louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04067154: Gas Exchange and CT Effects of PEEP in ARDS
Official title: Does a Bedside Method for Describing Functional Gas Exchange Compare Well With Anatomical Description Via CT Scans, and Could it Predict the Effects of Recruitment and Ventilation/Perfusion Mismatch Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results

Detailed description: In ARDS patients on mechanical ventilation, we will compare model-based estimation of gas exchange parameters (shunt, ventilation/perfusion mismatch) with CT-based estimation of effects of low and high PEEP

Eligibility criteria: Inclusion Criteria:

- ARDS patients requiring mechanical ventilation

Exclusion Criteria:

* \<18 years old
* Requirement of extracorporal life support
* Hemodynamic instability
* Barotrauma

Primary outcomes:
measure: Gas Exchange and lung recruitability at diferent PEEP levels
timeFrame: Approximately two hours
Secondary outcomes:
measure: Physiologic Parameter 1
timeFrame: Approximately two hours
measure: Physiologic Parameter 2
timeFrame: Approximately two hours
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: MI
Study officials:
References:
citation: Karbing DS, Panigada M, Bottino N, Spinelli E, Protti A, Rees SE, Gattinoni L. Changes in shunt, ventilation/perfusion mismatch, and lung aeration with PEEP in patients with ARDS: a prospective single-arm interventional study. Crit Care. 2020 Mar 23;24(1):111. doi: 10.1186/s13054-020-2834-6.
Clinical trial NCT02221154: Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
Official title: Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: in vitro fertilization
ovarian hyperstimulation
pregnancy
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.

The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.


Eligibility criteria: Inclusion Criteria:

* Patients PCOS (Rotterdam ESHRE / ASRM criteria)

Combination of at least two of the following three criteria:

* Cycle disorder
* Clinical hyperandrogenism and / or biological
* Account antral follicles\> 24
* Age ≤ 18 ≤ 38 years
* BMI \<35 kg / m²
* Able to understand the protocol and signed informed consent

Exclusion Criteria:

* Patients not having the Rotterdam criteria
* Patients\> 38 years and / or BMI\> 35 kg / m²
* Woman enjoying a measure of legal protection
* Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171)
* Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation

Primary outcomes:
measure: Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI de Créteil
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Nantes
country: France
facility: CHU de Nantes
city: Saint Nazaire
country: France
facility: CH de Saint Nazaire
Study officials:
affiliation: CHD Vendée La Roche sur Yon
name: Fabienne DELAY, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01814254: Comparison of Body Hydration State in Hemodialysis Patients
Official title: Comparison of Body Hydration State in Hemodialysis Patients With the Hydra 4200 and ZOE (100 and 5 kHZ) Bioimpedance Devices
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hemodialysis
Chronic Kidney Disease
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hemodialysis clinics

Brief summary: Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice.

The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to measure whole body and segmental body fluid volumes but Hydra is approved only for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple measurement before, during and after dialysis. Preliminary results in clinical studies have shown that optimal hydration state of HD patients may be determined by the calf method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8 mA current instead of 100 kHz and 2 mA.

The subjects of this study include a group of hemodialysis patients and a group of healthy controls. The healthy controls are used to identify a normal range within the healthy population for each method. Each hemodialysis patient will be studied twice in different hydration state. The study will not change the procedure of the patient's dialysis treatment. Since all devices are based on noninvasive bioimpedance technique, this study has minimal risk.


Eligibility criteria: Inclusion Criteria:

* Clinically stable

Exclusion Criteria:

* Implants including pacemakers, implantable pumps, artificial joints
* Limb amputations
* Pregnancy
* Simultaneous participation in another clinical study except observational trials.

Primary outcomes:
measure: Calf bioimpedance measurement
timeFrame: 2 dialysis treatments within 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Yorkville Dialysis
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05429554: The Effect of Metformin and DPP4 Inhibitors on Cognition and Cardiovascular Protection in Type 2 Diabetic Patients
Official title: The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and Cardiovascular Protection in Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: MTI University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Endocrinology, Egypt
First posted: 2022-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study contains 2 groups each group consists of 30 patients

Brief summary: The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients

Detailed description: This study aims to investigate the effect of daily oral DPP4 inhibitors and oral metformin on neurodegeneration in type 2 diabetic patients.

This study aims to compare between the cardiovascular protective properties of DPP-4 inhibitors and Metformin in type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

* Patient should be diagnosed with Type 2 diabetes mellitus (T2DM) and guided with HA1c ≥7, age ≥40 years.
* moderate hypertension.

Exclusion Criteria:

* • Diabetic patients who have been currently receiving anti-diabetic agents other than metformin and/or insulin

  * Patients with type 1 DM, active liver disease, recent history of cardiovascular disease (acute coronary syndrome, coronary artery intervention, New York Heart Association Class III/IV heart failure, stroke, transient ischemic neurologic event, or new/worsening symptoms of coronary heart disease or cerebrovascular disease), severe peripheral vascular disease, triglyceride levels ≥ 600 mg/dL, history of HIV infection, pancreatitis, malignancy or clinically important hematologic disorder, and an estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease formula) less than 30 mL/min/1.73 m2.
  * Moreover, patients with dementia, AD, those were in delirium status during evaluation period, patients with psychotic disease (schizoaffective disorder, etc.)
  * Alcohol and substance addiction were not enrolled in the study.
  * Also, patients who have any hypersensitivity to metformin or to DPP4 inhibitors were also excluded.

Primary outcomes:
measure: improve the neurodegeneration and cardiovascular effect in diabetic patients
timeFrame: September 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Institute of diabetes and endocrinology
state: Al Kasr Al Aini
Study officials:
affiliation: Bachelor of Pharmacy and Pharmaceutical sciences (Clinical Pharmacy)
name: Toka Hesham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02927054: Effect of Education on Resident Physician Knowledge of Sepsis
Official title: Effect of Education on Resident Physician Knowledge of Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Systemic Inflammatory Response Syndrome
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A questionnaire was provided, including clinical vignettes and free text answers, to assess and evaluate the ability of resident physicians to identify systemic inflammatory response syndrome (SIRS), sepsis, and severe sepsis. Questionnaire scores were compared between specialties. A whole-hospital educational campaign was provided with the aim to improve sepsis recognition, and the questionnaire survey was repeated after one year to assess the effect of the education on the recognition of sepsis.

Detailed description: Sepsis is the number one cause of mortality in US hospitals. An aim of this study was to evaluate the ability of resident physicians with different training backgrounds to recognize SIRS, sepsis, and severe sepsis. A survey assessment of the definition of SIRS, sepsis, and severe sepsis was administered to internal medicine, emergency room, orthopedic, neurosurgery, and general surgery residents. Then, an intensive educational campaign designed to improve recognition of the patient with sepsis was launched. For approximately 1 year, posters with this educational information were displayed in the hospital, one-on-one educational sessions were provided to residents, and didactic sessions focusing on sepsis were conducted. The survey was then redesigned and administered it to the same groups as described previously.

Eligibility criteria: Inclusion Criteria:

Resident physician in an University of Utah training program

Exclusion Criteria:

Not willing to participate

Primary outcomes:
measure: Change in sepsis recognition and treatment survey score
timeFrame: Baseline and 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Devin J Horton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poeze M, Ramsay G, Gerlach H, Rubulotta F, Levy M. An international sepsis survey: a study of doctors' knowledge and perception about sepsis. Crit Care. 2004 Dec;8(6):R409-13. doi: 10.1186/cc2959. Epub 2004 Oct 14.
citation: Assuncao M, Akamine N, Cardoso GS, Mello PV, Teles JM, Nunes AL, Maia MO, Rea-Neto A, Machado FR; SEPSES Study Group. Survey on physicians' knowledge of sepsis: do they recognize it promptly? J Crit Care. 2010 Dec;25(4):545-52. doi: 10.1016/j.jcrc.2010.03.012. Epub 2010 Jun 19.
Clinical trial NCT02925377: Neuromuscular Warm-up Intervention to Improve Postural Control in Female Handball Players
Official title: Efficacy of a Specific Warm-up Program to Improve Static and Dynamic Postural Control in Adult Female Handball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control.


Eligibility criteria: Inclusion Criteria:

* Gender: Female
* Handball players
* Actively participated in competitions
* Uninjured at study enrollment

Exclusion Criteria:

-

Primary outcomes:
measure: Change from Baseline: Static postural control
timeFrame: 3, 6, 9, and 11 weeks
measure: Change from Baseline: Dynamic postural control
timeFrame: 3, 6, 9, and 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Sport Science and Sport; FAU Erlangen-Nürnberg
state: Bavaria
Study officials:
affiliation: Institute of Sports Science, Friedrich-Schiller-Universität Jena
name: Astrid Zech, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steib S, Zahn P, Zu Eulenburg C, Pfeifer K, Zech A. Time-dependent postural control adaptations following a neuromuscular warm-up in female handball players: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Oct 13;8:33. doi: 10.1186/s13102-016-0058-5. eCollection 2016.
Clinical trial NCT05703477: The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection
Official title: The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clostridium Difficile Infection
Fecal Microbiota Transplantation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. Recently, FMT has been widely used in the treatment of various gastrointestinal diseases, including but not limit in CDI. In this study, we focused on the demonstration of FMT action mechanism in CDI treatment.


Eligibility criteria: Inclusion Criteria:

1. aged over 18 years old;
2. positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase;
3. can tolerate nasojejunal tube and complete full course of FMT treatment;
4. the clinical data are relatively complete and there is follow-up available for evaluation

Exclusion Criteria:

1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment

Primary outcomes:
measure: changes of microbiota before and after FMT treatment
timeFrame: 7 days, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
name: Hongliang Tian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517177: Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR.

Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.


Eligibility criteria: Inclusion Criteria:

* healthy male volunteer
* aged from 20 to 35
* affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
* who accepts to take part in the study
* who has given their written stated consent
* who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude .There will be no additional test

Exclusion Criteria:

* persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
* persons who take any medication or drugs influencing the autonomic cardiovascular control

Primary outcomes:
measure: The heart rate (HR) and the heart rate variability (HRV) derived from the ECG
timeFrame: baseline
measure: The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP)
timeFrame: baseline
measure: The autonomic cardiovascular control evaluated with a spectral analysis of HRV and BPV.
timeFrame: baseline
measure: the blood pressure variability (BPV) derived from the continuous blood pressure recording
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT00002177: A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection
Official title: A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Recent HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Pilot Projects
HIV-1
Didanosine
Drug Therapy, Combination
Stavudine
Hydroxyurea
RNA, Viral
Nelfinavir
Anti-HIV Agents
Viral Load
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of these drugs over CD4 cell counts.


Eligibility criteria: Inclusion Criteria

Patients must have the following symptoms and conditions:

* Treatment naive.
* Recent HIV infection.
* Baseline laboratory values within acceptable ranges.
* Written, informed consent from parent or legal guardian for patients \< 18 years old.
* Available for follow-up for at least 96 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Documentation of other cause for previously mentioned clinical conditions.
* Intractable diarrhea.
* Signs and symptoms of bilateral peripheral neuropathy \>= Grade 2.
* Inability to tolerate oral medication.
* Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue.

Patients with the following prior conditions are excluded:

History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.

* No other anti-HIV therapy allowed.
* Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed).

  1. Any prior antiretroviral therapy.
* Prior vaccination with a candidate HIV therapeutic vaccine.
* Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
* Previous therapy with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed) within 14 days prior to study entry or at any time while on study.

Active alcohol or substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Univ of California at San Francisco Gen Hosp
state: California
Study officials:
References: