louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04660942: Child Development and Genetic Biomarkers
Official title: Child Development and Genetic Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 446
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy children, children with developmental delay and adults whose children had gene abnormality were recruited.

Brief summary: A study of the relation between genetic biomarkers and child development in Taiwan.

Detailed description: The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child development.

Eligibility criteria: Inclusion Criteria of Healthy Child:

* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Healthy Child:

* Central nervous system disease
* Neuromuscular Disorders
* Congenital Abnormality
* Genetic Disease
* Dysesthesia
* Hearing Impairment

Inclusion Criteria of Child with developmental delay:

* Patients with Language Disorder
* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Child with developmental delay:

* Hearing Impairment

Inclusion Criteria of Adult:

* His or her child participated in this study, and gene abnormality was found.

Primary outcomes:
measure: Scores of cognitive function 1
timeFrame: baseline
measure: Scores of cognitive function (2 y/o to 6 y/o)
timeFrame: baseline
measure: Scores of cognitive function (6 y/o to 16 y/o)
timeFrame: baseline
measure: Scores of cognitive function 3
timeFrame: baseline
measure: Scores of cognitive psychological function
timeFrame: baseline
measure: Scores of language function
timeFrame: baseline
measure: Scores of language function 2
timeFrame: baseline
measure: Scores of general development
timeFrame: baseline
measure: Scores of social behavior 1
timeFrame: baseline
measure: Scores of social behavior 2
timeFrame: baseline
measure: Scores of motor ability 1
timeFrame: baseline
measure: Scores of motor ability 2
timeFrame: baseline
measure: Gene test (Mircoarray)
timeFrame: baseline
measure: Gene test (WES1)
timeFrame: baseline
measure: Gene test (WES2)
timeFrame: baseline
measure: Gene test (WES3)
timeFrame: baseline
measure: Gene test (WES4)
timeFrame: baseline
Secondary outcomes:
measure: Scores of participation(2-5 y/o)
timeFrame: baseline
measure: Scores of participation(>6 y/o)
timeFrame: baseline
measure: Scores of activities
timeFrame: baseline
measure: Scores of quality of life
timeFrame: baseline
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04000542: Pharmacist Use of ECG to Inform Drug Therapy Decisions for Patients Receiving QT Prolonging Medications
Official title: Community Pharmacist Use of Mobile ECG to Inform Drug Therapy Decision Making for Patients Receiving QT Prolonging Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Torsades de Pointe Caused by Drug (Disorder)
Torsades de Pointes
Qt Interval, Variation in
Lead sponsor: Northeast Iowa Medical Education Foundation
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Torsade de pointes (TdP) is a cardiac arrhythmia associated with QT interval prolongation which may lead to cardiac arrest. Prescription medications which cause QT interval prolongation are commonly used in daily practice. To lessen risk of TdP, pharmacists work to minimize combinations of QT interval prolonging drugs. If community pharmacists had real-time information about a patient's QT interval duration, this would have the direct ability to inform their decision making about which patients may be at highest risk of TdP and who may need heightened avoidance of QT prolonging drugs. This project will provide 3 community pharmacies with mobile ECG devices to easily determine QT intervals among patients who have a prescription profile alert for QT interval prolongation. Study outcomes will include: frequency of QT interval prolongation, changes in drug therapy related to QT interval determination, and patient and pharmacist satisfaction with having pharmacist assessment of QT interval.


Eligibility criteria: Inclusion Criteria:

1. Male or female at least 18 years of age.
2. Subject is receiving a prescription medication for which there is a "QT/QTc interval prolongation" alert observed on the dispensing pharmacy prescription software.
3. English speaking

Exclusion Criteria:

1. Patients with implantable pacemakers or automatic implantable cardioverter defibrillators
2. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
3. Patient has known atrial or ventricular arrhythmia

Primary outcomes:
measure: Frequency of medication order changes due to QTc interval prolongation
timeFrame: through study completion (anticipated to last 8 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: United States
facility: Northeast Iowa Family Practice
state: Iowa
Study officials:
References:
Clinical trial NCT01470742: Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
Official title: A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 70
2. Histologically or cytologically confirmed adenocarcinoma of the gastric
3. Advanced ,metastatic/recurrence gastric cancer
4. ECOG performance status of 0 to 2
5. Life expectancy≥3months
6. No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is \> 6months from the study entry date)
7. No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
8. Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
9. Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
10. Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT \< normal x 3)
11. provision of a signed written informed consent

Exclusion Criteria:

1. History of any medical or psychiatric condition
2. Active infections
3. Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 \>=Grade 1 )
4. symptomatic brain metastases
5. Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
6. History of other malignancy except:

   Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ
7. Known hypersensitivity to Fluoropyrimidines/platinum
8. Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
9. Required immunosuppressive therapy(transplant patients, severe autoimmune disease)

Primary outcomes:
measure: Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA)
timeFrame: 36months
Secondary outcomes:
measure: response rate
timeFrame: 36months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical Center
Study officials:
References:
Clinical trial NCT04802642: Evaluation of COVID-19 Fear, Anxiety and Their Effects in Physiotherapy Technician Students
Official title: Evaluation of COVID-19 Fear, Anxiety and Their Effects in Physiotherapy Technician Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Anxiety and Fear
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 volunteers between the ages of 18-65, who are physiotherapy technician students, were included in the study.

Brief summary: 80 participants studying in the physiotherapy technician department were included in this cross-sectional study. Participants' age, gender, year of being a student, the people they live with, the precautions they take regarding COVID-19, whether there is a history of COVID-19 in them or their immediate surroundings, and whether they have COVID-19 transmission and / or contagion fears during their vocational training, whether there are fears of achieving professional goals and competence because of COVID-19 and / or its consequences were recorded. Afterwards, the participants were asked to answer the questions on the coronavirus anxiety scale, the fear of COVID-19 scale and the cognitive and behavioral avoidance subscales of the Avoidance Attitudes from COVID-19 scale.


Eligibility criteria: Inclusion Criteria:

1. Being between the ages of 18-65
2. Being a physiotherapy technician student

Exclusion Criteria:

1. Being under the age of 18, over the age of 65

Primary outcomes:
measure: Coronavirus anxiety scale
timeFrame: 2 months
measure: The Fear of COVID-19 Scale
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
state: Çankaya
Study officials:
affiliation: Ufuk University
name: elzem Bolkan Günaydın
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04937270: Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
Official title: Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Dysmucorrhea
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Superficial heat therapy is mainly used to relieve menstrual pain, but it does not penetrate deeper than the skin tissue. In order to penetrate deep into the deep layers and promote tissue relaxation, deep heat therapy can be effective. The treatment time for deep heat treatment is controversial, and there is no study on deep heat treatment using radio frequency for dysmenorrhea. Therefore, in this study, by applying radiofrequency waves at different times to the lower abdomen for patients with primary dysmenorrhea, the pain and changes in the autonomic nervous system were compared with thermotherapy to suggest appropriate therapeutic interventions.


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18-50
* Regular menstrual cycle (24-32 days)
* Those who have had symptoms of primary dysmenorrhea for at least 1 year
* Those who have lower back pain symptoms related to menstrual pain of 5 or higher on the Visual Analysis Scale (VAS)
* The body mass index is between 20-30

Exclusion Criteria:

* pelvic inflammatory disease
* uterine fibroids, polycystic ovary syndrome. Those with gynecological findings such as endometriosis
* Those who have used an intrauterine contraceptive device
* Those who took birth control pills or nonsteroidal anti-inflammatory drugs at the time of the experiment

Primary outcomes:
measure: Heart Rate Variability
timeFrame: immediate change after intervention in baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The wells neuropain clinic
Study officials:
References:
Clinical trial NCT05522270: Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
Official title: Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotic Pulp
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

Brief summary: Regenerative endodontic procedures (REPs) are the most recent proposal to manage immature permanent teeth with necrotic pulps. So in this study, the investigator will evaluate the clinical and radiographical revitalization success in necrotic young permanent anterior teeth of participants by using Concentrated Growth Factor versus Platelet-Rich Fibrin

Detailed description: has been entered

Eligibility criteria: Inclusion Criteria:

* Healthy patients with immature permanent incisors
* Presence of clinical signs and symptoms of necrosis or chronic apical periodontitis. The chronic apical periodontitis signs and symptoms include little discomfort with intermittent episodes of pus discharge through the sinus tract.

Exclusion Criteria

1. Abnormal tooth mobility.

* Positive history of allergic reaction, systemic diseases, severe emotional or behavioral problems.
* Unrestorable teeth
* Abnormal tooth mobility
* Children with systemic, severe behavioral, or emotional problems

Primary outcomes:
measure: Clinical success rate
timeFrame: one year
measure: Radiographic success using Periapical index (PAI)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04037670: Efficacy of SASI Bypass in Super Obese Patients
Official title: Assessment of the Efficacy of SASI Bypass in Super Obese Patients With BMI> 50 Kg/m2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 20
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: TREATMENT

Brief summary: Although previous studies investigated weight loss and improvement in comorbidities after SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the aim of the present study was to investigate the outcome of SASI bypass in patients with super obesity to assess the success of this novel bariatric procedure in this challenging group of patients in regards weight loss and improvement in associated comorbid conditions at 12 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Patients included to the present study were adult patients of both genders aging between 18 and 65 years with primary morbid obesity with BMI ≥50 kg/m2 with or without obesity-associated comorbidities such as hypertension, diabetes mellitus (DM), dyslipidemias, and gastroesophageal reflux disease (GERD).

Exclusion Criteria:

* Pregnant women.
* Patients unfit for general anasthesia (ASA 4, 5)
* Endocrine or psychiatric disorders.
* History of previous upper abdmominal laparotomy.
* Alcoholic addiction
* Liver cirrhosis
* Coagulopathy

Primary outcomes:
measure: percentage of excess weight loss
timeFrame: at 12 months of follow-up
Secondary outcomes:
measure: Resolution of diabetes mellitus
timeFrame: at 12 months of follow-up
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05670470: A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial
Official title: A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation
Keywords: Bowel Preparation
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-04
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study compared with active control arm.

Detailed description: This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Male and female outpatients and inpatients aged: ≥19
* A prospective colonoscopy person
* Written informed consent to participate in the trial

Exclusion Criteria:

* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Patients with ongoing severe acute Inflammatory Bowel Disease
* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
* Pregnant women or pregnant women or pregnant women
* Patients who have not been confirmed to have COVID-19 for a month
* Severe heart disease (cardiac failure (NYHA class 3 and 4))
* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases
* Patients with severe chronic renal impairment (glomerular filtration rate less than 30ml/min/1.73m2)
* People who have hypersensitivity or allergies to clinical trial drug components

Primary outcomes:
measure: Number of Patients With Successful Bowel Cleansing (Overall Colon)
timeFrame: 1 day of scheduled colonoscopy
Secondary outcomes:
measure: Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
timeFrame: 1 day of scheduled colonoscopy
measure: Adenoma/Polyp Detection Rate (Overall Colon)
timeFrame: 1 day of scheduled colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Gangdong
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Jae Myung Cha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00265070: Trial of Iressa in Prostate Cancer Patients
Official title: An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-14
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.


Eligibility criteria: Inclusion Criteria:

* Removal of prostate for prostate cancer
* Raised level of prostate specific antigen (PSA) post-surgery
* Can have received some radiation therapy

Exclusion Criteria:

* Any after surgery male hormone blocking therapy.
* Low white blood cell count
* Abnormal liver function test

Primary outcomes:
measure: The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate
Secondary outcomes:
measure: To estimate the duration of PSA response
measure: To estimate the partial PSA response rate
measure: To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
measure: To investigate the change in PSA levels after discontinuation of ZD1839
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Canada Oncology Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01475370: Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
WT1
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.


Eligibility criteria: Inclusion Criteria:

* Patients who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.
* Patients who are capable of giving informed consent

Exclusion Criteria:

* Patients failed to discontinue the Study 311-10-001 even though patients met the discontinuation criteria.
* Patients who have participated in any other clinical trials , excluding the Study 311-10-001).

Primary outcomes:
measure: Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
timeFrame: Treatment period (from the first IMP administration until the time of discontinuation)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center
Study officials:
References: