louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00640458: Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder
Official title: A Double Blind, Placebo Controlled 2-way Cross-over Study to Assess the Clitoral Engorgement Response as Measured by Non-contrast Magnetic Resonance Imaging (MRI) in Women With Female Sexual Arousal Disorder (FSAD) When Administered a Single Dose of Sildenafil (100mg) Followed by Audio/Visual Sexual Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Sexual Arousal Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal women aged 18-45 with a primary diagnosis of Female Sexual Arousal Disorder for at least 6 months prior to entering the study. The FSAD could have been associated with female orgasmic disorder (FOD) and/or superficial or introital dyspareunia.

Exclusion Criteria:

* Subjects with hypoactive sexual desire disorder.
* Subjects not using an acceptable mean of contraception for the duration of the study.
* Subjects who were prescribed and/or taking medication which were contraindicated or cautioned with concomitant intake of sildenafil.

Primary outcomes:
measure: To determine the % of subjects who respond within 30 minutes of dosing by achieving an increase in clitoral engorgement >50% from baseline measured by MRI following audio/visual sexual stimulation in females with FSAD.
timeFrame: Up to 30 minutes post-dose
Secondary outcomes:
measure: To determine the % of subjects who respond to sildenafil 100mg by achieving an increase in clitoral engorgement >50% from baseline within 40, 50 and 60 minutes of dosing respectively.
timeFrame: Up to 60 minutes post-dose
measure: To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings.
timeFrame: 30 days post-dose
measure: Assess plasma levels of sildenafil and metabolite
timeFrame: Day of dosing
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03973658: Dizziness Among First Time Users of Hearing Aids
Official title: Dizziness Among First Time Users of Hearing Aids
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dizziness
Hearing Loss
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years and older patients using hearing aids for the first time

Brief summary: The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared


Eligibility criteria: Inclusion Criteria:

* Hebrew speaking
* First time users of hearing aids

Exclusion Criteria:

* Using a wheelchair
* Neurological disorders
* Spine of leg surgery in the previous 6 months

Primary outcomes:
measure: Dizziness Handicap Inventory (short version) score. The scale measures the degree of dizziness associated handicap as experienced by the patient. Minimun score: 0 Maximum score: 13. A higher score means better outcome.
timeFrame: 2 months
Secondary outcomes:
measure: Usage of hearing aids
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03759158: N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Official title: N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhoses
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 100
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: Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast imaging for various conditions. The risk associated with the development of CIN are still under evaluation. Even with patients having normal kidney functions there is a risk of contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is cirrhosis is also an avenue which requires more studies and also there is a need for formulation of a Score to predict this CIN. Hence this study is being done to assess the incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.


Eligibility criteria: Inclusion Criteria:

* Age-18-70 years
* Normal kidney parameters (Creatinine below \<1 ,Creatinine clearance \>60)
* Cirrhosis of liver
* eGFR\>60ml/min

Exclusion Criteria:

* Chronic kidney disease
* H/o anaphylaxis to contrast
* Prior h/o AKI
* GFR\<60 ML/MIN
* Prior H/o TACE/HVPG /Contrast ECHO in the last 4 weeks

Primary outcomes:
measure: Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.
timeFrame: Day 2
Secondary outcomes:
measure: Mean change in serum creatinine from baseline in both groups
timeFrame: Day 2
measure: Mean change in serum creatinine from baseline in both groups
timeFrame: Day 6
measure: Adverse events of N-Acteyl Cysteine in both groups
timeFrame: Day 6
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT03907358: The Pathogenesis of Human Senile Cataract
Official title: The Pathogenesis of Age-related Cataract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 94
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the explicit diagnosis of cataract are willing to undergo cataract surgery.

Brief summary: To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics.

Detailed description: Tissue samples and aqueous humor samples will be collected from each individual patients by cataract surgery. After sample treatment, different techniques will be applied for analysis. And bioinformatics approach is applied for data treatment and analysis.The data of genomics, transcriptomics, and proteomics will be analyzed for study of pathological mechanism of cataract.

Eligibility criteria: Inclusion Criteria:

* Patients with the explicit diagnosis of cataract (including senile cataract, congenital cataract, complicated cataract, metabolic cataract, traumatic cataract, etc.) in the operated eye are willing to undergo cataract surgery.

Exclusion Criteria:

* Patients whose cataracts need not be operated
* Patients with any contraindications to cataract surgery
* Patients are unwilling to undergo cataract surgery

Primary outcomes:
measure: Characterization of miRNA in micro-scale human aqueous humor
timeFrame: 12 month
measure: Favored amplification recovery via protection-chromatin immunoprecipitation-Seq of human eye tissue samples
timeFrame: 24 month
measure: Study of cataract by genomics, transcriptomics, and proteomics approaches
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University
Study officials:
References:
Clinical trial NCT01140958: A Retrospective Pharmacoeconomic Study of Lung Cancer
Official title: A Retrospective Pharmacoeconomic Study of Lung Cancer in Wan-Fang Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: lung cancer
pharmacoeconomics
new agents
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lung cancer patients in WanFang Hospital

Brief summary: Lung cancer is the No. cause of cancer death in Taiwan. Yet most of lung cancer are diagnosed at late stage, not amenable to surgical resection. With the introduction of new targeted agents, such as EGFR tyrosine kinase inhibitors and the identification of EGFR mutations, lung cancer management has markedly changed in recent years. However, these new agents are costly and their payment is restricted in certain situations defined National Insurance Agency. Therefore, using databases from National Insurance Agency might not be able to reflect the exact impact on pharmacoeconomics. In this study, the investigators will analyze the data from a tertiary medical center, where all the costs including insurance reimbursement, co-payment, and payment not covered by insurance. The investigators will also compare with the investigators results with national database to analyze the cost benefit of these new agents on lung cancer.


Eligibility criteria: Inclusion Criteria:

* lung cancer patients in WanFang Hospital

Exclusion Criteria:

* non

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hsin-Gjin Eugene Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04433858: An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Official title: An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Treatment Resistant Depression
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
Collaborators: name: COMPASS Pathways
First posted: 2020-06-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of at least moderate Major Depressive Disorder (MDD)

Exclusion Criteria:

* Comorbidities

Note for CA site: Only Veterans are Eligible

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: From Baseline (Day -1) to three weeks post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Healthcare System/Stanford Medicine
state: California
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
Study officials:
affiliation: Sheppard Pratt Health System
name: Scott Aaronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04847258: Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation
Official title: Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the outpatient clinic at the Department of Orthopaedic Surgery at Vejle Hospital, Denmark

Brief summary: The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.

Detailed description: All included patients are referred to municipal rehabilitation to resolve effusion and range of motion deficits before the first screening (baseline screening) is completed. Hereafter the patients follow 3 months municipal rehabilitation before the second screening (3 months screening). A physiotherapist performs the screening and at the second screening, this is performed prior to consulting an orthopaedic surgeon.

Eligibility criteria: Inclusion Criteria:

* unilateral primary ACL injury
* Index injury no older than 6 months

Exclusion Criteria:

* Multiligament rupture
* Large cartillage or meniscus injuries
* Scheduled ACL reconstruction within 3 months

Primary outcomes:
measure: Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: Vejle Hosptal
name: Claus Varnum, ph.d.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04445558: Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients
Official title: Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.

Detailed description: The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).

Eligibility criteria: Inclusion Criteria:

* Patient with renal failure, on hemodialysis for at least 12 months;
* Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);
* Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;
* Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:
* Patient who signed an informed consent form to participate in the study

Exclusion Criteria:

* Known allergy to PEPA® ;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Patient with a chronic infection in progress;
* Patient with life expectancy \<6 months according to the investigator;
* Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);
* Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: Evolution of the nutritional status
timeFrame: Month 6
Secondary outcomes:
measure: Evolution of nutritional assessment
timeFrame: Month 6
measure: Appearance of adverse events
timeFrame: Month 6
measure: Measure of the Quality of life
timeFrame: Month 6
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Privé La Louvière
Study officials:
References:
Clinical trial NCT04680858: Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19
Official title: Impact of Digital Enhanced Telecommunication for Team Communication in Endoscopic Procedures During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopy
Communication
Keywords: endoscopy
team communication
endoscopic procedure
COVID-19
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.

Detailed description: Optimal communication is crucial for team work in high class endoscopy. Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly. Digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances.

Materials and methods:A prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (EGD, colonoscopy, EUS, ERCP) were randomly assigned (1:1) to a group that was performed with DECT equipped endoscopy team or with standard communication. All examinations were performed under protective equipment. Primary outcome was rate of communication associated adverse events. Secondary outcomes included team subjectively perceived comfort with DECT enhanced communication during endoscopic work, duration of examinations, SAE.

Eligibility criteria: Inclusion Criteria:

* Member of staff of the endoscopic team (Doctor, nurse)

Exclusion Criteria:

* Deafness
* significantly impaired hearing

Primary outcomes:
measure: Communication associated adverse events
timeFrame: From start to stop of endoscopic procedure
Secondary outcomes:
measure: Severe adverse events
timeFrame: From start to stop of endoscopic procedure
measure: Subjective Comfort of DECT communication
timeFrame: From start to stop of endoscopic procedure
measure: Endoscopic time
timeFrame: From start to stop of endoscopic procedure
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
References:
Clinical trial NCT05406258: Self-Catheterization Mirror System for Female Patients
Official title: Self-Catheterization Mirror System for Female Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 2
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to test a modified mirror system for female patients to use during self-catheterization.

Detailed description: Many female patients have difficulties with self-catheterization. Mirrors currently used for this procedure have limited stability and visibility to easily view the urethral opening during catheterization, particularly for individuals with motor impairments. This can be especially frustrating because catheterization is performed frequently throughout the day and may need to occur at home or in public facilities.

The purpose of this study is to test the usability and efficacy of a modified self-catheterization mirror system for female patients. The modified self-catheterization mirror system makes adjustments to a standard, hospital-provided cathing mirror to help female patients with a range of motor abilities catheterize themselves in various postures and settings. Namely, the system offers (1) an alternative way to hold the mirror, by suspending it between the legs rather than attaching it to the toilet, and (2) lights that can be turned on for improved visibility during the self-catheterization process.

Eligibility criteria: Inclusion Criteria:

* Females age 13 or older
* Urinary retention related to spinal cord injury or other medical conditions resulting in need for catheterization
* Individuals with sufficient upper limb function to catheterize independently or with minimal assistance, or as deemed appropriate for the study by the Principle Investigator.

Exclusion Criteria:

* Individuals younger than 13 years old
* Individuals with cognitive deficits or visual impairments that may impact safe use of the devices used
* Severe ROM restrictions of the upper and/or lower extremities
* Pregnant

Primary outcomes:
measure: System Usability Scale
timeFrame: 1-7 days
Secondary outcomes:
measure: Time to Self-Cath
timeFrame: 1-7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References: