louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05824052: Investigating the Impact of Ex Vivo Ozone Injection on Synovial Fluids in Patients Diagnosed With Knee Osteoarthritis
Official title: Investigating the Impact of Ex Vivo Ozone Injection on Synovial Fluids in Patients Diagnosed With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Dose-dependent effect
knee osteoarthritis
ozone therapy
pro-inflammatory cytokines
synovial fluid
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
First posted: 2023-04-21
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Synovial fluid samples taken from patients will be prepared to form 3 separate groups, one fluid will not be treated, one will be injected with 10 gamma and the other with 30 gamma ozone.
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to examine the effect of varying ozone doses on the levels of pro-inflammatory cytokines in synovial fluid collected from individuals with knee osteoarthritis.

Detailed description: In this study, synovial fluid samples will be collected from patients diagnosed with knee osteoarthritis for in vitro studies. The synovial fluid will be collected under sterile conditions by a joint puncture, and ultrasonography will be performed before sample collection. The synovial fluid samples will then be transferred to sterile urine culture tubes, with one containing only synovial fluid and the others containing synovial fluid and ozone gas. Afterward, the synovial fluid samples will be centrifuged, and the upper portion will be stored at -80°C for biochemical analyses. The total protein content will be measured using a commercial kit based on the Bradford method, and the total antioxidant level and Total oxidant levels will be measured using commercially purchased kits according to the manufacturer's instructions. The oxidative stress index will be calculated using the formula (TOS/TAS) and will be normalized to the total protein content measured in the synovial fluid.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with knee osteoarthritis.
* Giving consent to participate in the study.

Exclusion Criteria:

- Not giving consent.

Primary outcomes:
measure: Protein Determination
timeFrame: 1 day
measure: Measurement of Total Antioxidant Level (TAL)
timeFrame: 1 day
measure: Measurement of Total Oxidant Level (TOL)
timeFrame: 1 day
measure: Oxidative Stress Index (OSI)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi
state: Kadıköy
Study officials:
affiliation: Sultan Abdulhamid Han Training and Research Hospital
name: Emre Ata, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270152: Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter
Official title: Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Occluded Totally Implanted Central Venous Catheter
Keywords: ascorbic acid
catheterization central venous
nursing care
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally implanted central venous catheter

Detailed description: Totally implanted catheter is often occluded and thrombolytic drugs are usually used to restore permeability. In Brazil, the ascorbic acid has been used successfully by a service specialist in cancer treatment. However, no literature on international research that evaluates the efficacy and safety of this procedure. That was why it was decided to develop this research.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of partial or complete obstruction of the totally implanted central venous catheter;
* No signs of inflammation in the area of the port.

Exclusion Criteria:

* Use of oral anticoagulants or intravenous administration in the last seven days;
* Diagnostic and / or suspected infection in the totally implanted central venous catheter;
* Rupture, displacement or fissure of the totally implanted central venous catheter;
* Presence of thrombosis in the vein where the catheter is inserted.

Primary outcomes:
measure: Restore patency
timeFrame: 60 minutes after administration of ascorbic acid
Secondary outcomes:
measure: Eosinophil count
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinical Hospital of Medicine College of Ribeirão Preto, University of São Paulo
state: São Paulo
Study officials:
affiliation: University of São Paulo, College of Nursing at Ribeirão Preto
name: Christiane I Vasques, Doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02809352: Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program for Cervical Cancer
Official title: Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program Entitled START-HPV (STudy of Primary Screening in the ARdennes Department by Testing for HPV Infection)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Infection
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 348
Sex: FEMALE
Minimum age (years): 31
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who participate in START-HPV pilot screening program and tested positive for high-risk HPV

Brief summary: Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.


Eligibility criteria: Inclusion Criteria:

* to live in the Ardennes department (France)
* affiliation to a health insurance organism
* 31 to 65 years old

Exclusion Criteria:

* current follow-up for cervical cytological abnormalities
* history of hysterectomy
* reimbursement for a Pap smear in the last 3 years

Primary outcomes:
measure: HPV genotyping
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Chu Reims
state: Reims
Study officials:
References:
Clinical trial NCT02654652: Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated
Official title: Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Synbiotics
Nutrition Therapy
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

Detailed description: The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.

Eligibility criteria: Inclusion Criteria:

* head and neck cancer with primary surgical treatment, enteral nutrition by enteral tube.

Exclusion Criteria:

* three months antibiotic use earlier the surgery, recently radiotherapy or quimiotherapy, inflammatory bowel disease.

Primary outcomes:
measure: Serum DAO Enzyme Concentration
timeFrame: 7 days
Secondary outcomes:
measure: Infection Rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Belo horizonte
country: Brazil
facility: UFMG Hospital
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Priscilla C Lages, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? 1987. Classical article. Nutr Hosp. 2008 Jul-Aug;23(4):400-7. No abstract available.
citation: Lages PC, Generoso SV, Correia MITD. Postoperative symbiotic in patients with head and neck cancer: a double-blind randomised trial. Br J Nutr. 2018 Jan;119(2):190-195. doi: 10.1017/S0007114517003403. Epub 2017 Dec 26.
Clinical trial NCT04700852: Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis
Official title: Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis Due to Grass Pollen
Allergic Inflammation
Lead sponsor: Puressentiel
Sponsor class: INDUSTRY
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-01-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis.

Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. A day 0 (first NPT) the following outcomes are recorded: allergic Rhinitis control test (ARCT) and Inspiratory nasal peak flow (INPF) before and 30 min after the NPT. Nasal lavage is performed 30 min after the NPT and 3 cytokines (IL4, IL5 and IL13 are measured by ELISA.

An other NPT is performed at day 30 and the same outcomes measured.

30 min before NPT 2 nasal sprays of PNPS are administered in each nostril in a randomized manner and cross over, the patient being is own control.

The primary outcomes ins the IL4, IL5 and IL13 concentrations in the nasal lavage. ARCT and INPF are the secondary outcomes.


Eligibility criteria: Inclusion Criteria:

* patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma

Exclusion Criteria:

* patients sensitized to a perrianual allergen
* patients with viral infection 4 weeks before inclusion
* patients with severe non controlled asthma
* patients with chronic sinusitis
* pregnancy or breast feeding
* patients with hypersensitivity to essential oil (eucalyptus radie)
* epileptic patient
* patients treated with nasal corticosteroid or anti-histamine

Primary outcomes:
measure: Change in concentration of IL-13 in the nasal lavage will be assessed
timeFrame: measurements at day 1 and day 30
Secondary outcomes:
measure: Change in concentration of IL-5 in the nasal lavage will be assessed
timeFrame: Day1 and Day30
measure: Change in concentration of IL-4 in the nasal lavage will be assessed
timeFrame: Day1 and Day 30
measure: Change in Nasal Inspiratory Peak Flow will be assessed
timeFrame: Day 1 and Day 30
measure: Change in Allergic Rhinitis Control test (ARCT) will be assessed
timeFrame: Day 1 and day 2
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01519752: A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site, Study Comparing Oxiconazole Nitrate Cream 1% (Taro Pharmaceuticals,Inc) to Oxistat® (Oxiconazole Nitrate Cream) Cream 1% (PharmaDerma) in the Treatment of Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tinea Pedis
Keywords: Tinea Pedis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 661
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, 12 years of age or older.
2. Signed informed consent form, which meets all criteria of current FDA regulations
3. If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study {e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives)and (must have used the same product for at least 30 days prior to the study start and use the same product throughout the duration of the study), transdermal or implanted hormonal contraceptives}
4. A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot. (the non-interdigital lesions should not be hyperkeratotic i.e., characteristic of moccasin).
5. The presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination.

Exclusion Criteria:

1. Females who are pregnant, or lactating or likely to become pregnant during the study.
2. Any known hypersensitivity to oxiconazole nitrate or other antifungal agents.
3. Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy (i.e. recurrent tinea pedis, more than 3 infections in the past 12 months, which were unresponsive to previous antifungal therapy).
4. Participation in a research study in the past 30 days prior to screening/randomization.

Primary outcomes:
measure: Therapeutic Cure
timeFrame: Day 42
Secondary outcomes:
measure: Clinical Cure
timeFrame: Day 42
measure: Mycological Cure
timeFrame: Day 42
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04886752: The Effect of Liposome Vitamin C on the Absorption and Metabolism of the Human Body.
Official title: The Effect of Liposome Vitamin C on the Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin C Deficiency
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the difference between vitamin C in the form of oral liposomes and general vitamin C in a fixed period of time in plasma and urine.

Detailed description: we recruited 11 healthy subjects and adopted a cross-over test. the subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start. The subjects were informed to consume one sachet vitamin C without liposome, liposomal process A vitamin C, or liposomal process B vitamin C (Double Nutri™) every test, and vitamin C concentration was measured at baseline (0 hours), 0.5, 1, 2, 3, 4, and 8 hours after taking test sample.

Eligibility criteria: Inclusion Criteria:

1. Adults between 20-60 years old,
2. No heart, liver, kidney, endocrine and major organic diseases

Exclusion Criteria:

1. Renal insufficiency and dialysis
2. Cancer
3. Underweight (BMI≦17) or obese (BMI≧27),
4. Take chronic disease drugs,
5. Blood pressure systolic blood pressure ≧130 mmHg or diastolic blood pressure ≧85 mmHg,
6. Too high fasting blood glucose ≧ 100 mg/dL,
7. Triglyceride ≧ 150 mg/dL,Total cholesterol ≧ 200 mg/dL,
8. Have a history of vitamin C allergy,
9. People with mental illness,
10. Pregnant or breastfeeding women,
11. Hematosis,
12. Kidney stones,
13. Long-term vitamin C supplements (at least 200 mg per day for more than one month)

Primary outcomes:
measure: vitamin c detection
timeFrame: at 8 hours after taking test sample
measure: The change of Triglyceride
timeFrame: at 8 hours after taking test sample
measure: The change of body mass index (BMI)
timeFrame: Time 0, 0.5, 1, 2, 3, 4, and 8 hours after taking test sample
measure: The change of aspartate aminotransferase
timeFrame: at 8 hours after taking test sample
measure: The change of alanine aminotransferase
timeFrame: at 8 hours after taking test sample
measure: The change of creatine
timeFrame: at 8 hours after taking test sample
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Research & Design Center, TCI CO., Ltd
Study officials:
affiliation: National Taiwan University Hospital
name: Jaw-Shiun Tsai, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05240352: Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients with Bipolar Depression
Official title: Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients with Bipolar Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anhedonia
Keywords: bipolar depression
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Milken Institute
First posted: 2022-02-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether transcranial direct-current stimulation (tDCS) will engage reward-related brain circuitry, more specifically the uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus accumbens (NAcc) regions. Also to evaluate whether the changes in the fractional anisotropy (FA) of the UF tract are associated with changes of clinical symptoms of anhedonia and finally to investigate the moderation role of simulated electric fields (EFs) in an association between FA of the UF and symptoms of anhedonia.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Bipolar Disorder and clinically significant anhedonia
* mild symptoms of depression

Exclusion Criteria:

* substance abuse/dependence and any use of drugs (except alcohol or nicotine) in the previous month of the baseline assessment
* participants with personality disorder that would interfere with study participation according to clinical judgment
* previous neurological conditions (epilepsy, traumatic brain injury, stroke, etc)
* any severe, life-threatening non-psychiatric medical condition
* specific contraindications for tDCS (metallic plates in the head)
* Participants identified as acutely suicidal or severely agitated

Primary outcomes:
measure: change in the fractional anisotropy of the uncinate fasciculus
timeFrame: baseline, 6 weeks
Secondary outcomes:
measure: changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C)
timeFrame: baseline, 6 weeks
measure: change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)
timeFrame: baseline, 6 weeks
measure: change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)
timeFrame: baseline, 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jair C Soares, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02051452: Reversal of General Anesthesia With Methylphenidate
Official title: Reversal of General Anesthesia With Intravenous Methylphenidate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post Operative Cognitive Dysfunction
Emergence From Anesthesia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate whether methylphenidate (Ritalin) can actively induce emergence from general anesthesia in patients having a pancreaticoduodenectomy (Whipple procedure), a pancreatectomy, or a prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* American Society of Anesthesiologists classification 1 or 2
* Scheduled to undergo a pancreaticoduodenectomy or distal pancreatectomy at Massachusetts General Hospital

Exclusion Criteria:

* American Society of Anesthesiologists physical status classification of 3 or beyond.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Time to Emergence From General Anesthesia
timeFrame: 1-4 hours
Other outcomes:
measure: Post Operative Cognitive Function at ½ Hour, 1 Hour and 2 Hours After Emergence as Measured by the Mini Mental Status Exam.
timeFrame: up to 4 hours
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: