louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00951171: Effect of Cervical Occlusion During Intrauterine Insemination (IUI)
Official title: Evaluation of the Effect of Cervical Occlusion During Infertility Treatment by Intrauterine Insemination
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 93
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for sonohysterograms as compared to those performed with a standard inseminator.

The investigators will compare pregnancy rates in patients undergoing routine IUI either with balloon occlusion or with standard insemination. The patients will receive the standard clinical care per the investigators' office guidelines, except they will be randomized to insemination with either of two catheters.

Detailed description: An open speculum will be used and patients will undergo insemination with their partners sperm (same quantity in both arms). If randomized to treatment arm a balloon catheter will be filled with 1cc of air prior to insemination. The speculum will be removed immediately and the catheter will be left in for 15 minutes and then removed. Pregnancy outcomes will be recorded in both groups.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing IUI for unexplained infertility in our office: Center for Reproduction and Infertility (Providence, RI)

Exclusion Criteria:

* "Abnormal" Semenalysis TMC \< 5 million
* Blocked Fallopian tubes

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 1 month
Secondary outcomes:
measure: Live Birth
timeFrame: 9 months
measure: Positive Pregnancy Test
timeFrame: 14 days
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Reproduction and Infertility
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Andrew Blazar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00849771: Operative Versus Nonoperative Treatment for Scapula Fractures
Official title: Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Scapula Fracture
Clavicle Fracture
Keywords: Displaced Scapula Fracture
Scapula Fracture
Extraarticular Scapula Fractures
Clavicle
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will include patients seen at participating facilities for the care of scapula fractures, who are 18 years of age or older, meet inclusion/exclusion criteria and are willing to consent.

Brief summary: The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.

The potential impact is a clearer set of choices in treatment options for this type of injury.


Eligibility criteria: Inclusion Criteria:

* 18 Years of Age or Older
* Displacement of glenoid neck and scapula body of greater than 2 cm
* Angular deformity between the fracture fragments of greater than 45 degrees.
* A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees
* A glenopolar angle less than 22 degrees
* A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC)

Exclusion Criteria:

* Age Less Than 18 years Old
* Brachial Plexus Injury
* Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation
* Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage
* Ipsilateral Upper Extremity Injury
* Previous Shoulder Surgery
* Insufficient English proficiency to complete the DASH Questionnaire

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William T. Obremskey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Peter Cole, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02102971: Observational Study of Biomarker During Liver Surgery
Official title: Autophagy in Liver Injury: Changes in Autophagy Biomarkers During Liver Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Cancer
Hepatobiliary Tract Adenomas and Carcinomas
Keywords: liver
ischemia
reperfusion
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-04-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver Disease Requring Liver Resection Surgery

Brief summary: The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve hepatic function of patients with liver diseases.

Detailed description: If asked to participate in this research study, it is because a liver resection/liver transplantation surgery has been scheduled. During the procedure a small section will be collected for additional testing of Sirtuin 1. In addition, information concerning the liver disease, laboratory and pathology results after surgery will be collected by the investigators.

Eligibility criteria: Inclusion Criteria:

* liver resection \> 2 segments,
* plate count \> 100 x 109/L, and
* prothrombin activity \>60%.

Exclusion Criteria:

* liver cirrhosis,
* portal hypertension,
* steatohepatitis or severe steatosis,
* patients receiving additional ablation therapies,
* laparoscopic resection, and
* simultaneous extrahepatic procedures such as colorectal resection or pancreatoduodenectomy

Primary outcomes:
measure: Biochemical analysis of sirtuin1 from liver tissues during liver surgery
timeFrame: 30 minutes during liver surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Jae-Sung Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04110171: Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With Multiple Sclerosis.
Official title: Relationship Between the Nutritional Habits and Relapsing and Disability Rates in Patient With
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Habits in Multiple Sclerosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patient 20 and 40 years ago with both gender diagnosed with multiple sclerosis under treatment or not

Brief summary: patient with multiple sclerosis will undergo and completed comprehensive survey measuring body mass index and assessment of obesity ,health related quality of life,disability,relapsing and complete data on their dietary habits.


Eligibility criteria: Inclusion Criteria:

* 20 to 40 years of age
* males or females
* all cases of diagnosed multiple sclerosis under treatment or not

Exclusion Criteria:

* disable cases
* long standing disease more than five years.

Primary outcomes:
measure: measurement of the body mass index and so assessment of obesity of the patient and multiple sclerosis . also assessment of nutrition habits by dietary habits questionnaire in theses patient .
timeFrame: one and half year
measure: assessment of disability rates of the patient of multiple sclerosis.
timeFrame: one and half year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06069271: Kettlebell Swings and Paraspinal Muscle Function
Official title: The Immediate Effects of a Standardized Kettlebell Swing Protocol on Lumbar Paraspinal Muscle Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Training
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized control trial is to determine the extent of muscle fatigue in the lumbar erector spinae musculature secondary to a high-intensity interval kettlebell swing protocol utilizing TMG previously published by Jay et. al in 2011.

Detailed description: Background: Kettlebell swings are commonly utilized to target the lumbar erector spinae and lower body musculature. This exercise exhibits distinct loading properties that requires cyclical contraction of the trunk extensors and posterior chain, potentially explaining its novel influence on muscle contractility. Tensiomyography (TMG) is a reliable, noninvasive, passive technique that may be used to examine muscular fatigue produced by kettlebell swings. Purpose: The purpose of this randomized control trial is to determine the extent of muscle fatigue in the lumbar erector spinae musculature secondary to a high-intensity interval kettlebell swing protocol utilizing TMG previously published by Jay et. al in 2011. Subjects: Forty-one adults between the ages of 18 and 45 were recruited. Inclusion criteria included subjects with no recent history of low back pain and clearance by the physical activity readiness questionnaire. Methods: Participants were randomly allocated to either a kettlebell swing group (KBS; n=21) or a control group (CON; n=20) who only performed the unloaded warm up. Participants were assessed at baseline, post-intervention, and 24-hours post-intervention for bilateral erector spinae fatigue, measured by five TMG parameters (Dm, Tc, Tr, Td, Ts).

Eligibility criteria: Inclusion Criteria:

* Ages of 18 and 45 years of age.
* Clear PAR-Q

Exclusion Criteria:

* history of low back pain
* pre-existing injuries
* If "YES" was the response to any of the seven questions in the PAR-Q, the participant was deemed to be unable to exercise safely.

Primary outcomes:
measure: Tensiomyography
timeFrame: Baseline, immediate after exercise, 24 hours after exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: William J Hanney, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02455271: Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
Official title: Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 438
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have completed Study LUN01S and need to continue eszopiclone

Brief summary: To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.


Eligibility criteria: Inclusion Criteria:

1. Participants who have completed LUN01S and need to continue eszopiclone

Primary outcomes:
measure: Assessment of overall improvement
timeFrame: At month 3
measure: Assessment of overall improvement
timeFrame: At month 6
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
name: Akira Endo
role: STUDY_DIRECTOR
References:
citation: Japanese Journal of Sleep Medicine 11: 81-94, 2017.
Clinical trial NCT06550271: The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals
Official title: The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals: A Retrospective Study and Review With Clinical Implications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: Bioavailability
Rapamycin
Aging
Longevity
Sirolimus
Healthy aging
age-related conditions
energy improvement
Lead sponsor: AgelessRx
Sponsor class: INDUSTRY
First posted: 2024-08-13
Enrollment: 67
Sex: ALL
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who sought rapamycin prescription for longevity support, pain reduction, energy improvement, weight loss, mood improvement, sleep improvement, or oral health improvement were included in the study. To be eligible to receive AgelessRx's standard rapamycin treatment protocol, participants had to be ≥40 years of age, without a history of uncontrolled disease. All patients treated with rapamycin and opted for at least one blood draw test between May 1, 2023, and December 15, 2023, were included in this retrospective study.

Brief summary: This study collected real-world evidence to better understand and define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).


Eligibility criteria: Inclusion Criteria:

* Receive AgelessRx's standard Rapamycin treatment protocol
* Opted to complete at least 1 blood draw at their local Quest Lab

Exclusion Criteria:

* Not approved for current AgelessRx standard Rapamycin treatment
* History of uncontrolled disease
* Unable to complete at least 1 blood draw at their local Quest Lab

Primary outcomes:
measure: define the relative bioavailability ratio between compounded rapamycin and generic rapamycin
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: AgelessRx
state: Michigan
Study officials:
affiliation: AgelessRx
name: Sajad Zalzala, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01740271: A Study of Genetic Based Chemotherapy Dosing for Breast Cancer Patients
Official title: Pharmacogenetic Dosing of Epirubicin in FEC Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast cancer
non-metastatic carcinoma of the breast chemotherapy
adjuvant therapy
neoadjuvant
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Epirubicin is a common chemotherapy medication used in the treatment of breast cancer. However, chemotherapy dosing is calculated based on people's height and weight, which may not be the most accurate way. The purpose of this study is to see if epirubicin dosing based on people's genetic profiles is better than the usual methods.


Eligibility criteria: Inclusion Criteria:

1. Female patients with histologically confirmed non-metastatic invasive breast cancer who are scheduled to receive at least three cycles of FEC100 in the adjuvant or neoadjuvant setting
2. Documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor \[ER\], progesterone receptor \[PR\] and HER-2 status
3. Eastern Cooperative Oncology (ECOG) performance status of ≤ 2
4. A Left Ventricular Ejection Fraction (LVEF) ≥ 50%.

Exclusion Criteria:

1. Uncontrolled congestive heart failure (CHF) or angina, history of myocardial infarction within 2 months before study enrollment, or cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification.
2. Psychiatric disorder(s) that would interfere with consent, study participation, or follow up.

Primary outcomes:
measure: The goal of this study is to determine the safety of pharmacogenetic guided dosing of epirubicin for each UGT2B7 genotype.
timeFrame: 10 years
Secondary outcomes:
measure: Secondary Objectives i) To verify relationships between uridine glucuronosyltransferase 2B7 polymorphisms and epirubicin pharmacokinetics ii) To verify relationships between body composition and epirubicin pharmacokinetics
timeFrame: 10 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Michael B Sawyer, MD FRCPC BScPharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: John R Mackey, MD FRCPC
role: STUDY_DIRECTOR
References:
Clinical trial NCT01062971: Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Official title: Comparative Clinical Study of The Safety And Efficacy of A New Fixed-Combination of Timolol-Brimonidine-Dorzolamide In Patients With Open Angle Glaucoma Or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Open-angle glaucoma
Ocular hypertension
POAG
Treatment
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare intraocular pressure lowering effectiveness of a new fixed combination drug.

Detailed description: This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.

Eligibility criteria: Inclusion Criteria:

* Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
* Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).

Exclusion Criteria:

* Clinically relevant ophthalmic or systemic conditions may be excluded.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: basal (day 1 ) and final (day 60)
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: basal (day 1 ) and security call (day 75)
Other outcomes:
Locations:
city: Montemorelos
country: Mexico
facility: Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos
state: Nuevo Leon
Study officials:
affiliation: Clinical Research Department. Laboratorios Sophia S.A de C.V.
name: Leopoldo M Baiza-Duran, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03345771: Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Official title: Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or portable negative pressure wound dressing is superior in preventing wound complications and infection rates in obese patients undergoing total joint arthroplasty (TJA). Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and analyze the cost benefit of each.


Eligibility criteria: Inclusion Criteria:

* Those identified at pre-operative testing to have an elevated BMI (\> 35)

Exclusion Criteria:

* Active infection
* previous scar or wound healing complication
* post traumatic degenerative joint disease (DJD) with hardware
* revision surgery
* inflammatory arthritis
* anticoagulation outside of the standard of care.

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: Day 8
measure: Wound Evaluation Scale (WES)
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ran Schwarzkopf, MD
role: PRINCIPAL_INVESTIGATOR
References: