louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05530720: Acceptance of Complementary Medicine in Germany
Official title: Acceptance of Complementary Medicine in Germany - an Anonymous Representative Cross-sectional Study Including a Qualitative Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Population
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Otto-Friedrich-University Bamberg, Chair of Sociology, Prof. Dr. Rasmus Hoffmann
First posted: 2022-09-07
Enrollment: 4505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Respondents are recruited from Respondi institute's pool of test persons, but remain completely anonymous with regard to their personal data and answers; they are also not subsequently or indirectly identifiable.

Brief summary: Complementary medicine is widely practiced in Germany and worldwide. The aim of this study is to explore how many people use complementary medicine methods in Germany, for which health-related issues they do and for which they would not.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age at least 18 years
* Sufficient language skills as well as cognitive ability to participate in an online survey or interview lasting approximately 30 minutes
* Active consent to the online consent form

Exclusion Criteria:

- Lack of consent to participate in the study

Primary outcomes:
measure: Assessment of attitudes towards complementary medicine
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Sociodemographic Parameters
timeFrame: Up to 24 weeks
measure: Assessment of knowledge of complementary medicine
timeFrame: Up to 24 weeks
measure: Assessment of own application of complementary medicine
timeFrame: Up to 24 weeks
measure: Assessment of medical history and quality of life by EQ-5D-5L
timeFrame: Up to 24 weeks
measure: Assessment of attitudinal and behavioral questions (e.g. lifestyle)
timeFrame: Up to 24 weeks
measure: Assessment of use of complementary medicine in the Covid-19 pandemic
timeFrame: Up to 24 weeks
Other outcomes:
measure: Qualitative interviews of experts
timeFrame: Conducted after completion of the questionnaire (once), up to 24 weeks
measure: Qualitative interviews of participants
timeFrame: Conducted after completion of the questionnaire (once), up to 24 weeks
Locations:
city: Bamberg
country: Germany
facility: Otto-Friedrich-University Bamberg
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
Study officials:
References:
Clinical trial NCT01817920: Integrated Interdisciplinary Program for Fall Prevention in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Fall Rates
the Severity of Injuries
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Falls are very common accidents in Hospital. It not only results in injuries, less mobility among patients but increases their length of stay, cost and family burdens. Reducing the rates and injuries of falls is an urgent issue around hospitals.

An integrated multidisciplinary fall prevention program (IMFPP) was implemented from 2006 in CCH. Members include physicians, nurses, case manager therapists, engineers and staffs of maintenance. The aim of this study is to determine whether IMFPP efforts support interventions with multiple components do reduce the fall rates and severity of injuries.


Eligibility criteria: Inclusion Criteria:

* Patient in CCH's fall incidence reports system

Exclusion Criteria:

* No

Primary outcomes:
measure: Severities of injury as fall
timeFrame: within 1 day after fall
Secondary outcomes:
measure: Rate of recurrent fall
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06449820: Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis
Official title: Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for ulcerative colitis disease relapse and treated during their stay with JAKi (tofacitinib, filgotinib, or upadacitinib) between 01/01/2019 and 01/12/2023.

Brief summary: Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis.

The aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old,
* Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and Colitis Organisation) criteria,
* Hospitalisation at any point for treatment of ulcerative colitis disease relapse,
* Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe UC during inpatient stay,
* Endoscopically confirmed active disease (Mayo endoscopic subscore ≥ 2) within previous four weeks,
* Patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data.

Exclusion Criteria:

* Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,
* Receiving JAKi prior to admission,
* Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission.

Primary outcomes:
measure: Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness
timeFrame: after study completion, average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Nancy University Hospital
state: Sélectionnez Un Département / État
Study officials:
References:
Clinical trial NCT02374320: Exparel as a Nerve Block for Severe Hand Pain
Official title: Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: CREST Syndrome
Peripheral Vascular Disease
Raynaud Disease
Scleroderma, Diffuse
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) status I-IV

Exclusion Criteria:

* True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine
* Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee

Primary outcomes:
measure: Radial and Ulnar Arterial Diameter
timeFrame: 1 hour
Secondary outcomes:
measure: Pain Measured by Numerical Rating Scale
timeFrame: 1 month
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Jose Soberon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04490720: The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
Official title: The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

Detailed description: This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.

Eligibility criteria: Inclusion Criteria:

1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
2. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).

Exclusion Criteria:

1. Pregnant women.
2. People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
3. No person has undergone major surgery.

Primary outcomes:
measure: Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)
timeFrame: Days 1, 28, and 56
Secondary outcomes:
measure: Change from baseline in Body Mass Index (BMI)
timeFrame: Days 1, 28, and 56
measure: Change from baseline in waist-hip ratio
timeFrame: Days 1, 28, and 56
measure: Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
timeFrame: Days 1, 28, and 56
measure: Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)
timeFrame: Days 1, 28, and 56
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mao-Hsin Lin, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01903720: A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of macular edema
* Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye

Exclusion Criteria:

* Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
* Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
* Any active ocular infection in either eye

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in Central Retinal Thickness (CRT) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in BCVA at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in CRT at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in BCVA at Each Visit
timeFrame: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
measure: Change From Baseline in CRT at Each Visit
timeFrame: Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
measure: Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA
timeFrame: Baseline, Months 6 and 12
measure: Percentage of Participants Receiving a Second Injection
timeFrame: 12 Months
measure: Percentage of Participants Receiving a Third Injection
timeFrame: 12 Months
measure: Time to Second Injection
timeFrame: 12 Months
measure: Time to Third Injection
timeFrame: 12 Months
measure: Percentage of Participants Who Received Laser Treatments
timeFrame: 12 Months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Yoon YH, Kim JW, Lee JY, Kim IT, Kang SW, Yu HG, Koh HJ, Kim SS, Chang DJ, Simonyi S. Dexamethasone Intravitreal Implant for Early Treatment and Retreatment of Macular Edema Related to Branch Retinal Vein Occlusion: The Multicenter COBALT Study. Ophthalmologica. 2018;240(2):81-89. doi: 10.1159/000487547. Epub 2018 Apr 11.
Clinical trial NCT00894920: Biotin Status in Pregnancy
Official title: Biotin Status in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biotin Deficiency
Keywords: biotin
deficiency
pregnancy
lymphocyte propionyl-CoA carboxylase
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to estimate the number of pregnant women who, during pregnancy, have low levels of the vitamin biotin. The hypothesis of this study is that a large number of pregnant women will have low biotin levels. This information will be used to later determine if low biotin levels during pregnancy cause certain birth defects.


Eligibility criteria: Inclusion Criteria:

* age 18-40
* in early pregnancy (less than 15 weeks gestation)
* under care of physician
* normal pregnancy
* taking prenatal vitamin with less than 30 mcg biotin

Exclusion Criteria:

* prenatal vitamin with greater than 30 mcg biotin
* antibiotic use
* known renal disease
* drug, alcohol abuse
* gastric bypass
* daily diet high in biotin
* use of certain meal replacement products high in biotin
* previous history of children with birth defects

Primary outcomes:
measure: Lymphocyte propionyl-CoA carboxylase (PCC) activities
timeFrame: 2-3 months
Secondary outcomes:
measure: Urinary biotin excretion
timeFrame: 2-3 months
measure: Urinary 3-hydroxyisovaleric acid (3HIA) excretion
timeFrame: 2-3 months
measure: Other biotin-related indicators in urine and blood
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Donald M Mock, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621920: Efficacy Study of Bowel Preparation Before Colonoscopy
Official title: Efficacy Study of Bowel Preparation Before Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Cleansing Prior to Colonoscopy
Lead sponsor: C.B. Fleet Company, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
* Are able to communicate with study personnel and comply with study requirements.
* Are able and willing to follow study-specified testing, diet, and hydration regimen.
* Have been informed of the nature and risks of the study and have given written informed consent.

Exclusion Criteria:

* Have known or suspected liver disease or any history of abnormal liver function tests.
* Have clinically active cardiovascular disease within the past 6 months.
* Have blood pressure greater than 150/90 mm Hg.
* Have known or suspected renal insufficiency.
* Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
* Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
* Have diabetes or a history of diabetes.
* Have clinical evidence of dehydration.
* Are pregnant or breast-feeding.
* Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.
* Use prohibited medications of the study in the defined timeframes.
* Have received any investigational agent within 30 days before dosing.
* Have any known contraindications to the study treatment.
* Have any known or suspected allergies to the components of the study medication.
* Have any other condition which would make the subject unsuitable for inclusion in the study.

Primary outcomes:
measure: Effectiveness of bowel cleansing based on a grading scale.
timeFrame: During colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Omaha
country: United States
facility: Qualia Clinical Services
state: Nebraska
Study officials:
References:
Clinical trial NCT03513120: Return to Sport After Posterior Spinal Fusion
Official title: Return to Sport After Posterior Spinal Fusion in Adolescent Athletes With Idiopathic Scoliosis: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Posterior Spinal Fusion
Keywords: Adolescent Idiopathic Scoliosis
Posterior Spinal Fusion
Return to Sport
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All enrolled subjects will be competitive athletes with a diagnosis of adolescent idiopathic scoliosis and plans to undergo posterior spinal fusion.

Brief summary: The primary purpose of this prospective study is to determine when adolescent athletes with idiopathic scoliosis are able to return to sports participation after posterior spinal fusion surgery.

Detailed description: The investigators aim to determine at what time subjects return to athletic activity, and how long after surgery they are performing at pre-surgical levels. The investigators will enroll adolescent athletes that meet the inclusion criteria below, and follow their postoperative activity level with standardized activity questionnaires on a monthly basis until the subject reaches their baseline pre-surgical performance level. The investigators primary aim is to determine at what time patients return to sports without any restrictions to contact level or type of play. The investigators secondary aim is to quantitatively assess when patients are able to compete at their prior level of play as determined by self-assessment surveys, as well as identify any post-operative complications in these patients after return to sports.

Eligibility criteria: Inclusion Criteria:

* Level of play: high school or club level
* Frequency of play at above level: \>3mos/year
* Age: 10-18 years of age (inclusive)
* Sports: at least one sport, contact, non-contact, or collision. No sports exclusion criteria
* Spinal deformity criteria: Adolescent idiopathic scoliosis, curve size 40-75 degrees

Exclusion Criteria:

* Play at recreational/intramural level
* Non-English Speaking Patient
* Sports participation \<3 mos/year
* Non idiopathic etiology or curves \>75 degrees
* Treatment outside of Children's Hospital Colorado provider care network

Primary outcomes:
measure: Return to Sport
timeFrame: Less than 1 year following surgery
Secondary outcomes:
measure: Physical Function Levels
timeFrame: Less than 1 year following surgery
measure: Postoperative Complications
timeFrame: Up to 1 year follow up
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Sumeet Garg, MD
role: STUDY_DIRECTOR
affiliation: University of Colorado School of Medicine
name: Allison Tetreault, MD
role: PRINCIPAL_INVESTIGATOR
References: