louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06487754: New-onset Chronic Pelvic Pain in Transgender People Using Testosterone Therapy: an Exploratory Qualitative Study.
Official title: New-onset Chronic Pelvic Pain in Transgender People Using Testosterone Therapy: an Exploratory Qualitative Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgender Persons
Pelvic Pain
Testosterone
Gender-Affirming Care
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trans masculine individuals using a gender affirming hormonal therapy (testosterone) and having pelvic pain.

Brief summary: This descriptive qualitative study aim to describe the characteristics of pelvic pain in transgender (trans) individuals using testosterone therapy and the impact on their quality of life. This study also aim to understand the levers and obstacles to consulting a health care professional.

Detailed description: This study ai to accurately describe the chronic pelvic plan (CPP) from which transmasculine people can suffer, as well as their impact on quality of life, and to understand what are the obstacles and levers to the implementation of adapted care.

Method: It is an observational, single-center, qualitative study. 10 to 15 trans individuals using testosterone therapy and having pelvic pain for at least 6 months, and that had appeared or changed since taking testosterone, will undergo a semi-structured interview. They will be recruited through community care associations, mailing lists and flyers.

Results: This is a qualitative study aimed at accurately describing the symptoms of pelvic pain experienced by trans people thus we will do a qualitative analysis. QCAMAPS will be used for the coding step.

Eligibility criteria: Inclusion Criteria:

* Being a trans masculine individual
* Taking a gender affirming hormonal therapy (GAHT)
* living close to Grenoble
* having pelvic pain that appeared or were modified after taking GAHT

Exclusion Criteria:

* Subject under guardianship or subject deprived of liberty Refusal of voice recording

Primary outcomes:
measure: Pelvic pain and impact on quality of life description
timeFrame: 1.5 hours during semi structured interviews
Secondary outcomes:
measure: pelvic pain intensity at the time of the interview
timeFrame: at the beginning of the interview
Other outcomes:
Locations:
city: Saint martin d'hères
country: France
facility: UGA
Study officials:
References:
Clinical trial NCT05491954: Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance
Official title: The Use of Continuous Glucose Monitors Among Women With Various Degrees of Glucose Intolerance: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes, Gestational
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ages 18-45 living in central Ohio living with or without gestational diabetes mellitus

Brief summary: Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years
* Women with a viable singleton or twin intrauterine pregnancy between 24 0/7 and 31 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
* Planning to deliver at OSU Wexner Medical Center
* Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

* Abnormal early 50g GCT screen, thereby necessitating 100g OGTT at 24-28 weeks
* Known pregestational diabetes (type 1, type 2, MODY)
* 50g GCT \>200 mg/dl leading to GDM diagnosis without the performance of 3hr 100g GTT
* Abnormal obstetrical ultrasound suspicious for major congenital abnormality
* Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
* Participation in another trial that may influence the primary outcome, without prior approval
* Participation in this trial in a prior pregnancy
* Higher order pregnancy

Primary outcomes:
measure: Changes in glycemic control over late gestation as measured by A1c
timeFrame: 9 months
Secondary outcomes:
measure: The number of neonatal hypoglycemic episodes
timeFrame: 1 week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: tOSU Medical Center
name: Elizabeth Buschur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06031454: Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin
Official title: A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of Leritrelvir With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The drug-drug interaction study had been designed to investigate the effect of Leritrelvir on the pharmacokinetics of Midazolam, Omeprazole, Rosuvastatin and the effect of Verapamil and Rifampin on the pharmacokinetics of Leritrelvir


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg(male) or \>45kg(female) at screening (calculated as a function of measured height and weight according to the formula, BMI = kg/m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination,vital signs,12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with a history of hypersensitivity to study drug(Leritrelvir,Midazolam,Omeprazole,Rosuvastatin, Verapamil, and Rifampin) or any component of study medication;
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
4. Participants who donated blood/bleeding profusely (\>400 mL) 3 months prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF\>450ms;
6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
7. Participants who test positive at screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption

Primary outcomes:
measure: Pharmacokinetic - Cmax
timeFrame: 0-72 hours
measure: Pharmacokinetic -Area under the curve（AUC）
timeFrame: 0-72 hours
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Day1-Day31
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT06006754: Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock
Official title: Influence of Enteral Microbiome Composition and Microbiome Dependent Metabolites on Mortality of Patients With Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Microbial Colonization
Out-Of-Hospital Cardiac Arrest
Acute Heart Failure
Acute Myocardial Infarction
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years presenting to the clinic with cardiogenic shock will be included into the study within a 24 hours timeframe after onset

Brief summary: Cardiogenic shock is associated with a high mortality. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. The significance of the enteral micobiome on cardiovascular mortality of patients with cardiogenic shock is still not known.

This study aims to provide a deeper understanding of the role of the enteral microbiome and microbiome dependent metabolites in mortality and disease progression of patients with cardiogenic shock.


Eligibility criteria: Inclusion Criteria:

* \>18y
* signs of cardiogenic shock regardless of etiology

  * lactate \>3mmol/L
  * and signs of organ dysfunction (urine output \<30 ml/h, cold extremities, altered mental status)
  * and systolic blood pressure \<90 mmHg for \>30 minutes or need for vasopressor therapy

Exclusion Criteria:

* pregnancy/lactation period
* antibiotic treatment within \>24h
* chronic inflammatory bowel disease
* short bowel syndrome
* artificial bowel outlet
* persistent diarrhea or vomiting in the past 3 months
* simultaneous participation in another interfering nutrition study
* active chemo or radiation therapy

Primary outcomes:
measure: Correlation between enteral microbiome composition and mortality
timeFrame: Sampling will be performed within 24 hours of onset of cardiogenic shock and clinical evaluation will be performed after 1 month
Secondary outcomes:
measure: Correlation between TMAO serum level and mortality
timeFrame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
measure: Correlation between SCFA serum level and mortality
timeFrame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
measure: Correlation between inflammatory profile (CRP, PCT, Interleukin panel) and mortality
timeFrame: Sampling will be performed within 24 hours of onset of cardiogenic shock and on day 3
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Clinic Essen
name: Christos Rammos, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05472454: The Ready-to-Eat Meals for Cardiovascular Health Study
Official title: The Ready-to-EAt Meals for Cardiovascular Health (REACH) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet
Hypertension
Cardiovascular Diseases
Blood Pressure
Keywords: DASH
Dietary Approaches to Stop Hypertension
Meals
High Blood Pressure
Hypertension
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post design
Primary purpose: PREVENTION

Brief summary: The proposed project explores the acceptability and health benefits of ready-to-eat (RTE) meals based on the Dietary Approaches to Stop Hypertension (DASH) eating plan. The researchers have developed 14 recipes following the DASH eating plan, which is recommended for the prevention of cardiovascular disease (CVD). The prepackaged meals will be processed using Washington State University (WSU) microwave technologies to ensure food safety. In this pilot study, a sample of 30 participants will be recruited by to study the impact of the DASH meals on blood pressure. All meals will be provided to participants, who will consume the meals daily over a period of 4 weeks. Daily and weekly monitoring of participants (blood pressure and weight) will allow us to gain a scientific understanding on the preventive power of healthy diets in lowering blood pressure and reducing CVD risk.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years old or older
* BMI 18.5-40.0 kg/m2
* Daily access to working internet, microwave, refrigerator, and freezer
* English fluency

Exclusion Criteria:

* Regular use of drugs that affect BP, including weight loss medications
* Diagnosed hypertension OR systolic BP \>130 and/or diastolic BP \>80
* Diagnosis of any hypotensive disorders OR systolic BP \<100 and/or diastolic BP\<65
* Dietary restrictions, including allergy/intolerances
* Presence or history of diabetes
* Previous cardiac event, congestive heart failure, or angina
* Weight loss or gain\>15lb in previous 3 months
* Following a diet to increase or decrease body weight
* Cancer diagnosis or treatment in past 2 years
* ≥14 alcoholic drinks/week for men; ≥ 7 alcoholic drinks/week for women
* Use of nicotine, marijuana, or illicit drugs
* Pregnancy, planned pregnancy, or breastfeeding
* Inability to comprehend the nature of the study or instructions
* No access to the internet
* Planning to leave the Spokane area during the study
* Not fluent in the English language

Primary outcomes:
measure: Blood pressure
timeFrame: through study completion, measured weekly for 5 weeks
Secondary outcomes:
measure: Body weight (kg)
timeFrame: through study completion, measured weekly for 5 weeks
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Pablo Monsivais, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021654: What is the Future of Vulnerable New-borns
Official title: What is the Future of Vulnerable New-borns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Preterm birth; growth; neonatology; Pregnancy; Delivery
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 257
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm bith children

Brief summary: The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service) and compare the information with the national data of preterm birth.

Detailed description: The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service), it means, newborns who are in these following risk categories:

* Birth before 33 weeks of amenorrhea
* Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd for the gestation age
* Perinatal anoxic-ischemia
* Other children whose birth, perinatal history or the existence of a pathology classified them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.
* A regular follow-up is made in Pontoise hospital till the age of 7 to 8 year sold. It tries to screen growth anomalies (neuromotor, sensorial, behavioral, and cognitive or growth development) or health status. The data collect allow us to monitor these parameters and do a statistical study with them.

These information may be used to inform the parents about the future of the premature children cared at Pontoise. They also may be used to compare these children's future with the national data (EPIPAGE 2)

Eligibility criteria: Inclusion Criteria:

* Birth before 33 weeks of amenorrhea
* Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd percentile for the gestational age.
* Perinatal anoxic-ischemia

Other children whose birth, perinatal history or the existence of a pathology classifies them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.

Exclusion Criteria:

* Children born in normal conditions.

Primary outcomes:
measure: The pregnancy issues rate
timeFrame: 2 years
measure: Delivrey issues rate
timeFrame: 2 years
measure: % of preterm children with a failure to thrive.
timeFrame: 2 years
Secondary outcomes:
measure: Number of diseases in the children family health history.
timeFrame: 2 years
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
Study officials:
affiliation: Hôpital NOVO
name: Caroline Miler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05324254: Weighted Blankets for Postsurgical Pain
Official title: Effect of Weighted Blankets on Perioperative Anxiety and Postsurgical Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postsurgical
Keywords: mastectomy
anxiety
blankets
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The strongest psychological predictor of persistent pain after surgery is anxiety before surgery. The weight of blanket a person uses overnight may alter both anxiety and pain levels. The proposed study will determine whether a heavier or lighter blanket alters presurgical anxiety or postsurgical pain in individuals undergoing a breast surgery. We will also study whether any blanket-induced changes in postsurgical pain are related to reductions in anxiety before surgery induced by the blanket. Finally, we will examine clinical and psychological factors that might explain differences in how surgical patients respond to blanket weight. This research will improve our understanding of whether blanket weight can alter anxiety before a surgery or pain after a surgery.


Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Undergoing breast surgery
* Willing to sleep with a weighted blanket for up to 3 months
* BMI of at least 18.5 and able to safely lift up to 15lb
* Willing and able to use their personal smartphone for the ecological momentary assessment app to submit ratings using personal data plan

Exclusion Criteria:

* Pregnancy
* Chronic high-dose opioid use
* Current or previous use of a weighted blanket
* Claustrophobia
* Incarceration

Primary outcomes:
measure: Change in anxiety ratings from before to during blanket use before surgery
timeFrame: arrival to surgical center and final rating prior to surgery
measure: Change in postsurgical pain from before to after overnight blanket use
timeFrame: baseline (before surgery) and 1 and 3 months after surgery
measure: Change in medication use from before to after overnight blanket use
timeFrame: baseline (before surgery) and 1 and 3 months after surgery
Secondary outcomes:
measure: Change in postsurgical pain from before to after overnight blanket use
timeFrame: baseline, 1 week, 1 month, and 3 months
measure: Change in medication use from before to after overnight blanket use
timeFrame: baseline, 1 week, 1 month, and 3 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Actri, Ucsd
state: California
Study officials:
References:
Clinical trial NCT00884754: Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators
Official title: Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2009-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.


Eligibility criteria: Inclusion Criteria:

* any adult patient scheduled for elective surgery.
* ETT is indicated for the procedure in the opinion of the attending anesthesiologist.
* any operator who has performed ≤ 10 GlideScope intubations.

Exclusion Criteria:

* any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
* Patient with known cervical spine abnormalities.
* any patients with known or probable difficult airways. (This rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
* any patient requiring rapid sequence induction.

Primary outcomes:
measure: Time to Intubation (Seconds)
timeFrame: 30-150 seconds (anticipated)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: LHSC
name: Philip M Jones, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones PM, Loh FL, Youssef HN, Turkstra TP. A randomized comparison of the GlideRite((R)) Rigid Stylet to a malleable stylet for orotracheal intubation by novices using the GlideScope((R)). Can J Anaesth. 2011 Mar;58(3):256-61. doi: 10.1007/s12630-010-9440-z. Epub 2010 Dec 17.