louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04784000: Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527
Official title: A Phase 1 Study Assessing the Effect of Carbamazepine, a P-Glycoprotein Inducer, on the Pharmacokinetics of AT-527 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Use of other prescription drugs with 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Pharmacokinetics (PK) of AT-527 (RO7496998)
timeFrame: Day 1 vs Day 26
measure: Pharmacokinetics (PK) of AT-527 (RO7496998)
timeFrame: Day 1 vs Day 26
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Atea Study Site
state: Quebec
Study officials:
References:
Clinical trial NCT02419300: Could Colour Dopper Improve the Diagnosis of Retained Placental Fragments After Second Trimester Miscarriage ?
Official title: Value of Pelvic Ultrasonography and Colour Doppler in Diagnosing Retained Placental Fragments After Mid Trimester Miscarriage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Miscarriage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 82
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting The Obstetrics department in Ain Shams University Hospital complaining of early second trimesteric abortion

Brief summary: Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.

Detailed description: This is a study for diagnostic accuracy test where all patients will undergo US and Doppler examination after second trimester miscarriage. Then all patients with endometrial mass on US will undergo colour Doppler then surgical evacuation and results of histopathology will be recorded.

Now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, PPV and NPV of US and Doppler are the primary outcome

Eligibility criteria: Inclusion Criteria:

* Pregnancy duration: early mid-trimester from 14 to 20 weeks
* Endometrial mass upon ultrasound examination after second trimesteric miscarriage

Exclusion Criteria:

* Uterine congenital anomaly
* Patients with signs of sepsis.
* Negative scan after second trimesteric miscarriage

Primary outcomes:
measure: Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage
timeFrame: 60 minutes after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
state: Al Qahirah
Study officials:
References:
Clinical trial NCT00893100: Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%
Official title: Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.

Detailed description: Pain after hemorrhoidectomy remains a major postsurgical complication.Therefore pain management in patients is an important goal.Many studies have focused on surgical techniques,preoperative and postoperative regimes.We assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with grade 3 or 4 hemorrhoid who underwent Milligan-Morgan surgery.

Exclusion Criteria:

* Patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoidal surgery,or those who had previous adverse effect from calcium channel blocker drugs and also those who were pregnant.

Primary outcomes:
measure: Reduction of Pain
timeFrame: daily in one week
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Sina General Hospital
Study officials:
affiliation: Sina Hospital
name: Farshad Jalili, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04511000: Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg
Official title: A Randomized, Open-label, Parallel, Multi-Center Phase IV Study to Compare of the Efficacy and Safety of Lipilou 20 mg and Lipilou 10 mg in High-risk Patients With Hypercholesterolemia(PEARL Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 250
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: This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.

Exclusion Criteria:

* Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
* Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.

Primary outcomes:
measure: Change rate in LDL-C
timeFrame: 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References:
Clinical trial NCT00219700: Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
Official title: Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: NSAID-PC
IBU-PC
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: Texas Higher Education Coordinating Board
First posted: 2005-09-22
Enrollment: 125
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: To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events


Eligibility criteria: Inclusion Criteria:

* moderate osteoarthritis in the hip and/or knee requiring chronic pain medication
* others per protocol

Exclusion Criteria:

* sensitivity to NSAIDs and lecithin
* hypertension
* history of GI and other specific problems
* use of medications and other criteria per the protocol

Primary outcomes:
measure: Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
Secondary outcomes:
measure: WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03289000: A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System
Official title: A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteo Arthritis Knee
Keywords: osteoarthritis
knee arthroplasty
knee replacement
patient specific
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee replacement to treat any condition indicated on the device's instructions for use.

Brief summary: This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.

Detailed description: Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.

* Demographics and Medical History
* Pre \& Post-Operative Data including Range of Motion
* Surgical Data
* Survivorship (phone/email or last known visit)
* Patient Reported Outcomes (phone/email single time point visit)

  * Patient Satisfaction
  * KOOS Jr.

Eligibility criteria: Inclusion Criteria:

1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
2. Over 18 Years of age

Exclusion Criteria:

1. BMI \> 40

Primary outcomes:
measure: Demographics and Medical History
timeFrame: 1 year
measure: Pre and Post Operative Range of Motion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Huntington
country: United States
facility: Scott Orthopedic Center
state: West Virginia
Study officials:
References:
Clinical trial NCT06730659: A Clinical Study of CHT101 in CD70-Positive Advanced Solid Tumors
Official title: A Single-Arm, Open-Label, Phase I Study of CHT101 for CD70-Positive Relapsed/Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed / Refractory Solid Tumor
Keywords: Allogeneic CAR-T
Safety
Efficacy
PK
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
First posted: 2024-12-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.

Detailed description: 4 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and sign a written informed consent documen；
2. At the date of signing ICF, 18 \~70 years old, male or female；
3. Histopathological confirmed advanced or metastatic solid tumors patients who have failed to standard treatment or intolerance with standard treatment；
4. Positive CD70 expression;
5. At least one measurable lesion at baseline per RECIST version 1.1；
6. The expected survival time is more than 12 weeks;
7. ECOG 0-1 points;
8. Adequate organ functions;

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 28 days
measure: Disease control rate (DCR)
timeFrame: 28 days
measure: Progress-free survival(PFS)
timeFrame: 2 years
measure: Overall survival (OS )
timeFrame: 3 years
measure: pharmacokinetics (PK)
timeFrame: 6 months
measure: Pharmacodynamics (PD)
timeFrame: 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
References:
Clinical trial NCT05832359: Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
Official title: Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Rheumatic Diseases
Keywords: Childhood rheumatic diseases
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 278
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases.

Detailed description: to reveal the changes that can occur in different childhood rheumatic diseases, the treatment process of the disease and the drugs used on the dental age and mandible

Eligibility criteria: Inclusion Criteria:

* Patients aged 6 to 14 years with childhood rheumatism
* Patients without bilateral congenital germ deficiency in the lower teeth
* Patients with seven teeth (except no #8) on the left of the mandibula (No seven teeth on the left of the mandibula, there should be a symmetrical tooth on the right of the mandibula.

Exclusion Criteria:

* Patients with bilateral congenital germ deficiency in lower teeth in intraoral and/or radiographic examinations
* Patients with asymmetry and magnification errors and where anatomical structures cannot be seen clearly in the panoramic x-ray
* Patients with a significant number of missing teeth due to trauma or disease, root canal treatment, and pathological tooth structure
* Patients with a history of other chronic diseases

Primary outcomes:
measure: Dental Age Estimation
timeFrame: 3 months
Secondary outcomes:
measure: Mandibular bone morphometric measurements
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ecem Ipek
Study officials:
References:
Clinical trial NCT02730559: Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Keywords: Motivational Interviewing
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary focus of this proposal is to address growing concern of overweight/ obese adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled clinical trial to compare the effectiveness of Motivational interviewing (MI) interventions with the parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be recruited from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad will have more success due to the possible synergetic effect compared to adolescents alone. The study's primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary outcomes include overall improvement in their lifestyle and their responses to the MI intervention.


Eligibility criteria: Inclusion Criteria:

* Age at randomization: 10-17 years old
* 12 hour fasting lipid profile with triglycerides ≥39 mg/dL (1.0 mmol/L) or HDL-C ≤46 mg/dL (1.2 mmol/L), and with non-HDL-C ≥123 mg/dL (3.2 mmol/L)
* Waist to height ratio ≥0.5.

Exclusion Criteria:

* On lipid lowering medication
* non-English speaking
* Developmentally delayed

Primary outcomes:
measure: Changes in total cholesterol to HDL-C ratio
timeFrame: Initial clinic visit (baseline); Repeated 6 months after baseline;
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05811559: Investigation of Sensory Processing Patterns of Elderly Individuals Who Have Had Hip Fracture Surgery
Official title: Investigation of the Relationship Between Sensory Processing and Potential Impact Factors in Elderly Adults Receiving Hip Fracture Surgery for Falling
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensory Disorder
Sensory Processing Disorder
Hip Fractures
Fall Injury
Falling
Sensitivity
Elderly
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 134
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older adult individuals who have suffered a fall and therefore undergo hip fracture surgery.

Brief summary: This study aims to evaluate the sensory processing processes of elderly adults who have undergone fall-related hip fracture surgery in the last 6 months, according to different patterns, and to examine the relationship between physical performance, fall risk, fear of falling, and depression parameters that may be related to sensory processing.


Eligibility criteria: Inclusion Criteria:

* Being 65 years or older
* Being able to stand independently for 30 seconds
* Being able to walk 3 m independently (with an assistive device if necessary)
* Getting a score of 24 or more on the Mini Mental Test

Exclusion Criteria:

* Hip fracture patients receiving medical treatment for pathological hip fractures, polytrauma, traffic accidents, bone tumors
* Having a history of diseases that may directly affect the evaluation process (neurological diseases such as Parkinson's, Alzheimer's and cancer)
* Having vision and hearing loss
* Having a psychiatric illness

Primary outcomes:
measure: Adult Sensory Processing Scale
timeFrame: 20 minutes
measure: Short Physical Performance Battery
timeFrame: 25 minutes
measure: Timed Up and Go Test
timeFrame: 5 minutes
measure: Falls Efficacy Scale
timeFrame: 10 minutes
measure: Geriatric Depression Scale
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
state: Kagıthane
Study officials:
References:
Clinical trial NCT02729259: H2O VR for Burns 2015
Official title: Water Friendly Virtual Reality for Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Burn
Keywords: VRD
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
Collaborators: name: University of Washington
First posted: 2016-04-06
Enrollment: 56
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.

Detailed description: This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking

Exclusion Criteria:

* Age less than 18 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history

Primary outcomes:
measure: "Pain and anxiety" as measured by Graphic Rating Scale
timeFrame: up to an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R. Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: