louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04221113: Functional Recovery Measurement : Comparing Early Active Mobilization Versus Immobilization After Extensor Tendon Repair in Zones IV to VIII
Official title: Principle Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Extensor Tendon of Hand (Disorder)
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Healthy patients with only extensor tendon injuries will be recruited in this study and will randomly divided in two groups. An intervention in the form of rehabilitation will be given to patients in two different protocols than outcomes will be assessed.
Primary purpose: TREATMENT

Brief summary: Functional recovery measurement : Comparing early active mobilization versus immobilization after extensor tendon repair in zones IV to VIII.

Immobilization for six weeks has been the postoperative protocol for the patients with hand's extensor tendon repair in our institute. In this study early mobilization of the hand i.e. also an internationally followed way, is compared with the aforementioned immobilization protocol to see which turns out to be a better option in the interest of the patient.

Detailed description: patients selection in both groups will be random by using close envolupe technique.

In group A ( immobilisation) physiotherapy will start by the end of 4th week and the upper limit of flexion would be 45 degrees.

In group B ( EAM) physiotherapy will start by the end of 1st week and the upper limit of flexion would be 30 degrees.

Eligibility criteria: Inclusion Criteria:

* Patients of either gender having simple lacerations of extrinsic extensor tendons · of the hand in · Verdan's zones IV-VIII

  * Age range 18 to 65 years
  * Sharp Cut Injury

Exclusion Criteria:

* Patients with complex injured hands like significant skin loss, bone and/or joint injuries. · Flexor tendon injuries.

  * Partial tendon lacerations
  * Tendon injuries at multiple levels

Primary outcomes:
measure: To measure total active motion in the results of both groups to compare which one has better results.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Zaara Zahid
state: Sindh
Study officials:
References:
citation: Sameem M, Wood T, Ignacy T, Thoma A, Strumas N. A systematic review of rehabilitation protocols after surgical repair of the extensor tendons in zones V-VIII of the hand. J Hand Ther. 2011 Oct-Dec;24(4):365-72; quiz 373. doi: 10.1016/j.jht.2011.06.005. Epub 2011 Sep 1.
Clinical trial NCT03651713: Hyperglycemia, Exercise, and Endothelial Function
Official title: Effect of Short-Term Glucose Loading on Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Hyperglycemia
Keywords: exercise
glucose
vascular function
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine if exercise preserves vascular function during hyperglycemia. All subjects will consume a sugary beverage three times daily for seven days. Subjects will be randomly assigned to either the glucose with (GLU+EX) or without (GLU) structured exercise group.

Detailed description: Acute (oral glucose tolerance test) and chronic (type 2 diabetes) hyperglycemia are associated with impaired endothelial function. Both a single bout of exercise and chronic exercise training are associated with improvements in vascular endothelial function. It remains unknown if exercise can preserve vascular endothelial function during hyperglycemia.

Eligibility criteria: Inclusion Criteria:

- Healthy young men 18-35 years of age.

Exclusion Criteria:

* Hypertension,
* Hyperlipidemia,
* Smoking,
* Heart disease,
* Chest pain upon exertion,
* Previous heart surgeries or history of arrhythmias,
* Diabetes,
* Obesity (body mass index ≥30kg/m2),
* Kidney disease,
* Pulmonary disease,
* Autonomic disorders,
* Individuals whom engage in structured exercise (≥30min, ≥2d/wk),
* Current use of medications which influence outcome measures

Primary outcomes:
measure: Change in Vascular Endothelial Function
timeFrame: Before and after the seven-day intervention in both groups.
Secondary outcomes:
measure: Central Blood Pressure
timeFrame: Before and after the seven-day intervention in both groups.
Other outcomes:
measure: Physical Activity
timeFrame: Continuously throughout the seven-day intervention.
measure: Caloric Consumption
timeFrame: Continuously throughout the seven-day intervention.
Locations:
city: Iowa City
country: United States
facility: Medical Education Building
state: Iowa
Study officials:
References:
Clinical trial NCT01598636: The Lateral Tibial Tunnel in ACL Surgery
Official title: The Lateral Tibial Tunnel in Anterior Cruciate Ligament Surgery. A Clinical and Ct-graphic Study.to Evaluate the Concept
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anterior Cruciate Ligament Revision Surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: GZA Ziekenhuizen Campus Sint-Augustinus
First posted: 2012-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Lateral Tibial Tunnel technique is a new concept in Anterior Cruciate Ligament (ACL) surgery. In this technique a tibial tunnel is drilled from the antero-lateral side of the tibia towards the ACL footprint. This technique allows the surgeon to deal with bone stock problems in the antero-medial part of the tibia as often encountered in ACL revision surgery. In ACL revision surgery it is often impossible to perform a one-stage revision surgery procedure due to bone stock deficiency in the antero-medial side of the tibia. It is hypothesized that the Lateral tibial tunnel technique allows the surgeon to perform a one-stage procedure instead of a two stage procedure. Furthermore the lateral tibial tunnel technique allows better graft fixation in two-stage ACL revision surgery. Several biomechanical studies proved biomechanical superiority of the new technique compared to the classical technique.


Eligibility criteria: Inclusion Criteria:

* patients requiring ACL revision surgery
* patients requiring ACL surgery who have bone stock problems at the medial side of the proximal tibia

Primary outcomes:
measure: Evaluation of clinical scores pre-operative
timeFrame: pre-operative
measure: evaluation of clinical scores at 3 months
timeFrame: 3 months post operative
measure: Evaluation of clinical scores at 6 months
timeFrame: 6 months post operative
measure: Evaluations of clinical scores at 1 year
timeFrame: 1 year post operative
measure: Evaluation of CT scan and X-ray pre-operative
timeFrame: pre-operative
measure: Evaluation of CT scan and X-ray post-operative
timeFrame: post-operative
measure: Evaluation of CT scan and X-ray 1 year post-operative
timeFrame: 1 year post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: GZA Sint-Augustinus
city: Ghent
country: Belgium
facility: University Hospital
city: Leuven
country: Belgium
facility: University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Peter Verdonk, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515436: The Effect of Music Periodicity on Interictal Epileptiform Discharges
Official title: A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rolandic Epilepsy
Benign Childhood Epilepsy With Centrotemporal Spikes
Epilepsy
Seizures
Keywords: Rolandic Epilepsy
Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS)
Epilepsy
Seizures
Music
Mozart
Beethoven
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if having children listen to the music of Wolfgang Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike discharges on his/her Electroencephalography (EEG). These spike discharges often occur during a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike discharges after listening to Mozart's music, this information may lead to new understanding and possible treatments for epilepsy.


Eligibility criteria: Inclusion Criteria:

* Female or male with BCECTS clinical history, and at least one seizure, as defined by the International League Against Epilepsy.
* EEG consistent with features of BCECTS: centrotemporal (rolandic) interictal spike discharges (ISDs) with otherwise normal background interictal EEG
* Screening neurological examination normal (by PI or other pediatric neurologist in the Division of Pediatric Neurology at MUSC)
* Age 5-12 years, inclusive
* On less than or equal to 2 anti-epileptic drugs (AED) \[Range 0-2 AEDs\]

Exclusion Criteria:

* Currently taking Clonazepam or other Benzodiazepines
* Inability to complete 12 hour admission and comply with study protocol
* Prohibited Therapy or Activities During Study Period: Use of computer or video games. Viewing of video tapes will be prohibited due to potential effect of music in videos on underlying process of study.
* Due to the confounding factor of probably suppression of IEDs after a clinical seizure, any subject experiencing a seizure of any duration 24 hours prior to beginning the study will be excluded from the study.
* For any subject experiencing a seizure during the study, data analysis will cease from that point onward.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Robert P Turner, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476436: Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
Official title: Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Type IIb Hyperlipidaemia
Hypercholesterolemia Aggravated
Keywords: Cardio vascular risk factors
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2011-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Low carbohydrate diet may influence the plasma lipid levels.

Detailed description: Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate diet or usual diet for a period

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion criteria:

Any disease or use of prescriptional medication

Primary outcomes:
measure: Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet
timeFrame: From baseline to study end
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition
name: Kjetil Retterstøl, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05132036: Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients
Official title: Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients Using 8 Sites Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Ultrasound
Hemodialysis Complication
Keywords: Lung ultrasound
Hemodialysis Complication
hemodialysis ultrafiltration volume
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* patients on hemodialysis for more than 3 months;
* patients without cardiological or infectious event for at least 3 months;
* patients having at least 2 dialysis session per week;
* patients affiliated with a health insurance plan;
* patients having signed an informed consent.

Exclusion Criteria:

* Pulmonary fibrosis or active lung disease;
* residual diuresis over 500 mL per day;
* body mass index (BMI) \< 21 and \> 28 Kg/m²;
* medical history of major amputation (subgonal or transfemoral);
* pacemaker carrier;
* patients with orthopedic prosthesis.

Primary outcomes:
measure: number of patients with fluid overload
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT00752336: Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation
Official title: Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Capacity
Heart Transplantation
Keywords: HRQoL
exercise capacity
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2008-09-15
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.


Eligibility criteria: Inclusion Criteria:

Heart transplant (6-9 mts post Tx) stabile health condition at study entry (pt stays within home environment)

* Age ≥ 18 yrs
* Sufficient language skills to answer questionnaire
* Follow-up at our center
* Willingness to participate by written informed consent

Exclusion Criteria:

* TVP diagnosis before study inclusion
* Episodes of recurrent acute rejections
* Medical contra-indication for regular exercise ergometer training
* Malignancy

Primary outcomes:
measure: HRQoL,exercise capacity
timeFrame: 36 mts
Secondary outcomes:
measure: Weight gain; cardiovascular risk factors; social re-integration
timeFrame: 36 mts
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00758836: A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)
Official title: A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraine With or Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
* Willing to stay awake for at least 2 hours after taking study drug
* Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

* Breast-feeding, pregnant, or plan to become pregnant during the study
* Not able to tell migraine attack from other headaches
* Older than 50 years of age at migraine onset
* Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
* History of gastric or small intestinal surgery
* History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
* Currently participating or have participated in a study with in investigational compound or device in the last 30 days

Primary outcomes:
measure: Percentage of Participants With Pain Freedom at Two Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
timeFrame: Up to 48 hours post-dose
measure: Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
timeFrame: Up to 14 days post-dose
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours Post-dose.
timeFrame: 2 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.
Clinical trial NCT06000436: Cardiovascular Disease Risk of Awareness
Official title: The Effect on Risk Awareness, Perception and Risk Factors of Motivational Interview-Based Cardiovascular Risk Reduction Program (CARDIOREP) in Taxi-Minibus Drivers: A Randomized Controlled Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.

Detailed description: While 1/3 of premature deaths in individuals under the age of 70 in the world occur due to Cardiovascular Diseases (WHO 2022), circulatory system diseases are at the forefront with 36.76% according to the health statistics of the Ministry of Health in our country. It is necessary to raise awareness and gain healthy lifestyle behaviors in the prevention of cardiovascular diseases. The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.

Eligibility criteria: Inclusion Criteria:

* Not having been diagnosed with cardiovascular disease.
* Using a smartphone.
* Agree to use the Google Fit App.

Exclusion Criteria:

Primary outcomes:
measure: Cardiovascular Disease Risk Awareness Rating Scale Scores
timeFrame: at the end of 0th, 6th, and 12th weeks
Secondary outcomes:
measure: Cardiovascular risk perception
timeFrame: at the end of 0th, 6th, and 12th weeks
measure: International Physical Activity Questionnaire Scores
timeFrame: at the end of 0th, 6th, and 12th weeks
measure: Beck Anxiety Scale Scores
timeFrame: at the end of 0th, 6th, and 12th weeks
measure: Cardiovascular disease risk factors
timeFrame: at the end of 0th, 6th, and 12th weeks
measure: Cardiovascular disease risk factors
timeFrame: at the end of 0th, 6th, and 12th weeks
measure: Cardiovascular disease risk factors
timeFrame: at the end of 0th, 6th, and 12th weeks
measure: Cardiovascular disease risk factors
timeFrame: at the end of 0th, 6th, and 12th weeks
measure: Cardiovascular disease risk factors
timeFrame: at the end of 0th, 6th, and 12th weeks
Other outcomes:
Locations:
Study officials:
References: