louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06457061: Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia
Official title: Evaluation of Caregiver Burden and Depression Severity in Patients With Right and Left Hemiplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia
Caregiver Burden
Depression
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemiplegia patients treated in our outpatient and inpatient physical therapy and rehabilitation units and their first- or second-degree relatives who care for these patients constitute the study population.

Brief summary: This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Detailed description: Stroke is a disease characterized by neurological symptoms and signs lasting more than 24 hours, which can lead to death after the interruption of brain blood flow or due to focal brain damage. Post-stroke disability affects the patient's quality of life, makes the patient dependent on the caregiver, creates a caregiver burden, and brings socioeconomic and social consequences. Different hemispheres of the brain undertake different tasks. Different clinical conditions may occur in stroke patients with right or left hemiplegia following cerebrovascular infarction. This may affect the care burden of caregivers and the severity of depression. It was thought that knowing the care burden of patients with right and left hemiplegia would positively contribute to the quality of care given to patients.This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Eligibility criteria: Inclusion Criteria:

* Hemiplegia patients between the ages of 18 and 75 were included.
* Caregivers over 18 years of age
* At least 3 months must have passed since the patient was diagnosed.
* Caregivers of patients should be their first and second degree relatives.
* Caregivers must be competent to understand what they read and complete the questionnaires.
* Caregivers must have been caring for their patients for at least 3 months.

Exclusion Criteria:

* Patients and caregivers with a history of psychiatric illness

Primary outcomes:
measure: Beck's Depression Inventory
timeFrame: Day 1
measure: Zarit Caregiver Burden
timeFrame: Day 1
Secondary outcomes:
measure: Barthel Index for Activities of Daily Living Scale
timeFrame: Day 1
measure: Star Cancellation test
timeFrame: Day 1
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
References:
Clinical trial NCT01465061: A Survey on the Role and Benefits of Online Social Networks on Filipino Patients With Psoriasis
Official title: A Survey on the Role and Benefits of Online Social Networks on Filipino Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Online social network
Psoriasis
Filipino
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Philippine Dermatological Society
First posted: 2011-11-04
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of virtual psoriasis local support networks (Yahoo-based Psoriasis Philippine Online Community, Inc. and Facebook Psoriasis Online Support Group) will be the main subjects of the study.

Brief summary: With the rise of usage of the internet, online social networks have recently been gaining popularity. Joining these groups can be beneficial to patients with chronic medical illness, such as psoriasis.This was a cross-sectional online survey of psoriasis patients in the Philippines who are members of online support groups. The survey was conducted for a period of three months.The purpose of the research project was to describe the demographics, disease characteristics, activities and benefits of online support groups to Filipino patients with psoriasis. The extent to which members experience empowering processes and outcomes was also evaluated.


Eligibility criteria: Inclusion Criteria:

* diagnosis of psoriasis
* individuals who are willing to complete the online survey
* proficiency in English
* membership in an online psoriasis support network

Exclusion Criteria:

* nonmembers
* unwilling to participate in the study

Primary outcomes:
measure: Demographic profile of online support users
timeFrame: 3 months
measure: Disease characteristics of online support users
timeFrame: 3 months
Secondary outcomes:
measure: Activities performed and extent of participation of online support users
timeFrame: 3 months
measure: Empowering processes and outcomes experienced by online support group members
timeFrame: 3 months
measure: Correlation of variables
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of the Philippines-Philippine General Hospital Section of Dermatology
name: Charlene U Ang-Tiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181661: Internet-based Group Contingency Management to Promote Smoking Abstinence
Official title: Internet-based Group Contingency Management to Promote Smoking Abstinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Cigarette
Smoking
Nicotine
Contingency Management
Voucher Reinforcement
Smoking Abstinence
Internet
Internet-based Treatment
Group Contingencies
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to develop and test an Internet-based group contingency management program designed to promote smoking cessation.


Eligibility criteria: Inclusion Criteria:

* self-reported smoker
* ability to use the Internet
* permission to contact applicant by phone

Exclusion Criteria:

* self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study
* inability to avoid high levels of ambient CO (e.g., occupational exposure; lives with a another smoker who smokes in the home)

Primary outcomes:
measure: Breath CO
timeFrame: 8 weeks
Secondary outcomes:
measure: Point prevalence measure of abstinence
timeFrame: at the end of treatment (approximately week 4) and at 3 month follow-up
measure: Duration of abstinence during treatment.
timeFrame: 3 weeks
measure: Rate of social exchanges
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: New York City
country: United States
facility: National Development and Research Institutes
state: New York
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: Jesse Dallery, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02007161: Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers
Official title: Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supersaturation and Precipitation in the Stomach
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 20 - 35 years

Exclusion Criteria:

* Illness
* Acute / Chronic gastric disorder
* Use of medicine
* (possible) pregnancy
* Frequent exposure to X-rays during the past year
* HIV / Hepatitis B Virus or Hepatitis C Virus infection

Primary outcomes:
measure: Area under the Concentration - Time Curve
timeFrame: Every 10 minutes for 2 h
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02034461: Micro-Electrodes Implanted in a Human Nerve
Official title: Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Sensory Feedback Useful for Controlling a Prosthetic Device?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amputations
Peripheral Nerve Injury
Spinal Cord Injury
Keywords: Micro-Electrodes
Peripheral Nerve Injury
Amputation
Spinal Cord Injury
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The main objective of the intervention in the study is devise feasibility using high-count microelectrode arrays implanted into peripheral nerves of patients with limb amputations or peripheral nerve injury. These microelectrodes will be custom-made and are not available for commercial distribution. The investigators hypothesize that recording neural signals from a large number of microelectrodes will provide selective motor information in high enough numbers to allow control over future artificial devices with many moving parts, i.e. artificial limbs with shoulder, elbow, wrist, and/or individual fingers that move. These studies will also investigate to what extent microstimulation of nerve fibers can provide sensory feedback from a prosthetic limb.

The investigators will also conduct up to three acute surgeries where a Utah slanted Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb amputations. These acute implantations will provide Dr. Hutchinson with human surgical experience in implanting USEAs and evaluating the containment system we will be using to immobilize the implanted USEA in the nerve.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age and less than 65 years of age
* amputations
* peripheral nerve injury
* twelve participants for the 30 day implantation/physiological experimentation study
* three participants for the acute surgical implantation part of the study

Exclusion Criteria:

* incarceration
* pregnancy
* inability to consent
* psychiatric comorbidity
* increase the risk of adverse effects of general anesthesia

Primary outcomes:
measure: Device feasibility to collect data from peripheral nerves, and will consist of action potentials (mV) arising from the axons surrounding the tip of each electrode.
timeFrame: Up to 4 Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: The University Orthopaedic Center
state: Utah
Study officials:
affiliation: Orthopedic Surgery
name: Douglas Hutchinson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01740661: Cryotherapy and Joint Biomechanics During Running
Official title: Effects of Cryotherapy on Lower Extremity Joint Biomechanics During Running in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Injury
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the immediate effects of cryotherapy on the lower extremity biomechanics during running.

Detailed description: Cryotherapy or cold therapy has widely been used as a treatment modality in both acute and chronic injuries. It is believe that the application of cryotherapy can help to decrease pain, muscle soreness, soft tissue swelling, and cause vasoconstriction of blood vessels reducing heat loss. The nerve conduction velocity and muscle-spindle firing rate also decreases with cryotherapy, which results in changes in proprioception acuity. Cryotherapy has also been used prior to exercise (pre-cooling) to improve endurance activities. However, given the possible detrimental effects of cryotherapy on proprioception acuity, the use of this treatment modality prior to exercise could pose an increased risk of musculoskeletal injury. The effects of cryotherapy on lower extremity biomechanics during athletic movements is poorly understood despite the wide use among physiotherapists, athletic therapists and clinicians. Therefore, the purpose of this investigation is to determine the effects of cold water immersion on lower extremity biomechanics during running. The investigators hypothesize that cryotherapy as a form of treatment can increase the load in the lower extremity joint during gait biomechanics.

Eligibility criteria: Inclusion Criteria:

* males or females (18 - 40 yrs)
* no injuries of the lower extremity in the past 6 months prior to participation
* recreationally active
* in good health upon entry into the study
* willing to volunteer for the present project.

Exclusion Criteria:

* lower extremity injury within the last 6 months
* circulatory, vestibular or any contradiction to cryotherapy including Raynaud's disease

Primary outcomes:
measure: Knee frontal plane moments
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Human Performance Laboratory, University of Calgary
state: Alberta
Study officials:
References:
Clinical trial NCT01987661: The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD
Official title: German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Hypercapnic Respiratory Failure
Keywords: COPD
NIV
Airtrapping
Ventimotion2
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: Weinmann Geräte für Medizin GmbH + Co. KG
First posted: 2013-11-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night.

Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.


Eligibility criteria: Inclusion Criteria:

* Stable respiratory situation
* Clinically required NIV
* Capable of giving consent

Exclusion Criteria:

* Invasive ventilation
* Any other severe physical disease that requires immediate medical assistance
* Acute hypercapnic decompensation with pH \<7.30 in routine BGA
* Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
* Participation in a clinical trial within the last 4 weeks
* Pregnancy or nursing period
* Drug addiction

Primary outcomes:
measure: breathing frequency
timeFrame: 2 nights
Secondary outcomes:
measure: mean pCO2 level
timeFrame: 2 nights
Other outcomes:
measure: Sleep efficiency
timeFrame: 2 nights
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Hagen
state: NRW
Study officials:
affiliation: Helios Klinik Hagen
name: Georg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913861: Non-pharmacological Intervention for Colonoscopy
Official title: Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colonoscopy
Sedation
Hypnosis
Keywords: endoscopy
comfort
non-pharmacological
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 80
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: The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.

Detailed description: Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.

Eligibility criteria: Inclusion Criteria:

* patients classified as ASA 1 to 3
* colonoscopy with anesthesiological support
* capacity of consenting

Exclusion Criteria:

* pregnancy
* colonoscopy with gastroscopy
* emergency
* psychotic diseases
* deafness
* incapacity to understand french
* addiction of drugs and alcohol
* psychoactive drugs

Primary outcomes:
measure: total dose of propofol
timeFrame: the day of the colonoscopy, at the end
Secondary outcomes:
measure: gastroenterologist's satisfaction and quality of the colonoscopy
timeFrame: the day of the procedure, at the end of the procedure
measure: vital parameters
timeFrame: during all the procedure, every 5 minutes
measure: patient's comfort
timeFrame: during the procedure every 10 minutes and 1 and 14 days after the colonoscopy
measure: anxiety state
timeFrame: between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure
measure: patient's satisfaction
timeFrame: between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy
measure: duration of the procedure
timeFrame: the day of the procedure
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Division of Anesthesiology, University Hospitals of Geneva
Study officials:
affiliation: Division of Anesthesiology, University Hospitals, Geneva
name: Nicole Cheseaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04551261: GLS4/RTV and TAF Drug-drug Interaction
Official title: A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.

Detailed description: This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods.

Eligibility criteria: Inclusion Criteria:

* Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;
* Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;
* Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.

Exclusion Criteria:

* In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;
* Allergic constitution (multiple drug and food allergies);
* A history of alcoholism;
* Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;
* Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before screening;
* P-GP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 or MRP4 inhibitors or inducers, such as azithromycin, pantoprazole or St. John's herb, etc., was taken within 30 days before screening;
* Female subjects are lactating or have positive blood pregnancy results during the screening period;

Primary outcomes:
measure: Cmax
timeFrame: predose to 96 hour after dosing
measure: AUC
timeFrame: predose to 96 hour after dosing
measure: Adverse event
timeFrame: Baseline to day 22
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: