louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02061787: the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
Official title: the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Arterial Hypertension Associated With Schistosomiasis (Disorder)
Keywords: Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Arterial Hypertension
balloon pulmonary angioplasty
cardiopulmonary exercise test
Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 4000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pulmonary hypertension who may accomplish cardiopulmonary exercise testing.

Brief summary: cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment

Detailed description: patients diagnosed with pulmonary hypertension, including pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, will be evaluated by cardio pulmonary exercise test before and after medical or balloon pulmonary angioplasty treatment

Eligibility criteria: Inclusion Criteria:

* pulmonary arterial hypertension;( WHO1)
* chronic thromboembolic pulmonary hypertension;
* pulmonary arterial hypertension due to other cause;

Exclusion Criteria:

* massive hemoptysis;
* unable to accomplish cardiopulmonary exercise testing due to neuromuscular disorders;
* recent recurrent syncope;
* pulmonary hypertension due to hypoxia;
* pulmonary hypertension due to left heart diseases.

Primary outcomes:
measure: all cause mortality
timeFrame: 5 years
measure: mean pulmonary arterial pressure after treatment
timeFrame: 5 years
measure: achievement of low risk
timeFrame: 5 years
Secondary outcomes:
measure: deterioration of WHO function
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: center of pulmonary vascular disease, Fuwai hospital
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases
name: Zhihong Liu, MD，PhD
role: STUDY_DIRECTOR
References:
citation: Li X, Duan A, Jin Q, Zhang Y, Luo Q, Zhao Q, Yan L, Huang Z, Hu M, Xiong C, Zhao Z, Liu Z. Exercise feature and predictor of prognosis in patients with pulmonary artery stenosis-associated pulmonary hypertension. ESC Heart Fail. 2022 Dec;9(6):4198-4208. doi: 10.1002/ehf2.14154. Epub 2022 Sep 13.
citation: Tang Y, Yao L, Liu Z, Ma X, Luo Q, Zhao Z, Huang Z, Tu L, Gao L, Jin Q, Ni X, Xiong C. Effect of calcium channel blockers evaluated by cardiopulmonary exercise testing in idiopathic pulmonary arterial hypertension responding to acute pulmonary vasoreactivity testing. Pulm Pharmacol Ther. 2017 Apr;43:26-31. doi: 10.1016/j.pupt.2017.01.012. Epub 2017 Feb 1.
Clinical trial NCT06696287: The 6-minute Pegboard and Ring Test in Patients with Fibromyalgia Syndrome
Official title: Validity and Reliability of the the 6-minute Pegboard and Ring Test in Patients with Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18-65 years who are clinically stable and diagnosed with fibromyalgia syndrome and who are being followed up at the Rheumatology Polyclinic of the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study.

Brief summary: The aim of our study is to investigate the validity and reliability of the 6-minute pegboard and ring test in patients with fibromyalgia syndrome.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with fibromyalgia syndrome
* Being aged 18-65
* Stable use of medication for at least 3 months or longer
* Volunteering to participate in the study

Exclusion Criteria:

* Having a musculoskeletal problem that would prevent being tested
* Having cardiopulmonary and neurological disease
* Malignancy
* Pregnancy

Primary outcomes:
measure: Arm exercise capacity
timeFrame: 10 minutes
measure: Functional exercise capacity
timeFrame: 20 minutes
measure: Hand grip strength
timeFrame: 5 minutes
Secondary outcomes:
measure: Activities of daily living
timeFrame: 10 minutes
measure: Functional status/limitation
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Basak Kavalci Kol
role: STUDY_CHAIR
affiliation: Kirsehir Ahi Evran University
name: Figen Tuncay
role: STUDY_CHAIR
References:
Clinical trial NCT03840187: Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System
Official title: Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dysplasia
Keywords: digital cervicography
Gynescope system
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients reffered for colposcopy

Brief summary: Correlation between colposcopist findings and digital cervicography employing Gynescope system

Detailed description: Up to 30 women that will be referred for colposcopy examination at the standard indications will also undergo a colposcopy examination of the cervix by a gynescope. The physicain performing the optical test will record the findings in accordance with the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable will be included in every record. At later stage, the images obtained by the cervicography will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between the categorical findings in both assesments will be compared. The correlation measure will be performed by Kappa test according to the categorial result of both measurements.

Eligibility criteria: Inclusion Criteria:

- Patients reffered for colposcopy

Exclusion Criteria:

Patient refusion

Primary outcomes:
measure: Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilay University Medical Center
Study officials:
affiliation: Barzilai University Medical Center Ashkelon
name: Ofer Gemer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04518787: Genetic Biomarkers Associated With Child Language Development in Taiwan
Official title: Genetic Biomarkers Associated With Child Language Development in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Language
Keywords: language development
gene
whole-exome sequencing
body function and body structure
quality of Life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-08-19
Enrollment: 596
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control and experimental groups

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

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

Eligibility criteria: Inclusion Criteria of Healthy Child:

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

Exclusion Criteria of Healthy Child:

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

Inclusion Criteria of Child with language disorder:

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

Exclusion Criteria of Child with language disorder:

* Hearing Impairment

Inclusion Criteria of Adult:

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

Primary outcomes:
measure: Scores of cognitive function 1
timeFrame: baseline
measure: Scores of cognitive function (2 y/o to 6 y/o)
timeFrame: baseline
measure: Scores of cognitive function (6 y/o to 16 y/o)
timeFrame: baseline
measure: Scores of cognitive function 3
timeFrame: baseline
measure: Scores of language function 1
timeFrame: baseline
measure: Scores of language function 2
timeFrame: baseline
measure: Scores of general development
timeFrame: baseline
measure: Gene test 1
timeFrame: baseline
measure: Gene test 2
timeFrame: baseline
Secondary outcomes:
measure: Scores of participation(2-5 y/o)
timeFrame: baseline
measure: Scores of participation(>6 y/o)
timeFrame: baseline
measure: Scores of activities
timeFrame: baseline
measure: Scores of quality of life
timeFrame: baseline
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06211387: ADDITIVE BENEFITS of KALTENBORN SUSTAINED STRETCH JOINT MOBILIZATION with RESISTANCE EXERCISE TRAINING in KNEE OSTEOARTHRITIS
Official title: ADDITIVE BENEFITS of KALTENBORN SUSTAINED STRETCH JOINT MOBILIZATION with RESISTANCE EXERCISE TRAINING in KNEE OSTEOARTHRITIS
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to determine the supplementary effects of Kaltenborn sustained stretch mobilization when combined with resistance training in the management of knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

Grade I-III knee OA Both male and female nee osteoarthritis for at least 3 months knee pain no more than 8/10

Exclusion Criteria:

Malignancy Any additional Inflammatory disorders Infection Knee trauma lower limb fracture Lumbar radiculopathy or myelopathy knee surgery Intra-articular steroid therapy in the last 2 months Total knee replacement (TKR). Total hip replacement (THR). Any neurological disorder Any cardio-pulmonary complications Rheumatoid arthritis Septic arthritis Recent history of trauma Osteoporosis or osteomyelitis Grade IV osteoarthritis

-

Primary outcomes:
measure: Knee Pain
timeFrame: 4 weeks
measure: Physical Function
timeFrame: 4 weeks
measure: Isometric Muscle Strength
timeFrame: 4 weeks
measure: Functional Mobility strength
timeFrame: 4 weeks
measure: Cadence
timeFrame: 4 weeks
measure: Gait velocity
timeFrame: 4 weeks
measure: Stride length
timeFrame: 4 weeks
measure: Knee range of motion (ROM)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
state: Federal
Study officials:
affiliation: Foundation University Islamabad
name: Anas Hameed
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation University Islamabad
name: Muhammad Osama
role: STUDY_CHAIR
References:
Clinical trial NCT00547287: Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
Official title: Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impotence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 2760
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to determine if men from around the world prefer sildenafil to tadalafil.


Eligibility criteria: Inclusion Criteria:

* Must be of legal age according to your country.
* Must have had a history of erectile dysfunction for at least 3 months.
* Must currently and have been using sildenafil for the last six weeks.
* Agree to not use any other ED treatment during the study.
* Anticipate the same female sexual partner for the study.

Exclusion Criteria:

* History of other primary sexual disorder
* Treatment with nitrates
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Do not meet certain lab value reference ranges

Primary outcomes:
measure: Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase
timeFrame: 14 weeks
Secondary outcomes:
measure: Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03764787: Combination of Hypofractionated Proton Therapy With Immunotherapy
Official title: A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Proton Therapy
Immunotherapy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: YiZhou International Cancer Hospital
First posted: 2018-12-05
Enrollment: 30
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: The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using hypofractionated proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Detailed description: Hypofractionated radiotherapy (HFRT), also known as Stereotactic body radiation therapy (SBRT) or Stereotactic ablative radiotherapy (SABR), is a regular pattern of photon radiotherapy. HFRT could achieve comparable curative effect to surgery in variable type of tumor. With the development of proton radiotherapy technology, proton HFRT technique is available nowadays. However, proton HFRT technique is mainly effective in improving the local control rates. This study intends to observe the safety and efficacy of proton HFRT technique combined with immunotherapy in improving the overall anti-tumor effect.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Unspecified Adult Solid Tumor
* Intending to be treated with proton beam and immunotherapy
* Age ≥ 18 years old
* KPS≥70
* Signed written informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient under guardianship or tutorship
* Patients or legal guardians who are unable to understand informed consent document

Primary outcomes:
measure: Adverse events
timeFrame: Through 1 years after completion of treatment
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Through 2 years after completion of treatment
measure: Overall survival (OS)
timeFrame: Through 2 years after completion of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Xianshu Gao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06416787: Safety and Tolerability of IBI355 in Healthy Volunteers
Official title: A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy volunteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Understanding and Signing a written informed consent prior to selection;
2. Aged above 18 years old, male or female;
3. Body mass index (BMI) between 18-28kg/m2;
4. Normal label test;
5. No parenting plan for at least 6 months

Exclusion Criteria:

1. Subjects with a history of allergy；
2. Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
7. Subject with a hcg positive;
8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial

Primary outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: Up to week 24
Secondary outcomes:
measure: Area under the Curve(AUC) of multi-dose of IBI355
timeFrame: Up to week 12
measure: Peak serum concentration(Cmax) of multi-dose of IBI355
timeFrame: Up to week 12
measure: Clearance (CL) of multi-dose of IBI355
timeFrame: Up to week 12
measure: Half-life (t1/2) of multi-dose of IBI355
timeFrame: Up to week 12
measure: The ratio of Anti-drug antibody of multi-dose of IBI355
timeFrame: Up to week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05349487: SpeakFree Heat and Moisture Exchanger (HME)
Official title: Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Cancer
Laryngectomy
Keywords: Stoma
Voice Prosthesis
Total Laryngectomy
Heat and Moisture Exchanger (HME)
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME). The investigators will compare the SpeakFree to other modalities of stomal occlusion (digital occlusion and digital depression of an HME) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. In addition, the investigators will compare the SpeakFree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).


Eligibility criteria: Inclusion Criteria:

* Participants who have undergone a total laryngectomy who have and use a voice prosthesis as their primary form of communication for at least 3 months prior to study enrollment.
* Participants must have had at least 2 voice prosthesis management visits from a speech pathologist at the University of Miami prior to study enrollment.
* Participants must have fully healed suture lines.
* Participants must demonstrate fluent tracheoesophageal speech (i.e., maximum phonation time of at least 5 seconds during 3 consecutive trials)
* Current HME use for a minimum of 1 month
* Participants willing to complete the survey and provide a signed Informed Consent Form
* Males and non-pregnant females over the age of 18

Exclusion Criteria:

* Participants who do not have a voice prosthesis.
* Participants who have dysarthria.
* Participants who are currently receiving treatment for head and neck cancer.
* Participants who have an underlying neurologic condition potentially impacting speech.

Primary outcomes:
measure: Satisfaction as measured by VAS
timeFrame: Up to 1 month
measure: Voice Quality: Patient Rating
timeFrame: Up to 1 month
Secondary outcomes:
measure: Change in Maximum Phonation Time
timeFrame: Baseline, 1 month
measure: Change in Syllables Per Breath
timeFrame: Baseline, 1 month
measure: Pressure Needed to Phonate
timeFrame: Baseline
measure: Change in Voice Quality: Clinician Rating
timeFrame: Baseline, 1 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Mario A Landera, SLP.D.
role: PRINCIPAL_INVESTIGATOR
References: