louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00325572: Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
Official title: Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Autism
Pervasive Developmental Disorder
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2006-05-15
Enrollment: 89
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same sex and age children who are developing typically. The hypothesis is that there is a significant difference in the copper/zinc ratio between young children who have autism and their typically developing peers.

The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be statistically higher than typically developing children. Measurements of serum copper, zinc and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those children whose ratios have not fallen below 1.25, the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed evaluation of language skills, and a variety of behaviors will be evaluated prior to and after supplementation. The study will be placebo-controlled and double blind. Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study.

The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism.


Eligibility criteria: Inclusion Criteria:

* Ages 3-8 years
* Diagnosis of autism spectrum disorder
* Serum copper/zinc ratio greater than 2.0 or as determined in phase 1 of the study

Exclusion Criteria:

* Known chromosomal disorder or neurological disorders other than autism

Primary outcomes:
measure: Copper/Zinc Ratio of Children With Autism Compared to Typically Developing Children Phase 2: Change in Copper/Zinc Ratio With Supplementation of Zinc and Vitamin C
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Children's Hospital
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Jeanette C Ramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04079972: Personalized Lifestyle Intervention and Weight Control
Official title: Personalized Lifestyle Intervention Based on SNP Testing and Weight Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: DongGuk University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2019-09-06
Enrollment: 150
Sex: ALL
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: This trial aims to investigate whether tailored lifestyle consultation through SNP testing leads to more effective weight loss among overweight or obese individuals compared to general lifestyle guidance for weight control.


Eligibility criteria: Inclusion Criteria:

* overweight or obese individuals

Exclusion Criteria:

* a past history of bariatric surgery or eating disorders
* currently pregnant or planning a pregnancy within 2 years

Primary outcomes:
measure: weight change (kg)
timeFrame: at six months, 1 year, and 2 years after randomization
Secondary outcomes:
measure: waist circumference (cm)
timeFrame: at six months, 1 year, and 2 years after randomization
Other outcomes:
measure: body composition (% muscle)
timeFrame: at six months, 1 year, and 2 years after randomization
measure: body composition (% fat)
timeFrame: at six months, 1 year, and 2 years after randomization
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University
state: Kyungki Do
Study officials:
affiliation: DongGuk University
name: NaNa Keum, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03244072: Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
Official title: Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Endophthalmitis
Lead sponsor: Zion Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2017-08-09
Enrollment: 60000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

Detailed description: Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

Eligibility criteria: Inclusion Criteria:

* visually significant cataracts

Exclusion Criteria:

* allergy to fluoroquinolones, cobalamin (B12)

Primary outcomes:
measure: Endophthalmitis after cataract surgery
timeFrame: Subjects will undergo eye examinations at one day, one week, and one month post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Saint George
country: United States
facility: Zion Eye Institute
state: Utah
Study officials:
affiliation: Zion Therapeutics, LLC
name: Jason Ahee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005872: Nitrocamptothecin in Treating Patients With Recurrent Non-small Cell Lung Cancer
Official title: Phase II Study of RFS 2000 in Relapsed NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent non-small cell lung cancer.

Detailed description: OBJECTIVES: I. Determine the response rate, time to progression and overall survival of patients with recurrent non-small cell lung cancer when treated with nitrocamptothecin. II. Assess the toxicities and pharmacokinetics of this regimen in these patients.

OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent non-small cell lung cancer No more than one prior chemotherapy treatment Bidimensionally measurable disease No prior radiotherapy to target lesion OR Progression since prior radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled serious medical or psychiatric illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior camptothecin Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior major surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: SuperGen, Incorporated
state: California
Study officials:
affiliation: Astex Pharmaceuticals, Inc.
name: Show-Li Sun, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01095068: Effects of Physical Exercise in Type 2 Diabetics
Official title: Beneficial Effects of Exercise Training on Physical Capacity in Type 2 Diabetics: Improvement in Skeletal Muscle Energetic Capacity, Endothelial Dysfunction and Glycemic Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.The protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.


Eligibility criteria: Inclusion Criteria:

* sedentary adult with type 2 diabetes
* BMI between 25 and 35 kg/m²
* Hba1c \< 10 %

Exclusion Criteria:

* unstable coronary artery disease
* advanced peripheral occlusive arterial disease
* proteinuria \> 3 g/d and / or creatinine clearance \< 30 ml / mn
* advanced diabetic neuropathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Alain PRADIGNAC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06617468: Effect of the Computer Aided Diagnosis with Explainable Artificial Intelligence for Colon Polyp on Optical Diagnosis and Acceptance of Technology
Official title: Effect of the Computer Aided Diagnosis with Explainable Artificial Intelligence for Colon Polyp on Optical Diagnosis and Acceptance of Technology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colon Polyp
Keywords: colon polyp
optical diagnosis
computer-aided diagnosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to learn if computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable AI work to optical diagnosis performance and acceptance of technology in endoscopists. The main questions it aims to answer are:

Do computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable AI improve optical diagnosis performance in endoscopists?

Does experience using deep learning-based computer-assisted diagnosis and explainable AI-based computer-assisted diagnosis improve endoscopists' acceptance of computer-aided diagnosis as a technology?

Participants will:

Conduct a survey on acceptance and use of technology about computer-aided diagnosis.

Perform a test to estimate the pathologic diagnosis on 200 NBI still images without the aid of computer-aided diagnosis.

More than 1 month later, perform a same test to estimate the pathologic diagnosis on 200 NBI still images with computer-aided diagnosis with deep learning or explainable AI.

Conduct a survey on acceptance and use of technology about computer-aided diagnosis.


Eligibility criteria: Inclusion Criteria:

* Endoscopists with colonoscopy experience

Exclusion Criteria:

* Who can not perform colonoscopy

Primary outcomes:
measure: Accuracy of optical diagnosis
timeFrame: From baseline test to the follow up test (more than 1 month later from baseline test)
Secondary outcomes:
measure: acceptance of computer-aided diagnosis as a technology
timeFrame: From baseline test to the follow up test (more than 1 month later from baseline test)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Healthcare System Gangnam Center, Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05026268: The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
Official title: The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: right colon cancer
laparoscopic right colectomy
intracorporeal anastomosis
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2021-08-30
Enrollment: 2
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: This is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation.

Detailed description: The design involves random allocation of eligible patients to laparosopic colectomy with intracorporeal or extracorporeal anastomosis.

Postoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will be registred according to the visual analogue pain scale (VAS). Also the investigators will study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients age is 18 years and older
* Patients with right colon cancer
* Informed agreement

Exclusion Criteria:

* Carcinomatosis
* Primary tumor stage T4b
* Refusal of anastomosis
* Refusal of the patient to participate in the study

Primary outcomes:
measure: Post-operative complications rate
timeFrame: 0 to 30 days
Secondary outcomes:
measure: The level of postoperative pain
timeFrame: 0 to 10 days
measure: The time of activation of patients
timeFrame: 0 to 10 days
measure: The amount of self-help of patients
timeFrame: 0 to 10 days
measure: The time to discharge from hospital
timeFrame: 0 to 30 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology, Russian Federation
Study officials:
References:
Clinical trial NCT00307268: Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD
Official title: Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adolescents With ADHD: An Observational, Long-Term Follow-up Study of Routine Clinical Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords: ADHD Effectiveness
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Janssen-Ortho LLC
name: Purdue University
name: Shire
First posted: 2006-03-27
Enrollment: 195
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment.

Brief summary: To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials

Detailed description: This is a prospective, long-term, observational study of routine clinical care. The study measurements will be integrated into the clinical assessment and follow-up procedures of the outpatient services under the Provincial ADHD Program. The study is designed for systematic follow-up of children and adolescents, diagnosed with ADHD irrespective of comorbidity or whether they elect to receive medication treatment. Evaluations occur every 6 months for 24 months. The population to be examined is children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment. No studies have been conducted that have evaluated the outcome of core ADHD symptoms in a clinic setting. Metaanalysis of clinical trials of medication treatment for ADHD have suggested an effect size of approximately 0.8. Because of the heterogeneity of the clinic sample, a much lower effect size can be anticipated. Two hundred patients will be enrolled in this study with primary measure of effectiveness being change in ADHD symptoms.

Eligibility criteria: Inclusion Criteria:

Meet DSM-IV criteria for ADHD

Exclusion Criteria:

None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of BC
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Margaret Weiss, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Craig SG, Weiss MD, Hudec KL, Gibbins C. The Functional Impact of Sleep Disorders in Children With ADHD. J Atten Disord. 2020 Feb;24(4):499-508. doi: 10.1177/1087054716685840. Epub 2017 Jan 16.
Clinical trial NCT00263068: An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
Official title: An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: IDIOPATHIC RESTLESS LEGS SYNDROME
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-12-07
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.

All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.

A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication


Eligibility criteria: Inclusion Criteria:

* Idiopathic restless legs syndrome

Exclusion Criteria:

* Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
* Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent.
* Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.

Primary outcomes:
measure: Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating
timeFrame: 1 year
Secondary outcomes:
measure: To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period.
timeFrame: 1 year
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05630768: Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
Official title: A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 155
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year


Eligibility criteria: Main Inclusion Criteria:

1. Postmenopausal women
2. Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year

Main Exclusion Criteria:

1. Any contraindication to risedronate
2. Those evaluated as inappropriate at the discretion of the investigator

Primary outcomes:
measure: Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
References: