louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04354857: Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection
Official title: Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: anosmia
SARS-Cov-2
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 454
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: All adults referred for a suspicion of COVID-19 infection and tested by RT-PCR assay for detection of SARS-CoV-2 in a nasopharyngeal sample at the COVID Screening Center or in the infectious and tropical diseases department of the University Hospital of Nîmes,

Brief summary: Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with COVID-19 related symptoms including: fever, persistent cough, fatigue, shortness of breath, diarrhoea, abdominal pain, chest pain, sore throat, loss of smell or taste
* Subjects in prolonged contact with COVID-19 infected patients.

Exclusion Criteria:

* Patients directly admitted to the intensive care unit were excluded
* Patients opposing use of their health data

Primary outcomes:
measure: SARS-CoV-2 infection status
timeFrame: Day 0
measure: Olfactory and gustatory loss
timeFrame: Day 0
Secondary outcomes:
measure: Ability to detect odor
timeFrame: Day 0
measure: Ability to detect odor
timeFrame: Six months
measure: Ability to detect salty taste
timeFrame: Day 0
measure: Ability to detect salty taste
timeFrame: Six months
measure: Ability to detect sweet taste
timeFrame: Day 0
measure: Ability to detect sweet taste
timeFrame: Six months
measure: Olfactory and gustatory loss
timeFrame: Day 7
measure: Olfactory and gustatory loss
timeFrame: Day 14
measure: Olfactory and gustatory loss
timeFrame: Day 30
measure: Olfactory and gustatory loss
timeFrame: Day 60
measure: Severity of infection according to hospitalization rate
timeFrame: End of study (six months)
measure: Olfactory and gustatory loss
timeFrame: Six months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Benjamin Lallemant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04818957: Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Hematopoietic Stem Cell Transplantation (HSCT)
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options by using vitamin D oral thin film (OTF) administration.

Detailed description: The purpose of this study is to investigate efficacy of oral thin film (OTF) cholecalciferol (vitamin D3) replacement in hematopoietic stem cell transplantation (HSCT) recipients who failed to achieve or sustain adequate vitamin D levels after vitamin D supplementation using current standard of care, or those unable to take/tolerate currently available enteral vitamin D formulations. With oral thin film (OTF) cholecalciferol, investigators hope to significantly improve the ease of administration, restoring compliance and facilitating therapeutic vitamin D levels without relying on the gut for absorption.

Eligibility criteria: Inclusion Criteria:

* HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF.

Exclusion Criteria:

* Subjects with 25OHD level \>60ng/mL. Subjects can be re-screened multiple times and enrolled later if they meet study criteria.
* Subjects with clinically significant and uncontrolled hypercalcemia as deemed by treating physician.

Primary outcomes:
measure: Vitamin D Level
timeFrame: 12 weeks from starting vitamin D supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Allison Bartlett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Gregory Wallace, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03039257: Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates
Official title: Single, High Dose Vitamin A Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation and Its Role on MBI-LCBI Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Keywords: hematopoietic stem cell transplant
vitamin a
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to establish that single dose vitamin A supplementation is feasible and safe in pediatric and young adult bone marrow transplant recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.

Detailed description: The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), likely via decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A 3x3 dose escalation/de-escalation study design will be used to determine the safety and dosing required to maintain vitamin A levels in the upper quartile of normal range for age at day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem cell transplantation.

Eligibility criteria: Inclusion Criteria:

* Any patient undergoing HSCT.

Exclusion Criteria:

* Vitamin A hypersensitivity or allergy.
* Age less than 1 year at time of transplant.
* Baseline pre-HSCT vitamin A levels higher than the upper quartile of normal range for age.
* Enteral feeding or medication intolerance.
* Pregnancy.

Primary outcomes:
measure: Vitamin A Level
timeFrame: 30 days after HSCT
Secondary outcomes:
measure: Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)
timeFrame: 100 days after HSCT
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stella Davies, MBBS, PhD, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04985357: Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs
Official title: Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stage III Breast Cancer
Stage IV Breast Cancer
Stage III Lung Cancer
Stage IV Lung Cancer
AML
Multiple Myeloma in Relapse
Carcinoma
Carcinoma, Pancreatic
Carcinoma of Lung
Carcinoma, Non-Small-Cell Lung
Carcinoma Breast
Carcinoma Prostate
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Carcinoma, Neuroendocrine
Carcinoma, Small Cell Lung
Carcinoma, Ovarian
Carcinoma Bladder
Carcinoma of Esophagus
Carcinoma Cervix
Carcinoma, Thymic
Carcinoma, Ductal
Carcinoma of the Head and Neck
Carcinoma of the Lip
Carcinoma of the Oral Cavity
Carcinoma of Unknown Primary
Carcinoma of the Skin
Carcinoma of the Anus
Carcinoma of the Larynx
Carcinoma of the Penis
Carcinoma of the Oropharynx
Carcinoma of the Appendix
Carcinoma of the Paranasal Sinus
Carcinoma of the Vulva
Malignant Pleural Effusion
Malignant Ascites
Mesothelioma
Cholangiocarcinoma
Lead sponsor: Travera Inc
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 0
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: General population with cohort matched diagnoses.

Brief summary: The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.


Eligibility criteria: Inclusion Criteria:

* Sample collection or biopsy of tumor is clinically indicated as part of SOC
* Prior to preceding onto therapy for treatment

Exclusion Criteria:

* Unable to obtain sufficient sample

Primary outcomes:
measure: Best overall response (BOR)
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Travera Inc
name: Mark Stevens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Travera Inc
name: Robert Kimmerling, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04747457: Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination
Official title: Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fibrosis
Keywords: FibroScan
Vibration Control Transient Elastography
Vibration Guided Transient Elastography
Liver Stiffness Measurement
VCTE
VGTE
Lead sponsor: Echosens
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an European, prospective, interventional, and multicenter exploratory clinical investigation that will take place in 6 French sites and 200 patients will be included (adults and children). The study objective is to develop predictive indicators of homogeneous propagation of ultrasound and elastic waves to define an optimal region of interest for the measurement of liver stiffness during VCTE examination.


Eligibility criteria: Inclusion Criteria:

* Adult and pediatric patients, all etiologies combined
* Patient must be able to give written informed consent, or the parents in the case of a minor patient
* Patient affiliated to a social security system

Exclusion Criteria:

* Vulnerable patient- other than pediatric patients
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan)
timeFrame: 7 months
Secondary outcomes:
measure: The bias between the CAPc measured with the VCTE (Reference FibroScan) and the CAPc measured by the Vibration Guided Transient Elastography (VGTE) (Research FibroScan).
timeFrame: 7 months
measure: Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan).
timeFrame: 7 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Lille
country: France
facility: CHU de Lille
city: Montpellier
country: France
facility: Hôpital Saint Eloi
city: Nancy
country: France
facility: CHU de Nancy
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: University Hospital, Angers
name: Jérôme Boursier, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01503957: Nasya in Allergic Rhinitis
Official title: Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
Allergen
Allergy
Dustmite
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2012-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.


Eligibility criteria: Inclusion Criteria:

* History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years
* Written informed consent

Exclusion Criteria:

* Clinically significant disease that could interfere with the evaluation of study medication
* Participation in other studies within the last 4 weeks / during the study

Primary outcomes:
measure: Difference in Total Nasal Symptom Score
timeFrame: 75 minutes
Secondary outcomes:
measure: Difference in Total Nasal Symptom Score
timeFrame: Up to 240 minutes
measure: Difference in Total Ocular Symptom Score
timeFrame: Up to 240 minutes
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1
Study officials:
affiliation: Charite University, Berlin, Germany
name: Minoo Lenarz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03807648: I USE LR in the ED
Official title: Intermountain Utah Study Evaluating the Implementation of Lactated Ringers as Standard Resuscitation Fluid Starting in Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Injury
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data to determine study outcomes will be extracted from the EDW and stored in a secure database. No actualy contact with patients will take place for this data-only study

Brief summary: To study the difference in mortality and major adverse kidney events during and after treatment in the emergency department with intravenous fluids per standard of care at 30 days before and after the system-wide implementation.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years) receiving a minimum of 1000ml of intravenous fluids starting in the emergency department per standard of care

Exclusion Criteria:

* Patients aged ≤17 years
* Previously enrolled patients with \>1 ED admission within the 30-day follow-up period

Primary outcomes:
measure: Number of participants with major Adverse Kidney Events
timeFrame: within 30 days or at hospital discharge
measure: LR IV Fluids administered
timeFrame: Through study completion (an average of 1 year)
Secondary outcomes:
measure: Rate of hospital admission and readmission
timeFrame: Within 30 days of initial ED encounter
measure: Cost
timeFrame: Through study completion (an average of 1 year)
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References:
Clinical trial NCT00382148: A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
Official title: A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peanut Hypersensitivity
Keywords: TOPS
Peanut allergy
Peanut-induced allergy
Allergy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.


Eligibility criteria: Inclusion Criteria:

* Completion of last visit (or early termination visit, if applicable) for Study Q2788g
* Signed Informed Consent Form
* Use of an effective method of contraception for females of childbearing potential
* Body weight ≥ 20 kg and ≤ 150 kg
* IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE \< 30 IU/mL will be dosed at the lowest level on the dosing table \[30 IU/mL\], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)

Exclusion Criteria:

* Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
* Current participation in another investigational study
* Pregnancy or lactation
* History of brittle asthma
* Aspirin-sensitive asthma
* Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
* Have a polymorrphonuclear count \<1500/uL
* Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
* Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
* Thrombocytopenia as evidenced by a platelet count \< 100,000/uL
* Any systemic condition requiring regular administration of an immunoglobulin

Primary outcomes:
measure: Serious Adverse Events
timeFrame: Through Week 52
Secondary outcomes:
measure: Food Allergen Exposure, Assessed on Patient-reported Questionnaire
timeFrame: Every 4 weeks through Week 52
measure: Food-allergic Reactions As Assessed by the Ewan Scale
timeFrame: Through Week 52
measure: Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
timeFrame: Through Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Dennis Wong, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00441948: Enhanced Safety Laser Hair Removal System
Official title: Peterio™ - an Add-on Device for Enhanced Safety of Aesthetic Laser Treatments.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hirsutism
Hypertrichosis
Keywords: Hirsutism
Hypertrichosis
Lead sponsor: Scilex Ltd.
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a new laser system provides better safety and efficacy in hair removal than existing lasers.

Detailed description: Lasers are a well-established, popular modality for removal of unwanted hair. The existing lasers are based on a wavelength that is specifically absorbed by the pigment melanin found in the hair follicle, where the energy is converted to heat resulting in a thermal injury.

However, lasers for hair removal are not without limitations. A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle. The heating of hair follicle is done through heat dissipation from the hair shaft. One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy, resulting in inadequate heating of the hair follicles. The purpose of the study is an evaluation safety and efficacy of a new laser based device.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 years old
* Fitzpatrick skin types I to VI

Exclusion Criteria:

* Age below 18 or above 75 year old
* Use of photosensitive medications
* Photosensitive diseases
* Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
* Exposure to sun or artificial tanning during the last 3-4 weeks

Primary outcomes:
measure: Hair reduction as counted 1-3 months after each treatment session, depending on the treated area.
measure: Long term clearance will be calculated as the ratio between the value of the baseline hair count taken immediately before the first treatment, and the value obtained at the 3-6 month post treatment hair count.
Secondary outcomes:
measure: Measuring treatment discomfort as graded by the patients.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Dermatology
Study officials:
affiliation: Hadassah Medical Organization
name: Leon Gilad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.