louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03182114: Supine Versus Left Lateral Tilted Position During Cesarean Delivery
Official title: Hemodynamic Effects of Supine Position Versus Left Lateral Tilted Position During Cesarean Delivery: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cesarean Section Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position

Detailed description: Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.

Eligibility criteria: Inclusion Criteria:

* full term
* singleton pregnant women
* scheduled for elective cesarean delivery

Exclusion Criteria:

* Cardiac morbidities
* hypertensive disorders of pregnancy
* peripartum bleeding
* baseline systolic blood pressure (SBP) \< 100 mmHg
* body mass index \> 35

Primary outcomes:
measure: postspinal hypotension
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: severe postspinal hypotension
timeFrame: 30 minutes after spinal anesthesia
measure: Post-delivery hypotension
timeFrame: 10 minutes after delivery
measure: systolic blood pressure
timeFrame: 60 minutes after spinal block
measure: diastolic blood pressure
timeFrame: 60 minutes after spinal block
measure: heart rate
timeFrame: 60 minutes after spinal block
measure: incidence of nausea and vomiting
timeFrame: 60 minutes after spinal block
measure: ephedrine consumption
timeFrame: 60 minutes after spinal block
measure: Atropine consumption
timeFrame: 60 minutes after spinal block
measure: APGAR score
timeFrame: 1 minute after delivery
measure: APGAR score
timeFrame: 10 minute after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05559814: Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy
Official title: Intraluminal Peppermint Oil Can Increase Adenoma Detection Rate in Colon Cancer Screening Colonoscopy: A Double- Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Keywords: Peppermint oil, Adenoma detection rate, Colonic peristalsis
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: The Royal College of Physicians of Thailand
First posted: 2022-09-29
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a prospective randomized placebo-controlled trial to evaluate the efficacy of peppermint oil spraying into the colonic lumen through the scope channel during screening colonoscopy. The primary outcome is to compare the colonic peristalsis between peppermint oil and placebo. The secondary outcomes compare the procedural time, polyp detection rate, adenoma detection rate, and adverse events.


Eligibility criteria: Inclusion Criteria:

- Participants with age \> 18 years who attended for colorectal cancer screening colonoscopy.

Exclusion Criteria:

* Participants who had been colectomy
* Participants who diagnosed of inflammatory bowel disease or polyposis syndrome.
* Participants who had been took anti-spasmosic drugs prior to colonoscopy within 24 hours (Anticholibergic/Antimuscarinic : Hyoscine(Buscopan®), Dicyclomine(Berclomine®) or Smooth muscle relaxant : Mebeverine(Duspatin®,Colofac®), Pinaverium bromide(Dicetel®), Alverine(Meteospasmyl®), Peppermint oil(Colpermin®))
* Participants with Prothrombin time \> 3 second ULN, INR \> 1.5 or Platelet \< 50,000.
* Pregnancy or breast feeding
* Participants who cannot consent.
* Participants who had history of peppermint oil allergy.

Primary outcomes:
measure: Adenoma detection rate(ADR)
timeFrame: During colonoscopy
Secondary outcomes:
measure: Adenoma per posititive participants(APP)
timeFrame: During colonoscopy
measure: Colonic peristalsis grading
timeFrame: During colonoscopy
measure: Time of polyps resection
timeFrame: During colonoscopy
measure: Intravenous anti-spasmodic agents
timeFrame: During colonoscopy
measure: Adeverse events
timeFrame: 24 hours after colonoscopy
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of internal medicine siriraj hospital, Mahidol university
state: Bangkok
Study officials:
References:
Clinical trial NCT03024814: Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
Official title: Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intraventricular Haemorrhage Neonatal
Lead sponsor: King Saud Medical City
Sponsor class: OTHER_GOV
First posted: 2017-01-19
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.

Detailed description: It will be a double-blind randomized control trial, single center. The study will include neonates with a gestational age of less than or equal 32 weeks and a birth weight of less than or equal 1500 g, and will randomly assigned to two treatment groups (see below).

Infants will be randomized to equal-sized groups using block randomization with blocks of four. Stratified randomization for gender and gestational age will be included in the randomized blocks. Gestational age will be divided into two categories: 23 weeks +0 day to 27 weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. Gender (2) × gestational age (2) will give 6 strata, requiring 6 separate random number lists to achieve randomization.

Eligibility criteria: Inclusion Criteria:

* Premature baby less than or equal 32 week and birth weight less than or equal 1500 g

Exclusion Criteria:

* Out-born babies, infants with major congenital anomalies, babies have IVH III, IV, High expectancy of early death

Primary outcomes:
measure: The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.
timeFrame: within the first week of age
Secondary outcomes:
measure: The incidence of neonatal sepsis in the premature babies who received acetaminophen
timeFrame: Corrected 40 weeks of gestational age or time of discharge will be used
measure: The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen
timeFrame: Corrected 40 weeks of gestational age or time of discharge will be used
measure: The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen
timeFrame: Corrected 40 weeks of gestational age or time of discharge will be used
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Mountasser Al-Mouqdad
Study officials:
affiliation: King Saud Medical City
name: Mountasser Al-Mouqdad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709614: Psychological Factors That Influence Severity of Allergic Rhinitis
Official title: Influence of Immunological and Psychological Factors on Perceived Severity of Seasonal Allergic Rhinitis Caused by Grass Pollen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seasonal Allergic Rhinitis
Keywords: skin prick test
specific IgE
patient reported outcome
psychological factor
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were selected from 185 patients managed in our outpatient clinics with a presumptive diagnosis of allergic rhinitis

Brief summary: Objective biomarker of allergic rhinitis severity is necessary for monitoring disease severity and response to treatment in clinical setting and for research. We believe that psychological factors are the missing link between patient-perceived severity of allergic rhinitis and objective biomarkers. In our pilot study, several psychological factors were studied in relation to patient reported outcomes for severity of allergic rhinitis.

Detailed description: Monitoring allergic rhinitis (AR) severity with objective biomarkers is important for the clinical management of patients as well as for research purposes. The most commonly used tool for the assessment of AR severity is the Total Nasal Symptom Score (TNSS). Objective biomarkers like skin prick test size or specific IgE levels don't correlate with TNSS.

We studied skin prick test size and specific IgE and several patient reported outcomes including symptom score, medication scores, combined score and Juniper mini rhinitis quality of life questionnaire (RQLQ). Psychometric evaluation was performed using 5 different psychological questionnaires that measure 13 different psychological factors.

Eligibility criteria: Inclusion Criteria:

* positive grass pollen skin prick test (SPT) with a wheal diameter \>3mm and a history of allergic rhinitis during the grass pollen seasons

Exclusion Criteria:

* positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families

Primary outcomes:
measure: Symptom score
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Klinika Golnik
name: Mihaela Zidarn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073514: Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction
Official title: Clinical Trial of Bile Etiology,Proteomics and Metabonomics of Malignant Biliary Obstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Biliary Obstruction
Keywords: Malignant biliary obstruction (MBO)
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Malignant obstructive jaundice (MBO)

Brief summary: To investigate bile culture and susceptibility test in patients with malignant biliary obstruction (MBO) or relation between bile, portal vein or vein culture and biliary infection. Also to get the information of bile metabonomics to find potential tumor marker .Culture of the organism is recognized as the "gold standard" for diagnosis of infection. Our research may be one of the first research on culture and susceptibility test in patients with MBO. The results of the trial research will be benefit to experiential therapy of MBO with biliary infection and diagnosis of MBO.

Detailed description: We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples.

Eligibility criteria: Inclusion Criteria:

* Those with MBO who can receive Percutaneous Transhepatic Biliary Drainage(PTBD)

Exclusion Criteria:

* Those with MBO who cannot receive Percutaneous Transhepatic Biliary Drainage(PTBD)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institude and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: YU HAI PENG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: GUO ZHI, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06785714: Colorectal Cancer Screening in Xinxiang City
Official title: Colorectal Cancer Screening in Xinxiang City
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: The First Affiliated Hospital of Xinxiang Medical College
Sponsor class: OTHER
Collaborators: name: Xinxiang Municipal Health Commission
name: Xinxiang Center for Disease Control and Prevention
name: Xinxiang Central Hospital
name: The Affiliated People's Hospital of Xinxiang Medical University
name: The Third Affiliated Hospital of Xinxiang Medical College
name: Shanghai Jiao Tong University School of Medicine
First posted: 2025-01-21
Enrollment: 25000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single cohort of patients aged between 45 and 84, with no known high risk features, undergoing routine colorectal cancer screening as standard of care.

Brief summary: The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).

Detailed description: The project uses fecal hemoglobin and transferrin dual-index combined with reagents that can be self-tested at home (referred to as fecal protein dual-index detection reagents), combined with colorectal cancer risk factor questionnaires, to carry out colorectal cancer screening in people of specific ages in the city, aiming to achieve early screening, early diagnosis and early treatment, and evaluate the effect of fecal protein dual-index detection reagents in early screening of colorectal cancer, so as to provide a scientific basis for optimizing the national screening program.

Eligibility criteria: Inclusion Criteria:

1. Subjects aged 45-74 years at time of consent
2. Have not had gastrointestinal resection

Exclusion Criteria:

1. Previous history of colorectal cancer
2. Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
3. Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
4. Those with severe mental disorders and language communication disorders
5. History of contraindications to colonoscopy
6. Pregnant women

Primary outcomes:
measure: Sensitivity of colorectal cancer detection
timeFrame: 180 days
measure: Specificity of advanced neoplasia detection
timeFrame: 180 days
Secondary outcomes:
measure: Positive predictive value of colorectal cancer detection
timeFrame: 180 days
measure: Negative predictive value of colorectal cancer detection
timeFrame: 180 days
measure: Sensitivity and specificity of advanced adenoma detection
timeFrame: 180 days
Other outcomes:
Locations:
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
Study officials:
References:
Clinical trial NCT05452395: Post-acute Care for Patients With Frailty
Official title: Integrated Post-Acute Care Program for Frail Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Retrospective Study
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-11
Enrollment: 254
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute illness could be enormous stress for frail people. Combining comprehensive geriatric assessment and multifactorial intervention has positive effects on frail community older adults. However, few studies investigated the effects of post-acute care (PAC) in frail older patients who just recovered from acute hospitalization. This study aimed to evaluate the effects of PAC on frail older adults in Taiwan.

Detailed description: Frail patients aged \>= 75 were recruited and divided into PAC or control groups. The PAC group received comprehensive geriatric assessment (CGA) and multifactorial intervention for two to four weeks. The control group received CGA only. The primary outcomes were 90-day emergency room visits, readmissions, and mortality after PAC.

Eligibility criteria: Inclusion Criteria:

1. Mild to severe frailty identified by the Clinical Frailty Scale
2. Age ≥ 75 years
3. Diagnosis with Parkinson's disease, dementia, chronic obstructive pulmonary disease, or chronic kidney disease stage three or worse
4. Acute hospital stays between 3 to 30 days with deconditioning
5. Stable medical condition with no need of intensive care, laboratory examination, or oxygen dependence

Exclusion Criteria:

1. Refused to participate in the program
2. Candidate for other post-acute care programs (i.e. stroke, traumatic neurological injury, or fracture)
3. Unable to cooperate with the program due to mental or cognitive impairment
4. Long-term ventilator-dependence
5. Long-term bed-ridden status (\> 6 months)
6. Diagnosed as end of life and in need of palliative care
7. Diagnosed as major illness (i.e. end-stage renal disease) and in need of frequent inpatient treatment ( \> 3 times over recent 6 months)
8. Institutional residents
9. Home medical care participants

Primary outcomes:
measure: 90-day emergency room visits
timeFrame: 90 days after post-acute care
measure: 90-day readmissions
timeFrame: 90 days after post-acute care
measure: 90-day mortality
timeFrame: 90 days after post-acute care
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Department of Family Medicine, Taipei City Hospital, Zhongxing Branch
name: Tai-Yin Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830595: Lactoferrin Treatment in HIV Patients
Official title: Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Ventria Bioscience
First posted: 2013-04-12
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.


Eligibility criteria: Inclusion Criteria:

1. HIV-positive participants receiving Antiretroviral Therapy (ART) for \>1 year
2. HIV RNA level \<200 copies/mL for at least 6 months (≥2 separate values)
3. Age \>40 years

Exclusion Criteria:

1. Prior cardiovascular disease or stroke
2. Diabetes
3. Rheumatologic Diseases
4. Pregnancy
5. Chronic kidney disease, stage IV or V (creatinine clearance \<30 mL/min/1.73m2)
6. Cirrhosis or end-stage liver disease

Primary outcomes:
measure: Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event
timeFrame: During 3 months on Lactoferrin or Placebo (and following washout period)
measure: IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)
timeFrame: 3 months (Baseline to Month 3 or Month 5 to Month 8)
measure: Number of Participants Taking Medication as Assigned
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Activated Monocyte Phenotype (CD16+)
timeFrame: 3 months
measure: sCD163
timeFrame: 3 months
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Jason V Baker, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sortino O, Hullsiek KH, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser R, Schacker T, Sereti I, Baker JV. The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy. J Infect Dis. 2019 May 24;219(12):1963-1968. doi: 10.1093/infdis/jiz042.
Clinical trial NCT02032095: The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
Official title: The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Keywords: IVIG
Renal transplantation
desensitization
Lead sponsor: Japan Blood Products Organization
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.


Eligibility criteria: Inclusion Criteria:

* Patients with stage 4 or 5 on the CKD classification.
* Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor.
* Patients with positive FCXM-T after performing twice DFPP therapy

Exclusion Criteria:

* Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent.
* Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent.
* Patients who had Rituximab within 6 month before to informed consent.
* Patients who have undergone splenectomy.
* Patients with severe hepatic disorder or severe heart disorder.
* Patients with receiving treatment of malignancy.
* Patients with high risk of thromboembolism.
* Patients with history of shock or hypersensitivity to GB-0998.
* Patients with hereditary fructose intolerance or IgA deficiency.
* Patients with pregnant or probably pregnant.

Primary outcomes:
measure: Negative rate of FCXM-T after the fourth administration of GB-0998
timeFrame: at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Japan Blood Products Organization
Study officials:
References: