louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01698476: Immune Reconstitution in Tuberculosis Disease
Official title: Immune Reconstitution in Tuberculosis Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Tuberculosis (TB)
Keywords: pulmonary TB
cholecalciferol
sodium phenylbutyrate
antimicrobial peptides
immune response
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
name: Armauer Hansen Research Institute, Ethiopia
First posted: 2012-10-03
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.


Eligibility criteria: Inclusion Criteria:

HIV negative patients, adult patients \>18 years who has not started anti-TB therapy.

Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 criteria for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment).

Exclusion Criteria:

Patients who have already started treatment with anti-TB drugs for more that 5 days.

HIV-positive patients.

History of anti-TB treatment in the past 2 years.

Local extra-pulmonary TB in the absence of lung manifestations.

Hypercalcaemia (serum calcium \> 3 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

Primary outcomes:
measure: Composite clinical TB score
timeFrame: 0 (baseline) compared to 8 weeks.
Secondary outcomes:
measure: Clinical secondary endpoints
timeFrame: 0-4, 8, 16 and 24 weeks
measure: Laboratory secondary endpoints
timeFrame: 0, 4, 8, 16, 24 weeks
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine
state: Lideta sub city
Study officials:
affiliation: Karolinska Institutet
name: Susanna Brighenti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bekele A, Gebreselassie N, Ashenafi S, Kassa E, Aseffa G, Amogne W, Getachew M, Aseffa A, Worku A, Raqib R, Agerberth B, Hammar U, Bergman P, Aderaye G, Andersson J, Brighenti S. Daily adjunctive therapy with vitamin D3 and phenylbutyrate supports clinical recovery from pulmonary tuberculosis: a randomized controlled trial in Ethiopia. J Intern Med. 2018 Sep;284(3):292-306. doi: 10.1111/joim.12767. Epub 2018 May 23.
Clinical trial NCT01551576: Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
Official title: Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical oncologists with appropriate patient populations will be informed of the study and the inclusion and exclusion criteria. Potential participants will be recruited from the Stanford Urologic Oncology Clinic. A study investigator will follow-up with participants who are interested in participating in this study. Study information will be posted on the Stanford Cancer Center website as well.

Brief summary: The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.

Detailed description: PRIMARY OBJECTIVE(S):

The primary objective of this pilot study is to assess PAI-performance in a clinical setting to understand limitations of our current PAI instrumentation and to help improve the next-generation design.

SECONDARY OBJECTIVE(S):

To do preliminary evaluations of oxygen saturation in lesions based on PAI-measurements in order to distinguish malignant from benign prostatic tissue as a basis for future studies.

Eligibility criteria: Inclusion Criteria:

* Consent signed
* Male \>= 18 and \<= 80 years of age
* Patients must have an elevated PSA And/ Or Abnormal digital rectal exam Or Other indication for prostate biopsy Or Patients with biopsy proven prostate cancer who are scheduled for prostatectomy.

Exclusion Criteria:

* History of prostatectomy or other surgical history that would preclude transrectal imaging (i.e. abdominal perineal resection), anal stenosis/stricture disease
* Men with anatomic abnormalities or previous surgical history that make transrectal imaging impossible (for example, men with previous abdominal-perineal bowel resections or anal atresia/stenosis)

Primary outcomes:
measure: lesion signal intensity on Photoacoustic Imaging (PAI) in relation to different lesion characteristics and the surrounding tissues
timeFrame: 36 months
Secondary outcomes:
measure: Measures of hypoxia in the lesion
timeFrame: 36 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Institute
state: California
Study officials:
affiliation: Stanford University
name: Andrei H Iagaru, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Martin Karl Schneider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06147076: Social Support Counseling Intervention for Kidney Transplant Candidates
Official title: Journey to Transplant: Virtual Coaching for Potential Kidney Transplant Patients and Their Social Support Networks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant
Keywords: Interventional Counseling
Kidney Transplant
Interventional Mapping
Counseling
Social Support Networks
Dialysis
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2023-11-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group versus interventional group. Questionnaire completed by interventional group and their social support networks pre and post.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Virtual Coaching for Potential Kidney Transplant Patients

Detailed description: Individuals who are eligible for kidney transplant will be recruited by phone or email and randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a group education and counseling session along with members of their social support networks. The interventional counseling will then complete a pre and post survey (same as control group). Survey answers will be recorded within REDCAP.

Eligibility criteria: Inclusion

* Determined by transplant center to be suitable for continuation in evaluation for listing (or a member of that person's social support network)
* 18 Years of age or older
* English-speaking
* Willingness to participate with at least 2 social network members in the session and have calculator results shown to social network members (if a patient)
* Able to provide informed consent

Exclusion

* Prisoners
* Individuals with impaired ability to consent
* Pregnant females.
* Patients who choose to opt out of research.
* Non-English speaking

Primary outcomes:
measure: Correct Answers on Knowledge of Kidney Transplant Options Assessment
timeFrame: one month
Secondary outcomes:
measure: Decisional Conflict Scores
timeFrame: one month
measure: Social Support Scores
timeFrame: one month
measure: Knowledge Scores
timeFrame: one month
measure: Hearth Hope Index
timeFrame: one month
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
Study officials:
References:
Clinical trial NCT04713176: Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
Official title: A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Severe COVID-19
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients


Eligibility criteria: Inclusion Criteria:

* Adults over the age of 19 as of the signed date in written consent
* Subjects with COVID-19 according to RT-PCR test(within 10 days)
* Subjects who need to be hospitalized and injected Remdesivir

Exclusion Criteria:

* Subjects who cannot orally administer the investigational products
* Subjects who requiring mechanical ventilation or ECMO
* Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
* Subjects who need administration of immunosuppressants
* Subjects who are allergic or sensitive to investigational products or its ingredients
* Crcl \< 30 mL/min or eGFR \< 30 mL/min/1.73m\^2
* AST or ALT \>= 5xULN
* Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators

Primary outcomes:
measure: Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days
timeFrame: Up to 29 days
Secondary outcomes:
measure: Time to recovery
timeFrame: Day 3,5,8,11,15,22,29
measure: Desirable of Outcome Ranking (DOOR)
timeFrame: Day 15,29
measure: Duration of Hospitalization
timeFrame: Day 29
measure: Time to death
timeFrame: Day 15,29
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Medical Center
Study officials:
References:
Clinical trial NCT03388476: Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension
Official title: Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension in Patients With Suspicion of Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypertension, Pulmonary
Hypertension;Pulmonary;Primary
Chronic Thromboembolic Pulmonary Hypertension
Vascular Diseases
Lung Diseases
Keywords: pulmonary hypertension
endtidal co2
endtidal carbon dioxide
pulmonary arterial hypertension
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of a tertiary referral center retro- and prospective part of the study.

Afterwards in a next prospective study part patients in ambulant setting.

Brief summary: Measurement of the endtidal carbon dioxide by capnography to exclude or to ensure the diagnosis pulmonary hypertension. The aim of the study is to obtain an endtidal carbon dioxide cut-off value for the diagnostic algorithm for pulmonary hypertension as an easily measurable and cheap diagnostic tool in patients with suspicion of pulmonary hypertension.

Detailed description: The disease pulmonary hypertension is due to a remodeling of the lung vessels which results in a change of the exhaled air. This change is measurable with a so called capnograph. The investigators want to measure the breath from patients with and without pulmonary hypertension to detect a cut-off value for the diagnosis pulmonary hypertension.

Patients which have the probably diagnosis pulmonary hypertension and are older than 18 years are investigated. This patients will get an right heart catheterization and a measurement from their exhaled air.

Eligibility criteria: Inclusion Criteria:

Age \> 18 years, suspicion of pulmonary hypertension, planned or accomplished right heart catheterization

Exclusion Criteria:

none

Primary outcomes:
measure: Measurement PetCO2
timeFrame: At baseline
Secondary outcomes:
measure: Establishing a cut-off
timeFrame: At baseline
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Clinic Giessen and Marburg
state: Hessen
Study officials:
affiliation: University Clinic Giessen and Marburg - Campus Giessen
name: Henning Gall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinic Giessen and Marburg
name: Werner Seeger, Prof.
role: STUDY_DIRECTOR
affiliation: University Clinic Giessen and Marburg
name: Ardeschir Ghofrani, Prof.
role: STUDY_DIRECTOR
References:
citation: Hemnes AR, Pugh ME, Newman AL, Robbins IM, Tolle J, Austin ED, Newman JH. End tidal CO(2) tension: pulmonary arterial hypertension vs pulmonary venous hypertension and response to treatment. Chest. 2011 Nov;140(5):1267-1273. doi: 10.1378/chest.11-0155. Epub 2011 May 26.
Clinical trial NCT01730976: Asthma in the Elderly: The Role of Vitamin D
Official title: Asthma in the Elderly: The Role of Vitamin D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma in the Elderly
Keywords: asthma, elderly, vitamin D
Lead sponsor: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics.


Eligibility criteria: Inclusion Criteria:

* Asthma, age of 65 years old or older

Exclusion Criteria:

* Current smokers, subjects who smoked more than 10 pack/year, subjects taking digoxin, subjects with liver disease

Primary outcomes:
measure: Improvement in Asthma Control Test (ACT) score
timeFrame: Three months
Secondary outcomes:
measure: Improvement in pulmonary function tests values (FEV1%, etc.)
timeFrame: Three months
Other outcomes:
measure: Serum vitamin D and calcium levels
timeFrame: Three months
Locations:
city: Bryn Mawr
country: United States
facility: Rohr and Columbo Asthma, Allergy and Immunology Specialists
state: Pennsylvania
Study officials:
affiliation: Rohr and Columbo Associates
name: Michele Columbo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Columbo M, Panettieri RA Jr, Rohr AS. Asthma in the elderly: a study of the role of vitamin D. Allergy Asthma Clin Immunol. 2014 Sep 5;10(1):48. doi: 10.1186/1710-1492-10-48. eCollection 2014.
Clinical trial NCT04876976: Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair
Official title: Isoamyl 2-Cyanoacrylate Interposition in the Urethro-cutaneous Fistula Repair: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypospadias
Keywords: Isoamyl 2-cyanoacrylate
urethrocutaneous fistula
fistula repair
hypospadias
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 40
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer.

Cases of the control group (II) underwent the same procedure without using cyanoacrylate.
Primary purpose: TREATMENT

Brief summary: cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair

Detailed description: Hypospadias is a common congenital urological birth defect. Urethro-cutaneous fistula (UCF) is the most common complication of surgical repair hypospadias and it remains the primary concern of surgeons dealing with hypospadias repair.

cyanoacrylate has been reported to enhance the healing process. this study tries to evaluate the clinical impact of cyanoacrylate on the repair of urethro-cutaneous fistula after surgical repair of hypospadias

this study evaluates the impact of using cyanoacrylate as an interposition substance in surgical repair of UCF after hypospadias in comparison to the classic surgical repair technique

Eligibility criteria: Inclusion Criteria:

* Patients with Urethro-cutaneous fistula regardless of their age were included in our study.

Exclusion Criteria:

* Patients with fistula size more than 5 mm
* multiple fistulas
* uncorrected obstruction distal to the fistula
* necrotic tissue
* active infection at the fistula site
* severely scarred skin
* deficient dartos around the fistula
* fistulas more proximal to the mid penile position
* recurrent fistulas
* previous history of hypersensitivity to cyanoacrylate-based products

Primary outcomes:
measure: successful repair of the fistula
timeFrame: 6 months after surgery
Secondary outcomes:
measure: postoperative complications
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology department - ain shams university
Study officials:
References:
Clinical trial NCT05919576: Near Infrared Technology for the Detection of Proximal Caries
Official title: The Effectiveness of an Intraoral Scanner With Near-infrared Imaging (Transillumination) Technology for the Detection of Proximal Caries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caries,Dental
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 639
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have treatment appointments at Marmara University Faculty of Dentistry, Department of Restorative Dentistry

Brief summary: This study aims to determine the effectiveness of an intraoral scanner with near-infrared imaging (NIRI) for the diagnosis of proximal caries.

Detailed description: A total of 639 proximal surfaces (mesial-distal) of 22 volunteers without restoration of premolars and molars were examined. Results were scored for 4 different examination methods; intraoral examination by visual-tactile method (VTM), bitewing radiography (BWR), panoramic radiography (PR) and near-infrared imaging (NIRI). Scoring was made according to the type of lesion (0:no caries, 1:early enamel lesion(EEL), 2:lesion involving the dentin-enamel-junction (DEJ). Data were analyzed with IBM-SPSS-V23. McNemar-Test was used for comparison between the methods. The Kappa Test was used to examine the agreement between two methods in categorical data, and the Fleiss-Kappa Test was used to assess the agreement between more than two methods. The analysis results are presented as frequency(percentage).The significance level was considered p\<0.05.

Eligibility criteria: Inclusion Criteria

1. Presence of premolar and molar tooth
2. Having an appointment for restorative treatment

Exclusion Criteria

1. Restored proximal surfaces
2. Full mouth crowns and removable dental prothesis

Primary outcomes:
measure: VTM GROUP (Visual-tactile examination)
timeFrame: 08.08.2022 - 22.08.2022
measure: Bitewing Radiography
timeFrame: 08.08.2022-22.08.2022
measure: Panoramic Radiography
timeFrame: 08.08.2022-22.08.2022
measure: NIRI (Near infrared Imaging Technology)
timeFrame: 08.08.2022-22.08.2022
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01938976: Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels and Smoking Behavior Among Early Adolescents in Jordan
Official title: Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels, Nicotine Dependence, and Smoking Behavior Among Early Adolescents in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Tobacco
Waterpipe
Cigarettes
Keywords: Asthma
Tobacco
Waterpipe
Cigarettes
Adolescents
Peer education
Jordan
Lead sponsor: University of Technology, Sydney
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2013-09-10
Enrollment: 815
Sex: MALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study Hypotheses:

1. adolescents in intervention schools who are given Triple A program plus ASP will show more awareness in regards to cigarettee smoking health effects and less nicotine dependencethan those in the control schools who are given Triple A alone.
2. adolescents with asthma in intervention schools who are given Triple A program plus ASP will show less asthma symptoms and better control than those in the control schools who are given Triple A alone.
3. adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide (CO) in their breath than those who are not active or passive smokers.
4. there is a positive correlation between self-report questions regarding student smoking status and levels of CO in their breath


Eligibility criteria: Inclusion Criteria: students in grades 7 and 8 in Irbid city high schools, can speak and read in both Arabic and English, obtain parental agreement, attend regular school.

-

Exclusion Criteria:students with other chronic diseases (rather than asthma),

-

Primary outcomes:
measure: nicotine dependence level
timeFrame: 3 months
measure: Asthma Contol level
timeFrame: 3 months
Secondary outcomes:
measure: Carbon monoxide (CO) breath test
timeFrame: 3 months
measure: knowledge about health effects of cigarettee smoking
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: