louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04440397: Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis
Official title: Endoplasmic Reticulum Stress and Endometriosis Releated Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Endoplasmic Reticulum Stress
Endometriosis-related Pain
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women between the ages of 18-50 who were diagnosed with endometriosis by ultrasound or surgery and who did not have any rheumatological and metaboli disease were included in the study. women with drug use indicated in the last 3 months were excluded from the study.

Brief summary: The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients. XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.

Detailed description: Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study. Most of the patients are composed of newly diagnosed patients.

Eligibility criteria: Inclusion Criteria:

* diagnosed endometriosis with ultrasound or surgery
* no metabolic diseases
* no rheumatological diseases

Exclusion Criteria:

* Immune modulator, hormonal, anti-inflammatory use history in the last 3 months

Primary outcomes:
measure: Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis.
timeFrame: 5 months
Secondary outcomes:
measure: serum XBP-1levels in patients wit endometriosis
timeFrame: 5 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT01616797: A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan
Official title: A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Cognitive Training
Emotion Training
Emotion Regulation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention.

Detailed description: Participants will be recruited locally in the San Francisco Bay area with certain symptoms of anxiety and depression. They will complete a clinical assessment and then take part in a cognitive-emotion training delivered online.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of depression on the SCID, a total Ham-D≥16 and Ham-D anxiety/somatization subscale ≥ 7.

Exclusion Criteria:

* Current medication for psychiatric disorders
* Pregnant females
* Head trauma or injury that resulted in loss of consciousness
* MRI contraindication

Primary outcomes:
measure: Completion
timeFrame: 60 days
measure: Proximal outcomes
timeFrame: 60 days
measure: Distal outcomes
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System (VAPAHCS)
state: California
city: Stanford
country: United States
facility: Stanford University Department of Pscyhiatry and Behavioral Sciences
state: California
Study officials:
References:
Clinical trial NCT02485405: Gut Permeability and Stress
Official title: Gut Permeability in Volunteers Participating in a Stress Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 45
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy men aged 19-35 years old

Brief summary: The purpose of this study is to analyse gut permeability and stress.

Detailed description: Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while saliva and blood samples are withdrawn.

Saliva will be used for analysis of cortisol and blood will be used for analysis of various biomarkers.

Eligibility criteria: Inclusion Criteria:

* Man, 19-35 years old
* Healthy

Exclusion Criteria:

* Psychological disorders
* Use of antibiotics or other drugs

Primary outcomes:
measure: gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test
timeFrame: Volunteers will be followed by one hour after Trier social stress test
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Caroline Linninge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04994405: Lower Tourniquet Pressure Study
Official title: A Prospective, Double-blinded, Randomized Controlled Trial Evaluating Effectiveness of Lower Tourniquet Pressures in Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries
Upper Extremity Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study design is a prospective, double-blinded, randomized controlled trial evaluating the quality of bloodless surgical field with lower tourniquet pressures based on systolic blood pressure (SBP) compared to standard tourniquet pressures. A secondary goal is to evaluate the effect of lower tourniquet pressures on post-operative tourniquet site pain. The rationale behind the study is to provide evidence-based guidelines on tourniquet use to continue providing quality surgical care while minimizing pain and potential harm to patients.

Detailed description: Patients undergoing hand and upper extremity surgery at our institution will be offered participation in this study. Consenting patients will be randomized in a double-blinded fashion to either standard tourniquet pressure of 250 mmHg or lower tourniquet pressures based on SBP. Demographic data will be recorded as well as details of the surgical procedure. Post-operatively, the operating surgeon will complete a questionnaire about the quality of bloodless surgical field and the patient will complete a questionnaire about post-operative pain. This study will enroll approximately 150 patients. Statistical analysis will be completed to analyze the effectiveness of the intervention.

Eligibility criteria: Inclusion Criteria:

* Adult patient age 18 or older
* Undergoing hand or upper extremity procedure
* Tourniquet is used for procedure
* Willingness and ability to consent

Exclusion Criteria:

* Individuals with procedures that are over 120 minutes in length

Primary outcomes:
measure: Quality of the bloodless surgical field provided by lower tourniquet pressures
timeFrame: Immediately After surgery in recovery room time
Secondary outcomes:
measure: Effect of lower tourniquet pressures based on SBP on post-operative tourniquet site pain
timeFrame: Immediately After surgery in recovery room time
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Langone Brooklyn
state: New York
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Orthopedic Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ali Azad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06885905: Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being
Official title: Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pulmonary Aspergillosis
Keywords: CPA
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
name: Tayside Medical Science Centre
First posted: 2025-03-20
Enrollment: 100
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: Individuals with confirmed Chronic Pulmonary Aspergillosis

Brief summary: To develop and validate a novel disease-specific questionnaire for measuring HRQoL in patients with Chronic Pulmonary Aspergillosis (CPA-HAQ) for use in clinical research, including clinical trials.


Eligibility criteria: Inclusion Criteria:

1. All patients \>/= 18 years old and able to provide informed consent
2. Patients with a diagnosis of chronic pulmonary aspergillosis
3. To speak and understand English
4. Able to provide informed consent

Primary outcomes:
measure: Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
timeFrame: 30 months
Secondary outcomes:
measure: Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
timeFrame: 30 months
measure: Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
timeFrame: 30 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
city: London
country: United Kingdom
facility: Imperial College London
city: Manchester
country: United Kingdom
facility: Manchester NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02933905: Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Vitreomacular Interface
Anti-VEGF Treatment
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diabetic macular edema

Brief summary: Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors


Eligibility criteria: Inclusion Criteria:

* diabetic macular edema treatable with antiangiogenic drugs

Exclusion Criteria:

* age under 18
* cardiovascular events during the last year
* previous vitrectomy
* previous macular edema treatment during the last 4 months

Primary outcomes:
measure: Change in best-corrected visual acuity
timeFrame: One year
Secondary outcomes:
measure: Change in central macular thickness
timeFrame: One year
measure: Number of ranibizumab injections
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00859105: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
Official title: A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: Apotex Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 497
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study


Eligibility criteria: Inclusion Criteria:

* Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
* Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control
* Free of any systemic or dermatological disorder
* Any skin type or race, providing the skin pigmentation will allow discernment of erythema

Exclusion Criteria:

* Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
* History of cutaneous hyperreactivity or facial irritation to topical products
* Engaging in activities involving excessive or prolonged exposure to sunlight
* Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry
* Currently using or have used systemic steroids 2 months prior to study
* Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
* Pregnant or nursing mothers
* History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation
* Taking immunosuppressant medication

Primary outcomes:
measure: The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
timeFrame: 24 weeks
Secondary outcomes:
measure: The secondary objective is to compare the safety profiles of the three creams.
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Apotex Inc.
name: William Brooks
role: STUDY_DIRECTOR
References:
Clinical trial NCT05266105: A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
Official title: A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Olema Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2022-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).


Eligibility criteria: Inclusion Criteria:

* Confirmed and evaluable locally advanced or metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose
* Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
* Prior radiotherapy must have been completed 2 weeks prior to first dose
* Adequate safety laboratory tests
* Willingness to use effective contraception

Exclusion Criteria:

* Gastrointestinal disease
* Significant hepatic disease
* Significant cardiovascular disease
* Significant ECG abnormalities
* History of pulmonary embolism or high risk of thrombosis
* Known HIV infection
* Active infection (requiring antimicrobial therapy)
* Pregnant

Primary outcomes:
measure: Incidence of Dose Limiting Toxicities
timeFrame: From Cycle 1 Day 1 through C1 Day 28
measure: Characterization and Incidence in Adverse Events and Serious Adverse Events
timeFrame: From initial inform consent date through 30 days post last dose
measure: Plasma levels of OP-1250 and Palbociclib
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Waratah
country: Australia
facility: Site 6108
state: New South Wales
city: Westmead
country: Australia
facility: Site 6104
state: New South Wales
city: South Brisbane
country: Australia
facility: Site 6102
state: Queensland
city: Southport
country: Australia
facility: Site 6109
state: Queensland
city: Clayton
country: Australia
facility: Site 6101
state: Victoria
city: Frankston
country: Australia
facility: Site 6106
state: Victoria
city: Geelong
country: Australia
facility: Site 6103
state: Victoria
city: Nedlands
country: Australia
facility: Site 6105
state: Western Australia
Study officials:
affiliation: Olema Pharmaceuticals, Inc.
name: Sue Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02527005: A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
Official title: A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Pregnant
HIV
Keywords: IPT
malaria
pregnant
HIV positive
Lead sponsor: University of Ibadan
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized controlled single blind prospective comparative study

Detailed description: This study is intended to be a randomized controlled single blind prospective comparative study conducted to compare the efficacy of three monthly doses of sulphadoxine-pyrimethamine as intermittent preventive therapy for malaria with azithromycin in HIV positive pregnant women

Eligibility criteria: Inclusion Criteria:

* Pregnant HIV positive patients,
* Gestational age 16 weeks and above,
* No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment

Exclusion Criteria:

* Anaemia packed cell volume less than 30%,
* pre-existing medical conditions- diabetes mellitus,
* hypertension,
* allergy to sulphadoxine-pyrimethamine or azithromycin

Primary outcomes:
measure: Level of malaria parasitemia at delivery in HIV positive women following administration of Azithromycin or Sulphadoxine- pyrimethamine as intermittent preventive therapy for malaria in pregnancy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital,
state: Oyo
Study officials:
affiliation: UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
name: AYODELE O AROWOJOLU, MBBS IBADAN
role: STUDY_DIRECTOR
affiliation: UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
name: ORIYOMI O AKINYOTU, MBBS IBADAN
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
name: ADENIKE F BELLO, MBBS IBADAN
role: STUDY_DIRECTOR
affiliation: ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE
name: ADEOLA R ABDUS-SALAM, MBBS IBADAN
role: STUDY_DIRECTOR
References:
citation: Taylor WR, Richie TL, Fryauff DJ, Picarima H, Ohrt C, Tang D, Braitman D, Murphy GS, Widjaja H, Tjitra E, Ganjar A, Jones TR, Basri H, Berman J. Malaria prophylaxis using azithromycin: a double-blind, placebo-controlled trial in Irian Jaya, Indonesia. Clin Infect Dis. 1999 Jan;28(1):74-81. doi: 10.1086/515071.
Clinical trial NCT02069405: Relaxation Music to Lower Heart Rate Prior to Cardiac CT
Official title: Relaxation Music to Lower Heart Rate Prior to Cardiac CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease and Cardiac Anatomy
Patients Undergoing Coronary CT Angiogram
Patients Undergoing CT Pulmonary Vein Angiogram
Patients Undergoing CT Calcium Score
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To acquire low radiation dose and good quality cardiac CT images requires scanning at low heart rates which is usually done with beta-blockers. However, in some patients beta-blockers have little effect. This is thought to be due to a different mechanism of action which continues to maintain the heart rate despite administration of beta-blockers. This study aims to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety is thought to play a role in maintaining high heart rates. This study will randomise patients into a normal standard of care group compared to a normal standard of care group with music/ relaxation track and compare heart rate, radiation dose, image quality, amount of beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI) questionnaire.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years and above
* All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram

Exclusion Criteria:

* Deaf
* CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients
* Poor english literacy
* Pacemaker
* Post CABG
* Post heart transplant

Primary outcomes:
measure: Change in Heart Rate
timeFrame: Same day as CT scan
Secondary outcomes:
measure: Radiation Dose
timeFrame: Same day as CT scan
measure: Image Quality
timeFrame: Same day as CT scan
measure: IV metoprolol dose
timeFrame: Same day as CT scan
measure: Patient Satisfaction
timeFrame: Same day as CT scan
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Joint Department of Medical Imaging
name: Elsie Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Joint Department of Medical Imaging
name: Ming-Yen Ng, BMBS
role: STUDY_CHAIR
References: