louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01426399: Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
Official title: A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.


Eligibility criteria: Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 2months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Primary outcomes:
measure: AUCτ,ss
timeFrame: up to 171h30m
measure: Cmax,ss
timeFrame: up to 171h 30m
Secondary outcomes:
measure: Vital signs
timeFrame: up to 171h30m
measure: AUECτ,ss
timeFrame: up to 171h30m
measure: AUEC
timeFrame: up to 171h30m
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul national univ. hospital
name: Kyung-sang Yu, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin D, Cho YM, Lee S, Lim KS, Kim JA, Ahn JY, Cho JY, Lee H, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014 Jun;34(6):383-93. doi: 10.1007/s40261-014-0184-3.
Clinical trial NCT00470899: Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion
Official title: Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fetomaternal Transfusion
Keywords: Feto-maternal transfusion
Kleihauer-Betke
Lead sponsor: Lester E. Cox Medical Centers
Sponsor class: OTHER
First posted: 2007-05-08
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study hypothesis: umbilical cord drainage of fetal blood after delivery of the infant would reduce the incidence of feto-maternal transfusion. Patients were randomized to placental drainage or no drainage at the time of cesarean section. The incidence of fetal to maternal transfusion was noted postoperatively.

Detailed description: 86 patients were randomized to placental drainage vs. no drainage of fetal blood at the time of cesarean section. Kleihauer-Betke testing was performed within 12 hours postoperatively to assess the incidence of feto-maternal transfusion. A significant difference was found between the two groups.

Eligibility criteria: Inclusion Criteria:

* All women undergoing cesarean section

Exclusion Criteria:

* Preoperative Kleihauer-Betke, known antepartum erythrocyte sensitization, overt vaginal bleeding, history of a previous delivery by low vertical cesarean section, prolonged rupture of membranes, twin gestation, failure to obtain both preoperative and postoperative Kleihauer-Betke tests.

Primary outcomes:
measure: Presence/absence of fetal blood in maternal circulation
timeFrame: within 12 hours postoperatively
Secondary outcomes:
measure: no secondary outcome measures
timeFrame: end of study
Other outcomes:
Locations:
Study officials:
affiliation: Lester E. Cox Medical Center
name: Laird A Bell, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11. doi: 10.1097/01.AOG.0000277262.80793.0d.
Clinical trial NCT05813899: Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
Official title: Efficacy of Lactobacillus Paracasei PS23 for Patients With Post-COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-COVID-19 Syndrome
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2023-04-14
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate whether probiotics PS23 can improve the symptoms of patients with long COVID-19 ; also to evaluate the effects on blood cortisol and inflammation-related indicators in patients.

Detailed description: It is expected that a total of 120 subjects will be recruited within 3 years after IRB approval, divided into two groups of 60 subjects, respectively consuming PS23 heat-treated bacteria or placebo, and completing the 6-week period.

Eligibility criteria: Inclusion Criteria:

1. Aged above 20 years old and below 65 years old.
2. Those who consciously have long COVID-19 symptoms or actively respond to website advertisements to express interest in participating in this clinical researcher.
3. Those who received the confirmation SMS or the COVID-19 rapid test positive 4 weeks ago.

Exclusion Criteria:

1. Have taken antibiotics within one month or are receiving antibiotic treatment.
2. Have taken probiotic products have been used within two weeks (excluding yogurt, yogurt, Yakult and other related foods).
3. Cancer or immunocompromised patients undergoing treatment.
4. Those who are allergic to lactic acid bacteria products.
5. Diagnosed with dementia before being diagnosed with COVID-19.
6. Prior to or currently taking medication for acute or psychiatric illness prior to the diagnosis of COVID-19.
7. The investigator judges that it is not suitable to participate in the researcher.

Primary outcomes:
measure: Clinical Global Impression scales of Severity rated by clinician（CGI）
timeFrame: From Baseline to 6 Weeks Assessed
Secondary outcomes:
measure: Wechsler Adult Intelligence Scale 4th version
timeFrame: From Baseline to 6 Weeks Assessed
measure: Color Trails Test（CTT）
timeFrame: From Baseline to 6 Weeks Assessed
measure: Insomnia Severity Index（ISI）
timeFrame: From Baseline to 6 Weeks Assessed
measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
timeFrame: From Baseline to 6 Weeks Assessed
measure: State and Trait Anxiety Index (STAI)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Patient Heath Questionnaire-9 (PHQ-9)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Visual Analogue Scale-GI (VAS-GI)
timeFrame: From Baseline to 6 Weeks Assessed
measure: Patient Global Impression scales of Improvement rated by patient（PGI-C）
timeFrame: From Baseline to 6 Weeks Assessed
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References:
Clinical trial NCT06595199: PRAMS: Peer-support To Reduce Antenatal Maternal Smoking
Official title: PRAMS: Peer-support To Reduce Antenatal Maternal Smoking: Development And Feasibility Testing Of A Social Media Group To Provide Peer Support And Enhance Quit Rates For Women Who Smoke In Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Pregnancy Related
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Huddersfield
name: National Institute for Health Research, United Kingdom
name: The Leeds Teaching Hospitals NHS Trust
First posted: 2024-09-19
Enrollment: 72
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this feasibility is test the feasibility of conducting a randomised trial of the use of an online peer support group to promote smoking cessation and enhance sustained abstinence for women who smoke in pregnancy.

Researchers will compare the group who receive the intervention (along side standard care) with a group who receive standard care alone.

Detailed description: Participants will be asked to complete 2 questionnaires (and the intervention group will be asked to sign up to an online support group). They will be offered the opportunity to also take part in a follow up interview to explore acceptability and feasibility of the a future trial

Eligibility criteria: Inclusion Criteria:

* Pregnant
* Smoking at beginning of pregnancy
* Access to mobile phone

Exclusion Criteria:

* Under 16 years of age

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 months
measure: Attrition rate
timeFrame: 12 months
Secondary outcomes:
measure: Smoking status at end of pregnancy
timeFrame: 12 months
measure: Engagement with stop smoking services
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06639399: Effect of Different Acupuncture Schemes for Postoperative Urinary Retention in Cervical Cancer Patients
Official title: Effect of Acupuncture At Different Combinations of Acupoints for Postoperative Urinary Retention After Radical Hysterectomy of Cervical Cancer: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Urinary Retention (POUR)
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of postoperative urinary retention after radical hysterectomy of cervical cancer

Brief summary: This is a retrospective cohort study using a paired control design. We will review the patients of PUR after cervical cancer surgery who went to the acupuncture department and the urinary retention department in Zhejiang Cancer Hospital from October 2020 to August 2024, and 73 patients met the screening criteria. All patients provided written informed consent. The purpose of the study is to compare the effect of acupuncture at different combinations of acupoints for postoperative urinary retention (PUR) after radical hysterectomy of cervical cancer. All outcome-measures data were obtained from past medical records. It is an observational study rather than an intervention study. 73 patients met the screening criteria. They will be assigned into two groups according to the treatment scheme of acupoints combination for acupuncture: Group A (37 cases) and Group B (36 cases).


Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* Karnofsky Performance Scale (KPS) score \> 70
* met the diagnostic criteria of PUR
* no history of serious urinary system diseases or urinary retention before the operation
* had clear cognition and no severe mental diseases
* had complete medical records and records of residual urine volume data.

Exclusion Criteria:

* presence of other serious systemic diseases or advanced cachexia
* obstructive urinary retention caused by urethral stricture, stones, or other diseases
* receiving other treatments or self-change treatment
* poor compliance or failure to complete the acupuncture treatments
* incomplete clinical data.

Primary outcomes:
measure: The change value in residual urine volume
timeFrame: baseline and 2 weeks
Secondary outcomes:
measure: The patient's abdominal distension sensation by the visual analog scale (VAS) method
timeFrame: baseline and 2 weeks
measure: The occurrence of urinary tract infections
timeFrame: baseline and 2 weeks
measure: The total effective rate
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05773599: Midwifery Students and Laughter Yoga
Official title: The Evaluation of the Effect of Laughter Yoga on Sleep Quality and Life Satisfaction in Midwifery Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laughter Yoga
Midwifery
Life Satisfaction
Keywords: Yoga
Laughter
student
sleep
life
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 77
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: No study was found as a result of the literature review. It is thought that laughter yoga will affect the life satisfaction and sleep quality of individuals due to reasons such as increasing oxygen saturation in the blood, strengthening mental functions, providing mental well-being and reducing stress. stress and mental fatigue are thought to affect life satisfaction and sleep quality, so it was planned to evaluate the effect of laughter yoga on life satisfaction and sleep quality.

Detailed description: With laughter, oxygen saturation in the brain and body increases. Laughter yoga basically includes breathing, meditation and different stretching movements. Benefits of laughter yoga; relaxes the muscles, reduces the level of stress hormones, ensures effective breathing, increases pain tolerance, strengthens mental functions, stimulates the circulatory and immune system, reduces anxiety and depression symptoms, improves quality of life and creates psychosocial well-being. Life satisfaction is the result obtained by comparing the expectations of the individual with what he has. Life satisfaction is affected by many factors such as daily stress, work life, social relations, and mental state. Life satisfaction is not related to certain areas, but to be happy in all areas of life.

Sleep is of great importance in fulfilling daily functions and in maintaining mental and physical health. sleep quality; It is the quantitative evaluation of sleep such as the time to fall asleep, the total time spent in sleep, the number of awakenings, and the duration of awakening.

Eligibility criteria: Inclusion Criteria:

* Students who agreed to participate in the study

Exclusion Criteria:

* not be a midwifery student

Primary outcomes:
measure: The effect of laughter yoga on life satisfaction
timeFrame: one day
measure: The effect of laughter yoga on sleep quality
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University Faculty of Health Sciences Department
state: Yakuti̇ye/erzurum
Study officials:
affiliation: Atatürk University Faculty of Health Sciences Department of Midwifery Yakutiye/Erzurum
name: Safiye Ağapınar Şahin, Ass.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Atatürk University Faculty of Health Sciences Department of Midwifery Yakutiye/Erzurum
name: Sibel Öztürk, Ass. Dr.
role: STUDY_DIRECTOR
affiliation: research assistant
name: Nazlı Akar, assistant
role: STUDY_DIRECTOR
References:
Clinical trial NCT04337099: A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer
Official title: A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Prostate Cancer
Lead sponsor: Matrix Biomed, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-07
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for the treatment of prostate cancer. The single patient will be exposed to orally administered TEMPOL for up to 12 months at a maximum total daily dose of 800mg.

Detailed description: Localized therapy for prostate cancer is often curative; however, 20% to 30% of patients experience a recurrence. Biochemical recurrence (BCR) occurs in an estimated 50,000 men/year in the U.S and is marked by a rising prostate specific antigen (PSA) after definitive radical prostatectomy and/or radiation therapy for localized disease.

Continuous androgen deprivation therapy (ADT), in which serum testosterone is decreased to a castrate level (less than 50 ng/dL) is a standard treatment in BCR. ADT is associated with significant short term and long term toxicities, including declining quality of life on treatment and increased risk of osteoporosis, diabetes, and cardiovascular disease. MBM-02 is being tested as a novel non-hormonal agent with improved biologic activity and better tolerability for use in biochemically recurrent prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Biochemical Recurrent Prostate Cancer

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialists
state: California
Study officials:
References:
Clinical trial NCT04149899: Safety and IOP-Lowering Effects of WB007
Official title: A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Keywords: POAG
OHT
Primary open-angle glaucoma
ocular hypertension
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 - Open-labelled, single dose, 3-period dose escalation; Part 2 - Double-masked, randomized, parallel comparison
Primary purpose: TREATMENT

Brief summary: The study evaluated the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This was a 2-part study. Part 1 was a 3-period dose escalation that evaluated 3 concentrations of WB007 ophthalmic solution following a single dose in one eye. Part 2 was a randomized, double-masked, parallel comparison that evaluated two concentrations of WB007 (selected based on Part 1 results) in both eyes compared with timolol 0.5% for 14 days.


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria:

* History of orthostatic hypotension
* Any active ocular disease
* Anticipated wearing of contact lenses during study
* Contraindication to pupil dilatation

Primary outcomes:
measure: Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Part 2: Mean IOP at Day 14 - Study Eye
timeFrame: Baseline, Day 14
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Eye Research Foundation
name: David Wirta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01217099: Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Official title: A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Refractory Mycoplasma Pneumoniae Pneumonia
Keywords: refractory mycoplasma pneumoniae pneumonia
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 47
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia(MPP) .

Detailed description: Corticosteroid has been used in adulthood refractory MPP with satisfactory efficacy. But there were few studies about the use of corticosteroid in children with refractory MPP. Lee KY et al indicated oral prednisolone of 1 mg/kg/ day for 1 week be useful for children with severe MPP. Akihiro T et al demonstrated that intravenously administered methylprednisolone at a dose of 30 mg/kg once daily for 3 consecutive days had an efficacious treatment for children with refractory MPP.But the methods of corticosteroid use, such as the dosage, administration route, duration of treatment have not been well understood. So in this study, we planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia in a prospective, open-label fashion.

PMID: 11096025 PMID: 18033831 PMID: 10434547 PMID: 16437541 PMID: 18656264

Eligibility criteria: Inclusion Criteria:

* mycoplasma pneumoniae pneumonia
* prolonged fever and deterioration of radiological findings despite macrolides treatment for 7 days or more.

Exclusion Criteria:

* chronic cardiac and pulmonary disease
* immunodeficiency
* requiring mechanical ventilation
* with other pathogens detected during pneumonia.

Primary outcomes:
measure: efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.
timeFrame: 3-year
Secondary outcomes:
measure: safety of methylprednisolone pulse macrolide therapy for children with refractory MPP.
timeFrame: 3-year
Other outcomes:
Locations:
Study officials:
affiliation: Chongqing Medical University
name: zhengxiu luo, doctor
role: PRINCIPAL_INVESTIGATOR
References: