louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02949817: The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury
Official title: The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury: Single Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Children With Brain Injury
Keywords: upper limb function
multi-IMU (inertial measurement unit) sensors
Melbourne Assessment of Unilateral Upper Limb Function (MUUL-2)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was designed to establish the clinical evidence for effect of video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea, on upper limb function of children with cerebral palsy. First, the investigators would compare the effect of video-game based rehabilitation therapy to conventional occupational therapy.

Detailed description: * Purpose: to elucidate the effect of video-game based rehabilitation therapy system on upper limb function of children with cerebral palsy compared to conventional occupational therapy
* Subjects: total 30 children with cerebral palsy whose upper limb functions are impaired (all 30 children will receive the conventional occupational therapy, but 15 of these children will receive the additional video-game based rehabilitation therapy)
* Intervention: 4 weeks of therapy (6 days per week)
* Studies: functional MRI, computerized motion analysis, upper limb functional assessment (MUUL, ULPRS), ADL evaluation, cognitive evaluation
* Evaluation plan: 1) pre-intervention, 2) post-4 weeks of intervention, 3) 8 weeks after end of intervention

Eligibility criteria: Inclusion Criteria:

* MACS (Manual ability classification system) level I, II, III, IV
* Patients without cognitive impairment who are able to comply with protocol-required procedure
* male or female, 4 to 18 years

Exclusion Criteria:

* Patients with cognitive impairment who are unable to comply with protocol-required procedure
* Patients with significant visual impairment
* Patients with presence or history of musculoskeletal anomaly who are unable to apply device

Primary outcomes:
measure: Total score of Melbourne Assessment of Unilateral Upper Limb Function
timeFrame: 8 weeks
Secondary outcomes:
measure: Total score of upper limb physician's rating scale (ULPRS)
timeFrame: 8 week
measure: Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)
timeFrame: 8 week
measure: Kinematic data of computerized 3D motion analysis
timeFrame: 8 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01101217: Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure
Keywords: hemocystein zinc renal failure
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.

Detailed description: hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.

Eligibility criteria: Inclusion Criteria:

* hemodialysis for 3 months
* older than 18 years old
* serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female

Exclusion Criteria:

* acute renal failre
* malabsorption
* history of steroid or cytotoxic consumption

Primary outcomes:
measure: decreased hemocystein level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz,
country: Iran, Islamic Republic of
facility: Shiraz University Hemodialysis Center
state: Fars
Study officials:
References:
Clinical trial NCT04691817: Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
Official title: A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lung Cancer, Nonsmall Cell
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2020-12-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
* Prior exposure to at least 1 line of therapy
* Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
* ECOG PS 0-2

Exclusion Criteria:

* Presence of a driver mutation that is susceptible to targeted therapy
* No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
* Other active invasive malignancy requiring ongoing therapy
* Evidence of progressing or untreated brain metastases
* Evidence or history of leptomeningeal disease
* Uncontrolled tumor related pain
* History of an autoimmune disease or IPF

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: From first dose of protocol treatment until radiologic disease assessment at 12 weeks.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure.
measure: Dose Limiting Toxicities of the combination
timeFrame: From first dose of protocol treatment until 49 days post treatment
measure: Progression free survival (PFS).
timeFrame: From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months.
Other outcomes:
measure: Clinical outcomes
timeFrame: From enrollment until dealth due to any cause or last patient contact alive until 3 months after study closure
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Melina Marmarelis, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00706017: Observational Study to Evaluate the Safety of Levemir® in Diabetes
Official title: Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 2282
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from both general and speciality practice settings deemed appropraite to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing physician

Brief summary: This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetes
* Including newly diagnosed not on insulin or insulin analogue treatment
* Selection at the discretion of the physician
* Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion Criteria:

* Current treatment with Levemir®
* Previously enrolled in the study
* Hypersensitivity to Levemir®

Primary outcomes:
measure: Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)
timeFrame: during treatment
Secondary outcomes:
measure: Glucose control measures
timeFrame: during treatment
measure: Weight
timeFrame: during treatment
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03681717: Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laceration
Keywords: Virtual Reality
Pain
Anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Doctors of BC
First posted: 2018-09-24
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lacerations are a common reason for presentation to the Emergency Department and children needing laceration repair with sutures are experiencing pain and anxiety.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to pharmacoanalgesia during a laceration repair procedure. Investigators will measure pain, anxiety, satisfaction, amount of analgesia and the length of procedure and compare between the two groups.


Eligibility criteria: Inclusion Criteria:

* Children age 6 - \<17 years
* Arriving to the Emergency Department with a chief complaint of laceration
* The managing physician determines need for repair with suture
* Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

* Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
* Triage category 1 (resuscitation)
* Facial features or injury prohibiting wearing VR goggles

Primary outcomes:
measure: Pain using the Faces Pain Scale - Revised.
timeFrame: Pain is reported by children immediately following completion of the laceration repair
Secondary outcomes:
measure: Anxiety using the Venham Situational Anxiety Score
timeFrame: Anxiety is reported by children immediately following completion of the laceration repair
measure: Patient Satisfaction determined qualitatively by an open ended question
timeFrame: Satisfaction question is reported by children immediately following completion of the laceration repair
measure: Parent Satisfaction determined qualitatively by an open ended question
timeFrame: Satisfaction question is reported by parents immediately following completion of the laceration repair
measure: Medication Dose
timeFrame: These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes
measure: Timing
timeFrame: Documented immediately after patient and family given discharge paperwork
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ran D. Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527617: Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress
Official title: The Effect of Chronic Consumption of a Cranberry Beverage on Inflammation and Oxidative Stress in Healthy But Overweight/Obese Subjects: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Washington State University
name: Ocean Spray, Inc.
First posted: 2012-02-07
Enrollment: 79
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.


Eligibility criteria: Inclusion Criteria:

* Men \& women, aged 30-70 years
* BMI 27-34.9 kg/m2
* waist:hip ratio \> 0.8 for women and \> 0.9 for men

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use within last 6 months
* Individuals taking estrogen or testosterone
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use (\> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements)
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Immune deficiency conditions
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 139 mmHg and/or diastolic blood pressure \> 89 mmHg
* Regular use of systemic steroids, oral or injectable
* Regular daily intake of ≥ 2 alcoholic drinks
* Infrequent (\< 3/week) or excessive (\> 3/d) number of regular bowel movements
* Gain or loss of ≥ 5% of body weight in the last 6 months
* Pregnancy
* Strict vegetarians
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission

Primary outcomes:
measure: Change in biomarkers of inflammation compared with placebo
timeFrame: Baseline and 8 weeks
measure: Change in biomarkers of oxidative stress compared with placebo.
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
city: Pullman
country: United States
facility: Washington State University
state: Washington
Study officials:
References:
Clinical trial NCT01827917: The Protection Effect of Speeda® Rabies Vaccine for Human Use
Official title: Phase 4 Study of Speeda® Rabies Vaccinia That Use for Protection the Crowd Bitten by Animals to Three-level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rabies Vaccine Allergy
Lead sponsor: Beijing Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2013-04-10
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study was to achieve the post-marketing protective effect research of Speeda® rabies vaccine for human use from Chengda Bio.

Detailed description: When found the injury who is bitten by the animal to three-level, the investigators would enroll the participant after explaining the protection and making him signed the informed consent. The patient would inject rabies vaccine as follow the national regulation, meanwhile the investigators would get the blood samples to detect whether the man-killer carries the rabies virus.

Eligibility criteria: Inclusion Criteria:

* Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
* Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured
* The man-killer could found and detect whether it carries the virus

Exclusion Criteria:

* Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Apply passive immunity preparation

Primary outcomes:
measure: Observation of the subject after injured by the animals carrying the virus
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Centers for Disease Control and Prevention
state: Hunan
Study officials:
affiliation: Beijing Chaoyang District Centers for Disease Control and Prevention
name: Nianmin Shi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, Lu Q, Zhang Z, Luo F, Yu C, Li L. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25.
Clinical trial NCT06900517: The Efficacy of Salvia Officinalis Gel in the Treatment of Periodontitis CLINICAL TRIAL
Official title: The Efficacy of Salvia Officinalis Gel in the Treatment of Periodontitis by Monitoring Gingival Crevicular Fluid Volume and Interleukin 17 Concentration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontal Pocket
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 23
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).
Primary purpose: TREATMENT

Brief summary: From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone).

Detailed description: Background: Phytotherapy relies on the use of extracts derived from plants in pharmaceutical form. Herbal products have been effective in reducing periodontal diseases, as stated by many studies. Gingival crevicular fluid volume and concentrations of certain cytokines are precise and objective parameters in evaluating periodontitis treatment.

Aim of the study: Assessment of local application of Salvia officinalis (S. officinalis) gel as an adjunctive to scaling and root surface debridement (RSD) in the management of periodontitis.

Methods: A randomized clinical trial of split-mouth design for twenty-three subjects with periodontitis was assessed in this study. From each participant, two sites of periodontal pockets ( ≥ 5 mm ) were selected and randomly allocated to either the test site (treated with scaling and RSD with S. officinalis gel) or the control site (treated with scaling and RSD alone). A highly sensitive enzyme-linked immunosorbent assay (ELISA) was used to determine the concentration of interleukin 17 (IL-17) in gingival crevicular fluid (GCF).

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with periodontitis had at least 20 natural teeth, with probing pocket depth (PPD) ≥ 5 mm and attachment loss ≥ 4 mm

Exclusion Criteria:

* Exclusion criteria were pregnancy, lactation, smoking, and any systemic disease that might affect periodontal disease progression or require antibiotic usage. Likewise, patients who had received anti-inflammatory medications or antibiotics in the preceding three months were excluded.

Primary outcomes:
measure: GCF volume
timeFrame: 1 month
Secondary outcomes:
measure: IL-17
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References: