louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05469321: Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide
Official title: A Retrospective Study of Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuropathy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients presenting to the CHU of Nîmes with an acute or sub-acute neurological picture after having consumed N2O

Brief summary: Nitrous oxide (N2O) is a colorless, flammable, analgesic gas used in surgery and dentistry. The consumption of N2O has increased among young French people aiming to relax because of its short-lived neuropsychological effect (euphoria, depersonalization, analgesia) and its wide availability on the market.

It can be responsible in case of prolonged use and overdose of a vitamin B12 deficiency with possible neuropsychiatric complications: sensitivomotor neuropathy, myelopathy, behavioral and cognitive disorders of acute or sub-acute installation.

N2O inhibits the activitý of methionine synthase, decreases the activitý of methylmalonyl-CoA mutase leading to vitamin B12 deficiency but in addition to the interference with vitamin B12 metabolism there seems to be a direct toxicity of N20.

Myelin alteration was the typical electromyography finding but new axonal profiles were also described. Since myelopathy affects both the posterior and lateral cords, combined spinal cord sclerosis is the most common location of injury associated with N2O intoxication.


Eligibility criteria: patients presenting to the CHU of Nîmes with an acute or sub-acute neurological picture after having consumed N2O

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Primary outcomes:
measure: MRC score
timeFrame: baseline
measure: Romberg score
timeFrame: Baseline
measure: INCAT Sensory Sum score (ISS)
timeFrame: Baseline
measure: ONLS - Overall Neuropathy Limitations Scale
timeFrame: Baseline
measure: Rankin score
timeFrame: Baseline
measure: vitamin B12 level
timeFrame: baseline
measure: methyl malonic acid level
timeFrame: baseline
measure: electroneuromyogram
timeFrame: baseline
measure: Cerebral MRI
timeFrame: baseline
measure: Pan-medullary MRI
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT05752721: Impact of Online Ordering on Low-Income Adults' Food Security in Online Food Pantry Settings
Official title: Impact of Online Ordering on Low-Income Adults' Food Security in Online Food Pantry Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Security
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-03-03
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objectives of this study are to determine whether the transition to online ordering at a choice-based food pantry network influences food security status among low-income adults and determining whether there are differences in impact by age group.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or older
* have visited a food pantry that either is or is not scheduled to transition to online ordering at least once
* have capacity and willingness to provide consent
* speaks English

Exclusion Criteria:

* aged less than 18 years
* have not visited a food pantry that either is or is not scheduled to transition to online ordering at least once
* does not speak English

Primary outcomes:
measure: U.S. Household Food Security Survey Module: Six-Item Short Form Score
timeFrame: Baseline
measure: U.S. Household Food Security Survey Module: Six-Item Short Form Score
timeFrame: Month 8
Secondary outcomes:
measure: Time to Obtain Food From Food Pantry Per Visit
timeFrame: Baseline
measure: Time to Obtain Food From Food Pantry Per Visit
timeFrame: Month 8
measure: Composite Weekly Fruit & Vegetable Intake Score
timeFrame: Baseline
measure: Composite Weekly Fruit & Vegetable Intake Score
timeFrame: Month 8
measure: Center for Nutrition & Health Impact's Household Nutrition Security Survey Module: Four-Item Short Form Score
timeFrame: Baseline
measure: Center for Nutrition & Health Impact's Household Nutrition Security Survey Module: Four-Item Short Form Score
timeFrame: Month 8
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Pasquale Rummo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02298621: Pomegranate Juice and Metabolic Syndrome
Official title: The Effect of Pomegranate Juice Intake on Cardiometabolic Factors in Subjects With Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome.

Detailed description: The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome in shabestar.

Eligibility criteria: Inclusion Criteria:

* presence of ≥3 of the following diagnostic of MetS:

  * serum TGs of at least 150 mg/dL,
  * waist circumference of more than 102 cm (40 in) in men and more than 88 cm (35 in) in women,
  * high-density lipoprotein (HDL) level less than 40 mg/dL in men and less than 50 mg/dL in women,
  * blood pressure 135/85 mm Hg or higher, or
  * fasting glucose 100 mg/dL or Higher

Exclusion Criteria:

* liver cirrhosis,
* chronic pancreatitis,
* gastrointestinal or connective diseases,
* kidney stones, or
* renal failure,
* alcohol Consumption,
* having an allergy to pomegranate juice,
* a change in diet,
* the large increase in LDL so that required drug treatment.
* use of statins of fibrates, corticosteroids, nitrates, acetyl-salicylic acid or other anti-platelet drugs, oral hypoglycemic drugs, nonsteroidal anti-inflammatory drugs, or drugs interfering with coagulation;
* pregnancy or lactation in the past 6 mo, supplementation with vitamins or antioxidants

Primary outcomes:
measure: Change from baseline in values of metabolic syndrome components at 1 week
timeFrame: 1 week
Secondary outcomes:
measure: Change from baseline in values of insulin resistance (HOMA-IR), total cholesterol, LDL-C, VLDL-C and hs-CRP at 1 week
timeFrame: 1 weeks
Other outcomes:
Locations:
city: Urmia
country: Iran, Islamic Republic of
facility: Urmia University of Medical Sciences
Study officials:
affiliation: Urmia University of Medical Sciences
name: mohammad alizadeh
role: STUDY_DIRECTOR
References:
Clinical trial NCT02635321: MRI and Muscle Involvement in Patients With Mutations in GMPPB
Official title: MRI and Muscle Involvement in Patients With Mutations in GMPPB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb-girdle Muscular Dystrophy
Keywords: MRI
LGMD
GMPPB
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons diagnosed with mutations in GMPPB in Denmark and France are invited to the study.

Brief summary: Limb girdle muscular dystrophies (LGMD) are a very heterogeneous group of muscle disorders characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into more than 31 different types.

A new type - type 2T has been found. The genetic cause of type 2T is mutations in Guanosine Diphosphate (GDP)-mannose pyrophosphorylase B (GMPPB). Mutations in GMPPB can also cause Congenital muscular dystrophies (CMD). Only 41 patients with mutations in GMPPB has been reported.

In this study, the investigators examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle involvement using MRI.


Eligibility criteria: Inclusion Criteria:

* Persons with genetically verified mutations in GMPPB

Exclusion Criteria:

* All contraindications for undergoing an MRI scan

Primary outcomes:
measure: MRI scan for qualitative analysis of muscle involvement
timeFrame: One MRI scan per subject (exam lasts approximately 60 min.)
Secondary outcomes:
measure: Muscle biopsy for biochemical investigation
timeFrame: One muscle biopsy per subject (last approximately 15 min.)
measure: 10 meter walk test
timeFrame: Exam last approximately 5 min.
measure: Neurological examination and test of muscle strength
timeFrame: Exam last approximately 15 min.
measure: Questionnaires
timeFrame: Data will be collected once for patients with LGMD 2T (exam last approximately 45 min.)
measure: Heart examination
timeFrame: Exam last approximately 45 min
measure: Forced Vital Capacity (FVC)
timeFrame: Exam last approximately 15 min
measure: Electromyography (EMG)
timeFrame: Exam last approximately 30 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center
Study officials:
affiliation: Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University
name: Sofie T Østergaard, Bsc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02492321: A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Evaluation of the Efficacy, Safety, and Tolerability of EBI-005 in Subjects With Moderate to Severe Ocular Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis (AC)
Lead sponsor: Eleven Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 250
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 is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.

Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled into the study.


Eligibility criteria: Inclusion Criteria:

* Give written informed consent and any authorization required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
* Are ≥18 years of age;
* Have a positive history of ocular allergies during ragweed pollen season;
* Have signs and symptoms of allergic conjunctivitis in both eyes;
* If female and of child-bearing potential, she must not be pregnant or lactating

Exclusion Criteria:

* Have signs of ocular infection;
* Have a known history of alcohol or drug abuse;
* Have been exposed to an investigational drug or device within 30 days of the study;
* Have planned surgery (ocular or systemic) during the trial period or within 30 days after

Primary outcomes:
measure: Morning ocular itching diary scores
timeFrame: 14 days
Secondary outcomes:
measure: Late afternoon ocular itching diary scores
timeFrame: 14 days
measure: Evening ocular itching diary scores
timeFrame: 14 days
Other outcomes:
Locations:
city: Morrow
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Andover
country: United States
state: Massachusetts
city: Quincy
country: United States
facility: Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: Investigational Site
state: Missouri
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: Mason
country: United States
facility: Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Investigational Site
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Eleven Biotherapeutics
name: Michael Goldstein, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03013621: Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative
Official title: Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative (COVD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Renal Failure (ARF)
Keywords: Renal Failure
Renal Insufficiency
Acute Renal Failure
Acute Renal Injury
Kidney Failure
Kidney Insufficiency
Acute Kidney Failure
Acute Kidney Injury
Ventricular dysfunction
Venous congestion
Renal function
Kidney function
Venous heart failure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients in immediate postoperative period of cardiac surgery, hospitalized in surgical intensive care department

Brief summary: Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery, and is a major risk factor for mortality in this context.

The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common complication, close to 100% if one takes into account the transient dysfunction.

A recent study showed that right ventricular dysfunction and the IRA seemed related, rather on the slope of venous congestion. We wish to study this phenomenon more specifically in particular to offer reliable diagnostic markers of venous congestion.


Eligibility criteria: Inclusion Criteria:

* Age: all major patient
* Gender: both
* Subject has signed an informed consent
* IRA KDIGO stage 1 or urine output \<0.5 mL / kg / h for at least 6 hours / elevation creat\> 26.5μmol / L
* Patient in sinus rhythm at the time of the ultrasound measurements
* No diuretic since intervention
* Absence of circulatory failure (low doses of catecholamines tolerated)
* Extubated: absence of mechanical ventilation

Exclusion Criteria:

* Chronic heart failure right
* Chronic renal failure (GFR \<60)
* Usual treatment with high dose diuretics (furosemide\> 40mg / day)
* Endocarditis
* Emergency surgery (aortic dissection, emergency bypass surgery) / heart surgery D / redux
* Circulatory Support
* ACFA / electro-paced rhythm
* Inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...)
* Topic under judicial protection
* Topic guardianship or curatorship
* Pregnancy (women of childbearing age)
* Breastfeeding

Primary outcomes:
measure: Quantification of sonographic markers of right ventricular
timeFrame: 1 hour after cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Réanimation chirurgicale cardio-vasculaire - NHC
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Paul-Michel MERTES, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02952521: Ovarian Tumor Biopsies to Study Response to Treatments
Official title: Paired Biopsies to Develop a Cellular Signature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histological diagnosis of epithelial ovarian cancer

Brief summary: This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.

Detailed description: Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.

The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Histological diagnosis of epithelial ovarian cancer
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Life expectancy of greater than 3 months
* Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
* Must be agreeable to paired biopsies
* Must have disease amenable to paired biopsy.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Any contraindication to biopsy
* Need for anticoagulation that cannot be interrupted

Primary outcomes:
measure: Pearson correlation for changes between kinome and CA125
timeFrame: 5 years
measure: Paired T-test for differences in kinome between responders and non-responders
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Amit Oza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03009721: Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia
Official title: A Non-interventional, Multi-center, Retrospective Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia (ROSE Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 9707
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with essential hypertension and dyslipidemia

Brief summary: The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in patients with essential hypertension and dyslipidemia


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 19
* Patients have record of blood pressure (SBP/DBP) and LDL-C after prescription of Olostar Tab.

Exclusion Criteria:

* Patients that have participated clinical trials or PMS with Olostar Tab.

Primary outcomes:
measure: Percent change from baseline in blood pressure (SBP/DBP)
timeFrame: At 8 Weeks
measure: Percent change from baseline in LDL-Cholesterol (LDL-C)
timeFrame: At 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Dongguk Ilsan University Hospital
Study officials:
References:
Clinical trial NCT01423721: Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)
Official title: Relative Bioavailability of Bromhexine for Oral Administration of 16 mg of Bromhexine Hydrochloride Granules Compared to 16 mg of Bromhexine Hydrochloride Syrup in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Replicate Design Phase I Study With Two Treatments in Four Crossover Periods)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup


Eligibility criteria: Inclusion criteria:

- Healthy male and female volunteers

Exclusion criteria:

- Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC0-tz (area under the plasma concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: 48 h
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: 48 h
Secondary outcomes:
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)
timeFrame: 48 h
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 65.129.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: