louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04436172: Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus
Official title: Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus And Its Effect On Female Sexual Dysfunction As Assessed By Female Sexual Functioning Index (Fsfi) - A Pre-Post Intervention Design Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginismus
Lead sponsor: Karachi Medical and Dental College
Sponsor class: OTHER
Collaborators: name: Aziz Medical Center
First posted: 2020-06-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Painful sex continues to be a relationship issue and can lead to marital dys-harmony. Other consequences include infertility, low self-esteem, depression and anxiety.Our study shows that spinal anesthesia is an effective last resort management option in women with vaginismus. As a one-off treatment spinal anesthesia provides hope for such couples and brings about a positive change in their relationships.


Eligibility criteria: Inclusion Criteria:

* Virgin married women with non-consummation of marriage for more than two years due to vaginismus

Exclusion Criteria:

* partners reported erectile dysfunction
* who had vulvar skin conditions (e.g. lichen sclerosus)
* vulvovaginal and urinary tract infections
* endometriosis.

Primary outcomes:
measure: successful sexual intercourse
timeFrame: 1 year
measure: improvement in Female sexual functioning index
timeFrame: 1 year
Secondary outcomes:
measure: depression and relationship satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02930772: Sun Protection Factor Assay (SPF Assay 201/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT03653572: Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada
Official title: Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Use in Emergency/Medical Care
Keywords: Ultrasound
Emergency care
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of the study is to collect images data sets from clinical cases and periodic user feedback on the Next Generation Venue ultrasound system under clinical conditions. This is a medical device study designed as a clinical, open label, unblinded, non-randomized, prospective, feasibility research study.

Detailed description: Adult patients (aged \>18 years) will be enrolled as they present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), cardiac care unit (CCU), and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. Eligible subjects will undergo an ultrasound exam using the investigational ultrasound device. The exam type will be based on the subject's clinical condition. Users performing the scans will periodically be asked to provide feedback on User Survey forms prepared by the Sponsor. Image data sets from investigational exam will be stored electronically and de-identified data will be disclosed to the Sponsor.Results are for use in development and optimization of a next generation ultrasound system being developed by study Sponsor, GE Healthcare (GEHC) prior to future commercial release.

Eligibility criteria: Inclusion Criteria:

1. Adults (aged 18 years of age or older) at the time of consent;
2. Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning); AND
3. Able and willing to provide written informed consent for participation.

Exclusion Criteria:

1. Are pregnant subjects;
2. Require procedures that cannot be readily completed using available investigational devices; OR
3. Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.

Primary outcomes:
measure: Obtain Image sets using Ultrasound Venue System
timeFrame: Two months
measure: Periodic user feedback
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hopital Notre-Dame
state: Quebec
Study officials:
affiliation: Hopital Notre-Dame
name: Martin Girard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00156468: Office-Based Asthma Screening Intervention
Official title: Office-Based Asthma Screening Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Halcyon Hill Foundation
name: Robert Wood Johnson Foundation
First posted: 2005-09-12
Enrollment: 365
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In prior work, we found that even children who have been seen by their physicians within the prior six months were frequently misclassified as having mild rather than persistent asthma. This study evaluations whether systematic office-based screening assists primary care physicians in identifying children with significant asthma and improves preventive care for asthma. We hypothesize that standardized screening in the office setting will improve the physician's ability to (a) identify children with significant asthma and (b) prescribe appropriate preventive medications.


Eligibility criteria: Inclusion Criteria:

* Children ages 2-12
* Children arriving for an office visit in two Rochester, NY pediatric clinics
* Children with a prior diagnosis of asthma AND an exacerbation of symptoms within the previous 2 years

Exclusion Criteria:

* Children arriving at the office visit with an adult that is not their parent or guardian
* Children arriving at the office visit with a parent or guardian that does not speak English
* Children with other medical conditions making the assessment of asthma severity difficult (cystic fibrosis, heart conditions, etc.)

Primary outcomes:
measure: "Preventive Medication Actions (PMA)" taken by the provider at the time of the child's visit. A "PMA" is defined as a new medication prescription or change in medication dose.
Secondary outcomes:
measure: Alternate actions taken by the provider such as: discussion of environmental controls, medication refills, etc.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halterman JS, Kitzman H, McMullen A, Lynch K, Fagnano M, Conn KM, Yoos HL. Quantifying preventive asthma care delivered at office visits: the Preventive Asthma Care-Composite Index (PAC-CI). J Asthma. 2006 Sep;43(7):559-64. doi: 10.1080/02770900600859172.
citation: Halterman JS, Fagnano M, Conn KM, Szilagyi PG. Do parents of urban children with persistent asthma ban smoking in their homes and cars? Ambul Pediatr. 2006 Mar-Apr;6(2):115-9. doi: 10.1016/j.ambp.2005.10.004.
citation: Halterman JS, Fisher S, Conn KM, Fagnano M, Lynch K, Marky A, Szilagyi PG. Improved preventive care for asthma: a randomized trial of clinician prompting in pediatric offices. Arch Pediatr Adolesc Med. 2006 Oct;160(10):1018-25. doi: 10.1001/archpedi.160.10.1018.
Clinical trial NCT00507468: Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
Official title: Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ventricular Dysfunction
Myocardial Infarction
Keywords: bone marrow
autologous
ejection fraction
left ventricle
heart attack
myocardial infarction
left ventricular dysfunction post myocardial infarction
Lead sponsor: BioCardia, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (MI).

A secondary goal was to assess the possibility that such cell injections could improve ejection fraction (EF).


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* Able to give informed consent
* Must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline
* Must be a candidate for percutaneous heart catheterization
* Must have identifiable area of transmural scar within the left ventricle

Exclusion Criteria:

* Be a candidate for concurrent ventricular surgical restoration, AICD placement or valvular surgery
* Clinical evidence of infection
* Other complicating cardiovascular abnormalities
* Clinically significant electrocardiographic abnormalities
* Active malignancy
* Recent history or drug or alcohol abuse
* Pregnancy, planned or current
* Artificial aortic valve
* Ejection fraction less than 30 percent at baseline
* Myocardial infarction in the past 4 weeks

Primary outcomes:
measure: Safety of treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Swiss Clinic
city: Buenos Aires
country: Argentina
facility: Argentine Institute of Diagnosis and Treatment
Study officials:
affiliation: Argentine Institute of Diagnosis and Treatment
name: Luis de la Fuente, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487968: Eltrombopag Taste Testing in Healthy Adult Volunteers
Official title: Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Purpura, Thrombocytopenic, Idiopathic
Keywords: healthy adult volunteers
eltrombopag
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a high sensitivity to bitterness will be enrolled. The subjects will evaluate different formulations and rate them based on the bitterness and effectiveness of sweetners. The outcome of this study will help support a decision for a new pediatric formulation of eltrombopag.


Eligibility criteria: Inclusion Criteria:

* healthy adult based on a medical evaluation by a responsible physician
* male or female adult between 18 and 55 years old
* female subjects who are not pregnant or lactating
* females who are unable to have children must have documented medical verification
* females who are able to have children must have a negative pregnancy test
* capable of giving written informed consent

Exclusion criteria:

* subjects who are unable to taste bitterness or are extrememly sensitive to bitterness
* participated in a clinical trial within 30 days
* exposure to more than four new medicines within 12 months prior to the first day of dosing
* history of sensitivity to any of the study medications

Primary outcomes:
measure: To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2.
timeFrame: at initial dosing, 3hours, and 6 hours on Day 1 & 2.
Secondary outcomes:
measure: Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits
timeFrame: all visits
measure: - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2
timeFrame: done at Day 1 & 2
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: GSK Investigational Site
state: Kansas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02093468: Evaluation of MST-188 in Acute Lower Limb Ischemia
Official title: Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Limb Ischemia
Keywords: Acute limb ischemia
ALI
Acute lower extremity arterial occlusion
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 4
Sex: ALL
Minimum age (years): 30
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 safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.


Eligibility criteria: Inclusion Criteria:

* Age ≥30 to \<80
* Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb
* Subject is hospitalized or in the process of hospitalization for the treatment of ALI
* Angiographic confirmation of thrombotic lower limb arterial occlusion

Exclusion Criteria:

* Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement
* Treatment with a thrombolytic agent within the last 48 hours
* Subject's laboratory results indicate inadequate organ function
* NYHA Class IV congestive heart failure
* Prior major amputation of the target limb
* Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media

Primary outcomes:
measure: Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)
timeFrame: Baseline, 8 and 24 hours
measure: Assessment of the change in TcPO2 (Exploratory endpoint)
timeFrame: Baseline, 8, 12, and 24 hours
measure: Number of participants with adverse events
timeFrame: Randomization through 30 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Center
state: Arkansas
city: Tampa
country: United States
facility: Research Center
state: Florida
city: Brooklyn
country: United States
facility: Research Center
state: New York
city: Cleveland
country: United States
facility: Research Center
state: Ohio
Study officials:
affiliation: Mast Therapeutics, Inc.
name: Edwin L Parsley, D.O.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02340468: Breast Tumor Oxygenation During Exercise
Official title: Breast Tumor Oxygenation During Exercise
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Tumor
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2015-01-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be recruited from an outpatient at UC Irvine Health

Brief summary: In the field of cancer treatment, it is generally accepted that the enhancement of oxygen delivery to tumors can augment the effect of anti-cancer therapies. In the case of chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment reaching the tumor and having an effect.

Detailed description: While the benefits of exercise on overall health are widely documented, little is known about how exercise affects the progression or treatment of malignant neoplasms. Tumors have a complex vascular network which is likely affected by the global changes in hemodynamics and perfusion that occur during moderate exercise. Increased tumor oxygenation is clinically relevant as it may counteract the hypoxic tumor environment which is known to contribute to resistance to chemo- and radiation therapies, angiogenesis, invasiveness and metastasis, genomic instability, and resistance to cell death.

The researcher can use noninvasive optical imaging technology called diffuse optical spectroscopy to safely and non-invasively quantify the dynamics of blood flow and metabolism in tumors and normal tissue of subjects undergoing supervised cycling exercise. The researcher can determine that exercise will measurably increase tumor oxygenation, and that this effect will be proportional to the intensity and/or duration of the exercise performed.

Eligibility criteria: Inclusion Criteria:

* Tumor group, female, Greater than 21 years of age but less than 70 years of age, Current diagnosis of breast cancer stage 0 - IV or radiologically suspicious for breast cancer BI-RADS score 4 or 5.
* Control group,Female, Greater than 21 years of age but less than 70 years of age, Not currently diagnosed with breast cancer

Exclusion Criteria:

* Under 21 years of age, Pregnant or breastfeeding, Contraindications for moderate exercise, history of heart, pulmonary, or musculoskeletal disease; physician instructions to restrict physical activity.

Primary outcomes:
measure: Measure breast tumor oxygenation
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical Clinic
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Bruce Tromberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01647568: Safety of Continuing Anti-platelet Agents During Colonoscopic Polypectomy: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-polypectomy Bleeding
Anti-platelet Therapy
Colonoscopy
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2012-07-23
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the GI lab for elective colonoscopy.

Brief summary: At our VA hospital, in general, it is the policy of our GI lab to not stop our patients anti-platelet therapy whenever they see us for a routine colonoscopy. We do this because we believe the risk of stopping these sort of medications outweigh the risks of a complication from a colonoscopy.

Therefore, we are enrolling patients who are either on clopidogrel or prasugrel or not on any anti-platelet/anti-coagulant therapy that come to our GI lab routine colonoscopies. We perform the procedure just like we normally would and then follow-up with the patient 7 and 30 days after their procedure.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to the GI lab for elective colonoscopy

Exclusion Criteria:

* Patients on Coumadin or other anti-coagulants
* Patients with Inflammatory Bowel Disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
References:
citation: Feagins LA, Iqbal R, Harford WV, Halai A, Cryer BL, Dunbar KB, Davila RE, Spechler SJ. Low rate of postpolypectomy bleeding among patients who continue thienopyridine therapy during colonoscopy. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1325-32. doi: 10.1016/j.cgh.2013.02.003. Epub 2013 Feb 9.