louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03280914: Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community
Official title: Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community: a Real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Hypertension
Obesity
Diabetes
Hyperdiploid
Fatigue Syndrome, Chronic
Insomnia Chronic
Quality of Life
Economic Problems
Compliance, Patient
Health Impairment
Keywords: obstructive sleep apnea
real world
community
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients would be recruited from Community of Huanghua Road.

Brief summary: This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.

Detailed description: Patients with obstructive sleep apnea receiving CPAP or not would be observed in years. Primarily Impact of CPAP on health assessment andx control rate of hypertension would evaluated.

Eligibility criteria: Inclusion Criteria:

1) AHI \>= 5 events/h

Exclusion Criteria:

1. Any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe COPD, heart failure in NYHA class III to IV, and others
2. Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others
3. Patients receiving CPAP treatment

Primary outcomes:
measure: Health assessment
timeFrame: From 1st Aug 2017 to 31st Dec 2020
measure: Sleep quality
timeFrame: From 1st Aug 2017 to 31st Dec 2020
measure: Psychological assessment
timeFrame: From 1st Aug 2017 to 31st Dec 2020
measure: Control rate of hypertension
timeFrame: From 1st Aug 2017 to 31st Dec 2020
Secondary outcomes:
measure: Incidence of chronic diseases
timeFrame: From 1st Aug 2017 to 31st Dec 2025
measure: Death from all-cause
timeFrame: From 1st Aug 2017 to 31st Dec 2025
measure: Medical cost
timeFrame: From 1st Aug 2017 to 31st Dec 2025
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Community of Huanghua Road
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Qiong Ou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01529814: Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases
Official title: A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Early
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
Keywords: edentulism
dental implants
clinical study
Nanotite Certain Tapered implant
randomized
crestal bone level
early loading
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 49
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: Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.

Detailed description: In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by countertorque testing and cumulative success rate in cases that are loaded early

Eligibility criteria: Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching

Primary outcomes:
measure: Primary stability countertorque measures
timeFrame: 2 months
Secondary outcomes:
measure: Cumulative success rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad Mayor
Study officials:
affiliation: Universidad Mayor
name: Carlos Montoya, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05706714: Th1, Th2, Th17 Phenotype in Urea Cycle Disorders
Official title: Th1, Th2, Th17 Phenotype in Urea Cycle Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urea Cycle Disorder
Lysinuric Protein Intolerance
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 65
Sex: ALL
Maximum age (years): 53
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a diagnosis of urea cycle disorders and lysinuric protein intolerance

Brief summary: Infection-related hyperammonemia in patients with urea cycle disorders is an important cause of morbidity and mortality. The relationship between immune system cells and the metabolic pathways used by these cells and inborn errors of metabolism is still under investigation. Current studies are generally based on experiments in mice. The investigators' goal is to study specific T cell subsets to understand the effects of the urea cycle on T cells.

The investigators collected blood samples from participants with lysinuric protein intolerance and urea cycle disorders for basic immunophenotyping, lymphocyte proliferation in response to phytohemagglutinin and CDmix, and cytokine analysis involving Th1, Th2, and Th17 and compared them with age-matched healthy controls. They also examined amino acid profiles in sera and supernatants before and after stimulation with PMA-ionomycin.

Detailed description: The investigators aim to compare cellular immune response of T cell phenotype and proliferative functions in addition to lymphocyte subset analysis between urea cycle disorders and healthy controls.

Complete blood counts, immunoglobuline levels, lymptocyte subset analysis and Thelper cells will be analyzed. Additionally, T helper cells will be measured regarding their cytokine profile as Th1, Th2 and Th17. T cell proliferation response and aminoacid profiles in supernatants before and after stimulation will be measured.

Eligibility criteria: Inclusion Criteria:

* Children without any chronic conditions and having normal immunoglobulins and lymphocyte subsets

Exclusion Criteria:

* For healthy control, children having any signs for primary immune deficiencies

Primary outcomes:
measure: Measurement of Th1, Th2 and Th17 cells
timeFrame: baseline
Secondary outcomes:
measure: Measurement of T cell proliferative capacity
timeFrame: baseline
Other outcomes:
measure: Measurement of amino acid profile changes before and after stimulation
timeFrame: baseline
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayca Kiykim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01801514: Applications of Dual-Energy Computed Tomography
Official title: Applications of Dual-Energy Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Conditions That May Be A Focus of Clinical Attention
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2013-02-28
Enrollment: 337
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the feasibility of multilayer detection-based dual energy computed tomography scanner and to assess the added diagnostic value of dual energy applications


Eligibility criteria: Inclusion Criteria:

1. Male or female subject
2. Subjects with relative clinical findings indicative for CT examination. CT referral request approved by a physician is needed
3. Voluntary signed the Informed Consent Form

Exclusion Criteria:

1. Pregnant or potentially pregnant female subjects
2. Subjects who are not able or not willing to give written Informed Consent without a caregiver consent

Primary outcomes:
measure: Capability of producing dual energy computed tomography imaging and dual energy applications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
Study officials:
name: Jacob Sosna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02144714: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
Official title: A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-22
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Have a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

* History and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference investigational product formulation or comparable drugs
* Active or latent Tuberculosis or who have a history of Tuberculosis
* History of invasive systemic fungal infections or other opportunistic infections
* Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
* Serious infection associated with hospitalisation and/or which required intravenous antibiotics
* History of and/or current cardiac disease
* Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the final study visit
* Intake medication with a half-life \> 24 h within 4 weeks or 10 half-lives of the medication prior to investigational product administration

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
timeFrame: 0 to 1680 hours post-dose
measure: Maximum Serum Concentration (Cmax)
timeFrame: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 1680 hours post-dose
Secondary outcomes:
measure: Time to Cmax (Tmax)
timeFrame: pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Samsung Investigational Site
Study officials:
References:
citation: Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Clinical trial NCT02967614: KJ-TFC-004 Drug-drug Interaction Study
Official title: A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Study to Evaluate the Drug-drugs Interaction Between Dorzolamide and Brimonidine in Healthy Korean Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma
Eye Diseases
Ocular Hypertension
Lead sponsor: Kukje Pharma
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male subjects.

Detailed description: Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics of Dorzolamide in healthy volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy male adults aged between 19 and 50 during screening period
* BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg
* Signed the informed consent form prior to study participation.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.

Primary outcomes:
measure: Plasma concentration of Brimonidine and Dorzolamide
timeFrame: pre- and post dose of Brimonidine and Dorzolamide administration]
Secondary outcomes:
measure: Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide
timeFrame: pre- and post dose of Dorzolamide and Dorzloamide administration]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
affiliation: Clinical Trial Center, Seoul National University Hospital
name: Kyung-sang Yu, Ph.d., M.B.A
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03641014: Whether Using Sequential pH Would Improve Human Blastocyst Formation
Official title: Sequential pH Effect on Blastocyst Formation Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
name: Quena IVF Centre
First posted: 2018-08-21
Enrollment: 1312
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. The critical stages that lack robust mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a thawed embryo. This, in turn, could lead to a significant effect of the perturbations on embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a sequential pH to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of pH. However, whether this holds true remains to be examined.


Eligibility criteria: Inclusion Criteria:

* ICSI cycles

Exclusion Criteria:

* No exclusion

Primary outcomes:
measure: Ongoing Pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
measure: rate of usable blastocysts
timeFrame: 6 days of culture
measure: Blastocyst formation rate
timeFrame: 6 days of culture
measure: Clinical pregnancy rate
timeFrame: 3 months
measure: Implantation rate
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Quena
country: Egypt
facility: Quena IVF Centre
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
Study officials:
References:
Clinical trial NCT04500314: Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.
Official title: Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries. Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thermal Burn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of whole-body vibration device on Balance control, postural Stability and mobility after thermal burn injuries.

Detailed description: 40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%), will be randomly assigned either into the experimental group, received whole body vibration (WBV) plus the routine physical therapy program or the control group, received the same routine physical therapy program. All treatment interventions will be applied at a frequency of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome measures of the study.

Eligibility criteria: Inclusion Criteria:

* Age ranged between 20 and 45 years,
* Deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of burn as measured by "rule of nine" method, with complete wound healing or after 6 weeks from the injury.
* Body mass index of between 17 and 35, with no history of neurological disorders or injuries to the lower extremities.

Exclusion Criteria:

* Patients with open burn wound,
* Patients diagnosed with acute rheumatoid arthritis,
* Joint replacement within the past year,
* History of traumatic spine within the past six months,
* Prosthesis,
* Recent fracture or bone disease.

Primary outcomes:
measure: Postural stability
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: Time up and go test
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University, Faculty of physical therapy.
state: Giza
Study officials:
References:
Clinical trial NCT06335914: Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
Official title: Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Prostate Cancer
Keywords: Prostate Specific Membrane Antigen
Positron Emission Tomography
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.


Eligibility criteria: Inclusion Criteria:

* Male, age ≥ 18 years
* Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
* Poor risk patients with mCSPC at study enrollment
* De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI
* High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
* Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.
* No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study
* Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility

Exclusion Criteria:

* Under a randomized-controlled trial with unknown allocation of systemic therapy
* Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
* Unable to provide written consent by patient and their legal representatives
* In the opinion of the treating physician:
* conditions which would significantly impair the patient's ability to comply with study procedures and follow up
* Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging

  * another active malignancy
  * patient on dialysis
  * another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging

Primary outcomes:
measure: Proportion of patients with high volume mCSPC having PSMA avid disease
timeFrame: 5 years
Secondary outcomes:
measure: Proportion of patients with PSMA-/FDG+ discordant lesions
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre/University Health Network
name: Di (Maria) Jiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06374914: Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients
Official title: Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bladder Cancer
BCG
Gemcitabine
Docetaxel
Intravesical Instillation
Keywords: bladder cancer
BCG
Intravesical Instillation
Gemcitabine
Docetaxel
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a multi-center study within the scope of the Turkish Urooncology Association

Brief summary: Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients.


Eligibility criteria: Inclusion Criteria:

- BCG refractory/relapsed/unresponsive or intolerant Who do not want or are not suitable for radical cystectomy

Exclusion Criteria:

- BCG naive A history of multiple cancers Having a radical cystectomy plan

Primary outcomes:
measure: Recurrence rate
timeFrame: 5 years
measure: Progression rate
timeFrame: 5 years
measure: Adverse effects of intravesical chemotherapy
timeFrame: 5 years
measure: Intravesical chemotherapy versus radical cystectomy
timeFrame: 5 years
Secondary outcomes:
measure: treatment change
timeFrame: 5 years
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine Department of Urology
state: Other (Non U.s.)
Study officials:
References: