louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01696526: Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish
Official title: Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: vitamin D
bioeffiency
vitamin d fortified fish
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to investigate the bioavailability of conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.

Detailed description: Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum.

Groups/Cohorts Assigned Interventions

1. Placebo group receiving conventional fish
2. intervention group receiving vitamin D fortified fish

Eligibility criteria: Inclusion Criteria:

* 18 years
* healthy

Exclusion Criteria:

* supplementation of vitamin d and calcium
* hypercalcemia
* hypercalciuria
* chronical illness (diabetes, kidney diseases, cardiovascular diseases)
* serum-creatinine above 115 mmol/l
* pregnancy or breastfeeding women

Primary outcomes:
measure: change of 25-hydroxvitamin D
timeFrame: after 4 weeks of consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Halle/Saale
country: Germany
facility: Naturwissenschaftliche Fakultät
state: Sachsen Anhalt
Study officials:
affiliation: Institut für Agrar- und Ernährungswissenschaften
name: Gabriele I. Stangl, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03326726: Evaluation 2% Chlorhexidine Gluconate
Official title: Evaluation of the Area Covered by Medline 2% Chlorhexidine Gluconate Cloth Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Coverage
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin was allowed to air dry.


Eligibility criteria: Inclusion Criteria:

Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.

Primary outcomes:
measure: Medline 2% CHG Cloth Dosage of Coverage Area
timeFrame: 3 minutes
Secondary outcomes:
measure: Post-application Drying Time
timeFrame: Approximately 1 minute
Other outcomes:
Locations:
Study officials:
affiliation: Microbac Laboratories, Inc.
name: Hamid Bashir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558726: Case Management for Crack Users Who Seek Treatment in CAPSad in Brazil
Official title: Effectiveness of Case Management for Crack Users Who Seek Treatment in CAPSad in Six Brazilian Capitals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crack Abuse or Dependence
Keywords: Case Management
Crack abuse/dependents
Evaluation
Inpatient
ASI
Treatment retention
Abstinence
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
name: Brazilian Secretariat for Drug Policies (SENAD)
name: Federal University of Bahia
name: Federal University of Espirito Santo
name: Universidade Federal do Rio de Janeiro
name: Faculdade de Medicina do ABC
name: University of Brasilia
First posted: 2012-03-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of a Case Management (CM) intervention in crack users applied in Psychosocial Care Centers - Alcohol and Drugs (CAPSad) by trained social workers, in comparison to CAPSad conventional treatment on 30 and 90 days, considering the following outcomes: treatment retention, abstinence and changes in severity scores of the sixth version of Addiction Severity Index (ASI6) scale. The study hypothesis are: 1) The CM is going to improve the retention of crack users (cases) during the 3-month follow-up compared with usual care (controls); 2)Individuals who received the intervention with GC are going to present a higher rate of abstinence; 3)The summary scores of the ASI6 will be significantly lower in cases than in controls, at the end of 3 months follow-up.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of crack abuse or dependence
* \> 18 years old
* Initiating treatment (maximum of 1 month)

Exclusion Criteria:

* Homeless without permanent contact
* Psychotic symptoms during the intake interview

Primary outcomes:
measure: Treatment retention
timeFrame: 3 months
Secondary outcomes:
measure: Crack abstinence
timeFrame: 3 months
measure: ASI subareas scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul (UFRGS)
state: Rio Grande do Sul
Study officials:
affiliation: Center for Drug and Alcohol Research (CPAD) of Federal University of Rio Grande do Sul
name: Flavio Pechansky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284726: The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation
Official title: A Prospective, Controlled, Randomized Study on the Effect of Cold Storage Solutions on Complement Activation and Other Mediators of Ischemic Injury in Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Transplant Recipients
Keywords: Cytokines in lung transplantation
Cold storage solutions
Ischemic reperfusion injury
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-02-01
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to compare 2 different cold storage solutions, used to preserve donor lungs for lung transplantation, and their effect on cytokine activation related to ischemic reperfusion injury. Primary endpoint is 30 day survival.

Detailed description: The length of ischemic time in harvesting lung allografts is associated with graft survival. It is further thought that ischemic changes in early post-transplantation bronchoscopic biopsies has a direct correlation with later development of chronic rejection.

Eligibility criteria: Inclusion Criteria:

Any patient undergoing a lung trasnplant at Johns Hopkins Hospital -

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: John V. Conte, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793126: Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms
Official title: Clinical and Urodynamic Evaluation of Surgical Repair of Pelvic Organ Prolapse Associated With Lower Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pelvic Organ Prolapse
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 83
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All patients were subjected to clinical evaluation and urodynamic testing before surgery. All cases underwent surgical repair of pelvic organ prolapse. Follow-up clinical examination was performed at 1, 3, and 6 months postoperatively, and urodynamic examination was repeated 6 months after repair.
Primary purpose: DIAGNOSTIC

Brief summary: To assess the urinary symptoms and urodynamic findings concomitant with Pelvic organ prolapse before and after surgical treatment and to define the role of urodynamic study in treatment decision making.

Detailed description: Pelvic organ prolapse (POP) is a prevalent problem that affects women's quality of life women with POP may present with a variety of lower urinary tract symptoms (LUTS).

For POP patients with concomitant urinary symptoms, urodynamic (UDN) testing is proposed for proper evaluation of cases and identification of the pathophysiologic events in each case individually.

In this prospective study, the investigators aim to describe the urinary symptoms and urodynamic findings concomitant with POP before and after surgical treatment of POP. We also aimed at defining the role of UDN in decision-making regarding the treatment of POP when associated with LUTS.

Eligibility criteria: Inclusion Criteria:

* women with anterior pelvic organ prolapse (POP) associated with Lower urinary tract symptoms

Exclusion Criteria:

* Patients with POP less than POP-Q grade II, POP not in need for surgical repair, neurological diseases that could possibly affect voiding functions, pelvic infections, congenital bladder disorders, history of urinary fistula, history of malignancy, and patients on current medical treatment for voiding dysfunction.

Primary outcomes:
measure: Urodynamic study evaluation for the participants
timeFrame: 6 month after the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04392726: Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)
Official title: Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Parenchymal Lung Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known or suspected DPLD

Brief summary: The primary intention of this study is to determine the diagnostic performance of ultra-low-dose CT (ULDCT) in diagnosis and follow-up of diffuse parenchymal lung disease (DPLD). We hypothesize that inspiratory and expiratory chest ULDCT has comparable diagnostic yield to standard dose chest High-resolution computed tomography (HRCT) and utility for follow-up of patients with known DPLD. We will study this hypothesis through the following aims:

1. Determine whether inspiratory and expiratory ULDCT are comparable to HRCT in identifying mosaic attenuation due to air-trapping.
2. Determine whether ULDCT is as good as HRCT for follow-up of patients with established DPLD to identify disease progression.


Eligibility criteria: Inclusion Criteria:

1. suspected or known DPLD
2. referred to DPLD observation

Exclusion Criteria:

1. other lung related diseases

-

Primary outcomes:
measure: The primary outcome measure of this study is to determine the diagnostic performance of ULDCT in diagnosis of DPLD.
timeFrame: during the procedure/surgery
measure: The primary outcome measure of this study is to determine the prognostic performance of ULDCT in the follow up of DPLD.
timeFrame: during the procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT01310426: Risk Factors for Anal Sphincter Damage During Vaginal Delivery
Official title: Risk Factors for Anal Sphincter Damage During Vaginal Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Sphincter Injury
Fecal Incontinence
Keywords: Anal Sphincter injury
Fecal Incontinence
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are women between ages 17 and 40 after their first delivery at the Hadassa Mount Scopus hospital in Jerusalem, Israel.

Brief summary: Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Different risk factors such as: first births, instrumental delivery, high birth weight, prolonged second stage, epidural anesthesia etc. were assessed and found to be associated with anal sphincter disruption. The purpose of this study is to assess risk factors for anal sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D transperineal US).


Eligibility criteria: Inclusion Criteria:

* First Delivery
* Vaginal Delivery
* Birthweight \> 3000
* Singleton pregnancy

Exclusion Criteria:

* Anal sphincter disruption before birth

Primary outcomes:
measure: Anal sphincter damage
timeFrame: up to one year after vaginal birth
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Drorith Hochner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00384826: Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma
Official title: Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma, Bronchiolo-Alveolar
Keywords: Adenocarcinoma, Bronchiolo-Alveolar
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.


Eligibility criteria: Inclusion Criteria:

* CBA histologically proven (or cytologically with pneumonic presentation) PS \< 3 signed and written informed consent

Exclusion Criteria:

* visible tumoral lesion in bronchial fibroscopy

Primary outcomes:
measure: 16-week Disease Control Rate
timeFrame: 4-week
Secondary outcomes:
Other outcomes:
Locations:
city: Belfort
country: France
facility: Centre Hospitalier - Pneumologie
city: Bobigny
country: France
facility: APHP - CHU Avicenne - Oncologie Medicale
city: Caen
country: France
facility: Centre F. Baclesse
city: Caen
country: France
facility: CHU - Pneumologie
city: Grenoble
country: France
facility: CHU Grenoble - pneumologie
city: Paris
country: France
facility: APHP - Saint-Antoine - pneumologie
city: Paris
country: France
facility: APHP - Hopital Tenon - Pneumologie
city: Saint-priest En Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Strasbourg
country: France
facility: CHU Lyautey - Pneumologie
Study officials:
affiliation: APHP Hopital Tenon (Pneumologie) - Paris - France
name: Jacques Cadranel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. French.
citation: Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77. doi: 10.1378/chest.123.6.1868.
citation: Cadranel J, Gervais R, Merle P, Moro-Sibilot D, Westeel V, Bigay-Game L, Quoix E, Friard S, Barlesi F, Lethrosne C, Moreau L, Monnet I, Salaun M, Oliviero G, Souquet PJ, Antoine M, Langlais A, Morin F, Wislez M, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504. Eur Respir J. 2015 Nov;46(5):1440-50. doi: 10.1183/13993003.02358-2014. Epub 2015 Sep 17.
Clinical trial NCT01170026: Individual and Family Motivational Interviews for Substance Using Truant Teens
Official title: Individual and Family Motivational Interviews for Substance Using Truant Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: substance use
adolescents
intervention
truancy
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 69
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This application will provide a test of one potential model for adding substance use assessment and brief intervention into a truancy court program. The primary goal of this study is to determine whether a motivational intervention will reduce substance use among adolescents referred to truancy court for school attendance problems. In this treatment development application, an open trial with 20 families referred by truancy court will first be conducted. This trial will be used to adapt an existing motivational intervention to include material relevant to school attendance and performance. Then 100 families participating in the Rhode Island Truancy Court Program with adolescents between the ages of 13-16 years who report using substances will be randomly assigned to receive the experimental intervention plus standard truancy court procedures or psychoeducation plus standard truancy court procedures. The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion \& Kavanagh, 2003), a family based motivational interview. The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance. Follow-up interviews will be conducted at 3 and 6 months.


Eligibility criteria: Inclusion Criteria:

1. between the ages of 13-16 at the start of the project and living at home with at least one parent/guardian,
2. t- score of 70 or above on one of the diagnostic-oriented scales (internalizing or externalizing problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off),
3. the child must report 6 or more incidences of substance use in the last 90 days,
4. parental consent and child assent are obtained.

Exclusion Criteria:

1. adolescent meets diagnostic criteria for substance dependence suggesting need for more intensive services,
2. the family is not able to speak and understand English or Spanish well enough to complete study procedures.

Primary outcomes:
measure: Marijuana Use Days in Past 90 Days
timeFrame: 3 Month Follow-Up and 6 month follow-up
measure: Alcohol Use Days in Past 90 Days
timeFrame: 3 and 6 Month Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown Medicl School
name: Anthony Spirito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03421626: Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)
Official title: Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myelogenous, Chronic
Lead sponsor: Cepheid
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females at least 18 years of age who were previously diagnosed with CML from primary care clinics.

Brief summary: The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.


Eligibility criteria: Inclusion Criteria:

* prospective specimens:

  * Patient is at least 18 years of age
  * Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states.
  * Patient has been diagnosed with CML.
  * Patient consents to provide at least 12 mL of peripheral blood for study purposes
* frozen specimens:

  * Specimen is from a subject diagnosed with CML
  * Specimen meets the manufacturer's criteria to support testing by both diagnostic assays

Exclusion Criteria:

* prospective specimens:

  * Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider
  * Patient has been previously enrolled
* frozen specimens: • Specimen previously enrolled

Primary outcomes:
measure: Method comparison to an on-market molecular diagnostic assay
timeFrame: Baseline = testing upon enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Broward Oncology Associates
state: Florida
city: Boise
country: United States
facility: St. Alphonsus Regional Medical Center
state: Idaho
city: Columbia
country: United States
facility: WJB Dorn VA Medical Center
state: South Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Bridgeport
country: United States
facility: United Hospital Center
state: West Virginia
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
References: