumption in the past 3 months
* willing and able to be confined to the clinical research facility as required by the protocol

Exclusion Criteria:

* clinically significant history of allergy to drugs or latex
* history of alcohol or drug dependence in the past 12 months.
* donation of a significant amount of blood in the past 2 months
* willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic
* exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer

Primary outcomes:
measure: absolute bioavailability (Fp.o.) of bexagliflozin tablets
timeFrame: Up to 48 hours
Secondary outcomes:
measure: adverse events
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Clinical Research Site
state: Wisconsin
Study officials:
affiliation: Massachusetts General Hospital
name: Mason Freeman, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02544776: Amlodipine on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
Official title: Effect of Amlodipine and Clomid on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Infertility Associated With Anovulation
Keywords: pco
Amlodipine
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: On the basis of the current study, amlodipine seems to be a promising drug on improving uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level and pregnancy outcome in patients with pco.

Detailed description: To know if amlodipine has vasodilator effect on ovarian ar. In pco patient.

Eligibility criteria: Inclusion Criteria:

* Demographic features including females in age of ≥20 \& ≤35, and BMI of ≤39.
* Infertility secondary to polycystic ovary , The choice of polycystic ovary patients will be according to the Rotterdam consensus workshop (Rotterdam, 2004), and the diagnosis of polycystic ovary by ultrasonography will be made according to Adams et al. criteria which are the most often cited (Adams et al., 1985).The Rotterdam criteria as follows:

  * Oligo- or anovulation.
  * Clinical and/or biochemical signs of hyper androgynism
  * The presence of polycystic ovaries on ultrasound scan. Ultrasound findings of enlarged ovaries with multiple small cysts (10-12 or more of 2-9 mm in diameter) scattered around the periphery and highly echogenic stroma

Exclusion Criteria:

* Including other causes of infertility diagnosed during infertility work up.
* Patients refused to participate or to continue study.
* Also, hepatic, cardiac, and hypotensive patients will be excluded from the study.

Primary outcomes:
measure: change in ovarian artery perfusion
timeFrame: day number five and day number 9 of menstrual cycle
Secondary outcomes:
measure: Number of mature follicle
timeFrame: day 14 of menstrual cycle
measure: endometrial thickening
timeFrame: day number five and day number 9 of menstrual cycle
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03752476: Impact of Number of Rank of B-lactam Antibiotics on Emergence on Multidrug Resistant Bacteria
Official title: Impact of Number of Rank of B-lactam Antibiotics on Emergence on Multidrug Resistant Bacteria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Resistant Infection
Antibiotic Resistant Infection
Beta Lactam Resistant Bacterial Infection
Bacterial Resistance
Keywords: antibiotic resistant
multidrug resistant
Beta lactam
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017

Brief summary: This study evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug resistant bacteria colonization in intensive care

It's retrospective case controle study. Cases are colonized patient by multidrug resistant bacteria hospitalized in intensive care during the fist hospitalization in intensive care. Temoin are patients with the same characteristics than case but no colonized by multidrug resistant bacteria.

Detailed description: The emergence of multidrug resistant is a wordwide problem. B lactam resistant increase. The antibiotic prescription impact this problem.

B lactam antibiotic is prescribed everyday in intensive care unit. The switch of antibiotic is common. Antibiotic classes inclue a lot of rank with different spectum that impact the occurrence of resistant.

Eligibility criteria: Inclusion Criteria:

* all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017

Exclusion Criteria:

* patient under guardianship
* patient allergic to Beta lactam
* colonization with mutidrug resistant the first week of hospitalization in intensive care unit

Primary outcomes:
measure: number of Beta lactam class prescription
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00002276: The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia
Official title: Study of Bleeding Tendency, Platelet Function, and Pharmacokinetics of Azidothymidine (AZT) and Motrin (Ibuprofen) in HIV-Infected Hemophiliacs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Hemophilia A
Keywords: Blood Platelets
Ibuprofen
Drug Interactions
Zidovudine
Hemophilia A
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Hemophilia.
* HIV-seropositivity confirmed by Western Blot.

Prior Medication:

Required:

- AZT for study patients.

Allowed:

- Ibuprofen.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Hospitalization for opportunistic infection, bacterial infection or malignancy.

Concurrent Medication:

Excluded:

* AZT (for control group).
* Antibiotics or other medication for opportunistic infection, bacterial infection, or malignancy.

Patients with the following prior conditions are excluded:

Hospitalization for opportunistic infection, bacterial infection, or malignancy.

Required:

* Ibuprofen.
* AZT 1-2 gm daily (for study patient) or not taking AZT (for control).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Hemophilia Ctr of Western PA / Univ of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: Ragni MV, Miller BJ, Whalen R, Ptachcinski R. Bleeding tendency, platelet function, and pharmacokinetics of ibuprofen and zidovudine in HIV(+) hemophilic men. Am J Hematol. 1992 Jul;40(3):176-82. doi: 10.1002/ajh.2830400305.
Clinical trial NCT06986876: Exploration of the Perceptions of Women With a History of Gestational Diabetes From the Gonesse Hospital Catchment Area Regarding Their Risk of Developing Type 2 Diabetes.
Official title: Exploration of the Perceptions of Women With a History of Gestational Diabetes From the Gonesse Hospital Catchment Area Regarding Their Risk of Developing Type 2 Diabetes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Diabetes, Gestational
Lead sponsor: Centre Hospitalier de Gonesse
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of women aged 18 to 45 years who have a history of gestational diabetes, are French-speaking, and reside within the catchment area of Gonesse Hospital (Île-de-France region, France). These participants represent a population at increased risk of developing type 2 diabetes and are targeted for better understanding of the barriers and facilitators to post-partum diabetes screening.

Brief summary: This study focuses on the patients' perspective and aims to provide explanatory elements regarding the barriers to type 2 diabetes screening among women with a history of gestational diabetes. The main objective is to understand the obstacles and enablers in order to optimize type 2 diabetes screening in women with a history of gestational diabetes.


Eligibility criteria: Inclusion Criteria:

* Women with a history of gestational diabetes
* Aged between 18 and 45 years
* French-speaking
* Followed up at Gonesse Hospital

Exclusion Criteria:

* Under 18 or over 45 years old
* Non-French-speaking

Primary outcomes:
measure: Identification and qualitative analysis of the factors influencing participation in type 2 diabetes screening among women with a history of gestational diabetes.
timeFrame: 15 january 2025 - 15 may 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Gonesse
country: France
facility: France
Study officials:
References:
Clinical trial NCT02984176: Simethicone: Does it Improve Operative Field and Postoperative Pain?
Official title: Simethicone and Gynecological Laparoscopies: Does it Improve Operative Field and Postoperative Pain?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Simethicone
Keywords: Simethicone
Laparoscopies
Pain
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.

The investigators objective is to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.

Detailed description: Introduction: Simethicone is an oral antifoaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.

Objective: to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.

Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome measure will be the overall exposure of the surgical field and pain scoring. Assessment of the overall exposure of the surgical field was done using a five-point scale (poor, sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for assessment of postoperative pain and verbal analog scoring was used for assessment of patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Infertile patients
* aged 20 - 40 years old
* scheduled for laparoscopy

Exclusion Criteria:

* Women were excluded from the study if patients had one or more of the following:

  * scar of previous operation, uterine mass, severe endometriosis, suspicion of malignancy, history of allergic reaction to study drugs, psychiatric disorders and patient refusal

Primary outcomes:
measure: five-point scale
timeFrame: 1 hour
Secondary outcomes:
measure: The degree of bowel preparation
timeFrame: 1 hour
measure: VAS
timeFrame: 24 hours
measure: Patient satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02011776: A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
Official title: A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Sjögren Syndrome
Keywords: Corticosteroids Dry Eye Sjögren syndrome inflammation treatment
Lead sponsor: Santen Pharmaceutical(China) Co.,LTD
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the people who suffered from the dry eye disease coused by the Sjögren syndrome

Brief summary: The purpose of this study is to evaluate the effectiveness of fluorometholone combined with sodium hyaluronate eye drops in the treatment of Sjögren syndrome.


Eligibility criteria: Inclusion Criteria:

* willing to participate in this clinical study, and signed informed consent
* age from 18 to 70 years old,both genders are permitted
* diagnosed as the Sjögren syndrome
* have the symptoms and signs of dry eye disease as below:

  1. have at least 2 symptoms such as dryness,foreign body sensation ,eye strain,conjunctival congestion,secretion.The summed up score of symptoms greater than 6.
  2. the score of tear-film break up time less than 5 seconds or the score of Schirmer test less than 5mm/5min.
  3. the score of corneal fluorescein staining greater than 3.

     Exclusion Criteria:

Primary outcomes:
measure: tear-film breakup time
timeFrame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
measure: Schirmer test I without anesthesia
timeFrame: the enrolling day,2 weeks after treatment,4 weeks after treatment, 8 weeks after treatment
measure: corneal fluorescein staining
timeFrame: the enrolling day,2 weeks after treatment,4 weeks after treatment,8 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
Study officials:
References:
Clinical trial NCT01060176: Three Dose Regimen of Tranexamic Acid in Cardiac Surgery
Official title: Three Dose Regimen of Tranexamic Acid on Blood Loss and Allogeneic Transfusions in Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemostasis
Keywords: tranexamic acid
cardiac surgery procedures
hemostasis
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.


Eligibility criteria: Inclusion Criteria:

* Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
* Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
* Wrriten consent obtained

Exclusion Criteria:

* Non-primary cardiac surgery
* Preoperative liver or renal dysfunction
* Preoperative coagulation disorder
* Allergy
* Pregnancy or lactation
* Disabled in spirit or law
* Fatal conditions such as tumour

Primary outcomes:
measure: Rate of exposure to allogeneic erythrocytes transfusions
timeFrame: Perioperatively
Secondary outcomes:
measure: Volume of allogeneic erythrocytes transfusions
timeFrame: Perioperatively
measure: Rate and volume of fresh frozen plasma transfusion
timeFrame: Perioperatively
measure: Rate and volume of allogeneic platelet transfusion
timeFrame: Perioperatively
measure: Rate of reexploration for hemostasis
timeFrame: Perioperatively
measure: Postoperative blood loss
timeFrame: Postoperatively
measure: Thromboelastography
timeFrame: Perioperatively
measure: Coagulatory and fibrinolytic associated moleculars
timeFrame: Perioperatively
measure: Inflammation associated moleculars
timeFrame: Perioperatively
measure: Length of stay in ICU and hospital postoperatively
timeFrame: Postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
state: Beijing
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Lihuan Li, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Jia Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01628276: Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MS (Multiple Sclerosis)
Keywords: Multiple Sclerosis
MRI Scans
Lead sponsor: Sina Hospital, Iran
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This trial seeks to investigate brain network changes following cognitive rehabilitation in MS patients. The investigators hypothesize that rehabilitation interventions improve connectivity in the brain.Novel Magnetic Resonance Imaging technique is performed to investigate changes in brain plasticity.


Eligibility criteria: Inclusion Criteria:

* Definitive MS diagnosis
* Right handedness
* EDSS 0-4
* No relapse in past 6 weeks
* Willing to consent and participate in the study

Exclusion Criteria:

* Pregnancy
* Left handedness
* Neurologic or psychiatric disorder other than MS

Primary outcomes:
measure: functional connectivity
timeFrame: 0, 2nd, 4th Month
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Sina Hospital
Study officials:
References:
Clinical trial NCT03189576: Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
Official title: Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Residual Disease
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Circulating tumour DNA (ctDNA) is a promising tool when monitoring the residual disease in colorectal cancer (CRC). Current staging procedures are insufficient to identify the patient cohort at high risk, who might benefit from additional adjuvant therapy.

We will show that the assessment of ctDNA is a non-invasive approach and easily taken at different time points via simple blood draw to monitor residual disease from the colorectal cancer patients after primary surgery. Minimal residual disease could be used in the future for individualized treatment decisions after primary surgery.


Eligibility criteria: Inclusion Criteria:

* planned colorectal primary surgery

Exclusion Criteria:

* unfit patients with dementia

Primary outcomes:
measure: ctDNA level
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Pirkko-Liisa Kellokumpu-Lehtinen, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06317376: Group-based Cardiac Rehabilitation on Patients With Coronary Artery Bypass Graft Surgery
Official title: The Effect of Group-based Cardiac Rehabilitation on Pulmonary Function and Aerobic Capacity of Patients With Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-cardiac Surgery
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.
2. To determine the effect of MICT on aerobic Capacity of CABG patients.


Eligibility criteria: Inclusion Criteria:

* Males and females post CABG patients with ages of 40 to 60 years postoperatively.
* The patient with Post Op-Day 5.

Exclusion Criteria:

* Patients who have a history of other Cardiac disorders that interfere with daily life before surgery and those having congenital cardiac anomalies, Tetralogy of Fallot.
* Musculoskeletal and neurological disorders.
* Age more than 60 and less than 40

Primary outcomes:
measure: Borg rating of perceived exertion scale
timeFrame: 4 weeks
measure: 6min walk test
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: RMI
Study officials:
affiliation: Riphah International University
name: Maria Razzaq, MS
role: PRINCIPAL_INVESTIGATOR
References: