louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03050788: Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
Official title: Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kaposi Sarcoma
Keywords: Smartphone confocal microscopy
Kaposi Sarcoma
Point of care diagnosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Infectious Diseases Institute, Uganda
First posted: 2017-02-13
Enrollment: 363
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: The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.

Detailed description: The investigators will perform a cross-sectional study of 500 patients in routine clinical care settings who are suspected to have KS on clinical grounds and for whom skin punch biopsy and histopathological examination is indicated as part of standard of care. Patients will be evaluated with both the gold standard for diagnosis of KS (skin punch biopsy followed by histopathology) and portable confocal microscopy.

Eligibility criteria: Inclusion Criteria:

i. ≥ 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in areas which are considered safe to biopsy by the Ugandan providers, which means all areas of the skin except for the mouth and eye.

Exclusion Criteria:

i. Presence of suspected KS lesions exclusively on the mouth or eye unless clinical specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has proved to be problematic and definitive diagnosis is needed to inform a treatment plan.

Primary outcomes:
measure: Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy
timeFrame: Approximately 20 minutes (10 minutes for in vivo imaging)
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
Study officials:
affiliation: Massachusetts General Hospital
name: Dongkyun Kang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397188: Effect of Monitoring of Pulse Index Continuous Cardiac Output (PiCCO) on Shock Patients in Intensive Care Unit
Official title: Effect of Monitoring of Pulse Index Continuous Cardiac Output on Shock Patients in ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shock
Keywords: PiCCO
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PiCCO has become a widely used haemodynamic monitoring device in the management of shock patients in ICU patients nowadays. But the effects on outcome of use of Picco, such as hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP in shock patients has not been determined. Patients will be randomly assigned to a Picco group or the control group, hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP will be observed. The conclusion will supply evidence for the clinical effectiveness of Picco in shock patients.


Eligibility criteria: Inclusion Criteria:

* critically ill patients with shock: Mean arterial pressure (MAP) \< 65 mmHg (\< 8,7 kPa) or systolic arterial pressure (SAP) \< 90 mmHg (\< 12 kPa) or the need for vasopressor (Norepinephrine \<0.05µg/kg/min) to support the MAP ≥ 65 mmHg (≥ 8,7 kPa) or the SAP ≥ 90 mmHg ≥ 12 kPa), when one of these criteria has lasted for 4 hours or longer

Exclusion Criteria:

* Age \< 18 years
* Age \> 85 years
* Pregnancy (positive pregnancy test in women of child bearing age)

Primary outcomes:
measure: mortality at 28 days
timeFrame: 28 days
Secondary outcomes:
measure: vasoactive agents-free days
timeFrame: 28 days
measure: intensive care unit-free days
timeFrame: 28 days
measure: mechanical ventilation-free days
timeFrame: 28 days
measure: the change of lactate at 1,3,7 days after the insertion of the Picco catheter
timeFrame: 7 days
measure: the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter
timeFrame: 7 days
measure: mortality at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Medical College, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT00335088: Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Eye Infections
Keywords: Prophylaxis,
Intraocular surgery
Lacrimal sac
Eye lid
No conditions
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2006-06-08
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.

Detailed description: Over all 500 patients admitted for various intraocular surgeries will be included in the study. The study will be prospective, double blind, placebo controlled, and randomized. Patients will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. For patients treated with povidone iodine alone a placebo will also be given. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery. All patients will be followed for 6 weeks for symptoms and signs of infection. Bacterial and fungal culture results will be compared between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years.
* Various intraocular surgeries

Exclusion Criteria:

* Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.

Primary outcomes:
measure: Type and amount of bacterial growth
measure: Post surgery infections
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ophthalmology Department, HaEmek Medical Center, Afula, Israel
Study officials:
affiliation: HaEmek Medicak Center, Afula, Israel
name: Dan Miron, MD
role: STUDY_DIRECTOR
affiliation: HaEmek Medical Center, Afula, Israel
name: Orky Halachmi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01524588: C Terminal Variants of FSH Receptor
Official title: C Terminal Peptide Variants of the Fsh Receptor in Women Involved in an Assisted Reproduction Programm : Mechanistic Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Genotype
Phenotype
Genotypic Variation Between Patients
Genotypic Phenotypic Relationships
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 814
Sex: FEMALE
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 involved in an assisted reproduction programm, once engaged in a stimulation protocol

Brief summary: Follicle-stimulating hormone (FSH) is used in medically assisted procreation, to induce an ovarian stimulation in women. However, the FSH dose that has to be injected is quite hard to adjust, because an excess of exogenous hormone could lead to very severe complications for patient. This hormone acts on its cognate receptor, the FSHR, present on the granulosa cells surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain.

The investigators first aimed to research in the c-terminus part of the receptor the presence of allelic variants that could explain the variations of response to FSH stimulation.

The investigators also would want to complete the data already known on a functionally determinant single nucleotide polymorphism on 680 position in the c-terminus part of the hFSHR.

Then, the investigators would analyze the entire sequence of the hFSHR of patients presenting an unusual phenotype in response to FSH treatment, in order to detect a potential mutation involved in the receptor functionality.

The results of this study could allow us to increase our knowledge on the hFSHR physiology and functionality, in order to adjust treatment to the genetic profile of patients.


Eligibility criteria: Inclusion Criteria:

* patients above 18 years,
* entering an IVF cycle
* informed consent
* NHS operative

Exclusion Criteria:

* No

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: Tours Hospital
name: Dominique ROYERE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04641988: Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19)
Official title: Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19) : COROBIOCHIC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: SARS-CoV-2
Troponin
hs-cTnT
NT-proBNP
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with COVID-19

Brief summary: Objective: To assess the prognostic value of high-sensitive cardiac troponin T (hs-cTnT) and N-terminal pro brain natriuretic peptide (NT-proBNP) at ICU admission in patients with coronavirus disease 2019 (COVID-19).

Design: Multicenter retrospective observational cohort study Setting: Three ICUs at three hospitals in Occitanie, France. Patients: Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission, from March 9, 2020, to May 9, 2020.


Eligibility criteria: Inclusion criteria:

- Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission

Exclusion criteria:

- Age \< 18, pregnancy

Primary outcomes:
measure: hs-cTnT
timeFrame: at ICU admission
Secondary outcomes:
measure: NT-proBNP
timeFrame: at ICU admission
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Romaric Larcher, MD, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02496988: Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas
Official title: A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Advanced Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cytokine-Induced Killer Cells
Advanced Milignant Gliomas
Keywords: Cytokine-Induced Killer Cells
Milignant Gliomas
Temozolomide
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.


Eligibility criteria: Inclusion Criteria:

* Subjects with documented histologically confirmed primary grade 4 advanced malignant glioma.
* No more than 3 prior relapses or prior systemic treatments.
* Recurrent disease documented by MRI after prior therapy.
* Must have at least one site of bidimensionally measurable disease:

archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment.

* Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.
* Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.
* At least 18 years old.
* Both men and women must practice adequate contraception.
* Informed consent.

Exclusion Criteria:

* Progressed while on temozolomide.
* Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1.
* Not recovered from the toxic effects of prior therapy.
* Pregnant or breast feeding.
* History of diabetes mellitus.
* Uncontrolled intercurrent illness.
* Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
* HIV positive.
* Diagnosis of another malignancy may exclude subject from study.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02275988: Drug-Drug Interaction Study in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adult Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effects of clarithromycin on the pharmacokinetics of K-877 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 72 hours
Secondary outcomes:
measure: Area under concentration curve (AUC)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Stuart Campbell
role: STUDY_DIRECTOR
References:
Clinical trial NCT05371288: The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
Official title: The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: COVID-19
Keywords: Covid-19 Long-Haul
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Hudson Valley Healing Arts Center
First posted: 2022-05-12
Enrollment: 0
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: The purpose of this research study is to assess if glutathione, along with NAC (N-acetyl cysteine) and Alpha lipoic acid (ALA), can help reverse some of the COVID long-haul symptoms.Subjects will be randomized in to one of two groups. Depending on the group they are randomized in to, subjects will be taking either a combination of NAC, Alamax CR, and liposomal GSH or the same three nutritional supplements with a multivitamin and magnesium. Regardless of the group, subjects will be asked questions to assess their COVID symptoms, physical and mental health status. They will also be asked to take blood samples.


Eligibility criteria: Inclusion Criteria:

• Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list

Exclusion Criteria:

• History of a severe sulfa sensitivity (i.e., anaphylaxis, Stevens Johnson Syndrome), allergy to meat products and/or gelatin (alpha gal allergy) and/or a history of an allergic or adverse reaction to NAC, alpha lipoic acid and/or GSH.

Primary outcomes:
measure: Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC)
timeFrame: Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
measure: Change in Quality of Life Using SF-36 Survey
timeFrame: Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
measure: COVID Severity of Symptoms Questionnaire
timeFrame: Day 15, 28, end of months 2, 3, 4
measure: Change in Time to Clinical Recovery (TTCR)
timeFrame: Day 15 and 28 (month 1), and at the end of months 2, 3 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
Study officials:
References:
Clinical trial NCT03828188: Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Keywords: Red Ginseng Concentrated Powder
Hyperlipidemias
Clinical Trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.

Detailed description: This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)

Eligibility criteria: Inclusion Criteria:

* Age 19-70 years with Triglyceride 120-200 mg/dL

Exclusion Criteria:

* Lipid lowering agent within past 6 months
* Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Persons with significant hypersensitivity reactions to ginseng and red ginseng
* Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
* Those who have received antipsychotic medication within 2 months before screening
* Those with a history of alcoholism or substance abuse
* Those who participated in other clinical trials within 2 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Primary outcomes:
measure: Changes of Fasting triglyceride
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of Lipid metabolism indices
timeFrame: 30 weeks
measure: Changes of Arteriosclerosis indices
timeFrame: 30 weeks
measure: Changes of Carnitine (Serum)
timeFrame: 30 weeks
measure: Changes of lipoprotein lipase
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: