louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06213805: Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
Official title: Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Hôpital Privé de la Baie
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery. The secondary objective is to assess safety. The investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of MIMS. Patients are expected to experience fewer complications compared to traditional glaucoma surgery.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old who agree to participate in the study having signed informed consent
* Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and open iridocorneal angle ( trabecular meshwork visible on gonioscopy, Shaffer classification grade 3-4) and healthy and mobile conjunctiva (without scars or adhesions).
* Chronic angle closure glaucoma with indication for combined glaucoma and cataract surgery

Exclusion Criteria:

* Presence of other ophthalmological pathologies (except cataract)
* History of intraocular surgery (unless cataract surgery), history of trauma, or conjunctival scarring in the quadrant planned for surgery
* Visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (and angle-closure glaucoma unless associated cataract surgery), neovascular glaucoma or neovascularization of the iris, pachymetry \< 490 μm or \> 620 μm.
* Presence of severe systemic pathologies, pregnant or breastfeeding woman

Primary outcomes:
measure: Measurement of intraocular pressure by tonometry
timeFrame: day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery
Secondary outcomes:
measure: visual quality of life VFQ-25,
timeFrame: month 1, month 3, month 12 after surgery
measure: Optical Coherence Tomography
timeFrame: month 3, month 12
measure: Visual field test
timeFrame: month 3, month 12
Other outcomes:
Locations:
city: Avranches
country: France
facility: Hôpital Privé de la Baie
city: Bordeaux
country: France
facility: Clinique Thiers
city: Paris
country: France
facility: Fondation Rothschild
Study officials:
affiliation: Hôpital Privé de la Baie
name: Ana Miguel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02937805: Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Dryness
Vaginal Atrophy
Vulvar Dryness
Vulvar Atrophy
Lead sponsor: Aromtech Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Turun Gynekologikeskus Oy
name: Tekes - The Finnish Funding Agency for Technology and Innovation
First posted: 2016-10-19
Enrollment: 225
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. The objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.


Eligibility criteria: Inclusion Criteria:

* Symptoms of vaginal dryness, burning or itching
* Symptom severity at least moderate

Exclusion Criteria:

* Systemic hormonal replacement therapy during the last 12 months
* Local hormonal replacement therapy during the last 4 weeks
* Known allergy to ingredients of the study creams
* Pregnancy
* Breast-feeding

Primary outcomes:
measure: Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture
timeFrame: Baseline, 5 weeks
measure: Change in vaginal and vulvar pH
timeFrame: Baseline, 5 weeks
measure: Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist
timeFrame: Baseline, 5 weeks
measure: Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist
timeFrame: Baseline, 5 weeks
measure: Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist
timeFrame: Baseline, 5 weeks
measure: Change in symptoms of vaginal and vulvar atrophy and dryness: symptom questionnaires; scoring from 0 to 3 dryness, burning, itching; VAS evaluation of mucosal dryness, irritation, soreness, pain during exercise, pain during intercourse
timeFrame: Baseline, 5 weeks
Secondary outcomes:
measure: Change in symptoms of vaginal and vulvar atrophy and dryness: symptom logbooks; daily scoring from 0 to 3 dryness, burning, itching, pain, soreness, symptoms during intercourse
timeFrame: From baseline to 5 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turun Gynekologikeskus
Study officials:
affiliation: Turun Gynekologikeskus
name: Risto Erkkola, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03563105: Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
Official title: Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circulatory; Change
Keywords: tissue oxygen saturation
Lead sponsor: Modulated Imaging Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Vascular Occlusion Test
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system to measure potential circulatory compromise.

Detailed description: The objective of this study is to demonstrate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system, "The Ox-Imager Mini". Potential circulatory compromise will be imaged in healthy volunteers using both the subject and predicate devices (Ox-Imager CS) in a Vascular Occlusion Test (VOT) model. The VOT model is an established paradigm to introduce transient ischemia in skin and the the subjects will be imaged during this time. The primary endpoint will be to measure significant decrease in tissue oxygen saturation after occlusion for both predicate and subject devices.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* History of congestive heart failure
* Patients with existing wound or ulcer.
* Rheumatoid arthritis
* Pregnant or lactating women

Primary outcomes:
measure: Significant decrease in StO2 during occlusion
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Orange County Wound and Hyperbaric
state: California
Study officials:
affiliation: Modulated Imaging Inc.
name: Amaan Mazhar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04903405: Immune Function Monitoring and Immunotherapy in Sepsis
Official title: Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The patient was diagnosed with sepsis or septic shock according to Sepsis 3.0

Brief summary: At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.


Eligibility criteria: Inclusion Criteria:

* Patients with sepsis or septic shock according to Sepsis 3.0

Exclusion Criteria:

* None

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
measure: Percentage of sepsis patients receiving immune function monitoring
timeFrame: 28 days
measure: Percentage of sepsis patients receiving immunotherapy
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
citation: Pei F, Zhang GR, Zhou LX, Liu JY, Ma G, Kou QY, He ZJ, Chen MY, Nie Y, Wu JF, Guan XD; China Critical Care Immunotherapy Research Group. Early Immunoparalysis Was Associated with Poor Prognosis in Elderly Patients with Sepsis: Secondary Analysis of the ETASS Study. Infect Drug Resist. 2020 Jun 30;13:2053-2061. doi: 10.2147/IDR.S246513. eCollection 2020.
citation: Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
citation: Wu JF, Ma J, Chen J, Ou-Yang B, Chen MY, Li LF, Liu YJ, Lin AH, Guan XD. Changes of monocyte human leukocyte antigen-DR expression as a reliable predictor of mortality in severe sepsis. Crit Care. 2011;15(5):R220. doi: 10.1186/cc10457. Epub 2011 Sep 20.
Clinical trial NCT03863405: Metformin Use in Rheumatoid Arthritis
Official title: The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Future University in Egypt
First posted: 2019-03-05
Enrollment: 60
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: Metformin has been used clinically for over 50 years, as a glucose lowering agent.

Direct and indirect anti-inflammatory effects of metformin have been reported in animal and clinical studies, and this effect is independent of its hypoglycemic effect.

Animal studies showed that metformin decreased serum C-reactive protein (CRP) level in atherogenic rabbits and decreased proinflammatory cytokines (interleukin (IL)-1β, IL-6 and tumor necrosis factor (TNF-α) in obese mice .

Moreover, metformin also suppressed osteoclastogenesis ; this may partially result from decreased expression of inflammatory cytokines that promote osteoclastogenesis in the arthritic joint.

The objective of this study is to evaluate the efficacy and safety of addition of metformin to standard disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to ACR / EULAR 2010 criteria .
* Patients with moderate to high disease activity (DAS - 28 . score greater than 3.2)
* Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.

Exclusion Criteria:

* Known hypersensitivity to metformin.
* Patients who have a prior diagnosis with diabetes mellitus.
* Patients receive metformin for any other indications.
* Patients with congestive heart failure.
* Patients with a history of myocardial infarction.
* Patients with severe anemia.
* Patients with active infections or other inflammatory diseases.
* Patients receiving biological therapy.
* Pregnancy or lactation.
* Patients with impaired liver functions.
* Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
* Patients with malignancies.

Primary outcomes:
measure: disease activity scale in 28 joints ( DAS-28)
timeFrame: 6 months
Secondary outcomes:
measure: C reactive protein levels
timeFrame: 6 months
measure: The HAQ (Health Assessment Score)
timeFrame: 6 months
measure: serum adiponectin level
timeFrame: 6-months
measure: adverse effect incidence
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Zahraa University Hospital
Study officials:
References:
Clinical trial NCT02343705: Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
Official title: Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Cotera, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 67
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.


Eligibility criteria: Inclusion Criteria:

* History of pain due to medial osteoarthritis
* Qualifying baseline pain scores
* Kellgren-Lawrence Grades 2-3

Exclusion Criteria:

* Osteoporosis
* Rheumatoid arthritis
* Joint instability
* Metal ion allergy
* Permanent implant in or around the knee joint
* Prior anterior cruciate ligament reconstruction

Primary outcomes:
measure: Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant
timeFrame: 6 Months
measure: Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device
timeFrame: 6 Months
Secondary outcomes:
measure: Changes in knee outcome measures (KOOS, IKDC, NRS)
timeFrame: 6, 12 and 24 months
measure: Device and procedure complication rates
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Slotervaart Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Geldrop
country: Netherlands
facility: St. Anna Hospital
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Zwolle
country: Netherlands
facility: Isala
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz
city: London
country: United Kingdom
facility: Royal London Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Barts & The London NHS Trust
name: Manoj Ramachandran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02124005: Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery
Official title: Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Surgery
Postoperative Pain
Keywords: Knee surgery
Femoral block
Bupivacaine
Ultrasound
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 45
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: The purpose of the study is to determine the minimum effective concentration of bupivacaine (EC50) in femoral block for analgesia by ultrasound after knee surgery.

Detailed description: 45 patients classified as ASA P1 or P2 aged between 18 and 65 candidates for elective knee operation via arthroscopy were included in the study. All patients received femoral nerve block guided by ultrasound with bupivacaine, 22 ml. The first patient at a concentration of 0.25%. The other patients with higher or lower concentrations if the first patient has pain\> 3 or \<3 on visual analogic scale respectively after awakening of surgical anesthesia. For surgical anesthesia each patient will undergo general anesthesia. At the end of the surgical procedure and anesthetic awakening patients will be evaluated for analgesia by verbal numeric scale. The modified Dixon method was used to find the EC50 and EC95 of bupivacaine for analgesia of femoral nerve block guided by ultrasound. Concentration still correlated with motor block and side effects.

Eligibility criteria: Inclusion Criteria:

* patients to undergo knee surgery

Exclusion Criteria:

* patients with coagulopathy
* pregnant
* infection at the puncture site
* chronic pain

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Ed Carlos Moura, research
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01505205: Study on the Evolution of Genes Mutation Related With Gastrointestinal Stromal Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full Gene Sequences of c-KIT、PDGFRA and DOG1 Are Analyzed With the Screening-sequencing Approach
Investigate the Characteristics and Variations Associated With the Different Gene Mutations of c-KIT、PDGFRA and DOG1 in GIST Patients
Keywords: Gist,c-KIT,PDGFRA,DOG1,mutation
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Gist at the Department of Gastrointestinal and Glands Surgery of the First Affiliated Hospital of Guangxi Medical University in China.

Brief summary: Mutations of tumor-related genes are dynamic. Gastrointestinal stromal tumor cells often are obviously more invasive in case of recurrence. The great majority of relapses may be associated with secondary mutation in the GIST related genes. Full gene sequences of c-KIT、PDGFRA and DOG1, which is extracted from the specimen cells of repeated surgical resection or biopsy tissue in GIST patients with postoperative recurrence, are analyzed with the screening-sequencing approach, in order to investigate the characteristics and variations associated with the different gene mutations of c-KIT、PDGFRA and DOG1 in GIST patients and be likely to find out the evolutionary pattern, try to learn the facts about the effect of tyrosine kinase inhibitors on the GIST related genes, make a survey of any association of c-KIT、PDGFRA and DOG1 gene mutations and provide the basis for seeking molecular marker of GIST for monitoring course of disease, and offer a theoretical basis and new therapeutic strategies for application of clinical treatment.


Eligibility criteria: Inclusion Criteria:

* patients with Gist at the Department of Gastrointestinal and Glands Surgery of the First Affiliated Hospital of Guangxi Medical University in China.

Exclusion Criteria:

* patients with hepatitis and tuberculosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01006005: Adherence-Suppression-Resistance Relationships for Atripla Compared to Historical Antiretroviral Regimens
Official title: Adherence-Suppression-Resistance Relationships for Atripla Compared to Historical Antiretroviral Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Adherence
Keywords: HIV
Treatment experienced
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 51
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: HIV infected, marginally housed

Brief summary: The study is recruiting 50 patients initiating or switching to Atripla and comparing them to 250 individuals previously followed in a prospective study of HIV+ low income individuals recruited from homeless shelters, single room occupancy hotels and free meal food lines as part of the UCSF Reach Study. Adherence will be measured through monthly unannounced pill counts and electronic medication monitors.


Eligibility criteria: Inclusion Criteria:

* 18+ years old;
* HIV+;
* Initiating Atripla within 6-months of recruitment;
* Lives in the Tenderloin, South of Market, or Mission District San Francisco;
* Capable of providing informed consent; and
* Willing to complete all study procedures.

Exclusion Criteria:

* Intoxication, cognitive dysfunction or psychosis will preclude potential subjects from informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: