louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00940420: A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
Official title: Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 2695
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.


Eligibility criteria: Inclusion Criteria:

* adult patients \>/= 18 years of age
* serologic evidence of chronic hepatitis C infection
* compensated liver disease
* negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

Exclusion Criteria:

* history or other evidence of a medical condition associated with chronic liver disease other than HCV
* hepatitis A, hepatitis B or HIV infection
* hepatocellular carcinoma
* severe concomitant disease

Primary outcomes:
measure: safety and tolerability with regard to clinical AEs and laboratory parameters
timeFrame: assessed every 2 weeks throughout study and after 8 weeks follow-up
Secondary outcomes:
measure: safety with regard to hematological parameters
timeFrame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up
Other outcomes:
Locations:
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Bat Yam
country: Israel
city: Beer Sheva
country: Israel
city: Hadera
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Nahariya
country: Israel
city: Nazareth
country: Israel
city: Petach Tikva
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Safed
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00723320: Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis
Official title: Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Keywords: Atherosclerosis
Atorvastatin
Therapeutic lifestyle change
CIMT
ABI
PWV
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Peking University First Hospital
First posted: 2008-07-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether atorvastatin, aggressive lifestyle intervention, and their interaction are effective in delaying the progress of pre-clinical atherosclerosis.

Detailed description: Primary prevention of atherosclerotic disease remains a big challenge. Currently, it is not clear how to treat those subjects with evidence of pre-clinical atherosclerosis but without obvious conventional risk factors. This randomized, placebo controlled, double blind study is to evaluate the effect of Atorvastatin 10 mg daily, therapeutic lifestyle change, and their combination, on the progression of CIMT in those with higher baseline CIMT value but are not belong to 'high risk' category, according to the conventional risk factors.

Eligibility criteria: Inclusion Criteria:

* CIMT is not less than 0.9 mm
* without Clinical diagnosis of atherosclerotic disease
* without Diabetes

Primary outcomes:
measure: The progress of CIMT
timeFrame: 2 years
Secondary outcomes:
measure: The progress of ABI
timeFrame: 2 years
measure: The progress of PWV
timeFrame: 2 years
measure: Occurrence of atherosclerotic disease
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Jianping Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541020: Inspiratory Resistive Loading and Proprioceptive Postural Control
Official title: Inspiratory Resistive Loading and Proprioceptive Postural Control in Healthy Individuals and Individuals With Recurrent Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Respiratory Loading
Proprioceptive Impairment
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2012-02-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: young flemish volunteers

Brief summary: Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. Deficits in proprioception are found in a subgroup of patients with low back pain. In addition, disorders of respiration have been identified as strongly related to low back pain.

The aim of the study is to clarify whether loading of the inspiratory muscles has a negative effect upon proprioceptive postural control in healthy individuals and individuals with recurrent low back pain.


Eligibility criteria: Inclusion Criteria individuals with low back pain:

* Age: 18-45 years old
* At least 1 year of low back pain with/without referred pain in buttock/thigh
* At least 3 episodes of disabling low back pain
* At least a score of 20% on the Oswestry Disability Index
* Willingness to sign the informed consent

Inclusion Criteria healthy individuals:

* Age: 18-45 years old
* No history of low back pain
* A score of 0% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Smoking history

Primary outcomes:
measure: Proprioceptive postural control
timeFrame: 1 year
Secondary outcomes:
measure: Back muscle oxygenation
timeFrame: 1 year
measure: Kinematics
timeFrame: 1 year
measure: Respiratory muscle force
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Simon Brumagne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
Clinical trial NCT06640920: A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants
Official title: A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Uniquity One (UNI)
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.


Eligibility criteria: Key Inclusion Criteria:

1. At the time of initial screening, in general good health (age 18 to 65 years);

Key Exclusion Criteria:

1. Pregnancy or breastfeeding during the study.
2. Chronic infection - Treatment with prohibited medications.
3. Treatment with prohibited medications

Primary outcomes:
measure: Safety and tolerability
timeFrame: 140 days
Secondary outcomes:
measure: Absolute bioavailability
timeFrame: 140 days
measure: Concentration of immunogenicity
timeFrame: 140 days
measure: Parameters in healthy participants
timeFrame: 140 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
Study officials:
affiliation: Vice President, Clinical Research
name: Andrew W Lee, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00307320: Study Examining Stress During Pregnancy
Official title: Coping With Stress During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: pregnancy
stress
anxiety
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2006-03-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers at UVa Health System are interested in how women experience and deal with stress during pregnancy. Participants will be randomly assigned either to engage in coping strategies on one's own or to receive 6 weeks of relaxation training. Researchers will examine how coping strategies affect the course of the pregnancy and the health of the infant

Detailed description: Participants will be asked to fill out questionnaires and complete some tasks that require concentration as heart rate and other biological signals are monitored. Participants will also be asked to provide samples of saliva a few times during 1 day. These tasks will be repeated 3 times during pregnancy and participants will be asked to complete questionnaires at 6 months postpartum

A stress-reduction workshop will be offered to all participants at the completion of the study.

Participants will be paid for study completion

Eligibility criteria: Inclusion Criteria:

* beginning of the 2nd trimester of pregnancy
* feel stressed or overwhelmed
* do not yet have any children

Exclusion Criteria:

* more than 1 miscarriage
* currently receiving medication for anxiety or depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia, Department of Psychology
state: Virginia
Study officials:
affiliation: University of Virginia / University of Arizona
name: Andrea Chambers, MA
role: STUDY_DIRECTOR
affiliation: University of Virginia
name: Susan Kirk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920620: Inpatient Obesity Intervention With Phone Follow-up
Official title: Inpatient Obesity: Can Weight Loss Intervention During Hospitalization Lead to Sustained Weight Loss at Six Months Following Discharge?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity, inpatient, intervention, weight loss
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we sought to determine whether inpatient weight loss counseling with post discharge phone follow-up would result in weight loss at six months. Secondary endpoints included weight change from baseline, changes in waist-to-hip ratios, assessment of weight perceptions and changes in patient reported health outcome measures. To our knowledge, this is the first randomized trial designed to evaluate the effects of an obesity intervention with post-discharge follow-up in an inpatient general medicine population.


Eligibility criteria: Inclusion Criteria:

* Adults ages 18-65 years old
* Body mass index between 30-50 kg/m2
* Admitted to an internal medicine service

Exclusion Criteria:

* acute medical conditions known to affect weight (heart failure, cirrhosis, end-stage renal disease on dialysis, nephrotic syndrome, or pregnancy)
* Charlson comorbidity index \>3
* moderate to severe major depression
* prolonged steroid use (\>2 weeks)
* initiation of medications known to affect weight
* non-English speaking
* precontemplation stage of change

Primary outcomes:
measure: Weight loss between groups
timeFrame: 6 months
Secondary outcomes:
measure: Weight loss from baseline
timeFrame: 6 months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores
timeFrame: 6 months
measure: Change in waist-to-hip ratios
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Kelley N Wachsberg, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04638920: Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy
Official title: Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy (TripleEX)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Exacerbation
Keywords: Exhaled breath analysis
Mass spectrometry
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Deep Breath Intelligence (DBI)
First posted: 2020-11-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD (staged according to GOLD recommendations, aged ≥18 years) on adherent triple inhalational therapy, hospitalized due to COPD exacerbation

Brief summary: Determination of specific molecular breath patterns by secondary electrospray ionization mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association with clinical outcomes and treatment.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* age \>= 18 years
* staged according to GOLD recommendations
* GOLD stage 2-4, GOLD ABE classification
* hospitalization due to COPD exacerbation
* subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids)
* suitable for follow-up assessment
* \<48 hours after initiation of antibiotic therapy or systemic steroid therapy

Exclusion Criteria:

* physical or intellectual impairment precluding informed consent or protocol adherence
* known pregnancy
* congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect
* uncontrolled diabetes (e.g. HbA1c \>11% or Glc \>20mmol/l)
* acute or chronic pulmonary disease other than COPD
* renal failure or renal replacement therapy (GFR \< 15 mL/min)

Primary outcomes:
measure: Change in Exhaled Breath Metabolites
timeFrame: twice during 8 weeks
Secondary outcomes:
measure: Symptoms
timeFrame: twice during 8 weeks
measure: Inflammation
timeFrame: twice during 8 weeks
measure: Causative Agents
timeFrame: twice during 8 weeks
measure: Treatment
timeFrame: measured once during COPD exacerbation
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
References:
Clinical trial NCT05113420: The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations
Official title: The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Effect
Children, Only
Vascular Malformations
Surgery
Lead sponsor: Center for Vascular Pathology, Moscow
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children

Brief summary: The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.


Eligibility criteria: Inclusion Criteria: venous malformation

* venous malformation

Exclusion Criteria:

* allergy

Primary outcomes:
measure: Coagulation testing
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
measure: Satisfaction after treatment
timeFrame: 1 month
Locations:
city: Moscow
country: Russian Federation
facility: The Vascular Anomalies Center (VAC) "Hemangioma" LLC
Study officials:
affiliation: Vascular Anomalies Center (VAC) "Hemangioma" LLC.
name: Ekaterina Listovskaia, MD
role: STUDY_CHAIR
affiliation: Vascular Anomalies Center (VAC) "Hemangioma" LLC.
name: Dmitriy Romanov, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06910020: Effect of the Active Cycle of Breathing Technique on Coronary Artery Bypass Graft Patients' Outcomes
Official title: Effect of the Active Cycle of Breathing Technique on Coronary Artery Bypass Graft Patients' Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass
Coronary Arterial Disease (CAD)
Keywords: CABG
ACBT
Postoperative Pulmonary Complications
Chest tube duration
Hemodynamic parameters
Chest expansion
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Following CABG surgery, patients are at risk for several complications. One of the most common complications is postoperative pulmonary complications, which include atelectasis and dyspnea. These complications cause prolonged ICU length of stay and increased health care costs. Several studies recommended the active cycle of breathing technique as a method that increases secretion removal and improves lung functions, thus reducing the incidence of postoperative pulmonary complications. Our study aims to investigate the effect of the active cycle of breathing technique on coronary artery bypass graft patients' outcomes.


Eligibility criteria: Inclusion Criteria:

* Any adult patient who will undergo CABG

Exclusion Criteria:

* Mechanically ventilated patients on the first postoperative day.
* Patients with preoperative lung collapse or pleural effusion.

Primary outcomes:
measure: Atelectasis
timeFrame: The first three postoperative days
measure: Dyspnea
timeFrame: The first three postoperative days
measure: Functional capacity
timeFrame: The first three postoperative days
measure: Hemodynamic parameters
timeFrame: The first three postoperative days
measure: Chest expansion
timeFrame: The first three postoperative days
measure: Duration of chest tube
timeFrame: Up to 1 week
measure: Length of ICU stay
timeFrame: For up to 1 week
measure: Hemodynamic Parameters
timeFrame: For the first three postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Cardiothoracic and Vascular Surgery Center
state: Dakahliya
Study officials:
References:
Clinical trial NCT06613620: Additional Effects of Surface Electromyographic Biofeedback on Post Facilitation Stretching and Strengthening in Lower Crossed Syndrome;A Randomized Control Trial
Official title: Additional Effects of Surface Electromyographic Biofeedback on Post Facilitation Stretching and Strengthening in Lower Crossed Syndrome;A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Cross Syndrome
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: This study is a randomised control trial and the purpose of this study is to determine the additional effects of surface electromyographic biofeedback on post facilitation stretching and strengthening in lower crossed syndrome.

.

Detailed description: Participants will be recruited into their respective groups using a coin toss method. Lower crossed syndrome will be assessed using the following tests:

Prone hip extension test Trunk flexion strength test Tightness in erector spinae Modified Thomas test

Eligibility criteria: Inclusion Criteria:

* Age 19-35 years
* Both genders
* Positive modified Thomas test
* Positive prone hip extension strength test
* Positive trunk flexion strength test
* Tight erector spinae
* BMI normal (18.5-24.9 Kg/m2)
* Local intermittent lumbar pain
* moderate pain (NPRS 3-7)
* Painless movement and activity
* Pain only produced by sustained loading in relevant position, which is then relieved on moving from that pos

Exclusion criteria:

* Acute flare of LBP
* Centralization and peripheralization of pain
* Signs of stenosis(leg symptoms when walking that are eased upon flexion)
* Pain due to repetitive movements
* Paresthesia/Numbness
* Structual deformity(Kyphosis, spondylosis, spondylolisthesis,scoliosis and joint contractures)
* Curve reversal
* Pregnancy
* Post surgery
* Degenerative and inflammatory spine diseases

Primary outcomes:
measure: Lumber lordotic angle
timeFrame: 4 weeks
measure: Joint position sense
timeFrame: 4 weeks
measure: pain intensity
timeFrame: 4 weeks
measure: Functional disability
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Punjāb Chak
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References: