louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00965887: Bioequivalence of Two Tablet Forms of MK0974 (0974-045)
Official title: An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate vs. a Single Dose of a Tablet Form of MK0974 Hydrate in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the bioequivalence of two solid dose formulations of MK0974.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is a non-smoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has or has a history of any disease or condition that might make participation in the study unsafe or that might confound the results of the study

Primary outcomes:
measure: Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations
timeFrame: Through 48 hours postdose
measure: Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations
timeFrame: Through 48 Hours Post Dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04310787: Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure
Official title: The Investigation on Long-term Outcomes and Prognostic Factors of Patients With Hepatitis B Related Acute-on-chronic Liver Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B
Acute-On-Chronic Liver Failure
Keywords: Hepatitis B
Acute-On-Chronic Liver Failure
Prognosis
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study population were patients with hepatitis b-related acute on-chronic liver failure in the department of infectious diseases, the third affiliated hospital of sun yat-sen university.

Brief summary: This study is to investigate the long-term outcomes and prognostic risk factors in patients recovered from hepatitis B virus related acute on-chronic liver failure.

Detailed description: Chronic acute liver failure (ACLF) is a systemic multi-organ failure driven by acute liver injury in the basis of chronic liver disease. The main cause of chronic acute liver failure in China is hepatitis b virus infection.Previous studies on the prognosis of acute on-chronic liver failure mainly focused on the short-term survival rate and the follow-up time was relatively short, while the study on the long-term prognosis of patients with spontaneous recovery of chronic acute liver failure was still lack-ing. Thus,this study mainly retrospectively analyzed the clinical data of patients with chronic hepatitis b related acute liver failure admitted to the department of infectious diseases, the third affiliated hospital of sun yat-sen university, and con-ducted telephone follow-up survey to analyze the long-term prognosis of patients with chronic hepatitis b related acute on-chronic liver failure.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years old;
* The diagnosis consistent with hepatitis b associated chronic acute liver failure；
* After hospitalization, the survival time \> 90 days；
* The inpatient clinical data are complete.

Exclusion Criteria:

* Human immunodeficiency virus infection or congenital immune deficiency diseases;
* Liver cancer and other tumors, autoimmune liver disease, genetic and metabolic liver disease, or other serious diseases that significantly affect patient survival;
* Other conditions that the researchers judged not appropriate for inclusion.

Primary outcomes:
measure: adverse events
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06997887: Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
Official title: Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Female Patients Who Have Completed Pelvic Radiotherapy
Keywords: pelvic radiotherapy, CH2 vagina gel, vagina rehabilitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective clinical trial planning to enroll female patients who have completed pelvic radiotherapy. Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises. The primary endpoint is the change in the Female Sexual Function Index scores.

Detailed description: This is a prospective clinical trial planning to enroll female patients who have completed pelvic radiotherapy. Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises. The primary endpoint is the change in the Female Sexual Function Index (FSFI) scores. Follow-up assessments will be conducted to determine whether CH2 vaginal gel or vaginal rehabilitation can improve post-radiotherapy vaginal health and enhance the long-term quality of life for women with cancer.

Eligibility criteria: Inclusion Criteria:

1. Female patients aged between 20 and 70 years.
2. Completion of pelvic radiotherapy for gynecologic cancer, which may include external beam radiotherapy (EBRT), brachytherapy (BT), or a combination of both.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

Exclusion Criteria:

1. Individuals under the age of 18.
2. Presence of distant metastases or a history of malignancy currently under treatment within the past five years (excluding non-melanoma skin cancer).
3. Presence of severe comorbidities, such as uncontrolled diabetes, cardiovascular disease, or autoimmune disorders that may interfere with treatment or study participation.
4. Diagnosed psychiatric disorders or significant social factors that may prevent adherence to study requirements or completion of follow-up evaluations.
5. Inability to self-administer vaginal gel or vaginal rehabilitation exercises.

Primary outcomes:
measure: FSFI score
timeFrame: From enrollment to the end of intervention at at 3, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
Study officials:
affiliation: National Taiwan University Cancer Center
name: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02472587: Assessing Chronic Pain Conditions in General Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pelvic Pain
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women attending our institute in order to do Pap test

Brief summary: The purpose of this study is to determine the percentage of women, among those attending our institute in order to do Pap test, suffering of chronic pelvic pain. To such purpose the patients will be submitted to questionnaires.


Eligibility criteria: Inclusion Criteria:

* Women over 18 years of age

Exclusion Criteria:

* unwilling or unable to give consent

Primary outcomes:
measure: Chronic pelvic pain Questionnaire
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05115487: Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome
Official title: Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome Patients; A Controlled Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sjogren's Syndrome
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed primary Sjögren's syndrome according to 2016 ACR/EULAR primary Sjögren classification criteria

Brief summary: Hand functions are decreased in rheumatic diseases such as systemic sclerosis and rheumatoid arthritis.

Sjögren's syndrome (SS) is a chronic systemic rheumatic disease characterized by lymphoplasmacytic infiltration of exocrine glands, especially salivary and lacrimal glands.

SS may be "primary" when it occurs alone (pSS) and "secondary" (sSS) when associated with another autoimmune disease. PSS is the most common connective tissue disease after rheumatoid arthritis and affects 0.3-3% of the population. Joint involvement is the most common involvement of pSS after sicca syndrome (50% of patients). Patients may have arthralgia with inflammatory features (morning stiffness \> 30 minutes) or, less frequently, true symmetric polysynovitis mimicking rheumatoid arthritis (RA). The joint involvement of PSS is usually moderate (\<5 affected joints) and mostly affects the small joints of the hands and upper extremities. PSS may also be responsible for myositis. Widespread pain, similar to primary fibromyalgia, is common in about 50 percent of patients with PSS.

The hand is one of the most important components affecting the functionality of the upper extremity. Grasping is one of the hand functions, for the continuity of daily living activities.

is an important function. Studies have shown that hand grip strength is correlated with upper extremity muscle strength, as well as general body muscle strength and pulmonary muscle strength.

As far as we know, hand functions have not been evaluated in newly diagnosed patients with pSS.


Eligibility criteria: Inclusion Criteria:

* 1. Patients aged 18-65 years diagnosed with Primary Sjogren's 2. Patients with normal cognitive functions

Exclusion Criteria:

* 1. Other connective tissue diseases other than primary Sjögren's 2.Pregnancy 3.Malignancy 4. Chronic diseases (DM, HT, Hypothyroidism, hyperthyroidism) 5. Cognitive disorder 6. Neurological or traumatic hand disorders leading to hand disorders (MS, Trauma, SVO) 7. Patients who have undergone major salivary gland surgery, have Graft Versus Host disease, have received Sarcoidosis, Head and Neck Radiotherapy, have a history of HTLV-1 or HIV

Primary outcomes:
measure: Hand grip strength
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
Clinical trial NCT04204187: Developing and Validating the Caring Questionnaire of Service Learning Courses
Official title: Developing and Validating the Caring Questionnaire of Service Learning Courses: Using the Transformative Learning Model and Theory of Planned Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CARING
SERVICE LEARNING
Lead sponsor: Central Taiwan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2019-12-18
Enrollment: 483
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: undergraduate students

Brief summary: Research purposes: 1. Construct the caring scale in service learning courses. 2. Verify the reliability and validity of caring scale in service learning curriculum.

Detailed description: Background: The core value of healthcare education is caring. However, caring traits are learned and acquired. Service learning advocates learning by doing. Through experience learning, students are guided to learn caring attitude or caring behaviour. Thus, teachers should construct appropriate assessments to understand caring traits as a transformative process from students' learning. Teachers should also adjust the pace of teaching continuously and design appropriate courses to facilitate students' achievement of their learning goals.

Eligibility criteria: Inclusion Criteria:

* undergraduate students after attending a service learning course

Exclusion Criteria:

* undergraduate students who refuse or are unwilling to participate in service learning courses.

Primary outcomes:
measure: first impression scale of service facility
timeFrame: up to 48 month
measure: service-learning experience of scale for caring
timeFrame: up to 48 month
measure: organizational climate for service-learning
timeFrame: up to 48 month
measure: idea transformation questionnaire for service-learning
timeFrame: up to 48 month
measure: perceived behavioral control for caring
timeFrame: up to 48 month
measure: behavioral intention of caring
timeFrame: up to 48 month
Secondary outcomes:
measure: attitude of caring
timeFrame: after service-learning activity 1 month
measure: subjective norms
timeFrame: after service-learning activity 1 month
measure: selfishness questionnaire
timeFrame: after service-learning activity 1 month
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Central Taiwan University of Science and Technology
Study officials:
References:
Clinical trial NCT01674387: Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain
Official title: Lu's Acupuncture Protocol for Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pains
Keywords: electroacupuncture therapy
neck pain
McGill Pain Questionnaire
Acupuncture Therapy
Electroacupuncture
Meridians
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2012-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical basis for the chronic neck pain treatment and evaluation of efficacy.

Detailed description: According to statistics, the incidence of chronic neck pain has significantly increased year by year, particularly tending to younger people, as social competition increase fiercely and the pace of people's daily work and life accelerate. Studying the effective treatment and prevention of chronic neck pain has obvious medical, social and economic significance. Purpose of this trial is to observe and objectively evaluate electroacupuncture (EA) therapy on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical basis for the chronic neck pain treatment and evaluation of efficacy.

Eligibility criteria: Inclusion Criteria:

1. Age of a subject is older than 18 and is younger than 65.
2. With more than 3 months history of neck pain.
3. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal, hematological systems and so on.
2. Psychotic，patients with allergic constitution or easily getting infected or bleeding.
3. Patients have used drugs for preventing neck pain in the last four weeks.
4. Pregnant women or women in lactation.

Primary outcomes:
measure: chronic neck pain-the Neck Pain Scale (NPQ)
timeFrame: 20 days(One course)
measure: the short-form McGill Pain Questionnaire
timeFrame: 20 days(One course)
measure: the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
timeFrame: 20 days(one course)
Secondary outcomes:
measure: chronic neck pain-the Neck Pain Scale (NPQ)
timeFrame: one month after a course.
measure: the short-form McGill Pain Questionnaire
timeFrame: one month after a course
measure: the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
timeFrame: one months after a course
Other outcomes:
Locations:
Study officials:
affiliation: Longhua Hospital
name: Jian Pei, MD
role: STUDY_DIRECTOR
affiliation: Longhua Hospital
name: Qinhui Fu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Univercity of TCM
name: Jia Yan, MM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818987: Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures
Official title: A Multicentre Prospective Randomized Control Trial on the Treatment of Three and Four Part Proximal Humerus Fractures in Patients 70 Years and Older: Comparing Open Reduction and Internal Fixation With Non Operative Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: 3 and 4 Part Proximal Humerus Fractures
Keywords: Operative
Non operative
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if operative treatment of non operative management of these fractures is best. Hypothesis: There is no difference in functional outcome between operative and non-operatively treated 3- and 4-part proximal humerus fractures at one year's time.

Detailed description: Participants of 70 years of age or older who have been medically assessed as 'fit for surgery' are randomly (like flipping a coin) to either operative or non operative management of their injury. Clinical follow-up including x-rays, and physical assessment of injured shoulder, and outcomes questionnaires will be used to determine which if either resulted in the best outcome.

Eligibility criteria: Inclusion Criteria:

* Proximal humerus fracture patients

Primary outcomes:
measure: Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Functional and mental status instruments (i.e. SF-36/EQ-5D) used to assess the patient's health-related quality of life;, re-operation rates; and the time required to return to pre-injury level of independence
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Pierre Guy, MDCM, MBA, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Clinical trial NCT05190133: Drug-drug Interaction Study Between UIC201601 and UIC201602
Official title: An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201601 and UIC201602 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
* Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
* Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
* Subjects able to read and understand a written informed consent, and willing to participate in the study.

Exclusion Criteria:

* Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
* Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
* Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
* Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
* Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
* etc.

Primary outcomes:
measure: Plasma pharmacokinetics(AUCss,τ) of UIC201602
timeFrame: 0 hour to 24 hours after Day 14 and Day 49 administration
measure: Plasma pharmacokinetics(Css,max) of UIC201602
timeFrame: 0 hour to 24 hours after Day 14 and Day 49 administration
measure: Plasma pharmacokinetics(AUCss,τ) of UIC201601
timeFrame: 0 hour to 24 hours after Day 7 and Day 35
measure: Plasma pharmacokinetics(Css,max) of UIC201601
timeFrame: 0 hour to 24 hours after Day 7 and Day 35
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chungnam National University Hospital
name: Janghee Hong, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: