louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01443702: Use of Lapis Judaicus to Dissolve Kidney Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Kidney Calculi
Keywords: Kidney Calculi
Iranian traditional medicine
Lapis judaicus
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 60
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 investigators will investigate the safety and effectiveness of an Iranian traditional medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in random order. End points are changes in urinary chemistries and stone burden by Ultra sonography / CT scan.

It will be used in proven calcium stone forming adults who are not pregnant. This phase is a double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine supersaturations, pH and sodium determinations will be collected. Entry and final stone quantification Ultra sonography / CT scan will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* Mentally competent
* Medically effective birth control if fertile female
* History of calcium containing stone AND current quantifiable stone
* Able to comply with protocol

Exclusion Criteria:

* Prisoner
* Pregnant
* CKD

Primary outcomes:
measure: Stone size after 12 weeks
timeFrame: 8 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Motahhari Medical Center
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Jamshid Roozbeh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05412602: Chiropractic T Cell Study
Official title: Impact of a Corrective Model of Chiropractic Care on Immune Cell Phenotype and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Waitlist Control
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-arm randomized control trial
Primary purpose: BASIC_SCIENCE

Brief summary: Some studies suggest that specific chiropractic care (techniques known as "spinal manipulation therapy") can have benefits to the immune system but studies are scarce, sample sizes small, and methodology and analyses often not of the highest scientific standards. The investigators will example how 36 sessions of chiropractic care over 9-12 weeks can impact immune cell function using a randomized clinical trial design.


Eligibility criteria: Inclusion Criteria:

* Must be between the ages of 18-70.
* Must exhibit vertebral subluxation as measured by a misalignment between one or more vertebrae in relation to normal spinal alignment.
* Have not been sick for the past 3 weeks (immune function).
* Non-smoker.
* Must be able to fast for 10-12 hours.

Exclusion Criteria:

* To have had a chiropractic intervention within the past 6 months.
* To have a condition that may limit the ability to apply a high velocity, low amplitude (HVLA) thrust to the spine such as but not limited to ligament damage, reduced bone density, or other factors that weaken the body's ability to withstand reasonable care (bone cancer, fractures, osteoporosis, etc.)
* To have excessive scoliotic curvature of the spine (\> 30º) as measured by identifying the first vertebrae, and the most laterally displaced vertebrae that exhibits tilt below it.

Primary outcomes:
measure: Change in CD25+ Regulatory T Cell
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in CD4+ and CD8+ T cell
timeFrame: 12 weeks
Other outcomes:
measure: Changes in TNF alpha secretion
timeFrame: 12 weeks
measure: Changes in IFN gamma secretion
timeFrame: 12 weeks
measure: Change in body mass
timeFrame: 12 weeks
measure: Change in Blood Pressure
timeFrame: 12 weeks
measure: Change in vertebral subluxation
timeFrame: 12 weeks
measure: Quality of Life Assessment
timeFrame: 12 weeks
measure: Quality of Life Assessment
timeFrame: 12 weeks
measure: Quality of Life Assessment
timeFrame: 12 weeks
measure: Change in Posture
timeFrame: 12 weeks
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
References:
Clinical trial NCT00516802: A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine
Official title: A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 and Dacarbazine in the Treatment of Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma Neoplasms
Keywords: Poly(ADP ribose) polymerases
dacarbazine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: KuDOS Pharmaceuticals Limited
First posted: 2007-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who have not previously received systemic cytotoxic chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients must have:

  1. Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases.
  2. Histological or cytological confirmation of melanoma. Histological confirmation of melanoma from the primary site will suffice, unless the primary site is unknown.

Exclusion Criteria:

* Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from treatment for melanoma with isolated limb perfusion.
* Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
* Major surgery within 4 weeks of starting the study.

Primary outcomes:
measure: To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine.
timeFrame: assessed every 3 weeks
Secondary outcomes:
measure: Objective tumour response
timeFrame: assessed every 6 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: KuDOS Pharmaceuticals Ltd
name: Prof James Carmichael, BSc MBChB MD FRCP
role: STUDY_DIRECTOR
affiliation: Royal Marsden Hospital Trust, London, UK
name: Prof Martin Gore, PhD MRCP FRCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05841602: Quality of Nursing Care During The Covid-19 Pandemic
Official title: Quality of Nursing Care During The Covid-19 Pandemic From The Perspective Of Hospitalized Children: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Children, Only
Hospitalism
Nurse's Role
Feelings
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 128
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This cross-sectional descriptive study was conducted in a hospital in the Black Sea Region of XXX between February and June 2021

Brief summary: Enabling school-age children to evaluate the care they receive provides feedback on the quality of care by determining children's satisfaction with care, and gives important feedback on the quantity and quality of care. Evaluation of nursing care, emotions and behaviors from the perspective of children during the Covid-19 pandemic process will guide the improvement of the quality of care. As a result of the literature review on this subject, no research has been found, and it is thought that this research will contribute to the field. This research was conducted to evaluate nursing care and emotions from the perspective of hospitalized children during the Covid-19 pandemic process.


Eligibility criteria: Inclusion Criteria:

* The study included volunteer children who were hospitalized for at least 3 days in the - -- -pediatric clinic,
* whose native language was Turkish,
* between the ages of 8-13,
* who did not have any visual, auditory or mental problems, and whose parents gave consent for the study.

Exclusion Criteria:

* who fall outside the inclusion criteria

Primary outcomes:
measure: The Scale Evaluation Quality of Care From Children's Point of View
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
state: Eyalet/Yerleşke
Study officials:
affiliation: Tokat Gaziosmanpasa University
name: Mukaddes Demir Acar
role: STUDY_CHAIR
References:
Clinical trial NCT00232102: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Official title: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Dyspepsia, gastrointestinal, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 423
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.


Eligibility criteria: Inclusion Criteria:

* Female, 18 years and older
* Fulfilled eligibility criteria in CHTF919 D2302 (double blind study) and successfully completed the double-blind study

Exclusion Criteria:

- Early discontinuation from the double-blind study

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Long term safety at 6 months.
Secondary outcomes:
measure: Long term safety at 1 year.
measure: Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionnaire.
measure: Efficacy on satisfactory relief at month 6 and 12.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05290402: Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients
Official title: Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast Surgery Patients

Brief summary: The goal of this research study is to learn how accessible JEEVA is for patients during the perioperative period (the time after the pre-operative surgical appointment, and up to 30 days after surgery

Detailed description: Objectives:

Demonstrate feasibility of use for a mobile device-based application to provide perioperative resources and support in a multimedia format to breast surgery patients

Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ)

Eligibility criteria: Inclusion Criteria:

Subjects eligible for this study include breast surgical patients 18 years of age and older evaluated at the Texas Medical Center campus in the Nellie B Connally breast center or in the Houston Area Locations (HALs).

This includes patients undergoing excisional biopsy, segmental mastectomy, total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, sentinel lymphadenectomy, targeted axillary lymphadenectomy, axillary lymphadenectomy, and axillary reverse mapping.

Exclusion Criteria:

Patients who do not have a smartphone), which utilizes iOS or Android operating systems,

Patients who have visual impairment or blindness, which precludes effective utilization of an app, will be excluded.

Patients whose surgical planning is discussed by telephone outside of an in-person pre-operative visit, will be excluded from the study.

Patients who have cognitive impairment will be exclude

Primary outcomes:
measure: Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Christina Checka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01997502: Accuracy of Pulse CO-Oximetry Technology in Characterizing Noninvasive SpHb
Official title: Prospective Observational Study Characterizing Noninvasive Hemoglobin (SpHb) Measured With Pulse CO-Oximetry Technology in a Variety of Surgical Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Hemoglobin
Keywords: Hemoglobin
Non-invasive
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 621
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery.

Brief summary: This protocol is a request from Masimo to assist in the collection of data to be used to further refine the accuracy of the monitor's algorithm.

Detailed description: The specific aim of this study is to collect data to characterize Masimo's noninvasive Rainbow SpHb technology during surgeries. The purpose is to compare Masimo Rainbow technology to arterial blood samples taken during surgery. Hemoglobin concentrations in the arterial blood samples will be measured using standard blood analyzers on site and/or the sponsor's laboratory.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective surgery requiring intra-arterial pressure monitoring

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Prisoners

Primary outcomes:
measure: Comparison of Masimo Rainbow technology to arterial blood samples taken during surgery
timeFrame: Five year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
Study officials:
affiliation: Professor, Director, Cardiovascular and Thoracic Anesthesiology
name: Neal Fleming, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02434302: Characteristics and Outcomes of Childhood Moyamoya in the UK
Official title: Characteristics and Outcomes of Childhood Moyamoya in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moyamoya
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 98
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (0-18y) with moyamoya in the UK over study period (2014-2016 August)

Brief summary: This is a study to ascertain the number of children with moyamoya in the UK, their presenting features, clinical course and outcomes.

Detailed description: The study ahs 3 components:

1. Patient identification via the British Paediatric Surveillance Unit, and the 21 collaborating centres
2. Record review/patient interview to determine clinical features \& outcomes
3. Centralised review of imaging data to ascertain radiological phenotypes

Eligibility criteria: Inclusion Criteria:

* Radiological diagnosis of moyamoya

Exclusion Criteria:

* Refuse consent

Primary outcomes:
measure: Number of children with moyamoya in UK
timeFrame: 2 years
Secondary outcomes:
measure: clinical features & outcomes of childhood moyamoya
timeFrame: 2 years
measure: radioplogical features of childhood Moyamoya
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for CHidlren NHS Foundation Trust
Study officials:
affiliation: UCL Institute of Child Health
name: vijeya ganesan, MB ChB MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01781702: Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
Official title: A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelubiprofen
Celebrex
Rheumatoid Arthritis
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. \& Celebrex Cap. for Comparative Evaluation of Safety \& Efficacy in Rheumatoid Arthritis Patients


Eligibility criteria: Inclusion Criteria:

1. Adult males/Females aged 18\~80 years
2. Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
3. Patients who belong to ACR functional class 1, 2, 3

Exclusion Criteria:

1. Patients who belong to ACR functional class 4
2. Patients who are hypersensitive to clinical trial medicines or excipient
3. Patients who have experience of Cerebrovascular bleeding, bleeding disorder

Primary outcomes:
measure: Changes in '100 mm pain VAS' value from baseline
timeFrame: -14, 0, 14, 28, 42 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
Clinical trial NCT04587102: Whole Body Vibration Training for Diabetic Patients With Burn Injury
Official title: Whole Body Vibration Training for Diabetic Patients With Burn Injury: RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: vibration Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks , while group B is the control, both groups will receive their routine medical care and physical therapy rehabilitation.
Primary purpose: TREATMENT

Brief summary: Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological impairments. Lower limb burn involving Foot are still a challenging heath condition because of its important sensory role. Balance is disturbed either in patients with lower limb burn injury or diabetic patients. This study aime to compare between the effects whole body vibrational training and Yoga exercises on postural balance, and Activities-specific Balance Confidence in in type II diabetic Patients with foot burn

Detailed description: Thirty eight diabetic patients (17 male, 21female) with foot burn injury, with their age ranged from 40 to 55 years. They will randomly assigned into two equal groups. Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks (n=19), while group (B) the control group for 8 weeks (n=19) in addition both groups will receive their routine medical care and physical therapy rehabilitation including balancing exercises. Dynamic balance will be evaluated through Biodex balance system (BBS);and balance confidence will be measured by the Activities-specific Balance Confidence Scale (ABC) before the starting and after the end of treatment for all patients in both groups

Eligibility criteria: Inclusion Criteria:

* chronic lower limb burns injury for more than 6 months
* Total body surface area (TBSA) burnt ≤ 30%.;

Exclusion Criteria:

* cognitive or mentality dysfunctions,
* psychiatric conditions,
* fractures,
* pregnancy,
* cancer,
* severe vascular complications,
* inability to walk

Primary outcomes:
measure: Dynamic balance assessment
timeFrame: Change from Baseline at balance scores at 8 weeks
Secondary outcomes:
measure: The Activities-specific Balance
timeFrame: Change from Baseline at Activities-specific Balance scores at 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Zizi Mohammed Ibrahim Ali
state: Nnjkjk
city: Giza
country: Egypt
facility: Burn Unit at Om El Masrien Hospital
city: Riyadh
country: Saudi Arabia
facility: Zizi Mohammed Ibrahim Ali
Study officials:
affiliation: Cairo University
name: ZIZI MOHAMMED I ALI
role: PRINCIPAL_INVESTIGATOR
References: