louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01092000: The Nutrition Challenge: A Health Promotion Campaign
Official title: The Nutrition Challenge: A Health Promotion Campaign
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Promotion
Prevention
Keywords: Health Promotion, Dietary Guidelines, Physical Activity Guidelines
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 56
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants in each group are associated with the Department of Nutrition at the Unviersity of Tennessee.

Brief summary: The purpose of the challenge is to see if we, as the nutrition experts, can follow the dietary and physical activity guidelines promoted to the public. We have an opportunity to "practice what we preach." Scientific evidence demonstrates, knowledge is not enough to change ones'behaviors. It is through positive approaches and lifestyle changes that behavior can be altered. By experiencing the planning, work, and motivation required to make lifestyle changes we can all be better clinicians.


Eligibility criteria: Inclusion Criteria:

* Regular access to the internet

Primary outcomes:
measure: Average Cups of Fruit per Day
timeFrame: 12-weeks
measure: Average Cups of Vegetables per Day
timeFrame: 12 weeks
measure: Average Minutes of Physical Activity Per Week
timeFrame: 12-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: The Department of Nutrition at the University of Tennessee, Knoxville
state: Tennessee
Study officials:
affiliation: Healthy Eating and Activity Laboratory, University of Tennessee
name: Susan B MacArthur
role: PRINCIPAL_INVESTIGATOR
affiliation: Healthy Eating and Activity Laboratory, University of Tennessee
name: Shannon M Looney, MS, MPH
role: STUDY_CHAIR
affiliation: Faculty Advisor: Assistant Professor
name: Hollie A Raynor, PhD, RD, LDN
role: STUDY_DIRECTOR
References:
Clinical trial NCT01609400: An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Enhancement
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 11
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects treated in study 31GB0607

Brief summary: The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.


Eligibility criteria: Inclusion Criteria:

* subject treated with NASHA-gel in the breasts in study 31GB0607
* signed informed consent

Exclusion Criteria:

* no exclusion criteria in this study

Primary outcomes:
measure: Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI
timeFrame: 4 years
measure: Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI
timeFrame: 6 years
Secondary outcomes:
measure: Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.
timeFrame: 4 years
measure: Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos
timeFrame: 4 years
measure: Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)
timeFrame: 4 years
measure: Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.
timeFrame: 6 years
measure: Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos
timeFrame: 6 years
measure: Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)
timeFrame: 6 years
Other outcomes:
Locations:
Study officials:
affiliation: Akademikliniken, Stockholm, Sweden
name: Per Hedén, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Proforma Clinic AB, Stockholm, Sweden
name: Michael Olenius, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05993000: Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial
Official title: Effect Of Mobilization, Exercise And Music On Frozen Shoulder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
432 Hertz Frequency Music
Manual Therapy
Exercise
Keywords: Frozen Shoulder
432 Hertz Frequency Music
Manual Therapy
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the effect of listening to music during the treatment of frozen shoulder on pain, normal range of motion, functional activity status and quality of life.Upon recruitment, the subjects were randomly assigned to one of four treatment groups: Group 1 received Music + Mobilization + Exercise, Group 2 received Music + Exercise, Group 3 received Mobilization + Exercise, and Group 4 received Exercise only.

Detailed description: Forty individuals diagnosed with frozen shoulder were randomly allocated into four distinct treatment groups. Each participant received a total of eighteen treatment sessions, administered three days per week. Pain levels, range of motion of the shoulder joint, functional status, general health condition, and quality of life were measured and recorded for each participant both before and after the treatment.

Eligibility criteria: Inclusion Criteria:

* idiopathic or primary adhesive capsulitis5,20,32,
* a diagnosis of stage 2-3,
* unilateral condition,
* age between 30 to 65 years,
* normal findings on radiographs within the previous 12 months,
* no previous shoulder surgeries to the affected shoulder,
* no previous manipulations under anesthesia of the affected shoulder,
* passive joint movements limited to 50-75% of the normal range of motion of the joint, - and no hearing loss.

Exclusion Criteria:

* have shoulder girdle motor control deficits associated with neurological disorders.

Primary outcomes:
measure: Goniometer
timeFrame: baseline and 6 weeks
measure: Visual Analog Scale
timeFrame: baseline and 6 weeks
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: baseline and 6 weeks
measure: Modified Constant Score
timeFrame: baseline and 6 weeks
measure: 36-Item Short Form Health Survey
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: BMI(Basal Mass Index)
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: SELMA İŞLER, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuz Mayıs University
name: Seydi Ahmet Ağaoğlu, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00530400: Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery
Official title: Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Wound Infection
Keywords: Antibiotic prophylaxis
Bacterial Infections / prevention & control
Surgical wound infection / prevention & control
Neurosurgery
Postoperative Complications / prevention & control
Clinical trial [publication type]
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: GlaxoSmithKline
First posted: 2007-09-17
Enrollment: 1369
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk


Eligibility criteria: Inclusion Criteria:

* Age older than 18
* spinal surgery for herniated disk

Exclusion Criteria:

* known or suspected hypersensitivity to cephalosporins
* type I hypersensitivity to betalactamic antibiotics
* severe renal function impairment
* acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression
* antibiotic therapy for concomitant infection at the time of surgery
* pregnancy
* refusal to participate

Primary outcomes:
measure: Occurrence of a surgical site infection
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of a post-operative infection other than surgical site infection
timeFrame: 6 monts
measure: Serious adverse event
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaire de Genève
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Patrick Francioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00523900: Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
Official title: Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: malnutrition
underweight
low body weight
BMI under 19
under nourished
malnourished
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Quaker Oats Company
First posted: 2007-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intervention study in malnourished adults to assess whether a nutritional supplement given for 8 weeks in addition to the subject's usual diet improves body weight, body composition, biochemical and immune parameters.

Detailed description: Criteria to be included in this study include:

BMI (Body Mass Index) under 19 Free of cancer, HIV/AIDS, bulimia/anorexia and any malabsorption disorders

Description:

We are studying whether adding nutritional shakes will help participants gain weight and improve their health and immunity. This study lasts about 8 weeks and has a total of 7 visits.

Eligibility criteria: Inclusion Criteria:

* BMI (Body Mass Index) under 19
* Adult

Exclusion Criteria:

* HIV/AIDS
* Cancer
* malabsorption disorder

Primary outcomes:
measure: To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults.
timeFrame: 8 weeks
Secondary outcomes:
measure: To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence Cheskin, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531400: Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
Official title: Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 61
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.


Eligibility criteria: Inclusion Criteria:

Investigators recruited volunteer patient participants from patients referred to the electrodiagnosis laboratory of Department of Physical Medicine and Rehabilitation in a medical center using convenient sampling.

The inclusion criterion is:

* adult patient with working diagnosis of possible neurological disorder and
* is referred for both nerve conduction study and needle electromyography

Exclusion Criteria:

The exclusion criteria are:

* conscious disturbances,
* cognitive impairment, or
* language dysfunction.

Primary outcomes:
measure: Pain (Visual Analogue Scale)
timeFrame: baseline and after needle electromyography, to measure the "change" of pain
Secondary outcomes:
measure: Anxiety, assessed by Linear Analogue Anxiety Scale (LAAS)
timeFrame: baseline and after electromyography
Other outcomes:
Locations:
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Attending Physician
name: Yu-Cheng Pei, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02382952: Pilot Study Differential Dissector™ for Blunt Dissection
Official title: Pilot Study Differential Dissector™ for Blunt Dissection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgical Adhesions
Blood Loss, Surgical
Keywords: Abdominal surgery
Pelvic surgery
Stoma takedown
Bowel resection
Lysis of abdominal adhesions
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18
* Patient will be undergoing open abdominal surgery
* Patient willing and able to provide his/her own consent

Exclusion Criteria:

* Current alcohol or other substance abuse
* Current incarceration

Primary outcomes:
measure: Operative Blood Loss
timeFrame: From start of surgery to wound closure
measure: Post-operative Blood Loss
timeFrame: After surgical closure and drain insertion through drain removal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mark Koruda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06977152: Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head
Official title: Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pressure Injury
Keywords: pediatric patients
Pressure injury
Risk assessment
foam pillow
fluidized positioner
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Koç University Hospital
First posted: 2025-05-18
Enrollment: 64
Sex: ALL
Minimum age (years): 28
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the effectiveness of fluidized positioners and memory foam pillows in preventing pressure injuries in the head among pediatric patients.

H1: There is a significant difference between the fluidized positioner and the memory foam pillow in terms of pressure injury incidence in pediatric intensive care patients.

H2: The fluidized positioner reduces the risk of developing pressure injuries more effectively than the memory foam pillow.

H3: There is a significant difference in the pressure applied to the head region of the patient between the fluidized positioner and the memory foam pillow.

H4: The anatomical locations of pressure injuries (occipital, parietal, temporal, and ear regions) vary depending on the type of pillow used.

H5: Compared to the memory foam pillow, the fluidized positioner provides a more evenly distributed pressure across the occipital, parietal, temporal, and ear regions and prevents pressure concentration in specific areas.


Eligibility criteria: Inclusion Criteria:

* Being treated in the pediatric intensive care unit
* Being mechanically ventilated
* Being immobile, being in age interval of 28 days to 5 years
* Having consent for the participation of the study

Exclusion Criteria:

* Having surgical intervention in the head region
* Parents want to leave at any stage of the project
* Having hydrocephalus or burn in the head area
* Having PIs on admission to hospital
* Existing dermatologic diseases affecting the skin or connective tissue
* Having emergence of a new condition during the intervention may significantly affect the risk of pressure injury (e.g., sudden surgery or complication)
* Inability to obtain sufficient data during the study (e.g., patient transfer)

Primary outcomes:
measure: Pressure Injury Development
timeFrame: 0-14 days after the beginning of mechanical ventilation support
Secondary outcomes:
measure: Pressure Measurement
timeFrame: At multiple time points in the 0-14th day after beginning of mechanical ventilation support
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
state: Zeytinburnu
Study officials:
affiliation: Koç University
name: Enes Şimşek, MSc. PhD(c)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02750852: An Algorithm for Predicting Blood Loss and Transfusion Risk in Fast Track Total Hip Arthroplasty
Official title: An Algorithm for Predicting Blood Loss and Transfusion Risk in Fast Track Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Hip Replacement
Blood Loss
Lead sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 124 patients, in two different cohorts, undergoing total hip arthroplasty.

Brief summary: Aim of these study is to create an algorithm, using data from patients that undergoing total hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.

Detailed description: Two different cohorts of patients undergoing total hip arthroplasty will be analyzed to obtain data about hemoglobin trends. The first group will be used to obtain the algorithm, the second one to validate results of the first group, determining sensitivity and specificity.

Eligibility criteria: Inclusion Criteria:

* Patients with hip arthritis

Exclusion Criteria:

* ASA 4 - 5
* Active treatment with warfarin
* Coagulation disorders

Primary outcomes:
measure: Create an algorithm to predict blood loss after total hip arthroplasty
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06474052: Volume Kinetics of Gelofusine 4% During Vascular Surgery
Official title: Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Electrolyte Disorders
Keywords: colloid
volume kinetics
Gelofusine 4%
Lead sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients aged 18 to 80 years undergoing uncomplicated vascular surgery under general anesthesia.

Brief summary: The volume kinetics of the commercially available colloid fluid, Gelofusine 4%, have not been previously studied. Adult patients undergoing open vascular surgery, including femoral and carotid endarterectomy as well as bypass surgery, received general anesthesia. Following the induction of anesthesia, Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period. Hemoglobin concentration was monitored for up to 180 minutes post-administration to construct a plasma hemodilution profile.

Detailed description: Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period to adult patients undergoing uncomplicated vascular surgery. Arterial blood samples were taken to measure blood hemoglobin concentration and hematocrit at baseline and at 5-minute intervals up to 60 minutes after the infusion began, followed by 10-minute intervals up to 90 minutes, and then at 30-minute intervals up to 180 minutes. Urine output and total intraoperative blood loss were continuously monitored. The plasma hemodilution data were fitted to a bicompartmental model to derive the intercompartmental kinetics of Gelofusine 4%.

Eligibility criteria: Inclusion Criteria:

* Informed consent.
* Elective open vascular surgery with a minimal risk of perioperative complications.
* Hemodynamic stability before induction (no chest pain, SBP \> 100 mmHg, MAP ≥ 60 mmHg, 50 \< HR \< 100 bpm).

Exclusion Criteria:

* Known allergy to 4% Gelofusine.
* Patient refusal to participate in the study.
* Non-elective/emergency surgical interventions.
* The American Society of Anesthesiologists (ASA) \> 3.
* Any preoperative hemodynamic support (mechanical or pharmacological).
* Moderate or severe left ventricular dysfunction (LVEF ≤ 44%).
* Moderate or severe right ventricular dysfunction.
* Diastolic dysfunction of any degree.
* Baseline hypoxemia index \< 300 mmHg.

Primary outcomes:
measure: Plasma Volume
timeFrame: 180 minutes after the start of the Gelofusine 4% infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bucuresti
country: Romania
facility: Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu
state: București
Study officials:
affiliation: Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment
name: Robert Hahn, Professor
role: STUDY_DIRECTOR
References: