louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02739243: A Clinical Trial on a Group Treatment for Distressed Caregivers of Cancer Patients
Official title: Addressing the Hidden Patient - A Randomised-controlled Trial of a Tailored Group Intervention for Caregivers of Cancer Patients (PREPARE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Distress in Caregivers of Cancer Patients
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and study aims: Being a caregiver for someone with cancer can be very difficult emotionally. For many the patient is a family member or friend, and so this can cause the caregiver a great deal of psychological distress. There are currently very few studies looking into the effectiveness of psychological treatments for distressed caregivers of cancer patients. This study is looking at tailored group therapy program for carers of cancer givers. The aim of this study is to find out whether this program can help to lower levels of distress in cancer caregivers and help them to better cope with caring for someone with the illness.


Eligibility criteria: Inclusion Criteria:

1. Time since initial diagnosis (of patient) not longer than six months previously
2. Significant distress against the background of the cancer disease (QSC-R10C exceeding 16 points)
3. Provision of informed consent
4. Aged 18 or over, either gender

Exclusion Criteria:

1. Inability to give informed consent
2. Insufficient German language knowledge
3. Cognitive impairment impeding handling of questionnaires
4. Severe psychiatric disease (acute psychosis or acute suicidality)

Primary outcomes:
measure: Distress
timeFrame: change from baseline distress at 1 week post treatment
Secondary outcomes:
measure: Depression
timeFrame: change from baseline depression at 1 week post treatment and at 6 months post treatment
measure: Anxiety
timeFrame: change from baseline anxiety at 1 week post treatment and at 6 months post treatment
measure: General distress
timeFrame: change from baseline general distress at 1 week post treatment and at 6 months post treatment
measure: Unmet needs
timeFrame: change from baseline unmet needs at 1 week post treatment and at 6 months post treatment
measure: Self-efficacy in coping with the cancer disease
timeFrame: change from baseline self-efficacy at 1 week post treatment and at 6 months post treatment
measure: Utilisation of primary healthcare
timeFrame: change from baseline to 1 week post treatment and 6 months post treatment
measure: Positive bonding with the group
timeFrame: change from baseline bonding at 1 week post treatment and 6 months post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital
name: Markus W Haun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018043: Thai Cancer Anemia Survey in Chulalongkorn Hospital
Official title: Thai Cancer Anemia Survey in Chulalongkorn Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Cancer
Keywords: Cancer Anemia Survey
Chulalongkorn hospital
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anemic patients with cancer receiving chemotherapy

Brief summary: The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.

Detailed description: Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemoglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered

Eligibility criteria: Inclusion Criteria:

* Patients with cancer

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients that have anemia during cancer therapy
timeFrame: 6 months
Secondary outcomes:
measure: Characteristic of each patients example treatment duration,type and chemotherapy using, grade of anemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00589043: Computed Tomography Laser Mammography Breast Imaging Device
Official title: Computed Tomography Laser Mammography Breast Imaging Device Model 1020
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Imaging Diagnostic Systems
Sponsor class: INDUSTRY
First posted: 2008-01-09
Enrollment: 600
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heterogeneous or extremely dense breast patient population scheduled for biopsy

Brief summary: The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.


Eligibility criteria: Inclusion Criteria:

* Female
* 21 and over
* Heterogeneously or extremely dense breast
* Schedule for biopsy
* Gave informed consent

Exclusion Criteria:

* Mammogram not performed within the last 60 days
* Open lesions on the breast
* Previous breast biopsy within 60 days of the CTLM scan
* Surgical deformity of breasts
* Commercial Tattoos
* Protoporphyria
* Lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Imaging Diagnostic Systems
name: David Jin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03173443: Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube
Official title: Comparison of Insertion Time Over Fiberoptic Bronchoscope Between Double Lumen Tube and Single Lumen Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: Fiberoptic intubation
double lumen tube
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 89
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT.

The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiology Physical status 1,2

Exclusion Criteria:

* abnormality of upper airway, gastroesophageal disease, risk of aspiration, BMI \> 35

Primary outcomes:
measure: insertion time
timeFrame: at anesthesia induction
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou universiry hospital
state: Gyeonggi-do
Study officials:
affiliation: Ajou unversity hospital
name: Dae Hee Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02221843: Sunbit UV Measuring Device to Track Sun Behavior
Official title: An Observational Single Center Pilot Study Using a Wearable UV Sensor (Sunbit) Measuring UV Exposure of Patients at High Risk for Skin Cancer - SUNBIT Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Immunosuppression
Skin Neoplasms
Keywords: sun behavior
immunosuppression
skin neoplasms
sunbit
uv sensor
uv dosimeter
solar radiation
uv exposition
uv index
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of Dermatology of the University Hospital Zurich

Brief summary: Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the Sunbit.

Detailed description: A total of 20 patients will be included to wear the Sunbit system during the time of 4 weeks. After this 4 weeks Sunbit will be recollected and data in the form of UV Indices will be extracted and analyzed.

Patients will be recruited in the Department of Dermatology of the University Hospital Zürich. The target population comprises patients with a high risk of melanoma and non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to organ transplantation.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* History of skin cancer (melanoma or NMSC) or patients with high risk of skin cancer (e.g. immunosuppressive therapy)
* Oral and written informed consent

Exclusion Criteria:

* Any medical condition that renders the patient bedridden for the duration of 2 weeks

Primary outcomes:
measure: number of days wearing the device
timeFrame: after 4 weeks wearing the device
Secondary outcomes:
measure: difference between measured UV Indices and reference values
timeFrame: after 4 weeks wearing the device
Other outcomes:
measure: difference between the individual UV Indices
timeFrame: after 4 weeks wearing the device
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology of the University Hospital Zurich
Study officials:
affiliation: Department of Dermatology of the University Hospital Zurich
name: Günther Hofbauer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06264843: Peripheral Bypass Trial for Completion Control
Official title: Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in Chronic Limb-Threatening Ischemia (CLTI) Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Limb-Threatening Ischemia
Keywords: CLTI
Lead sponsor: Medistim ASA
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Limb-Threatening Ischemia patients scheduled to undergo a vein bypass with or without arterial inflow reconstruction to a below-knee and above ankle target

Brief summary: The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle


Eligibility criteria: Inclusion Criteria:

* Chronic Limb-Threatening Ischemia as defined by presence of Peripheral Artery Disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration\>2 weeks duration (ref Global Guidelines)
* Atherosclerotic infra-popliteal PAD
* Adequate distal anastomotic target (crural, tibial or popliteal below the knee with one single run-off) between knee and ankle distal to the stenotic/occluded segment.
* Available autogenous vein conduit based on preoperative vein mapping.
* Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent.

Exclusion Criteria:

* Bypass with artificial conduit or cryopreserved allografts
* Bypass for non-atherosclerotic lesions
* Life-expectancy less than 2 years
* Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up.
* Any condition that the investigator believes should exclude participation.
* Excessive risk for adverse events during open surgery as judged by the investigator.

Primary outcomes:
measure: Primary graft patency rate
timeFrame: at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
References:
Clinical trial NCT00343343: Comparison of NovoFine® Needles (4 mm vs. 6 mm)
Official title: A Comparative, Randomised Study With NovoFine® 4 mm Needle Versus NovoFine® 6 mm Needle in Regard to Anatomical Deposition of Sterile Air in Children and Thin Adults With Diabetes and Backflow of Test Medium (Only Adults) After Injection in Thigh and Abdomen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-06-22
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.


Eligibility criteria: Inclusion Criteria:

* Children
* Type 1 diabetes
* Insulin treatment for more than ½ year
* BMI lesser than or equal to 19 kg/m2
* Last HbA1c taken within the last year lesser than 10.5%
* Girls: only prepubertal
* Boys: both pre pubertal and pubertal. Adults
* Type 1 and 2 diabetes
* Insulin treatment for more than ½ year
* BMI lesser than or equal to 23 kg/m2
* Last HbA1c taken within the last year lesser than 10.5%

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products.
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any).
* Skin disease at abdomen and/or thigh

Primary outcomes:
measure: Deposition of sterile air depositions.
Secondary outcomes:
measure: Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
measure: Amount of backflow
Other outcomes:
Locations:
city: Ålborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Birkebaek NH, Solvig J, Hansen B, Jorgensen C, Smedegaard J, Christiansen JS. A 4-mm needle reduces the risk of intramuscular injections without increasing backflow to skin surface in lean diabetic children and adults. Diabetes Care. 2008 Sep;31(9):e65. doi: 10.2337/dc08-0977. No abstract available.
Clinical trial NCT02458443: Isometric Handgrip Exercise for Blood Pressure Management
Official title: Cardiovascular Response to Isometric Resistance Training in People With Hypertension for Blood Pressure Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of New England, Australia
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. The investigators intend to conduct the largest, longest, prospective, double-blind randomized controlled trial using isometric resistance training to reduce blood pressure to reduce hypertension.

Detailed description: We are looking to assess the effect of isometric exercise on ambulatory blood pressure in participants aged 40-70 years who are either pre- or mild hypertensive; either un-medicated or taking medication to control their blood pressure. Our secondary aims are to examine whether the size of blood pressure change is different in those people taking or not taking anti-hypertensive medication, to determine the anti-hypertensive mechanism to IRT, and to establish rate of de-training effects after participants have ceased IRT.

Eligibility criteria: Inclusion Criteria:

* Blood pressure above 120/80 currently not taking anti-hypertensive medications whose doctor has suggested would benefit from exercise; and
* people currently taking beta blockers for blood pressure management.

Exclusion Criteria:

* Younger than 30yrs and older than 70 yrs;
* unable to voluntary participate;
* unable to participate under doctor's recommendation;
* smokers;
* arthritis or carpal tunnel which may be aggravated with handgrip exercise;
* known cardiovascular disease (angina) and the following co-morbid conditions:

  * obesity,
  * insulin resistance,
  * depression,
  * mobility impairment,
  * sleep apnoea,
  * fatty liver disease or
  * renal disease

Primary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: Change measures: baseline and 12 weeks
Secondary outcomes:
measure: Compare and contrast change in systolic and diastolic blood pressure of medicated and un-medicated participants
timeFrame: Baseline and 12 weeks
measure: Detraining effects, changes in systolic and diastolic blood pressure after cessation of Isometric Resistance Training
timeFrame: 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Armidale
country: Australia
facility: UNE Exercise Physiology Lab
state: New South Wales
Study officials:
affiliation: University of New England
name: Neil Smart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlson DJ, Dieberg G, Hess NC, Millar PJ, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis. Mayo Clin Proc. 2014 Mar;89(3):327-34. doi: 10.1016/j.mayocp.2013.10.030.
Clinical trial NCT00436943: Smoking Cessation Program: A Quality Improvement Trial in a Resident-Based Outpatient Clinic
Official title: Smoking Cessation Program: A Quality Improvement Trial in a Resident Based Outpatient Clinic
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Smoking
Keywords: smoking cessation
nicotine replacement therapy
bupropion
smoking
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2007-02-19
Enrollment: 900
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinic

Brief summary: The researchers hypothesize that smoking cessation counseling improves with the implementation of a smoking status assessment data sheet in routine consults. This is a quality improvement study design to evaluate the impact of the implementation of a more formal smoking status evaluation in a resident/faculty driven outpatient clinic.

Detailed description: We hypothesize that smoking cessation counseling improves with the implementation of a smoking status assessment data sheet in routine consults. This is a quality improvement study design to evaluate the impact of the implementation of a more formal smoking status evaluation in a resident/faculty driven outpatient clinic. This will be an observational study in which differences in quality measures will be compared between baseline and re-measurement periods. Population target: 900 patients screened before and after the implementation of the QI intervention. Primary outcome: smoking status evaluation. Secondary Outcome: number of patients advised to quit, plan implementation for smoking cessation, smoking cessation program referrals, number of NRT and bupropion prescription.

Eligibility criteria: Inclusion Criteria:

* 21 years or older
* Seen at MMH family health center
* Current smoker

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Family Health Center at Morristown Memorial Hospital
state: New Jersey
Study officials:
affiliation: Atlantic Health System - Morristown Memorial Hospital
name: Patricia Harris, MD
role: PRINCIPAL_INVESTIGATOR
References: