louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05578625: ctDNA Methylation Sequencing for Myeloma
Official title: Circulating Tumor DNA Methylation Sequencing for Multiple Myeloma Minimal Residual Disease Detection and Clonal Evolution Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: circulationg tumor DNA
methylation sequencing
minimal residual disease
clonal evolution
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: MethylGene Tech Co., Ltd. China
First posted: 2022-10-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For patients aged between 18 and 75, and diagnosed with symptomatic multiple myeloma according to IMWG consensus will be included in this study.

Brief summary: 1. To carry out research on minimal residual disease (MRD) monitoring in patients with multiple myeloma (MM) based on plasma circulating tumor DNA (ctDNA) methylation sequencing, which aims to explore new MRD detection methods for MM;
2. Carry out ctDNA-based methylation sequencing in newly diagnosed, remission, and, relapsed MM patients, to track the clonal evolution patterns; and explore the in the initial diagnosis-remission-relapse stage of MM, track the clonal evolution characteristics of methylation profiles in MM patients during the disease progression.


Eligibility criteria: Inclusion Criteria:

- For myeloma patients: i) Age no less than 18 and no more than 75; ii) Diagnosed with symptomatic multiple myeloma according to IMWG consensus; iii) Provide informed consent in accordance with the declaration of Helsinki.

- For healthy controls: i) Age no less than 18 and no more than 75; ii) Provide informed consent in accordance with the declaration of Helsinki.

Exclusion Criteria:

- For myeloma patients: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons.

- For healthy controls: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons.

Primary outcomes:
measure: Sample Collection Completed
timeFrame: From Aug 31 2022 to Jun 30 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Institute of Hematology and Blood Diseases Hospital,Tianjin, China, 300020
name: InsituteHBDH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002325: A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
Official title: A Double-Blind, Placebo-Controlled Study of Fluconazole in the Prevention of Active Coccidioidomycosis and Other Systemic Fungal Infections in HIV-Infected Patients Living in the Coccidioidal Endemic Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycoses
HIV Infections
Coccidioidomycosis
Keywords: Mycoses
Fluconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Coccidioidomycosis
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of fluconazole versus placebo in preventing the development of active coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4 lymphocyte counts \< 250 cells/mm3 who are living in the coccidioidal endemic area.

Detailed description: Patients are randomized to receive either fluconazole or placebo daily.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 count \< 250 cells/mm3.
* No active coccidioidomycosis or other fungal disease requiring systemic antifungal therapy.
* Residence in area considered to be endemic for Coccidioides immitis.
* Consent of parent or guardian if under legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Unable to take oral medication.
* Positive serum cryptococcal antigen.

Concurrent Medication:

Excluded:

* Systemic antifungal therapy.

Patients with the following prior conditions are excluded:

History of hypersensitivity to azole or imidazole compounds.

Prior Medication:

Excluded:

* Systemic antifungal agents within 2 weeks prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: McDowell Clinic
state: Arizona
city: Tucson
country: United States
facility: Tucson Veterans Administration Med Ctr
state: Arizona
city: Rancho Mirage
country: United States
facility: Dr Lawrence Cone
state: California
Study officials:
References:
Clinical trial NCT03251625: Multi-strain Probiotic in the Management of IBS-D
Official title: Supplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, double-blind, placebo-controlled clinical trial
Primary purpose: TREATMENT

Brief summary: 1. To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for IBS in a tertiary referral centre

Detailed description: Background: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms.

Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed case of IBS using Rome III criteria
2. Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer
3. Age 18-55 years
4. No probiotics used in prior 3 months.
5. Agreed not to start any other drug unless clinically indicated.
6. No antibiotics in previous 2 months of enrolment.

Exclusion Criteria:

1. Age\<18 or \>55 years
2. Previous treatment with probiotics within last 3 months
3. Pregnant or lactating females
4. Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism)
5. Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc
6. Any previous gastrointestinal surgery

Primary outcomes:
measure: The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo
timeFrame: 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Probiotics International Ltd (Protexin)
name: Ashton Harper, MRCS
role: STUDY_DIRECTOR
References:
citation: Ishaque SM, Khosruzzaman SM, Ahmed DS, Sah MP. A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult(R)) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterol. 2018 May 25;18(1):71. doi: 10.1186/s12876-018-0788-9.
Clinical trial NCT06322225: Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions
Official title: Construction and Demonstration of Accurate Prevention and Treatment System for Colorectal Tubular Adenoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Tubular Adenoma
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: National Key Research and Development Program of China
First posted: 2024-03-21
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 30,000 patients diagnosed with colorectal tubular adenoma in our hospital and several research centers

Brief summary: Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.

The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database.


Eligibility criteria: Inclusion Criteria:

Voluntarily sign informed consent; Colorectal tubular adenoma was diagnosed according to JSGE clinical guidelines They are between 18 and 70 years old

Exclusion Criteria:

Refuse to sign the informed consent Patients who were judged by the investigator to be unsuitable for participation in this study.

The diagnosis is not tubular adenoma of colorectal or other adenomas according to JSGE clinical guidelines Age \< 18 or \> 70

Primary outcomes:
measure: Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images
timeFrame: 2024.05-2026.12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04837625: Study of Myasthenic Crisis in China
Official title: A Multicenter Prospective Registration Study of Myasthenic Crisis in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
Myasthenic Crisis
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 300
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: The study population will be recruited from multiple centers across China.

Brief summary: This study is a multicenter, prospective, observational research. It will register the basic demographic information, medical history characteristics, clinical features, auxiliary examinations, treatment, outcomes of tracheal intubation/ventilator related events, and clinical outcomes of Myasthenic Crisis patients. The objectives including:

1. Obtain epidemiological data of MC in China;
2. Establish a standardized registration system for MC patients in China;
3. Explore the epidemiology, clinical characteristics, serological characteristics, clinical characteristics of MC, predisposing and predictive factors, extubation process/time, weaning/extubation outcome and predictors of clinical outcome in Chinese MC patients.


Eligibility criteria: Inclusion Criteria:

* clinical history and signs of fluctuating weakness and fatigability;
* seropositivity forAChR/MuSKantibodies;
* If negative or the tested antibodies, positive repetitive nerve stimulation(RNS) at low frequency(2-5Hz) is required;
* Crisis: a serious, life-threatening, rapid worsening of MG requiring intubation or noninvasive ventilation to avoid intubation.
* Impending crisis: rapid clinical worsening of MG that, in the opinion of the treating physician, could lead to crisis in the short term (days to weeks) with blood gases suggest hypoxia (oxygen saturation \<95%) or elevated carbon dioxide (paco2\>50mmHg).

Exclusion Criteria:

* the RNS had over 100% increase after high frequency stimulation or R2 repeats,to differentiate from lambert-Eaton syndrome and congenital MG.
* except when intubation or noninvasive ventilation are employed during routine postoperative management.

Primary outcomes:
measure: MG-ADL of 3 years after off-mechanical ventilation
timeFrame: Sep,2026
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05851625: Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients
Official title: Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Chemotherapy-induced Nausea and Vomiting
Chemotherapy Effect
Keywords: acupuncture
ear acupuncture
CINV
cancer
press needle
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Mashhad University of Medical Sciences
First posted: 2023-05-10
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chemotherapy is a cancer therapy performed on advanced cancer with quite good success, but this therapy has quite a lot of side effects. Chemotherapy induced nausea and vomiting or commonly known as CINV, is a condition of nausea and vomiting experienced by cancer patients undergoing chemotherapy, with a prevalence of around 80% of all patients undergoing chemotherapy, and 40% has the potential to become severe. This study aims to determine the efficacy of a new acupuncture modality, namely the press needle, in preventing CINV symptoms in pediatric patients with cancer undergoing chemotherapy.

Detailed description: The study was conducted using a randomized controlled clinical trial (RCT) design in 64 pediatric cancer patients undergoing chemotherapy who were randomized into 2 groups, namely: (1) standard medical therapy as the control group; and (2) a combination of standard therapy with press needle acupuncture as the treatment group. The ear acupuncture points used are Shenmen and Stomach, and one body acupuncture point is PC6. Outcome measurements were carried out in the form of the RINVR questionnaire to assess the intensity of nausea and vomiting measured at 4 times: (1) 12 hours before chemotherapy; (2) 12 hours after chemotherapy; (3) 3 days after chemotherapy; (4) 7 days after chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with cancer who are undergoing chemotherapy.
* Age 6 - 18 years.
* Patients with platelet counts \> 20,000/μL and neutrophil values \> 1,000/μL.
* Willing to follow the research.

Exclusion Criteria:

* Patients with local infection in the puncture area.
* Patients with anatomic abnormalities in the auricle.
* Did not complete the acupuncture therapy until it was finished (three days after chemotherapy).

Primary outcomes:
measure: Rhodes Index of Nausea, Vomiting, and Retching (RINVR) questionnaire
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: RSUPN Dr. Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Wahyuningsih Djaali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01123525: Adenosine Cardioplegia; Improved Cardioprotection?
Official title: Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Angina Pectoris
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.


Eligibility criteria: Inclusion Criteria:

* Elective patients
* Ejection fraction \> 40%
* Age 40-75
* No release og TnT or CKMB within last week before CABG
* Pure CABG

Exclusion Criteria:

* Age \>75 or \< 40
* EF \< 40%
* Emergency operations
* Unstable angina
* Release of TnT or CKMB within the week before operation

Primary outcomes:
measure: Release of cardiac enzymes (TnT and CKMB)
timeFrame: First 48 hour postoperatively
Secondary outcomes:
measure: PiCCO
timeFrame: First 24 hours postoperatively
measure: Endothelial injury
timeFrame: Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion)
Other outcomes:
Locations:
city: Troomsø
country: Norway
facility: University Hospital of North Norway
Study officials:
References:
citation: Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
Clinical trial NCT03837925: Pharmaco-metabolomic Effects of Statins: METASTATINE
Official title: Pharmaco-metabolomic Effects of Statins: METASTATINE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Keywords: Statins
cardiovascular risk
primary prevention microbiota
metabolomics
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Fondation Coeur et Recherche
name: ICAN Nutrition Education and Research
name: Fédération francaise de cardiologie
First posted: 2019-02-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of patients having treatment or placebo
Primary purpose: TREATMENT

Brief summary: Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.

Detailed description: The aim of this prospective double blind placebo-controlled study is to evaluate the acute effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Patient with cardiovascular risk requiring statins in primary prevention
* Contraception for women of childbearing age

Exclusion Criteria:

* Previous antibiotics, proton pomp inhibitors, statins or other hypolipidemic drugs intake in the previous three months
* Renal insufficiency with creatinine clearance \<40ml/min
* Contra-indication to statins
* Previously known conditions affecting muscles, or digestive system
* Requirement of statins in secondary prevention

Primary outcomes:
measure: Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-6 in atorvastatin arm and placebo arm.
timeFrame: Week-6
Secondary outcomes:
measure: Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-2 in atorvastatin arm and placebo arm.
timeFrame: week-2
measure: Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured pre and post-prandially at week-2 and week-6 in atorvastatin arm.
timeFrame: Week-2 and week-6
measure: Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of circulating metabolomic profile (pre- and postprandial)
timeFrame: Week 2 and Week 6
measure: Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of the microbiome
timeFrame: Week 2 and Week 6
Other outcomes:
Locations:
city: Paris
country: France
facility: CIC La Sapétrière
city: Paris
country: France
facility: CIC HEGP
Study officials:
affiliation: CIC 1421 CHU Pitie Salpetriere
name: Joe Elie SALEM, MD
role: PRINCIPAL_INVESTIGATOR
References: