louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04484090: Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
Official title: Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Lead sponsor: OHH-MED Medical Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 28
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is estimated to affect up to 30 million men in the United States. The disorder is age-associated. The available treatments include oral therapy, vacuum-constriction devices; shockwave therapy, intracavernosal injections of vasoactive agents, including alprostadil (prostaglandin E1, transurethral delivery of alprostadil, Implantation of penile prostheses.

The OhhMed Company has developed the Vertica device that provides treatments for improvement of erectile function in patients with erectile dysfunction. This study assess the safety, efficacy, ease of use, and satisfaction of the Vertica device by men with mild to moderate erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* IIEF-EF score of 11-24 with or without the use of medication (PDE5 inhibitors).
* Erectile dysfunction for at least 3- months
* Steady relationship for at least 3-months.
* patient without sensory disorders
* patient with established organic of erectile dysfunction

Exclusion Criteria:

* investigator's impression of expected poor patient compliance or anatomic inadequacy (penile size/girth)
* Premature ejaculation
* Any psychiatric disorder
* Epilepsy
* Peyronie 's disease/ penile curvature
* Coagulopathy
* Any tumor in the pelvic or penile region within the last 3 years

Primary outcomes:
measure: Change in erectile function (EF)
timeFrame: Baseline to 1 month post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical center
Study officials:
affiliation: Rambam Medical Center, Haifa Israel
name: Ilan Gruenwald, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142790: Weekly and Every 3 Week Administration of Paclitaxel Liposome Injection in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.


Eligibility criteria: Inclusion Criteria:

* Female or Male \>18 years of age and \< 70years of age, If female of childbearing potential, pregnancy test is negative before first dose of study drug and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
* Stage IV disease
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Suitable for the treatment with paclitaxel as single agent regimen (first line or prior first line chemotherapy including adriamycin is allowed, If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen and if Her2+ patient, Herceptin therapy will be allowed.
* Patient has the following values at Baseline: Absolute neutrophil count ≥ 1.5 x 10\^9cells/L; platelets ≥ 100 x 10\^9 cells/L; hemoglobin ≥ 10 g/dL. Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ 1.5ULN; creatinine ≤ 1.5 mg/dL.
* Informed consent has been obtained.

Exclusion Criteria:

* Parenchymal brain metastases.
* History of other malignancy within the last 3 years
* New York Heart Association (NYHA) Grade 2 or greater congestive heart failure,history of myocardial infarction or unstable angina or new occured angina within 6 months prior to study enrollment.
* Concurrent other anticancer therapy.
* History of serious organic disorders (including active infection or Cardiovascular disease), serious hepatic disease, serious blood coagulation diseases, cachexia
* Sensory neuropathy of \> Grade 1 at baseline.
* Patients with prior hypersensitivity to paclitaxel
* Pregnant or nursing women
* enrolled in a different clinical study
* No psychiatric illness and other situations that would limit compliance of study

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 24 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 24 months
measure: Clinical Benefit Rate
timeFrame: 24 months
measure: Adverse Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT00018590: Center for the Study of Vascular Disease in Hispanic and Native Americans
Official title: Center for the Study of Vascular Disease in Hispanic and Native Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Disease
Keywords: Vascular Diseases
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This is a working registry of a longitudinal cohort of Hispanics, Native Americans, and non-Hispanic whites (as controls) for tracking of vascular disease endpoints. Blood samples collected for ongoing pilot projects as well as specimen banking. Pilot studies are observational and involve risk measures for stroke, atherosclerosis, and vascular inflammatory responses. Questionnaires on demographics, risk factors, and vascular disease history are performed. No interventions proposed as yet.


Eligibility criteria: Hispanics and Native Americans are oversampled, but non-Hispanic whites will be included for comparison purposes. No other exclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
Study officials:
name: Peter Reaven, M.D.
References:
Clinical trial NCT04988490: Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes
Official title: Quantification of Endo- and Phytocannabinoids With Comparison to Pain Medication Requirements and Surgical Outcomes for Patients Undergoing Abdominal Surgery for Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Surgical Pain
Post-Surgical Complication
Cancer
Cannabis Use
Keywords: Cannabis
Post-Surgical Complications
Post-Surgical Pain
Abdominal Surgery
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Institute of Cannabis Research
First posted: 2021-08-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients over the age of 18 undergoing inpatient abdominal surgery for the treatment of cancer who use cannabis daily prior to surgery or who are non-users of cannabis.

Brief summary: To determine how daily cannabis use affects surgical outcomes.

Detailed description: To determine if patients who are daily cannabis users that are undergoing inpatient abdominal surgery for the treatment of cancer are different from non-cannabis users regarding phytocannabinoid and endocannabinoid levels, pain scores, pain medication requirements, and surgical complications.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old
* Undergoing abdominal surgery for the treatment of cancer
* Report no cannabis use in the last year or chronic cannabis use (defined as at least weekly use for 3 months or more)

Exclusion Criteria:

* patients with chronic pain, chronic pain syndrome on opioids
* female patients who are pregnant or lactating
* patients who report use of illicit substances

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 30 days
measure: Correlation of postoperative opioid consumption
timeFrame: 30 days
measure: Correlation of postoperative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Ana Gleisner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04974190: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Lavandula Angustifolia Containing Nasal Spray Medical Device in Preventing Deterioration of COVID-19 in Symptomatic Patients
Official title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Lavandula Angustifolia Containing Nasal Spray Medical Device in Preventing Deterioration of COVID-19 in Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Infection
Lead sponsor: The Grasses of Eden Ltd
Sponsor class: INDUSTRY
Collaborators: name: Sherutei Briut Clalit
First posted: 2021-07-23
Enrollment: 550
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A control group is allocated a placebo solution
Primary purpose: TREATMENT

Brief summary: A Nasal Spray device containing Dead Sea minerals and plant extracts, used to shorten duration and mitigate effects of Covid-19 infection in mild to moderate adult patients

Detailed description: A Nasal Spray device containing Dead Sea minerals and plant extracts, designed to incur a PPAR-alpha agonistic effect, used to shorten duration and mitigate effects of Covid-19 infection in mild to moderate adult patients

Eligibility criteria: Inclusion Criteria: Having tested positive to Covid-19 on PCR test -

Exclusion Criteria: Pregnancy Low blood pressure On immune system suppressing medications

-

Primary outcomes:
measure: Covid-19 infection self-testing on days 2, 4 following testing positive on PCR test
timeFrame: First 7 days after testing positive on PCR test
measure: Symptoms monitoring
timeFrame: First 7 days after testing positive on PCR test
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05031390: the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
Official title: the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoroacetabular Impingement
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: La Trobe University
First posted: 2021-09-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).

Detailed description: The aim of this study is to investigate the feasibility of a 12-weeks (progressive) exercise program in patients with FAIS. Feasibility is evaluated on the recruitment strategy, patient adherence to the exercises and their experiences with and motivation for performing exercises. Furthermore, the investigators wish to investigate the variation of data before and after the exercise program to help estimate a suitable sample size for a future randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-50 years old
2. Diagnosed with FAIS according to the Warwick agreement
3. Patients having cam morphology should have an alpha angle of \> 55 degrees on an anterior-posterior radiograph.
4. Patients having pincer should have a lateral centre edge angle of \>39 degrees on an anterior-posterior radiograph.
5. Lateral joint space width should be \>3 mm.
6. Body mass index is below 30.
7. Motivated for participation in a 12 week training program with 8 physical attendances.

Exclusion Criteria:

1. Received physiotherapist-led treatment in the past 3 months,
2. Previous hip surgery in included hip or other major hip injury,
3. Systemic conditions e.g. rheumatoid arthritis, cancer,
4. Chronical pain syndromes,
5. Unable to perform testing procedures,
6. Unable to attend a 12-week treatment program or baseline and follow-up assessments
7. Contraindications to radiographs (e.g. pregnancy)
8. Unable to read or understand questionnaires and/or instructions

Primary outcomes:
measure: Number of completed exercise sessions
timeFrame: 0-12 weeks
measure: Completion of training program
timeFrame: 0-12 weeks
Secondary outcomes:
measure: The Copenhagen Hip and Groin Outcome Score (HAGOS)
timeFrame: Change from 0-12 weeks
measure: The International Hip Outcome Tool (iHOT-33)
timeFrame: Change from 0-12 weeks
measure: The Hip Sports Activity Scale (HSAS)
timeFrame: Change from 0-12 weeks
measure: Maximal hip muscle strength
timeFrame: Change from 0-12 weeks
measure: One-legged hop for distance
timeFrame: 0-12 weeks
measure: Y-balance board
timeFrame: 0-12 weeks
measure: Patient Acceptable Symptom State
timeFrame: 0-12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Regionshospitalet Horsens
name: Signe Kierkegaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04278521: Mechanism of Action of Transcranial Magnetic Stimulation
Official title: Mechanism of Action of Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Depression
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression.

Detailed description: This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar depression receiving TMS. Patients will be scanned before and after a full course of TMS and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of TMS at the circuit level (2) to study the use of fcMRI as a state biomarker for depression (3) to study the use of fcMRI as a predictor of response for depression.

Eligibility criteria: Inclusion Criteria:

1. Males and females between the ages of 18-80
2. DSM-IV diagnosis of Depressive Episode
3. Patients requiring TMS treatment as part of their psychiatric care

Exclusion Criteria:

1. Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia.
2. Substance use disorder (abuse or dependence) with active use within the last 3 months
3. Severe or unstable medical illness.
4. MRI contraindications as determined by MGH department of radiology.

Primary outcomes:
measure: Changes in Functional Connectivity of Key Nodes in Depression
timeFrame: Through Treatment Completion, Average of 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joan Camprodon, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921921: Does Extra-fine Hydrofluoroalkane-beclomethasone Dipropionate (HFA-BDP) Suppress Small Airways Inflammation in Chronic Obstructive Pulmonary Disease (COPD)?
Official title: Does Extra-fine HFA-BDP Suppress Small Airways Inflammation in COPD?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease or 'COPD' is a chronic disease, which means that it cannot be cured, but that inhalers and tablets can be used to control the symptoms. In COPD, the airways become inflamed which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in COPD.

The airways of the lung start in the windpipe and branch like the branches of a tree, getting smaller and smaller. In COPD the inflammation is deep in the lungs, out to the very small airways.

Different inhalers make the medicines into different sized particles. Most steroid inhalers used for COPD make the medicine into particles which are too big to get into the very small airways ('coarse particles'). Other inhalers make a mist, with much smaller particles ('fine particles'). These are as small as the smallest airways in the lungs.

Doctors have recently found a way to measure the inflammation in the small airways that are affected in COPD. The investigators want to find out if taking one of these 'fine-particle' steroid inhalers can treat that inflammation.


Eligibility criteria: Inclusion Criteria:

* Current or ex-smokers
* \> 40 years of age with a greater than 15 pack year history of smoking
* post-bronchodilator FEV1/FVC ratio \< 0.7
* FEV1 \< 80% predicted
* CANO \> 3 ppb at screening
* Informed consent and ability to perform exhaled nitric oxide assessment

Exclusion Criteria:

* Oral steroid use or exacerbation within 6 weeks
* Greater than 2 exacerbations requiring treatment in the previous 6 months
* Requirement for domiciliary oxygen
* Pregnancy or lactation
* Known or suspected contra-indication to any of the IMP's
* Diagnosis of asthma

Primary outcomes:
measure: Alveolar Nitric Oxide
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group, University of Dundee
state: Tayside
Study officials:
References:
citation: Short PM, Williamson PA, Lipworth BJ. Effects of extra-fine inhaled and oral corticosteroids on alveolar nitric oxide in COPD. Lung. 2012 Aug;190(4):395-401. doi: 10.1007/s00408-012-9378-8. Epub 2012 Feb 22.
Clinical trial NCT03142464: Intravenous Fluids After Laparoscopic Cholecystectomy
Official title: Intravenous Fluids After Laparoscopic Cholecystectomy: Necessary or Dispensable. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea
Postoperative Vomiting
Renal Function Abnormal
Hunger
Thirst
Fluid Electrolyte Disorders
Keywords: saline solution
laparoscopy
cholecystectomy
outcomes
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controls - convention postoperative IV fluids; intervention arm - no IV fluids postoperative
Primary purpose: TREATMENT

Brief summary: Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL) elective.

Detailed description: Patients undergoing elective laparoscopy cholecystectomies were randomized to either routine practice fluid prescription (control group) or no IV fluids in the postoperative period. Thirst, hunger, presence of nausea and vomiting, renal function and personal satisfaction were assessed.

Body composition was evaluated by bioimpedance

Eligibility criteria: Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

Exclusion Criteria: Co-existing severe renal failure, cardiac failure or pulmonary disease

-

Primary outcomes:
measure: Renal function
timeFrame: 24 hours
Secondary outcomes:
measure: Presence of thirst
timeFrame: 24 hours
measure: Presence of nausea
timeFrame: 24 hours
measure: Total intravenous prescribed fluids per body weight
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06822764: Mental Processes for Rating Pain Intensity
Official title: Mental Processes for Rating Pain Intensity
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pain
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: This new study builds on the principal investigator's earlier studies to improve communication about pain. The research team seeks to better understanding of the mental processes needed to rate pain.


Eligibility criteria: General inclusion criteria:

* 18 years old or older;
* visited a HCP for treatment of a painful musculoskeletal condition within previous year;
* has usually felt, at least, "mild" musculoskeletal pain on most days of the last 3 months in multiple locations; and
* has felt variable musculoskeletal pain intensity during the last 3 months.

General exclusion criteria:

* past or current employment as a licensed healthcare provider;
* diagnosed with a cardiac arrhythmia;
* has a battery-powered implant in the neck, chest, abdomen, or spine (e.g., pacemaker);
* diagnosed with a neurological condition that causes uncontrolled movement (e.g., Parkinsonism, epilepsy, etc.);
* smokes cigarettes or vapes; (6) has abused substances during the last week; or
* allergic to skin adhesives.

Primary outcomes:
measure: pain intensity
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References: