louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04740281: Footwear Among Medical Doctors
Official title: Footwear Among Medical Doctors: An Observational Study of Fashion in Footwear Between Subspecialties
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoes
Keywords: Footwear
Fashion
Medical doctors
Clogs
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2021-02-05
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Medical Doctors working at Aarhus University Hospital, Denmark. The participants will be divided into two groups: Doctors in specialization (In Danish; KBU-, Intro- and HU-læger) and senior doctors (Specialists).

Brief summary: The footwear fashion among medical doctors has been static for decades with a high preference for clogs. However, other types of shoes have been introduced, including sneakers, sandals etc. In some subspecialties with a "need-for-speed", high-agility footwear may be prioritized, while other subspecialist may benefit from "easy-to-clean" shoes. Even comfortability may influence the choice of footwear.

We intend to investigate measures of footwear fashion among medical doctors working at Aarhus University Hospital, Denmark. Participants will be blinded.


Eligibility criteria: Inclusion Criteria:

* Medical Doctor working at Aarhus University Hospital, Denmark
* Wear shoes at work
* Presence at the randomly selected meetings for medical doctors, where trial personal will perform the footwear assessment.

Exclusion Criteria:

* Medical student
* Nurse or other health care profession
* Unidentifiable gender and/or educational level

Primary outcomes:
measure: Footwear preference by subspecialty
timeFrame: Assessed in the data collection period - Spring 2021
Secondary outcomes:
measure: Footwear preference by seniority
timeFrame: Assessed in the data collection period - Spring 2021
measure: Footwear preference by sex
timeFrame: Assessed in the data collection period - Spring 2021
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Hepatology and Gastroenterology, Aarhus University Hospital
state: Central Denmark Region
Study officials:
affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital
name: Rasmus H Gantzel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital
name: Mikkel B Kjær
role: STUDY_DIRECTOR
affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital
name: Kristoffer Kjærgaard
role: STUDY_CHAIR
References:
citation: Gantzel RH, Kjaer MB, Kjaergaard K. [Christmas article: Footwear fashion amongst medical doctors - are clogs fashion or history?]. Ugeskr Laeger. 2021 Dec 13;183(50):V20214. Danish.
Clinical trial NCT03206281: Tall Stature Women Fetal Weight Estimation
Official title: Tall Stature Women Fetal Weight Estimation,Clinical Versus Sonographic Estimation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasonography, Prenatal
Keywords: clinical weight estimation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: To investigate the difference of clinical VS sonographic fetal weight estimation of tall women stature (above 10t percentile)

Detailed description: Women undergoing delivery after week 39 will be estimated of their fetal wight with clinical estimation and then sonographic estimation.

each women will be case control 1:1 for the actual fetal weight of the delivery.

the fetal weight will be blinded for each estimation.

Primary outcome is the actual fetal weight Secondary outcomes will be mode of delivery, fetal complication as APGAR score and fetal hypoxia and maternal complication as perineal laceration

Eligibility criteria: Inclusion Criteria:

* Pregnant women above 172 cm height
* above 39 weeks of gestation

Exclusion Criteria:

* contraindication for vaginal delivery
* Intrauterus growth restriction

Primary outcomes:
measure: The accuracy of fetal weight estimation
timeFrame: 2 weeks
Secondary outcomes:
measure: Mode of delivery and fetal complication
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kfar Saba,
country: Israel
facility: Meir Medical Center
Study officials:
References:
citation: Daykan Y, Shavit M, Yagur Y, Schreiber H, Weitzner O, Schonman R, Biron-Shental T, Markovitch O. Fetal weight estimation in tall women: is ultrasound more accurate than clinical assessment? A prospective trial. Arch Gynecol Obstet. 2022 Mar;305(3):567-572. doi: 10.1007/s00404-021-06177-6. Epub 2021 Aug 11.
Clinical trial NCT03440281: Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Indices in Preterm Labor
Official title: Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Index as Predictors of Spontaneous Preterm Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Labor
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant with singleton pregnancy, more than 28 and less than 35 gestational weeks.

Brief summary: Study included all pregnant women admitted with threatened preterm labor during the study period. All participants underwent estimation of maternal serum homocysteine level and assessment of uterine artery Doppler indices.

Detailed description: Prospective cohort study. Study approval by local ethics committee. Informed written consent. Study included all pregnant women admitted with threatened preterm labor during the study period. All participants underwent estimation of maternal serum homocysteine level and assessment of uterine artery Doppler indices.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* More than 28 and less than 35 gestational weeks.
* Threatened preterm labor

Exclusion Criteria:

* Medical disorders complicating pregnancy
* Obstetric conditions complicating pregnancy (e.g., placenta previa, multiple gestation,PPROM, ....etc)
* Fetal anomalies or distress

Primary outcomes:
measure: The accuracy of serum homocysteine levels and uterine artery pulsatility indices (UtA-PI ) for prediction of preterm labor
timeFrame: Single measurement at the end of the study ( around 37 gestational weeks)
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: Single measurement at the end of the study ( around 37 gestational weeks)
measure: Demographic and clinical characteristics of the study groups
timeFrame: Single measurement on the day one of hospital admission between 28-35 gestational weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00099281: DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer
Official title: A Phase III Study of DPPE Combined With Epirubicin and Cyclophosphamide vs Epirubicin and Cyclophosphamide Alone as First Line Treatment in Metastatic/Recurrent Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Metastases
Keywords: Metastatic breast cancer
Lead sponsor: YM BioSciences
Sponsor class: INDUSTRY
First posted: 2004-12-10
Enrollment: 700
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in patients with metastatic and/or recurrent breast cancer who may have received previous hormone treatment but have not had exposure to anthracycline treatment. Stratification allocation will be within the following subgroups:

1. Prior cytotoxic treatment;
2. Estrogen receptor status;
3. ECOG performance status;
4. Number of cycles of chemotherapy.

Detailed description: Endpoints of the trial are as follows:

primary: overall survival; secondary: response rate, progression free survival, toxicity, neurocognitive function.

Eligibility criteria: Inclusion Criteria:

* Histological proof of breast cancer
* Documented evidence of metastatic and/or recurrent breast cancer
* Presence of at least one bi-dimensional or uni-dimensional lesion
* ECOG status 0, 1 or 2
* Quality of life

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Response rate
measure: Progression-free survival
measure: Toxicity
measure: Neurocognitive function
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: PharmOlam
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Kathleen Pritchard, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01877681: Reference Nurse Program for Pressure Ulcers in Primary Care
Official title: Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pressure Ulcers
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2013-06-14
Enrollment: 58
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC) can improve the effectiveness of interventions and cost savings.

Objective: To evaluate the effectiveness and costs reduction after the implementation in PC setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses for the management of PU in patients in home care setting.

Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza will be randomly assigned to two parallel groups: experimental group and control group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III. The intervention will consist of a telematic advice from the reference nurse regarding chronic wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of the intervention, multilevel models or linear mixed models to take into account the auto-correlation at the individual level and nurse, will be used


Eligibility criteria: Inclusion Criteria:

* New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia)

Exclusion Criteria:

* Patients with chronic wounds that are not PU
* PU in patients with plastic surgery
* Patients who move periodically
* Patients requiring hospitalization during follow-up
* Patients in which nurse is expected to be changed during follow-up
* Terminal patients

Primary outcomes:
measure: healing progression
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Osakidetza
name: Cristina Quesada, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05312281: Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.
Official title: Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Stenosis
Lead sponsor: SRH Gesundheitszentrum Bad Herrenalb
Sponsor class: NETWORK
First posted: 2022-04-05
Enrollment: 100
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 aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly faster pain and pain medication after surgery

Detailed description: Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality level 1 studies are not available.

A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar orthoses in neurogenic spinal claudication in the context of conservative therapy (9). Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless, in a survey of North American spine surgeons, over 60% reported prescribing an orthosis postoperatively (11).

2 Aim of the study

The aim of this study is to show that patients after surgical decompression for lumbar spinal stenosis and patients after surgical sequestrectomy benefit from temporary postoperative immobilization using a lumbar orthosis.

To show that postoperative therapy with a lumbar orthosis prolongs walking distance and reduces early recurrence.

It will be shown that postoperative pain decreases significantly faster and thus pain medication can be reduced faster early postoperatively.

Eligibility criteria: Inclusion Criteria:

* Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy. Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis.
* Age 20-80 years
* Pre-operative walking distance at least 100m
* Consent form signed by the patient

Exclusion Criteria:

* Fusion surgery or recurrent surgery
* Tumors of the spine
* Cervical spinal stenosis or myelopathy
* Rheumatoid arthritis or similar autoimmune disease
* Infection - request for a pension
* Dyspnea due to heart failure with limited walking distance
* Peripheral Arterial Occlusive Disease (PAOD)-

Primary outcomes:
measure: Recurrence rate or reherniation/restenosis by means of MRI results
timeFrame: at 104 weeks
Secondary outcomes:
measure: Pain and Disability Index
timeFrame: At 0, 2, 6, 12, 24, 52 and 104 weeks
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe
Study officials:
affiliation: SRH Ges.-Zentrum Bad Herrenalb
name: Andreas Veihelmann, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03481881: Pharmacokinetics of Drugs Administered to Children
Official title: Pharmacokinetics of Drugs Administered to Children Per Standard of Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric ALL
Keywords: pharmacokinetics
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (\<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver

Brief summary: This is a prospective study of children \<21 years of age with the goal of characterizing the PK of drugs administered per standard of care as prescribed by the treating caregiver.


Eligibility criteria: Inclusion Criteria:

* Children (\< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

Exclusion Criteria:

* Failure to obtain consent/assent (as indicated)

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Data will be collected throughout the hospital or outpatient stay up to 90 days
measure: Time to achieve maximum concentration (Tmax)
timeFrame: Data will be collected throughout the hospital or outpatient stay up to 90 days
measure: Absorption rate constant (ka)
timeFrame: Data will be collected throughout the hospital or outpatient stay up to 90 days
measure: Elimination rate constant (kel)
timeFrame: Data will be collected throughout the hospital or outpatient stay up to 90 days
measure: Half-life (t1/2)
timeFrame: Data will be collected throughout the hospital or outpatient stay up to 90 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT01196481: Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.
Official title: A Prospective,Open Labeled, Randomized Controlled Trial Comparing Carvedilol + VSL# 3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2010-09-08
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: PREVENTION

Brief summary: Patients of cirrhosis will be enrolled who have large esophageal varices, which have never bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to 6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous pressure gradient (HVPG) will again be measured to find out responders (hepatic venous pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure gradient \<12 mm Hg) and non responders (hepatic venous pressure gradient \<20% reduction).The responders will be excluded from the study while the non responders will be randomize into carvedilol+VSL#3 versus Endoscopic Variceal Ligation.


Eligibility criteria: Inclusion Criteria:

* Patients of cirrhosis with portal hypertension aged 18 to 75 years who have large esophageal varices with or without red color signs and have not bled previously.

Exclusion Criteria:

* Any contra-indication to beta-blockers
* Coagulopathy with INR \>1.8 at the time of enrollment
* Any Endoscopic Variceal Ligation or sclerotherapy within last 3 months
* Any past history of surgery for portal hypertension
* Significant cardio or pulmonary co-morbidity
* Any malignancy
* Refusal to participate in the study

Primary outcomes:
measure: Development of first variceal bleeding
timeFrame: 1 Year
Secondary outcomes:
measure: Survival
timeFrame: 1 Year
measure: Reduction in Portal pressure
timeFrame: 1 Year
measure: Time to bleed
timeFrame: 1 Years
measure: Adverse events
timeFrame: 1 Year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences (ILBS)
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences (ILBS)
name: Shiv Kumar Sarin, MBBS, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02818881: Electromyography and Yoga
Official title: Differences in Energy Expenditure of Two Commonly Used Yoga Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Keywords: aerobic
muscle activity
energy expenditure
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study examined the muscle activity, movement patterns, and oxygen consumption during a series of yoga poses with slow and rapid transitions.


Eligibility criteria: Inclusion Criteria:

* Have at least 1 year of yoga experience;
* Practice a minimum of twice per week (app 2 hours or more);
* Demonstrate good form in the poses (asanas) making up the Sun A and Sun B sequences;

Exclusion Criteria:

* If they have any uncontrolled neuromuscular, orthopedic or cardiovascular disease;
* If they have been advised by their physicians that they should not exercise;
* If they cannot complete three cycles each of the Sun A and B sequence in good form.

Primary outcomes:
measure: Comparison of energy expenditures for high-speed and low-speed yoga
timeFrame: Day 3
Secondary outcomes:
measure: Comparison of muscle activities for high-speed and low-speed yoga
timeFrame: Day 3
measure: Comparison of oxygen utilization for high-speed and low-speed yoga
timeFrame: Day 2
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Max Orovitz Laboratory
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00494481: E3 Breast Cancer Taxotere Combination
Official title: A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Breast Cancer
Keywords: Zactima
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-06-29
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology


Eligibility criteria: Inclusion Criteria:

* Females with histological/cytological confirmation of breast cancer.
* Subjects with a measurable lesion or bone lesions

Exclusion Criteria:

* Previous radiotherapy within 6 weeks
* Significant cardiac events, arrhythmias or other cardiac conditions

Primary outcomes:
measure: Number of Patients With a Disease Progression Event
timeFrame: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research SIte
city: Cape Town
country: South Africa
facility: Research Site
city: Observatory
country: South Africa
facility: Research Site
city: Baracaldo
country: Spain
facility: Research Site
city: Lérida
country: Spain
facility: Research SIte
city: Zaragoza
country: Spain
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: