louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03122041: Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome
Official title: Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance IGT and Type 2 Diabetes T2D in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Keywords: metformin intolerance
PCOS
Sitagliptin
beta cell function
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.


Eligibility criteria: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria)
* BMI of 30 kg/m2 or higher

Exclusion Criteria:

* significant cardiovascular disease
* significant kidney or hepatic disease
* personal or family history of medullary thyroid carcinoma
* known history of gallbladder disease
* known history of pancreatitis

Primary outcomes:
measure: The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index).
timeFrame: Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point and after 12 weeks of clinical trial.
Secondary outcomes:
measure: The secondary outcome was change in fasting plasma glucose level (G0)
timeFrame: Patient's fasting glucose level was measured at the base point and after 12 weeks of clinical trial.
measure: The secondary outcome was change in plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT).
timeFrame: Patient's plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT) was measured at the base point and after 12 weeks of clinical trial.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01250041: Continuous Saphenous Block Versus Continuous Femoral Block for Total Knee Arthroplasty
Official title: Continuous Saphenous Block Vs. Continuous Femoral Block for Total Knee Arthroplasty: Prospective, Randomized, Double Blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty Secondary to Osteoarthritis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this study we compare two techniques for pain control after total knee arthroplasty in terms of preserving the motor function (the strength of the quadriceps muscles of the thigh) which will facilitate the rehabilitation and accelerate the hospital discharge. We will use ultrasound guided technique to block either the femoral nerve in the control group or the saphenous nerve in the experimental group. The primary outcome is the functional capacity and the impact of each block on the ability to walk by measuring the distance patients are able to walk in two minutes in post operative day one in the two groups. The secondary outcome is the morphine consumption in the two groups.


Eligibility criteria: Inclusion Criteria:

- Subject age over 18 years coming for total knee arthroplasty secondary to osteoarthritis

Exclusion Criteria:

* ASA 4-5
* Abnormal liver enzymes, hepatic failure, renal failure and cardiac failure if they become contraindication for the use of regional anesthesia
* Contraindications for spinal anesthesia
* Morbid obesity
* Organ transplant
* Neuropathic pain
* History of stroke or major neurological deficit
* Sensory and motor disorders in the operated limb
* Previous drug dependency
* Chronic use of opioids
* Allergy to local anesthetics
* Inability to comprehend pain assessment

Primary outcomes:
measure: to assess the functional capacity and the impact of each block on the ability to walk by measuring the distance (the 2 minute walk test) in post op day one in the two groups.
timeFrame: post op day one
Secondary outcomes:
measure: the morphine consumption in the two groups.
timeFrame: post op day one
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: JF Asenjo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05948241: Online Psychological Support Group for Patients With Heart Failure and Depression
Official title: Online Psychological Support Group for Patients With Heart Failure and Depression in Promoting Self-care: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Depression
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with heart failure
* Age between 18 and 79 years B)
* After hospital discharge
* Depression (BDI-II score above 14 points)
* Acceptance of the Term of Consent;

Exclusion Criteria:

* Patients with dementia
* Communication barriers
* Octogenarians
* People unable to access the internet for the intervention
* Who declined to participate;

Primary outcomes:
measure: Changes in European Heart Failure Self-Care Behavior Scale's Scores
timeFrame: From baseline to 4 months
Secondary outcomes:
measure: Changes in Beck Depression Inventory Scores (BDI-II)
timeFrame: From baseline to 4 months
measure: Changes in Morisky and Green points
timeFrame: From baseline to 4 moths
measure: The average hospitalization's days in 1 year follow up
timeFrame: From baseline to 1 year follow up
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Marcia Moura Schmidt
state: Rio Grande Do Sul
Study officials:
affiliation: IC-FUC
name: MARCIA M SCHMIDT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850641: A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis
Hyperphosphatemia
Keywords: Hemodialysis
Hyperphosphatemia
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Receiving stable maintenance hemodialysis 3 times a week
* Dialysis patients with hyperphosphatemia

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder
* Patients having severe gastrointestinal disorders
* Patients having severe hepatic disorders

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: TSAT at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: Hb Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: Constipation Condition
timeFrame: 12 weeks
measure: Satisfaction With Bowel Movement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References:
Clinical trial NCT01088841: Sweet Taste Receptors and the Secretion of Glucagon-like Peptide-1 and Peptide YY
Official title: The Functional Significance of Gut-expressed Taste Receptors in the Secretion of Glucagon-like Peptide-1 and Peptide YY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Appetite and General Nutritional Disorders
Hormone Replacement
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of GI satiety peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gut.

Detailed description: There is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled receptors have been identified in the human gut, including the sweet taste responsive T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for unsaturated long-chain free fatty acids.The functional significance of sweet taste receptors in glucose stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion of 75 g glucose with different concentrations of lactisole (150 ppm, 300 ppm and 450 ppm)in a double blind, 4-way crossover trial including 16 healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* BMI of 19.0-24.5
* Age 18-40
* stable body weight for at least 3 month

Exclusion Criteria:

* smoking
* substance abuse
* regular intake of medication
* medical or psychiatric illness
* gastrointestinal disorders or food allergies

Primary outcomes:
measure: Gastrointestinal peptide secretion
timeFrame: 2 hours blood sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Clinical Research Center
Study officials:
affiliation: Clinical Research Center, University Hospital Basel
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002741: Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants
Official title: Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ductus Arteriosus, Patent
Keywords: patent ductus arteriosus
PDA
Preterm
Infant
Electrocardiography
Paracetamol
Acamol
ibuprofen
Placebo
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Detailed description: Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Eligibility criteria: Inclusion Criteria:

* Preterm infants born at 24-37 gestational age
* diagnosis of Hemodynamically significant patent ductus arteriosus
* Medical staff decided to treat with Ibuprofen
* Parents have signed informed consent

Exclusion Criteria:

* Contraindication for ibuprofen
* Alanine transaminase /Aspartate transaminase≥ 200 U/L
* Significant congenital heart disease

Primary outcomes:
measure: The incidence of patent ductus arteriosus closure
timeFrame: 3-10 days after first dose of Ibuprofen + study drug
Secondary outcomes:
measure: Adverse effects
timeFrame: until discharge home (usually within 2-3 months since recruitment)
measure: The need for surgical ligation for PDA
timeFrame: 3-21 days after first dose of Ibuprofen + study drug
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT02063841: Digestive Endoscopy Suite Radiation Controlling Protective Strategies
Official title: A Prospective Double-blind, Randomized, Sham-controlled Trial to Evaluate the Effect of a Lead Free Drape on Scatter Radiation Exposure to Endoscopy Staff During Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Radiation Exposure
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 2
Sex: ALL
Minimum age (years): 45
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: ERCP is associated with radiation exposure to the endoscopist and staff, which may be significant at high volume programs despite the use of lead aprons. We hypothesize that draping of the fluoroscopy image intensifier may significantly reduce staff radiation exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable) principle.

Detailed description: A total of 100 consecutive ERCP procedures were randomly assigned to the radiation-attenuating or sham drape in a 1:1 ratio. There were 2 subjects, the endoscopists performing ERCP and the nurse assisting in the procedure.

Eligibility criteria: Inclusion Criteria:

* All the ERCP procedures done by the same endoscopist and nurse are enrolled
* Patients age \>19

Exclusion Criteria:

* Fluoroscopic procedures other than ERCP were excluded.

Primary outcomes:
measure: Amount of radiation exposure
timeFrame: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
Secondary outcomes:
measure: Estimate cumulative annual radiation risk
timeFrame: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
Other outcomes:
Locations:
city: New Have
country: United States
facility: Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Priya Jamidar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542541: A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans
Official title: A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal FDG Uptake
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2012-03-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG) that is taken-up by active cells such as cancer cells. This contrast can then be seen in the body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can produce "false positive" signals from the colon. Our hypothesis is that much of this signal comes from bacteria that are present in high concentrations in the colon. If this is the case, using an antibiotic to suppress the activity of bacteria may improve the ability of PET-CT to distinguish abnormal cells from normal cells in the colon.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma

Exclusion Criteria:

* Patients with known Inflammatory Bowel Disease
* Patients with known colon cancer

Primary outcomes:
measure: SUVmax of FDG in Each Colonic Segment
timeFrame: Day 2
Secondary outcomes:
measure: SUVavg in Each Colonic Segment
timeFrame: Day 2
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT04523441: Early Support and Physiotherapy for Children and Their Motor Skills
Official title: Identification of the Needs and Difficulties Associated With the Perceptual-motor Management of Infants at High Risk of Cerebral Palsy During the First 24 Months Following Neonatal Hospitalization. Qualitative Study Among Parents and Health Professionals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant
Cerebral Palsy
Neonatal
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 37
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: Parents of children under 24 months of age and health professionals working in the paediatric intensive care unit at the Dijon Bougogne University Hospital.

Brief summary: The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and precisely describe the needs and difficulties present during the child's rehabilitative care during the first months of life.


Eligibility criteria: Inclusion Criteria:

1. For the parents:

   Parents of children under 24 months of age at high risk of cerebral palsy who have given their oral consent.

   Children at high risk of cerebral palsy are defined as :
   * Premature children ≤ 31 WG + 6 days or birth weight less than 1000g.
   * Children who have had a stroke or stage 2 or 3 hypoxia-ischemia according to the Sarnat classification.

   The selection of parents may be retrospective with less than 24 months since hospital discharge.
2. For the health professionals:

Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy.

Exclusion Criteria:

* A person who is physically or cognitively unable to participate in a one-on-one interview or who does not have a sufficient command of the French language.
* Parents aged \<18 years
* Parents in protective custody
* Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy.
* Parents of a child with a genetic disease.

Primary outcomes:
measure: Typology and categorization of the needs and difficulties encountered by the parents.
timeFrame: Through study completion an average of 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: