louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01377974: Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis
Official title: Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leishmaniasis
Leishmaniasis, Mucocutaneous
Keywords: Leishmaniasis
Mucocutaneous Leishmaniasis
Therapeutics
meglumine antimoniate
miltefosine
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.

Detailed description: Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mucosal leishmaniasis
* Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study
* Use of contraceptive method, if female on child bearing age
* Sign the agreement and consent form

Exclusion Criteria:

* Previous leishmanicidal treatment on the past 6 months before the enrollment on the study
* Electrocardiogram abnormalities on the pretreatment exams
* Previous kidney, liver and/or heart diseases
* Diabetes Mellitus
* Hypersensitivity to miltefosine or meglumine antimoniate
* Pregnant women or breastfeeding mothers
* Hiv patients

Primary outcomes:
measure: Cure
timeFrame: 6 months
Secondary outcomes:
measure: Adverse effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Brasilia University Hospital
state: DF
Study officials:
affiliation: University of Brasilia
name: Juliana SF Silva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brasilia
name: Raimunda NR Sampaio, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02502474: Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne
Official title: Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STAPHYLOCOCCAL INFECTIONS
Keywords: staphylococcus aureus
digestive carriage
mucosal colonization
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. The aim of this study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous infections due to this bacterium.


Eligibility criteria: Inclusion Criteria:

* Patient affiliated to French social security
* Written consent of the patient
* Patient needing a colonoscopy in the University Hospital of Saint-Etienne, France

Exclusion Criteria:

* Patient who decline to participate to the study
* Patient in the incapacity to give consent
* Patient receiving treatment with anticoagulant or antiaggregant platelets
* Patients with a known haemostatic disorder
* Pregnant woman
* Patients with a chronic disease of the gastrointestinal tract
* Patients receiving long-term corticosteroid
* Patient receiving anti staphylococcal antibiotics

Primary outcomes:
measure: Number of patient with Staphylococcus aureus colonic carriage
timeFrame: Day 1
Secondary outcomes:
measure: Number of patient with similar Staphylococcus aureus strains in the nose and in the rectum
timeFrame: Day 1
measure: Number of patient with Staphylococcus aureus carriage in the nose
timeFrame: Day 1
measure: Number of patient with Staphylococcus aureus carriage in the throat
timeFrame: Day 1
measure: Number of patient with Staphylococcus aureus carriage in the groin
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Philippe Berthelot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02251574: Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
Official title: Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.

Detailed description: Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring. OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure.

Although anyone can develop OSA, it commonly affects people who are obese. The more someone weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for overweight individuals to help improve OSA. However, not enough research has been done for doctors to be able make specific recommendations to their patients.

Eligibility criteria: Inclusion Criteria:

* AHI score of ≥ 5
* Body mass index (BMI) between 30 to 49.9 kg/m2

Exclusion Criteria:

* Report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event
* Currently or planning to become pregnant during the next 9 months
* Not weight stable (-4.6 kg) for 3 mos. prior to intake
* Report current participation in a weight reduction program involving diet or PA
* Unwilling to be randomized to 1 of 3 study groups
* Report symptomology of an eating disorder as determined by the Eating Attitudes Test
* Unable to participate in moderate intensity physical activity

Primary outcomes:
measure: Change in Apnea Hypopnea Index (AHI)
timeFrame: Change from Baseline to Month 3
Secondary outcomes:
measure: Change in Apnea Hypopnea Index (AHI)
timeFrame: Change from Baseline to Month 9
measure: Change in metabolic syndrome (MetS) risk factors
timeFrame: Change from Baseline to Month 3 and Month 9
measure: Change in Quality of Life
timeFrame: Change from Baseline to Month 3 and Month 9
measure: Change in Daytime Sleepiness
timeFrame: Change from Baseline to Month 3 and Month 9
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeannine Goetz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245674: SOLIACS: Solian Solution in the Acute Setting
Official title: Solian Solution to Treat Schizophrenic Patients During an Acute Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode.

The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* schizophrenic in-patients with an acute episode
* aged between 18 and 65 years
* written informed consent

Exclusion Criteria:

* pregnancy and breast-feeding
* breast cancer, prolactinoma, pheochromocytoma
* hypersensitivity to amisulpride or one of the other excipients
* contra-indications when using amisulpride as per the SmPC

Primary outcomes:
measure: *analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
Secondary outcomes:
measure: *analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Dr. Christian Fassotte, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02148874: Immune Responses to the Flu Shot During Pregnancy
Official title: Immune Responses to the Flu Shot During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: pregnant
flu shot
influenza
vaccine
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 287
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample, prenatal clinic

Brief summary: This study will examine effects of everyday life stress and obesity on immune responses to influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody levels against influenza (the flu) increase. Higher antibody levels indicate better immune protection from influenza. In addition to providing protection from the flu for yourself, being vaccinated during pregnancy may protect your baby from the flu during the first six months of life during which time infants cannot be vaccinated. Our primary goals are to determine whether greater life stress and obesity reduce 1) antibody responses to the flu shot in women and 2) antibody levels in the newborn at the time of delivery.


Eligibility criteria: Inclusion Criteria:

* less than 29 weeks pregnant
* ages 18-42
* planning to deliver at The Ohio State University Wexner Medical Center

Exclusion Criteria:

* prior serious adverse reaction to seasonal influenza vaccine

Primary outcomes:
measure: Maternal HAI Antibody Titers
timeFrame: 30-days after influenza vaccination
measure: Maternal HAI Antibody Titers
timeFrame: at delivery
Secondary outcomes:
measure: Infant HAI Antibody Titers
timeFrame: cord blood at delivery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Lisa M. Christian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christian LM, Beverly C, Mitchell AM, Karlsson E, Porter K, Schultz-Cherry S, Ramilo O. Effects of prior influenza virus vaccination on maternal antibody responses: Implications for achieving protection in the newborns. Vaccine. 2017 Sep 18;35(39):5283-5290. doi: 10.1016/j.vaccine.2017.05.050. Epub 2017 Aug 1.
Clinical trial NCT02713074: Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy
Official title: A Comparison Between Povidone-iodine and Normal Saline in Vaginal Cleansing Before Office Hysterosocpy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 147
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.


Eligibility criteria: Inclusion Criteria:

1 - All women who will subject to office Hysterosocpy for gynecological problems

Exclusion Criteria:

1. All patients have current vaginitis or urinary tract infection before the hysteroscopy
2. Diabetic women.
3. Women with body mass index \> 25 kg/m2.

Primary outcomes:
measure: rate of postoperative vaginal irritation symptoms
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT02243774: Mail Outreach To Increase Vaccination Acceptance Through Engagement
Official title: Mail Outreach To Increase Vaccination Acceptance Through Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Influenza
Human Flu
Keywords: Vaccination
Immunization
Randomized Controlled Trial
Prevention & Control
Preventive Measures
Health Promotion
Medicare
Intention Prompts
Letters
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Centers for Medicare and Medicaid Services
name: United States Social and Behavioral Sciences Team
First posted: 2014-09-18
Enrollment: 228000
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether receiving a core letter signed by the Surgeon General or the Director of the National Vaccine Program that provides only information about influenza, or a core letter signed by the Surgeon General with an added basic or enhanced implementation prompt, will increase rates of influenza vaccination among Medicare beneficiaries when compared to a control group.


Eligibility criteria: Medicare fee-for-service beneficiaries aged 66 and older are eligible for study inclusion. There will be no additional exclusion criteria.

Primary outcomes:
measure: Number of study participants who receive influenza vaccination
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Centers for Medicare & Medicaid Services
state: Maryland
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Niteesh K Choudhry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02606474: Placenta Accreta&Its Complications in Placenta Previa Cases
Official title: Incidence of Placenta Accreta & it's Complications in Cases of Previous Cesarean With Placenta Previa Anterior
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta in Placenta Previa Anterior
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant with gestational age more than 30 weeks with previous one or more cesarean section with placenta previa anterior

Brief summary: Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta accreta is diagnosed during cesarean section \&confirmed by pathology. All complications are monitored in cases with placenta accreta and without.

Detailed description: 100 cases of gestational age 30 weeks or more with placenta previa anterior with previous one or more cesarean section will be enrolled. History,examination \&routine investigations will be taken. Colour doppler will be done to diagnose cases with suspected placenta accreta. Pre \& postoperative Hb concentration will be taken. Cases with nonseparation of the placenta will be diagnosed as accreta \& confirmed by pathology. Operative time \& complications like bladder or intestinal injury will be noted. All data will be analyzed.

Eligibility criteria: Inclusion Criteria:

* all pregnant women more than 30 weeks with previous one or more cesarean section with placenta previa anterior

Exclusion Criteria:

* pregnant with unscarred uterus
* scars other than cesarean section

Primary outcomes:
measure: Number of patients with placenta accreta.
timeFrame: 3 months
measure: Number of patients with bladder injury.
timeFrame: 3 months
measure: Number of patients with intestinal injury.
timeFrame: 3 months
measure: Number of patients with cesarean hysterectomy.
timeFrame: 3 months
measure: Number of deaths.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00880074: FLT-PET in Predicting Response to Chemotherapy in Patients With Advanced Malignancies
Official title: Early Prediction of Clinical Response to Chemotherapy With FLT-PET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies fluorine F-18 fluorothymidine (FLT)-positron emission tomography (PET) in predicting response to chemotherapy in patients with advanced malignancies. FLT solution can help locate cancer cells inside the body. Diagnostic procedures, such as FLT-PET, may help find tumors and measure a patient's response to treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To determine if concurrent treatment with temsirolimus and bevacizumab demonstrates a dose-dependent decrease in FLT-PET standardized uptake value which correlates with clinical response.

SECONDARY OBJECTIVES:

I. To determine the relationship between FLT-PET and markers of angiogenesis and drug activity in tumor biopsy, along with surrogate peripheral blood markers of target inhibition and drug activity.

OUTLINE:

Patients undergo fluorine F-18 fluorothymidine PET at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.

Eligibility criteria: Inclusion Criteria:

* Patients actively enrolled and being treated on protocol 2007-0668: Combination Therapy with Bevacizumab and Temsirolimus in Patients with Advanced Malignancy at M.D. Anderson Cancer Center; these patients must have met the inclusion and exclusion criteria for that protocol
* Women of child-bearing potential (as defined as women who are not post-menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
* Ability to understand and the willingness to sign a written informed consent document
* Patient actively enrolled and being treated on protocol 2012-0061 "A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in Patients with Advanced Malignancy" at M.D. Anderson Cancer Center

Exclusion Criteria:

* Pregnant or breast-feeding women
* History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) or any component of the formulation

Primary outcomes:
measure: Response to Chemotherapy Shown in FLT-PET Scans
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sarina A Piha-Paul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277874: Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
Official title: Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Prematurity
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 0
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.


Eligibility criteria: Inclusion Criteria:

* Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
* Ordered respiratory treatment of NCPAP

Exclusion Criteria:

* Major congenital defect
* Known or suspected chromosomal disorder

Primary outcomes:
measure: Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
timeFrame: 2 months
measure: Need for mechanical ventilation following the initiation of NCPAP.
timeFrame: 2 months
Secondary outcomes:
measure: Total duration of non-invasive and invasive respiratory support in each study group.
timeFrame: 2 months
measure: total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.
timeFrame: 2 months
Other outcomes:
Locations:
city: Madera
country: United States
facility: Valley Children's Healthcare
state: California
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Donald Null, MD
role: PRINCIPAL_INVESTIGATOR
References: