louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03876366: Fertility Preservation in Men Affected by Cancer
Official title: Fertility Preservation in Men Affected by Cancer: Assessment of Patients' Needs and Development of an Online Decision-aid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: cancer patients
male cancer patients
Decision Aid (DA)
online Decision Aid tool
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Krebsforschung Schweiz, Bern, Switzerland
First posted: 2019-03-15
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients who are/were possible candidates for FP (patients with fertility compromising cancer treatment) will be invited to participate. Eligible patients will be approached by their former or current treating oncologist, urologist or specialist in reproductive medicine.

Brief summary: This is a single center cross-sectional retrospective study with a quantitative and qualitative approach (phase 1 and 2). In phase 1 an online survey will be realized and targets male cancer survivors. Phase 2 will take a qualitative approach, in which information about patient's experiences, needs and helpful support will be collected by establishing focus groups of cancer patients who had been diagnosed during the reproductive age.

In the end, the results of this study will be integrated into the development of an online support tool concerning Fertility Preservation (FP).


Eligibility criteria: Inclusion Criteria:

* German speaking
* Cancer diagnosis within the last 10 years (minimum age at diagnosis 13 years)
* Cancer therapy that was expected to impair fertility

Exclusion Criteria:

* Prepubertal at diagnosis

Primary outcomes:
measure: male cancer patients level of information with regard to FP
timeFrame: Phase 1 online survey at baseline
measure: male cancer patients level of information with regard to FP
timeFrame: Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
Secondary outcomes:
measure: male cancer patients needs regarding decision-making about FP
timeFrame: Phase 1 online survey at baseline
measure: male cancer patients expectation with regard to an online DA tool about FP
timeFrame: Phase 1 online survey at baseline
measure: male cancer patients needs regarding decision-making about FP
timeFrame: Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
measure: male cancer patients expectation with regard to an online DA tool about FP
timeFrame: Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Frauenklinik University Hospital Basel
Study officials:
affiliation: Frauenklinik Universitätsspital Basel
name: Sibil Tschudin, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05784766: Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
Official title: Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 480
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients with cancer have a higher incidence of AF but despite the higher incidence of AF in the cancer population, there are no randomized controlled trials (RCTs) for AF screening in this population. RCTs of AF screening in the general population have shown that screening can effectively detect AF earlier, and helps to identify candidates for appropriate anticoagulation that may lead to improvement in clinical outcomes.

Detailed description: The Investigators will conduct an open label, prospective, pilot RCT. After informed consent, patients will be randomized 1:1 into screening or usual care. Screening will be done at a single time point. Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). Patients randomized to usual care will not receive a screening ECG. Primary outcome will be detection of newly diagnosed AF by screening vs usual care.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients age ≥65 with a current diagnosis or history of cancer.
2. Patients currently undergoing or history of chemotherapy, radiotherapy or cancer related surgeries will be included.
3. The age is restricted to ≥65 years because prevalence of AF is extremely low. .

Exclusion Criteria:

1. Known history of atrial fibrillation.
2. Non-English-speaking participants will not be enrolled

Primary outcomes:
measure: The Investigators will compare the incidence of newly diagnosed AF identified by screening versus usual care
timeFrame: 6 MONTHS
Secondary outcomes:
measure: To determine the effect of screening-detected AF on initiation of anticoagulation.
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: OU Health
name: Zain Asad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808366: Efficacy and Safety of RV4104A Ointment in Onychomycosis
Official title: A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Onychomycosis
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail)
* Target nail plate showing ≥ 12.5% of clinically infected area
* Patient must have at least 2 mm of the proximal end of the target nail free of infection
* Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)

Exclusion Criteria:

* Patient with more than 2 affected toenails
* Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
* Patient with moccasin-type tinea pedis
* Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit

Primary outcomes:
measure: Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs
timeFrame: D21
Secondary outcomes:
measure: Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation
timeFrame: D21
measure: Patient self-assessment
timeFrame: D21, D77, D105
measure: Clinical cure
timeFrame: D77, D105
measure: Mycological cure
timeFrame: D105
measure: Complete cure of onychomycosis
timeFrame: D105
measure: Local tolerability
timeFrame: D7, D21
measure: Adverse Event reporting
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Purpan
Study officials:
affiliation: Hôpital Purpan, Toulouse - FRANCE
name: Carle PAUL, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04452266: Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome
Official title: Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome: Study Conducted in the Hauts-de-France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lynch Syndrome
Keywords: lynch syndrome
endometrial cancer
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women included are all carriers of Lynch syndrome, already diagnosed by genetic analysis in the Molecular Biology Laboratory of the CHU de Lille and whose analysis was transmitted during a consultation at the Guy Fontaine Genetics Clinic during the period from 01/01/1998 to 30/11/2019 at the CHU de Lille or in advanced consultations in the regions.The database PROGENY will be use to extract population corresponding to the study

Brief summary: Lynch Syndrome increases Endometrial Cancer Occurrence in women due to failure in MisMatch Repair System. Lifetime Cumulative risk of developing endometrial Cancer is approximatively 40% in women with Lynch Syndrome.

Endometrial cancer is the third women cancer in France. Many risk factors are known in general population. Lots of factors are related to over exposure to estrogen.

Data about influence of general risk factors in Women with Lynch Syndrome are poor. Recently, a cohort study appears to have shown a significant decrease in the risk of endometrial cancer with multiparity, the use of hormonal contraception and late menopause in Lynch women. The impact of weight and certain metabolic parameters on the occurrence of endometrial cancers remains poorly known to this day.


Eligibility criteria: Inclusion Criteria:

* Lynch Syndrome Diagnosis at University Hospital
* Alive at study time
* Age over 30 at endometrial cancer or Lynch Syndrome Diagnosis

Case group :

- No cancer before endometrial cancer diagnosis

Control group :

* No endometrial cancer developped
* Free cancer women at Lynch Syndrome diagnosis

Exclusion Criteria:

* Refusing to participate
* Poor understanding of the French language
* Other cancer diagnosed before endometrial cancer
* Hysterectomy before lynch diagnosis for free cancer women

Primary outcomes:
measure: Correlation between endometrial cancer and predictif factors
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between endometrial cancer and predictif factors in post menopausal woman
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres
Study officials:
affiliation: University Hospital, Lille
name: Solveig MENU-HESPEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912366: Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy
Official title: A Prospective, Single Center, Observational Study Comparing the Safety and Efficacy of CVATS, HVATS and Open Surgery for Subjects Diagnosed With NSCLC Scheduled to Undergo a Lobectomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non Small Cell Lung Cancer
Keywords: VATS
Lung cancer
NSCLC
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 39
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: Subjects referred for lobectomies at the hospital.

Brief summary: Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years of age or older.
* Subject must have been clinically diagnosed with stage I to stage IIA non small cell lung cancer measuring and judged to be resectable.
* Subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy

Exclusion Criteria:

* Subject is pregnant (documented by pregnancy test) or breastfeeding.
* Subject has other severe illnesses that would preclude surgery such as

  * Unstable angina
  * Myocardial Infarction within 3 months
  * Coronary Artery Bypass Graft Surgery
* Subject has other active cancers
* Subject is unable to comply with any of the following:

  * Study requirements
  * Give valid informed consent
  * Follow-up schedule

Primary outcomes:
measure: Assess hospital length of stay (LOS).
timeFrame: 1 time point (discharge)
measure: Pain Scale Evaluation
timeFrame: 5 time points out to 6 months
Secondary outcomes:
measure: Assess quality of life.
timeFrame: 2 time points out to 6 months
measure: Assess peri-operative and post-operative complications.
timeFrame: 5 time points out to 6 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
References:
Clinical trial NCT06190366: Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain
Official title: Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Back Pain, Low
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of a bloodletting acupuncture at the fossa poplitea in comparison to bloodletting acupuncture at the regio glutaea and a waiting list control group in patients with subacute and chronic non-specific pain low back pain.


Eligibility criteria: Inclusion Criteria:

* Specialist confirmed diagnosis of subacute or chronic non-specific low back pain for at least 6 weeks prior to inclusion
* Average pain intensity with at least 50 mm on the VAS from 0 to 100 mm

Exclusion criteria:

* Serious illnesses
* Poor general condition
* Coagulation disorder, therapy with anticoagulants
* Thrombophlebitis, skin inflammation in the area of the lower extremities
* Alcohol, drug or medication addiction
* Pregnancy
* Lack of willingness to cooperate, linguistically or mentally unable to understand the contents of the study
* Participation in another clinical trial during the study period
* Starting a new therapy for the treatment of low back pain in the last 2 weeks

Primary outcomes:
measure: Change from baseline in average pain intensity in previous week
timeFrame: Baseline, 3 weeks
Secondary outcomes:
measure: Change from baseline in average pain intensity in previous week
timeFrame: Baseline, 6 weeks
measure: Change from baseline in average pain intensity of the last 24 hours
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change from baseline for back pain specific disability
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change from baseline in pain bothersomeness in previous week
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change from baseline for days with pain medication use
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change from baseline for health related quality of life
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change from baseline for pain self-efficacy
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change from baseline for anxiety and depression
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change from baseline for work productivity
timeFrame: Baseline, 3 weeks, 6 weeks
Other outcomes:
measure: Number of participants with adverse events as a measure of safety and treatment adherence
timeFrame: 3 weeks, 6 weeks
measure: Treatment adherence
timeFrame: 3 weeks
measure: Treatment expectation: effectiveness of bloodletting acupuncture in reducing low back pain
timeFrame: Baseline
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin
Study officials:
References:
Clinical trial NCT04011566: Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Official title: Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus, Normal Pressure
Keywords: Asymptomatic Normal Pressure Hydrocephalus
Ventriculoperitoneal Shunt
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: NeuroDx Development
First posted: 2019-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of asymptomatic normal pressure hydrocephalus research subjects who have a ventriculoperitoneal shunt with a single ventricular catheter implanted for adult hydrocephalus and are visiting for routine care. Evaluation will be within 2 weeks of shunt placement.

Brief summary: The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent.

Exclusion Criteria:

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.

Primary outcomes:
measure: Specificity of ShuntCheck test
timeFrame: 15 minutes
measure: Negative Predictive Value of ShuntCheck test
timeFrame: 15 minutes
Secondary outcomes:
measure: Specificity of performing ShuntCheck test twice
timeFrame: 60 minutes
measure: Negative Predictive Value of performing ShuntCheck test twice
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Department of Neurological Surgery and Brain Repair
state: Florida
Study officials:
affiliation: University of South Florida
name: Naomi Abel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05431166: Virtual Yoga for Social Isolation and Loneliness in Rural Veterans
Official title: Virtual Yoga for Social Isolation and Loneliness in Rural Veterans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Loneliness
Social Isolation
Keywords: Veterans
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Wait list Control
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overarching goal of this project is to decrease social isolation and loneliness through increased awareness and uptake of virtual yoga group classes among rural Veterans.


Eligibility criteria: Inclusion Criteria:

* Enrolled in VA Healthcare
* Residential address associated with VA Portland Health Care System that is "rural" or "highly rural; except among Collaborative Aging Research using Technology (CART) participants
* Valid contact info (mailing address, email, and phone number)
* High speed Internet access
* Positive screen for loneliness (NIH Toolbox Loneliness Scale Score greater or equal to 13)

Exclusion Criteria:

* Any VA or non-VA yoga visit in the preceding 12 months
* Visually or hearing impaired, or any mobility limitation that would impact computer/mobile device use, without availability of appropriate assistive devices
* Cognitive impairment, upcoming medical procedures, or significant unstable medical and psychiatric conditions that may limit study participation

Primary outcomes:
measure: UCLA Loneliness Scale, Version 3
timeFrame: 10 Weeks
Secondary outcomes:
measure: NIH Toolbox Loneliness Scale
timeFrame: 10 Weeks
measure: Modified Duke Social Support Index, Social Interaction Subscale
timeFrame: 10 Weeks
measure: Modified Duke Social Support Index, Social Interaction by Relationship Subscale
timeFrame: 10 Weeks
measure: Promis Social Roles and Activities
timeFrame: 10 Weeks
measure: Promis Satisfaction with Social Roles and Activities
timeFrame: 10 Weeks
measure: PHQ-9
timeFrame: 10 Weeks
measure: PC-PTSD-5
timeFrame: 10 Weeks
measure: NIH CoRonavIruS Health Impact Survey (CRISIS)
timeFrame: 10 Weeks
measure: CSQ-8
timeFrame: 10 Weeks
measure: Treatment Delivery
timeFrame: 10 Weeks
measure: Treatment Fidelity Checklist
timeFrame: 10 Weeks
measure: Attitudes Toward Yoga
timeFrame: 10 Weeks
measure: Sociodemographic Characteristics
timeFrame: 10 Weeks
measure: PEG (Pain, Enjoyment, General Activity) Scale
timeFrame: 10 Weeks
measure: SF-12
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
References: