louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05251519: The Efficacy of Derotation Banding on Outcome Measures in Children With Cerebral Palsy
Official title: The Efficacy of Derotation Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Femoral Internal Rotation Deformity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Kinesio taping
Cerebral palsy
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the conventional rehabilitation program and derotation taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with femoral internal rotation deformity.

Detailed description: Conventional rehabilitation (CR) practices will be applied to the control group. Conventional rehabilitation (KT) application will be applied to the study group in addition to Kinesio Tex tape derotation banding. With the kinesio tape application, it is aimed to provide economical, ergonomic and effective support to the patients in non-clinical times. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.

Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
* Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
* Understanding simple commands and signing the consent form

Exclusion Criteria:

* Presence of a static cause of femoral internal rotation deformity
* Situations that may prevent assessments or communication
* Lack of cooperation during work
* Presence of surgery that may affect assessments, such as joint freezing
* Presence of botulinum toxin administration in the last 6 months
* Development of an allergic reaction on the skin to the tape

Primary outcomes:
measure: 6MWT
timeFrame: Change from Baseline 6MWT at 3 days
measure: PBBT
timeFrame: Change from Baseline PBBT at 3 days
measure: MAS
timeFrame: Change from Baseline MAS at 3 days
measure: EVGS
timeFrame: Change from Baseline EVGS at 3 days
measure: KINDL
timeFrame: Change from Baseline KINDL at 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Fethiye Private Son Atılım Special Education and Rehabilitation Center
state: Fethiye
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Ahmet İmerci, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: İsmet Tümtürk, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04839419: Obesity-hypoventilation in Metabolic Syndrom Patients
Official title: Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Syndrome
Obesity Hypoventilation Syndrome
Capnography
Lead sponsor: SOS Oxygene Mediterranee
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected as part of their usual care, during a consultation for their respiratory and metabolic monitoring.

Brief summary: The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

Detailed description: After being informed about the study and potential risks, patient agreed to participate and undergo :

a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.

Eligibility criteria: Inclusion Criteria:

* BMI\>30 kg/m2
* no treatment with CPAP nor NIV

Exclusion Criteria:

* obstructive respiratory disease
* non-treated cardiac dysfunction

Primary outcomes:
measure: Capnia
timeFrame: Up to one mont after inclusion
measure: Arterial pression in CO2
timeFrame: At the inclusion
Secondary outcomes:
measure: BMI
timeFrame: At the inclusion
measure: Arterial pression in oxygen
timeFrame: At the inclusion
measure: somnolence
timeFrame: At the inclusion
measure: Physical activity level
timeFrame: At the inclusion
measure: Arterial blood bicarbonates
timeFrame: At the inclusion
measure: Arterial blood gases
timeFrame: At the inclusion
measure: Hemoglobin
timeFrame: At the inclusion
measure: obstructive sleep apnea items
timeFrame: Up to one mont after inclusion
measure: Night Oxygen saturation
timeFrame: Up to one mont after inclusion
Other outcomes:
Locations:
city: Bondigoux
country: France
facility: Clinique du Château de Vernhes
Study officials:
affiliation: Clinique du Chateau de Vernhes
name: Mathieu Despeaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05862519: A Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy
Official title: A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Libido
Intimacy
Gastrointestinal Issues
Lead sponsor: 906 CMVI Holdings
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-05-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. This study will be conducted as a single group, virtual trial, in which all participants will take all four supplements and complete online questionnaires. Participants will take the indicated supplements for the indicated amounts of time over 12 weeks. Questionnaires will be completed at baseline, and then at indicated times throughout the trial.


Eligibility criteria: Inclusion Criteria:

* Male (biological at birth) within the LGBTQIA+ community
* Aged between 18-44
* Generally healthy - don't live with any uncontrolled chronic disease
* Generally active lifestyle or seeking to achieve health improvement
* Sexually active with a partner

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone with known severe allergic reactions.
* Unwilling to follow the study protocol.
* Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g. eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder)
* Current substance abuse disorder
* Diagnosis of an autoimmune disease, such as multiple sclerosis and rheumatoid arthritis
* Self-reported or diagnosed high blood pressure or hypotension (BP \< 90 over 60)
* Currently, or in the past 6 months, undergoing hormone therapy
* Any medical condition that is unstable or uncontrolled
* A history of sexual trauma or abuse
* Has introduced any new prescription medication or supplements within the past 12 weeks that influence gastrointestinal issues, libido, or testosterone production.

Primary outcomes:
measure: Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life [Time Frame: Baseline to 12 weeks]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT01688219: Immune Response in the SAPHO Syndrome
Official title: Immune Mechanisms During SAPHO Syndrome and Treatment by Etarnecept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SAPHO Syndrome
Keywords: SAPHO syndrome
Innate immunity
TNF alpha
Polymorphonuclear neutrophils
Propionibacterium acnes
Interleukin-8
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 39
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SAPHO syndrome patients

Brief summary: The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological components. The investigators examined innate and adaptative immune responses in SAPHO syndrome as compared with psoriatic arthritis and rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of SAPHO syndrome
* Must have bone lesions

Exclusion Criteria:

* Infliximab treatment

Primary outcomes:
measure: IL-8 production by PMN
timeFrame: 24 h
Secondary outcomes:
measure: TNFalpha production by PMN
timeFrame: 24 h
Other outcomes:
Locations:
Study officials:
affiliation: Assitance Publique-Hopitaux Paris
name: Gilles Hayem, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06454019: Phone Outreach Nudges Among Individuals Losing Medicaid Coverage
Official title: Evaluating Impact of Outreach Nudges Among Individuals Losing Medicaid Coverage in California
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Behavioral Economics
Health Insurance
Keywords: Health Insurance
ACA marketplace
Behavioral Economics
Nudge
Lead sponsor: Covered California
Sponsor class: OTHER_GOV
First posted: 2024-06-12
Enrollment: 60045
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In May 2023, Covered California, California's ACA marketplace, implemented its automatic enrollment program for individuals losing Medicaid coverage, as defined by Senate Bill 260. If individuals are found eligible for subsidized marketplace coverage, individuals will be automatically enrolled in the lowest cost silver plan available to them, but individuals must still take action to confirm their plan or pay their first month's premium. To identify whether the phone outreach is the effective outreach strategy to increase take-up in this population, Covered California implemented this intervention. The results of this evaluation will inform operational and budgeting decisions.


Eligibility criteria: Inclusion Criteria:

* Lost Medi-Cal (California's Medicaid coverage) in July 2023-June 2024
* Auto-enrolled into lowest cost silver plan with Covered California as per Senate Bill 260 and have not opted-in (effectuated) into the coverage
* Have a valid phone number on the health insurance application
* Do not have a delegated agent to their case
* Still have Covered California Program eligibility, not reverted back to Medi-Cal coverage
* Have English or Spanish as preferred speaking language

Primary outcomes:
measure: Health Plan Effectuation
timeFrame: within 30 days from the start date of plan they are auto-enrolled into
Secondary outcomes:
measure: Tenure with Covered California (measured in months)
timeFrame: measured 1-2 years after the intervention
measure: Office visit
timeFrame: measured 1-2 years after the intervention
measure: Prescriptions filled
timeFrame: measured 1-2 years after the intervention
measure: Emergency Room Visit
timeFrame: measured 1-2 years after the intervention
measure: Hospital admission
timeFrame: 1-2 years before and after the intervention
measure: Out-of-pocket spending on healthcare services
timeFrame: measured 1-2 years after the intervention
measure: Uninsured
timeFrame: measured 1-2 years after the intervention
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Covered California
state: California
Study officials:
affiliation: Covered California
name: Emory Wolf, MPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04302519: Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Official title: Clinical Study of Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: COVID-19
Lead sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dental pulp mesenchymal stem cells were injected intravenously
Primary purpose: TREATMENT

Brief summary: Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells

Detailed description: Open, single center, single arm test design. Plan to enroll 24 subjects. On the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial.

Injection dose: 1.0x106 cells /kg. Injection method: slowly and quietly drop 50 mL of normal saline, then the endodontic mesenchymal stem cell injection (after 60 min), and then 50 mL of normal saline.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≥ 18, age ≤ 75, gender unlimited;
* 2. novel coronavirus diagnosed severe pneumonia and confirmed no effective treatment plan. (severe patients meet any of the following: (1) respiratory distress, RR \> 30 times / minute; (2) resting state, oxygen saturation is less than 93%; (3) arterial oxygen partial pressure (PaO2) / oxygen inhalation (FiO2) is less than 300 mmHg (1mm Hg=0.133 kPa).
* 3. Those who voluntarily participate in the clinical study and can cooperate with researchers to carry out the study, and the patients themselves or their legal representatives voluntarily sign the informed consent.

Exclusion Criteria:

* 1. Patients with autoimmune diseases in the past or screening;
* 2. Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
* 3. Known or self-reported HIV or syphilis infected persons;
* 4. Have participated in stem cell clinical research;
* 5. Pregnant or lactating women or those who have fertility plans in the past year;
* 6. The estimated life cycle is less than 48 hours;
* 7. Those who participated in other clinical trials within 3 months before screening;
* 8. Other conditions that the researcher thinks are not suitable for participating in the experiment.

Primary outcomes:
measure: Disppear time of ground-glass shadow in the lungs
timeFrame: 14 days
Secondary outcomes:
measure: Absorption of Lung shadow absorption by CT Scan-Chest
timeFrame: 7, 14, 28 and 360 days
measure: Changes of blood oxygen
timeFrame: 3, 7 and 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Research office of wuhan renmin university
name: Liwei cheng, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004419: Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Hyperglycemia
Keywords: endocrine disorders
insulin resistance
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion, hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have failed other therapies.

II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary abnormalities in this patient population.

III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like growth factor binding protein 1, the regulation of sex hormone binding globulin, and hypothalamic pituitary gonadal axis in this patient population.

Detailed description: PROTOCOL OUTLINE: This is an open label study. Patients receive the first dose of subcutaneous recombinant human insulin-like growth factor I (rhIGF-I) on day 7.

Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner, and are hospitalized for the first week of therapy. Patients return for an outpatient exam on day 19 of rhIGF-I therapy. Approximately 30 days into the therapy, patients are readmitted to the clinical center for repeat screening tests. Patients then receive maintenance therapy of rhIGF-I for up to 6-12 months. A washout period follows the maintenance therapy phase.

Patients are followed weekly, biweekly, or monthly depending on blood glucose response of patients off rhIGF-I therapy. Weekly phone contact with study coordinator is mandatory during this time.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Hematologically proven severe insulin resistance with or without diabetes
* Fasting insulin greater than 40 U/mL
* Post glucose insulin greater than 300 U/mL (unless overt diabetes mellitus is present)

--Prior/Concurrent Therapy--

Endocrine therapy: No concurrent oral hypoglycemic agents and/or insulin

Other: No concurrent birth control pills

--Patient Characteristics--

* Not pregnant
* Negative pregnancy test
* Effective barrier contraceptive method must be used by fertile patients
* Good health

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Alan C. Moses
role: STUDY_CHAIR
References:
Clinical trial NCT06837519: Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Official title: A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lidocaine
Dexmedetomidine
Infusion
Perioperative Pain
Video-Assisted Thoracoscopic Surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 75
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 aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.

Detailed description: Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure allowing the reduction of surgical stress. However, postoperative pain management is crucial for patients undergoing VATS, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction.

Dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (PONV), and speed of recovery.

Lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status of I, II.
* Patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.

Exclusion Criteria:

* Hypersensitivity to any of the used drugs.
* Coagulation disorder.
* Body mass index \>35 kg/m2.
* History of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse.
* Contraindication to the use of local anesthetics.
* Cardiovascular disease.
* Severe respiratory, renal or hepatic impairment.
* Insulin-dependent diabetes mellitus.
* Central nervous system or psychiatric disease.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time of extubation
timeFrame: 24 hours postoperatively
measure: Time to the first request for the rescue analgesia
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04422119: Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
Official title: Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Wound
Knee Disease
Keywords: Surgical wound healing
knee arthroplasty
postoperative dressings
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Fundació Institut Germans Trias i Pujol
First posted: 2020-06-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is: to evaluate the efficacy of two post-operative dressings in the management of the surgical wounds in patients who received a knee prosthesis

Detailed description: This was a randomised, controlled, clinical trial on patients who received a primary knee prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac. The control group received standard treatment with povidone-iodine and a gauze dressing with plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the characteristics of the surgical wound, patient reported comfort and adaptability according to the physiotherapist. Secondary outcome measures were: the clinical status and quality of life level according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical significance of 5%.

Eligibility criteria: Inclusion Criteria:

* Surgical intervention of total primary knee prosthesis
* Informed consent approved and signed by participants.

Exclusion Criteria:

* Sensitivity or allergy to study dressings

Primary outcomes:
measure: Change in number of dressing changes
timeFrame: From fist day post-surgery to 7th postoperative day
Secondary outcomes:
measure: Change in patient comfort
timeFrame: From fist day post-surgery to 7th postoperative day
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol University Hospital
name: Antonia Salmerón-Ramírez, RN
role: PRINCIPAL_INVESTIGATOR
References: