louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02582450: Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia
Official title: Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemophilia
Keywords: Haemophilia
Adherence of Treatment
Knowledge of Illness
Medical-patient Relationship
Illness Behavior
Treatment Difficulties
Veritas
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
Collaborators: name: Medtep Inc.
First posted: 2015-10-21
Enrollment: 70
Sex: MALE
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia around the country that will participate in study.

Brief summary: Research project for validation of a questionnaire on compliance to treatment in patients with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the international methodology validation questionnaires: reverse translation, according to intersubject patients, psychometric validation and reliability analysis with large sample of patients.

Detailed description: The validated questionnaire obtained in this project will identify the actual degree of patient compliance to drug therapy, using as gold standard the difference between the treatment prescribed and administered.

Eligibility criteria: Inclusion Criteria:

* Patients with hemophilia A and B
* Patients who have previously signed the informed consent document

Exclusion Criteria:

* Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
* Patients with cognitive impairment, or oral or written understanding

Primary outcomes:
measure: Translation of the original questionnaire (English) to Spanish
timeFrame: 1 day (Screening visit)
measure: The translated version of the questionnaire
timeFrame: 1 day (Screening visit)
measure: Sending the questionnaire to a large sample of patients for final validation
timeFrame: 1 day (Screening visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Real Fundación Victoria Eugenia
Study officials:
affiliation: Real Fundación Victoria Eugenia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04077450: Heart-Focused Breathing in Alzheimer's Disease Caregivers
Official title: Effectiveness of Heart-focused Breathing on Reducing Burden in Alzheimer's Caregivers: An Online Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burnout, Caregiver
Quality of Life
Keywords: Stress
Caregiver Burden
Alzheimer's Disease Caregiver
Informal Caregiver
Anxiety
Heart-Focused Breathing
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial in which participants will be randomized into (a) the modified waitlist-control arm or (b) the intervention arm.
Primary purpose: TREATMENT

Brief summary: This research study will explore the effects of an online heart-focused breathing intervention on 20 informal caregivers of patients with Alzheimer's Disease (AD) over a period of two weeks.

Detailed description: Informal caregivers are often live-in, unpaid spouses, relatives, partners, or friends that help with a loved one's activities of daily living. As a result of caring for a person with Alzheimer's Disease (AD), many informal caregivers experience caregiver burden. The demanding physical, emotional, and financial responsibilities to care for an AD patient can be detrimental to the caregiver's health.

A group of 20 men and women who consider themselves the primary caregiver of a person with AD will be recruited and enrolled into the study. Participants will be randomized into one of two study arms, (a) the modified-waitlist control arm or (b) the intervention arm. The study will explore the effects of an online heart-focused breathing intervention on heart rate variability (measured by the Welltory app on their smart device), perceived burden, stress, and quality of life in the intervention arm over a two-week period.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years of age or older
* Live-in and unpaid informal caregiver to a loved one with Alzheimer's Disease
* Provides care or supervision for at least 4 hours per day for more than 6 months
* Experiencing stress

Exclusion Criteria:

* Caregivers who report a low risk assessment score and/or report a medically diagnosed arrhythmia or have a pacemaker will be excluded

Primary outcomes:
measure: Caregiver Burden
timeFrame: 2 weeks
Secondary outcomes:
measure: Life Quality
timeFrame: 2 weeks
measure: Perceived Stress
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT06240650: Tolerability of a Modified Health-Dx
Official title: Randomized Controlled Study to Evaluate Tolerability of a Modified Health-Dx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Celero Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals ages 18 - 75 inclusive
* Subject is a suitable candidate for study participation in the opinion of the Investigator
* Subject has been informed of the nature of the study and has provided written informed consent as approved by the WVU IRB

Exclusion Criteria:

* Subjects with a history of any condition that may impact the GI tract
* Subjects who are unable to swallow a 000 sized capsule
* Subjects with an implanted medical device that has wireless data communication capability
* Subjects planning to undergo an MRI within 30 days after the study
* Subjects with a BMI \> 40 (severe obesity)
* Subjects who are pregnant or are nursing
* Any subject deemed to be at risk of a gastrointestinal complication as evaluated by a gastroenterologist prior to study enrollment

Primary outcomes:
measure: The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects.
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
Clinical trial NCT02245750: Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: hysteroscopy - recurrent implantation failure
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.

Detailed description: A randomized controlled study involving 300 patients with recurrent implantation failure

Eligibility criteria: Inclusion Criteria:

1. Patient's age ranged from 20-40 years.
2. Normal appearance of the uterine cavity on hysterosalpingography.
3. Patients prepared for IVF/ICSI cycle.

Exclusion Criteria:

1. Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).
2. Patients with uterine cavity pathology previously known to the examiner.
3. Patients with previous uterine surgery such as myomectomy.
4. Patients with abnormal HSG.

Primary outcomes:
measure: • Clinical pregnancy rate.
timeFrame: 6 months
Secondary outcomes:
measure: • Live Birth Rate
timeFrame: 6 months
Other outcomes:
measure: • Uterine anomalies detected by Hysteroscopy
timeFrame: 6 months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity hospital
Study officials:
affiliation: Ain Shams University
name: mostafa f gomaa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04958850: The Third Epidemiological Research of Refractory Wounds in China
Official title: The Third Epidemiological Research of Refractory Wounds in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound of Skin
Keywords: cutaneous wounds
epidemiology
China
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese Patients who underwent treatment of chronic cutaneous wounds in our hospital from 1/2018-12/2018

Brief summary: This study is a cross-sectional survey in patients who underwent treatment of chronic cutaneous wounds from a nationally representative sample in our hospital from January 2018 to December 2018．

Detailed description: Chronic cutaneous wounds represent a major health care burden in China However, limited information exists regarding the epidemiologic changes associated with recent social and economic devdopment．We designed a cross-sectional survey in patients who underwent treatment of chronic cutaneous wounds from a nationally representative sample in our hospital from January 2018 to December 2018．

Eligibility criteria: Inclusion Criteria:

- Patients who underwent treatment of chronic cutaneous wounds in our hospital from 1/2018-12/2018．

Exclusion Criteria:

- No

Primary outcomes:
measure: the prevalence of chronic cutaneous wounds among hospitalized patients
timeFrame: 1 year
Secondary outcomes:
measure: cause of disease
timeFrame: 1 year
measure: Bacterial etiology
timeFrame: 1 year
measure: Treatment expense
timeFrame: 1 year
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
name: Han Chunmao, Pro
role: STUDY_CHAIR
References:
Clinical trial NCT04531150: Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
Official title: A Single Center, Phase I, Double-Blind, Placebo-Controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male or female
* Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg
* Non- or ex-smoker
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

* Female who is pregnant or lactating
* Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
* History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
* Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum QTc of 450 for males and 470 for females)

Primary outcomes:
measure: Pharmacokinetic parameters - Maximum Concentration (Cmax)
timeFrame: 72 hours
measure: Pharmacokinetic parameters - AUC
timeFrame: 72 hours
measure: Pharmacokinetic parameters - Half-live
timeFrame: 72 hours
Secondary outcomes:
measure: Adverse events
timeFrame: 72 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Altasciences
state: Quebec
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04412850: Intravenous Magnesium Sulphate in Acute Ischemic Stroke
Official title: Role of Intravenous Magnesium Sulphate in Improving Clinical Outcome in Patients Suffering From Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Stroke
Ischemic Stroke
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH Stroke Scale (NIHSS) in patients with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Adults with a confirmed diagnosis of ischemic stroke on neurological examination and CT scan findings aged between 45 -95 years of age of either gender.
* Adults presenting within a stroke onset of 24 hours.

Exclusion Criteria:

* Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial bleed or space occupying lesion)

  * Subjects with systolic blood pressure less than 90mmHg
  * Presence of Bundle Branch block or atrioventricular block.
  * Serum Creatinine \> 3mg/dl
  * Respiratory failure (O2 saturation \<90% or Respiratory Rate \>24 or \<12)
  * Pregnancy.

Primary outcomes:
measure: Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.
timeFrame: 7 days
Secondary outcomes:
measure: adverse effects
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03557450: A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
Official title: A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Subjects
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To evaluate if a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) with sodium fluoride can measure bone blood flow to the hip.

Detailed description: The purpose of this research is to validate technique on a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) along with sodium fluoride as the tracer for determining blood flow to the bone. Up to 12 subjects will have PET/CT scans so that we can determine the repeatability and reliability of the images prior to using PET/CT for this use on subjects in the Phase 1b part of Dr. Nancy Lane's clinical research study entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Glucocorticoids" (IRB Protocol #866350).

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study.

1. 20 - 75 years old
2. Must be ambulatory and able to attend all appointments
3. Women must agree to use one of the following methods of birth control for the duration of the clinical trial:

   systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device
4. Subject undergoing PET/CT scans must have the ability to lay motionless for up to 30 minutes.

Exclusion Criteria:

1. Subjects undergoing PET/CT scans must not be breast-feeding.
2. History of hypersensitivity to fluoride

Primary outcomes:
measure: Measure of Blood Flow to the proximal femur
timeFrame: Within a week of the scan
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
References:
Clinical trial NCT00932750: Study of Coffee Mannooligosaccharides for Weight Management
Official title: THE EFFECTS OF COFFEE MANNOOLIGOSACCHARIDES ON INDICES OF BODY WEIGHT, BODY COMPOSITION, AND SATIETY IN HUMANS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Body composition
Weight loss
Weight management
Beverages
Diet
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. Luke's-Roosevelt Hospital Center
First posted: 2009-07-03
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to establish the role of coffee mannooligosaccharides (MOS), provided in a beverage format, on body weight regulation. Overweight and obese men and women will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and safe. In the first phase, subjects will be counseled once monthly on a nutrition-related topic on an individual basis. They will be asked to maintain their regular eating and exercise habits for the duration of the 12 week period. An 8-week washout period will follow during which time they will not be required to consume the beverages. The second phase of the study will be a weight loss phase. For this phase, subjects will be re-randomized and may consume the alternate or the same beverage as the first phase, depending on the outcome of randomization. During this phase, they will undergo group counseling on a weekly basis. Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each phase. This study will allow us to determine whether MOS helps maintain body weight and prevent weight gain (first phase) and whether it helps to stimulate weight loss (second phase). The results will allow us to find ways in which overweight and obese individuals can incorporate beverages in their diets that will help promote weight loss.


Eligibility criteria: Inclusion Criteria:

* Body mass index 27-33 kg/m2
* Stable body weight

Exclusion Criteria:

* Body width \> 46 cm
* Medications known to affect body weight, lipids, blood pressure
* Pregnant or lactating women
* Less than 1 y post-partum

Primary outcomes:
measure: Body Composition by Magnetic Resonance Imaging
timeFrame: Baseline and Endpoint
measure: Blood pressure
timeFrame: Weekly
measure: Body weight
timeFrame: Weekly
measure: Waist circumference
timeFrame: Weekly
Secondary outcomes:
measure: Appetite/Satiety
timeFrame: Weekly
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's/Roosevelt Hospital
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Marie-Pierre St-Onge, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04005950: Comparison of a Conventional and a Realistic Self-modified Model
Official title: Evaluation and Comparison of a Modified Skalpell-Bougie-technique for Cricothyreotomie: Comparison of a Conventional and a Realistic Self-modified Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cricothyroidotomy
Difficult Airway
Obesity
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 70
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: medical doctors of the Department of anesthesiology of the University hospital Mainz, Germany

Brief summary: According to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended.

Even though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational requirements like food hygiene, limited shelf-life and preparation time and expense.

Therefore the investigators modified an available for purchase cricothyroidotomy trainer (the AirSim Combo X) with everyday suitable and cost-effective utensils.

As a control group the investigators used a conventional simple plastic model.

Detailed description: Obesity is an important risk factor for a cannot intubate cannot ventilate situation. Obese patients are more likely to require a cricothyroidotomy, due to failure rates of routine airway management. Relevant landmarks can be difficult to palpate. And the greater depth of the soft tissues overlying the larynx. Due to this reasons the investigators modified the adult intubation manikin AirSim Combo X with a drunk baby diaper to simulate the neck of an obese patient.

As a further modification the investigators prepared freezer bags filled with faked blood to simulate a possible bleeding.

35 medial doctors of the department of anesthesiology and 35 paramedics are going to perform two cricothyroidotomies in each model.

For the one time participants use the ScalpelCric Set and for the other time participants use the ScalpelCric Set plus a speculum.

Primary endpoint is the evaluation of reality of the two different manikins.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* german language in speaking and writing
* capability of giving consent

Exclusion Criteria:

* participants unwilling or unable to give informed consent

Primary outcomes:
measure: evaluation of realistic applicability
timeFrame: 12 minutes
Secondary outcomes:
measure: Time from initial handling equipment to a successful placement of the tracheal cannula
timeFrame: 300 seconds
Other outcomes:
measure: Number of trials
timeFrame: up to 12 minutes
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenberg - Universität
state: Rhineland Palatinate
Study officials:
References: