louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00946673: Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
Official title: A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Cancer
Neoplasm Metastasis
Lung Cancer
Carcinoma, Non-Small-Cell Lung
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2009-07-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.


Eligibility criteria: Inclusion Criteria:

* All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.
* Adequate organ function (section 3.1.10).
* ECOG performance status 0-2.
* Life expectancy of \>=12 weeks.
* Systemic chemotherapy washout period \>=7 days.

Exclusion Criteria:

Patients who have previously been treated with whole brain irradiation, pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent.

Primary outcomes:
measure: The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
timeFrame: 30 days following Stereotactic Radiosurgery
measure: During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed.
timeFrame: 30 days following Stereotactic Radiosurgery
measure: The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
timeFrame: 3 months following Stereotactic Radiosurgery
Secondary outcomes:
measure: The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.
timeFrame: 12 months
measure: The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.
timeFrame: 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Stanford University
name: Griffith R. Harsh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146273: Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
Official title: A Pharmacokinetic Crossover Comparison Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin Deficiency
Lead sponsor: Galilee CBR
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals defined in the protocol

Detailed description: This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals:

1. Tablet/capsule administration - up to 20 healthy volunteers will be recruited to the study. The tablet/capsule will be administered as a single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.
2. Gel administration - the gel will be administrated to the same group of patients in the single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female and aged 18-65 years
* BMI - 19-24
* Subject is not pregnant and is not nursing
* Signed Informed Consent Form

Exclusion Criteria:

* Current use of multivitamin or mineral complexes (washout of 4 days before Visit 2 is permitted)
* Participants with known vitamins or mineral deficiencies
* Diabetes Type II
* Smoking
* Subjects who have undergone surgery within the last 3 months.
* Subjects with a clinically significant (during last 3 months) infectious, immune-mediated or active malignant disease.
* Subjects who are receiving an elemental diet or parenteral nutrition.
* Subjects who are treated with insulin.
* Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
* Subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
* Known sensitivity to any ingredients in the study product
* History of addiction or drug abuse
* Alcoholic regular use

Primary outcomes:
measure: Mean fractional absorption
timeFrame: 6 hours
Secondary outcomes:
measure: Absorption rate
timeFrame: 6 hours
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Israel
state: Central
Study officials:
References:
Clinical trial NCT03003273: Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study
Official title: Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: a Randomized Controlled Study -DALFEN Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neutropenia, Febrile
Pediatric Cancer
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 142
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.


Eligibility criteria: Inclusion Criteria:

* All pediatric febrile neutropenia patients treated on outpatient basis
* Age 3 years - 18 years
* Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )
* Afebrile for at least 24 hours, on intra-venous antibiotics

Exclusion Criteria:

* Bone marrow involvement in solid tumor
* Already enrolled once, in previous episode
* On antibiotics prophylaxis
* Retroviral positive patients
* Patient undergone stem cell transplant

Primary outcomes:
measure: Treatment is considered to be successful if the following is attained without changing the regimen - Patient remains afebrile till recovery of ANC ≥500 •Measure of effect: Proportion of patients afebrile in each arm
timeFrame: till ANC ≥ 500 or reappearance of fever during the period ≤ 10 days
Secondary outcomes:
measure: Rate of re-admission
timeFrame: till ANC ≥ 500 or reappearance of fever during the period ≤10 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Medical Oncology, AIIMS
Study officials:
affiliation: Department of Medical Oncology, 2nd Floor, B.R.A.I.R.C.H, All India Institute of Medical Sciences, New Delhi, India
name: Sameer Bakhshi, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04979273: The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding
Official title: The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastro Intestinal Bleeding
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 66
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 study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper GI bleeding.


Eligibility criteria: Inclusion Criteria:

* Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
* Patients consented to study participation

Exclusion Criteria:

* Patients with thrombocytopenia (thrombocyte count \<100.000 cells/ul) and other forms of coagulopathy

Primary outcomes:
measure: Hemostatic success
timeFrame: 5 minute
Secondary outcomes:
measure: Re-bleeding
timeFrame: 7 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Dr Cipto Mangunkusumo General Hospital
name: Hasan Maulahela, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01025973: Evaluation and Validation of New Biomarkers by Mass Spectrometry
Official title: A New Approach by Mass Spectrometry for Evaluation and Validation of New Biomarkers of Fetus and Mother
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 99
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with or without diabetes and their newborn.

Brief summary: The investigators will perform biochemical and metabolic evaluations on cord blood, venous blood of the mother and urine of the foetus and mother using time-of-flight and tandem mass spectrometry. The investigators could evaluate, dose and validate gestational diabetes mellitus biomarkers of the fetus and mother.


Eligibility criteria: Inclusion Criteria:

For women:

* Aged 18 or more
* 24 weeks of gestation or more
* Type 1, type 2 or gestational diabetes mellitus for group 1
* Without diabetes for group 2.

For newborn:

* 37 weeks of gestation or more
* Birth weight 2500 g or more

Exclusion Criteria:

* Multiple birth

Primary outcomes:
measure: Foetal HbA1c
timeFrame: At delivery
Secondary outcomes:
measure: Foetal acetylated Hb
timeFrame: At delivery
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche clinique Etienne-Le Bel du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dupont FO, Hivert MF, Allard C, Menard J, Perron P, Bouchard L, Robitaille J, Pasquier JC, Auray-Blais C, Ardilouze JL. Glycation of fetal hemoglobin reflects hyperglycemia exposure in utero. Diabetes Care. 2014 Oct;37(10):2830-3. doi: 10.2337/dc14-0549. Epub 2014 Jul 10.
Clinical trial NCT02023073: Determination of Physical Parameters Relevant to Ophthalmic Lasers
Official title: Study of Physical Parameters Related to Laser Radiation and Its Interaction With Different Parts of the Human Eye
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Volunteers
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The use of lasers in medicine in general, and diagnosis and treatment in ophthalmology in particular, increased significantly. Making retinal surgery using lasers have become increasingly common. The goal: to diagnose eye diseases safely


Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* Refraction up to ±0.25D,
* General good health
* Written informed consent to participate in the study.

Exclusion Criteria:

* known current ophthalmic pathology
* known past ophthalmic pathology (including LASIK surgery)
* eye glasses or contact lenses

Primary outcomes:
measure: Reflected laser radiation (Watt/cm 2)
timeFrame: 1 day
Secondary outcomes:
measure: Reflection of laser radiation from the cornea (Watt/cm2)
timeFrame: 1 day
measure: Reflection of laser radiation from the retina (Watt/cm 2)
timeFrame: 1 day
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Goldschleger Eye Research Institute, Sheba Medical Center,
Study officials:
affiliation: Sheba Medical Center
name: Ygal Rotenstreich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04487873: COVID-19 Phobia in Patients With Bronchiectasis During Covid-19 Pandemic
Official title: COVID-19 Phobia and Quality of Life in Patients With Bronchiectasis During Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Bronchiectasis
Keywords: phobia
quality of life
health anxiety
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthy individuals between 18-60 years old, who are diagnosed with non-cystic fibrosis bronchiectasis, and whose local language is Turkish will be included in the study.

Brief summary: In the literature, there are no studies evaluating COVID-19 phobia, quality of life, health anxiety, physical activity level and quality of sleep in patients with bronchiectasis during COVID-19 pandemic. The investigators will evaluate these parameters in patients with bronchiectasis and compare the findings of healthy individuals during COVID-19 pandemic


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with non-cystic fibrosis bronchiectasis
* No acute bronchiectasis exacerbation or infection in the past 2 weeks
* Volunteering to participate in the research

Exclusion Criteria:

* Having a cognitive problem
* Not being literate

Primary outcomes:
measure: COVID-19 Phobia
timeFrame: 5 minutes
measure: Qol
timeFrame: 10 minutes
Secondary outcomes:
measure: Health anxiety
timeFrame: 10 minutes
measure: Physical activity
timeFrame: 5 minutes
measure: Quality of sleep
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Merve Firat, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Deniz İnal-İnce, Professor
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Melda Saglam, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ebru Calik-Kütükcü, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Aslıhan Cakmak, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT04398173: Detection Rate of Prostate Cancer in Men Undergoing MRI
Official title: A Retrospective Observational Study to Assess Prostate Cancer Detection Rate in Men Undergoing Magnetic Resonance Imaging: Comparison Between Subjects With Previous Negative Biopsy and Biopsy Naive Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasm
Keywords: magnetic resonance imaging
prostate biopsy
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 400
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with clinical suspicion of PCa, eligible for prostate biopsy

Brief summary: To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy.

Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.

Detailed description: The trial is a retrospective observational study, with the aim to compare two cohorts of patients with suspicion of PCa who will undergo MRI. Group A is composed by patients with previous negative biopsy, while group B is composed by men with no previous negative prostate biopsy.

To reach primary aim, men with positive MRI (clinically significant lesions with PI-RADS score \>= 3) and biopsy data will be considered.

In men with negative MRI (clinically insignificant lesions or regions classified as PI-RADS 2 at MRI), follow-up with PSA data and repeated MRI and/or biopsy will be considered.

Eligibility criteria: Inclusion Criteria:

* age 50 and life expectancy greater than 10 years
* PSA values persistently greater than 4 ng/ml
* multiparametric MRI of the prostate between nov-2014 and nov-2016
* MRI with endorectal coil

Exclusion Criteria:

* previous history of PCa

Primary outcomes:
measure: PCa detection rate
timeFrame: 24 months
Secondary outcomes:
measure: Negative predictive value of MRI
timeFrame: 24 months
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
state: Turin
Study officials:
References:
Clinical trial NCT01382173: Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)
Official title: Monitoring Of Helsingborg Acute Knee Injuries (MOHAK) to Understand Osteoarthritis Development After Injury.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Injury
Knee Osteoarthritis
Keywords: Knee injury
Osteoarthritis
Anterior Cruciate Ligament injury
Patellar dislocation
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Crafoord Foundation
First posted: 2011-06-27
Enrollment: 192
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will recruit approximately 150 patients annually over 3-4 years with the goal of including at least:

* 200 knees with isolated or combined ACL injuries
* 50 isolated meniscus tears
* 50 primary patellar dislocations
* 50 contusions without ligamentous, cartilage or meniscus injury.

Patients will be recruited using two different strategies:

1. Those seeking medical care at the orthopedic emergency room (ER) at Helsingborg hospital
2. Those referred to the orthopedic outpatient health care unit of Helsingborg hospital due to an acute knee injury by their primary health care unit will be scheduled for a clinical visit for baseline assessment (visit 1) within four weeks from their injury. To facilitate recruitment, primary care units in the local area of Helsingborg will be offered an opportunity to refer all patients with rotational knee trauma and effusion directly to the orthopedic outpatient care unit.

Brief summary: Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.


Eligibility criteria: Inclusion Criteria:

1. Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval)
2. A history of knee injury not more than 4 weeks prior to inclusion
3. Agreement and informed consent to participate in the study

Exclusion Criteria:

1. Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)
2. Pregnancy
3. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
4. General disease that effects physical function or systemic medication/abuse of steroids
5. Any other condition or treatment interfering with the completion or assessment of the trial.

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 5 yrs
Secondary outcomes:
measure: Radiographic osteoarthritis
timeFrame: 5 yrs
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Department of Orthopedics, Helsingborg hospital
Study officials:
References: