louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03765086: Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus
Official title: Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be a randomized controlled trial in which there will be comparison of the effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal pilonidal sinus


Eligibility criteria: Inclusion Criteria:

* Patients with pilonidal sinus of any sex and aged 20 years or above
* Non infected pilonidal sinus

Exclusion Criteria:

* Infected pilonidal sinus
* Uncontrolled diabetes
* Patient on immunosuppressive therapy

Primary outcomes:
measure: Percentage of patients presenting with recurrence of pilonidal sinus
timeFrame: 8 to 12 weeks
Secondary outcomes:
measure: Number of weeks in which the operative wound will be healed
timeFrame: 4 to 6 weeks
measure: percentage of patients developing postoperative pain
timeFrame: 3 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT01674686: The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm
Official title: A Prospective, Single-center, Randomized Study to Evaluate the Effect of Sarpogrelate, a Selective Serotonin Receptor Antagonist, and High Dose Statin on the Reduction of Coronary Spasm in the Patients With Variant Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Variant Angina
Keywords: Vasospasm
Sarpogrelate
Statin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.


Eligibility criteria: Inclusion Criteria:

* Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
* Angiographically proven coronary spasm; TIMI flow \< 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.

Exclusion Criteria:

* Cardiac arrest by coronary spasm
* Left main coronary spasm
* Significant fixed coronary artery stenosis; Diameter stenosis \> 70% in the major epicardial artery by coronary angiography
* Left ventricular ejection fraction \< 30%
* Coagulation disorders or bleeding tendency (Platelet count \< 50k, PT INR \> 2.0)
* Significant liver disease (AST or ALT \> 100 U/ml)
* Renal failure (S-Cr \> 2.0 mg/dl)
* hypersensitivity for statin
* Pregnancy

Primary outcomes:
measure: Ergonovine provocation test 12months later
timeFrame: 1 year later
Secondary outcomes:
measure: C-reactive protein lever 12months later
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyoen-Cheol Gwon, MD,PhD
Study officials:
References:
Clinical trial NCT00465686: Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy
Official title: Ergonomic Classroom Furniture and the Printing Legibility of Elementary School Students With CP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Palsy
Keywords: handwriting
child
primary school
posture
assistive device
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to gather the data needed to do a larger research study to determine whether children with cerebral palsy print better sitting at an ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.

Detailed description: This pilot study will allow us to gather information for a high-quality randomized controlled trial to study the efficacy of ergonomic school furniture as a remedial handwriting intervention for young students with cerebral palsy. We will conduct the study in two parts. In the first part, 30 children with Gross Motor Function Classification System (GMFCS) Level I and II cerebral palsy will each provide manuscript handwriting samples using two different school furniture configurations. A blinded assessor will score the legibility of handwriting samples using the Minnesota Handwriting Assessment (MHA) as a primary outcome measure. In the second part, seven occupational therapy experts will attend a focus group to help us determine the minimal clinically important difference score for the MHA. We will use the data collected to determine the sample size requirements for a proposed randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* primary diagnosis of cerebral palsy
* functional status of Gross Motor Function Classification System Level I or II

Exclusion Criteria:

* genetic disorder;
* attention-deficit hyperactivity disorder; or,
* pervasive developmental disorder

Primary outcomes:
measure: Minnesota Handwriting Assessment
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Bloorview Research Institute, Bloorview Kids Rehab
state: Ontario
Study officials:
affiliation: Bloorview Research Institute, Bloorview Kids Rehab
name: Stephen E Ryan, MSc, PEng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05183386: Histological Outcome of the Use of Different Biomaterials for Fresh Socket Regeneration. A Split-mouth Design
Official title: Histological Outcome of the Use of Different Biomaterials for Fresh Socket. A Split Mouth Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh sockets using four different materials and at different times points.

Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological and histomorphometrical characteristics of fresh sockets from 30 patients. One socket per patient will healed spontaneously (control) and, at least, one fresh socket, will be grafted with platelet-rich growth factor (PRGF), PRGF+autologous bone, autologous bone or PRGF+demineralized freeze dried bone allograft (DFDBA). The day of the implant placement, biopsies will be taken at different time points divided into three assessment groups: short duration (2-4 months), intermediate duration (5-6 months) and long duration (7-12 months). The histologic findings will be assessed to quantify the trabeculae pattern, the degree of mineralization and the quality of bone regeneration.


Eligibility criteria: Inclusion Criteria:

* Patients in need of at least one bilateral tooth extraction due to one or more of the following causes:

  * periodontal disease,
  * vertical fracture
  * included teeth.
* Patients seeking dental implant to replace their missing teeth.
* All sockets should have intact or partially conserved buccal wall according to Elian´s classification (Type I, II).

Exclusion Criteria:

* Patients under 18 years old.
* Patients with a severely untreated periodontal disease.
* Smokers of more than 15 cigarettes a day.
* patients suffering from any systemic disease requiring pharmacological treatment.
* Patients whose socket´s buccal wall is totally missing after tooth extraction

Primary outcomes:
measure: Degree of mineralization
timeFrame: 2-12 months
measure: type of bone maturation
timeFrame: 2-12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05911386: Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
Official title: Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases (Including Pediatric Inflammatory Multisystemic Syndromes Related to Covid 19, Kawasaki Disease and Myocarditis)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myocarditis
Pediatric Inflammatory Multisystem Syndrome
Kawasaki Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age \< 18 years initial management and follow up in Nancy university children hospital center for PIMS Myocarditis and Kawasaki disease patients

Brief summary: Acquired inflammatory or infectious cardiac diseases, in pediatrics, include Kawasaki disease, myocarditis, and Covid-19-related Pediatric Multisystemic Inflammatory Syndrome (PIMS).

These 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. Nevertheless their modalities of monitoring, management and evolution are different. The investigators wish to retrospectively analyze biological and echocardiographic data of Kawasaki disease, myocarditis, PIMS patients managed at Nancy Children Hospital from January 1, 2017 to June 31, 2023.

The primary objective of this study is to identify, for these 3 pathologies, the prognostic factors of initiation of inotropic support.

The secondary objective is to identify the prognostic factors of degradation of ventricular function.


Eligibility criteria: Inclusion Criteria:

* diagnostic of PIMS, myocarditis or kawasaki disease patients
* age \< 18 years

Exclusion Criteria:

* uncertain diagnosis
* other complex heart disease
* management out of Nancy University children hospital center

Primary outcomes:
measure: need of hemodynamic support
timeFrame: up to 20 days
Secondary outcomes:
measure: deterioration of Left Ventricular Ejection fraction
timeFrame: up to 20 days
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Gilles BOSSER
Study officials:
References:
Clinical trial NCT02242786: Diffusion-Weighted Magnetic Resonance Imaging
Official title: Response Assessment for External Beam Radiation Therapy in Spinal Metastasis of Hepatocellular Carcinoma (HCC): Usefulness of Diffusion-Weighted Magnetic Resonance (MR) Imaging as A Functional Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Spine Metastasis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic applications. Especially, it is expected the DW MRI could provide valuable information about early response evaluation after treatment using rapid apparent diffusion coefficient (ADC) value change. It has demonstrated potential usefulness in response evaluation in the liver tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy (RT). Furthermore, it is a functional imaging technique that does not require a contrast agent, it can be safely used in patients with renal insufficiency or other medical contraindications for contrast agents.

The optimal assessment of early response of RT could provide one of the most important information to prescribe patient and cancer specific RT dose. It might be also important in palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.

This study is performed to evaluate the usefulness of DW MRI in early response evaluation after RT for HCC bone metastasis.


Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma
* Spine metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
* 20 or older age
* informed consent
* consent to birth control during 6 months after treatment

Exclusion Criteria:

* less than 12 weeks of expected survival
* indication of emergency operation
* uncontrolled ascites or encephalopathy
* previous RT field lesion (within in 1 month)

Primary outcomes:
measure: oral morphine equivalent doseresponse criteria
timeFrame: 3 months after RT completion
Secondary outcomes:
measure: Modified Response Evaluation Criteria in Solid Tumor
timeFrame: 3 months after RT completion
measure: Time to local tumor progression
timeFrame: From RT start to the date up to 24 weeks
measure: Overall survival
timeFrame: From RT start to the date up to 24 weeks
measure: Quality of Life
timeFrame: 3 months after RT completion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jong Won Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913686: Effect of Music on Mental and Physical Performance in Young Tennis Players
Official title: Effect of Music on Mental and Physical Performance in Young Tennis Players : a Pre-experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Performances
Mental Performances
Keywords: Music
physical performance
mental training
,stress management
concentration
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Optimal athletic performance is the result of a synergy between physical abilities and mental skills. Faced with increasing pressure in the world of tennis, athletes are constantly seeking new methods to optimize their performance. Music is a non-pharmacological tool that has demonstrated its effectiveness in reducing anxiety and improving sports performance. This innovative study explores the use of music as a tool to enhance the physical and mental abilities of young Tunisian tennis players. The results of this research could revolutionize training practices and offer new tools to help athletes reach their full potential.

Work objectives: Evaluate the impact of a musical intervention on the physical and mental performance of athletes, particularly young tennis players.


Eligibility criteria: Inclusion Criteria:

* Competitive category : Participants must be regular tennis players (number of hours per week) who engage in organized tennis activities (e.g., regular training or participation in competitions).
* Agreement to participate: Participants (players and/or their legal representatives) who agree to participate in the study.

Exclusion Criteria:

* Player's age \<10 and \> 18 years.
* Non-regular young tennis players (Recreational category): Participants who do not engage in tennis practice regularly.
* Diagnosed psychiatric disorder
* Hearing disorder Severe hearing impairments and certain types of tinnitus. Severe neurological disorders: auditory epilepsy and musicogenic epilepsy (audiogenic seizures are a rare neurological condition characterized by seizures triggered by auditory stimulation).

Amusia and musical deafness (a neurological anomaly where rhythm, melody, and musical chords are not perceived).

Specific psychological issues. Personal sensitivities to certain types of music. History of trauma related to music (intense emotional reactions to certain types of music).

* Refusal to participate: Participants (players and/or their legal epresentatives) who refuse to participate in the study.

Primary outcomes:
measure: The Perception of Success Questionnaire
timeFrame: before and immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: TUN
Study officials:
References:
Clinical trial NCT06673186: Patient Satisfaction and Prosthetic Complications of Bar Locator Versus Bar Clip Attachments for Mandibular Two-Implant Overdentures
Official title: Patient Satisfaction and Prosthetic Complications of Bar Locator Versus Bar Clip Attachments for Mandibular Two-Implant Overdentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulism
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose: This study evaluated patient satisfaction and oral health-related- quality of life (OHRQoL) with implant overdentures retained with bar locator versus bar clip attachment for mandibular two-implant overdentures. Materials and methods: This study included sixteen edentulous patients. Every patient received new maxillary and mandibular dentures. Two dental implants have been embedded in the mandibular canine areas. The participants were randomly divided into two equal groups: Group I (bar locator): Patients were given overdentures with bar locator attachments, Group II (bar clip): Patients were given overdentures with bar clip attachment. Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.

The aim of this study was to document and report on the prosthetic complications associated with mandibular implant overdentures using bar locator and bar clip attachments. The study aimed to test the null hypothesis that the complications would not differ based on the type of retention (locator or clip).


Eligibility criteria: Inclusion Criteria:

* Each patient had sufficient remaining alveolar ridge in the upper and lower jaw to support implants in the lower jaw area
* a minimum length of 11 mm and a diameter of 3.7 mm, as confirmed by cone beam computed tomography.
* patient had a class I jaw relationship
* adequate space between the arches.
* healthy, firm gum tissue.

Exclusion Criteria:

* participants with uncontrolled diabetes,
* heavy smoking
* drinking habits
* temporomandibular joint (TMJ) issues.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.
measure: prosthetic complications
timeFrame: Mechanical complications were clinically examined and included Distortion /wear of retentive components, Bar screw loosening, Fracture of opposing prosthesis, Teeth wear, Fracture at the midline of the prosthesis and Teeth separation within 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Heba Wageh Abozaed
Study officials:
References:
Clinical trial NCT01293786: Serum Magnesium and Vascular Calcification
Official title: Comparison of Vascular Calcification Between Kidney Transplant Recipients and Predialysis Chronic Kidney Disease and Its Association With Serum Magnesium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Calcification
Chronic Kidney Disease
Keywords: magnesium
kidney transplantation
hypomagnesemia
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplant recipients and predialysis chronic kidney disease patients from outpatient nephrology clinic of Ramathibodi hospital, Mahidol University

Brief summary: Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced kidney function. Low serum magnesium is more prevalent in KT recipients. The present study examines the difference in vascular calcification between KT and CKD and its association with serum magnesium.

Detailed description: Kidney transplantation (KT) improved quality of life and longevity of CKD patients. Nevertheless, kidney function deteriorates overtime in a manner not different from CKD counterparts. Hypomagnesemia is prevalent in KT recipients secondary to immunosuppressive therapy. In addition to serum calcium, phosphate and elemental calcium intake, the relationship between low serum magnesium and vascular calcification (VC) has been observed in small studies in CKD. Whether low serum magnesium associates with VC in KT has never been elucidated. The present study compares vascular calcification between KT and CKD and its association with serum magnesium.

Eligibility criteria: Inclusion Criteria:

* kidney transplant recipients at least 1 year post surgery
* predialysis chronic kidney disease with serum creatinine \> 1.1 mg/dL in female and 1.3 mg/dL in male

Exclusion Criteria:

* acute kidney injury
* parathyroidectomy

Primary outcomes:
measure: The difference in vascular calcification score between KT and CKD
timeFrame: Baseline
Secondary outcomes:
measure: The association of serum magnesium with vascular calcification in KT
timeFrame: Baseline
measure: The association of serum magnesium with vascular calcification in CKD
timeFrame: Baseline
Other outcomes:
Locations:
city: Phayathai
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University
name: Sinee Disthabanchong, MD
role: PRINCIPAL_INVESTIGATOR
References: