louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01054261: To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.
Official title: A Phase I, Open-Label, Parallel-Group, Single Dose, Non-Randomized Study to Compare the Pharmacokinetics of Avanafil in Male Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal
Keywords: avanafil, renal, impairment, TA-1790
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment and to assess the safety and toleration of avanafil in subjects with mild and moderate renal impairment.


Eligibility criteria: Inclusion Criteria:

* Adult male subjects,
* 21-78 years of age, must be medically healthy with no clinically significant screening results (except for the subjects in Groups 2 and 3).
* Subjects with normal renal function (Group 1) must have an estimated CLcr of ≥80 mL/min.
* Subjects with renal impairment (Groups 2 and 3) must fulfill the additional following criteria: (a) Stable renal impairment; (b) Group 2 subjects with mild renal impairment must have a CLcr of ≥50 to \<80 mL/min and (c) Group 3 subjects with moderate renal impairment must have a CLcr of ≥30 to \<50 mL/min.

Exclusion Criteria:

* Major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal (with the exception of renal insufficiency for subjects in Groups 2 and 3), hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the Investigator; systolic blood pressure \< 90 or \>160 mmHg; diastolic blood pressure \< 50 or \> 95 mmHg; allergy to or previous adverse events with PDE5 inhibitors or its constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days prior to Day 1; use of any investigational drug within 30 days prior to Day 1; use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breathe alcohol test; positive cotinine test, positive urine drug screen (except in renally impaired subjects following approval by Sponsor). Additional exclusion criteria are listed in Section 4.2.

Primary outcomes:
measure: Single dose PK of avanafil
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VIVUS LLC
name: Shiyin Yee
role: STUDY_DIRECTOR
References:
Clinical trial NCT02039661: Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Curettage;
Pain Score
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-01-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of lidocaine spray on pain relief during endometrial sampling.

Detailed description: The study population will comprise women with abnormal uterine bleeding who will be scheduled for endometrial sampling or women who will have control biopsies before surgery due to other pathologies. We have two groups; the first group consisted of patients who receive lidocaine spray. The second group consisted of patients who receive placebo spray. Patients will be asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring will be performed at 3 different time points: immediately before to the procedure, during the procedure(immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients will be asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.

We will document the patients' demographics and medical information. All procedures will be performed by a single operator and the same team to avoid possible operator-dependent pain factors (counseling, patient preparation, attitude and operative steps during operation, moral and psychological support).

Eligibility criteria: Inclusion Criteria:

* Age\>18 years no allergy Patients with abnormal uterine bleeding

Exclusion Criteria:

* cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea

Primary outcomes:
measure: Pain Score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Education and Research Hospital of Medicine
Study officials:
affiliation: Kayseri Education and Research Hospital of Medicine
name: Gökhan Açmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942461: Inflammatory Response in Laparoscopic and Open Colectomy
Official title: Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: a-defensins
TLRs
Inflammatory Cytokines
CRP
No metastases
No other obvious inflammation
No chronic diseases
Lead sponsor: G. Hatzikosta General Hospital
Sponsor class: OTHER
Collaborators: name: University of Ioannina
First posted: 2009-07-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery


Eligibility criteria: Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* metastases
* stage 4 colorectal cancer
* recurrent disease
* chronic diseases
* obvious inflammatory condition

Primary outcomes:
measure: Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer
timeFrame: preoperative, intraoperative, 6h postop, 24h postop
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: G Hatzikosta General Hospital
Study officials:
References:
citation: Tsimogiannis KE, Tellis CC, Tselepis AD, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Toll-like receptors in the inflammatory response during open and laparoscopic colectomy for colorectal cancer. Surg Endosc. 2012 Feb;26(2):330-6. doi: 10.1007/s00464-011-1871-2. Epub 2011 Sep 5.
citation: Tsimogiannis KE, Telis K, Tselepis A, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Alpha-defensin expression of inflammatory response in open and laparoscopic colectomy for colorectal cancer. World J Surg. 2011 Aug;35(8):1911-7. doi: 10.1007/s00268-011-1140-5.
Clinical trial NCT05313061: MTX Hold During Covid-19 Booster
Official title: Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.


Eligibility criteria: Inclusion Criteria:

* Males or females ≥ 19 years of age at time of consent
* Have a diagnosis of RA per ACR criteria
* Require methotrexate for RA treatment
* Subject to a Covid-19 booster vaccination
* Must understand and voluntarily sign an informed consent form including writing consent for data protection

Exclusion Criteria:

* Pregnant or lactating females
* Previous anaphylactic response to the vaccine components
* Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
* Any condition including laboratory abnormality which places the subject at unacceptable risk
* Subjects who decline to participate

Primary outcomes:
measure: Covid-19 antibody titer before and after Covid-19 vacciation
timeFrame: 2 weeks
Secondary outcomes:
measure: T cell activation after vaccination
timeFrame: 2, 4, 16 weeks
measure: B cell activation after vaccination
timeFrame: 2, 4, 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.
citation: Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.
citation: Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, Sadun RE, Turner AS, Williams EA, Mikuls TR. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Arthritis Rheumatol. 2021 Oct;73(10):e60-e75. doi: 10.1002/art.41928. Epub 2021 Aug 4.
Clinical trial NCT06021483: Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
Official title: Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SCLC
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Metastatic SCLC who have failed first-line platinum-based chemotherapy

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.


Eligibility criteria: Inclusion Criteria:

* Patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study
* Patients who have received or are scheduled to receive Zepzelca™ inj., according to domestic approval indications
* Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy

Exclusion Criteria:

* Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment
* Patients with a history of hypersensitivity reactions to this drug or its components
* Pregnant, potentially pregnant, or lactating women
* Patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining)
* Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.

Primary outcomes:
measure: ORR (Overall Response Rate)
timeFrame: 6 months after the start of administration
Secondary outcomes:
Other outcomes:
measure: SAE & SADR Incidence Rate
timeFrame: 6 months after the start of administration
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
Study officials:
References:
Clinical trial NCT06600061: Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy
Official title: Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erector Spinae Plane Block
Opioid
Sparing
Selective Dorsal Rhizotomy
Pediatric
Spastic Cerebral Palsy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy.

Detailed description: Cerebral palsy (CP) is the most common physical disability affecting children. Selective dorsal rhizotomy (SDR) is a neurosurgical procedure that permanently reduces lower limb spasticity in children with CP by selectively targeting and removing sensory rootlets with aberrant activity.

Postoperative pain is often distressing for patients and their families and can result in complications, delayed participation in therapy, and poor functional recovery. Erector spinae plane block (ESPB) is a newly described interfascial plane block. ESPB is effective on both visceral and somatic pain.

Eligibility criteria: Inclusion Criteria:

* Age from 6 to 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status II, III.
* Patients with spastic cerebral palsy undergoing selective dorsal rhizotomy.

Exclusion Criteria:

* Allergy to local anesthetics.
* Severe fixed joint deformity.
* Previous orthopedic surgery.
* Patient with abnormal liver/kidney function.
* Patient with skin damage or infection at the proposed puncture site.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT00951561: A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Official title: A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea
Lead sponsor: Another Way Products
Sponsor class: INDUSTRY
First posted: 2009-08-04
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.

Detailed description: Pain caused by dysmenorrhea can range from mild to severe. At least 50% of all menstruating women experience appreciable pain at some time during their menstruation. An estimated 600 million work hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee. Treatment of dysmenorrhea may include either non-pharmacological or pharmacological measures. Pharmacological treatments include oral contraceptives to treat hormonal imbalances, over-the-counter analgesics or non-steroidal anti-inflammatory drugs. The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation. This study aims to provide information on the safety and efficacy of the Vipon in a randomized controlled clinical trial.

Eligibility criteria: Inclusion Criteria:

* Females ages \>= 18 years
* 4 consecutive monthly menstrual cycles
* Self-assessment of dysmenorrhea
* Non-pregnant status
* Agrees to use adequate birth control during the trial
* Consents to use tampons through the test of cure assessment
* Provides informed consent for participating in the trial

Exclusion Criteria:

* Prohibited use of pain medication 4 hours prior to treatment and during the first 2 hours after treatment with study medication
* Positive pregnancy test
* Unwilling or unable to comply with protocol
* Allergic to ibuprofen

Primary outcomes:
measure: Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model
timeFrame: 1 month, 2 months, 3 months, 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Department of Obstetrics and Gynecology
state: Missouri
Study officials:
References:
Clinical trial NCT02746861: Peer-Supported Diabetes Self-Management Support
Official title: Web-based Training of Peers to Deliver Diabetes Self-Management Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: peer mentor
peer supporter
peer coach
peer-to-peer mentoring
Lead sponsor: InquisitHealth, Inc.
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-04-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1c\>9%
* African American or Hispanic ethnicity

Primary outcomes:
measure: Average reduction in HbA1c from baseline
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: River Edge
country: United States
facility: InquisitHealth
state: New Jersey
Study officials:
affiliation: Chief Medical Officer
name: Ashwin Patel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01747083: Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
Official title: A Randomized, Open Label, Single Dose, Crossover Study to Investigate Food-effect Bioavailability of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)Under Fed and Fasting Conditions in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)


Eligibility criteria: Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* BMI between 19.0 - 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 90 days
* Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Primary outcomes:
measure: AUClast
timeFrame: up to 48 h post-dose
measure: Cmax
timeFrame: up to 48 h post-dose
Secondary outcomes:
measure: AUCinf
timeFrame: up to 48 h post-dose
measure: Tmax
timeFrame: up to 48h post-dose
measure: t1/2
timeFrame: up to 48 h post-dose
measure: Cmax
timeFrame: up to 48h post-dose
measure: AUClast
timeFrame: up to 48h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT02822183: Online Survey of Clinicians to Learn About Their Interpretation of Capnography Waveforms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Interpretation of Capnography Waveforms
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinicians who have at least two years of experience in interpreting capnography waveforms in their clinical practice

Brief summary: This online survey presents capnography waveforms and asks the survey participants to give feedback about their interpretation of the patient status, both in the form of a score and a set of text to describe their interpretation.

Detailed description: The capnography waveforms presented were originally collected from patients in various clinical settings, with patients both intubated and non-intubated. The de-identified waveforms are presented along with a statement about whether the patients were intubated or not, the amount of supplemental oxygen provided, and in some cases, the oxygen saturation of hemoglobin in the blood (SpO2). The participants are asked to provide a score between 1 and 10 to indicate their interpretation of the wellbeing of the patient. The participants are also asked to provide up to two sentences of text to describe their interpretation of the patient condition based on the information provided.

Eligibility criteria: Inclusion Criteria:

* Clinicians who have at least two years of experience in interpreting capnography waveforms in their clinical practice

Exclusion Criteria:

-

Primary outcomes:
measure: Wellbeing score
timeFrame: 1 day (survey completion)
measure: Text messages selected by survey participant
timeFrame: 1 day (survey completion)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: