louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05090436: Schroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities
Official title: Schroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Spinal Deformities
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abnormal spinal curvature can occur as a result of neurologic, orthopedic or idiopathic factors. The role of physiotherapy is not only to prevent intrinsic changes that may occur in the spine but also be used to correct postural abnormalities. this study will investigate the impact of Schroth Exercise compared to Functional Electrical Stimulation in Adolescent With Spinal Deformities (scoliosis and or kyphosis).


Eligibility criteria: Inclusion Criteria:

* Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles .
* All children are normal \&perform all activities of daily living
* They were able to understand and follow verbal commands and instructions included in the testing procedures.

Exclusion Criteria:

* All of them could be part of recreational activities in their public schools but no competitive sports.
* Children who participated in any regular sport activities involving the lower extremities will be excluded.
* None of them had any surgical intervention .
* None of them had any history of other musculoskeletal deformities or neuromuscular disorders.
* They had neither visual, auditory defect.

Primary outcomes:
measure: cobb angle
timeFrame: at the beginning of the study
measure: cobb angle
timeFrame: by the end of successful two month of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References:
Clinical trial NCT04345536: Prospective Quality Register of Patients With Confirmed Covid-19 at Oslo University Hospital
Official title: Prospective Quality Register of Patients With Confirmed Covid-19 at Oslo University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 2519
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients in a secondary and tertiary care University Hospital.

Brief summary: Covid-19 is a recently emerging infectious disease with a very large impact on health care world-wide. The disease is still poorly described. It is an urgent need for better clinical characteristics. A prospective, quality register is therefore established for increasing the knowledge about the disease, the covid patients and the prognosis.

Detailed description: All patient hospitalized at Oslo University Hospital, Ullevål, is prospectively registered in the approved quality register. Background, clinical and paraclinical data is harvested and registered, as well as treatment and mortality.

Eligibility criteria: Inclusion Criteria:

* Confirmed covid-19
* hospitalized

Exclusion Criteria:

* None

Primary outcomes:
measure: Mortality
timeFrame: 3 month
measure: Severe disease
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kristian Tonby, MD
role: STUDY_DIRECTOR
References:
citation: Holten AR, Nore KG, Tveiten CEVWK, Olasveengen TM, Tonby K. Predicting severe COVID-19 in the Emergency Department. Resusc Plus. 2020 Dec;4:100042. doi: 10.1016/j.resplu.2020.100042. Epub 2020 Oct 21.
Clinical trial NCT02511236: Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Official title: Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
name: James and Esther King Biomedical Research Program
First posted: 2015-07-29
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.


Eligibility criteria: Inclusion Criteria:

* Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic
* Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm
* be over age 18
* speak/read English and/or Spanish

Exclusion Criteria:

* Contraindications for transdermal nicotine patch therapy (TNP)
* Cognitive or mental health impairment that inhibits group treatment
* Currently being treated for smoking cessation, alcoholism, or illicit drug use
* Unable to attend sessions
* Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)
* Does not self-identify as African American, Hispanic, or White (non-Hispanic)

Primary outcomes:
measure: The Number of Participants Reporting 7 Day Point Prevalence Abstinence
timeFrame: 12-months
measure: Change in Perceived Stress Scores
timeFrame: Baseline, 4 weeks
measure: Change in Depressive Symptoms Scores
timeFrame: Baseline, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: David Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Webb Hooper M, Lee DJ, Simmons VN, Brandon KO, Antoni MH, Unrod M, Asfar T, Correa JB, Koru-Sengul T, Brandon TH. Reducing racial/ethnic tobacco cessation disparities via cognitive behavioral therapy: Design of a dualsite randomized controlled trial. Contemp Clin Trials. 2018 May;68:127-132. doi: 10.1016/j.cct.2018.03.017. Epub 2018 Apr 1.
Clinical trial NCT00644436: Study to Determine if Tetrix Cream is Removed From the Hands by Gentle Washing With Soap and Water
Official title: A Study of the Substantivity of Tetrix Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: tetrix cream
substantivity
resistance to a gentle wash
Tetrix Cream remaining on hands after gentle washing with soap and water.
Lead sponsor: Coria Laboratories, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine if Tetrix Cream remains on the hands after gentle washing with soap and water


Eligibility criteria: Inclusion Criteria:

* Normal subjects
* Male and Female

Exclusion Criteria:

* Under the age of 18 years

Primary outcomes:
measure: amount of Tetrix remaining on the skin compared to control, after gentle washing with soap
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services
state: South Carolina
Study officials:
affiliation: Dermatology Consulting Service
name: Zoe Draelos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00747136: WavSTAT® Optical Biopsy System to Target Esophageal Biopsies
Official title: A Prospective Evaluation of the WavSTAT® Optical Biopsy System to Target Esophageal Biopsies: An Adjunctive Tool to Assist the Endoscopist to Identify Dysplasia or Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Barrett's Esophagus
Keywords: Barrett's
Dysplasia
esophageal cancer
Patients
Lead sponsor: SpectraScience
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Barrett's esophagus

Brief summary: The purpose of this study is to demonstrate the clinical utility of the WavSTAT Optical Biopsy System as an adjunctive tool to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus.

Detailed description: In the clinical portion of this prospective study, the algorithm developed in the preclinical evaluation will be blindly tested using the pathologists' assessment of the biopsies as a gold standard to determine the clinical sensitivity and specificity of the WavSTAT Optical Biopsy System to identify dysplastic or cancerous tissue in the esophagus. In addition, the endoscopist's unaided clinical sensitivity and specificity to identify dysplasia or cancerous tissue will also be determined by recording the endoscopist's visual assessment of whether the physical biopsy has dysplasia or cancer or does not have dysplasia or cancer prior to performing the biopsy The endoscopist's assessment will be correlated and compared with the pathologist's interpretation. The clinical utility of the WavSTAT System to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus will be evaluated by testing the hypothesis that the sensitivity of a WavSTAT-assisted endoscopic examination improves that of standard endoscopy alone.

Eligibility criteria: Inclusion Criteria:

* The patient is between 18 and 80 years of age.
* The patient is willing to sign an informed consent form.
* The patient is a candidate for endoscopic examination
* Female patients of child-bearing age, uncertain of pregnancy status, must have a negative pregnancy test.

Exclusion Criteria:

* The patient has congenital deformities, which preclude a physical biopsy procedure during endoscopy.
* The patient is pregnant or nursing by admission.
* The patient has other contraindications for physical biopsy.

Primary outcomes:
measure: Determine sensitivity/specificity to identify dysplasia/cancer in the esophagus WavSTAT System alone, endoscopist alone/combination of WavSTAT and endoscopist. Sensitivity of the endoscopist will be compared to combination of endoscopist and WavSTAT.
timeFrame: 9-15 months estimated
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Department of Veterans Affairs
state: Missouri
Study officials:
References:
Clinical trial NCT01161836: An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)
Official title: An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi) Administered at Cycle 1 as a 60-minute Intravenous Infusion to Patients With Advanced Solid Tumors Followed by Extended Treatment With BSI-201 With or Without Additional Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-07-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, multi-center, open-label study.

During Segment 1, patients are administered a single IV administration of \[14C\]-iniparib.

During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.


Eligibility criteria: Male or female patients with advanced solid tumors that are refractory to standard treatment or for which no standard treatment exists; patients must be at least 18 years old.

Additional criteria are also required and should be evaluated by the research staff.

Primary outcomes:
measure: The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib
timeFrame: Up to 35 days
measure: The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity
timeFrame: up to 35 days
measure: The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration
timeFrame: 96 hours
measure: The metabolic pathways of iniparib and identify the chemical structures of the main metabolites.
timeFrame: Up to 35 days
Secondary outcomes:
measure: The clinical and biological tolerability of iniparib.
timeFrame: During treatment and until 30 days post treatment
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01518036: Use of Somatropin in Turner Syndrome
Official title: The Use of Norditropin® in Turner's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genetic Disorder
Turner Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 57
Sex: FEMALE
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.


Eligibility criteria: Inclusion Criteria:

* Turner Syndrome
* Not previously treated with growth hormone or androgen
* Well-documented height over the previous 12 months
* Informed consent of parents (and child if appropriate)

Exclusion Criteria:

* Growth hormone (GH) deficiency based on a GH stimulation test

Primary outcomes:
measure: Final height in cm
Secondary outcomes:
measure: Ratio between change in bone age and change in chronological age
measure: Age at onset of puberty
measure: Adverse events
Other outcomes:
Locations:
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00562536: Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks
Official title: Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Keywords: Umbilical cord clamping
Preterm infants
Randomized controlled trial
For women giving birth to singleton infants 32 weeks gestational age or less
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2007-11-22
Enrollment: 296
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.

Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.


Eligibility criteria: Inclusion Criteria:

* Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.
* Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).

Exclusion Criteria:

* Moderate to life threatening fetal anomalies
* Multiple live gestations at birth (e.g. twins, triplets, etc)
* Intrauterine fetal demise
* Previous participation
* Stem cell collection

Primary outcomes:
measure: Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
timeFrame: 3 years
Secondary outcomes:
measure: Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Kellie E Murphy, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chu KS, Shah PS, Whittle WL, Windrim R, Murphy KE. The "DUC" trial: a pilot randomized controlled trial of immediate versus delayed cord clamping in preterm infants born between 24 and 32 weeks gestation. J Matern Fetal Neonatal Med. 2021 Dec;34(24):4049-4052. doi: 10.1080/14767058.2019.1702959. Epub 2019 Dec 25.
Clinical trial NCT02450136: Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Solid Tumors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.

This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.

To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.


Eligibility criteria: Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
6. Adequate Organ Function Laboratory Values

   * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
   * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
   * creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
8. Adequate heart function.

Exclusion Criteria:

1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. Any previous treatment with Pazopanib.

Primary outcomes:
measure: progression-free survival
timeFrame: expected average of 24 weeks
Secondary outcomes:
measure: objective response rate
timeFrame: expected average of 24 weeks
measure: Time to progression
timeFrame: expected average of 24 weeks
measure: overall survival
timeFrame: expected average of 24 weeks
measure: Number of subjects with Adverse Events as a measure of toxicity profile
timeFrame: expected average of 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02857036: Rhythm and Depression
Official title: Characterization of Rhythmic Markers Associated With the Response to Antidepressants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: rhythm
depression
antidepressant treatment
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: University Hospital, Strasbourg, France
First posted: 2016-08-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study aims to characterize the rhythmic parameters of unipolar depressed patients that are associated with the response to antidepressants after 6 weeks of treatment.

Detailed description: Patients are included at the time of their hospitalization in the psychiatry unit. They perform rhythmic parameters recording within 48hours after the initiation of the antidepressant treatment. An evaluation of the evaluation of the severity of depression symptoms is performed at 2, 4 and 6 weeks after the initiation of the antidepressant treatment.

A correlation analysis will be performed with rhythmic parameters and the response to the antidepressant treatment.

Eligibility criteria: Inclusion Criteria:

* current unipolar major depressive disorder according to the Diagnostic ans Statistics Manual (DSM)V
* MADRS score \> 25

Exclusion Criteria:

* other psychiatric disorder
* current treatment with thymoregulating agent
* clozapine treatment
* heart disease that could alter heart rate characteristics
* disease associated with fever
* shift work within 3 months before inclusion
* transmeridian travel in the preceding month
* guardianship

Primary outcomes:
measure: significant difference of temperature amplitude between responder and non-responder
timeFrame: 6 weeks
measure: significant difference of activity duration between responder and non-responder
timeFrame: 6 weeks
measure: significant difference of RR interval of the heart rate between responder and non-responder
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Doubs
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Emmanuel Haffen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: