louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01736969: A Substantial Equivalence Study of RD04723 and Predicate Device
Official title: Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Scar
Keloid Scar
Lead sponsor: Oculus Innovative Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent and release health information
* Ability to follow study instructions and study requirements
* Have a hypertrophic or keloid scar accessible for treatment and evaluation
* Negative pregnancy test for women of childbearing potential
* Agreement to use effective birth control method for study duration

Exclusion Criteria:

* History of allergy or sensitivity to components
* History of diabetes
* History of collagen vascular disorders
* Anticipated need for surgery or hospitalization during the study
* Pregnant, nursing, or planning a pregnancy during the study
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

Primary outcomes:
measure: Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)
timeFrame: 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Pain and itch
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Adverse Events
timeFrame: Baseline, Weeks: 2, 4, 8, 12 and early termination
measure: Treatment satisfaction
timeFrame: 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: DermResearch Inc
state: Texas
Study officials:
affiliation: Derm Research, PLLC
name: Janet C DuBois, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02025569: The Effect of Strain-counterstrain on Ankle Instability
Official title: The Effectiveness of Strain Counterstrain in the Treatment of Patients With Chronic Ankle Instability: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Other Instability, Ankle and Foot
Keywords: chronic ankle instability
lateral ankle sprain
manual therapy
star excursion balance test
strain and counterstrain
Lead sponsor: Long Island University
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.

Detailed description: This study aimed to determine the effect of Strain Counterstrain (SCS) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability (CAI). Although many studies have been published on CAI, the cause for this common clinical dysfunction remains inconclusive. No studies have assessed the effectiveness of SCS on CAI. Baseline information on all participants includes a demographic questionnaire, the Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM). Participants were randomized into the SCS intervention group or the sham SCS control group. All participants received an intervention (as assigned) once a week for four weeks in addition to performing a prescribed home exercise program. At week four all participants repeated the outcome measures and completed a Global Rating of Change (GROC) form. The primary aim was examined with a 2-way analysis of variance (ANOVA).

Eligibility criteria: Inclusion Criteria:

* history of at least 1 ankle sprain, with pain and/or limping for more than 1 day, at least 3 months earlier
* 3 of more episodes of ankle giving way in the last 12 months
* chronic instability attributed to the original sprain injury
* age between 18-55

Exclusion Criteria:

* history of fracture or surgery in the affected ankle
* any other lower extremity musculoskeletal injury on the side of the involved ankle
* vestibular dysfunction or disorder
* history of balance dysfunction
* history of stroke or any other neurological pathology or disease
* history of ACL injury
* current participation in physical therapy or rehabilitation for the ankle injury
* evidence of CNS dysfunction

Primary outcomes:
measure: Star Excursion Balance Test
timeFrame: baseline
measure: Star Excursion Balance Test
timeFrame: 4 weeks
Secondary outcomes:
measure: Foot and Ankle Ability Measure
timeFrame: baseline
measure: Foot and Ankle Ability Measure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Long Island University
state: New York
Study officials:
affiliation: Long Island University
name: Cristiana K Collins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00709969: Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria
Official title: Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plasmodium Falciparum Malaria
Keywords: Malaria
co-artemether
auditory
Plasmodium falciparum
marsh fever
remittent fever
artemether
artemisinins
lumefantrine
child
infant
Africa
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: World Health Organization
name: Avenue Appia 20
name: CH - 1211 Geneva 27
name: Switzerland
First posted: 2008-07-03
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.


Eligibility criteria: Inclusion Criteria:

* male or female weighing ≥ 5kg and ≤ 25kg
* P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3
* with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite

Exclusion Criteria:

* complicated malaria
* ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks
* severe anaemia
* severe malnutrition
* malaria due to other than P. falciparum

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations
timeFrame: 28 days
Secondary outcomes:
measure: Proportion of patients free of parasites at 7, 14 and at 28 days
measure: Time to clearance from parasites (asexual forms)
measure: Time to clearance of fever
measure: Time to clearance of gametocytes (parasite sexual forms)
Other outcomes:
Locations:
city: Kilifi
country: Kenya
facility: Kemri-Wellcome Trust Programme
city: Ibadan
country: Nigeria
facility: University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis
role: STUDY_CHAIR
References:
citation: Falade CO, Ogunkunle OO, Dada-Adegbola HO, Falade AG, de Palacios PI, Hunt P, Virtanen M, Oduola AM, Salako LA. Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children. Malar J. 2008 Nov 27;7:246. doi: 10.1186/1475-2875-7-246.
Clinical trial NCT05447169: Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening
Official title: Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma Screen
EBV DNA
EBV antibody
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Wuzhou Red Cross Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: Hunan Cancer Hospital
name: The Third Affiliated Hospital of Nanchang University
name: First People's Hospital of Foshan
name: Yuebei People's Hospital
name: Xiangya Hospital of Central South University
name: Changsha Central Hospital
First posted: 2022-07-07
Enrollment: 11625
Sex: MALE
Minimum age (years): 30
Maximum age (years): 62
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residences in Southern China

Brief summary: The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.

Detailed description: The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A， Epstein-Barr nuclear antigen 1-immunoglobulin A， early antigen-immunoglobulin A， Zta-immunoglobulin A， Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.

Eligibility criteria: Inclusion Criteria:

* residents in Southern China
* 30-62 years old
* male
* a first-degree relative of at least one nasopharyngeal carcinoma patient
* no medical record of nasopharyngeal carcinoma
* Eastern Cooperative Oncology Group score of 0-2
* be able to comprehend, sign, and date the written informed consent document to participate in the study

Exclusion Criteria:

* history of nasopharyngeal carcinoma
* heavy cardiovascular, liver or kidney disease
* on systemic steroid or immunosuppressant treatment or active autoimmune disease

Primary outcomes:
measure: positive predictive value
timeFrame: 3 years
measure: negative predictive value
timeFrame: 3 years
Secondary outcomes:
measure: sensitivity
timeFrame: 3 years
measure: specificity
timeFrame: 3 years
measure: early diagnose rate
timeFrame: 3 years
measure: cost-effectiveness
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-Yuan Chen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00751569: microRNA Profile in Umbilical Cord Blood NK Cells
Official title: microRNA Profile in Umbilical Cord Blood NK Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnant Women
Keywords: umbilical cord blood
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-12
Enrollment: 5
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal pregnant women

Brief summary: Umbilical cords contain immature blood cells, including a group of lymphocytes, that are important in the so-called natural immunity. We want to study the cytokine levels in umbilical cord NK cells and its regulation a family of newly identified small RNAs (microRNAs).

Detailed description: Our preliminary data pointed to the possibility of cytokine regulation by microRNAs in NK lymphoma and NK lymphoma cell lines. We want to use umbilical cord blood as controls for the biological significance in normal NK cell development.

Eligibility criteria: Inclusion Criteria:

* Normal pregnant women

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Chung-Wu Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06903169: Understanding End User Preferences for Hand Hygiene Enabling Technologies in Urban and Peri-urban Lusaka Zambia
Official title: Understanding End User Preferences for Hand Hygiene Enabling Technologies in Urban and Peri-Urban Lusaka Zambia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Handwashing
Keywords: handwashing facility attributes
handwashing facility ranking
Lead sponsor: Centre for Infectious Disease Research in Zambia
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2025-03-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be based in two peri urban communities located in the western part of Lusaka, George and Matero compounds. George and Matero compounds located geographically next to each other have over 320,000 residents with the majority of residents accessing water from water kiosks that are managed by the local council. Some residents still access water from shallow wells that are generally heavily contaminated and polluted.

Matero and George compounds are characterized by dense, informal settlement patterns, where housing is unplanned and access to WASH is an ongoing challenge. Water supply from the municipality is largely provided through communal boreholes accessed during limited times in a day at a minimal fee. Where affordability is a challenge, residents often resort to using unprotected shallow wells as their main source of water. During the rainy season flooding is common because of unplanned housing and poor drainage systems. Residents mostly rely o

Brief summary: The goal of this study is to explore the perceived attributes, acceptability, and use of various improved handwashing facility designs.

The study aimed to establish what are the characteristics of handwashing facilities (attributes) that are prioritized among various groups of potential end users and how do existing improved HWF designs rank according to these preferences? Also how acceptable are promising HWF designs among multiple groups of potential end users in a real-world setting, how do potential users adapt and modify existing HWF for use in their homes.


Eligibility criteria: Inclusion Criteria:

* Living within the designated study area
* Meeting category requirements (i.e adult male, adult women, caregivers of under 5 or elderly (\>65)

Exclusion Criteria:

* Not from within designated area
* Less than 18 years of age

Primary outcomes:
measure: Attribute Identification
timeFrame: Same day
measure: Handwashing facility ranking
timeFrame: Same day
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: George Health Centre
Study officials:
References:
Clinical trial NCT06996769: Constraint-Induced Movement Therapy After Stroke
Official title: Constrain Induced Therapy to Improve Motor Function and Body Balance in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiplegia Following Ischemic Stroke
Keywords: Constraint-Induced Movement
stroke
motor function
body balance
Lead sponsor: Al-Zaytoonah University of Jordan
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constraint-induced movement therapy (CIMT) is a neurological rehabilitation treatment designed to improve upper and lower extremities motor functions after stroke. The basis of CIMT is improving the function of the affected limb after a stroke by restricting the use of the healthy limb and forcing the use of the affected side. The core strategy of CIMT is the application of movement techniques, behavioral techniques and restriction methods to increase the frequency of use of the affected limb in stroke patients, improve the quality of movement of the affected limb in real-life scenarios, prevent or correct the learned non-use of the affected limb, and promote the recovery of motor function in the affected limb. This method induces the use of the affected limb, corrects or reverses habitual disuse and neglect of the affected limb, and provides structural and functional training and repeated practice opportunities for the affected limb.


Eligibility criteria: Inclusion Criteria:

* grade 1 or 1+ modified ashower scale
* Walk independently

Exclusion Criteria:

* moderate to sever spasticity
* balance dysfunction

Primary outcomes:
measure: motor function
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Al Zaytoonah University
Study officials:
References:
Clinical trial NCT01721369: Applicability of Syncope Guidelines in Cataluña
Official title: Observational Study of the Application of the ESC2009 Syncope Guidelines in Cataluña
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brief Loss of Consciousness
Keywords: TLOC
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-11-04
Enrollment: 581
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Transient Loss of Conscience: T-LOC

Brief summary: The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of these patients.

Detailed description: The aim of SYNCAT study is to analyze the level of adherence of Syncope Guidelines ESC2009 for the management, diagnosis and treatment of syncope in a specific territory with similar health structure, the region of Cataluña in Spain that includes aprox. 7,000,000 inhabitants, including different complexity level of hospitals and the impact that following guidelines can have in the prognosis of these patients.

Eligibility criteria: Inclusion Criteria:

* Each patient that comes from the Emergency room and/or in office doctors visit (Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience (T-LOC)

Exclusion Criteria:

* Patients younger than 15 years old
* Pregnant women

Primary outcomes:
measure: Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Vall d'Hebron
name: Angel Moya, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Arnau de Vilanova de Lleida
name: Jordi Tomàs, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Parc Sanitari Sant Joan de Déu
name: Joan Nicolàs, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Joan XXIII
name: Jordi Mercè, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Municipal de Badalona
name: Francesc Planas, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03930069: Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
Official title: Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Submucous Leiomyoma of Uterus
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-04-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .

Detailed description: This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .

Eligibility criteria: Inclusion Criteria:

* symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
* grade 0 and grade 1 submucous myomas
* less than 5 centimeters in diameter

Exclusion Criteria:

* Patients with grade 2 submucous myoma or more
* patients with submucous myomas larger than 5 cm in diameter
* postmenopausal women
* patients received GnRh analogue in last 6 months
* patients with anticoagulant therapy
* patients with endometrial premalignant or malignant pathologies
* patients with cardiovascular diseases, asthma or impaired kidney functions

Primary outcomes:
measure: intraoperative bleeding
timeFrame: start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure
measure: operative time
timeFrame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure
measure: haemoglobin and hematocrit deficit
timeFrame: 24 hours before myomectomy and 24 hour after myomectomy
Secondary outcomes:
measure: Degree of visual clarity
timeFrame: start with the first resectoscope myoma cut till the completion of myoma resection
measure: Fluid deficit
timeFrame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure
measure: time need for cervical dilatation
timeFrame: start from grasping the cervix till insertion of hysterescope
Other outcomes:
Locations:
Study officials:
References: