louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03244631: Pain Control in Hip Arthroscopy: Comparing Lumbar Plexus Versus Peri-capsular Injection
Official title: Prospective, Single Blind Randomzied Controlled Trial Comparing Lumbar Plexus Peripheral Nerve Block Versus Peri-capsular Injection for Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Hip Arthroscopy
Lead sponsor: Washington Orthopaedics and Sports Medicine
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 64
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized
Primary purpose: PREVENTION

Brief summary: Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during hip arthroscopy

Detailed description: The purpose of this study is to compare two different methods of pain control during and after hip arthroscopy surgery. It is not clear which of many different pain control methods are ideal to reduce pain for patients; consequently, the investigators are performing this study to compare the two main choices for pain control commonly used in order to identify if either is superior to the other.

Eligibility criteria: Inclusion Criteria:

1. Patient scheduled to undergo hip arthroscopy with Dr. Wolff
2. Patient age between 25 and 60 years of age.

Exclusion Criteria:

1. Patient has known allergy to ropivicaine or morphine.
2. Patient unable to speak/read English (No translators available in clinic site).
3. Pregnant female.
4. Patient has a pre-operative narcotic use for hip pain
5. Patient has pre-existing chronic pain disorder (i.e. fibromyalgia)

Primary outcomes:
measure: Pain score
timeFrame: At the one hour point in the PACU
Secondary outcomes:
measure: Morphine equivalents
timeFrame: At the two hour point in the PACU
measure: Time spent in PACU
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Chevy Chase
country: United States
facility: Washington Orthopedics and Sports Medicine
state: Maryland
Study officials:
affiliation: Washington Orthopaedics and Sports Medicine
name: Andrew Wolff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scanaliato JP, Christensen D, Polmear MM, Salfiti C, Gaspar PS, Wolff AB. Prospective Single-Blinded Randomized Controlled Trial Comparing Pericapsular Injection Versus Lumbar Plexus Peripheral Nerve Block for Hip Arthroscopy. Am J Sports Med. 2020 Sep;48(11):2740-2746. doi: 10.1177/0363546520943580. Epub 2020 Aug 6.
Clinical trial NCT02533531: Proof of Concept Study for 1 Lead Patch Technology
Official title: Proof of Concept Study for 1 Lead Patch Technology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Telemetry
Lead sponsor: LifeWatch Services, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.

Detailed description: This study is a two-phase evaluation of the use of a 1 Lead Patch System to monitor electrocardiogram (ECG) data and send the data to the LifeWatch Service Center, in the same manner as the existing ACT ambulatory telemetry system. It will be used in parallel with the standard 3 Lead ACT testing equipment used to monitor ECG outside the hospital. This study will not address safety or effectiveness and no comparator groups will be used. This study will not be treating any particular disease or condition and no randomization or blinding is required. Subjects will be selected in conjunction with their need for current outpatient telemetry monitoring.

Eligibility criteria: Inclusion Criteria:

* Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
* Be recently prescribed a LifeWatch 3 Lead ACT monitor

Exclusion Criteria:

* under 21-years old
* pregnant or who may become become pregnant during the investigation period
* using internal or external defibrillators
* who are using pacemakers or implantable loop recorders
* showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
* meeting any contraindications for a patch biosensor

Primary outcomes:
measure: Composite Outcome Measure - 100% Successful ECG Acquisition
timeFrame: Between 7 and 14 days
Secondary outcomes:
measure: Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch
timeFrame: Between 7 and 14 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
Study officials:
affiliation: Mt. Sinai Medical Center
name: Vivek Reddy, MD FACC FHRS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mt. Sinai Medical Center
name: Marie Noelle-Langan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00545831: Effect of Taurolidin on Prevention of Bloodstream Infection
Official title: Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Keywords: Home Parenteral Nutrition
Sepsis Prevention
Central Venous Catheters
Taurolidine
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.

The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.

Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.


Eligibility criteria: Inclusion Criteria:

* Age superior to 18 years
* Home parenteral nutrition on tunnelized central venous catheters
* Bloodstream infection confirmed by differential hemocultures
* Informed consent form signed
* Negative B-HCG test

Exclusion Criteria:

* Subject unable to give his informed consent
* Pregnancy
* Subject who have a two or three-way catheter, or a non-tunnelized central venous catheter
* Hospital related infection
* Central venous catheters placed since less than 15 days
* Neutropenia \< 500 PNN/mm3
* Fungal Infection, polymicrobial who need ablation of the central venous catheters
* No-response to clinical treatment of the Infection
* Septic thrombophlebitis
* Chemotherapy ongoing
* On going malignancy

Primary outcomes:
measure: Number of recurrence of catheter-related infection in each group
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clichy
country: France
facility: APHP Beaujon Hospital
city: Grenoble
country: France
facility: UH of Grenoble
city: Lille
country: France
facility: UH of Lille
city: Lyon
country: France
facility: UH of Lyon
city: Nice
country: France
facility: UH of Nice
city: Rouen
country: France
facility: University Hospital of Rouen
city: Toulouse
country: France
facility: UH of Toulouse
Study officials:
affiliation: University Hospital, Rouen
name: Stéphane Lecleire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00444431: Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study
Official title: Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance in Children With Scintigraphically Prooved Obstruction. A Prospective, Randomized, Controlled Multi-Center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unilateral Ureteropelvic Junction Obstruction
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2007-03-07
Enrollment: 240
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.


Eligibility criteria: Inclusion Criteria:

* unilateral ureteropelvic junction obstruction
* diameter of renal pelvis greater 12 mm
* partial renal function of 35%-55% proofed by scintigraphy
* urodynamically relevant decrease in renal drainage proofed by diuresis scintigraphy at the age of 4 weeks up to 6 months
* Abscence of clinical symptoms
* Healthy contralateral kidney

Exclusion Criteria:

* Global decrease in renal function
* renal dystopia
* megaureter
* vesico-ureteral reflux
* progressive hydronephrosis
* oligohydrammnion
* voiding dysfunction
* bilateral hydronephrosis
* severe chronical illness
* decrease of partial renal function of more then 5% during allocation

Primary outcomes:
measure: partial renal function
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital of Essen, Department of Pediatric Nephrology
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: University Hospital of Essen, Department of Urology
state: Nordrhein-Westfalen
Study officials:
affiliation: University Hospital, Essen
name: Herbert Rübben, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Essen
name: Peter Hoyer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870531: Korean Transient Ischemic Attack eXpression Registry
Official title: Transient Ischemic Attacks in Korean: Hospital-based, Multi-center Prospective Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Ischemic Attack
Keywords: Transient Ischemic Attack
Lead sponsor: Seoul National University Boramae Hospital
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University Hospitals

Brief summary: This study is to determine the clinical and neuroimaging characteristics of Transient Ischemic Attacks in Korean populations.


Eligibility criteria: Inclusion Criteria:

* Clinical symptoms and signs consistent with transient ischemic attack
* Subject who admitted hospital within 24 hours after symptom onset
* Subjects who underwent MRI (including diffusion-weighted images) and MRA (or CT angiography)

Exclusion Criteria:

Transient neurological symptoms due to

* Migraine aura
* Basilar migraine
* Seizures
* Syncope
* Peripheral vertigo
* Transient global amnesia

Primary outcomes:
measure: Vascular events including ischemic strokes, myocardial infarctions, cardiovascular deaths
timeFrame: 90 days
Secondary outcomes:
measure: Recurrent transient ischemic attacks
timeFrame: 90 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Boramae Hospital
name: Yong-Seok Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05933031: Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
Official title: A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Helicobacter Pylori Infection
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 381
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.

Detailed description: A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.

Eligibility criteria: Inclusion Criteria:

* H. pylori positive at screening
* Subjects who have upper gastrointestinal disease

Exclusion Criteria:

* Having received prior therapy for eradication of H. pylori
* Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hosptial
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Jae Gyu Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01003431: A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
Official title: A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Rotavirus Gastroenteritis
Diphtheria
Tetanus
Pertussis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.


Eligibility criteria: Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* History of abdominal disorders, intestinal folding, or abdominal surgery
* Impaired immune system
* Prior administration of any rotavirus vaccine or DTwP/DTaP
* Fever of \>= 38.1C (100.5F) at the time of vaccination
* History of prior rotavirus infection, chronic diarrhea, or failure to thrive
* Evidence of active gastrointestinal illness

Primary outcomes:
measure: Geometric Mean Titer (GMT) for Pertussis Toxoid
timeFrame: 1 month post dose 3
Secondary outcomes:
measure: Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
timeFrame: 1 month post dose 3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01607931: Exercise, Glucose Kinetics, and the Incretin Effect
Official title: The Effects of Acute Exercise on Glucose Kinetics, Beta-cell Function and the Incretin Effect in Subjects Representative of the Whole Glucose Tolerance Continuum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Exercise
Physical activity
Type 2 diabetes
Obesity
Incretin effect
GLP-1
GIP
Insulin secretion
Glucagon
Beta-cell function
Disposition Index
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Human volunteers will be stratified by oral glucose tolerance status: normal glucose tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4 experimental trials: \[1\] an oral glucose tolerance test (OGTT) combined with infused and ingested stable isotopes of glucose to assess glucose kinetics. \[2\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by the same OGTT combined with stable isotope glucose tracers used in trial 1. \[3\] an isoglycemic clamp to match the plasma glucose profile measured in trial 1. \[4\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by an isoglycemic clamp to match the plasma glucose profile measured in trial 2.

Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon secretion, and the incretin effect will be examined. The exercise responses will be compared between the subjects groups of different glucose tolerance status.


Eligibility criteria: Inclusion Criteria:

* age 18-60 years
* BMI 18-35 kg/m2

Exclusion Criteria:

* insulin dependency
* pregnancy
* presence or history of chronic cardiovascular, pulmonary, hepatic, renal, or hematological disease, or cancer
* contraindication to physical activity as assessed by ECG

Primary outcomes:
measure: Glucose tolerance
timeFrame: Plasma glucose will be measured at 10 minute intervals during the OGTT (3 hours) immediately following the period of rest or exercise
measure: Incretin effect
timeFrame: Plasma insulin and C-peptide will be measured at 10 minute intervals during the OGTT (3 hours) and isoglycemic clamp (3 hours) immediately following the period of rest or exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT00522431: A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Official title: An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Keywords: Hypogonadism
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 149
Sex: MALE
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: Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.


Eligibility criteria: Inclusion Criteria:

* Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

  * Single serum total testosterone concentration \< 250 ng/dL, or
  * Two consecutive serum total testosterone concentrations \< 300 ng/dL (determined at least one week apart during the screening period).
* Has a BMI ≥ 22 kg/m2 and \< 35 kg/m2.

Primary outcomes:
measure: Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Secondary outcomes:
measure: Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Other outcomes:
Locations:
Study officials:
affiliation: Strakan Pharmaceuticals, Inc.
name: Liz Waldie
role: STUDY_DIRECTOR
References:
Clinical trial NCT00857831: Vitamin D and Calcium Study
Official title: Vitamin D and Calcium Replacement/Supplementation in Subjects With Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
Vitamin D deficiency
Functional Electrical Stimulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Kessler Foundation
First posted: 2009-03-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vitamin D aids in the body's ability to absorb calcium, it is a vital component in bone formation and break down. Reduced levels of vitamin D can indicate a vitamin deficiency and may depress serum calcium levels. The following is a list of common causes of vitamin D deficiency: lack of dairy products, alcohol usage, elderly, lack of exposure to sunlight, individuals with reduced mobility, GI malabsorption problems, dark complexion, severe liver damage, and renal failure. Many of these factors can be found in individuals with spinal cord injury. SCI results in disuse bone loss after acute injury, which continues with duration of injury. The goal of this study is to determine the effects of vitamin D and calcium supplements on calcium metabolism and vitamin D deficiency in individuals undergoing functional electrical stimulation (FES) stand retraining (SRT).


Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury (paraplegia or quadriplegia)
* Vitamin D deficiency
* Absolute deficient Vitamin D \[25(OH)D\] \< 16 ng/ml
* Relative deficient Vitamin D \[25(OH)D\] \<30ng/ml - participation in the FES/SRT study at Kessler Institute for Rehabilitation

Exclusion Criteria:

* History of kidney stones
* History of bone disorders
* Currently pregnant

Primary outcomes:
measure: Effects of Vitamin D and Calcium supplements on calcium metabolism and vitamin D deficiency
timeFrame: 15-20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: VA Medical Center, Bronx
state: New York
Study officials:
affiliation: VA Medical Center, Bronx
name: William Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References: