louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06505590: STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Official title: STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Diagnosis
Moderate or Severe Score of Cancer-related Fatigue (CRF)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
name: Institut Bergonié
First posted: 2024-07-17
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Decentralized, randomized hybrid type 2 (effectiveness/implementation) controlled trial comparing the effectiveness of three different digital aid modalities programs in reducing the perceived burden of CRF in cancer patients while also gathering data on the implementation strategy.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older.
* Having a clinical diagnosis of cancer including patients on active treatment or cancer survivors.
* Self-reporting moderate to severe CRF for at least one week (worst level of fatigue ≥ 4 on a 10-point numerical rating scale, retained in international guidelines as an optimal cutoff for identifying clinically significant CRF).
* Being able to read and understand French.
* Having access to a smartphone.
* Patients must be affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

* Suffering from current psychiatric disorder or cognitive disorder that would interfere with the ability to consent or participate.
* Currently engaging in cognitive-behavioral therapy.
* Currently engaging in another non-drug (behavioral) clinical trial.
* Suffering from physical related reversible and treatable causes of fatigue (anemia, electrolytes unbalance, infections, renal dysfunction, active metastases causing fatigue, hormonal unbalances (hypothyroidism, adrenal insufficiency, etc.) - according to physician's judgement at the moment of inclusion.

Primary outcomes:
measure: Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient.
timeFrame: 3 months and 6 months after the end of the program.
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References:
Clinical trial NCT02153164: Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content
Official title: Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Patient Position on Airway Heat Content
Keywords: Enthalpy
Trendelenberg position
Mechanical ventilation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective surgery requiring steep Trendelenberg position.

Brief summary: This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in patient position on the measurement of respiratory heat loss (enthalpy). This study would be carried out on patients whose operation requires the use of the steep Trendelenburg position independent of this study.


Eligibility criteria: Inclusion Criteria:

* age greater than 18 years
* scheduled for an elective surgical procedure requiring general anesthesia, positive pressure ventilation using an endotracheal tube and the steep Trendelenburg position

Exclusion Criteria:

* Adults unable to give primary consent
* age less than 18 years
* pregnancy
* prisoners
* infusion of inotropic drugs
* positive end expiratory pressure (PEEP) requirements \>8 cm H2O Women, minorities or non-English speaking subjects will not be excluded.

Primary outcomes:
measure: Respired gas heat content
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California Davis, Department of Anesthesiology and Pain Medicine
name: Neal W. Fleming, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02550964: Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy
Official title: Incidence and Risk Factor Evaluation for Toxic Maculopathy Associated With Hydroxychloroquine and Chloroquine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Toxic Maculopathy
Keywords: Autoimmune Disease
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Hydroxychloroquine(HCQ)
Chloroquine(CQ)
Toxic Maculopathy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 124
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The purpose of this cohort study is to evaluate the incidence and risk factor. We will recruit a total of 124 participants considering the study budget.

Brief summary: The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the investigators will screen these patients by baseline examination (Fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography) and observe with same examination for every year.


Eligibility criteria: Inclusion Criteria:

* Patient who treated with HCQ or CQ due to autoimmune diseases such as RA, SLE
* Patient who did not previously diagnosed with HCQ/CQ toxic retinopathy

Exclusion Criteria:

* Aged less than 19 years

Primary outcomes:
measure: Incidence of toxic maculopathy associated with HCQ or CQ
timeFrame: 1 years
Secondary outcomes:
measure: Risk factor of HCQ/CQ retinopathy
timeFrame: 5 years
measure: Characteristics and type of HCQ/CQ retinopathy (parafoveal or pericentral retinopathy)
timeFrame: 5 years
measure: Progression of retinopathy after drug cessation
timeFrame: 1 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: JooYong Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02873364: High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria
Official title: High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Urticaria
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.


Eligibility criteria: Inclusion Criteria:

* Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks

Exclusion Criteria:

* Physical urticaria aquired or hereditary angioedema Calcium level \> 10.3 mg/dl Glomerular filtration rate \<50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation

Primary outcomes:
measure: Urticaria symptom severity questionnaire after 1 week
timeFrame: 1 weeks
Secondary outcomes:
measure: Urticaria symptom severity questionnaire after 6 week
timeFrame: 6 weeks
measure: Urticaria symptom severity questionnaire after 12 week
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Keramatallah Jahanshahi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03143790: Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
Official title: Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Erectile Function
Keywords: Erectile Function
Prostatectomy
Extracorporeal Shock Wave Therapy
IIEF-5
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to active or placebo treatment.
Primary purpose: TREATMENT

Brief summary: Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.

Detailed description: All patients have undergone prostatectomy and are without recurrence. None of the men have sufficient effect of medical treatment for erectile dysfunction (tablets or injection therapy).

Each participant will fill out two validated sexual function questionnaires: IIEF-5 (International Index of Erectile Function), and EHS (Erection Hardness Score).

Our treatment protocol consists of one treatment sessions per week for 5 wk. The shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mJ/mm2.

Patients are randomized to active treatment or placebo.By placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. None of the attending staff members will be familiar with who receive active and who receive placebo treatment.

For evaluation, the International index of erectile function (IIEF-5) will be used after 1, 3- and 6-mo follow-up.

Eligibility criteria: Inclusion Criteria:

* Erectil dysfunction after radical prostatectomy less than two years ago
* IIEF - less than 20
* EHS - less than 4

Exclusion Criteria:

* drop out
* not sexual active
* penile prostesis

Primary outcomes:
measure: IIEF-5 point
timeFrame: 1, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: OUH
Study officials:
References:
Clinical trial NCT01943890: High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients
Official title: Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Hypertonic saline
Lung physiotherapy
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.

The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

Detailed description: Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy.

HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age \> 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.

Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis

Exclusion Criteria:

* Non-adherence

Primary outcomes:
measure: Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second
timeFrame: 24 months
Secondary outcomes:
measure: Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients
timeFrame: 24 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dept. of Thoracic Medicine, Haukeland University Hospital
Study officials:
affiliation: Dept. of Physiotherapy, Haukeland University Hospital, Bergen, Norway
name: Stian Hammer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02692690: TENS in Optimizer(R) Patients
Official title: Electromagnetic Interference by Transcutaneous Neuromuscular Electrical Stimulation in Patients With Optimizer(R) - a Pilot Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure.

Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life.

It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients with Optimizer® pacemaker systems for improvement of heart failure.

This pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study.

Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF) on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the Optimizer®-system respectively.


Eligibility criteria: Inclusion Criteria:

* \>18 years, with implantation of the Optimizer ® \>6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months.

Exclusion Criteria:

* Local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation

Primary outcomes:
measure: The patients with CCM-system are assessed for EMI during TENS-application
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04129190: Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
Official title: Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes in Pregnancy
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 225
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: With the increasing prevalence of diabetes in pregnancy it is necessary to design a simple, sensitive, cost effective method for screening of hyperglycaemia in pregnancy specially in resource constrained settings.

There is no universally agreed screening and diagnostic criteria to detect hyperglycemia in pregnancy. In present study, DIPSI (non-fasting OGTT) is compared with fasting oral glucose tolerance test (OGTT) to evaluate sensitivity and specificity of both methods in our population.


Eligibility criteria: Inclusion Criteria:

All pregnant women

Exclusion Criteria:

Known diabetic

Primary outcomes:
measure: Oral Glucose Tolerance
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Isra University, Karachi Campus
state: Sindh
Study officials:
References:
Clinical trial NCT05642390: SEBBIN INTEGRITY Round Implants
Official title: Prospective Observational Study About SEBBIN Silicone Gel-filled INTEGRITY Mammary Implants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Complication
Prosthesis Durability
Lead sponsor: Groupe SEBBIN
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 5
Sex: FEMALE
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: The study population will be recruited from prospective adult patients operated for breast augmentation or reconstruction, unilaterally or bilaterally with SEBBIN silicone gel filled INTEGRITY mammary implants.

Brief summary: This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility criteria: Inclusion Criteria:

* The patient is at least 18-year-old.
* The patient is a woman.
* The patient was prescribed with a surgery for a breast augmentation or reconstruction, unilaterally or bilaterally with silicone gel-filled SEBBIN INTEGRITY mammary implants.
* The patient has been informed of the study, has read the patient information letter and provided consent in writing.

Exclusion Criteria:

* The patient is pregnant or breastfeeding.
* The patient has silicone implants somewhere else than in the breast.
* The patient was diagnosed with one of the following pathologies:

  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
  * History of implant-associated anaplastic large cell lymphoma (BIA-ALCL).
  * Symptomatic autoimmune disease.
* The patient has a pathology that could delay healing (does not apply to the reconstruction group).
* The patient has cancer (does not apply to the reconstruction group).
* The patient has anatomical or physiological conditions that could lead to postoperative complications.

Primary outcomes:
measure: Complication rate
timeFrame: At 10 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Ouen-l'Aumône
country: France
facility: SEBBIN
Study officials:
References:
Clinical trial NCT06861790: WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)
Official title: Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Weight Loss
Keywords: Weight loss and brain function
Effects of bariatric surgery on brain function
Reduced glucose insulin changes and brain function
tVNS intervention post-surgery
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-03-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. This study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention initiated 30 days post-surgery improves brain function and thinking. The study does NOT cover any costs associated with bariatric surgery.

Detailed description: There will be one group of study participants.

The group will (independently of this research study) have weight loss surgery to help them with weight loss.

All research participants in this group will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will also undergo a non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention days post-surgery, for 30 days at home with the device that is provided.

The group will have an MRI Brain Scan at each time-point to study the changes in the structure and function of the brain tissue.

Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.

Eligibility criteria: Inclusion Criteria:

* Between age: 20-75 yrs, English speaking, Physically mobile
* Body Mass Index (BMI) \>35 kg before surgery
* Compatible of MRI Scanning
* Willing to give a small blood sample
* Capable of providing informed consent

Exclusion Criteria:

* Prior or current neurological disorder
* Major psychiatric disturbance
* Unstable medical conditions (cancer)
* MRI contraindications (claustrophobia, metal implants, waist/torso circumference)

Primary outcomes:
measure: Brain inflammation - MRS
timeFrame: 18 months
measure: Cognitive functioning - Global functioning score
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida - College of Public Health and Health Professions
state: Florida
Study officials:
affiliation: University of Florida
name: Eric Porges, PhD
role: PRINCIPAL_INVESTIGATOR
References: