louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05472987: Robotic Versus Open Ventral Hernia Repair
Official title: Robotic Versus Open Ventral Hernia Repair: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventral Hernia
Keywords: Robotic
Hernia
Ventral hernia
Open hernia
Mesh
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.

Detailed description: This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. This is a superiority trial with a primary outcome of length of stay in the hospital, theorizing that robotic retromuscular ventral hernia repairs are superior to open ventral hernia repairs by reducing length of stay by 24 hours. Patients will be blinded to the intervention, groups will be in parallel, and the primary outcome (when the patient is discharged) will be determined by a blinded assessor.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* 7 cm to 15 cm wide hernia midline defects
* BMI less than or equal to 45
* Patient deemed both an open and robotic candidate by operating surgeon

Exclusion Criteria:

* 17 years old or younger
* prisoners
* pregnant patients
* Emergent patients
* BMI greater than 45
* Hernia defects less than 7 cm or greater than 15 cm in width

Primary outcomes:
measure: Length of Stay
timeFrame: 30 days
Secondary outcomes:
measure: Post-operative wound complications
timeFrame: 30 day and one year
measure: Other post operative complications
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: Opioid consumption
timeFrame: 30 days and one year
measure: Acute pain scores
timeFrame: 5 days after surgery
measure: Hernia Related Specific Quality of Life Score
timeFrame: 30 days and one year
measure: Direct cost
timeFrame: 30 days
measure: Hernia recurrence
timeFrame: 30 days and one year
measure: Quality of life scores using European Hernia Society (EuraHS) scale
timeFrame: 30 day and one year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center, Knoxville
state: Tennessee
Study officials:
affiliation: The Cleveland Clinic
name: Lucas Beffa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01821287: Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
Official title: Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Nutritional Failure
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 75
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with Single Ventricle Congenital Heart Disease (CHD) being treated at CCHMC and Healthy newborns recruited from CCHMC and private practices

Brief summary: The purpose of this study is to understand the causes of growth failure and to define biochemical markers of nutritional failure in patients with single ventricle Congenital Heart Disease (CHD).


Eligibility criteria: Inclusion Criteria:

* CHD infants: Infants with a single ventricle CHD admitted to CCHMC for neonatal medical management or surgical palliation
* Normal controls: Healthy newborns (full-term infants with no known medical problems) recruited from CCHMC and private practices.

Exclusion Criteria:

* CHD infants: 1) Premature birth (\<36 weeks), 2) Chromosomal abnormalities, 3) Major gastrointestinal, pulmonary or neurologic anomalies
* Normal controls: 1) Premature birth (\<36 weeks), 2) Chromosomal abnormalities, 3) Major gastrointestinal, pulmonary or neurologic anomalies., 4) Cardiovascular anomalies

Primary outcomes:
measure: Resting Energy Expenditure (REE) for infants with a single ventricle compared to the age-matched control infants using the analysis of covariance procedure
timeFrame: At 12 months of age
Secondary outcomes:
measure: The relationship between REE and weight changes in infants with a single ventricle and control subjects; measures include REE, weight, and z-score (weight for age)
timeFrame: At 12 months of age
Other outcomes:
measure: The relationship between biochemical markers of nutrition (prealbumin, IGF-1, IGFBP-3, IL6, IL8, TNF-α, cortisol, insulin, and lymphocyte subclasses) and weight changes in infants with a single ventricle
timeFrame: at newborn hospitalization (at 1-5 days)
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jeffrey Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01329887: The Effect of Ketanserin on the Microcirculation in Sepsis
Official title: Evaluation of the Effect of Ketanserine on Sublingual Microcirculation by SDF Imaging in Septic Patients on the Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Sepsis
Septic Shock
Keywords: microcirculation
SDF
ketanserin
severe sepsis
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 10
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: This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.

Detailed description: This is a pilot study, including 10 ICU patients with severe sepsis with MFI \< 2,5 after fulfillment of a strict resuscitation protocol. At the start of the study, a baseline SDF measurement is made, when MFI \< 2,5 inclusion in the study is permitted and intravenous ketanserin administration is started and subsequently increased, guided by the effect on sublingual MFI, until a safe maximum dosage is reached. Safety margins for hypotension are defined in the study protocol.

Eligibility criteria: Inclusion Criteria:

* severe sepsis and MFI \< 2,5 after resuscitation

Exclusion Criteria:

* age \< 18 year old
* pregnant
* participation other trials prolonged Qt interval

Primary outcomes:
measure: microcirculation
timeFrame: 2 hours
Secondary outcomes:
measure: ketanserine dosage
timeFrame: 48 hours
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
affiliation: Frisius Medisch Centrum
name: E Boerma, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01565187: Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation
Official title: Development of a Psychosocial Assessment Database for Reconstructive Hand Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arm Injuries
Keywords: Hand Transplantation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 3
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: Candidate who will be receiving a hand transplant at Mayo Clinic.

Brief summary: A prospective multicenter study utilizing standardized instruments for the psychological assessment of hand transplant candidates pre and post-transplant as well as those candidates excluded for transplantation.

Detailed description: The semi-structured psychological interview describes the assessment of significant psychosocial characteristics and it is based on the psychosocial domains of the "Transplant Evaluation Rating Scale (TERS)" by Twillman and colleagues for evaluating organ transplant candidates. The interview guide was developed as a tool to guide clinicians through the interview process for hand transplant candidates. The protocol highlights issues that are specific for reconstructive hand transplantation and give clinicians an immediate understanding of what type of information is necessary to conduct a comprehensive psychosocial assessment.

Additionally, the psychological assessment provides standardized psychological screening procedures and continuous follow-up ratings by psychometrical testing. The test battery will be performed at the time of initial psychosocial assessment, immediately after transplant, at six and twelve months for the transplant candidates and at initial evaluation, six and twelve months for candidates excluded for transplant.

Eligibility criteria: Inclusion Criteria:

* 18 years old
* Undergoing evaluation for hand transplantation

Exclusion Criteria:

* unable to complete surveys

Primary outcomes:
measure: Assessment of change in Psychosocial characteristics of hand transplantation candidates
timeFrame: one year posttransplant
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sheila Jowsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03114787: Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service?
Official title: Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Physiotherapy
Resuscitation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation


Eligibility criteria: Inclusion Criteria:

* Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
* Major Patient over 18 years of age
* Patient affiliated to social security

Exclusion Criteria:

* Sedate
* With restrictive or tracheotomized syndrome
* With rib fractures
* Not able to benefit from physiotherapy within 3 hours after the start of the weaning protocol
* Refusal of patient or family
* Physiotherapy contraindications
* Patient under tutorship or curatorship
* Pregnant women

Primary outcomes:
measure: Time between initiation of weaning protocol and extubation.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT02905487: Relationship Between Gestational Diabetes Mellitus and Inflammatory Adipocytokins in Obese Mothers and Their Newborn at Delivery
Official title: Relation Entre diabète Gestationnel et Adipocytokines Inflammatoires Chez Des mères obèses et Leur Nouveau-né à l'Accouchement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes, Gestational
Keywords: Gestational Diabetes Mellitus
Obesity
Adipocytokin
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mother-child pairs from obese women with GDM or not

Brief summary: ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)

Detailed description: ADIPOGEST is a cross sectional study in which mothers are divided into 2 groups : exposed and unexposed to GDM, matched on pregestational BMI, date of delivery and child gender.

Mothers are recruited in the maternity ward of the University Hospital in South of Reunion Island.

It is planned a conveniance sample of 20 mother-child pairs per group.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Obese women (BMI : 30 kg/m² or more)
* Aged over 18 years
* With single pregnancy
* With alive newborn at 37 weeks of amenorrhea or more
* With informed consent

Exclusion Criteria:

* Smoker
* Treatments by corticoïds or thyroid hormons
* Overt diabetes
* Complicated pregnancy
* Premature delivery threat

Primary outcomes:
measure: Blood levels of leptin in mother and her child
timeFrame: 2 years
measure: Blood levels of adiponectin in mother and her child
timeFrame: 2 years
measure: Blood levels of IL-6 in mother and her child
timeFrame: 2 years
measure: Blood levels of TNF-alpha in mother and her child
timeFrame: 2 years
measure: Blood levels of C- Reactive Protein in mother and her child
timeFrame: 2 years
Secondary outcomes:
measure: Blood level of C-peptide in mother
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: Centre Universitaire de La Réunion
Study officials:
References:
Clinical trial NCT00700687: Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib
Official title: Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: cardiovascular prophylactic therapy
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female subjects greater than or equal to 50 years as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

* Standard exclusion criteria for a study of this nature

Primary outcomes:
measure: Lanza scores
timeFrame: entire course of study
Secondary outcomes:
measure: safety of three treatments
timeFrame: entrie course of study
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
Study officials:
References:
Clinical trial NCT00186082: Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs
Official title: A Randomized Controlled Trial of the Effect of Prophylactic Antibiotics on the Infection Rate in Postpartum Third and Fourth Degree Perineal Tear Repairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications, Infectious
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Health & Hospital System
First posted: 2005-09-16
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.

Detailed description: After obtaining consent patients who sustained third or fourth degree perineal laceration after vaginal delivery were randomly assigned to a single dose of antibiotic (cefotetan or cefoxitin, 1 g intravenously or clindamycin, 900 mg intravenously, if allergic to penicillin), or placebo (100ml normal saline) intravenously.

Eligibility criteria: Inclusion Criteria:

- third and fourth degree perineal laceration

Exclusion Criteria:

- chorioamnionitis, HIV positive, inflammatory bowel disease

Primary outcomes:
measure: No perineal breakdown or infection
timeFrame: Six weeks post partum
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Yehia El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duggal N, Mercado C, Daniels K, Bujor A, Caughey AB, El-Sayed YY. Antibiotic prophylaxis for prevention of postpartum perineal wound complications: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1268-73. doi: 10.1097/AOG.0b013e31816de8ad.
Clinical trial NCT00958282: Treatment of Cocaine Dependence With Lisdexamfetamine
Official title: Lisdexamfetamine Treatment for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: cocaine
treatment
lisdexamfetamine
dependence
addiction
crack
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.

Detailed description: This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.

Eligibility criteria: Inclusion Criteria:

* Eligible participants must:

  1. Be treatment-seeking males or females between 18 and 65 years-of-age;
  2. Understand the study procedures and provide written informed consent;
  3. Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;
  4. Meet DSM-IV criteria for cocaine-dependence.

Exclusion Criteria:

* Exclusion criteria include:

  1. DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification;
  2. Current use of any prescription medications;
  3. Females currently pregnant or nursing;
  4. Current elevation of liver enzyme levels above twice normal limits;
  5. Existing cardiovascular disease as determined by physician, EKG evaluation;
  6. History of significant acute or chronic physical illness precluding participation;
  7. History of hyperthyroidism, glaucoma, or seizures.

Primary outcomes:
measure: Cocaine-positive Urine Results
timeFrame: 14 Weeks
Secondary outcomes:
measure: Drug Craving
timeFrame: 14 Weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Ambulatory Research Center/Fairview University Psychiatry Dept
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Marc Mooney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04981782: Passive Cervical Range of Motion in Infants
Official title: Passive Cervical Range of Motion in Infants With and Without Torticollis, Before, During and After Chiropractic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthrogenic Torticollis
Keywords: arthrogenic Torticollis
cervical range of motion
infant
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 74
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants with torticollis

Brief summary: Infants with and without torticollis will be measured at different time points to assess their passive cervical spine range of motion (pCROM).

Detailed description: Infants at the age of 2 to 12 month will be measured at several time points to assess their passive cervical range of motion. One group will include healthy subjects, the other group infants with a diagnosed torticollis. Healthy subjects will be measured at the age of 3, 4, 6 and 9 months. Infants diagnosed with torticollis, at their visit at a Chiropractor and one week later.

Eligibility criteria: Inclusion Criteria:

* age 2-12 month
* signed informed consent
* diagnosed with torticollis

Exclusion Criteria:

* defense reaction e.g. crying, screaming
* other illnesses
* neck trauma
* neck surgery
* developmental delay

Primary outcomes:
measure: passive cervical range of motion (pCROM)
timeFrame: baseline
measure: passive cervical range of motion (pCROM)
timeFrame: three months
measure: passive cervical range of motion (pCROM)
timeFrame: six months
measure: passive cervical range of motion (pCROM)
timeFrame: four months
measure: passive cervical range of motion (pCROM)
timeFrame: nine months
Secondary outcomes:
measure: Demographic data child
timeFrame: baseline
measure: Demographic data mother
timeFrame: baseline
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
state: Zurich
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: University of Zurich and Balgrist University Hospital
name: Petra Schweinhardt, PhD
role: STUDY_CHAIR
References: