louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00497614: Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
Official title: 18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Positron emission tomodensitometry
Tumor necrosis factor alpha inhibitor
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha). Identification of RA patients who respond to biologics is a challenging goal to avoid unnecessarily, costly and potentially harmful treatment.

The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR (American College of Rheumatology) criteria will by enrolled. Patient will receive adalimumab according to the current guidelines i.e. 40mg /14 days sub cutaneously. The decision will stand on a high activity of the disease defined by the DAS 28 (Disease Activity Score) above 5.1. Positron emission tomography will be performed before, 2 and 12 weeks after the begin of the treatment. The response to adalimumab will by assessed by the SUV (standard Unit value) measured on the inflammatory joints of hands, wrist, ankle, feet and knees and compared to measurement of clinical (total swollen and tender joints count) echographic (synovium thickness and power doppler) and chemical biomarkers (erythrocyte sedimentation rate, C reactive protein).


Eligibility criteria: Inclusion Criteria: - Patients with active Rheumatoid arthritis PR définie selon les critères ACR (1987) (annexe 7) \[18\], Activité importante de la maladie (DAS 28 \> 5,1) (annexe 5) \[7\], Indication d'un traitement par adalimumab (en accord avec l'A.M.M.), Homme ou femme dont l'âge est supérieur ou égal à 18 ans, Acceptant de participer à l'étude et ayant donné son consentement éclairé, Affiliés ou bénéficiaire d'un régime de sécurité sociale.

Primary outcomes:
measure: There is no primary outcome measure specified for this study.
Secondary outcomes:
measure: There are no secondary outcome measures specified for this study.
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: CHRU de Tours
name: Denis Mulleman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05345314: Endoscopic Grading of Intestinal Metaplasia
Official title: Endoscopic Grading of Gastric Intestinal Metaplasia: a Validation Study in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narrow-band Imaging
Magnifying Endoscopy
Gastric Intestinal Metaplasia
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 242
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.

Brief summary: Long-term Helicobacter pylori infection causes premalignant gastric conditions, such as atrophic gastritis and intestinal metaplasia. Image-enhanced endoscopy techniques such as narrow-band imaging (NBI) and magnifying endoscopy improve the diagnosis of gastric intestinal metaplasia (GIM). However, there are no comparative data on the utility of NBI and magnifying endoscopy for diagnosing GIM.

Detailed description: This study aims to evaluate the diagnostic performance of NBI and magnifying endoscopy for GIM in a country with high risk of gastric premalignant lesions.

Eligibility criteria: Inclusion Criteria:

* Gastroscopy can be performed
* Pathological analysis can be performed for analysis of gastric atrophy and intestinal metaplasia

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics
* History of H. pylori eradication
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding

Primary outcomes:
measure: Gastric intestinal metaplasia
timeFrame: 4 weeks
Secondary outcomes:
measure: Degree of chronic gastritis
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Digestive Disease Center, Soonchunhyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jun-Hyung Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573114: Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke
Official title: Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Healthy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: •First-ever ischemic stroke in the territory of the middle cerebral artery (MCA)

Brief summary: This is a proof-of-concept study with a prospective observational design, where the association between progressive levels of verticalization and cerebral blood flow velocity (Ultrasound) in subacute stroke patients and healthy subjects will be investigated.


Eligibility criteria: Inclusion Criteria:

* First-ever ischemic stroke in the territory of the middle cerebral artery (MCA)
* ≤12 hours after mechanical thrombectomy
* Conscious
* Hemodynamically stable
* 18 years or older
* Informed consent of the patient and/ or legal representative

Exclusion Criteria:

* Verticalization not allowed according to treating physician
* Known pre-stroke disease affecting cerebral blood flow
* Temporal bone windows insufficient to enable ultrasound penetration
* Intubation anticipated or occurred
* Venous thromboembolism
* Symptomatic intracranial hemorrhage

Primary outcomes:
measure: Blood flow velocity
timeFrame: within 12 hours post thrombectomy
Secondary outcomes:
measure: Blood pressure
timeFrame: within 12 hours post thrombectomy
measure: Heart rate
timeFrame: within 12 hours post thrombectomy
measure: Oxygen saturation
timeFrame: within 12 hours post thrombectomy
measure: Impairment caused by a stroke
timeFrame: within 12 hours post thrombectomy
measure: Neurological status
timeFrame: within 12 hours post thrombectomy
measure: Adverse events
timeFrame: within 12 hours post thrombectomy
Other outcomes:
measure: Reperfusion after thrombectomy
timeFrame: within 12 hours post thrombectomy
measure: Perfusion imaging
timeFrame: within 24 hours post thrombectomy
measure: Disability
timeFrame: 3 month post stroke
measure: Health-related quality
timeFrame: 3 month post stroke
measure: Independence in gait
timeFrame: 3 month post stroke
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
affiliation: University of Zurich
name: Andreas Luft, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04960514: Prospective Decision Impact Trial of KidneyIntelX
Official title: A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Kidney Disease
Chronic Kidney Disease Stage 1
Chronic Kidney Disease Stage 2
Chronic Kidney Disease, Stage 3 (Moderate)
Lead sponsor: Renalytix AI, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.

Brief summary: The current trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.


Eligibility criteria: Inclusion Criteria:

* 23 years of age or older.
* Clinical history of confirmed type 2 diabetes.
* Evidence of DKD Stages 1-3:
* Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
* Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
* All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

* Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
* Patients with ESRD or on renal recovery treatments at time of enrollment.
* Patients who are pregnant at the time of enrollment.
* Patients who are currently hospitalized.
* Patients who are currently on Enbrel.

Primary outcomes:
measure: Blood pressure
timeFrame: 12 Months
measure: HbA1c
timeFrame: 12 Months
measure: ACEi/ARB
timeFrame: 12 Months
measure: SGLT2/ GLP1
timeFrame: 12 Months
measure: Urine albumin to creatinine ratio
timeFrame: 12 Months
measure: Referrals
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist - Family Medicine - Piedmont Plaza
state: North Carolina
Study officials:
References:
Clinical trial NCT06529614: An In-situ Detection for MicroRNA
Official title: A New Detection Method for MicroRNA in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who have diagnosed with breat cancer

Brief summary: We designed a new in-site detection method for MicroRNA in the serum of patients with breast cancer.


Eligibility criteria: Inclusion Criteria: Healthy without serious diseases

-

Exclusion Criteria:

* situations that may affect the results

Primary outcomes:
measure: Sensitivity and specificity of test
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Shabei Xu, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03257514: Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section
Official title: Assessing The Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section by Using Saline Contrast Sonohysterography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cesarean Section; Dehiscence
Cesarean Scar Niche
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar healing after cesarean section by using saline contrast sonohysterography

Detailed description: This is a triple blind randomized placebo controlled prospective clinical trial that will be conducted in Ain Shams University Maternity Hospital.

in which a consecutive series of participant attending emergency room 102 women undergoing cesarean section for the first time will be randomized into two groups.

Group A (Study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for 6 weeks after cesarean section and saline sonohysterography will be done after that.

Group B (Control group): 51 women will receive a placebo drug twice daily for 6 weeks after cesarean section and saline sonohysterography will be done after that.

Eligibility criteria: Inclusion Criteria:

* Term pregnancy (gestational age between 37-41 weeks).
* Women undergoing cesarean section for the first time.
* Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.
* Uncomplicated cesarean section.
* Lower uterine segment cesarean sections while the women not in labor.

Exclusion Criteria:

* Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound
* Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant.
* Women who will use intrauterine device as a contraceptive method
* Women with uterine abnormality as cervical stenosis or fibroid uterus
* Women with pelvic infection at the time of saline sonohysterography

Primary outcomes:
measure: presence of scar niche
timeFrame: six weeks after CS
measure: The healing ratio
timeFrame: six weeks after CS
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
state: Abbassia
Study officials:
References:
Clinical trial NCT02849314: Combination of Cryosurgey and NK Immunotherapy for Recurrent Laryngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Laryngeal Cancer
Keywords: laryngeal cancer
cryosurgery
NK immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent laryngeal cancer.

Detailed description: By enrolling patients with recurrent laryngeal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05505214: Topical Steroids & Bacterial Decolonization for Radiation Dermatitis
Official title: Topical Corticosteroid and Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Radiation Dermatitis
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prior to recruitment, the study statistician conducted randomization in a 1:1:1 model, which will divide patients into three arms: (a) bacterial decolonization regimen (b) topical corticosteroid use daily or (c) topical corticosteroid use daily with antibacterial decolonization regimen.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether bacterial decolonization of the nares and skin, topical steroid therapy, or a combination of the two regimens prior to treatment with radiotherapy (RT) for breast and head and neck cancer patients can prevent grade 2 or higher grade radiation dermatitis (RD) graded via the Common Terminology Criteria for Adverse Events (CTCAE) scale and improve quality of life.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18
* Diagnosis of a breast or head and neck cancer with plans for fractionated RT (greater than or equal to 15 fractions in 40 Gy (Gray)) with curative intent, including post-operative patients deemed eligible for RT by their surgeons and radiation oncologists

Exclusion Criteria:

* Prior RT to the region of interest
* Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds; known allergy to intervention therapies)

Primary outcomes:
measure: Incidence of grade >2 RD
timeFrame: At study screening/enrollment, before RT treatment has started
measure: Incidence of grade >2 RD
timeFrame: At last RT treatment session, an average of 5 weeks after treatment initiation
measure: Incidence of grade >2 RD
timeFrame: Two weeks after RT treatment completed
Secondary outcomes:
measure: Quality of life Score Change
timeFrame: At study screening/enrollment, before RT treatment has started
measure: Quality of life Score Change
timeFrame: At last RT treatment session, an average of 5 weeks after treatment initiation
measure: Quality of life Score Change
timeFrame: Two weeks after RT treatment completed
Other outcomes:
measure: Changes in the cutaneous microbiome and transcriptome
timeFrame: through study completion, an average of 2 years
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center-Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Yana Kost
role: STUDY_DIRECTOR
affiliation: Montefiore Medical Center
name: Lindsay Pattison
role: STUDY_DIRECTOR
References:
Clinical trial NCT06168214: Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication
Official title: Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: the Eradication Rates of Helicobacter Pylori
Keywords: Helicobacter pylori ; Vonoprazan
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 1404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:

* Main indicators: the eradication rate of Helicobacter pylori for eradication.
* Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.

Exclusion Criteria:

* Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment
Secondary outcomes:
measure: Incidence of adverse effects
timeFrame: 14 days of treatment, and 28 days after treatment
measure: Treatment compliance
timeFrame: 7 or 14 days of treatment
measure: Symptom relief rate
timeFrame: 14 days of treatment, and 28 days after treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ying han
state: Shaanxi
Study officials:
References: