louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05921071: Do Patients Who Received Tranexamic Acid in Vaginal Hysterectomy Loose Les Blood, Comparing to Patients Who Did Not?
Official title: Do Patients Who Are Treated With Tranexamic Acid Loose Les Blood, Comparing to Patients Who Are Not Treated, During Vaginal Hysterectomy? a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Hysterectomy
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-06-27
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

Detailed description: This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.

Eligibility criteria: Inclusion Criteria:

\*Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).

Exclusion Criteria:

* allergy to TXA
* familial or personal history of hypercoagulability disorder or thromboembolic events
* impaired renal function or hematuria
* patients receiving antithrombotic therapy
* additional concurrent abdominal/ laparoscopic procedures
* malignancy
* Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.

Primary outcomes:
measure: Mean objective assessment of blood loss
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Mean subjective blood loss (SBL)
timeFrame: Immediately after surgery
measure: Mean difference in hemoglobin levels before and after surgery
timeFrame: One day after surgery
measure: The number of patients who need blood products transfusion
timeFrame: 30 days after surgery
measure: The size of pelvic hematoma after surgery
timeFrame: One day after surgery
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Wolfson medical center
Study officials:
affiliation: Wolfson Medical Center
name: Ohad Gluck
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946971: Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
Official title: Lansoprazole in Preterm Infants With Gastroesophageal Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Premature Infants
Gastroesophageal Reflux
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 12
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.


Eligibility criteria: Inclusion Criteria:

* preterm infant
* symptoms suspecting gastroesophageal reflux

Exclusion Criteria:

* unstable general conditions due infection or acute illness
* congenital anomaly in upper gastrointestinal tract including esophagus
* drug history of H2, proton pump inhibitor, blocker during last 1 week
* medication of warfarin, carbamazepine, phenytoin, rifampin
* inappropriate clinical conditions judged by researchers

Primary outcomes:
measure: Acid reflux time (%)
timeFrame: day 0, day 7, day 14
Secondary outcomes:
measure: Acid reflux frequency
timeFrame: day 0, day 7, day 14
measure: Composite score
timeFrame: day 0, day 7, day 14
measure: Acid reflux fraction
timeFrame: day 0, day 7, day 14
measure: acid bolus reflux time/%,
timeFrame: day 0, day 7, day 14
measure: nonacid bolus reflux time/%
timeFrame: day 0, day 7, day 14
measure: bolus reflux time/%
timeFrame: day 0, day 7, day 14
measure: I-GERQ GERD score
timeFrame: day 0, day 7, day 14
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Suk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05437471: Effects of Co-treatment on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure
Official title: Effects of Co-treatment With Aromatase Inhibitor or Progestin on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Miscarriage, Recurrent
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All recruited women will be allocated in three groups, and endometrial tissue sampling will be obtained prior to medical intervention assigned during luteal phase depending on their menstrual cycle. All these women will be divided randomly in three groups A, B \& C equally by using the auto-randomized program in SPSS version 21.0.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the abv3-integrin expression in endometrium tissue among RIF women between the GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B) and GnRH analogue alone as control group (Group C)

Detailed description: i. To determine the abv3-integrin expression isolated from endometrium tissue from women with RIF prior to medical therapy.

ii. To determine the abv3-integrin expression isolated from endometrium tissue from Group A, Group B and Group C following the medical therapy.

iii. To compare the abv3-integrin expression from endometrium tissue obtained from Group A, B and C following the medical therapy.

iv. To compare the implantation rates among Group A, B and C following the medical therapy.

v. To compare the ongoing pregnancy among Group A, B and C following the medical therapy

Eligibility criteria: Inclusion Criteria:

* Women of 18 to 40 years of age
* No significant pre-existing major medical.
* Diagnosed as recurrent implantation failure - at least two or more failure of achieving pregnancy following embryo transfer (ET) despite the optimum endometrial thickness and good quality of embryo (unexplained).
* Regular menstrual cycle atleast 3 months prior to treatment
* Not taking any hormonal treatment for atlest 3months prior to recruitment
* Agreed to participate

Exclusion Criteria:

* Concurrent significant pre-existing major medical conditions such as uncontrolled diabetes, active systemic lupus erythematosus (SLE) or Anti Phospholipid Syndrome (APS) that will interfere with implantation.
* Poor quality of embryo
* Suboptimal endometrial thickness(\<8mm) during the embryo transfer (ET).
* On hormonal therapy prior to recruitment.
* Not agreed to participate

Primary outcomes:
measure: endometrial abv3-integrin expression expressions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: UniversitiKMMC
Study officials:
References:
Clinical trial NCT04719871: Vitreous Detachment and Glaucoma Progression
Official title: Rate of Visual Field Progression Before and After Posterior Vitreous Detachment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Posterior Vitreous Detachment
Keywords: Glaucoma
Vitreous
Progression
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective cohort of patient with glaucoma follow in Montpellier hospital

Brief summary: Posterior vitreous detachment is a common event. With optical coherence tomography, the investigators can precisely follow the stage of posterior vitrous detachment. In this study, the investigators investigate if the loss of contact between the vitreous and the fovea is the start of glaucoma progression.


Eligibility criteria: Inclusion criteria:

* Patient with glaucoma
* at least 4 years of follow up
* at least 6 visual fields
* at least 4 optical coherence tomographies

Exclusion criteria:

* pars plana vitrectomy
* others ophtalmological or neurological disease which can modify visual fields

Primary outcomes:
measure: Glaucoma progression
timeFrame: 1 day
Secondary outcomes:
measure: RNFL decr
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH MONTPELLIER
name: MAX VILLAIN, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01766271: GENErating Behavior Change, An Integrative Health Coaching and Genetic Risk Testing Pilot
Official title: GENErating Change, An Integrative Health Coaching and Genetic Risk Testing Pilot in Primary Care: A Multidisciplinary Approach to Personalized Medicine Targeting CHD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease Risk
Keywords: Coronary heart disease
cardiovascular disease
risk
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the feasibility and logistics of incorporating genetic risk information (9p21)into standard Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in primary care at 2 Duke Clinics.


Eligibility criteria: Inclusion Criteria:

* age 18+,
* presence of at least one of the following:

  * FPG \> 100,
  * HbA1c \> 5.7%,
  * diabetic,
  * LDL \> 129,
  * triglycerides \> 150,
  * total cholesterol \> 200,
  * SBP \> 130,
  * BMI \> 25,
* able to speak and understand English,
* able and willing to give informed consent

Exclusion Criteria:

* diagnosed CHD (MI or documented coronary artery disease),
* inability to ambulate or participate in physical activity,
* serious chronic disease related complications,
* current participation in a risk communication study for chronic disease,

Primary outcomes:
measure: Diet
timeFrame: 6 months
measure: Physical Activity
timeFrame: 6 months
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: 6 months
measure: Systolic blood pressure
timeFrame: 6 months
measure: Body mass index
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
measure: Low Density Cholesterol (LDL)
timeFrame: 6 months
measure: Triglyceride
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05126771: Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection
Official title: Using CUSUM to Analyze the Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cumulative Sum Learning Curves
Stanford Type A Aorta Dissection
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: age between 18 years and 65 years who underwent standford type A aorta dissection

Brief summary: stanford type A aortic dissection is the most common cause of death caused by aortic disease in Chinese mainland. Patients who are hospitalized need immediate surgical treatment.Emergency aortic arch replacement is difficult and risky. Different surgical methods have different effects on postoperative prognosis. Aortic arch replacement is divided into total-arch replacement (Sun's operation) and hemi-arch replacement. In this study, and the learning Curve of Aortic Arch Replacement Surgery was evaluated with cumulative cum curve.


Eligibility criteria: Inclusion Criteria:

* age over 18 years who underwent surgery for stanford type A aorta dissection without concurrent cardiac Surgery

Exclusion Criteria:

* data miss greater than 10%

Primary outcomes:
measure: Cardiopulmonary bypass (CPB) time
timeFrame: Intra-operative
measure: Aortic clamping (AC) time
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
Study officials:
References:
Clinical trial NCT02464371: Interest of Plasma microRNAs
Official title: Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: muscle weakness
microRNAs
septic shock
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: septic shock patients admitted into ICU.

Brief summary: ICU acquired muscle weakness (IAMW) is a common disease that is associated with high morbidity and mortality. Patients with septic shock are particularly at risk.

The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only usable in sufficiently awaken patients.

Several studies have highlighted the role of microRNAs in regulating physiological processes and diseases related to the skeletal muscles. To date, no study was interested in IAMW.

The aim of this study is to compare the microRNA detection kinetics on the appearance of IAMW.

In septic shock patients, the kinetics of nine microRNAs will be compared between two groups: those with IAMW (IAMW + group) and those without IAMW (IAMW - group).

Detailed description: MicroRNAs (miR-1, miR-21, miR-133, miR-155, miR-206, miR-208a, miR-208b, miR-486, miR-499) will be measured at day 1, day 2, day 5 and day 7 after septic shock onset.

Eligibility criteria: Inclusion Criteria:

Patients with septic shock criteria:

* At least two of the following criteria: temperature \< 36 ° C or \> 38 ° C, heart rate \> 90 beats / minute, respiratory rate\> 20 breaths / minute or PaCO2 \< 32mmHg, leukocytes \> 12,000 / mm3 or \< 4000 / mm3
* Refractory Hypotension (blood pressure \< 90mmHg or need norepinephrine) or lactate ≥ 4 mmol / L

Exclusion Criteria:

* Age\<18years
* Patients with preexisting neuromuscular disease
* Pregnancy
* Moribund patients with early therapeutic limitation
* Patients who had a seizure in the last 6 months

Primary outcomes:
measure: Values of microRNAs between day 1 and day 7
timeFrame: Day 7
Secondary outcomes:
measure: predictive threshold of evolution to the IAMW
timeFrame: Day 1
measure: predictive threshold of evolution to the IAMW
timeFrame: Day 3
measure: predictive threshold of evolution to the IAMW
timeFrame: Day 5
measure: predictive threshold of evolution to the IAMW
timeFrame: Day 7
Other outcomes:
Locations:
city: Roanne
country: France
facility: Ch Roanne
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jerome MOREL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00475371: A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
Official title: A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Healthy Males
Keywords: Healthy
Diabetes Mellitus: Type II
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit.

Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels.

Detailed description: This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety \& tolerability of MKC253 (GLP1/TechnosphereÂ®)Inhalation Powder.

The trial consists of a screening, dosing and a follow-up visit. Single dose administration of MKC253 occurs at the dosing visit. Five doses are being assessed: 0.05, 0.45, 0.75, 1.05 \& 1.5 mg GLP-1. Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safety/tolerability data

Eligibility criteria: Inclusion Criteria:

* Healthy males = 18 and = 45 years of age
* Written Informed Consent.
* Body Mass Index (BMI) of \< 30 kg/m2
* Non-smoker
* Normal pulmonary function and performance on pulmonary function tests

Exclusion Criteria:

* Clinically significant disease including diabetes mellitus
* Fasting blood glucose \> 110 mg/dL (6.1 mmol/L)
* Significant psychiatric condition or drug or alcohol abuse
* Any other condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial
* Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria

Primary outcomes:
measure: Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of pulmonary and other AEs
timeFrame: 2 weeks
measure: Pharmacokinetic (PK) parameters of plasma GLP-1
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: Mannkind Corporation
name: Robert Baughman
role: STUDY_DIRECTOR
References:
Clinical trial NCT04368871: Radiographic Findings and Their Temporal Changes in COVID-19 Positive Changes Patients: A Prospective Study
Official title: Radiographic Findings and Their Temporal Changes in COVID-19 Positive Changes Patients: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the study population will include all the COVID-19 pateints of Max Super speciality Hospital, New Delhi, India, all males and females with minimum age 18 years old and who underwent Chest radiograph will be included in the study

Brief summary: All Patient irrespective of age with confirmed COVID-19 admitted to hospital and who underwent chest radiograph will be enrolled in the study to find raduigraphic findings and their temporal changes in COVID-19.

Detailed description: In this prospective trial the investigator will work on radiology findings and their temporal changes in COVID-19 positive patients and who underwent chest radiograph will be enrolled in our study.

Patient selection will be consecutive in addition of age , gender and comorbid conditions clinical information will included travel,expose and contact history. All patients should be positive for COVID-19 via laboratory testing with real time reverse transcriptase polymerase chain reaction(rRT-PCR) In addition, the number of rRT-PCR tests performed on each patient, on which test a positive result was found,and the number of days between symptomology onset and date of first positive test will be recorded.

In view of the current dynamics, any other reliable diagnostic test(s) if added to the clinical protocol will also be considered for inclusion in this study.

Tabulation of radiographic findings for all consecutive X-rays will be done along with the temporal changes of these findings. further, the clinical findings with the outcomes(duration of hospital findings, ventilatory support and discharge/death).

Eligibility criteria: Inclusion Criteria:

1.Patients confirmed positive for COVID-19 by rRT-PCR irrespective of age.

Exclusion Criteria:

1.Patients with flu like symptoms but negative for COVID-19 by rRT-PCR.

Primary outcomes:
measure: Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study
timeFrame: 4-8 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital, A Unit of Devki Devi Foundation
Study officials:
References: