louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02741206: Preventing Postpartum Depression in Prenatal Care
Official title: Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-partum Depression
Keywords: psycho-education
maternal depression
Reach Out Stay Strong Essentials
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is randomized control trial of a brief intervention called Bellevue ROSE (Reach Out Stay Strong Essentials). Bellevue ROSE is a manualized and highly structured interpersonal intervention that provides women with psycho-education about maternal depression and strategies for strengthening social support and connectedness. Investigators use motivational interviewing strategies to improve treatment compliance and resource acquisition


Eligibility criteria: Inclusion Criteria:

* English speaking
* Women who score between 5-19 on the PHQ-9 and \>23 on the ANRQ

Exclusion Criteria:

* Women who score \<5 or \>19 on the PHQ-9
* Women who are currently suicidal, active substance users, currently experiencing domestic violence, or have a current or past history of bipolar or psychotic disorder diagnosis.
* Women who are currently in treatment for psychotherapy.
* Unable to speak and/or understand English proficiently
* Unable to provide informed consent

Primary outcomes:
measure: Depression severity measured by Patient Health Questionnaire (PHQ-9)
timeFrame: 6 Months
measure: Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
timeFrame: Screening
measure: Measure of perceived social support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 6 Months
measure: Measure of stress using Perceived Stress Index (PSS)
timeFrame: 6 Months
measure: Parenting Practices and treatment assessed by Parenting Practices and Treatment Questionnaire
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Bonnie Kerker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000706: Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Official title: Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Quinine
Probenecid
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects.

Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.

Detailed description: Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.

In part I, four patients who are now receiving AZT at the usual dose take part in pharmacokinetic studies (how much of the drug enters the blood stream, what happens to the drug in the body, and how it leaves the body) of AZT defined after a dose while at steady state and then again after a new steady state has been reached following the addition of quinine sulfate. Part II studies the pharmacokinetics of AZT in eight patients receiving AZT at 1 of 2 doses and then at the lower dose of AZT plus probenecid with or without quinine.

Eligibility criteria: Inclusion Criteria

Patients must:

* Have symptomatic HIV infection.
* Be taking zidovudine (AZT), 100 or 200 mg, 5 or 6 x/day.

Allowed:

* History of Pneumocystis carinii pneumonia (PCP).
* Advanced AIDS related complex (ARC).
* HIV antibody positive with an absolute CD4 lymphocyte count of \< 200 cells/mm3 before study entry.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions are excluded:

* Glucose-6-phosphate dehydrogenase deficiency.
* Allergy to sulfa drugs, probenecid, or quinine.

Concurrent Medication:

Excluded:

- Other drugs that might influence the metabolism or renal excretion of zidovudine (AZT).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
Study officials:
name: Kornhauser D
role: STUDY_CHAIR
References:
citation: Kornhauser DM, Petty BG, Hendrix CW, Woods AS, Nerhood LJ, Bartlett JG, Lietman PS. Probenecid and zidovudine metabolism. Lancet. 1989 Aug 26;2(8661):473-5. doi: 10.1016/s0140-6736(89)92087-4.
Clinical trial NCT01307306: Glucose Control in Severely Burned Patients
Official title: Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Thermal injury
Chemical Burn
Flame Burn
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. The investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.


Eligibility criteria: Inclusion Criteria:

* between 18 and 90 years of age
* \>20% TBSA
* Admitted to the burn unit within 120 hours following burn
* At least 1 surgical intervention necessary

Exclusion Criteria:

* death upon admission
* decision not to treat due to burn injury severity
* presence of anoxic brain injury that is not expected to result in complete recovery
* known history of AIDS, ARC, HIV, Hepatitis B-E
* history of cancer within 5 years of malignancy currently under treatment
* inability to obtain informed consent
* previous or existing renal dysfunction, liver disease, or hepatic dysfunction
* pre-existing type I diabetes mellitus
* pregnancy
* allergy to metformin

Primary outcomes:
measure: Perform oral glucose tolerance test
timeFrame: at 1-2 months post-admission, up to 6 months
measure: Perform oral glucose tolerance test
timeFrame: assessed at discharge (1-4 months post admission depending on the severity of injury)
Secondary outcomes:
measure: Measure concentrations of serum cytokines
timeFrame: weekly until discharge (1-4 months post admission depending on severity of injury)
measure: Record the episodes of sepsis
timeFrame: daily until discharge (1-4 months post admission depending on severity of injury)
measure: Record the episodes of Pneumonia
timeFrame: daily until discharge (1-4 months post admission depending on severity of injury)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Marc G Jeschke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824706: Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
Official title: A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: cranial prosthesis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient implanted with the Custombone prosthesis

Brief summary: A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™

The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.

The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).


Eligibility criteria: Inclusion Criteria:

* Patient planning to have a cranioplasty and be implanted with the Custombone™ medical device
* Patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter

Exclusion criteria:

- Patient who does not accept to take part in the study after being informed

Primary outcomes:
measure: Explantation rate after 2 years of follow-up
timeFrame: 24 months after implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CH Amiens
city: Angers
country: France
facility: CHU Angers
city: Bayonne
country: France
facility: CH de la cote basque
city: Brest
country: France
facility: CHU la cavale blanche
city: Clichy
country: France
facility: CHU Beaujon
city: Créteil
country: France
facility: CHU Henri Mondor
city: Lille
country: France
facility: CHRU Roger Salengro
city: Lyon
country: France
facility: CHU Lyon
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Nice
country: France
facility: CHU Pasteur
city: Paris
country: France
facility: CHU Lariboisière
city: Paris
country: France
facility: CHU La¨Pitié Salpêtrière
city: Reims
country: France
facility: Hopital Maison Blanche
city: Rennes
country: France
facility: Hôpital Ponchaillou
city: Saint-Etienne
country: France
facility: CH Saint Etienne
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Tours
country: France
facility: CH Bretonneau
city: Villeurbanne
country: France
facility: Clinique du Tonkin
Study officials:
affiliation: Hospital Lariboisiere Paris
name: S Froelich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00939406: Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Official title: A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Degenerative Spinal Stenosis
Disk Herniation
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 45
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 of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation.
* Subjects who have failed conservative care for at least 6 weeks.

Exclusion Criteria:

* Contraindication to MRI
* Instrumented fusion

Primary outcomes:
measure: Rate of adverse events
timeFrame: 6 months
measure: Extent of epidural fibrosis
timeFrame: 12 months
Secondary outcomes:
measure: differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results
timeFrame: 12 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main
city: Woerden
country: Netherlands
facility: Sint Maartenskliniek, Nijmegen, The Netherlands
city: Bern
country: Switzerland
facility: Klinik Sonnehof
Study officials:
affiliation: Sint Maartenskliniek, Nijmegen, The Netherlands
name: Paul Pavlov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05164406: Impact of Blood Salvage Therapy on Outcomes After Oncologic Liver Surgery
Official title: Impact of Blood Salvage Therapy During Oncologic Liver Surgeries on Allogenic Transfusion Events, Survival and Recurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Keywords: Blood salvage therapy
Oncologic liver surgery
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing liver surgery for any cancer in our institution between january 2018 and August 2019 (blood salvage group) and patients who underwent liver surgery without blood salvage between 2011 and 2018 (control group)

Brief summary: A before and after trial comparing the systematic use of blood salvage therapy with leucocyte filter during oncologic liver resections. Recurrence, survival, allogenic transfusion rates and surgical outcomes are compared with a representative historic cohort.

Detailed description: Blood salvage therapy in oncologic liver surgery is seldom used based on unproven concerns about the safety of the technique regarding potential cancer dissemination or recurrence. Nevertheless, the technique has proven advantages in other surgical settings regarding the allogenic transfusion outcomes. Allogenic blood transfusion has been scientifically proven to worsen prognosis in oncologic surgery. This study compares a cohort of patients systematically exposed the blood salvage therapy to one comparable cohort without the therapy and outcomes regarding transfusion rates, post-operative Hb measurement, recurrence, overall survival, and post-operative adverse events.

Eligibility criteria: Inclusion Criteria:

* Adult Oncologic liver surgery scheduled in our institution

Exclusion Criteria:

* Condition precluding consent for trial Pregnancy

Primary outcomes:
measure: Recurrence free survival
timeFrame: 18 months
measure: Overall survival
timeFrame: 18 months
measure: Transfusion
timeFrame: Up to 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Yves Collin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725906: Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication
Official title: Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Self Efficacy
Keywords: genotypic resistance guided therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-11-14
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.

Detailed description: The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).

Eligibility criteria: Inclusion Criteria:

* Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.

Exclusion Criteria:

* Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.

Primary outcomes:
measure: Eradication rate after third line rescue therapy
timeFrame: 8 weeks
Secondary outcomes:
measure: eradication rates in subgroup analysis by antibiotic resistance and regimen
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Universtiy Hospital
city: Yun-Lin County
country: Taiwan
facility: National Taiwan University Hospital, Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Ming Liou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liou JM, Chen PY, Luo JC, Lee JY, Chen CC, Fang YJ, Yang TH, Chang CY, Bair MJ, Chen MJ, Hsu YC, Hsu WF, Chang CC, Lin JT, Shun CT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection. Gastroenterology. 2018 Oct;155(4):1109-1119. doi: 10.1053/j.gastro.2018.06.047. Epub 2018 Jun 30.
Clinical trial NCT06905106: POlycythemia, Proteins and ErYthropoiesis
Official title: POlycythemia, Proteins and ErYthropoiesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Erythropoiesis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 400
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: Patients with polycythemia

Brief summary: Erythropoiesis encompasses all the stages and mechanisms involved in the production of red blood cells, or erythrocytes, under the control of a large number of regulatory agents, most often proteins. Among these proteins, erythropoietin and interleukin-3 play a major role. Similarly, proteins involved in iron metabolism (erythroferrone, hepcidin, ferroportin, transferrin, ferritin) influence erythrocyte production more or less directly. The regulation of erythropoiesis is a fine, complex mechanism involving a large number of players, not only through the stimulation of hypoxia pathways to control erythropoietin synthesis, but also through the availability of iron, an essential element for erythropoiesis. Excessive erythrocyte production can lead to polycythemia, the causes of which are varied, primary or secondary, acquired or constitutional. The aim of this work is the descriptive study (quantitative and/or qualitative) of the various proteins involved in the regulation of erythropoiesis in patients with polycythemia. These proteins will be measured in the plasma of patients obtained after blood sampling or bloodletting (bloodletting being the most common treatment for polyglobulic patients) and will be compared with the proteins of patients without polycythemia.


Eligibility criteria: Inclusion Criteria:

- Persons who have given their non-opposition

Patients with polycythemia:

* haemoglobin value \> 16 g/dl female or \> 16.5 g/dl male
* with a well-identified cause: either primary (polycythemia Vaquez, erythropoietin receptor or LNK/SH2B3 mutation...) or secondary \[cardio-respiratory pathologies, renal pathologies (post-transplant, polycystic kidney disease), metabolic pathologies, tumour (leiomyoma, pheochromocytoma...), constitutional mutations (hyperaffine haemoglobins, HIF2/EPAS1, PHD/EGLN1, VHL, ...)

Patients control:

- persons with a similar pathology to that of polycythemia patients, essentialy secondary, but without polycythemia, i.e. with a haemoglobin value of \< 16 g/DL for women and \< 16.5 g/DL for men

Exclusion Criteria:

* Person subject to a measure of legal protection (guardianship, tutorship)
* Person subject to a court order
* Pregnant, parturient or nursing woman
* Incapable of expressing consent
* Minor

Primary outcomes:
measure: Measurement of various proteins involved in the regulation of erythropoiesis
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03509506: A Self-care Mobile Health App in Individuals With Heart Failure
Official title: Usability and Effectiveness of a Self-care Mobile Health App in Individuals With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Management
Mobile Applications
Heart Failure
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was designed to determine the potential benefits that individuals with heart failure (HF) could experience from using a mobile application.

Detailed description: The mobile application is called the Heart Failure Health Storylines (HFHS). The potential benefits will be examined by determining the changes in physical activity and quality of life of the participants, who will use the application and compare the results with the participants, who will not use the application.

Eligibility criteria: Inclusion Criteria:

* Adults with chronic heart failure, class I - III based on New York Heart Association (NYHA) scale
* Walking independently with/without an assistive device

Exclusion Criteria: The participant will be excluded if one or more of the following is present

* Cognitive impairment (\< 26 on Montreal Cognitive Assessment).
* Uncorrected vision
* Hearing problems
* Neurological disorders.
* Cannot speak and read the English language,
* Not owning a smart cell phone with internet access.

Primary outcomes:
measure: Quality of Experience
timeFrame: Change from baseline to 4 weeks
Secondary outcomes:
measure: Quality of Life for Individuals with Heart Failure
timeFrame: Change from baseline to 4 weeks
measure: Quality of Life for Individuals with HF
timeFrame: Change from baseline to 4 weeks
measure: Physical Activity will be indicated by daily step counts
timeFrame: Change from baseline to 4 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Suh Jen Lin, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: