louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01508403: A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
Official title: A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2012-01-12
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all inpatients used or will use Shuxuetong injection in 20 selected hospitals in mainland China

Brief summary: The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

Detailed description: This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.

It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.

However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.

In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.

To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.

According to the 'rule of three', 30,000 cases need to be registered at least.

Eligibility criteria: Inclusion Criteria:

* all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay

Primary outcomes:
measure: Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
timeFrame: to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03488303: Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
Official title: Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstruction; Airway, With Asthma
Lead sponsor: Revenio Research
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital Srebrnjak
First posted: 2018-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young children admitted to the ward at the hospital due to acute lower airway obstruction/asthma exacerbation.

Brief summary: The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.


Eligibility criteria: Inclusion Criteria:

* Age 1-7
* Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment

Exclusion Criteria:

* Need for an ICU treatment
* Bronchiolitis
* Pneumonia (not including viral infections)
* Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
* Implanted or external active medical devices

Primary outcomes:
measure: Association between clinical status and tidal breathing flow-volume (TBFV) curves
timeFrame: 2-4 nights while at ward
Secondary outcomes:
measure: Association between lung function and tidal breathing flow-volume (TBFV) curves
timeFrame: 2-4 nights while at ward and 2 + 2 nights after discharge from hospital
measure: Association between asthma control and tidal breathing flow-volume (TBFV) curves
timeFrame: 2 + 2 nights after discharge from hospital
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Children's Hospital Srebrnjak
Study officials:
affiliation: Children's Hospital Srebrnjak
name: Davor Plavec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03013803: Acceptability Study on Nutricomp® Drink Plus Fibre in Adults
Official title: Acceptability Study on Nutricomp® Drink Plus Fibre in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Patients in Need of High-energy Oral Nutritional Supplementation
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 19
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: Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to show that it is acceptable for patients in the United Kingdom.


Eligibility criteria: Inclusion criteria:

* Male and female participants ≥ 18 years of age
* Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
* Anticipated period of nutritional support ≥ 12 days
* Patient has the capacity and is willing to provide informed consent.

Exclusion criteria:

* Participants with mental in capabilities who are unable to give informed consent
* Hypersensitivity to any of the active substances or excipients within the IP
* Severely impaired gastrointestinal function or complete failure
* More than 50% of nutrition from Parenteral Nutrition
* Simultaneous participation in another interventional study
* Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
* Participants with dysphagia requiring thickened fluids
* Participants with significant renal impairment (CKD)
* Pregnancy

Primary outcomes:
measure: Occurrence of gastrointestinal tolerance parameters
timeFrame: Day 1 - day 13
Secondary outcomes:
measure: Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)
timeFrame: Day 1 - day 13
measure: Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang
timeFrame: Day 1 - day 13
Other outcomes:
Locations:
city: Leigh On Sea
country: United Kingdom
facility: AC Health & Nutrition Ltd
Study officials:
References:
Clinical trial NCT02192203: A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Official title: Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 227
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 research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women participants with 18 years of age or older.

Exclusion Criteria:

* Participants with a history of hypersensitivity, allergy with the use of NSAIDs or menthol or currently receiving systemic or topical NSAIDs within 3 days of visit 1.
* Participants having psoriasis and/or active atopic dermatitis/eczema, and skin infected.
* Lesions, burn or wound in the application site.

Primary outcomes:
measure: Skin irritation
timeFrame: At least 23 days but not more than 30 days for induction and challenge phases combined
Secondary outcomes:
measure: Effects on Superficial Layers of the Skin
timeFrame: At least 23 days but not more than 30 days for induction and challenge phases combined
measure: Response notation
timeFrame: At least 23 days but not more than 30 days for induction and challenge phases combined
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research Inc
state: New Jersey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00313703: Prospective ED Headache Cohort Study
Official title: Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Keywords: headache
emergency department
migraine
recurrent headache
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-04-12
Enrollment: 477
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample of ED patients

Brief summary: The purpose of this study is to determine how often headaches recur and to learn how to predict continued suffering from headache after emergency department discharge.

Detailed description: The majority of the 5 million people who arrive at Emergency Departments (ED) with a headache every year are suffering from an acute exacerbation of a chronic, recurrent headache disorder. The role of the ED in treating these patients has been ill-defined. Often emergency physicians will treat the acute exacerbation and will not attend to the natural history of the disease. However, about two thirds of primary headache patients will suffer a recurrent headache in the 24 hours after discharge from the ED. And, many patients will continue to suffer recurrent headaches for months after their ED discharge.

The purpose of this study is to learn how often headaches recur and to try to find a way to predict who will have a recurrent headache after ED discharge.

After standard ED treatment for headache, participants in the study will be asked to answer questions about prior headaches and medical history, and some census-like questions about race/ethnicity, salary, and education via a 20-minute interview with a research associate. The researchers will follow-up with 10-minute telephone calls to each participant's home in 24 hours and in 3 months with additional questions. Total length of time for study participation is approximately 40 minutes.

Eligibility criteria: Inclusion Criteria:

* Emergency Department patients who present primarily for headache.
* Need to consent to and be available for follow-up

Primary outcomes:
measure: Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge
timeFrame: 24 hours after Emergency Department (ED) discharge
Secondary outcomes:
Other outcomes:
measure: Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal
timeFrame: 3 months
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, 111 East 210th Street
state: New York
Study officials:
affiliation: Department of Emergency Medicine, Montefiore Medical Center
name: Benjamin Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417203: Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty
Official title: Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty Surgeries? Can an Answer be Found by Perfusion Index?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two gropus planned for study

1. group - Hyperbaric spinal anesthesia
2. group - Hypobaric spinal anesthesia
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effects of hypobaric and hyperbaric spinal applications on patient haemodynamics, duration of anaesthetic effect and postoperative analgesia. Thus, it was aimed to determine the method that protects haemodynamics more and suppresses postoperative pain complaints of patients better in this patient group with advanced age, comorbid systemic diseases and high risk of operation.

Detailed description: Patients who are planned to be operated for partial hip replacement at Adıyaman University Training and Research Hospital, who are informed about the study and who agree to participate in the study with their written consent will be included in the study.

Patients who agree to participate in the study will be divided into two groups: hypobaric and hyperbaric spinal anaesthesia patients will be divided into two groups to be decided by the Anaesthesiology and Reanimation specialist responsible for the operation (hyperbaric/hypobaric). Before the start of the operation, perfusion index (PI) values will be monitored with a probe in both lower extremities with standard ASA monitoring. Haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), PI values of both extremities, duration of motor and sensory block, postoperative numeric pain scores of all patients will be recorded and these values will be compared in both groups.

Thus, it was aimed to compare the efficacy, safety, block times and contribution to pain management of each application.

Eligibility criteria: Inclusion Criteria:

* ASA I-II

Exclusion Criteria:

* ASA III-IV
* Deny to participiate
* conditions that spinal anesthesia contraindicated

Primary outcomes:
measure: Visual analog pain score (VAS)
timeFrame: three months
Secondary outcomes:
measure: Quality of recovery (QoR-15)
timeFrame: Three months
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman Training and Research Hospital
Study officials:
References:
Clinical trial NCT06867003: Comparison of Exercise With & Without Bracing in Office Workers With Kyphosis
Official title: Effectiveness of Physical Therapy With &Amp; Without Bracing on Posture, Pain and Functional Outcomes in Office Workers With Kyphosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kyphosis
Keywords: Kyphosis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to Compare PT and bracing in improving posture, pain, and functionality in patient with kyphosis.

It also assess the additive benefits of combining PT with bracing. It also identify sustainable, non-surgical approaches for managing kyphosis in office

Detailed description: The study focuses on understanding Kyphosis, defined as excessive forward curvature of the thoracic spine, has become increasingly prevalent in modern work environments due to the sedentary nature of desk jobs. Kyphosis, characterized by a rounded upper back or "hunchback" appearance, is a clinical and postural problem with significant physical, functional, and psychosocial implications. Among office workers, the condition is primarily postural, driven by long hours of desk work, inappropriate ergonomic settings, and inadequate postural awareness. The increasing prevalence of kyphosis in this demographic has led to a pressing need for effective nonsurgical management strategies, including physical therapy (PT) and spinal bracing.

Eligibility criteria: Inclusion Criteria:

* Office workers diagnosed with Postural Kyphosis
* age limit 30 to 45years
* Experience of upper back or neck pain lasting at least three months
* Spend a minimum of 6 hours per day in a seated position for work.

Exclusion Criteria:

* History of spinal surgery, severe scoliosis, or other significant spinal deformities.

Current engagement in any structured physical therapy program or use of bracing for posture. Any neurological or musculoskeletal disorders impacting posture or movement.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 4 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malakand
country: Pakistan
facility: Riphah international University malakand campus
state: KPK
Study officials:
affiliation: Riphah International University
name: Ataur Rahman, MS-PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789503: Nursing-Home Residents Given Bread Fortified With Vitamin D3
Official title: Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Vitamin D Deficiency
Low Bone Density
Keywords: dietary fortification
Vitamin D3
Osteomalacia
bread
bone mineral density
geriatrics
cholecalciferol
calcidiol
osteoporosis
dual-energy photon absorptiometry
bread fortification
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Natural Ovens of Manitowoc, Manitowoc, USA
First posted: 2008-11-13
Enrollment: 45
Sex: ALL
Minimum age (years): 58
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.

Objective: We wanted to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D3.

Detailed description: Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium.

Eligibility criteria: Inclusion Criteria:

* Healthy seniors in an institution in Romania

Exclusion Criteria:

* Known hypercalcemic or hypercalciuric disease

Primary outcomes:
measure: Serum 25-hydroxyvitamin D response
timeFrame: 12 months
Secondary outcomes:
measure: Effects on serum calcium
timeFrame: 12 months
measure: Effects on urine calcium
timeFrame: 12 months
measure: Change in spine and hip bone mineral density, baseline vs final
timeFrame: 12 months
measure: Change in parathyroid hormone, baseline vs final
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Mocanu V, Vieth R. Three-year follow-up of serum 25-hydroxyvitamin D, parathyroid hormone, and bone mineral density in nursing home residents who had received 12 months of daily bread fortification with 125 mug of vitamin D(3). Nutr J. 2013 Oct 11;12:137. doi: 10.1186/1475-2891-12-137.
citation: Mocanu V, Stitt PA, Costan AR, Voroniuc O, Zbranca E, Luca V, Vieth R. Long-term effects of giving nursing home residents bread fortified with 125 microg (5000 IU) vitamin D(3) per daily serving. Am J Clin Nutr. 2009 Apr;89(4):1132-7. doi: 10.3945/ajcn.2008.26890. Epub 2009 Feb 25.
Clinical trial NCT00585403: Exercise Changes to Peripheral Blood Mononuclear Cells in Children
Official title: PBMC, Exercise and Children: Initial Mechanisms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Physical Fitness
Obesity
Child Development
Growth
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early and late pubertal boys and girls recruited from Orange County, CA

Brief summary: The goal of this research is to determine how the peripheral immune system is altered by exercise and differences related to gender, pubertal status and health.

Detailed description: SPECIFIC AIMS:

1. To systematically measure for the first time in healthy children and adolescents the effects of brief bouts of exercise on:

   1. Numbers of circulating PMBCs, their subsets and key intercellular adhesion molecules (ICAMs).
   2. PBMC gene regulation of stress, inflammatory, and growth/repair mediators \[including: interleukin-4 (IL-4), IL-6, IL-10, tumor necrosis factor-alpha (TNF-alpha), interferon-gamma), growth hormone (GH), insulin-like growth factor-I (IGF-I), heat shock proteins (Hsp)\].
   3. Circulating (serum) and intracellular PBMC levels of key mediators by flow cytometry and cell culture techniques.
   4. Circulating endogenous triggers of PBMC mediator responses-soluble Hsp, IL-6, and F2-isoprostanes.
2. To determine how the acute PBMC responses are altered by gender, pubertal status, body composition (measured by whole-body and regional DEXA), and fitness (measured by progressive cycle ergometry and gas exchange).
3. To determine the relationship in healthy children and adolescents among acute PBMC responses to exercise, biochemical precursors of the metabolic syndrome (insulin, glucose, lipids), and the balance of the TH1/TH2 immune response.

Eligibility criteria: Inclusion Criteria:

* appropriate Tanner Stage
* No evidence of disease or disability

Exclusion Criteria:

* no use of antiinflammatory medications, alcohol, illegal drugs or bronchodilators
* elite children participating in extensive exercise or dance programs
* pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: General Clinical Research Center
state: California
Study officials:
affiliation: Univ. California, Irvine, CA
name: Dan M Cooper, M.D.
role: PRINCIPAL_INVESTIGATOR
References: