louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04047381: Validity and Reliability of the Turkish Version of Atrial Fibrillation Impact Questionnaire (AFImpact)
Official title: Validity and Reliability of the Turkish Version of Atrial Fibrillation Impact Questionnaire (AFImpact)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Quality of life
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2019-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Turkish patients diagnosed with atrial fibrillation

Brief summary: Validity and reliability of the Turkish version of 'Atrial Fibrillation Impact Questionnaire (AFImpact)' will be evaluated in the study.

Detailed description: Atrial fibrillation (AF) is the most common sustained arrhythmia with a reported incidence of 2.1% in Turkish population aged 60 and above. Although a minority of patients have minimal or no symptoms, palpitations, dyspnea and fatigue are frequently reported by AF patients. It is well documented that AF patients, including those with no symptoms, have poorer quality of life (QoL) compared to healthy population. Worrying about their condition, side effects of treatments and worsening health are the other factors that have an impact on QoL, beside symptoms. Management of QoL is a key therapeutic goal in AF treatment and guidelines recommend that QoL in these patients should be measured regularly. There is a concern in the literature that generic QoL measures may not be sufficiently sensitive or specific to measure AF related QoL, thus using disease specific QoL measures are recommended for AF patients. An AF-specific quality of life measure is lacking in Turkish language, thus our aim in this study is to validate the Turkish version of 'Atrial Fibrillation Impact Questionnaire (AFImpact)' in Turkish AF patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of paroxysmal, persistant or permanent atrial fibrillation
* To be able to read and understand Turkish

Exclusion Criteria:

* Diagnosis of heart failure or any chronic lung diseases
* Recent coronary bypass surgery
* Previous heart valve surgery
* Rheumatic valvular heart disease
* Recent acute myocardial infarction
* Having a pacemaker

Primary outcomes:
measure: Atrial Fibrillation Impact Questionnaire (AFImpact)
timeFrame: 5 minutes
Secondary outcomes:
measure: Short-form 36 (SF-36)
timeFrame: 10 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa, Institute of Cardiology
Study officials:
References:
Clinical trial NCT01366781: Gut Hormones After Meal Ingestion in Males Versus Females
Official title: Effects of Varying Meal Size on Gut Hormone and Islet Hormone Secretion in Males Versus Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Non-fluency
Keywords: Gut hormones
Insulin secretion
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined.

Detailed description: In healthy males and females, meals with 511, 743 and 1034 kcal will be given orally. Samples will be taken during the following 300 min and gut hormones (glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1) will be determined along with insulin and glucagon levels.

Eligibility criteria: Inclusion Criteria:

* Healthy status

Exclusion Criteria:

* Diabetes
* Liver disease
* kidney disease
* thyroid disease

Primary outcomes:
measure: Release of gut hormones
timeFrame: 300 min
Secondary outcomes:
measure: Insulin secretion
timeFrame: 300 min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Clinical Sciences Lund, Lund University
Study officials:
affiliation: Lund University
name: Bo Ahrén, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alsalim W, Omar B, Pacini G, Bizzotto R, Mari A, Ahren B. Incretin and islet hormone responses to meals of increasing size in healthy subjects. J Clin Endocrinol Metab. 2015 Feb;100(2):561-8. doi: 10.1210/jc.2014-2865. Epub 2014 Nov 6.
Clinical trial NCT04094181: A Study of VPRIV in Participants With Gaucher Disease Previously Treated With Other Enzyme Replacement Therapies or Substrate Reduction Therapies
Official title: VPRIV® Non-Interventional Study in Patients Previously Treated With Other Enzyme Replacement Therapies (ERTs)/Substrate Reduction Therapies (SRTs)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gaucher Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-09-18
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants included in the study will have a diagnosis of Type 1 GD and be in enzyme/substrate replacement therapy other than VPRIV, for at least 6 months prior to enrolment in the study, or have been previously treated with an ERT/SRT other than VPRIV for a minimum of 6 months prior to transitioning to VPRIV.

Brief summary: The main aim of this study is to describe the safety profile of velaglucerase alfa (VPRIV) in participants with Gaucher disease type 1. Participants will be transitioning from other enzyme replacement therapies or substrate reduction therapies to VPRIV. Some participants may have already transitioned to treatment with VPRIV before this study started.

In this study, data on VPRIV will be collected from the medical records of participants who already transitioned to VPRIV before this study started. Other participants will join this study when they transition to VPRIV. All participants will be followed to allow for 12 months of observation from time of transition to VPRIV.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.


Eligibility criteria: Inclusion Criteria:

* Participant with GD1 currently being treated with an ERT/SRT other than VPRIV for at least 6 months before baseline enrolment; or participant previously treated with another ERT/ SRT for at least 6 months prior to transitioning to VPRIV..
* Participant or legally authorized representative has provided written informed consent.

Exclusion Criteria:

* In the opinion of the investigator, participant is at high risk of non-compliance.
* In the opinion of the investigator, participant is unsuitable in any other way to participate in this study.
* Participant is pregnant.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) Following the Transition From Other ERTs/SRTs to VPRIV
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Change From Baseline in Use of Glucosylspingosine (Lyso-Gb1) Biomarker
timeFrame: Baseline, Month 12
measure: Change From Baseline in Gaucher Disease Questionnaire Patient Reported Outcomes (PRO) Score at Month 12
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/Medical Genetics Clinic
state: Alberta
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03579381: Specimen Repository for HIV Immunopathogenesis
Official title: Specimen Repository for HIV Immunopathogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Acute HIV Infection
Lead sponsor: AIDS Healthcare Foundation
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2018-07-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acutely HIV infected individuals HIV infected individuals who are not on anti-retrovirals and have a viral load between 50 and 3,000 HIV infected individuals who are not on anti-retrovirals and have a viral load less than 49

Brief summary: Specimen Repository for HIV Immunopathogenesis Studies

Detailed description: The goal is to build a large specimen repository for collaborating scientists to run studies of immunity and HIV-1.

Eligibility criteria: Inclusion Criteria:

1. HIV positive (acutely infected, viremic and elite controllers)
2. Signed Informed Consent Form
3. Age at least 18 years old
4. Immune controllers, two types: "Elite suppressors" (HIV-positive with any three consecutive plasma HIV-1 RNA PCR undetectable while off treatment) or "viremic suppressors" (HIV-positive with any three consecutive HIV-1 RNA PCR \<3000 while off treatment).
5. Acutely infected subjects:

Persons identified to have a negative HIV antibody response (ELISA) but positive detection of HIV-1 in the blood (RT-PCR) or individuals who have evidence of a recent (past 30 days) HIV negative result along with a current HIV positive result.

Exclusion Criteria:

1. Uncontrolled bleeding diathesis.
2. Pregnant.
3. Inability to provide informed consent.

Primary outcomes:
measure: HIV progression from acute infection to viral suppression
timeFrame: 2 years
measure: HIV progression and control by elite and viremic suppressors
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation - Public Health Division
state: California
Study officials:
affiliation: Scientific Director
name: Otto O Yang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04618081: Revlimid® Capsules General Drug Use-results Surveillance (Relapsed or Refractory FL and MZL)
Official title: Revlimid® Capsules General Drug Use-results Survey (Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma Nonhodgkin
Keywords: Lymphoma
Nonhodgkin
low-grade
B-cell
Follicular
Marginal zone
Safety
Revlimid
Rituximab
Actual use conditions
R2 combination therapy
Bone marrow depression
Neutropenia
Tumor flare
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This survey will be conducted in patients who have been diagnosed with follicular lymphoma (FL) or marginal zone lymphoma (MZL) who receive R2 combination therapy with the drug and rituximab for the first time.

Brief summary: To ascertain the safety of Revlimid® Capsules 2.5 mg or 5 mg under the actual use conditions in patients who received R2 combination therapy with the drug and rituximab for the first time for relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

In particular, this surveillance will collect only information of occurrence state and treatment methods on bone marrow depression (neutropenia), which is specified as a safety specification, as well as on tumor flare, for which attention should be called.

1. Planned registration period 1.5 years
2. Planned surveillance period 3 years from the start of this survey


Eligibility criteria: Inclusion Criteria:

- Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00675181: Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow
Official title: Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasospastic Syndrome
Keywords: melatonin
skin blood flow
choroidal blood flow
vasospastic subjects
normal subjects
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (VS)?

The main questions are:

Do women with VS exhibit...

* a different basal metabolic rate
* a reduced choroidal blood flow
* a reduced increase of oxygen consumption after intake of ice-water
* a different oxygen consumption after melatonin intake
* a different choroidal blood flow after melatonin intake
* a different oxygen consumption after melatonin intake and after intake of ice-water....?

Detailed description: Study description:

Melatonin, a natural hormone of the pineal gland exclusively released during the dark phase, exhibits vasodilatatory effects in distal skin regions and reduces core body temperature. This study investigates whether exogenous melatonin (5mg p.o. at 2p.m.) in the afternoon, when no endogenous melatonin is secreted, increases not only distal skin blood flow, but also choroidal blood flow and changes oxygen consumption. Two subject groups were studied, women with vasospastic syndrome (VS) and controls. The main hypothesis is: melatonin normalizes distal vasoconstriction in VS.

Further questions will also be answered:

Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (VS)?

Do women with VS exhibit:

* a different basal metabolic rate
* a reduced choroidal blood flow
* a reduced increase of oxygen consumption after intake of ice-water
* a different oxygen consumption after melatonin intake
* a different choroidal blood flow after melatonin intake
* a different oxygen consumption after melatonin intake and after intake of ice-water....?

Eligibility criteria: Inclusion Criteria:

* vasospastic syndrome
* healthy

Exclusion Criteria:

* sick
* BMI \>25 or \<18
* migraine
* drug intake

Primary outcomes:
measure: -choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension
timeFrame: continously or 2-5 times
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Eye Clinic
Study officials:
affiliation: University Eye Clinic, Basel, Switzerland
name: Selim Orguel, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01449981: Development and Testing of Adolescent Twelve-Step Facilitation
Official title: Development and Testing of Adolescent Twelve-Step Facilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Alcohol Dependence
Drug Abuse
Drug Dependence
Keywords: Adolescents
Alcohol Abuse
Alcohol Dependence
Drug Abuse
Drug Dependence
Substance Use Disorder
Alcoholics Anonymous
Motivational Enhancement Therapy
Cognitive Behavioral Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 59
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. In the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the preliminary integrated TSF protocol. In the second phase of the study, the investigators will compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. As a result, the investigators will examine potential mechanisms that may underlie the efficacy of iTSF in improving alcohol and other drug use outcomes. The investigators will test group differences on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance and involvement) and whether these variables are associated with substance use outcomes.


Eligibility criteria: Inclusion Criteria:

* Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.

Exclusion Criteria: Youth

* with an active psychotic disorders
* who are in another substance use disorder (SUD) treatment program or receiving SUD related psychotherapy that could conflict with our treatment
* with a history of severe or complicated withdrawal (e.g., alcohol seizure history)
* who may be using alcohol/drugs prior to study entry at levels likely to result in severe withdrawal complications, in the absence of any history
* taking addiction treatment medications (e.g., Buprenorphine)
* who cannot speak English because the treatment and assessment instruments will be conducted in English

Primary outcomes:
measure: Percent Days Abstinent (PDA)
timeFrame: Up to 9 months
Secondary outcomes:
measure: Treatment Acceptability
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Addiction Medicine 60 Staniford Street
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John F. Kelly, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01241981: Digital Breast Tomosynthesis in Younger Symptomatic Women
Official title: Digital Breast Tomosynthesis (DBT): Sensitivity for Cancer and Accuracy in Assessing Extent of Malignant Disease in Symptomatic Women Below 60 With Clinical or Ultrasound Signs Compatible With Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast
Cancer
Digital
Mammography
Tomosynthesis
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
Collaborators: name: University of Dundee
First posted: 2010-11-16
Enrollment: 446
Sex: FEMALE
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women under 60 years of age with clinical or ultrasound suspicion of breast cancer

Brief summary: This study will examine a new imaging technique called digital breast tomosynthesis (DBT) compared to standard mammography in women under 60 presenting with signs of breast cancer. The reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.


Eligibility criteria: Inclusion Criteria:

* Female
* Under 60 years old
* Clinical or ultrasound suspicion of breast cancer

Exclusion Criteria:

* Unable to give informed consent
* Male
* Obvious advanced breast cancer
* Obvious medical problems meaning surgery would not be an option

Primary outcomes:
measure: Sensitivity of DBT for breast cancer, compared with FFDM
timeFrame: Two years
Secondary outcomes:
measure: Accuracy of DBT compared with FFDM in assessment of tumour extent
timeFrame: Two years
measure: Relative accuracy of DBT and FFDM by breast density
timeFrame: Two years
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: NHS Tayside, Ninewells Hospital & Medical School
state: Tayside
Study officials:
affiliation: University of Dundee, NHS Tayside
name: Andrew J Evans, FRCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04563481: Effectiveness of Telerehabilitation on Scleroderma
Official title: Investigation of the Effectiveness of Telerehabilitation on Individuals With Hand-Affected Scleroderma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scleroderma
Scleroderma, Systemic
Scleroderma Associated Digital Ulcer
Hand Rheumatism
Physiotherapy
Rehabilitation
Keywords: Scleroderma
Systemic sclerosis
Telerehabilitation
Hand therapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Study
Primary purpose: TREATMENT

Brief summary: The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of traditional physiotherapy practices.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with scleroderma
* Stability of medical treatments
* To be able to adapt to the exercises

Exclusion Criteria:

* The patient has a history of neurological disease or trauma that may affect his symptoms
* Systemic involvement that affects the treatment process
* Being in the active phase of the disease

Primary outcomes:
measure: Hand Mobility in Scleroderma (HAMIS)
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: 9-Hole Peg Test
timeFrame: change from baseline at 8 weeks
measure: Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: change from baseline at 8 weeks
measure: Semmes Weinstein Monofilaman Test
timeFrame: change from baseline at 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: change from baseline at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Tugba Civi Karaaslan
state: Buyukcekmece
Study officials:
affiliation: Research Assistant
name: TUGBA CIVI KARAASLAN, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References: