louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00841594: MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
Official title: MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Raynaud's Phenomenon
Keywords: healthy volunteers
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.


Eligibility criteria: Inclusion Criteria:

* 18 to 50 years of age
* Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
* Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.

Exclusion Criteria:

* Subjects who can not safely discontinue current prescription medications.
* Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
* Subjects with an unstable medical problem.
* Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
* Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
* Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
* Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
* Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
* Pregnant or nursing women.
* Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.

Primary outcomes:
measure: Measurement and comparison of the levels of nitroglycerin and its dinitrate metabolites in the blood of healthy human volunteers after a single topical dose of MQX 503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
timeFrame: 12 hours
Secondary outcomes:
measure: Observation for any adverse events such as headache.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Charles River Clinical Services
state: Washington
Study officials:
References:
Clinical trial NCT00146094: Bone Mineral Density (BMD) in HIV Infection
Official title: Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Osteoporosis
Keywords: Osteopenia
osteoporosis
bone mineral density
HIV infection
bone metabolism
Treatment Naive
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: BASIC_SCIENCE

Brief summary: Osteopenia and osteoporosis are increasingly reported in HIV-infected patients, and appear to be more frequent than in general population. However, pathogenesis remains unclear, and published studies still give non concordant results.

We therefore started a prospective study, to assess the potential role of ARV in the occurrence of osteopenia and osteoporosis. BMD evolution over a 2-years period of follow-up, will be compared between patients starting ARV therapy, and subjects without HAART (no indication of treatment). A correlation between BMD and several factors will be looked at (see below).

This study with individual direct benefice, is conducted in 3 outpatients clinics (Strasbourg, Colmar, Mulhouse) in collaboration with the rheumatologic teams. 60 patients are planned to be included over a 3-years inclusion period


Eligibility criteria: Inclusion Criteria:

* HIV-1 infected men, Caucasian, age \> 18 years, ARV-naïve

Exclusion Criteria:

* HIV-infected women, subjects \< 18 years, non-Caucasian men, ARV-experienced patients, subjects not able or willing to give informed consent, endocrine disease or treatment which could affect bone metabolism

Primary outcomes:
measure: BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects
Secondary outcomes:
measure: BMD (baseline, and at 2 years) according to:
measure: - calcium intake, physical activity,
measure: - CD4 lymphocyte count, HIV viral load,
measure: - bone metabolism biological markers (osteocalcine, C telopeptide collagen type I in urine),
measure: - leptine, parathormone, 25 OH D3
Other outcomes:
Locations:
city: Colmar
country: France
facility: Centre Hospitalier de Colmar
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: David REY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06451094: Effectiveness Transfer Energy Capacitive and Resistive Therapy in Patients With Carpal Tunnel Syndrome
Official title: Comparison of the Effectiveness of Ultrasound and Transfer Energy Capacitive and Resistive (TECAR) Therapy in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Energy Transfer Capacitative and Resistive Therapy
Keywords: Carpal tunnel syndrome
TECAR therapy
median nerve CSA
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The aim of this study was to evaluate the effect of Transfer Energy Capacitive and Resistive (TECAR) therapy on pain, symptom severity and function in patients diagnosed with carpal tunnel syndrome (CTS) based on clinical and electromyography (EMG) findings and to compare it with ultrasound therapy (US).

Methods: A total of 42 patients aged between 18 and 65 years, were randomly divided into two groups; group 1, US therapy 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions, group 2 TECAR therapy 5 min capacitive (CAP) and 10 min resistive (RES), 3 days a week for 2 weeks, for a total of 6 sessions. Both groups received paraffin therapy and wrist orthosis. All Patients were evaluated using the Visual Analog Scale (VAS) for pain and paresthesia levels, the Boston Carpal Tunnel Questionnaire (BCTQ) for symptom severity and functional levels. Additionally, median nerve CSA was measured by ultrasound, at the baseline, post-treatment, first and third months.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and over
* had pain and numbness in their hands for more than 3 months were evaluated
* Patients diagnosed with mild and moderate CTS by EMG

Exclusion Criteria:

* metabolic, rheumatic, or neurological diseases that could affect the median nerve cross-sectional area (CSA)
* patients who had previously undergone surgery on the wrist,
* oncology patients,
* pregnancy,
* pacemakers.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
Secondary outcomes:
measure: Median nerve cross-sectional area (CSA) measurement
timeFrame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Özge TEZEN
Study officials:
References:
Clinical trial NCT04439994: Activation of miRNA and Proteins After Acute Experimental Pain. (miRNA: Micro RNA)
Official title: Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertonic Saline
Isotonic Saline
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups of subjects: one group will receive hypertonic injection (0.1 ml) and the other group will receive isotonic saline injection (0.1 ml)
Primary purpose: BASIC_SCIENCE

Brief summary: In this experiment, the investigators would like to test the following:

1. Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ?
2. Can these canges correlate with the development of local hyperalgesia?
3. How does the plasma miRNA expression change over a duration of 24 hours post pain induction ?
4. Which mRNA targets are potentially affected by acute pain?


Eligibility criteria: Inclusion Criteria:

* Healthy men and women in the age 18-80 years
* Speak and understand English

Exclusion Criteria:

* Acute and chronic pain
* Pregnancy or breastfeeding
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.)
* Lack of ability to cooperate
* Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Primary outcomes:
measure: miRNA expression over time
timeFrame: Before injection
measure: miRNA expression over time
timeFrame: 30 minutes post-injection
measure: miRNA expression over time
timeFrame: 3 hours post-injection
measure: miRNA expression over time
timeFrame: 24 hours post-injection
measure: Protein expression over time
timeFrame: Before injection
measure: Protein expression over time
timeFrame: 30 minutes post-injection
measure: Protein expression over time
timeFrame: 3 hours post-injection
measure: Protein expression over time
timeFrame: 24 hours post-injection
Secondary outcomes:
measure: Assessment of pain: visual analog scale
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
city: Aalborg
country: Denmark
facility: AAlborg University
state: Nordjylland
Study officials:
References:
Clinical trial NCT06031194: Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
Official title: Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System Lymphoma
Diffuse Large B-Cell Lymphoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 20
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: Patients with DLBCL or primary CNS lymphoma planned to undergo treatment with HDMTX (≥ 3 g/m\^2) at the James Cancer Hospital

Brief summary: This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.

Detailed description: PRIMARY OBJECTIVES:

I. To identify SNPs associated with delayed MTX clearance. II. To explore any association between SNPs and increased toxicity.

OUTLINE: This is an observational study.

Participants undergo blood sample collection and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* \* Adult (age ≥ 18 years at diagnosis)

  * Diagnosis of DLBCL or PCNSL
  * Planned to undergo treatment with HDMTX (≥ 3 g/m\^2) at the James Cancer Hospital.

Note: patients with CKD are eligible to participate regardless of eGFR provided the treating physician is planning a dose of HDMTX of at least 3 g/ m\^2.

* Ability to provide informed consent.

Exclusion Criteria:

* \* Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation

  * Pregnancy (positive serum or urine pregnancy test), lactating or breast feeding
  * Prisoners or incarcerated patients
  * Total bilirubin \> 5 mg/dL

Primary outcomes:
measure: SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Timothy Voorhees, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05413694: Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
Official title: Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The island of Reunion, a French overseas department of 860,000 inhabitants, located in the Indian Ocean (OI) zone, recorded its first case of COVID-19 on March 11, 2020. The epidemic, which was described as not very severe during the year 2020 in Reunion was much more intense and more deadly in 2021, with the arrival of the new variants (South African and Indian) and exploded at the beginning of the year 2022 (variant Omicron).

Reunion has a specific island context both climato-geographically and demographically. Indeed, this French island located in the southern hemisphere in the middle of the Indian Ocean (OI) has a tropical climate and a multi-ethnic population, younger than in mainland France (16% are over 60 years old). It is also marked by a higher prevalence in the general population of certain risk factors, such as obesity (11%) and type 2 diabetes (\>10%), recognized as factors favoring severe clinical forms of COVID-19. as well as "persistent COVID-19".

This study will allow the constitution of a large-scale French cohort located in a closed overseas territory to provide answers to local specificities and to the management of the epidemic in the territory.


Eligibility criteria: Inclusion Criteria:

* over 18 years old
* having been hospitalized at the University Hospital Center (CHU) of Reunion (minimum of one night in the hospital)
* with a positive diagnosis of COVID-19 (positive RT(reverse transcription)-PCR(Polymerase Chain Reaction) SARS-CoV-2 on a nasopharyngeal swab or positive serology or confirmed diagnosis in the medical file)
* registered in the COVIDEPI database
* whose telephone numbers are available in the computerized patient file
* residing on the island of Reunion
* knowing how to understand and speak French

Exclusion Criteria:

* deceased
* opposing the use of their data
* deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curators

Primary outcomes:
measure: cumulative incidence of patients with "persistent COVID-19"
timeFrame: 24 month
Secondary outcomes:
measure: Determine the factors associated with the persistence of symptoms
timeFrame: 24 month
measure: Measure physical and mental quality of life
timeFrame: 24 month
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: CHU de la Réunion
Study officials:
References:
Clinical trial NCT04397094: Theracal Pulpotomy in Primary Molars
Official title: Theracal Versus Formocresol Pulpotomy in Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Caries
Keywords: Theracal
formocresol
pulpotomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

Detailed description: sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.

Eligibility criteria: Inclusion Criteria:

* healthy, cooperative children
* mandibular primary molars with vital pulp exposures

Exclusion Criteria:

* clinical or radiographic evidence of irreversible pulpitis
* physiological root resorption

Primary outcomes:
measure: Clinical Examination
timeFrame: 12 months
Secondary outcomes:
measure: Radiographic Examination
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
References:
Clinical trial NCT00710294: Device Based Therapy in Hypertension Extension Trial
Official title: DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Refractory Hypertension
High Blood Pressure
Uncontrolled Blood Pressure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-04
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up period (4-months or longer). The information obtained in this trial is intended to support regulatory approvals and market release of this therapy.

Detailed description: This extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under the long term provisions of the DEBuT-HT study to describe and analyze the changes in ongoing drug treatment, the programming parameters of the implanted active device and any occurring adverse events over a period of up to 13 months after implant surgery in the DEBuT-HT trial. Annual follow-ups of up to five years are planned subsequently to the 13-month follow-up period.

Eligibility criteria: Inclusion Criteria:

* Have completed the follow-up period (4-month or longer) of the DEBuT-HT trial (protocol No.: 360004-001)
* Have signed an approved informed consent form for participation in this study

Exclusion Criteria:

* Are unable to comply with protocol requirements.
* Are enrolled in another concurrent clinical trial.

Primary outcomes:
measure: Describe the safety of Rheos Baroreflex Hypertension Therapy System by evaluating all adverse events and estimating the system and procedure related adverse event rate until and including the 13-month follow-up.
timeFrame: after last 13-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: University Hospital Bad Oeynhausen
city: Berlin
country: Germany
facility: Charité Campus Buch
city: Hannover
country: Germany
facility: University Hospital Hannover
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: CVRx, Inc.
name: Myriah Elletson
role: STUDY_CHAIR
References:
Clinical trial NCT06101160: Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy
Official title: Long-term Follow-up of Safety and Efficacy of OnabotulinumtoxinA for Treatment of Sialorrhea in Juvenile Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sialorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 61
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Juvenile CP patients

Brief summary: A 100 units of botulinum toxin was injected in both parotid and submandibular glands for children (2 - 12 years) with incapacitating sialorrhea in juvenile cerebral palsy patients and they are followed up for 1 year

Detailed description: This was a prospective, longitudinal analysis with 1-year follow-up of 52 children with juvenile cerebral palsy (JCP) suffering from sialorrhea enrolled from 3 tertiary pediatric neurology rehabilitation centers (two in Cairo and one in Alexandria) and subjected to repeated BoNT-A injection.

The recruitment period was between June 30, 2021, until May 1, 2022 (the last patient follow-up ended on April 30, 2023).

Intervention: 100 units of OnabotulinumtoxinA (Botox®) were injected in the parotid and submandibular glands Follow-up visits: mo 1 post-injection (for every injection session) and every 3 months thereafter

In each visit; the following efficacy variables were assessed:

Primary outcome measures: The severity and frequency of sialorrhea evaluated by Drooling Severity Scale (DSS), and Drooling Frequency Scale (DFS) and visual-analogic ratings of familial distress (VAS-FD).

Secondary outcome measure: The carers' Global Impression of Change Scale score measured on a 7-point Likert scale from -3 (very much worse) to +3 (very much improved)

Also, adverse events were assessed in each visit

Eligibility criteria: Inclusion Criteria:

* Juvenile cerebral palsy with age range (4 - 12 years)
* Having severe drooling (DFS \> 4)
* Signing written informed consent by the legal guardians.

Exclusion Criteria:

* Previous BoNT-A injection in the last three months
* Patients receiving systemic medicine for the treatment of sialorrhea in the last 6 weeks
* Any contraindications to treatment with BoNT

Primary outcomes:
measure: Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hatem Shehata
Study officials:
References: