louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03018171: Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor
Official title: Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor Pain
Keywords: clonidine, spinal injections
Lead sponsor: San Giovanni Calibita Fatebenefratelli Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 268
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 study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.


Eligibility criteria: Inclusion Criteria:

* Written maternal informed consent
* Singleton pregnancy
* Gestational age ≥ 37 weeks,
* ASA I
* BMI \< 30
* fetus in cephalic presentation

Exclusion Criteria:

* Suspect or certainty of fetal malformation,
* Presence of conditions such as preeclampsia, multiparity, preterm labor
* History of adverse reaction to α-2 adrenergic agonists
* Nicotine addiction
* Chronic use of opioid

Primary outcomes:
measure: local anesthetic consumption reduction
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital
Study officials:
affiliation: Fatebenefratelli San Giovanni Calibita - Tiberine Island
name: Claudia Claroni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00908271: Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects
Official title: Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-05-25
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
* Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
* Exposure to significant radiation within 12 months prior to admission to the clinical facility

Primary outcomes:
measure: Absolute oral bioavailability
timeFrame: Within the 3 days after study drug administration
Secondary outcomes:
measure: Adverse events (AE)
timeFrame: Within the 3 days after study drug administration
measure: Vital signs
timeFrame: Within the 3 days after study drug administration
measure: Clinical safety labs
timeFrame: Within the 3 days after study drug administration
measure: Electrocardiograms (ECGs)
timeFrame: Within the 3 days after study drug administration
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03683771: Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
Official title: Assessment of Endometrial Pattern and Sub-endometrial Vascularity in Prediction of Pregnancy Rate in ICSI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
First posted: 2018-09-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 patients will be included in the study whom will meet the inclusion criteria.

Brief summary: Despite constant progress in in vitro fertilization (IVF) techniques and ovarian stimulation, pregnancy and embryo implantation rates remain modest . The phenomenon of embryo implantation depends both on the embryo itself and on endometrial receptivity

Detailed description: A favorable uterine medium is necessary for embryo implantation, but endometrial receptivity can be negatively affected by ovarian stimulation . Study of endometrial receptivity is especially limited in the context of IVF cycles .

Biopsy of the endometrium cannot be considered during the treatment, and this has encouraged the development and use of ultrasonography and Doppler-like non-invasive methods to evaluate ovarian response to the stimulation and uterine receptivity .

Eligibility criteria: Inclusion Criteria:

- Maternal age from 20 to 40 years. Women with BMI range from 20 - 35 Women diagnosed with primary infertility

Exclusion Criteria:

Maternal chronic medical disorder (diabetes mellitus or hypertension). Women diagnosed with autoimmune diseases or antiphospholipid syndrome

Primary outcomes:
measure: The number of patients who will have positive pregnancy rate
timeFrame: within 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy hospital
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: STUDY_CHAIR
References:
Clinical trial NCT00197171: Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
Official title: Evaluate the Persistence of Immune Response of GSK Biologicals' TWINRIX™ ADULT, Administered According to 0,6 Month Schedule and 0,12 Month Schedule, in Volunteers Aged 12-15 Years Inclusive at the Time of First Vaccine Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Hepatitis A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 143
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.

Detailed description: Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine at either 0, 6 month schedule or 0, 12 month schedule. These long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.

Eligibility criteria: Inclusion Criteria:

* Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.

Primary outcomes:
measure: Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who
Secondary outcomes:
measure: To record the SAEs that was reported since the last time point.
Other outcomes:
Locations:
city: Paramatta
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00516971: The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population
Official title: The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Non-erosive reflux disease
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2007-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of proton pump inhibitor for the treatment of non-erosive reflux disease (NERD) in Chinese population. Studies from the western population have estimated a worldwide prevalence of gastro-oesophageal reflux disease from 10 to 20 %. Monthly symptoms of heartburn or acid regurgitation were found in 9.3% of subjects according to a population survey in Hong Kong. Most of these patients did not show evidence of erosive change during upper endoscopy. However, patients with NERD suffer from similar impairment of quality of life as patients with erosive oesophagitis and their symptoms are as severe as patients with erosive disease. Data on the use of proton pump inhibitor for the treatment of NERD in Chinese patients are scanty. Thus we want to perform a double-blind randomised placebo-controlled study to evaluate the efficacy of proton pump inhibitor for the treatment of NERD in Chinese population.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients with age between 18 -80 years old,
* Patients with predominant symptoms of heartburn or acid regurgitation at least once weekly with no evidence of endoscopic pathology.

Exclusion Criteria:

* Patients under 18 or over 80 years of age,
* Symptoms of gastrointestinal bleeding,
* Patients who had previous upper gastrointestinal surgery,
* Patients with concomitant serious medical diseases,
* Patients who had received H2-receptor antagonists or proton pump inhibitors in the past 4 weeks,
* Pregnant or lactating women.

Primary outcomes:
measure: Symptoms assessment, quality of life.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Compliance
timeFrame: 8 Weeks
measure: Adverse effects
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine, The University of Hong Kong
name: Ting Kin Cheung, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02128178: Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Official title: Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Morbid Obesity
Pulmonary Embolism
Keywords: Morbid obesity
Laparoscopic surgery
Compression ultrasonography
Pulmonary embolism
Bleeding
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.

Detailed description: Two regimens of prophylaxis are supposed , the 1st one is to give enoxaparin 40mg 2 hours before surgery and continued daily for 10 days after, and the 2nd one is to start 12 hours before surgery and continued in the same way like the 1st one.

Eligibility criteria: Inclusion Criteria:

* BMI \>40 OR \>35 with comorbidities

Exclusion Criteria:

* No

Primary outcomes:
measure: Venous thrombosis and/or pulmonary embolism (PE)
timeFrame: Postoperative 4 weeks
Secondary outcomes:
measure: Bleeding from the surgery site , drain if any, GIT bleeding,
timeFrame: postoperative 4 weeks
measure: hospital stay
timeFrame: 4 WEEKS
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Manoura University
Study officials:
affiliation: Mansoura University
name: mohamed e abd ellatif, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04134078: Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide
Official title: Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cardiac Arrest
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sudden cardiac arrest (CA) is a leading cause of death worldwide. CA claims the lives of an estimated 300,000 Americans each year. Despite advances in cardiopulmonary resuscitation (CPR) methods, only approximately 10% of adults with CA survive to hospital discharge, and up to 60% of survivors have moderate to severe cognitive deficits 3 months after resuscitation. Most of the immediate and post-CA mortality and morbidity are caused by global ischemic brain injury. The goal of this grant application is to test the hypothesis that resuscitation from cardiac arrest can be improved by improving cerebral oxygenation through inhalation of nitric oxide. This strategy will also improve the chances of return of spontaneous circulation (ROSC), improve short-term survival and neurologic outcome.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years and above
2. In-hospital cardiac arrest as defined by cessation of heartbeat
3. Presence of Endotracheal Tube

Exclusion Criteria:

1. Age below 18 years
2. Absence of Endotracheal Tube
3. Patients with out-of-hospital cardiac arrest
4. Patients involved in trauma and/or patients in the SICU or CTICU
5. Preexisting intra-cerebral lesions such as any head injury (old or new), brain hematoma, cerebral hemorrhage or known frontal lobe disorders such as tumors
6. Any patient with a terminal condition that cannot be treated (specifically any terminal malignancy, end stage lung fibrosis, chronic heart failure with an ejection fraction \<20%)
7. Patients with do not resuscitate and/or do not intubate (DNR/DNI) status
8. Therapeutic window has passed

Primary outcomes:
measure: Rate of return of spontanueous circulation (ROSC)
timeFrame: 1 day
measure: Change in cerebral oxygenation (rSO2)
timeFrame: 1 day
Secondary outcomes:
measure: Neurologic outcomes at hospital discharge
timeFrame: upto 24 weeks
measure: short term survival
timeFrame: upto 24 weeks
Other outcomes:
Locations:
city: S. Setauket
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Jignesh K Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel JK, Schoenfeld E, Hou W, Singer A, Rakowski E, Ahmad S, Patel R, Parikh PB, Smaldone G. Inhaled nitric oxide in adults with in-hospital cardiac arrest: A feasibility study. Nitric Oxide. 2021 Oct 1;115:30-33. doi: 10.1016/j.niox.2021.07.001. Epub 2021 Jul 3.
citation: Magliocca A, Fries M. Inhaled gases as novel neuroprotective therapies in the postcardiac arrest period. Curr Opin Crit Care. 2021 Jun 1;27(3):255-260. doi: 10.1097/MCC.0000000000000820.
Clinical trial NCT00477178: The Effect of Codeine on Driving Abilities
Official title: The Effect of Codeine on Driving Abilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: possible problems using codeine when driving
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic pain patients driving more than 50,000 km/yr

Brief summary: 20 chronic pain patients using codeine are compared with 20 chronic patients not using opioids and 20 healthy volunteers with respect to driving ability measured by neurophysiological tests and driving in a car simulator.


Eligibility criteria: Inclusion Criteria:

* patients with chronic pain
* driving more than 50 000 km

Exclusion Criteria:

* addiction
* eyesight disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Petter C Borchgrevink, Professor
role: STUDY_CHAIR
References:
citation: Nilsen HK, Landro NI, Kaasa S, Jenssen GD, Fayers P, Borchgrevink PC. Driving functions in a video simulator in chronic non-malignant pain patients using and not using codeine. Eur J Pain. 2011 Apr;15(4):409-15. doi: 10.1016/j.ejpain.2010.09.008. Epub 2010 Oct 13.
Clinical trial NCT01792778: RIGHT IV Pilot Study
Official title: Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Intravenous Catheters
Keywords: IV Catheters
Blood control
Lead sponsor: Smiths Medical, ASD, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Willing and able to independently sign an English Informed Consent
* Have adequate veins for placement of IV catheters in both right and left upper extremities

Exclusion Criteria:

* Currently taking anti-coagulation medication
* Have a known bloodborne disease or bleeding tendency
* Have a known fear or adverse reaction to needles or blood
* Women who are pregnant or nursing

Primary outcomes:
measure: Clinical performance and acceptability
timeFrame: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Interprofessional Education and Resource Center
state: Minnesota
Study officials:
affiliation: Smiths Medical
name: Lori Schwartz, MBA, MSN, RN, PHN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856278: Clinical Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of ATC
Official title: Clinical Exploratory Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of Anaplastic Thyroid Cancer (ATC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Anaplastic Throid Carcinoma
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The patients with anaplastic thyroid cancer were treated with CAR-NK immune cells combined with PD-1 monoclonal antibody, and the safety and tolerability of the patients were observed and evaluated.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years (including boundary values), male or female.
2. Be diagnosed with anaplastic thyroid cancer histopathologically with a measurable lesion≥1cm.
3. Liver and kidney function is good, and can tolerate treatment.
4. Be able to cooperate with the completion of treatment and follow-up work.
5. No other systemic diseases, including other malignancies.

Exclusion Criteria:

1. Need to breastfeed the baby or have fertility needs；
2. Immune system diseases;
3. Diseases of the blood system;
4. Mental system diseases;
5. Interstitial pneumonia, lung disease, etc.;
6. Failure to follow rules of this study.

Primary outcomes:
measure: Safety and tolerability
timeFrame: From the start of the trial to day 56 after the first infusion of CAR-NK.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03374878: Oral Contraceptive and Strength Training
Official title: E5 - Oral Contraceptive and Strength Training (2nd Generation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: exercise
oral contraceptive
strength training
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross sectional study with 16 in each group.
Primary purpose: BASIC_SCIENCE

Brief summary: Cross sectional study investigating the effect of strength training in users and non-users of oral contraceptives (OC) (2nd generation OC)


Eligibility criteria: Inclusion Criteria:

* 18.5 - 30 years
* BMI \< 30

Exclusion Criteria:

* Medicine influencing protein turnover
* Surgery on the knee
* Arthritis
* Diabetes
* Smoking
* irregular menstruation (\<24 days or \>35 days cycles)
* Non-users: not have used contraceptives for the last 3 months.
* Unstable weight (+/- 5 kg within the last 6 months)
* Regular training/exercise more than 2 hours/week for the last 6 months. Maximum 70 km of cycling transport/week.
* Strength training \>1time/month for the last 6 months.
* Pregnancy
* Diet og eating disorder
* Can not read or understand danish

Primary outcomes:
measure: Muscle mass
timeFrame: Baseline + after 10 weeks of resistance training.
Secondary outcomes:
measure: Muscle fiber size
timeFrame: Baseline + after 10 weeks of resistance training.
measure: Muscle strength
timeFrame: Baseline + after 10 weeks of resistance training.
measure: Blood values
timeFrame: Baseline + after 10 weeks of resistance training.
measure: Functionality
timeFrame: Baseline + after 10 weeks of resistance training.
measure: Fat free mass (FFM)
timeFrame: Baseline + after 10 weeks of resistance training.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
affiliation: University of Aarhus
name: Mette Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: