louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002190: A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
Official title: A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.

Detailed description: A total of 30 patients receive the triple drug regimen saquinavir plus zidovudine plus lamivudine until the completion of the analysis after at least 4 weeks of therapy.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV antibody positive.
* CD4 count \>= 150 and \<= 500 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior antiretroviral therapy.
* Prior protease inhibitor therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Davies Med Ctr / c/o HIV Institute
state: California
city: Sherman Oaks
country: United States
facility: Pacific Oaks Med Group / Rsch & Scientific Investigation
state: California
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
Study officials:
References:
Clinical trial NCT04070690: The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
Official title: The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: metabolic acidosis
sodium bicarbonate
hemodialysis
dialysate
Lead sponsor: Camillians Saint Mary's Hospital Luodong
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background:

Patients with decreased kidney function are in the positive acid balance due to insufficient renal acid excretion. To correct the varying degrees of metabolic acidosis in these HD patients, a high concentration of HCO3 in the dialysate is routinely used.

During every 3-to-4 hours of HD treatment, a massive surge of HCO3 would enter the circulation and typically overcorrects predialysis acidosis to alkalosis and alkalemia.

The sharp acid-base shift can cause some adverse consequences.

The investigators believe that the rapid correction (or overcorrection) from the pre-dialysis metabolic acidosis to post-dialysis metabolic alkalosis during the 3-to-4 hours HD treatment would relate to adverse effects on HD patients.

Thus the investigators conduct this study to prove the hypothesis that "prevention of post-dialysis alkalosis by using lower dialysate HCO3 concentration might cause less adverse outcomes in ESRD patients on HD."

Study design:

Prospective cross-over case-control study.

Study population:

A total of 60 patients who receive regular hemodialysis (three times per week) for more than 6 months in the regional teaching hospital.


Eligibility criteria: Inclusion Criteria:

* adult uremic patients who received hemodialysis thrice weekly

Exclusion Criteria:

* Hospitalized patients
* Patients newly initiated on HD (\<6 months)
* Patients with HD access problems
* Patients recently discharged from the hospital (within one month).
* Patients on chemotherapy for cancer.
* Patients with a kidney transplant.
* Patients on steroids or other immunosuppressive therapy.
* Patients with recent surgery (within one month)
* Patients with an active bacterial infection.
* Patients with decompensated cirrhosis.

Primary outcomes:
measure: Blood pressure during the hemodialysis
timeFrame: four months
measure: Respiratory rate during the hemodialysis
timeFrame: four months
measure: O2 saturation during the hemodialysis
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Yilan
country: Taiwan
facility: Saint Mary's Hospital Luodong
Study officials:
affiliation: Saint Mary's Hospital Luodong
name: Chih-Chung Shiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06051890: Assessing Optimal XRB Initiation Points in Jail
Official title: Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Opioid Use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-09-25
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.


Eligibility criteria: Inclusion Criteria:

* Incarcerated men able to provide written informed consent in English.\*
* Unsentenced.
* Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.
* Minimum anticipated jail stay is 4 days.
* Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).

Exclusion Criteria:

* Sentenced.
* Allergy, hypersensitivity or medical contraindication to either medication.
* Chronic pain requiring opioid pain management or other contraindicated medications.

Primary outcomes:
measure: Percentage of participants released from jail with at least 7 days of buprenorphine in their system
timeFrame: Up to Month 6
Secondary outcomes:
measure: Percentage of participants continuing MOUD treatment in the community
timeFrame: Up to Month 9
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University Health Sciences
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: New Brunswick
country: United States
facility: Middlesex County House of Corrections
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health - 180 Madison Ave
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Farabee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835390: SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery
Official title: SIMDiscovery: The Benefits of Utilizing a Preparation Program With Simulation in Reducing Anxiety and Increasing Preparedness Among Parents and Their Children Undergoing Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis Idiopathic Adolescent
Keywords: Anxiety
Preparedness
Spinal Fusion
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study aiming to examine preliminary effectiveness of a preparation program which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of preparedness among parents and their children who will undergo spinal fusion surgery. SIMDiscovery is an experiential learning preparation program which aims to educate children and families about different medical procedures through simulation play.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents with adolescent idiopathic scoliosis and their parent(s)
* Spinal fusion surgery scheduled
* Developmental Age range (10+; no upper age range)
* Males and females of all races and ethnicities
* English-speaking families (although English need not be their primary language)
* Both patient and caregiver (when patient is under 18 years of age) are able to attend SIMDiscovery program

Exclusion Criteria:

* - Other significant chronic medical conditions (e.g., spina bifida, muscular dystrophy)
* Anterior surgical access
* ICU stay expected post-op
* Cognitive functioning level below 10yo

Primary outcomes:
measure: Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory
timeFrame: Baseline, 1 month
measure: Change from Child's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory for Children
timeFrame: Baseline, 1 month
measure: Change from Parent's Baseline Feelings of Preparedness at 1 month using Caregiver Preparedness Scale
timeFrame: Baseline, 1 month
measure: Change from Child's Baseline Feelings of Preparedness at 1 month using a modified Caregiver Preparedness Scale
timeFrame: Baseline, 1 month
Secondary outcomes:
measure: Knowledge of Perioperative Procedures measured by Spinal Fusion Knowledge Assessment
timeFrame: Baseline, 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Daniel Hedequist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Lauren Potthoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01288690: Stress Reduction in Middle Eastern Refugees
Official title: Stress Reduction in Middle Eastern Refugees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: Refugees
Trauma
Narrative
Exposure
Middle East
Therapy
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This interventional, randomized controlled study tests the effects of a a brief psychological intervention (Narrative Exposure Therapy) against a wait list control group among refugees who have experienced trauma and have some symptoms of PTSD.


Eligibility criteria: Inclusion Criteria:

* Refugees from the Middle East, and possible from Africa, who have experienced conflict-related trauma, have symptoms of PTSD, and speak either Arabic or English

Exclusion Criteria:

* Currently received exposure therapy for PTSD
* Planning to leave area in next 4 months

Primary outcomes:
measure: Post traumatic stress disorder symptoms: Harvard Trauma Questionnaire
timeFrame: Baseline to 4 months.
Secondary outcomes:
measure: Physical symptoms: Patient Health Questionnaire
timeFrame: Baseline to 4 months
measure: Depression symptoms: Beck Depression Inventory II
timeFrame: Baseline to 4 months.
measure: Quality of sleep: Karolinska Institute Sleep Questionnaire
timeFrame: Baseline to 4 months
measure: Daily functioning
timeFrame: Baseline to 4 months
measure: Post traumatic growth: Post Traumatic Growth Inventory
timeFrame: Baseline to 4 months
measure: General Psychological Well-being: WHO Well-being Index
timeFrame: Baseline to 4 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark A Lumley, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04110990: Retrospective Observational Study on the Epidemiological Characteristics of Influenza Patients
Official title: Retrospective Observational Study on the Epidemiological Characteristics of Influenza Patients Who Consulted in the Emergency Services of the University Hospitals of Strasbourg From September 2018 to March 2019
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza
Keywords: Influenza
Grippe
Emergency Services
Influenza, Human
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who consulted the Emergency Department of the Adult Emergencies of the Strasbourg University Hospitals between September 2018 and March 2019

Brief summary: Seasonal influenza outbreaks contribute to the saturation of emergency services. Better knowledge of the epidemiology and clinical presentation of this pathology would optimize the organization of emergency reception services and provide better care for patients, disseminate educational elements to the population more appropriate as well as optimal recommendations for health professionals.


Eligibility criteria: Inclusion criteria:

* Major subject ((≥18 years old)
* Subject who consulted the Emergency Department of the Adult Emergencies of the Strasbourg University Hospitals between September 2018 and March 2019
* Subject for which the flu smear is positive
* Subject not expressing opposition to the use of his data for research purposes

Exclusion criteria:

* Subject having expressed his opposition to participating in the study
* Subject for which the flu smear is negative
* Subject under the protection of justice
* Subject under guardianship or curators

Primary outcomes:
measure: Retrospectively study of the epidemiological characteristics of influenza patients consulted at the Adult Emergencies of Strasbourg University Hospitals
timeFrame: Files analyzed retrospectily from September 1st, 2018 to March 30, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de réanimation médicale
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Christine Kummerlen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00456690: Endocrine and Nutritional Assessment in B Thalassemia Major
Official title: Endocrine and Nutritional Assessment in B Thalassemia Major - A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thalassemia
Keywords: Thalassemia
Nutrition
Endocrine
BMI
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 133
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: B Thalassemia patients developed short stature and low weight in spite no evident endocrine abnormalities. One hypothesis is that they developed some degree of malnutrition,then the purpose of this study is to assess the nutritional status before nutritional intervention and after one year. Siblings of the patients will serve as a control group.

BMI, lipid and endocrine profile and leptin levels will be analysed in the study group only.

Detailed description: The nutritionist will advice the patients about calories requirement and intake, balance diet and follow up the patients during the study period of one year. No special medicaments or drug therapy will be provided as part of the study protocol

Eligibility criteria: Inclusion Criteria:

* All patients above age 5 ys treated in the clinic.

Primary outcomes:
measure: BMI
timeFrame: 1 year study
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - HaEmek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit, Ha'Emek Medical Center
name: Carina Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Hematology Unit - Ha'Emek Medical Center
name: Ariel Koren, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00112190: Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
Official title: A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Functional dyspepsia
Abdominal Symptom relief
Fullness
Bloating
Indigestion
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-06-01
Enrollment: 645
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

Detailed description: The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.

Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from functional dyspepsia according to Rome II criteria

  * 18-65 years old
  * Absence of, or infrequent heartburn (one episode per week or less)
  * Helicobacter pylori (H. pylori) negative
  * Normal upper endoscopy

Primary outcomes:
measure: Symptom relief
Secondary outcomes:
measure: Impact of symptom relief on quality of life
measure: Safety
Other outcomes:
Locations:
city: Mont St-Hilaire
country: Canada
facility: AXCAN Pharma Inc.
state: Quebec
Study officials:
affiliation: Mayo Clinic, Rochester, Minn
name: Nicholas Talley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00555490: Long-Term Effect of Soy Consumption on Cardio-Renal Indices and CRP in Type 2diabetes With Nephropathy
Official title: Soy-Protein Intake, Cardio-Renal Indices and C-Reactive Protein in Type 2 Diabetes With Nephropathy: a 4-y Randomized Clincal Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Transplantation
Keywords: Soy
Diabetes
Nephropathy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2007-11-08
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic patients with nephropathy.

Detailed description: Background: Several short-term trials on the effect of soy consumption on cardiovascular risks are available, but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy.

Objectives: To determine the effects of long-term soy consumption on cardiovascular risks, C-reactive protein and kidney-function indices among type 2 diabetic patients with nephropathy.

Design: This longitudinal randomized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy (18 men and 23 women). Twenty patients in soy protein group consumed a diet containing 0.8 g protein/kg body weight (35% animal proteins, 35% textured soy protein, and 30% vegetable proteins) and 21 patients in control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins for 4-years.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

* Dialysis
* Transplantation

Primary outcomes:
measure: mortality or using dialysis
timeFrame: 4-years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences, School of Health
name: Leila Azadbakht, PhD
role: PRINCIPAL_INVESTIGATOR
References: