louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01223638: The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congenital Hypothyroidism
Hearing Loss
Keywords: Congenital hypothyroidism(CH)
Hearing loss among children with CH
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 2-30 years with congenital hypothyroidism which are being followed at the Pediatric Endocrine Department at Ha'Emek Medical Center.

Brief summary: Congenital hypothyroidism (CH) occurs in 1:4000 live births. Neurological disturbances like speech delay, motor delay and lower IQ were reported in children with CH. Evidence from animal experiments indicate that CH is associated with high frequency of deafness. Morphological changes of the external and internal cholera hairs were reported in mutagenic mice with CH. Anatomical changes of the internal ear and low hearing threshold were reported in mice bearing Dual oxidase 2 (Duox2) gene mutations, which is responsible of oxidation of iodide. Knockout of Pax8 gene in mice resulted in both agenesis of thyroid gland and deafness. Early L-thyroxin therapy prevented the development of deafness in those mice. The expression of thyroid receptor α (TRα) in the external and internal cholera hairs in mice indicates that the thyroid hormones have an important role in the development of the internal ear.

The etiology of deafness in human is both genetic and environmental. The prevalence of deafness in live births is 1:1000 and among them 60% is genetic. Connexin 26 gene mutations are the most common cause of inherited deafness and account for about 40% of the genetic cases. In two conditions in human the coexistence of hypothyroidism and deafness were reported; Pendred syndrome and thyroid hormone resistance syndrome.

The prevalence of hearing loss in human with CH was explored in only few studies and the results are contrary.

The aim of the current study is to study the prevalence of hearing loss among children with CH and to compare the clinical, biochemical and genetic characteristics between subjects with hearing loss to those without hearing loss.


Eligibility criteria: Inclusion Criteria:

* Patients with congenital hypothyroidism aged 2-30 years

Exclusion Criteria:

* Hearing defects in the family
* Intrauterine infections
* Perinatal hypoxia
* Long term therapy with aminoglycosides
* Acoustic trauma in the past

Primary outcomes:
measure: Hearing Level
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
Study officials:
References:
Clinical trial NCT00464438: A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Conjunctivitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 171
Sex: ALL
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age


Eligibility criteria: Inclusion Criteria:

* diagnosed with bacterial conjunctivitis

Exclusion Criteria:

* chemical or foreign body trauma to either eye
* infection in either eye (besides bacterial conjunctivitis)
* white spots in the cornea or ulcers in either eye
* clinical diagnosis of chlamydia or gonorrhea in either eye

Primary outcomes:
measure: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7
timeFrame: Day 7
Secondary outcomes:
measure: Percentage of Patients With Microbiological Improvement
timeFrame: Day 7
measure: Percentage of Patients With Improvement in Ocular Signs for Lid Erythema
timeFrame: Days 7
measure: Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Sacramento
country: United States
state: California
city: Whitby
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04833738: Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome
Official title: Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement
Pain, Shoulder
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. This study aims to compare the effect of hyaluronic acid, corticosteroid, and electrotherapy in subacromial impingement syndrome.

Design: Ninety five patients were randomised into three equal groups according to treatment types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and Shoulder Disability Questionnaire (SDQ) were used as outcome measures.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of subacromial impingement syndrome

Exclusion Criteria:

* Patients aged \<20 or \>50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 min.
measure: range of motion
timeFrame: 5 min.
measure: Shoulder Disability Questionnaire
timeFrame: 15 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04487938: Oral Cancer Screening and Education in Hong Kong
Official title: THE HONG KONG ORAL CANCER EDUCATION AND SCREENING (HOCES) PROGRAM: REFINING DISEASE PREVENTION, RISK STRATIFICATION AND EARLY DETECTION
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancer
Oral Leukoplakia
Oral Submucous Fibrosis
Proliferative Verrucous Leukoplakia
Oral Erythroplakia
Erosive Lichen Planus
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 3190
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hong Kong residents aged 45 years and above residing in Southern and Central and Western district council districts (DCD).

Brief summary: This study will be conducted to obtain data on oral cancer risk factors to generate machine learning models with good predictive accuracy for stratifying individuals with high-oral cancer risk and delineating high-risk and low-risk oral lesions. Likewise, this study will seek to provide oral cancer-related health education and training on oral-self-examination for beneficiaries


Eligibility criteria: Inclusion Criteria:

* Healthy individuals satisfying age and residential area criteria with no previous history of oral cancer. Individuals with a history of other cancers will be included in the study provided they have been in remission for more than three years.

Exclusion Criteria:

* Participants with reduced mouth opening (irrespective of the cause) to permit proper administration of VOE or photosensitive epilepsy will be excluded. Likewise, those who decline the provision of written consent or participation in any part of the study.

Primary outcomes:
measure: Accuracy of machine learning algorithms for predicting high-risk persons
timeFrame: 24 months
measure: Accuracy of machine learning algorithms for discriminating high-risk and low-risk lesions
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Peter Thomson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adeoye J, Choi SW, Thomson P. Bayesian disease mapping and the 'High-Risk' oral cancer population in Hong Kong. J Oral Pathol Med. 2020 Oct;49(9):907-913. doi: 10.1111/jop.13045. Epub 2020 Jun 10.
citation: Adeoye J, Brennan PA, Thomson P. "Search less, verify more"-Reviewing salivary biomarkers in oral cancer detection. J Oral Pathol Med. 2020 Sep;49(8):711-719. doi: 10.1111/jop.13003. Epub 2020 Mar 5.
citation: Adeoye J, Chu CS, Choi SW, Thomson P. Oral Cancer Awareness and Individuals' Inclination to Its Screening and Risk Prediction in Hong Kong. J Cancer Educ. 2022 Apr;37(2):439-448. doi: 10.1007/s13187-020-01834-x.
citation: Adeoye J, Thomson P. Strategies to improve diagnosis and risk assessment for oral cancer patients. Faculty Dental Journal. 2020;11(3):122-7.
Clinical trial NCT01508143: Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination
Official title: A Comparative Study of Vaginal Misoprostol Two Dosing Regimen for First Trimester Pregnancy Termination in Patients Admitted at Bandarabbas in Shariati Hospital in 2009
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Termination
Keywords: Abortion
Pregnancy
Termination
Misoprostol
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Detailed description: Studies on determining the optimal dosage for misoprostol in pregnancy termination are continuing and still there is no evidence for ideal misoprostol regimen for pregnancy termination. The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Eligibility criteria: Inclusion Criteria:

* All women who were candidates for early pregnancy termination because of fetal death or other medical conditions
* Before 14th week of gestation calculated according LMP or first trimester sonography

Exclusion Criteria:

* Chorioamnionitis
* Hypersensitivity to prosstaglandins
* Past medical history of cardiovascular, kidney or liver or lung diseases
* Positive history for uterus pathologies
* suspicious to extra-uterus pregnancy
* sign and symptoms of uterus infection
* Molar pregnancy

Primary outcomes:
measure: Abortion
timeFrame: 48 hours after treatment
Secondary outcomes:
measure: Duration of abortion
timeFrame: Form the begining of treatment to complete abortion
measure: Adverse Effects
timeFrame: 48 hours after treatment
measure: Need for surgery
timeFrame: 48 hours after treatment
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences
state: Hormozgan
Study officials:
References:
Clinical trial NCT05789043: Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
Official title: Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acral Melanoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 140
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: It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.


Eligibility criteria: Inclusion Criteria:

* age:≥18 years, male or female.
* Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
* Has not received any systematic anti-tumor drug treatment.
* Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
* ECOG 0-1.
* Adequate organ function.
* Life expectancy of greater than 12 weeks.
* Patient has given written informed consent.

Exclusion Criteria:

* Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
* Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
* Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
* Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
* Received a live vaccine within 4 weeks before the first dose of study medication.
* Pregnancy or breast feeding.
* Decision of unsuitableness by principal investigator or physician-in charge.

Primary outcomes:
measure: Progression Free Survival, PFS
timeFrame: Within 2 years
Secondary outcomes:
measure: Overall Survival ,OS
timeFrame: Within 2 years
measure: ORR
timeFrame: Within 2 years
measure: DCR
timeFrame: Within 2 years
measure: Adverse Events (AEs)
timeFrame: Within 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Guo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726543: Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract
Official title: Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Angle Glaucoma
Cataract
Keywords: canaloplasty
non-penetrating deep sclerectomy
glaucoma
cataract
ophthalmology
glaucoma surgery
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.


Eligibility criteria: Inclusion Criteria:

* co-existing glaucoma and cataract
* glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)
* eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP \>16mmHg on medication or without, or IOP\<16mmHg on 2 or more medications.
* uncontrolled IOP
* patients not tolerating antiglaucoma medications,
* patients with poor compliance
* progression in visual field

Exclusion Criteria:

* previous surgical glaucoma procedure
* previous cataract surgery
* visual function under 0,004
* closed angle glaucoma
* poorly controlled diabetes mellitus
* advanced AMD
* active inflammatory disease
* pregnancy
* mental disease or emotional instability, that could

Primary outcomes:
measure: IOP
timeFrame: Change from Baseline at 24months
measure: number of antiglaucoma medications
timeFrame: Change from Baseline at 24months
measure: visual acuity
timeFrame: Change from Baseline at 24months
measure: intraoperative complications
timeFrame: surgery day
Secondary outcomes:
measure: Secondary procedures
timeFrame: within 24 months
measure: Early and late complications
timeFrame: within 24 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
Study officials:
affiliation: Military Institute od Medicine National Research Institute
name: Marek Rekas, MD,PhD,Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01206543: 1.5T Intraoperative MR Imaging in Craniopharyngiomas
Official title: Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup ("Intraoperative Nutzung Eines Kernspintomographie-Systems in Direkter Kopplung Mit Einem Neuronavigations-System")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniopharyngioma
Keywords: Craniopharyngioma
Surgery
Intraoperative imaging
Rate of total removal
Lead sponsor: Hofmann, Bernd, M.D.
Sponsor class: INDIV
First posted: 2010-09-22
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.


Eligibility criteria: Inclusion Criteria:

* complex craniopharyngioma \> 1cm extension within 2 or more cranial fossae or ventricular system
* Patient or legal representative able to provide written informed consent

Exclusion Criteria:

* tumor size\< 1 cm
* Patients with any condition considered a contraindication to MRI
* Patients with any condition considered a contraindication for surgery
* Hypothalamic disturbances
* Hypothalamic edema

Primary outcomes:
measure: Rate of additional tumor removal
timeFrame: up to 3-4 months following surgery
measure: Rate of achievement of intended extent of removal
timeFrame: up to three months following surgery
measure: Diagnostic reliability
timeFrame: within 3 -4 months following surgery
Secondary outcomes:
measure: Surgical complication
timeFrame: within 1st week following surgery
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Neurosurgery University of Erlangen
Study officials:
name: Bernd Hofmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205643: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Official title: A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2019-12-19
Enrollment: 548
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: This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis


Eligibility criteria: Inclusion Criteria:

* Patient is male or female aged 18 to 75 years, inclusive.
* Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points

Exclusion Criteria:

* Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
* Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives

Primary outcomes:
measure: Percentage of Patients Achieving Clinical Remission at Week 54
timeFrame: Week 54
Secondary outcomes:
measure: Percentage Patients Achieving Clinical Response at Week 54
timeFrame: Week 54
measure: Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54
timeFrame: Week 54
measure: Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54
timeFrame: Week 54
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
Study officials:
References:
Clinical trial NCT00299143: Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes
Official title: Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina, Unstable
Keywords: SIPA
acute coronary syndrome
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2006-03-06
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted in the intensive care unit with acute coronary syndrome

Brief summary: The purpose of this study is to determine whether shear-induced platelet aggregation is able to discriminate first acute coronary syndrome (ACS) from recurrent ACS

Detailed description: Predictive factors of recurrence of ACS are not well determined. Platelet aggregation and leucocyte activation seem to be involved in the pathogenesis. The aim of our study is to compare SIPA, platelet activation and platelet-leucocytes aggregates on the onset of the ACS and 3 months later in 2 groups of patients scheduled for a first episode of ACS or recurrent ACS .

Eligibility criteria: Inclusion Criteria:

over 18 years old. informed consent signed. acute coronary syndrome not associated with co-morbidity as bleeding diathesis or myocardial infarction during the procedure.

clinical symptoms in agreement with myocardial infarction during the preceding 24 hours.

CK OR troponin elevation and one or more of the following criteria: ECG modifications transient ST elevation\>1 mm. new inversion of ST \<1 mm on 2 contiguous derivations.

Exclusion criteria:

Acute coronary syndrome with persistent ST elevation. Angioplasty in emergency before blood sampling. Inflammatory disease or cancer. Coagulation abnormalities. Antiphospholipid syndrome. Treatment by vitamin K antagonist. Severe disease with life expectancy lower than 2 years. One-year follow up impossible.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: APHP
name: Philippe G Steg, Professor
role: STUDY_DIRECTOR
affiliation: APHP, INSERM
name: Nadine Ajzenberg, Dr
role: PRINCIPAL_INVESTIGATOR
References: