louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04556812: Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
Official title: Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Habitual Patellar Dislocation
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adult habitual dislocation of the patella is a common dislocation of the patella. The range of lesions is wide and the severity is high. Clinical diagnosis and treatment are difficult. In clinical work, misdiagnosis and treatment are not targeted at pathological mechanisms. This leads to irregular diagnosis and treatment, high failure rate and revision rate, and patients undergoing multiple operations. The project team developed a "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement" in the preliminary research, which overcomes the disadvantages of traditional knee extension surgery and is suitable for adults. Early research Shows safe and effective clinical efficacy. The purpose of this application project is to take independent innovation of core surgical technology as the lead, adopt a two-way cohort study method, compare the clinical efficacy of the new "four-in-one" technology and traditional soft tissue surgery in the treatment of adult habitual patellar dislocation, and analyze and formulate adult habituation Comprehensive and systematic solutions for patella dislocation, relying on this scientific research project to conduct multi-center and large-sample clinical case studies, and evaluate the effectiveness and safety of independent innovative technologies through standardized medical research methods to improve the surgical treatment of adult habitual patella dislocation Success rate, reduce recurrence rate and failure rate, improve the level of clinical treatment of the disease, and finally put forward a special clinical diagnosis and treatment system for the disease in the international academic community.


Eligibility criteria: Inclusion Criteria:

* Patients with habitual dislocation of the patella over 14 years old
* agree to participate in the study

Exclusion Criteria:

* Combined with other knee ligament injuries
* recurrent patellar dislocation
* Skin and soft tissue conditions do not allow surgery

Primary outcomes:
measure: Kujala score
timeFrame: 1 year postoperatively
measure: quadriceps strength
timeFrame: 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sports Medicine Service, Beijing Jishuitan hospital
name: Hui Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02966912: Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
Official title: Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
First posted: 2016-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.

Detailed description: The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.

Eligibility criteria: Inclusion Criteria:

Body mass index greater than 30 kg/m2

Exclusion Criteria:

1. History of hospitalization for heart failure (systolic or diastolic);
2. Unstable angina or prior myocardial infarction;
3. LV ejection fraction \<50% on imaging study;
4. Valvular heart disease (stenosis or insufficiency) greater than moderate degree;
5. Renal dysfunction, serum creatinine \>2.5 mg/dL or estimated creatinine clearance \<30 mL/min/1.73 m2 (30),
6. Pregnant women or actively breastfeeding women
7. History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained

Primary outcomes:
measure: Left ventricular mass (by cardiac MRI)
timeFrame: 24 weeks
measure: Left ventricular myocardial triglyceride content (by cardiac MRI)
timeFrame: 24 weeks
measure: Left ventricular extracellular volume fraction (by cardiac MRI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 24 weeks
measure: Aortic pulse wave velocity (by cardiac MRI)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
Study officials:
References:
Clinical trial NCT05791812: Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE
Official title: Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE - Heimanwendung Der Transkraniellen Gleichstromstimulation Zur Behandlung Der Chronischen Fatigue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Keywords: transcranial direct current stimulation
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a one-arm open-label interventional study with transcranial direct current stimulation in an remote home-based setting with the aims to evaluate the feasibility (usability of the device, compliance of patients, usability of the teletherapy), the effectiveness (clinical ratings) and the compatability of this intervention in 20 patients with myalgic encephalomyelitis/chronic fatigue syndrome.


Eligibility criteria: Inclusion Criteria:

* ME/CFS diagnosis according to the Canadian Consensus Criteria
* residence near Regensburg and mother language German
* written informed consent
* stable medication if possible

Exclusion Criteria:

* contraindications for transcranial direct current stimulation
* certain neurological conditions as assessed by study physician
* participation in another study
* pregnancy and lactation period

Primary outcomes:
measure: Usability for the patients
timeFrame: 6 weeks
measure: Usability for the handlers/clinicians
timeFrame: 6 weeks
measure: Number of days out of 30 the patients used the device
timeFrame: 6 weeks
measure: Number of patients who completed the treatment regularly
timeFrame: 6 weeks
measure: Number of responders according the the clinical global impression change score for patients in the per protocol analysis
timeFrame: 6 weeks
measure: Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score
timeFrame: 6 weeks
measure: Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Major Depression Inventory
timeFrame: 18 weeks
measure: World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)
timeFrame: 18 weeks
measure: Clinical Global Impression change
timeFrame: 18 weeks
measure: Pittsburgh sleep quality index
timeFrame: 18 weeks
measure: numeric analogue scale pain
timeFrame: 18 weeks
measure: d2 test
timeFrame: 18 weeks
measure: digital span
timeFrame: 18 weeks
measure: Chalder fatigue scale
timeFrame: 18 weeks
measure: Bell score
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Regensburg
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05855512: Impact of Nurse-led Intervention on Asthma Control in Children
Official title: Impact of Nurse-led Intervention on Asthma Control in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control group
Primary purpose: TREATMENT

Brief summary: This randomized control trial design (RCT) study was conducted on children aged 6 -11 years

Detailed description: This randomized control trial design study was conducted on children aged 6 -11 years, visiting the pediatric outpatient department and emergency at Dr. Ruth Pfau Civil Hospital Karachi.

For the experimental group, a nursing educational intervention session was conducted with the patient and family/caregiver by the principal investigator, and a doctor provided the usual care/treatment. In contrast, the control group received only the usual care/treatment provided by the doctor.

For the control group, educational material on asthma was provided in a booklet according to Global Initiative of Asthma (GINA) guidelines. Pre Childhood-Asthma Control Test (C-ACT) score of participants was measured before the intervention, and post-C-ACT score measurement was made after one month using the same questionnaires and C-ACT tool.

Eligibility criteria: Inclusion Criteria:

* Children between the aged 6 to 11 years
* Have asthma diagnosed by a physician at least 6-month back
* Uncontrolled asthma based on C-ACT score 19 or less 19.

Exclusion Criteria:

* Chronic respiratory illnesses like T.B. cystitis and fibrosis.
* Sinusitis,
* Gastrointestinal reflux disease,
* Rhinitis

Primary outcomes:
measure: Childhood asthma control test (C-ACT) Score
timeFrame: 4 weeks
measure: Number of times got Admissions due to asthma in the last 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of times visited emergency due to asthma in last 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil Hospital
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences Karachi
name: Waqas Farooqi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02095912: Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients
Official title: Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma
Keywords: Squamous Cell Carcinoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Organ Transplant Recipients with:

* \> 9 Squamous Cell Carcinoma (SCC) in total or
* \> 2 SCC per year (in any one year) or
* any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis

Brief summary: To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.

Detailed description: Squamous Cell Carcinomas (SCC) are one of the most common skin cancers. They belong to the epithelial neoplasm of the skin, which manifest a local aggressive growth and have potential for metastasis. Organ transplant recipients have a hundredfold higher incidence of SCC.

Unfortunately the primary tumor, regional nodes, metastasis (TNM)-Classification for the prognosis of SCC in this group of patient has not yet been established. Therefore there are no standardised criteria for evaluation of local recurrence or prognosis.

The aim of this study is to identify criteria, which permit a risk assessment relating to aggressiveness of SCC.

Eligibility criteria: Inclusion Criteria:

Organ transplant recipients with:

* \> 9 SCC in total or
* \> 2 SCC per year (in any one year) or
* any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis

Exclusion Criteria:

* Non organ transplant recipients

Primary outcomes:
measure: Diameter of Squamous Cell Carcinoma
timeFrame: 1 year
Secondary outcomes:
measure: Sun exposure history
timeFrame: 1 year
Other outcomes:
measure: Transplantation history
timeFrame: 1 year
Locations:
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Dermatology
name: Guenther Hofbauer, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557712: Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks
Official title: Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effectiveness of ketamine (infusion of 0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major depression (MADRS score ≥ 20 ) to six weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or over,
* Introducing a single depressive episode or recurrent unipolar
* Responding to the diagnosis of severe major depressive episode according to DSM IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition): MADRS score ≥ 20,
* absence of treatment with ketamine for analgesia or anesthesia during the last 6 months
* Affiliate (or beneficiary) to a social security system
* Informed consent signed

Exclusion Criteria:

* Contraindication to ketamine administration or treatment with venlafaxine;
* Failure of treatment with venlafaxine in the current episode (as low as 150 mg for 15 days);
* Axis I diagnosis according to DSM IV bipolar disorder (type I, II or III), schizoaffective disorder, schizophrenia, alcohol and other toxic or weaned for at least 6 months;
* Current Episode resistant stage V according to the classification of Thase and Rush (failed a course of bilateral ECT);
* Major depressive episode with severity criteria (significant risk of suicide is a MADRS score ≥ 5-SI; decubitus complications, intravenous hydration);
* episode currently being treated with fluoxetine;
* Patients hospitalized without their consent or measure of legal protection (guardianship, curatorship);
* Affection Organic likely to affect cognitive abilities and brain structures (eg, HIV, MS, lupus, Parkinson's disease, epilepsy, dementia ...) or decompensation;
* Pregnancy or breastfeeding underway.

Primary outcomes:
measure: Depressive state
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre hospitalier universitaire
Study officials:
References:
Clinical trial NCT04594512: Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report
Official title: Fresh Corneal Lenticule Implantation and Autologous Serum - New Approach in Treatment of Advanced Keratoconus Disease - Case Report
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Keratoconus
Keratoconus of Right Eye
Keratoconus, Unstable, Right Eye
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 1
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the feasibility and the effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients to implant in patients with keratoconus disease using VisuMax Femtosescond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary to improve visual acuity and reduces K-values and to show the autologous serum drop improve the recovery of patients with mild dry eye in keratoconus disease.

Detailed description: A 19-year-old female patient with keratoconus and chronic hydrops cornea referred to the cornea department of our clinic with thin cornea and hydrops in chronic stage and minimal dry eye symptoms. Minimum corneal pachymetry in the right eye was 378 µm as measured by optical coherence tomography(AS-OCT-Zeiss). Atlas corneal topography showed steep K-values 82.60 ax.37 and flat K 75.15 D ax 127 with -7.45 corneal astigmatism. Her best corrected visual acuity was 0.0.5 in right eye and 1.0 in the left eye. Slit lamp examination showed intense punctate epitheliopathy (Figure 1), tear film break-up time (TBUT) was measured as 7-8 sec and Schirmer test was 10 mm in right eye, and the other eye examinations were determined normally.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age, male or female, of any race
* Willingness and ability to follow all instructions and comply with schedule for follow-up visits
* For females: Must not be pregnant

Exclusion Criteria:

* Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
* If female, pregnant

Primary outcomes:
measure: Treatment of advanced keratoconus disease
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
Clinical trial NCT04571281: Dynamics of the Capillary Lactate Levels in OHCA
Official title: Dynamics of the Capillary Lactate Levels in Patients With Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Out-Of-Hospital Cardiac Arrest
lactic acid
Cardiopulmonary resuscitation
Survival
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study will be eligible all patients with OHCA due to primary or secondary cardiac arrest.

Brief summary: Serial capillary lactate measurements during cardiopulmonary resuscitation (CPR) in patients with out-of-hospital cardiac arrest (OHCA).

Detailed description: Capillary lactate measurements will be measured every ten minutes during CPR in OHCA.

Eligibility criteria: Inclusion Criteria:

* adults with OHCA

Exclusion Criteria:

* children with OHCA
* trauma
* hypothermia

Primary outcomes:
measure: ROSC
timeFrame: 2 years
measure: Comparison between primary and secondary cardiac arrest
timeFrame: 2 years
measure: No ROSC
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: Community health center Maribor, Prehospital unit
Study officials:
affiliation: University medical center Maribor
name: Matej Strnad, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lurie KG, Nemergut EC, Yannopoulos D, Sweeney M. The Physiology of Cardiopulmonary Resuscitation. Anesth Analg. 2016 Mar;122(3):767-783. doi: 10.1213/ANE.0000000000000926.
citation: Patil KD, Halperin HR, Becker LB. Cardiac arrest: resuscitation and reperfusion. Circ Res. 2015 Jun 5;116(12):2041-9. doi: 10.1161/CIRCRESAHA.116.304495.
citation: Corral Torres E, Hernandez-Tejedor A, Suarez Bustamante R, de Elias Hernandez R, Casado Florez I, San Juan Linares A. Prognostic value of venous blood analysis at the start of CPR in non-traumatic out-of-hospital cardiac arrest: association with ROSC and the neurological outcome. Crit Care. 2020 Feb 22;24(1):60. doi: 10.1186/s13054-020-2762-5.
citation: Sariaydin T, Corbacioglu SK, Cevik Y, Emektar E. Effect of initial lactate level on short-term survival in patients with out-of-hospital cardiac arrest. Turk J Emerg Med. 2017 May 15;17(4):123-127. doi: 10.1016/j.tjem.2017.05.003. eCollection 2017 Dec.
Clinical trial NCT01820481: Safety and Efficacy of WIN-901X in Asthma
Official title: Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Lead sponsor: Whanin Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 209
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.

Detailed description: Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 20 and less than 80 years of age
* Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
* FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
* No history of smoking at least one year prior to the screening
* Having voluntarily signed an informed consent

Exclusion Criteria:

* Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
* Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
* Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
* Have malignant tumor

Primary outcomes:
measure: Compare the change of FEV1% to the baseline after the medication
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Compare the change of ACQ to the baseline after the medication
timeFrame: Baseline, week 12
measure: Ratio of the date, where no rescue drug was used, during the trial
timeFrame: Baseline, week 12
measure: Ratio of symptom free days during the trial
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
Study officials:
affiliation: Yes
name: Park Hae Sim, M.D., Professor
role: STUDY_CHAIR
References: