louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04231422: A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
Official title: A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Penile Elongation
Keywords: platelet-rich plasma
Lead sponsor: BrandeisMD
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants comprised of men with a desire for penile elongation.

Brief summary: The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.


Eligibility criteria: Inclusion Criteria:

1. Stretched penile length between 3.5 - 8.0 in
2. Age 20-55 years of age
3. Desire penile length elongation
4. Willing to complete all aspects of combined treatment plan
5. Able to measure erect penile length and mid-shaft girth at 1-month intervals
6. Judged to be in good health based on medical history, physical exam, and laboratory profile
7. Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)

Exclusion Criteria:

1. No prior surgical Peyronie's disease treatment
2. No chordee with or without hypospadias
3. No infiltration by benign or malignant mass
4. No active STD
5. No infiltration by an infectious agent such as lymphogranuloma venereum
6. No uncontrolled psychiatric conditions
7. No uncontrolled neurologic conditions
8. No other uncontrolled medical conditions such as HTN or DM
9. No history of spontaneous priapism
10. Is unable to safely use the study devices as determined by the principal investigator
11. No thrombosis of the dorsal penile artery or vein
12. No known history of coagulation disorder
13. No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study
14. Testosterone level lower than 500

Primary outcomes:
measure: Stretched penile length
timeFrame: baseline to six months
Secondary outcomes:
measure: SHIM Score
timeFrame: baseline to six months
measure: BDD-YBOCS
timeFrame: baseline to six months
measure: Safety Measurement
timeFrame: baseline to six months
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: BrandeisMD
state: California
Study officials:
affiliation: BrandeisMD
name: Judson Brandeis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839122: A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Benign Prostate Hyperplasia
Keywords: Dutasteride
Tadalafil
Lead sponsor: Yuyu Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-20
Enrollment: 28
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 19 to 45 years
* BMI score 19 kg/m2 to 28 kg/m2
* SBP \< 140 mmHg and ≤ 90 mmHg or DBP \< 90 mmHg and ≥ 50 mmHg
* Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
* Voluntarily signed the informed consent form

Exclusion Criteria:

* Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months
* History of hypersensitivity
* History of Cardiovascular disease
* History of degenerative Retina disease
* Lactose intolerance
* History of vision loss
* Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system
* Donated whole blood (transfusion, apheresis etc..) within 60 days
* Participated and administered the investigational products in other clinical trial within 90 days
* Taking drugs which may affect Clinical trial within 30 days
* Excessive alcohol consumption (\> 3 units/week, 1 unit)
* Taking food which may affect Clinical trial within 7 days
* Positive result from Urinary test, Serum test
* Not eligible due to other reasons including laboratory results
* Clinically significant disorders result from Electrocardiography test
* Not eligible due to investigator's judgments

Primary outcomes:
measure: Area Under the Curve(AUC) of Dutasteride
timeFrame: 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,32,48,72,96,144,192,240 hours
measure: Area Under the Curve(AUC) of Tadalafil, Dutasteride
timeFrame: 0,24,72,96,96.5,97,97.5,98,99,100,102,104,106,108,120,120.5,121,121.5,122,122.5,123,123.5,124,125,126,128,132,144,152,168,192,216,264,312,360 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AIDS Malignancy Consortium
name: hyeng-seok H Lim, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03990922: CTPVB for Hepatectomy
Official title: Continuous Thoracic Paravertebral Block for Open Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Paravertebral Block
Hepatectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.

The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Primary outcomes:
measure: the postoperative recovery quality on postoperative day 7
timeFrame: at the 7th postoperative day
Secondary outcomes:
measure: the postoperative recovery quality on postoperative day 3
timeFrame: at the 3th postoperative day
measure: The pain scores determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 8, 24,48 hours after the surgery
measure: cumulated morphine consumption
timeFrame: At 8, 24,48 hours after the surgery
measure: time to resumption of bowel movement
timeFrame: Up to 2 weeks after surgery
measure: time to out-of bed activity/ambutation
timeFrame: Up to 2 weeks
measure: post operative length of stay
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: xulei cui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05834322: Exercise, PA, Sleep Quality and Cognitive Function Among Older Adults.
Official title: Relationship Between Exercise, Physical Activity Levels, Sleep Quality and Cognitive Function Among Older Adults.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Function
Keywords: physical activity
cognitive function
sleep
older adults
Lead sponsor: National Changhua University of Education
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants should be over 65 and haven't been diagnosed with MCI or dementia.

Brief summary: The rapid increase in the prevalence of dementia in Taiwan poses an economic burden on healthcare systems as well as the families of the patients. Thus, how to prevent dementia is a crucial issue. Mild cognitive impairment (MCI) is defined as cognitive decline objectively and subjectively and it has been deemed as a transitional state between normal cognition and dementia. Identifying and preventing MCI can be a venue for reducing the prevalence of dementia. Sleep and physical activity are modifiable risk factors of MCI. Both factors could influence brain structure, such as the volume of the hippocampus. As a result, physical activity and adequate sleep are helpful to prevent the decline of cognitive function. In addition, sleep could regulate physical activity and change cognitive function indirectly. To our knowledge, there has been no research investigating the relationship between sleep, physical activity, and cognitive function in Taiwan. Hence, this research will aim to explore the relationship between sleep, physical activity, and cognitive function. Whether sleep and physical activity can be predictors of MCI will be investigated. We will recruit 150 participants aged above 65, who haven't been diagnosed with MCI or dementia. The measurements will include the Chinese version of The Pittsburgh Sleep Quality Index (PSQI), the Chinese Version of the Physical Activity Scale for the Elderly (PASE-C), and the Chinese version of Montreal Cognitive Assessment (MoCA). The relationship between sleep, physical activity level, and cognitive function will be analyzed by multiple linear regression and Pearson correlations. A prediction equation will be established.


Eligibility criteria: Inclusion Criteria:

* aged above 65
* haven't been diagnosed with MCI or dementia
* be able to read and write in Chinese

Exclusion Criteria:

* elders who unable to talk or communicate

Primary outcomes:
measure: Cognitive function
timeFrame: at the time the participants enroll
measure: Sleep quality
timeFrame: at the time the participants enroll
measure: Physical activity levels
timeFrame: at the time the participants enroll
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: National Chunghua University of education
Study officials:
References:
Clinical trial NCT02024022: A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy
Official title: A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Cleansing Process
Colonoscopy
Keywords: colonoscopy
bowel cleansing
polyethylene glycol
sodium picosulphate / magnesium citrate
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.


Eligibility criteria: Inclusion Criteria:

* all patients \> 18 years of age undergoing elective colonoscopy on an outpatient basis

Exclusion Criteria:

* refusal to sign informed consent
* pregnancy
* advance kidney, liver or heart disease
* suspicion of malignant / benign stenosis of the digestive tract

Primary outcomes:
measure: bowel cleansing
timeFrame: 24 hours
Secondary outcomes:
measure: patient comfort level during bowel cleansing
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Cluj
country: Romania
facility: Institutul Regional de Gastroenterologie si Hepatologie prof. dr. Octavin Fodor
city: Cluj
country: Romania
facility: Spitalul CFR
Study officials:
affiliation: Clinical Hospital Colentina
name: Theodor Voiosu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Voiosu T, Ratiu I, Voiosu A, Iordache T, Schipor A, Baicus C, Sporea I, Voiosu R. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol. J Gastrointestin Liver Dis. 2013 Jun;22(2):129-34.
Clinical trial NCT06232122: Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer
Official title: Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer With CA125 Elevation From Complete Response After Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Keywords: 68Ga-FAPI-46
18F-FDG
CA-125
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy

Detailed description: Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.

Eligibility criteria: Inclusion Criteria:

* Pathologically proven ovarian cancer with complete response after therapy
* Age between 30 and 80
* Elevation of serum CA125 value above the normal range (\>35 U/mL) or doubling of serum CA125 value within the normal range
* ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
* Willing to enter this prospective study with signed informed consent form

Exclusion Criteria:

* Patients with history of other malignancy
* Patients who are pregnant or lactating
* Patients with fasting fingerstick glucose level higher than 200 mg/dl
* Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
* Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators

Primary outcomes:
measure: Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset
timeFrame: 2 months for individual participants to complete all visits
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou Branch
Study officials:
References:
Clinical trial NCT00542022: Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)
Official title: A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 149
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: To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.


Eligibility criteria: Inclusion Criteria:

* Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
* Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
* Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

* Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
* Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
* Female patient is pregnant or breast-feeding

Primary outcomes:
measure: MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count
timeFrame: 12 weeks
Secondary outcomes:
measure: MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03049722: Clinical Investigation Plan for the AVOPT Data Collection Clinical Study
Official title: Clinical Investigation Plan for the AVOPT Data Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Pacemaker, Artificial
Lead sponsor: Biotronik Canada Inc
Sponsor class: INDUSTRY
First posted: 2017-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.


Eligibility criteria: Inclusion Criteria:

* Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker
* Possessing 1st or 3rd degree AV block
* Implanted with Biotronik bipolar RA and RV leads
* Implantation date should be at least 4 months prior to this study

Exclusion Criteria:

* Patient is a minor (18 years old or younger)
* Patient is pregnant or breast-feeding
* Patient does not have the legal capacity to provide consent
* Patient has Mobitz type I or Mobitz type II heart block
* Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats.
* Patient is participating in other clinical studies during the clinical study
* Patient is strictly pacemaker dependent (physician discretion)

Primary outcomes:
measure: Correlation analysis between measured PWD and optimal AVD.
timeFrame: Up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: Rouge Valley Centenary
state: Ontario
city: Sherbrooke
country: Canada
facility: CHUS - Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
References:
Clinical trial NCT00828022: Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer
Official title: A Single-Institution, Open-Label, Single-Arm phase1/2 Study of Measles Vaccine as Consolidation in Patients With Measles Virus-Positive, Stage 3B/4 Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non-Small Cell Lung Cancer
Measles
Keywords: measles-positive NSCLC
measles vaccine
consolidation
Stage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of the study are to assess the efficacy and safety of live, attenuated measles vaccine as consolidation therapy in patients with measles-positive, non-small cell lung cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4) tumors in remission.

Detailed description: This is a single-institution, non-randomized phase 1/2 study in patients with locally-advanced or metastatic NSCLC in remission after receiving standard systemic chemotherapy of four cycles of combination chemotherapy consisting of four cycles of cisplatin combined with vinorelbine.

Eligibility criteria: Inclusion Criteria:

* Patients in remission after first-line chemotherapy

Exclusion Criteria:

* Progressive disease

Primary outcomes:
measure: To assess progression-free survival (PFS) and overall survival (OS) in patients with NSCLC in remission receiving subcutaneous live-attenuated measles virus vaccine as consolidation therapy in patients with measles-positive tumors.
timeFrame: 2-years
Secondary outcomes:
measure: To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms.
timeFrame: 2 years
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Department of Oncology, Soroka Medical Center
Study officials:
References: