louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00893191: The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
Official title: The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sildenafil
Sleep Apnea
Sexual Dysfunction
Obesity
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-05-05
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 healthy males aged 40 - 65 years

Brief summary: Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. The aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. In addition we wish to assess the effect of sildenafil on sleep-disordered breathing.


Eligibility criteria: Inclusion Criteria:

* Age - 40-65 years
* BMI equal to or over 30

Exclusion Criteria:

* A known cardiorespiratory, liver or kidney disease
* Treatment with nitrates or alfa blockers
* Performed polysomnography in the past

Primary outcomes:
measure: apnea hypopnea index after sildenafil vs. placebo
timeFrame: Hours
Secondary outcomes:
measure: Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo
timeFrame: hours
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
References:
Clinical trial NCT01461291: Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Official title: A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open-angle Glaucoma
Keywords: Primary open-angle glaucoma
POAG
Trabecular meshwork
iStent inject
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 505
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate open-angle glaucoma
* Characteristics consistent with mild/moderate glaucoma
* Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

* Pigmentary or pseudoexfoliative glaucoma
* Prior incisional glaucoma surgery

Primary outcomes:
measure: ≥ 20% Reduction in Intraocular Pressure (IOP)
timeFrame: Baseline and Month 24
Secondary outcomes:
measure: Diurnal IOP Reduction from Baseline
timeFrame: Baseline and Month 24
Other outcomes:
measure: Safety follow-up post-PMA to be through 36 months
timeFrame: 36 months
Locations:
city: Racine
country: United States
facility: Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens, O.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03325491: Assessing the Effects of Increased Mitochondrial Function Exercise Training on Muscle Performance
Official title: Assessing the Effects of Increased Mitochondrial Function and Chronic Aerobic or Resistance Exercise Training on Skeletal Muscle Performance in Older Men; a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Impaired Mitochondrial Function, Muscle Performance
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Royal Devon and Exeter NHS Foundation Trust
First posted: 2017-10-30
Enrollment: 2
Sex: MALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. There is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail. This is possible by measuring how the muscles work and respond to exercise before and after taking the supplement alongside an aerobic (i.e. cycling) and resistance (i.e. weight lifting) exercise programme. This will give us the basic information investigators would need to see if this is a useful idea.


Eligibility criteria: Inclusion Criteria:

* Male
* Age between 65-75 years
* Body mass index between 19-29
* No active cardiovascular or metabolic disease
* No active respiratory disease
* No current musculoskeletal injuries
* A sedentary lifestyle (i.e. does not engage in strenuous, planned physical activity)
* The ability to give informed consent

Exclusion Criteria:

* Currently taking a statin drug or NSAIDs
* Have a current peptic ulcer
* Have any renal impairment
* Have a known hypersensitivity to Acipimox
* Suffer from vertigo
* Smoker

Primary outcomes:
measure: Change in mitochondrial function
timeFrame: Baseline, 3 weeks, 6 weeks
Secondary outcomes:
measure: Chronic changes in habitual muscle protein synthetic rates
timeFrame: Baseline, 3 weeks and 6 weeks
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: NIHR Exeter Clinical Research Facility
state: Devon
Study officials:
affiliation: University of Exeter
name: Colleen Deane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793191: Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain
Official title: Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain in the Gynecological Laparoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Gynecological Disease
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the women scheduled for elective gynecological laparoscopy in the tertiary care clinic

Brief summary: To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy


Eligibility criteria: Inclusion Criteria:

* women scheduled for elective gynecological laparoscopy

Exclusion Criteria:

* psychiatric disease eg. anxiety, depression, etc.
* diagnosed as cancer
* the use of vasoactive drug
* chronic pain except lower back pain

Primary outcomes:
measure: the intensity of acute postoperative pain
timeFrame: during 30 min in the recovery room
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine
name: Young Eun Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00395980: Muscle Pressure in the Flank Position
Official title: Muscle Pressure in the Flank Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Breakdown
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2006-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Using healthy volunteers, participants will lay on an operating room table in various positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine which areas of the body are subject to higher pressures. Using padding devices (foam, gel, water mattress)which are currently used in the operating room will be employed and measurements will be taken to determine which padding material and configurations is optimal to reduce the pressure to those body parts at risk for excessive pressure subject during laparoscopic surgery.


Eligibility criteria: Exclusion Criteria:

* Subjects with musculoskeletal disabilities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Leslie A. Deane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956280: Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer
Official title: Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: The frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC
KRAS mutation in population with advanced NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Laboratorio Progenetica
First posted: 2009-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Advanced Non Small Cell Lung Cancer

Brief summary: The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
* Tumour sample (block of slides) available for KRAS analysis

Exclusion Criteria:

* Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
* Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)

Primary outcomes:
measure: To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC.
timeFrame: March 31, 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Santo André
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
Study officials:
affiliation: AstraZeneca do Brasil, MC Medical Director
name: José Eduardo Pipolo das Neves, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02189980: Aromatherapy Using a Nasal Clip After Surgery
Official title: Aromatherapy Using a Nasal Clip After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-operative Nausea
Keywords: Nausea
Post-operative
Lead sponsor: Balanced Health plus
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
First posted: 2014-07-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this follow up study is to determine the duration of action regarding aromatherapy to treat nausea occurring postoperatively.

Detailed description: The primary hypothesis of the study is that post-operative patients who meet eligibility criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have more relief from nausea than those who receive normal saline inhalation using the same delivery system.

The secondary purposes of the study is to determine the duration of effectiveness of the essential oil blend as compared to the saline in the relief of post-operative nausea and to investigate the degree of comfort participants report using the nasal clip delivery system for aromatherapy.

Eligibility criteria: Inclusion Criteria:

* 18 years or over
* cognitively able to give consent based on nurse's assessment,
* having gynecological or other abdominal surgery
* not allergic to peppermint, spearmint, cardamom or ginger
* not receiving blood thinning medications

Exclusion Criteria:

* less than 18 years old
* unable to cognitively give consent
* allergic to ginger, peppermint, cardamom or spearmint.
* receiving warfarin (Coumadin) or any antiplatelet drug (heparin, 325 mg Aspirin, clopidogrel (Plavix) or other) or a diagnosis of bleeding diatheses (predisposition to abnormal blood clotting/hemorrhage) will not be included in this study.
* all surgeries other than gynecological or abdominal surgery

Primary outcomes:
measure: Duration of effectiveness of the essential oil blend
timeFrame: Immediately to one-day post-operative
Secondary outcomes:
measure: Participant comfort using the nasal clip delivery system
timeFrame: Immediately post-op to one-day post-op
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: CMC -- University
state: North Carolina
Study officials:
affiliation: Balanced Health plus
name: Ronald Hunt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725880: Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
Official title: Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
HuCNS-SC cells
Human Neural Stem Cells
Neural Stem Cells
Stem Cells
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who had undergone intramedullary transplantation of HuCNS-SC cells in the thoracic region.

Brief summary: The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.

Detailed description: The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.

Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.

Eligibility criteria: Inclusion Criteria:

* Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
* Must agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria:

* Subjects have received or are receiving off-protocol immunosuppressive medications
* Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.

Primary outcomes:
measure: American Spinal Injury Association (ASIA) Impairment Scale Improvement
timeFrame: Four years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Uniklinik Balgrist
Study officials:
affiliation: StemCells, Inc.
name: Stephen Huhn, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01771380: Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum
Official title: Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impaired Glucose Tolerance
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 78
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with known impaired glucose tolerance

Brief summary: In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free fraction that is biologically active. Polymorphisms in DBP are related to the serum level of 25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the total serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we will calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and also measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we will relate total serum 25(OH)D as well as the free and biologically active (free- albumin-bound) 25(OH)D to the well established vitamin D effect marker serum parathyroid hormone as well as to the RNA expression in peripheral blood to evaluate the biological importance of the free versus the total fraction of 25(OH)D. We will invite 300 subjects from an ongoing vitamin D supplementation study to participate in the study which will be one visit only and include collection of blood samples.


Eligibility criteria: Inclusion Criteria:

* Impaired glucose tolerance
* living in the Tromsø area

Exclusion Criteria

* pregnancy
* serious illness

Primary outcomes:
measure: Free fraction of 25(OH)D
timeFrame: 1 day
Secondary outcomes:
measure: DBP polymorphisms
timeFrame: 1 day
Other outcomes:
measure: RNA expression in peripheral blood
timeFrame: 1 day
Locations:
city: Tromsø
country: Norway
facility: University of Tromsø
Study officials:
References:
Clinical trial NCT00384280: Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796
Official title: An Open Label, 2-period, Sequential Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label, 2-period, sequential study to determine the impact of multiple doses of rifampin on single-dose pharmacokinetics of HCV-796


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Primary outcomes:
measure: To evaluate the effects of multiple oral doses of rifampin on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects.
Secondary outcomes:
measure: To assess the safety and tolerability of HCV-796 and rifampin when coadministered to healthy subjects.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02270580: Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy
Official title: Patient Navigation to Improve Quality of Life and Screening Practices Among Latino Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2014-10-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized controlled trial (RCT) with 2 patient navigator conditions: PN+ and usual PN in which (condition 1) we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors. In usual PN, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

Detailed description: This RCT involves a 2 (group) by 2 (time) repeated measures design with experimental condition (specialized PN+cancer survivorship program over 6 months versus PN only (control condition) as the between-groups factor, and time-point (baseline pre-randomization and post-PN at 6 months follow-up) as the within-groups factor. This RCT involves 2 patient navigator conditions: PN+ and usual PN in which (condition 1) we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors. In usual PN, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

Eligibility criteria: Inclusion Criteria:

* report a primary diagnosis of breast cancer
* have completed primary treatment within the past 36 months
* evidence of verbal fluency in English or Spanish
* self-identify as HL

Exclusion Criteria

* evidence of metastatic disease
* current severe mental illness such as psychosis
* substance dependence within the past year
* active suicidality
* ongoing neo-adjuvant therapy
* unavailable for follow-up over the course of the study period

Primary outcomes:
measure: General quality of life
timeFrame: 6 months
measure: Disease-specific quality of life
timeFrame: 6 months
measure: Treatment follow-up compliance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Amelie G Ramirez, DRPH
role: PRINCIPAL_INVESTIGATOR
References: