louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03850184: Translation of the "Exercise in Mental Illness Questionnaire (EMIQ)" to German
Official title: Translation of the "Exercise in Mental Illness Questionnaire (EMIQ) - Health Practicioners Version" From English to German
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Psychiatric Disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to evaluate the questionnaire in mental health professioals (psychiatrists, psychologists, nurses) currently working with patients with mental disorders

Brief summary: The "The Exercise in Mental Illness Questionnaire (EMIQ) - Health Practicioners Version" is a questionnaire designed to assess the prescription behaviour of physical activity as well as related knowledge, barriers and exercise behaviour of mental health professionals.

As a lot of research on prescription behaviour is done using unvalidated questionnaires we want to translate this validated questionnaire into German for further use in this research field.

Detailed description: The "The Exercise in Mental Illness Questionnaire (EMIQ) - Health Practicioners Version" is a questionnaire designed to assess the prescription behaviour of physical activity as well as related knowledge, barriers and exercise behaviour of mental health professionals.

As a lot of research on prescription behaviour is done using unvalidated questionnaires we want to translate this validated questionnaire into German for further use in this research field. Therefore we plan to translate the questionnaire in accordance to established questionnaire translation guidelines.

Then we plan to validate the questionnaire in a sample of about 30 mental health professionals (psychiatrists, psychologists, nurses) currently working with patients with mental disorders. We plan to evaluate re-test-reliability using repeated measurement within 7 days.

Eligibility criteria: Inclusion Criteria:

* Psychiatrist, Psychologist or Nurse
* Working with patients with mental disorders
* German mother language

Exclusion Criteria:

- None

Primary outcomes:
measure: The Exercise in Mental Illness Questionnaire (EMIQ)
timeFrame: within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Departement of Psychiatry
Study officials:
affiliation: Charité University Medicine Berlin - Department of Psychiatry and Psychotherapy - CCM, Berlin, Germany
name: Moritz B Petzold, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stanton R, Happell B, Reaburn P. The development of a questionnaire to investigate the views of health professionals regarding exercise for the treatment of mental illness,. Mental Health and Physical Activity 7(3): 177-182, 2014.
Clinical trial NCT00682084: Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome
Official title: Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome Before and After Surgical Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cushing's Syndrome
Insulin Resistance
Keywords: Cushing's syndrome
Glucose tolerance
Insulin sensitivity
Substrate metabolism
Body composition
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2008-05-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recently diagnosed with Cushing's syndrome, recruited from the clinic.

Brief summary: The purpose of this study is to investigate the effect og chronic elevated levels of cortisol on metabolism and insulin sensitivity.


Eligibility criteria: Inclusion Criteria:

* Written consent
* Age between 18 and 70
* Diagnosed with Cushing's syndrome

Exclusion Criteria:

* Suspected malignancy

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Before and after treatment
Secondary outcomes:
measure: Glucose tolerance, QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism.
timeFrame: Before and after treatment
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology
state: Aarhus
Study officials:
affiliation: Aarhus University Hospital, Department of Endocrinology
name: Jens Otto L. Jørgensen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03054584: Genetic Basis of Melanocytic Nevi
Official title: Genetic Basis of Melanocytic Nevi
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanocytic Nevi
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects seen in UC Davis dermatology clinic diagnosed as having melanocytic nevi will be recruited from the clinic during their routine visit. Subjects identified in clinic will be approached after their clinic visit.

Brief summary: The objective of this protocol is to further elucidate the genetic mutations that drive melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole genome, whole exome, or targeted sequencing of de-identified specimens.

Herein, the investigators plan to isolate DNA from de-identified skin biopsy specimens and blood samples:

1. From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the tissue will be submitted for routine diagnostic dermatopathology and investigational histomorphologic and immunohistochemical analysis.
2. From corresponding normal tissue (blood). DNA isolated from blood will be used as a normal control when analyzing sequencing data to identify somatic mutations in lesional tissue.


Eligibility criteria: Inclusion criteria:

* Male or female subjects that are 18 years or older
* Subjects with melanocytic nevi\\

Exclusion criteria:

* Patients less than 18 years of age
* Patients without melanocytic nevi
* Patients with a bleeding disorder or are taking anticoagulation medication

Primary outcomes:
measure: Genome Wide Mutation Analysis
timeFrame: Feb 2017 - December 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Department of Dermatology
state: California
Study officials:
References:
Clinical trial NCT00180284: SITELINE 2 Polyurethane
Official title: SITELINE 2 Polyurethane Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bradycardia
Keywords: Pacemaker leads
Electrodes, implantable
Cardiac pacing, aritificial
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.

Detailed description: This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans

Eligibility criteria: Inclusion Criteria:

* Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol
* Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atrium and the right ventricle
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
* Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals
* A life expectancy of more than 180 days

Exclusion Criteria:

* Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
* Have surgically uncorrected primary valvular heart disease
* Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously)
* Requiring ICD therapy
* Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug
* Enrolled in any concurrent study, including drug investigation, without Guidant written approval, that may confound the results of this study
* Women who are pregnant or plan to become pregnant

Primary outcomes:
measure: Pacing voltage threshold at 3 Months
timeFrame: 3 months
measure: Pacing impedance at 3 Months
timeFrame: 3 months
measure: Sensed amplitude at 3 Months
timeFrame: 3 months
measure: Lead complication-free rate up to 3 Months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Multiple Locations in the United States
state: Minnesota
Study officials:
References:
Clinical trial NCT04212884: Functional Decline and QoL in People Aging with HIV in Asia
Official title: Functional Decline and Quality of Life in People Aging with HIV in Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Disability Physical
HIV/AIDS
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: National Taiwan University
name: Chongqing Public Health Medical Center
name: Tan Tock Seng Hospital
First posted: 2019-12-30
Enrollment: 1500
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All PLWH followed up at the five participating HIV centers will be screened and invited to participate in this study. Each site will also enroll age and sex-matched HIV-uninfected participants in a 1:2 ratio.

Brief summary: This is a multi-center prospective cross-sectional study to determine the burden of decline in intrinsic capacity and functional ability, and the prevalence of geriatric syndromes, such as frailty, and disability in adult people living with HIV (PLWH) in Asia.

Detailed description: This research project is expected to have the following clinical impact

1. To understand the impact of impaired functional status in PLWH in Asia would be important to determine the long-term health burden needs in this aging population in this part of the world.
2. The identification of risk factors associated with impaired functional status would be important to guide clinical decisions in patient management, such as the choice of anti-retroviral regimen, and screening of and early intervention for modifiable risk factors. These are of paramount importance in the promotion of healthy aging in this population.
3. This proposed cross-sectional study lays the foundation for the establishment of a longitudinal cohort for long-term follow up of people aging with HIV in Asia, with the objectives of evaluating the long-term impact of aging on clinical outcomes and functional status in PLWH in this region.

Eligibility criteria: Inclusion Criteria:

* HIV antibody positive
* Age 35 years or above
* Asian ethnicity, including but not limited to Chinese, Malay and Indian

Exclusion Criteria:

* Inability or refusal to consent
* Active infections requiring in-hospital treatment

Primary outcomes:
measure: Functional disability
timeFrame: 24 months
Secondary outcomes:
measure: Composite score for intrinsic capacity
timeFrame: 24 months
measure: Physical performance
timeFrame: 24 months
measure: Cognitive decline
timeFrame: 24 months
measure: Frailty
timeFrame: 24 months
measure: Sarcopenia
timeFrame: 24 months
measure: Health-related quality of life
timeFrame: 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Grace LUI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590784: Reliability and Validity of Thai Calgary Depression Scale of Schizophrenia (CDSS)
Official title: The Reliability and Validity of the Thai Version of Calgary Depression Scale for Schizophrenia (CDSS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Depression
Schizophrenia
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pariticipants diagnosed with schizophrenia according to DSM-IV-TR.

Brief summary: Depression in patients with schizophrenia is common. Several factors was found to be associated with depression including medical illness, quality of life, positive symptoms, and typical antipsychotics. The Calgary depression scale of schizophrenia (CDSS) is commonly used for screening depression in schizophrenia,however; the Thai version of CDSS has not been validated.

This study aims to a.) test the reliability and validity of the Thai version of Calgary depression scale of schizophrenia (CDSS) and b.) identify the prevalence and factors associated with depression in patients with schizophrenia including quality of life, type of antipsychotic drugs, and severity of schizophrenia in 60 patients with schizophrenia at the Faculty of Medicine, Chiang Mai University, Thailand.

Detailed description: Measurements:

The Thai version of Calgary depression scale of schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Hamilton Rating Scale for Depression-17 (HAM-D 17), Montgomery-Asberg Depression Rating Scale (MADRS), the Thai abbreviated version of World Health Organization quality of life (WHOQOL-BREF-THAI).

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or over
* Diagnosis of schizophrenia according to DSM-IV-TR

Exclusion Criteria:

* Having organic brain syndrome
* Not fluent in Thai

Primary outcomes:
measure: The reliability of the Thai version of the Calgary Depression Scale for Schizophrenia (CDSS) in schizophrenia patients.
timeFrame: 3 months
measure: The validity of the Thai version of the Calgary Depression Scale for Schizophrenia (CDSS) in schizophrenia patients.
timeFrame: 3 months
Secondary outcomes:
measure: The prevalence of depression in patients with schizophrenia
timeFrame: 3 months
measure: The association between depression in schizophrenia and quality of life.
timeFrame: 3 months
measure: The association between depression in schizophrenia and type of antipsychotic drugs.
timeFrame: 3 months
measure: The association between depression in schizophrenia and severity of schizophrenia.
timeFrame: 3 months
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Sirijit Suttajit, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03115684: Pain Relief in the Emergency Department Waiting Room: a Prevalence Study
Official title: Antalgie à l'Accueil Des Urgences- étude de prévalence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 2371
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admited to an emergency department waiting room after triage with a documented pain score upon arrival

Brief summary: Pain in the emergency room is under documented and pain relief suboptimal. Data on nurse driven analgesia in emergency department waiting rooms is lacking. The primary objective of this study is to determine the proportion of patients in pain receiving pain therapy administered by the triage nurse (prevalence study). The secondary objectives are to 1) describe nursing practices in analgesia and adherence to the dedicated protocol; 2) to determine the factors associated with the non administration of painkillers and for these factors, to estimate the strength of the association


Eligibility criteria: Inclusion Criteria:

* Documented pain score on arrival by the triage nurse and
* Patients having to wait in the ER waiting room

Exclusion Criteria:

* patients directly admitted to the consultation room
* patients for whom pain was not recorded

Primary outcomes:
measure: Proportion of patients receiving pain medicine in the ER waiting room by the triage nurse after pain documentation
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00836784: Comparison of New and 3-Month-Old Toothbrush in the Removal of Plaque in Children
Official title: Comparing Efficacy of Old Versus New Toothbrushes in Plaque Removal in the Hands of 7-9 Year Old Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Removal
Keywords: Old tooth brush
Plaque removal
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 93
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to validate or invalidate non-inferiority in the plaque removal efficacy of old versus new toothbrushes in the hands of 7-9 year old children. This study was conducted in 93 Iranian students aged between 7-9 year old.

Detailed description: At baselines, each student is given a new toothbrush which they will use for 3 months. The amount of wearing the 3-month-old brushes will determine by measurement of brushing surface areas using NIH imaging software. The outcomes will be measured after 3 month. The tooth brush which used in this study is "Jordan" with the following specifications: Length: 128 mm, 9 rows of bristles, 27 tufts, 24 monofilaments per tuft, height of monofilaments 10 mm and diameter of filaments 0.3 mm. The students will attend on two occasions following 48 hour periods of no oral hygiene. Following plaque scoring, students will brush with a new tooth brush at one visit and with a brush that they had used previously for 3 months at the other visit. Brushing time was 60 seconds. Plaque then will be re-scored and the percentage reduction in plaque score will be calculate using the Turesky plaque index. All plaque scoring will be performed by one examiner who is blind with the groups allocations.

Eligibility criteria: Inclusion Criteria:

1. subjects should be have central and lateral incisors, first permanent molar in each quadrant of maxilla and mandible
2. they should be without restoration on facial, lingual surfaces
3. subjects should be healthy without any disabilities

Exclusion Criteria:

1. subjects who wearing oral prosthesis,orthodontic brackets or removable appliances
2. subjects using mouthwashes which improve the oral hygiene

Primary outcomes:
measure: Turesky plaque index
timeFrame: before and after brushing the teeth
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University
Study officials:
affiliation: Shahid Beheshti medical Science University
name: Beheshte Malekafzali
role: STUDY_CHAIR
affiliation: Shahid Beheshti medical Science University
name: Mina Biria
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti Medical Science University
name: Hoshyar Abbasi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00039884: Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
Official title: Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anemia
Cervix Neoplasms
Keywords: Cervical cancer
Lead sponsor: Mirhashemi, Ramin, M.D.
Sponsor class: INDIV
First posted: 2002-06-17
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical trial (a type of research study) designed to describe the efficacy (effectiveness) and toxicity (safety) of a new medical treatment, NESP (Novel Erythropoiesis Stimulating Protein). This study will be offered to patients with cervical cancer undergoing a combination of chemotherapy and radiation. This treatment may lower your red blood cells. The use of NESP may stimulate the body to produce more red blood cells. Our hypothesis is that higher red blood cells will be beneficial to the patient during treatment for cervical cancer.


Eligibility criteria: * Consent form completed and signed
* Hemoglobin between 9-13 g/dL
* Life expectancy of at least 4 months
* Karnofsky Performance Status =/\> 70
* No evidence of hemolysis, GI bleeding, or bleeding due to recent surgery
* Adequate renal and liver function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center/JMH
state: Florida
Study officials:
References: