louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04483063: Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
Official title: Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: C. Acnes
Arthroscopic Rotator Cuff Repair
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff repair.


Eligibility criteria: Inclusion Criteria:

* primary arthroscopic rotator cuff repair

Exclusion Criteria:

* younger than 18 years
* having previous shoulder surgeries or shoulder infection episodes
* having a history of allergy to chlorhexidine
* who refused to participate

Primary outcomes:
measure: Culture positive
timeFrame: Within 2 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT00290563: Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)
Official title: A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Overactive Bladder
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 557
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Patients with predominantly urge incontinence overactive bladder episodes
* Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards

Exclusion Criteria:

* History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia
* Lower urinary tract symptoms associated with benign prostatic hypertrophy
* Active or current Urinary Tract Infections (UTIs)
* Surgery to correct prolapsed uterus or stress incontinence

Primary outcomes:
measure: Change in baseline in average daily micturitions as recorded on patient voiding diaries.
timeFrame: Duration of Trial
Secondary outcomes:
measure: The incidence of dry mouth.
timeFrame: Duration of Treatment
measure: Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
timeFrame: Duration of Treatment
measure: Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms.
timeFrame: Duration of Treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Frenkl TL, Zhu H, Reiss T, Seltzer O, Rosenberg E, Green S. A multicenter, double-blind, randomized, placebo controlled trial of a neurokinin-1 receptor antagonist for overactive bladder. J Urol. 2010 Aug;184(2):616-22. doi: 10.1016/j.juro.2010.03.147. Epub 2010 Jun 19.
Clinical trial NCT04698863: Assessment of Oxygenation With Oxygen Reserve Index for General Anesthesia
Official title: Assessment of Oxygenation With Oxygen Reserve Index for Different Fresh Gas Flows in General Anesthesia Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperoxia
Keywords: General anesthesia
Oxygen reserve index
Oxygenation
Hyperoxia
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aged between 18-65 years undergoing tympanomastoidectomy surgery

Brief summary: To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) risk class I-II,
* Undergoing tympanomastoidectomy

Exclusion Criteria:

* Morbid obesity
* Opioid sensitivity Alcohol or drug addiction
* Chronic obstructive pulmonary disease
* Coronary artery disease,
* Congestive heart failure
* Pronounced anemia
* Have a history of liver or kidney disease

Primary outcomes:
measure: to assess oxygenation with the oxygen reserve index (ORI) in different fresh gas flows in general anesthesia.
timeFrame: During the surgery procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
Study officials:
References:
Clinical trial NCT00004763: Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperandrogenism
Keywords: endocrine disorders
hyperandrogenism
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Baylor College of Medicine
First posted: 2000-02-25
Enrollment: 45
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to a 6-month course of leuprolide versus ethinyl estradiol/norethindrone (Ovcon 35) versus leuprolide plus Ovcon 35. Leuprolide is administered intramuscularly in depot form every 28 days.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Disease Characteristics

* Ovarian hyperandrogenism with Lorenzo hirsutism score 7 to 20, with or without severe acne
* Serum hormone levels: Follicle-stimulating hormone no greater than 40 mIU/mL Luteinizing hormone no greater than 40 mIU/mL Testosterone 60 to 200 ng/dL Dehydroepiandrosterone sulfate no greater than 430 micrograms/dL 17-hydroxyprogesterone no greater than 3.3 ng/mL in follicular phase Prolactin no greater than 18 ng/dL
* No adrenal or ovarian tumors

Prior/Concurrent Therapy

* At least 6 months since exogenous steroids At least 48 hours since drugs other than acetaminophen, ibuprofen, and aspirin

Patient Characteristics

* No malignancy, including the following carcinomas: Breast Cervix Ovary Uterus No other serious illness No cigarette smokers No nursing women No pregnancy within 6 months prior to entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Karen E. Elkind-Hirsch
role: STUDY_CHAIR
References:
Clinical trial NCT02283463: Novel Cervical Retraction Device
Official title: Patient Discomfort With a Novel Suction Based Cervical Retractor Compared to the Traditional Cervical Tenaculum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Due to Certain Specified Procedures
Lead sponsor: Bioceptive
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test a suction-based method of engaging the cervix. Bioceptive has developed a device that more gently and atraumatically attaches to the cervix with no bleeding. This novel attachment mechanism may diminish pain and discomfort. Pre-clinical testing has been performed on the device including testing on synthetic uterine models, human cadavers, and human uteri immediately post-hysterectomy (Utah IRB # 00059096). Results from these efforts have shown effective attachment to the cervix and the ability for the device to maintain suction throughout a procedure atraumatically. This study proposes to introduce this minimal risk device in a clinical setting to determine the response of women undergoing gynecologic procedures.


Eligibility criteria: Inclusion Criteria:

* Subjects presenting for IUD insertion or endometrial biopsy
* Able to consent for study in English or Spanish

Exclusion Criteria:

* Post-menopausal
* Current pregnancy
* Cervical abnormalities (cervical polyp, cervical lesion, or irregularity)
* Use of narcotics or Benzodiazepines prior to procedure

Primary outcomes:
measure: Pain Intensity Measure 100 point visual analogue scale
timeFrame: 1 day
Secondary outcomes:
measure: Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)
timeFrame: < 1 hour
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, School of Medicine
state: Utah
Study officials:
affiliation: University of Utah, Dept. of Obstetrics and Gynecology
name: David Turok, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turok DK, Simmons RG, Cappiello B, Gawron LM, Saviers-Steiger J, Sanders JN. Use of a novel suction cervical retractor for intrauterine device insertion: a pilot feasibility trial. BMJ Sex Reprod Health. 2018 Nov 5:bmjsrh-2017-200031. doi: 10.1136/bmjsrh-2017-200031. Online ahead of print.
Clinical trial NCT03873363: Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay
Official title: Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Outcome
Implant Design
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to one of two surgical techniques.
Primary purpose: TREATMENT

Brief summary: Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

Detailed description: The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).

For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).

Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

Eligibility criteria: Inclusion Criteria:

* Indication for TKA with a non-linked, bicondylar total knee replacement
* written informed consent

Exclusion Criteria:

* Chronic pain patients
* Neuromuscular Diseases
* general illnesses that make mobilisation more difficult and/or prevent follow-up
* Known posterior cruciate ligament insufficiency
* Need for a higher degree of linkage
* BMI over 40 kg/m²
* Study doctor, his family, employees or other dependent persons

Primary outcomes:
measure: Knee Flexion
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Function assessed by the Knee Society Score
timeFrame: 10 years after surgery
measure: Patient Reported Outcome
timeFrame: 10 years after surgery
measure: Health-related Quality of Life
timeFrame: 10 years after surgery
measure: Activity assessed by UCLA activity score
timeFrame: 10 years after surgery
Other outcomes:
measure: Adverse Events
timeFrame: 1 year after surgery
Locations:
city: Dresden
country: Germany
facility: University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
state: Saxonia
Study officials:
References:
Clinical trial NCT00130663: Recognition of Abnormal Pediatric Blood Pressures in Primary Care
Official title: Recognition of Abnormal Pediatric Blood Pressures in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2005-08-16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will look at general pediatricians' effectiveness at screening children for elevated blood pressure values in the primary care setting. Two new screening tools will be introduced and their effectiveness will be measured against current practice by way of medical chart review.


Eligibility criteria: Inclusion Criteria:

* Health care supervision visit
* Documented measured blood pressure and height
* Between the ages of 3 years and 17 years

Exclusion Criteria:

* Younger than 3 years of age
* Older than 17 years of age
* No documented blood pressure measurement
* Not a health supervision encounter

Primary outcomes:
measure: written documentation by MD in medical record acknowledging elevated BP
Secondary outcomes:
measure: compliance with interventions
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric Academic Association/Ohio State University School of Medicine
name: Douglas J McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00209963: A Study of Gaboxadol in Primary Insomnia
Official title: A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Insomnia
Keywords: Primary insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of gaboxadol in primary insomnia.

Detailed description: To obtain long-term safety and tolerability data with gaboxadol.

Eligibility criteria: Inclusion Criteria:

* patients with Primary insomnia

Primary outcomes:
measure: Long-term safety in gaboxadol.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: H. Lundbeck A/S
name: Please contact: Annelies van der Hammen Legters
role: STUDY_DIRECTOR
References:
Clinical trial NCT03109535: MapTrek for Sedentary Workers
Official title: MapTrek for Sedentary Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 146
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine if participants randomized to our mHealth MapTrek game increases daily physical activity (average steps/day, active minutes/day) compared to a control group among sedentary office workers over 10 weeks. The investigators hypothesize the MapTrek intervention group will significantly increase their daily steps and active minutes compared to the control group over 10 weeks.


Eligibility criteria: Inclusion Criteria:

* Eligible participants were 21 to 65 year of age, working full-time (at least 35 hours/week) in a desk-dependent job (self-report sitting \>75% of work day), who owned a smart phone.

Exclusion Criteria:

* Exclusion criteria included ages \<18 years or \>65 years, pregnancy or planned pregnancy, prisoner status, and any contraindications to engaging in regular physical activity as identified by the Physical Activity Readiness Questionnaire (PAR-Q), not owning a smart phone, (Cardinal, Esters, \& Cardinal, 1996).

Primary outcomes:
measure: Average daily steps
timeFrame: 10 weeks
Secondary outcomes:
measure: Average daily active minutes
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Gremaud AL, Carr LJ, Simmering JE, Evans NJ, Cremer JF, Segre AM, Polgreen LA, Polgreen PM. Gamifying Accelerometer Use Increases Physical Activity Levels of Sedentary Office Workers. J Am Heart Assoc. 2018 Jul 2;7(13):e007735. doi: 10.1161/JAHA.117.007735.
Clinical trial NCT03746535: Cardiovascular Disease Risk in Women With Endometriosis
Official title: Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Endometriosis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-11-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 cohort clinical trial
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

Detailed description: Our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation. This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.

Eligibility criteria: Inclusion Criteria:

* Young women between the ages of 18 and 45 years (Controls);
* Young women between the ages of 18 and 45 years with endometriosis.

Exclusion Criteria:

* Subjects who smoke
* Subjects who have diabetes,
* Subjects with sleep apnea or BP\>140/90 will be excluded.
* Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.

Primary outcomes:
measure: Flow Mediated Vasodilation Microvascular skin blood flow analysis
timeFrame: 2 minutes
measure: Microdialysis perfusions
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Nina Stachenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06507735: The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera
Official title: The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of our study is to investigate the effects of supplemental mannose on sera of humans who are healthy. We will perform proteomics studies to elucidate changes to glycan structure and protein level changes. We hypothesize that we may find that mannose supplies more properly glycosylated protein substrate and helps expedite protein synthesis, that excess mannose leads to alternative glycan structures which confer improved stability, or that there are new sites that become glycosylated after mannose supplementation.

Detailed description: Subjects will be enrolled and a baseline blood sample taken. Subjects will take mannose supplements for 1 week (3-4 packets of a standard dose in water), then a follow up blood sample will be taken.

Subject blood will be analyzed by proteomic analysis for 1) change in glycan structure or 2) other protein based approaches to measure changes in levels of proteins.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* No known medical conditions
* Taking no medications or nutritional supplements
* Agree to the study and provide informed consent

Exclusion Criteria:

* Less than 18 years of age
* Known medical diagnosis, including pregnancy
* Presently taking medications and/or nutritional supplements
* Do not provide consent

Primary outcomes:
measure: Changes to glycan structure
timeFrame: ~1 month
measure: Change in glycoprotein levels
timeFrame: ~1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Jeffrey SoRelle, M.D.
role: PRINCIPAL_INVESTIGATOR
References: