louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02212665: Life Without Diabetes
Official title: Life Without Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Developing Type 2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim of the study 'Live - without diabetes' is to investigate the effects of increased physical activity on a daily basis with or without (high intense interval training) HIIT (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes

Detailed description: A total of 125 individuals with pre-diabetes will be included and randomized into four different groups (N=25, each group): 1) Increased daily activity detected by the pedometer, 2) increased daily activity detected by the pedometer + HIIT, 3) HIIT, and 4) increased daily activity detected by the pedometer + group intervention 5) a control group (maintain unchanged activity and life-style during the duration of the study).

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \> 25 kg/m2
* Prediabetes: 6.1 % ≤ glycated hemoglobin A1c (HbA1c) ≤ 6.4 % and / or increased fasting plasma glucose (FPG): 6.1 mM ≤ FPG ≤ 6.9 mM and / or abnormal glucose tolerance (7.8 mM ≤ 2 hour plasma glucose (PG) ≤ 11.0 mmol)
* Weekly training status \<150 minutes

Exclusion Criteria:

* BMI \<25 kg/m2
* Diabetes
* Pregnancy and breastfeeding
* Treatment with medicine, there influence glucose metabolism
* Decreased liver function (liver transaminases \> 3 times of limit of normal)

Primary outcomes:
measure: Changes in insulin sensitivity
timeFrame: At baseline and after 12 weeks
Secondary outcomes:
measure: Changes in oxygen peak oxygen uptake
timeFrame: At baseline and after 12 weeks
measure: Changes in glycaemic control
timeFrame: At baseline and after 12 weeks
measure: Changes in key proteins in glucose and fat metabolism (Skeletal muscle)
timeFrame: At baseline and after 12 weeks
measure: Changes in body weight (kg)
timeFrame: At baseline and after 12 weeks
measure: Changes in key proteins in glucose and fat metabolism (Adipose fat tissure)
timeFrame: At baseline and after 12 weeks
measure: Patient-reported outcome measure
timeFrame: At baseline and after 12 weeks
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Diabetes Research, Gentofte Hospital
Study officials:
References:
Clinical trial NCT01331265: Perceived Lactose Intolerance
Official title: Understanding Perceived Lactose Intolerance in White, Black, and Hispanic Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactose Intolerance
Keywords: perceived lactose intolerance
calcium/dairy consumption
specific health outcomes
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2011-04-08
Enrollment: 3815
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: white, black, and Hispanic adults; 18-50 years of age

Brief summary: The goal of this study was to examine the effects of self-perceived lactose intolerance (SPLI) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults.


Eligibility criteria: Inclusion Criteria:

* adults between 18 and 50 years old

Exclusion Criteria:

* pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Nicklas TA, Qu H, Hughes SO, Wagner SE, Foushee R, Shewchuk RM. Prevalence of Self-reported Lactose Intolerance in a Multi-ethnic Sample of Adults. Nutrition Today 44(5):222-227, 2009
citation: Nicklas TA, Qu H, Hughes SO, He M, Wagner SE, Foushee HR, Shewchuk RM. Self-perceived lactose intolerance results in lower intakes of calcium and dairy foods and is associated with hypertension and diabetes in adults. Am J Clin Nutr. 2011 Jul;94(1):191-8. doi: 10.3945/ajcn.110.009860. Epub 2011 Apr 27.
Clinical trial NCT03172065: Dexmedetomidine and Laparoscopic Surgery
Official title: The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Complication
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia.

The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered


Eligibility criteria: Inclusion Criteria:

* Elective gynaecological laparoscopic surgery
* Age 20-45 yrs
* Suspected surgery time 30 minutes
* Inflation pressure \<13 Cm H20

Exclusion Criteria:

* Contraindications to regional block (infection at the needle insertion site)
* Altered conscious level.
* Pregnancy
* Body mass index \>35
* Height \<155 cm
* Patients who have difficulty understanding the study protocol

Primary outcomes:
measure: occurrence shoulder tip pain
timeFrame: 48 hours
Secondary outcomes:
measure: intraoperative haemodynamic stability, et co2, sao2.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT01618565: Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management
Official title: Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shoulder Dystocia
Keywords: shoulder dystocia
training
To assess the effectiveness of hands-on training versus expert demonstration
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model.

Detailed description: We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized SD algorithm scheme on a pelvic training model. Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.

Eligibility criteria: Inclusion Criteria:

* informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: OSATS Score
timeFrame: 30 minutes
Secondary outcomes:
measure: Performance Time
timeFrame: 30 minutes
measure: Global Rating Scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Dept. OBGYN Ruhr University Bochum
city: Herne
country: Germany
facility: Dept. OBGYN, Ruhr University Bochum
Study officials:
References:
citation: Buerkle B, Pueth J, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial. Obstet Gynecol. 2012 Oct;120(4):809-14. doi: 10.1097/AOG.0b013e31826af9a9.
Clinical trial NCT00850265: Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma
Official title: Rol of Spacer in the Combined Treatment With Extrafine Beclomethasone-Formoterol in Stable Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Formoterol
Beclomethasone
Extrafine formulation
Spacer
Moderate
Severe
Stable
Lead sponsor: Hospital General de Requena
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 40
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: TREATMENT

Brief summary: Combined inhaled treatment with long acting adrenergics and steroids in an unique inhaler plays an important role in the management of non-mild asthma. Some studies have demonstrated that the use of spacers achieve better lung deposition and decrease the number of side effects. Recently a new combined treatment for asthma has been developed (extrafine formoterol plus beclomethasone dipropionate). The small size of the extrafine particles of this new combination get the small airway and theorically improve their positive effect. Some authors have stated that the use of a spacer with extrafine particle could decrease the effectiveness of this treatment due to the adhesion of particles on the walls of the spacer because of the electrostatic characteristics of plastic spacers. However, there are no clinical or functional studies demonstrating the role of this phenomena in the control of asthmatic patients. The investigators' hypothesis is that the benefit of using spacers with this new treatment is at least equal in magnitude than the loss of efficacy because of the adhesion of particles on the wall of the spacer and then the investigators hypothesized that the use of spacer with extrafine formoterol-beclomethasone do not suppose a decrease in clinical or functional control in stable moderate-severe asthma patients.


Eligibility criteria: Inclusion Criteria:

* Moderate-severe asthma
* Stable asthma
* 18-75 years old

Exclusion Criteria:

* Exacerbation of asthma
* Instability with the study treatment
* Other cardiopulmonary disease

Primary outcomes:
measure: Asthma Control Questionnaire
timeFrame: at 3 months
Secondary outcomes:
measure: Peak Flow
timeFrame: at 3 months
measure: Asthmatics Symptoms
timeFrame: at 3 months
measure: Side effects
timeFrame: at 3 months
measure: Inhalation technique
timeFrame: at 3 months
Other outcomes:
Locations:
city: Requena-Valencia
country: Spain
facility: Hospital General de Requena
state: Valencia
Study officials:
References:
Clinical trial NCT05618665: The Effect of Asthma Education Given by Taking Health Literacy Into Account
Official title: The Effect of Education Given to Asthmatic School Children and Their Parents by Taking Health Literacy Into Account on Disease Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Health Literacy
Child Health
Asthma Management
Nursing
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomized controlled trial was to examine the effect of education given to asthmatic children and their parents by taking health literacy into account on disease self-management.

The study was conducted with 88 children and their parents between October 2018 and July 2019. While education and booklets were given to both children and parents in intervention group 1, only the children were given the education and the booklets in intervention group 2. There was no intervention applied for the control group. Post-test was performed 3 weeks after the education and then follow-ups were carried out in the next three months over the phone.


Eligibility criteria: Inclusion Criteria:

* Having asthma children with a physician diagnosis,
* Studying in one of the public primary schools in the district where the study was conducted,
* Using asthma medication,
* Having parents without any reading difficulties.

Exclusion Criteria:

* Being in the 1st grade in their school,
* Not using any medication for asthma,
* Having parents with reading difficulties.

Primary outcomes:
measure: Health Literacy for School-Aged Children - HLSAC
timeFrame: 4 Months
measure: Health Literacy Scale
timeFrame: 4 Months
measure: Asthma Control Test
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Department of Nursing Ege University
Study officials:
affiliation: Department of Nursing, Ege University
name: Ayla BAYIK TEMEL, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00393965: Multiple Dose Study of MPC-6827 in Subjects With Refractory Brain Metastases
Official title: Phase 1 Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Neoplasms
Keywords: Metastases
Refractory
Brain
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.


Eligibility criteria: Inclusion Criteria:

* Refractory Brain Metastases
* At least 1 measurable intracranial lesion as defined by RECIST
* ECOG less than or equal to 1
* Adequate hematology/organ function
* No baseline peripheral or central neuropathy above grade 1

Exclusion Criteria:

* Hypersensitivity to Cremophor EL
* Pregnant or Lactating
* Spinal Cord Compression
* Pre-existing dementia/cognitive disfunction
* Require Neupogen or Neulasta to Maintain Neutrophil Count
* Have Primary Brain Cancer
* Have History of Ischemic Heart Disease
* Have Diabetes

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 1 year
measure: Pharmacokinetics
timeFrame: 1 year
Secondary outcomes:
measure: Antitumor Activity
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Myrexis Inc.
name: Margaret Yu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03465865: Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition
Official title: Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition for Surgical Repair of Macular Holes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are invited for a follow-up one year after ILM-flap transposition for surgical repair of macular holes

Brief summary: ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.

Detailed description: Patients that have been scheduled for vitrectomy with ILM-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.

Eligibility criteria: Inclusion Criteria:

* history of ILM-flap transposition

Exclusion Criteria:

* none

Primary outcomes:
measure: OCT
timeFrame: 5 minutes
Secondary outcomes:
measure: visual acuity
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Study officials:
affiliation: VIROS at Hanuschkrankenhaus Vienna
name: Oliver Findl, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00865865: Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty
Official title: Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty- 2-Year Results of a Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Knee
Computer
Gap
Soft tissue
Balancing
Replacement
Arthroplasty
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.

Detailed description: The success of total knee arthroplasty depends on restoration of limb alignment, precise implant positioning and optimal gap balancing. The advent of computer aided surgery (CAS) has improved limb alignment and implant positioning. The objective of this study was to evaluate the functional outcome of computer aided soft tissue gap balancing in total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* primary osteoarthritis of the knee

Exclusion Criteria:

* rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant

Primary outcomes:
measure: Sagittal stability of knee
timeFrame: 2 YEARS
Secondary outcomes:
measure: Functional status of postoperative patients
timeFrame: 2 YEARS
Other outcomes:
Locations:
Study officials:
affiliation: Singapore General Hospital
name: SENG-JIN YEO, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00635765: Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
Official title: Open Label Extension Study Evaluating the Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, Administered Intra Muscularly Every 6, 5 or 4 Weeks in Acromegalic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
Lead sponsor: Ambrilia Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.


Eligibility criteria: Inclusion Criteria:

•Subjects who have completed the 24-week C2L-OCT-01 PR-301 study

Exclusion Criteria:

* Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating
* Subjects who have experienced any clinically significant adverse event related to study medication in C2L-OCT-01 PR-301 study
* Subjects with uncontrolled Diabetes type II
* Subjects with signs or symptoms related to a tumor compression of the optical chiasm
* Subjects with symptomatic cholelithiasis

Primary outcomes:
measure: Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study.
timeFrame: Up to 96 weeks
Secondary outcomes:
measure: To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.
timeFrame: Up to 96 weeks
measure: Compare plasma concentrations of C2L-OCT-01 PR.
timeFrame: First 6 months
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Republican Centre for Medical Rehabilitation and Water-therapy
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi
city: Bucharest
country: Romania
facility: Institue of Endocrinology "C.I Parhon" Bucharest
city: Belgrade
country: Serbia
facility: Institute of Endocrinology, University Clinical Center
city: Bratislava
country: Slovakia
facility: Fakultna Nemocnica s Poliklinkow Bratislava
city: Kiev
country: Ukraine
facility: V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Study officials:
affiliation: Ambrilia Biopharma, Inc.
name: Raphael Naudin, M.D.
role: STUDY_DIRECTOR
References: