louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02002767: Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Official title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Virus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.


Eligibility criteria: Key Inclusion Criteria:

* General good health with stable chronic kidney disease in Severe Renal Impairment Group
* Screening labs within defined thresholds
* Creatinine clearance must be \< 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group

Key Exclusion Criteria:

* Females who are pregnant or nursing, or males who have a pregnant partner
* Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast
timeFrame: Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1
measure: PK Parameter of Velpatasvir: AUCinf
timeFrame: Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1
measure: PK Parameter of Velpatasvir: Cmax
timeFrame: Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1
Secondary outcomes:
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: First dose date plus 30 days
measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
timeFrame: First dose date plus 30 days
measure: Percentage Protein Binding of Velpatasvir
timeFrame: 2 or 3 hours post-dose on Day 1
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Saint Paul
country: United States
state: Minnesota
city: San Antonio
country: United States
state: Texas
city: Christchurch
country: New Zealand
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00212667: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Official title: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Involutional Osteoporosis
Keywords: ONO-5920, osteoporosis, bisphosphonate
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2005-09-21
Enrollment: 650
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.


Eligibility criteria: Inclusion Criteria:

1. Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
2. Patients having radiographically confirmed vertebral (T4-L4) fractures
3. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients having secondary osteoporosis or another condition that presents low bone mass
2. Patients having findings on X-ray that affect evaluation of vertebral fracture
3. Patients that have been administered bisphosphonate derivatives
4. Other exclusion criteria as specified in the study protocol

Primary outcomes:
measure: New fragility vertebral fracture
Secondary outcomes:
measure: New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain
Other outcomes:
Locations:
Study officials:
affiliation: Ono Pharmaceutical Co. LtTd.
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
citation: Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009 Aug;20(8):1429-37. doi: 10.1007/s00198-008-0816-7. Epub 2008 Dec 20.
Clinical trial NCT06780267: Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics
Official title: Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Postoperative Pain in Orthopaedics
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective orthopedic surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of severe allergies
2. Subjects with nervous system disease
3. Subjects with a history of mental illness
4. Subjects with abnormal liver and renal function
5. Subjects with poorly controlled hypertensive or hypotensive
6. QTc：\>450ms（male），\>470ms（female）
7. Subjects who screened positive for substance abuse
8. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
9. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: Safety：Incidence and severity of AE/SAE
timeFrame: from ICF signing date to day 12 since last dose(14 days)
Secondary outcomes:
measure: the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition
timeFrame: 48hours
measure: The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication
timeFrame: 48hours
measure: Participant ' satisfaction score for analgesia treatment
timeFrame: 48hours
measure: Investigator satisfaction score for analgesia treatment
timeFrame: 48hours
measure: Time of first use of remedial analgesic medication
timeFrame: 48hours
measure: Cumulative use of remedial analgesics
timeFrame: 48hours
measure: Cmax
timeFrame: 5 days
measure: Tmax
timeFrame: 5 days
measure: AUC0-12h
timeFrame: 5 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04682067: Diabetes Smoking Cessation Incentives Study
Official title: Incentives to Promote Smoking Cessation for Individuals With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Diabetes Type 2
Keywords: financial incentives
contingency management
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility of contingency management on improving smoking cessation among individuals with type 2 diabetes.

Detailed description: Type 2 diabetes (T2DM) and cigarette smoking are major causes of morbidity and mortality in US, and research indicates there is a complex relationship between these two risk factors. Smoking cessation is recommended as a standard treatment of diabetes by the American Diabetes Association; however, patients with T2DM and their providers are often inundated with other challenging lifestyle changes and disease management. Due to the complex relationship between diabetes and smoking and the large number of competing lifestyle changes recommended at diagnosis, smokers with T2DM may benefit from a contingency management (CM) program that incentivizes cessation. Providing patients tangible rewards to reinforce positive behaviors such as smoking abstinence has been proven effective in substance abuse programs, smoking cessation among pregnant women unwilling or unable to quit, and other population subgroups. In this CRUK2 study the investigators aim to test and further explore the potential effectiveness of financial incentives contingent upon proof of quitting smoking. The investigators will gather diabetes-related contextual factors associated with participation in the program and smoking cessation.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* earn a score \> 4 on REALM indicating \> 6th grade English literacy level
* willing to quit smoking 7 days from their first visit
* have an expired CO level \>8 ppm suggestive of current smoking at baseline
* currently smoking \> 5 cigarettes per day
* willing and able to attend 6 study visits

Exclusion Criteria:

* unable to demonstrate use of or unwilling to use the remote CO monitor and phone app

Primary outcomes:
measure: Number of participants completing 6 study visits
timeFrame: 5 weeks
measure: Number of participants with >80% completion of daily ecological momentary assessments (EMA) completed
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of participants with biochemically verified abstinence at 4 weeks post quit
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Tobacco Research Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Sydney Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02074267: Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathy
Pain
Lead sponsor: Nang Kuang Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taichung Veterans General Hospital
First posted: 2014-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Gabapentin (Carbatin \& Neurontin) in patients with neuropathy pain.


Eligibility criteria: Inclusion Criteria:

* Subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) completed a screening / baseline period before randomization. Additional disease-specific inclusion criteria are listed in Table 1.
* Subjects must be 20 years of age or older.

Exclusion Criteria:

* Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives.
* Subjects who have a clinically significant or unstable medical or psychiatric condition.
* Subjects who are known of hypersensitivity to Gabapentin.
* Serum creatinine \> 1.5 times the upper limit of normal
* Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period.
* Subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain).
* Subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit.
* Subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.

Primary outcomes:
measure: Evaluation of pain intensity using the visual analog scale (VAS)
timeFrame: up to six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Nang Kuang Pharmaceutical Co., LTD
Study officials:
References:
Clinical trial NCT04214301: An Open-Label Preference Evaluation of BLI800
Official title: An Open-Label Preference Evaluation of BLI800
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

Detailed description: The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.

Eligibility criteria: Primary Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication
* 18 to 85 years of age (inclusive)
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Primary Exclusion Criteria:

* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon
* Subjects with ongoing severe, acute inflammatory bowel disease
* Subjects who had previous significant gastrointestinal surgeries
* Subjects with known severe renal, hepatic or cardiac insufficiency
* Subjects undergoing insulin therapy for any indication
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration
* Subjects undergoing colonoscopy for foreign body removal and/or decompression

Primary outcomes:
measure: Ease of Preparation Consumption
timeFrame: 2 days
Secondary outcomes:
measure: Preparation Compliance
timeFrame: 2 days
measure: Rating of Overall Experience
timeFrame: 2 days
measure: Comparison to Prior Preparation
timeFrame: 2 days
measure: Willingness to Repeat Preparation
timeFrame: 2 days
measure: Refuse if Prescribed Again
timeFrame: 2 days
measure: Rating of Aftertaste
timeFrame: 2 days
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Braintree Research Site 1
state: New York
city: Bellevue
country: United States
facility: Braintree Research Site 2
state: Washington
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John Mcgowan, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06885801: Evaluation of a Novel Nasal Conformer in Pediatric Patients
Official title: Evaluation of a Novel Nasal Conformer in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cleft Lip
Nasal Surgical Procedures
Lead sponsor: East Tennessee Children's Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.


Eligibility criteria: Inclusion Criteria:

* Patient's undergoing primary cleft lip repair or release of nasal scarring

Exclusion Criteria:

* patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate

Primary outcomes:
measure: Ease of use
timeFrame: 6 months
measure: safety of the conformer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00040001: Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Aderis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-06-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety of DTI-0009 in patients with atrial fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial fibrillation with rapid ventricular response.


Eligibility criteria: Inclusion Criteria

* Primary diagnosis of atrial fibrillation with rapid ventricular response of any duration as documented by an ECG

Exclusion Criteria

* Presence of other significant cardiac disease or history of significant neurological, hepatic,cardiovascular, renal, gastrointestinal, thyroid, respiratory, rheumatologic, or hematologic disease or impairment that in the investigator's judgment is serious enough to preclude the patient from safely participating in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Multiple locations
state: Virginia
Study officials:
References:
Clinical trial NCT04545801: Ketamine for Analgesia After Cesarean Section
Official title: Ketamine for Analgesia After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Postoperative Pain
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

Detailed description: In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

The patients were randomized in two groups:

* Group Ketamine: these patients recieved 0.25 mg/kg of Ketamin intravenously 5 minutes after the spinal anesthesia.
* Group Placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture.

The investigators recorded intra demographic, intraoperative and post operative data.

The main outcome was the analgesic score: the visual analog scale (VAS). dynamic VAS was also monitored at 24 hours post operatively.

Eligibility criteria: Inclusion Criteria:

* full term pregnant adult patients
* Monofetal pregnancy
* scheduled for urgent or elective cesarean section under spinal anesthesia

Exclusion Criteria:

* necessity of general anesthesia during the procedure
* Post partum hemorrage

Primary outcomes:
measure: Dynamic Visual Analog Scale
timeFrame: 24 hours after cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim University Hospital
state: Tunis
Study officials:
References:
Clinical trial NCT05692401: Weight Change with Controlled Ankle Movement (CAM) Boot Use
Official title: Weight Change with Controlled Ankle Movement (CAM) Boot Use
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ankle Injuries
Foot Injuries and Disorders
Body Weight Changes
Keywords: controlled ankle movement
CAM boot
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Milton S. Hershey Medical Center
First posted: 2023-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.

Detailed description: The study objectives include: 1) Determine if patients wearing a CAM (Controlled Ankle Movement) boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines at the time the CAM is dispensed and perform upper body exercises through the treatment period. 2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) To qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when CAM boot is used

Eligibility criteria: Inclusion Criteria:

* Age greater or equal to 18 years
* Participants with foot or ankle injury who are prescribed a CAM boot as standard of care
* Participants willing to have height and weight measured at the time of enrollment and final visit
* Participant is able to provide voluntary, written consent
* Fluent in written and spoken English
* Participant in the opinion of the Principal Investigator, is able to understand the clinical investigation

Exclusion Criteria:

* Age less than 18 years
* Pregnant women
* Participants with vertigo or other balance issues
* Participants unable to provide informed consent
* Participants with foot or ankle injury who will not be wearing a CAM boot
* Participants unable/unwilling to perform upper body exercises and follow nutrition recommendations

Primary outcomes:
measure: Weight change
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health Hershey Medical Center
name: Nell Blake, DPM
role: PRINCIPAL_INVESTIGATOR
References: