louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01401764: Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Official title: Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory.
* Body mass index of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.

Primary outcomes:
measure: Relative perception of pain of platform II versus PASS using a likert scale
timeFrame: 0 minute after injections
measure: Relative perception of pain of platform II versus PASS using a likert scale
timeFrame: 2 minute after injections
measure: Relative perception of pain of PASS versus Arg 100 using a likert scale
timeFrame: 0 minute after injections
measure: Relative perception of pain of PASS versus Arg 100 using a likert scale
timeFrame: 2 minute after injections
measure: Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
timeFrame: 0 minute after injections
measure: Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
timeFrame: 2 minute after injections
measure: Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
timeFrame: 0 minute after injections
measure: Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
timeFrame: 2 minute after injections
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Investigational Site
Study officials:
affiliation: Ablynx, a Sanofi company
name: Josefin-Beate Holz
role: STUDY_DIRECTOR
References:
Clinical trial NCT02608164: A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status
Official title: A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status: a Randomised Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Concentration
Vitamin D Status
Keywords: Healthy adults
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Northern Ireland Executive
name: HSC Public Health Agency
First posted: 2015-11-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution with capsules at raising vitamin D status over winter.

This randomised crossover trial will aim to recruit a total of 22 healthy participants for a total of two 4-week interventions separated by a 10-week washout.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy
* Over the age of 18

Exclusion Criteria:

* Those that intend to consume a supplement containing vitamin D at any point during the study
* Those under the age of 18.
* Individuals that are on prescribed medication that is known to affect vitamin D metabolism
* Those following a vegan diet
* Sun-bed users
* Participants that are planning a sun holiday during the study

Primary outcomes:
measure: Total 25-hydroxyvitamin D concentration
timeFrame: At baseline and weeks 4, 14 and 18
Secondary outcomes:
measure: Biomarkers of vitamin D metabolism
timeFrame: At baseline and weeks 4, 14 and 18
measure: Dietary vitamin D intake
timeFrame: At week 18 only
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit (HISU), University of Ulster
state: Londonderry
Study officials:
affiliation: University of Ulster
name: Pamela J Magee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05196464: ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans
Official title: ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Access to Care
Psychological Distress
Lead sponsor: Syracuse VA Medical Center
Sponsor class: FED
Collaborators: name: VA Office of Research and Development
name: Michael E. DeBakey VA Medical Center
First posted: 2022-01-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two intervention randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This study investigates access, effectiveness, and acceptability of 1-day ACT workshops on problematic mental health symptoms.

Detailed description: This study proposes to investigate access, effectiveness, and acceptability of 1-day ACT workshops delivered in 2 rural VA primary clinics with 32 Veterans with problematic mental health symptoms (i.e., depression, PTSD, or anxiety) that are risk factors for suicide.

Eligibility criteria: Inclusion Criteria:

* 1) current mental health symptoms as measured by one of the following indicators: PHQ-9 ≥ 10, PCL-5 ≥ 30, or GAD-7 ≥ 10.

Exclusion Criteria:

1. cognitive impairment measured by BOMC,
2. current psychosis or mania as evidenced in the medical record,
3. current suicidal intent as measured by the P4,
4. use of mental health services within or outside of VA in the last 6 months as measured by CPRS and the non-VA services questionnaire.

Primary outcomes:
measure: Access to mental health care
timeFrame: 1 month
measure: Psychological Distress
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse Veterans Affairs Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04168164: Aquatic Therapy in Patients With Adquired Brain Injury.
Official title: Aquatic Therapy in Patients With Adquired Brain Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Keywords: aquatic therapy; balance; acquired brain injury.
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the relative effectiveness of three different treatment groups for improvements of postural control and for improvements of balance in these patients using aquatic therapy.

Detailed description: Forty-five patients diagnosed with acquired brain injury, with over one year's evolution and independent gait over a distance of 10 meters, with our without the use of an orthopedic aid, were selected and randomized in 3 groups. Dry land therapy group (DT group), which received sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs; Experimental group (EG group) , which received Ai Chi aquatic therapy; Combined group (DT+EG group), which received alternate sessions of therapy on dry land and aquatic therapy with Ai Chi.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of acquired brain injury traumatic or non-traumatic, with over one year's evolution
* the ability to walk independently over a distance of more than 10 meters, with or without an orthopedic aid
* scores on the Mini- Mental State Examination \> 24

Exclusion Criteria:

* cardiovascular and/or respiratory problems, a previous history of neurological pathologiesand the presence of coadjuvants to the acquired brain injury

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 6 months
measure: Five Times Sit-to-Stand test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Sagrario
Study officials:
affiliation: Universidad de Almeria
name: Sagrario Pérez- de la Cruz, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03251664: Food Groups Associated With Anaemia in Pregnant Women
Official title: The Relation of Locally Available Food Items With Anemia Status Among Pregnant Women in Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Dietary Habits
Food Habits
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 592
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women in Addis Ababa city, Ethiopia

Brief summary: This study investigates the association between locally consumed food items with anemia among pregnant women, in Addis Ababa city, Ethiopia.

Detailed description: Prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda in Ethiopia. Anemia is a significant contributor to poor pregnancy outcomes, including low birth weight and maternal mortality. Anemia is of multiple influences, which in most of the cases include dietary factors. Consumption food items rich in iron and other nutrients involved in red blood cell production promotes optimal hemoglobin level. Dark green leafy vegetables, meat, and beans are some of the food groups reported to be associated with lesser risk of anemia. Studies on the relation of indigenous food items with health outcome are limited in developing countries. For example, teff, consumed only in Ethiopia and parts of Eritrea, is traditionally believed to be protective of anemia because of its high iron content, but Khat chewing, a pervasive social practice in Ethiopia, has been associated with restrictive eating pattern and anemia. In this study, the association of locally consumed food groups with anemia was investigated among pregnant Ethiopian women.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Age 18 years and above
* Residence in Addis Ababa city

Exclusion Criteria:

* Serious medical illness

Primary outcomes:
measure: Food items/groups association with anemia
timeFrame: October 2015 to February 2016
Secondary outcomes:
measure: Reproductive factors associated with anemia
timeFrame: October 2015 to February 2016
measure: Sociodemographic and economic factors association with anemia
timeFrame: October 2015 to February 2016
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Ababa Health Bureau
Study officials:
affiliation: Tehran University of Medical Sciences
name: Ahmad Esmaillzadeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohammed SH, Taye H, Larijani B, Esmaillzadeh A. Food taboo among pregnant Ethiopian women: magnitude, drivers, and association with anemia. Nutr J. 2019 Mar 23;18(1):19. doi: 10.1186/s12937-019-0444-4.
citation: Mohammed SH, Taye H, Sissay TA, Larijani B, Esmaillzadeh A. Teff consumption and anemia in pregnant Ethiopian women: a case-control study. Eur J Nutr. 2019 Aug;58(5):2011-2018. doi: 10.1007/s00394-018-1759-1. Epub 2018 Jun 23.
Clinical trial NCT01985802: Pacing in First-degree AV-block
Official title: Optimal Pacing in Patients With First-degree AV-block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First-degree AV-block
Pacing
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 21
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 explore if there is a less harmful way to pace patients with first-degree AV-block to ensure that the negative effects inferred by the pacing do not outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that His-bundle pacing will offer a more physiological mode of pacing in patients with first-degree AV-block than conventional pacing.

Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular ejection fraction will be included. During the AF ablation three different pacing modes (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the completion of all six pacing protocols (i.e., three modes at two different rates) the experimental part of the procedure ends.

The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary end-points will include left ventricular ejection fraction, left ventricular volume, mitral regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay. Since the research study is conducted in parallel with the standard catheter ablation, we do not anticipate any additional side effects as a result of the study.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for catheter ablation of atrial fibrillation in sinus rhythm and PR prolongation exceeding or equal to 200 ms
* QRS duration less than 120 ms
* Normal left ventricular ejection fraction on echocardiography.

Exclusion Criteria:

* Any bundle branch block
* Second- or third-degree AV-block
* Congestive heart failure, cardiomyopathy, myocardial infarction or major surgical procedure.

Primary outcomes:
measure: Echocardiographic evidence of dyssynchrony (AV, intra- or inter-ventricular)
timeFrame: During each step of the pacing procedure the echocardiographic data will be recorded; over approximately 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: James P Daubert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508102: Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
Official title: Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Awareness
Keywords: remifentanil
bispectral index
Caesarean delivery
general anesthesia
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.

Detailed description: Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The investgators assessed the average value of BIS at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. The investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood gas analysis.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia

Exclusion Criteria:

* multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication

Primary outcomes:
measure: the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
timeFrame: the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
Secondary outcomes:
measure: incidence of intraoperative awareness
timeFrame: one day and one week after delivery.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02600702: A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee
Official title: A Randomized Control Study of Siriraj Home Exercises Protocol for Primary Knee Osteoarthritis Patients Versus Usual Orthopedic Outpatient Consultation in Primary Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Home base exercise
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 135
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee.


Eligibility criteria: Inclusion Criteria:

* 1st osteoarthritis of the knee Age \>/= 50 yrs

Exclusion Criteria:

* Previous knee surgery for OA knee treatment
* Has plan or schedule for knee surgery
* Severe degree of OA knee.

Primary outcomes:
measure: WOMAC score
timeFrame: 3 months
Secondary outcomes:
measure: 6 mins walk test
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
References:
Clinical trial NCT02323802: Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
Official title: Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity /Overweight
Acute Myocardial Infarction (STEMI/ NSTEMI)
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Results after interventions on lifestyle in the secondary prevention of ischemic heart disease are not always consistent, and the Guidelines multidisciplinary measures aren't easily achievable.

Therefore, the purpose of this research project is the identification of an interventional approach to effective secondary prevention and realistic feasibility, in a field of multifactorial risk. The study is open to patients who totaled a double chronic disease, obesity/overweight and coronary heart disease, and who experienced a first event of ischemic cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational intervention in a sample of overweight and obese patients (BMI \> 24.9) incurred in a first episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic approach of prescriptive diet therapy.


Eligibility criteria: Inclusion Criteria:

Subjects of both sexes and age ≥ of 18 years consecutively admitted to the Coronary Unit of IRCCS Foundation Policlinico S. Matteo, at first episode of STEMI or non-STEMI AMI, with BMI greater than 24.9.

Exclusion Criteria:

Patients who can not provide informed consent (because illiterate or with significant language barrier or severe deficit/cognitive decays). Subjects with diseases and/or disabling organ damage. Subjects affected by active neoplasm. Individuals who have submitted arhythmic complications in acute and/or heart failure, or people referring to post-AMI residential rehabilitation. Subjects that are carriers of severe psychiatric disorders diagnosed by DSM-V -TR.

Primary outcomes:
measure: reduction of body weight
timeFrame: 6 months
Secondary outcomes:
measure: Reduction of reinfarction and revascularization
timeFrame: 1 year
measure: general and specific mortality
timeFrame: 1 year
measure: quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
state: PV
city: Pavia
country: Italy
facility: Cardiology department
Study officials:
References:
Clinical trial NCT06486402: DISPARITY Study: An Observational Evaluation of Characteristics of Participants in Clinical Studies
Official title: An Observational Evaluation of Characteristics of Participants in Clinical
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Participation Rate, Patient
Patient Participation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of various clinical trials, both falling within and outside the scope of the WMO, involving adult patients undergoing various types of medical surgeries. Importantly, only studies that did not preclude women beforehand and obtained consent before participation were included in the analysis.

Brief summary: The aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. The main outcome is Participation Prevalence Ratio (PPR), which means the representation of female/male patients in a study in relation to their representation in the disease population undergoing surgery.

To achieve this, we will use the average proportion of female participants enrolled per study and, in addition, data from the CBS for population benchmarking, determining the proportions of males and females undergoing surgery (elective cardiac and non-cardiac surgery) and the proportions of these populations in an academic hospital.


Eligibility criteria: Inclusion criteria:

* various clinical trials, both falling within and outside the scope of the Medical Research Involving Human Subjects Act
* adult patients undergoing various types of medical surgeries.

Exclusion criteria:

. studies which excluded or did not equally approach women beforehand

Primary outcomes:
measure: Participation rate
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-holland
Study officials:
References: