louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06525792: A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke
Official title: A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Cerebrovascular Disease
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 62
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: Clinical studies applying ozonated autohemotherapy to treat acute cerebrovascular diseases have validated the safety and efficacy of this treatment, as well as explored its mechanism of action.


Eligibility criteria: Inclusion Criteria:

1. Confirmed by cranial CT or MRI examination, first-ever stroke, hospital admission within \<24 hours of symptom onset,
2. age \>18 years,
3. NIHSS score between 4 and 15,
4. TOAST classification as large artery atherosclerosis,
5. complete clinical records, minimum follow-up period of ≥3 months post-discharge,
6. willingness to undergo brachial blood puncture treatment, and provision of informed consent

Exclusion Criteria:

1. other neurological disorders, cerebral infarction caused by vertebral-basilar artery disease, cardioembolic stroke, or large-vessel vasculitis, acute or chronic infectious diseases, autoimmune or hematologic disorders, malignant tumors, mental abnormalities, severe heart, liver, or kidney dysfunction, intracerebral hemorrhage, and craniocerebral surgery history.
2. Contraindications for ozone therapy included hyperthyroidism, favism, severe coagulation disorders, and abnormal puncture site barriers

Primary outcomes:
measure: The expression of SOD(Superoxide dismutase)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fifth Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT05853692: Prevention of Oral Mucositis in Head and Neck Cancer.
Official title: Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Mucositis
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted as a single-blind randomized clinical trial (RCT). The population will be divided into two groups, receiving respectively the medical device and a solution based on Sodium Bicarbonate (5 g/L)
Primary purpose: TREATMENT

Brief summary: Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.

Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.

The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose
* Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection
* Patients able self-apply the product.

Exclusion Criteria:

* Patients with documented contraindication to any of the components of "Gel X" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors
* Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
* Patients participating to other clinical studies

Primary outcomes:
measure: Oral Mucositis
timeFrame: One week after the end of Radiotherapy
Secondary outcomes:
measure: Time of Oral Mucositis Onset
timeFrame: From Day 0 to 2 months
measure: Severity of Oral Mucositis
timeFrame: One week after the end of Radiotherapy
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Catholic University of the Sacred Hearth
Study officials:
References:
Clinical trial NCT05498792: Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Official title: MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Locally Advanced or Metastatic Melanoma
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Incuron
First posted: 2022-08-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

Detailed description: The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

Eligibility criteria: Inclusion Criteria:

1. Patients must have:

   1. Pathologically proven stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST v. 1.1) amenable to biopsy and/or surgery OR:
   2. Patients considered to have stage III or stage IV disease amenable to serial biopsies as determined by the treating physician. Note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates.
   3. Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.
2. Age \> 18 years
3. ECOG performance status 0 or 1
4. Patients must have normal organ and marrow function

Exclusion Criteria:

1. Patients may not be receiving any other investigational agents
2. Patients with a known active autoimmune disease
3. Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
4. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids
5. Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy

Primary outcomes:
measure: Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Anthony Olszanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06475092: Relation Between Muscle Mass, Total Body Fat, Visceral Fat, Waist Hip Ratio and Sleeping Hours in Patient With Nonspecific Back Pain
Official title: Relation Between Muscle Mass, Total Body Fat, Visceral Fat, Waist Hip Ratio and Sleeping Hours in Patient With Nonspecific Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Back Pain
Sleep
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 30 male and female patient, Their ages will range from 20-40 years old. All of them suffer from mild to moderate degree of low back pain. and they complain from low back pain for 1 month ago

Brief summary: Objective: To find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain.

Design: Cross sectional study. Subjects: 30 male and female patients with age ranged from 25 to 40 years old diagnosed as nonspecific low back pain will participate in this study.

Main measures: the Outcome measures will be including the assessment of muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours.

Results: The results will be analyzed via co relation test.

Detailed description: Objective: To find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain.

methods:

* tatinia bioelectric impedance device used for measurement of muscle mass total body fat and visceral fat
* waist hip ratio measured by tape measurement The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement (W⁄H).

participants 30 male and female patient will participate in this study

Eligibility criteria: Inclusion Criteria:

* •adulthood with low back pain

  * Their ages will range from 20-40 years old.
  * All of them suffer from mild to moderate degree of low back pain.
  * The subjects complain from low back pain for 1 month ago

Exclusion criteria:

Exclusion criteria were a history of any of the following condition:

* inflammatory diseases or any rheumatic disorders,
* a history of vertebral fractures
* surgical spinal fixation.
* •any neurological disorders like MS

Primary outcomes:
measure: Tanita device will be used for measurement of total body fat , muscle mass and visceral fat
timeFrame: baseline
measure: Waist hip ratio will be measured by tape measurement
timeFrame: base line
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram Canadian university
Study officials:
References:
Clinical trial NCT01863992: The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study
Official title: The Quality of Life a Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Receiving Ventilation at Home for Chronic Illness or Disease
Keywords: home ventilation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children receiving home ventilation for chronic illness or disease

Brief summary: The investigators wish to learn about the quality of life (QOL) of children needing long term home ventilation and also that of their regular caregivers. In addition, the investigators will monitor the extra health-related expenses these families must meet. Data will be collected using two age-specific questionnaires of QOL plus a third one validated for assessing chronic health care costs. Questionnaires will be administered at an initial face to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses, one and two months later.


Eligibility criteria: Inclusion Criteria:

All families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment

Exclusion Criteria:

Refusal to join the study

Primary outcomes:
measure: The Quality of Life and Direct Financial Costs Associated With Home Ventilation
timeFrame: One year starting june 2013.
Secondary outcomes:
measure: The Quality of Life a Direct Financial Costs Associated With Home Ventilation
timeFrame: One year starting june 2013
Other outcomes:
measure: The Quality of Life and Direct Financial Costs Associated With Home Ventilation
timeFrame: One year starting june 2013
Locations:
city: Vancouver
country: Canada
facility: BC's Children's Hospital
state: British Columbia
Study officials:
affiliation: British Columbia's Children's Hospital
name: Mike Seear, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BCCH
name: Mike Seear, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seear M, Kapur A, Wensley D, Morrison K, Behroozi A. The quality of life of home-ventilated children and their primary caregivers plus the associated social and economic burdens: a prospective study. Arch Dis Child. 2016 Jul;101(7):620-7. doi: 10.1136/archdischild-2015-309796. Epub 2016 Mar 3.
Clinical trial NCT00440492: Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
Official title: An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis, Rheumatoid
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.


Eligibility criteria: Inclusion Criteria:

* Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years
* RA disease onset after 16 years of age and has had the disease for at least 6 months
* Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months

Exclusion Criteria:

* Evidence of unstable clinically significant disease

Primary outcomes:
measure: To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Lake Success
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Vancouver
country: Canada
state: British Columbia
city: Mississauga
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04726592: Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
Official title: Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Migraine
Migraine Without Aura
Migraine with Aura
Headache
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room

Detailed description: Each patient will receive the usual migraine treatment: IV ketoprofen 100 mg and, if he suffers nausea and/or vomiting, additional IV metoclopramide 10 mg.

Depending on randomization assignment, patient will receive additional placebo (standard treatment arm) or additional IV Clorazepate 20 mg (study arm). The central pharmacy will be responsible for preparing the medications, using a double-blind protocol.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 70
* Patient suffering migraine or probable migraine (diagnosis made by neurologist according to IHCD3)
* Present migraine attack lasting ≤ 72 hours
* Headache intensity moderate or severe on the verbal ordinal scale (4 levels: no headache, mild, moderate or severe)
* Patient requiring parenteral treatment
* Affiliation to the French Health-care System "sécurité sociale"

Exclusion Criteria:

* abnormalities of neurological exam, seizure, fever (≥ 38°C), and/or SBP≥180 and/or DBP≥110 mmHg
* suspicion of secondary headache
* inability to understand the consent or scales
* pregnancy or breast-feeding
* known respiratory or liver insufficiency
* acute alcohol consumption or alcoholism
* myasthenia
* Patient requiering treatment with sumatriptan SC, particularly in the event of failure of an anti-inflammatory drug at an effective dose taken within 6 hours
* recent use of benzodiazepines (\< 24h diazepam, clonazepam, clorazepate ; \< 6h alprazolam, lorazepam, midazolam)
* recent use of pain killers (\< 2h)
* contraindication to any of the investigational medication
* contraindication to intravenous access
* previous participation to this study

Primary outcomes:
measure: Pain relief
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
state: Ile-de-France
Study officials:
References:
Clinical trial NCT01242592: Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis
Official title: Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis: Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Tuberculosis
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of relapsed Pulmonary TB.


Eligibility criteria: Inclusion Criteria:

relapse pulmonary tuberculosis patients with acid-fast bacilli smear positive by microscopy, using ZiehlNieelsen staining as recommended by WHO, unfit for DOTS -

Exclusion Criteria:

pregnancy, clinical sign of any concomitant disease such as diabetes mellitus, acute renal failure or infectious disease including TB/HIV and HIV positive, currently or taken any alternative therapies in past 6 months

Primary outcomes:
measure: Sputum conversion
Secondary outcomes:
measure: Quality of Life
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP medical Research Institute
state: Rajastha
Study officials:
affiliation: NMP Medical Research Institute
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01988792: Human Milk Fortification in Very Low Birth Neonates
Official title: Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature; Infant
Enteral Nutrition
Human Milk
Fortification
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

Detailed description: Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.

Eligibility criteria: Inclusion Criteria:

* Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).

Exclusion Criteria:

* Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
* Died or extended to die within 48 hours of life

Primary outcomes:
measure: The days to reach full enteral feeding volume (140 ml/kg/day).
timeFrame: 4 - 6 weeks
Secondary outcomes:
measure: Neonatal Outcomes
timeFrame: until 36 weeks PMA
measure: Neonatal Outcomes
timeFrame: until 36 weeks PMA
measure: Neonatal Outcomes
timeFrame: Until full feeding volume
measure: Neonatal Outcomes
timeFrame: Until full feeding volume
measure: Neonatal Outcomes
timeFrame: until 36 weeks PMA
measure: Neonatal Outcomes
timeFrame: until 4 weeks of life
measure: Neonatal Outcomes
timeFrame: until 4 weeks of life
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee, Health Science Center, The Regional Medical Center
state: Tennessee
Study officials:
affiliation: UTHSC, Memphis, TN
name: Sanket D Shah, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: UTHSC, Memphis, TN
name: Ajay J Talati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23.