louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06646900: Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial
Official title: Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: Pakistan Association of Cognitive Therapists
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial to evaluate the feasibility and acceptability of delivering a new intervention. Participants who meet the inclusion criteria will be randomly allocated to intervention or control groups in a 1:1 ratio.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized controlled trial (RCT) will compare the efficacy and feasibility and acceptability of a culturally adapted CBT manual with a standard CBT manual, focusing on addressing cultural factors in therapy delivery.

Detailed description: Randomized Controlled Trial (RCT): Participants will be randomly assigned to either the culturally adapted CBT manual group or the standard CBT manual group. A culturally adapted manual will integrate cultural values, norms, and idioms of suffering into CBT techniques, ensuring relevance and acceptance within the target cultural group. The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations.

Eligibility criteria: Inclusion Criteria:

1. Individuals aged 18 to 65 years
2. 5 years of education
3. Symptoms of depression and anxiety

Exclusion Criteria:

1. Substance use disorder according to DSM-5 criteria as determined by primary care clinician
2. Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician
3. Active psychosis as determined by their primary care clinician

Primary outcomes:
measure: Feasibility and acceptability measures
timeFrame: 12 weeks
measure: Clinical Measures
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Association of Cognitive Therapists
state: Punjab
Study officials:
References:
Clinical trial NCT01045200: Nurse-or Surgeon-led Follow-up After Rectal Cancer
Official title: Nurse-or Surgeon-led Follow-up After Rectal Cancer: a Randomised Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: rectal cancer
follow-up
specialist nurse
Lead sponsor: Centrallasarettet Västerås
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Operated for rectal cancer at the colorectal unit of the Central Hospital in Västerås, Sweden.

Brief summary: Follow-up programmes consume a large amount of resources with less time for the surgeon to take on new patients. The aim of this randomised study was to compare patient satisfaction, resource utilisation, and medical safety in patients curatively operated for rectal cancer that were followed-up by a surgeon or a nurse.


Eligibility criteria: Inclusion Criteria:

* Patients curatively operated for rectal cancer.
* Patients had to be more than 18 years of age and written and oral informed consent was obtained.

Exclusion Criteria:

* Those with psychiatric disorders, dementia and whose general condition had deteriorated with an expected survival of less than six months were not eligible.

Primary outcomes:
measure: Patient satisfaction
timeFrame: At each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery.
Secondary outcomes:
measure: Resource utilisation
timeFrame: at each patient visit, i.e. every 6 months during the first three years than every year after rectal cancer surgery.
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Departement of Surgery, Central Hospital
Study officials:
References:
Clinical trial NCT04530500: COVID-19 In-vitro Diagnostic Test and Androgen Receptor Gene Expression
Official title: In-vitro Diagnostic Test to Predict COVID-19 Mortality and Disease Severity
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid19
Androgen Receptor Gene Overexpression
Keywords: androgen receptor
severity
mortality
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Applied Biology, Inc.
First posted: 2020-08-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males over age 18 who have tested positive for SARS-CoV-2 infection within the University of California, Irvine Health System.

Brief summary: This research study will evaluate the association of Androgen Receptor (AR) gene expression and COVID-19 disease severity and mortality. The research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. This saliva will be used in a COVID-19 Androgen Sensitivity Test (CoVAST) which will detect AR gene expression. Eligible participants are males, at least 18 years or older, and have tested positive for COVID-19.


Eligibility criteria: Inclusion Criteria:

* Male over the age of 18
* Laboratory confirmed SARS-CoV-2 infection
* Able to give verbal informed consent

Exclusion Criteria:

* Unable to give informed consent
* Diagnosed with an additional respiratory co-infection
* XXY males

Primary outcomes:
measure: Number of patients deceased
timeFrame: 28 days
Secondary outcomes:
measure: Number of patients discharged
timeFrame: 14 days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Applied Biology, Inc
state: California
city: Irvine
country: United States
facility: University of California, Irvine - Dermatology Clinical Research
state: California
Study officials:
affiliation: University of California, Irvine
name: Natasha Mesinkovska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02138500: A Study to Examine the Distribution of PF-06372865 in the Brain of Healthy Volunteers Using Positron Emission Tomography and a Radioactive Tracer Following Oral Administration of One Dose of PF-06372865
Official title: A Phase 1, Open-label Study To Evaluate Central Occupancy Of The Benzodiazepine Binding Site Of Gabaa Receptors By Positron Emission Tomography (Pet) With Ligand [11c]Flumazenil Following Single Dose Of Pf-06372865 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-06372865
phase 1
open-label
GABA-A receptor occupancy
positron emission tomography
healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will see how PF-06372865, an experimental drug distributes in the brain after one dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-06372865in these subjects and will measure the level of PF-06372865 in the blood.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Known or suspected sensitivity to flumazenil and other benzodiazepines.

Primary outcomes:
measure: GABAA RO in the whole brain
timeFrame: Change from baseline to days 1 and 2
measure: Average plasma concentration of PF-06372865 in post-dose PET scans after single oral doses of PF-06372865
timeFrame: Change from baseline to days 1 and 2
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
city: New Haven
country: United States
facility: Anlyan Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02900300: A Biobank for Diaphragm Muscular Fiber
Official title: Constitution of a Biobank to Optimize in Vitro an Antioxydant Treatment for Diaphragm Dysfunction Induced by Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Dysfunction
Mechanical Ventilation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing a surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm

Brief summary: This non-interventional study focuses on mechanical ventilation used in intensive care unit to supplement ventilatory function in patients. Mechanical ventilation can "paradoxically" be at the origin of complications that can be life-threatening in patients. This muscular pathology is called ventilation-induced diaphragmatic dysfunction (DDIV).

Diaphragmatic muscle collected during a digestive surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm from the care will be conserved. The diaphragm biopsy from the care will be retained for biobanking to obtain myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.


Eligibility criteria: Inclusion Criteria:

* age between 30 and 65 years old
* patient treated by the digestive surgery department of Montpellier University Hospital for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm
* Non-smoker patient for more than 6 months
* patient clinically stable at the time of the study, ie not requiring any treatment

Exclusion Criteria:

* Patients undergoing treatment with antibiotics or corticosteroids, or recently within the last 4 months
* Patients with a body mass index \> 30
* Patients with any criteria that may in themselves impair respiratory muscle function such as chronic obstructive pulmonary disease, heart failure, systemic infection, neuromuscular pathology, psychiatric pathology or metabolic disorder.

Patients with coagulopathy or thrombocytopenia.

Primary outcomes:
measure: Myoblast differentiation capacity
timeFrame: 24 month
Secondary outcomes:
measure: Myoblast proliferation capacity
timeFrame: 24 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT05907200: Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers
Official title: Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: rehabilitation
skin ulcer
ultrasound therapy
disability
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with IDU. The main questions it intends to answer are:

• Is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life?

Participants will receive rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water immersion. The researchers will compare the group of participants, called the treatment group, with a control group to see if:

• Is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?


Eligibility criteria: Inclusion Criteria:

* diagnosis of SSc according to the ACR and EULAR criteria
* presence of IDU in active phase
* naïve to rehabilitation treatment for their hands and upper limbs
* written in-formed consent to participate in the study.

Exclusion Criteria:

* presence of skin lesions due to other conditions (e.g., trauma);
* pregnancy;
* infectious diseases (e.g. HIV, HBV, HCV);
* myositis;
* arthritis;
* other rheumatological diseases and immunodepression.

Primary outcomes:
measure: functional capacity
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: pain intensity
timeFrame: after 4 weeks of treatment
measure: ulcer assessment
timeFrame: after 4 weeks of treatment
measure: disease-related quality of life
timeFrame: after 4 weeks of treatment
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Study officials:
References:
Clinical trial NCT02077400: Prophylactic Antibiotic in Treatment of Fingertip Amputation
Official title: The Use of Prophylactic Antibiotic in Treatment of Fingertip Amputation: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Rate After Fingertip Amputation
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fingertip amputation is a common injury. Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury. The investigators goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment. The study hypothesis was that infection rates were similar in the two groups.


Eligibility criteria: Inclusion Criteria:

* fingertip amputation with bone exposed

Exclusion Criteria:

* under the age of 18 years
* if the patient had diabetes
* oncological disorder
* immune deficiency
* bleeding disorder
* used steroids regularly
* presented with a grossly contaminated wound or other injury requiring antibiotic treatment
* were currently taking antibiotics, or had a previous allergic reaction to cephalosporins.

Primary outcomes:
measure: infection rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek medical center
Study officials:
References:
Clinical trial NCT06280300: Multi-disciplinary Care for Brain Metastases
Official title: Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Metastases, Adult
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cohort study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases.

Detailed description: This is a cohort study of patient with newly diagnosed brain metastases assigned to standard of care (SOC) or intensive multi-disciplinary care (IMDC). Care for all patients with brain metastases involves complex medical decision making and requires input for multiple stakeholders, including medical oncology, neurosurgery, radiation oncology, and neuro-oncology. Palliative care should be an essential component of the care team for all patients with brain metastases by the very nature of this advanced malignancy. At the University of Vermont, our current process for diagnosis and management of patients with brain metastases relies heavily on the physician and team who make the initial diagnosis to consult others as they see appropriate. This process may look different for different patients. We rationalize that a systematic approach with intensive multidisciplinary care (IMDC) will benefit patients with brain metastases by providing consistent access to multi-disciplinary discussion.

Eligibility criteria: Inclusion Criteria:

* Patients of all genders must be at least 18 years of age.
* Patients must have histologically confirmed, newly diagnosed brain metastases from known or suspected solid tumor primary neoplasms.
* Patients must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
* Patients must be able to complete questionnaires in English.
* Patients must have the ability to provide informed consent.

Exclusion Criteria:

* Patients who are \< 18 years of age are not eligible.
* Patients who are Pregnant are not eligible.

Primary outcomes:
measure: Patient reported outcomes
timeFrame: 6-12 months
Secondary outcomes:
measure: Feasibility
timeFrame: 6-12 months
measure: Patient understanding of prognosis
timeFrame: 6-12 months
measure: survival
timeFrame: 6-12 months
Other outcomes:
measure: Exploratory survival outcome
timeFrame: 6-12 months
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References:
Clinical trial NCT00607100: High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve
Official title: High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Band Atrophy
Chiasmal Compression
Neural Loss
Keywords: High-Resolution Optical Coherence Tomography
Retinal Nerve Fiber Layer
Band Atrophy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with band atrophy from chismal compression and controls

Brief summary: The purpose of this study is to compare the abilities of high-speed,high-resolution (HR) optical coherence tomography (OCT) and Stratus OCT for detection of retinal nerve fiber layer (RNFL) loss in eyes with band atrophy (BA) of the optic nerve.


Eligibility criteria: Inclusion Criteria:

* Visual acuity better than 20/30
* Refractive error less 5 spherical diopter and 3 cylinder diopter
* Temporal field defect

Exclusion Criteria:

* Presence of glaucoma and optic nerve anomalies
* A normal nasal field

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo - Ophthalmology Department
Study officials:
affiliation: University of Sao Paulo
name: Luciana Costa Cunha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa-Cunha LV, Cunha LP, Malta RF, Monteiro ML. Comparison of Fourier-domain and time-domain optical coherence tomography in the detection of band atrophy of the optic nerve. Am J Ophthalmol. 2009 Jan;147(1):56-63.e2. doi: 10.1016/j.ajo.2008.07.020. Epub 2008 Sep 6.
Clinical trial NCT05921500: Clinical and Radiographic Evaluation of Intra Coronal Bleaching of Primary Anterior Teeth
Official title: Clinical and Radiographic Evaluation of Intra Coronal Bleaching of Primary Anterior Teeth Using Sodium Perborate With Walking Bleach Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Trauma
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 13
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique

Detailed description: This study will be conducted for the clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique

Eligibility criteria: Inclusion Criteria:

* Children aged between 3-5 years.
* Parents/caregivers acceptance.
* Traumatized anterior teeth with sensitivity to percussion and palpation with gray discoloration.
* Discolored anterior teeth indicated for intracoronal bleaching.
* Traumatized anterior teeth no response to an electric pulp test.
* Discolored teeth with satisfactorily previously obturated root canal .
* Absence of preapical lesions or apex resorption.

Exclusion Criteria:

* Teeth with signs tooth mobility indicated for extraction.
* Teeth with vertical root fracture.
* Teeth with preapical lesions or apex resorption.
* Teeth with discolorations from restorative materials.
* Children with lack of cooperation for post-operative recall and follow up.

Primary outcomes:
measure: clinical evaluation of internal bleaching of primary teeth
timeFrame: two weeks to month
Secondary outcomes:
measure: radiographic evaluation of internal bleaching of primary teeth
timeFrame: six months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Yasser Mohammed Bedir
Study officials:
affiliation: associate professor
name: alaa eldin mohamed, associate professor
role: STUDY_DIRECTOR
affiliation: lecture
name: hamdy badreldin, lecture
role: STUDY_DIRECTOR
References:
citation: Arikan V, Sari S, Sonmez H. Bleaching a devital primary tooth using sodium perborate with walking bleach technique: a case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 May;107(5):e80-4. doi: 10.1016/j.tripleo.2009.01.050.
citation: Sharma DS, Barjatya K, Agrawal A. Intra-coronal bleaching in young permanent and primary tooth with biologic perspectives. J Clin Pediatr Dent. 2011 Summer;35(4):349-52. doi: 10.17796/jcpd.35.4.p372w1h5j2kg5734.