louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01476241: Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist
Official title: Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist: a Single Institution Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that had undergone PEG tube placement in a tertiary care center.

Brief summary: The investigators main endpoint was focused on the analysis of the type, rate and the impact of different clinical parameters on the complications of the PEG tube placements performed at the Department of Otorhinolaryngology - Head and Neck Surgery since October 2008. In addition, the investigators aimed to compare the results with a historic cohort patient group (September 2005 - October 2008) sent to the Department of Surgery for PEG tube placement in order to evaluate the results of the changed routine.

Detailed description: We retrospectively reviewed a cohort of patients that had undergone PEG tube placement from October 2008 until October 2010 at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital (HUCH), Helsinki, Finland, with a health care district currently including approximately 1.5 million inhabitants. Hospital surgical and discharge registries were used to identify the patients. Medical records were studied and details collected on the patients' age, sex, preoperative condition, preoperative laboratory parameters, coexisting medical diagnoses (Charlson Comorbidity Index, CCI (Hall 2004)), indication and date for PEG tube placement, complications, the time of PEG use, follow-up time, and clinical status at last follow up. The study period was aimed to run from PEG tube placement to the last clinical evaluation (minimum 12 months) or the time of death. These results were compared with those from a historic cohort group of patients with the PEG tube placed in the Department of Surgery, HUCH, Helsinki, Finland from September 2005 until October 2008.

Eligibility criteria: Inclusion Criteria:

* ENT patient with PEG tube placement

Exclusion Criteria:

* electrolyte imbalance
* coagulation imbalance
* morbid obesity (BMI \> 40 kg/m2)
* large volume ascites
* previous gastrectomy
* sepsis

Primary outcomes:
measure: Complications and mortality
timeFrame: 12 months follow-up time
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Dept of Otorhinolaryngology - Head and Neck Surgery
Study officials:
affiliation: Dept of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Central Hospital and University of Helsinki, Finland
name: Leif JJ Bäck, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03343041: Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
Official title: Pilot Study of Low-Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bacterial Sepsis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The ultimate goal is to perform a prospective, single-center, double-blinded, parallel group, randomized, controlled trial on the safety and efficacy of low-carbohydrate enteral nutrition in adult patients admitted to the MICU with bacterial septic shock.
Primary purpose: TREATMENT

Brief summary: This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.

Detailed description: This study seeks to assess the tolerability of utilizing low-carbohydrate nutrition in patients admitted to the MICU with bacterial septic shock. Low carbohydrate feeds have been used before in the critical care setting and were well-tolerated.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-65 admitted to the MICU with a diagnosis of severe sepsis or septic shock
2. Patients with 35 \> BMI \> 18.5
3. Patients with serum pro-calcitonin \> 1 ng/mL in the first 24 hours of hospitalization

Exclusion Criteria:

1. Patients with chronic kidney disease as defined by glomerular filtration rate \< 60 for \> 6 months
2. Patients with chronic liver disease as defined by radiographic or tissue evidence of cirrhosis or persistently abnormal liver function tests for \> 6 months
3. Patients with current malignancies
4. Patients with autoimmune disease on current immunotherapy
5. Patients on corticosteroids at doses of prednisone or prednisone-equivalents \> 5 mg for \> 6 months
6. Patients with weight-reduction surgeries
7. Patients with positive viral studies in the first 24 hours of admission

Primary outcomes:
measure: Length of stay (LOS) in the ICU.
timeFrame: discharge: average 5 days.
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale School of Medicine Department of Rheumatology
name: Andrew Wang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439241: Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy
Official title: Assessment of the Performance of a New Ostomy Device in Sub-jects Having an Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose was to investigate the performance of a new ostomy device measured with a measuring device.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Can use a product with max cut size 45 mm
5. Self-reported problems with leakage (3 x within 14 days)
6. Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period
7. Must be able to use custom cut product
8. Minimum change of product every third day
9. Get a negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation Exception: Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP278) protocol.
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation

Primary outcomes:
measure: wear time (hours)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Medical Director
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810641: Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Official title: Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HC-BPPV
Keywords: BPPV(benign paroxysmal positional vertigo)
HC-BPPV(BPPV involving the horizontal semicircular canal)
Nystagmus
Treatment outcome
Horizontal Canal Benign Paroxysmal Positional Vertigo
Lead sponsor: Chonbuk National University
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2008-12-18
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).

Detailed description: A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

Eligibility criteria: Inclusion Criteria:

* a history of brief episodes of positional vertigo,
* direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) or undermost (geotropic nystagmus) ear in both the lateral head turning positions,
* no spontaneous nystagmus during upright sitting position, and
* absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.

Exclusion Criteria:

* central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus

Primary outcomes:
measure: Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Cholabuk-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyoungki-do
Study officials:
References:
citation: Kim JS, Oh SY, Lee SH, Kang JH, Kim DU, Jeong SH, Choi KD, Moon IS, Kim BK, Oh HJ, Kim HJ. Randomized clinical trial for apogeotropic horizontal canal benign paroxysmal positional vertigo. Neurology. 2012 Jan 17;78(3):159-66. doi: 10.1212/WNL.0b013e31823fcd26. Epub 2011 Dec 14.
Clinical trial NCT00546741: Drug Interaction With Metformin
Official title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male and Female Subjects
Keywords: Diabetes,NOS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion Criteria:

* Unwilling to use acceptable method of birth control
* current or recent (within 1 month) smoker
* abnormal liver function tests
* presence of edema
* history of diabetes mellitus
* history of heart failure or renal insufficiency
* history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
* history of Hepatitis C

Primary outcomes:
measure: To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
timeFrame: measures taken daily throughout the study
Secondary outcomes:
measure: To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment
timeFrame: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Bristol-Myers Squibb Clinical Pharmacology Unit
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01009541: An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule
Official title: An Open-Label, Multiple-Dose, Randomized, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal As Compared To The Immediate Release Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin pharmacokinetics bioavailability bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.


Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ
timeFrame: 5 days
measure: Minimum plasma concentration at steady-state within a dosing interval (Cmin)
timeFrame: 5 days
measure: Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)
timeFrame: 5 days
measure: The average plasma concentration at steady-state (Cav), half-life
timeFrame: 5 days
measure: Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)
timeFrame: 5 days
Secondary outcomes:
measure: Safety endpoints include evaluation of adverse events.
timeFrame: 5 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03313141: Study of the Diaphragmatic Function by Transient Elastography (ELASTODIAPH)
Official title: Study of the Diaphragmatic Function by Transient Elastography : Comparison With Mechanical and Electrophysiological Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To compare diaphragm elastrography provided by ultrasound to diaphragm function indices provided by magnetic/electrical phrenic nerves stimulation
Primary purpose: BASIC_SCIENCE

Brief summary: The study of diaphragmatic function is usually measured by the pressures and volumes generated by contraction of the diaphragm, which is often difficult (cumbersome technique, difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically analyze the diaphragm compared to other accessory respiratory muscle groups). In this study, the investigators aimed at analysing diaphragmatic function by measuring the shortening, stiffness, strain and thickening of the diaphragm by ultrasound.


Eligibility criteria: Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

* chronic respiratory, neurologic or cardiac disease
* swallowing disorders
* pregnancy

Primary outcomes:
measure: Transdiaphragmatic pressure
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitie Salpêtrière Hospital
Study officials:
References:
Clinical trial NCT00423241: SEMPERFLO* Pain Management System in Inguinal Hernia Repair
Official title: A Prospective, Randomized, Exploratory Comparison of the SEMPERFLO* Pain Management System to a Commercially Available Pain Relief System in Subjects Undergoing Open Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inguinal Hernia
Pain
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the clinical performance of the SEMPERFLO\* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures.

\*Trademark

Detailed description: Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure
* Subject is 18 years or older
* Subject must be willing to participate in the study, and provide informed consent to participate.

Exclusion Criteria:

* Subjects undergoing recurrent hernia repair;
* Subjects who plan to undergo another elective surgical procedure prior to the completion of this study;
* Subjects with known allergy to bupivacaine;
* Subjects with immunodeficiency diseases (including known HIV);
* Subjects with any findings identified by the surgeon that may preclude conduct of the study;
* Subjects who are known current alcohol and/or drug abusers;

Primary outcomes:
measure: Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
timeFrame: twenty-four hours post procedure
Secondary outcomes:
measure: Narcotic and non-narcotic analgesic usage
timeFrame: 24, 48, 72, 96 and 120 hours post- procedure
measure: Numeric pain scale scores at rest and with coughing
timeFrame: 24, 48, 72, 96, and 120 hours post-procedure
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Boca Raton Community Hospital
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Knoxville
country: United States
facility: Universtiy of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: North Texas Surgery Center
state: Texas
city: Houston
country: United States
facility: Michale E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01832441: Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus.
Official title: Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus.
Keywords: Diabetes Mellitus stem cells [MNCS ]
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by\>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

Detailed description: his study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by\>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

Eligibility criteria: Inclusion Criteria:

* Patient should suffer from Diabetes Mellitus.
* Willingness to undergo Bone Marrow derived Autologous cell Therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
* Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion Criteria:

* Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure. Alcohol and drug abuse / dependence. Patients with History of Hypertension and Hypersensitive.

Primary outcomes:
measure: Abolition or reduction of insulin by >50 percentage
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in HbA1C levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, M.S
role: PRINCIPAL_INVESTIGATOR
References: