louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05032014: Probiotics Enhance the Treatment of PD-1 Inhibitors in Patients With Liver Cancer
Official title: Probiotics Enhance the Treatment of PD-1 Inhibitors in Patients With Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Inner Mongolia University of Science and Technology
First posted: 2021-09-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Human microbes have been called "the second genome of humanity".On May 13,2016,the White House launched the National Microbiome Initiative (NMI), with an estimated investment of us $521 million, to elevate microbiome research to a national strategic status. The gut is the largest microecological environment in the human body. The research in the field of intestinal microbiome has become one of the most advanced and hot research directions in the scientific field of the world today. At present, more than 50 diseases have been found to be related to intestinal microbiome disorders. Pd-1 (programmed death receptor 1) is an important immunosuppressive molecule.It regulates the immune system and promotes tolerance by down-regulating the immune system's response to human cells and by suppressing T cell inflammatory activity. In the past, the research team and colleagues in related fields have found a strong correlation between Gut Microbiome and the efficacy of anti-PD-1 immunotherapy in cancer patients.This protects against autoimmune diseases, but it also prevents the immune system from killing cancer cells. As more and more scientific evidence shows that intervention of human intestinal flora may improve the efficacy of anti-PD-1 immunotherapy in tumor patients, intestinal flora, as the most effective way to intervene human intestinal flora, has been mentioned by many research institutions and international drug manufacturers in combination with anti-PD-1.Our previous study showed that the abundance of beneficial bacteria such as lactic acid bacteria, bifidobacteria and Akkermansia Muciniphila was significantly correlated with pD-1 inhibitor response, and regulating the intestinal flora content could improve the effect of PD-1 inhibitor on mouse tumors, indicating that microbial flora was involved in regulating cancer immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Karnofsky score ≥90 in patients receiving immunotherapy for liver cancer at our cancer center

Exclusion Criteria:

* any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to V9

Primary outcomes:
measure: (objective remission rate)ORR
timeFrame: 6 months
Secondary outcomes:
measure: PFS
timeFrame: 6 months
measure: OS
timeFrame: 6 months
Other outcomes:
Locations:
city: NanCHang
country: China
facility: Chunling Jiang
state: Jiang XI
Study officials:
References:
Clinical trial NCT02160314: A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Official title: A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence, SUI, pessary
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.


Eligibility criteria: Inclusion Criteria:

* be female 18 years or older;
* provide written informed consent prior to study participation and been given a signed copy;
* be in generally good health as determined by the Investigator;
* have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
* be willing to use the pessary investigational device to control stress urinary incontinence;
* be willing to comply with study requirements and instructions;

Exclusion Criteria:

* are pregnant, lactating, or planning to become pregnant during the study;
* within 3 months post partum;
* intrauterine device (IUD) placement of less than 6 months;
* has self-reported difficulty emptying her bladder;
* a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
* experience difficulty inserting or wearing an intra-vaginal device, including a tampon;
* vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
* has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator and could impact the safety of the subject or the outcome of the study; or
* for any reason, the Investigator decides that the subject should not participate in the study.

Primary outcomes:
measure: Treatment-emergent Serious Adverse Event
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Study Center
state: Arizona
Study officials:
affiliation: Radiant Research, Inc.
name: Randall Severance, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734014: Strengthening Healthy Relationships Among Apsaalooke Youth
Official title: Strengthening Healthy Relationships Among Apsaalooke Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Youth Engagement
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 11
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The feasibility study includes pilot testing activities and an evaluation of the activities. This study focused on developing the lessons that would promote cultural connectedness.
Primary purpose: PREVENTION

Brief summary: This pilot project uses community based participatory research principles to build upon cultural strengths to develop a feasibility of intervention to promote relationality and connectedness among Apsáalooke youth. This project worked closely with a Community Advisory Board (CAB) members to develop all stages of the project. The CAB identified 5th grade as an important age to focus. The feasibility study is developing pilot activities related to respecting promoting intergenerational, family, community and land connectedness among Crow youth.


Eligibility criteria: Inclusion Criteria: Students who are entering the fifth and sixth grade and who live on or near the Crow reservation will be invited to participate in the summer camp.

Primary outcomes:
measure: Youth Engagement
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Vanessa Simonds
state: Montana
Study officials:
References:
Clinical trial NCT01771614: Glucotoxicity and Acute Exercise
Official title: The Effects of Hyperglycaemia on the Response to Acute Exercise
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Glucotoxicity
Exercise
Beta-cell function
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. The effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. Changes in pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress will be measured.


Eligibility criteria: Inclusion criteria for participation:

* Male
* Age 18-50 years
* Body Mass Index 19-30 kg/m2
* Generally healthy

Exclusion criteria for participation:

* Regular use of anti-inflammatory medication
* Smokers
* More than 2 kg weight change in prior 6 months
* Previous weight loss surgery
* Cancer, or evidence of chronic haematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal disease
* Evidence of diabetes
* Engaged in moderate or vigorous activity on more than 5 days per week

Primary outcomes:
measure: Pancreatic endocrine function
timeFrame: 0, 6, 7, 9, and 24 hours
Secondary outcomes:
measure: Glucose tolerance
timeFrame: 0, 6, 7, 9, and 24 hours
measure: Endothelial function
timeFrame: 0, 6, 7, 9, and 24 hours
measure: Oxidative stress
timeFrame: 24 hours
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Thomas P Solomon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02014714: Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
Official title: Randomized Comparison Study of Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2013-12-18
Enrollment: 40
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: Obstructive Sleep Apnea (OSA) is a common clinical problem with a reported prevalence of 2% to 4% in the general population. The incidence was double on patients who had a diagnosis of OSA going for orthopedics surgery.

Little literature composed mostly of case reports or small retrospective case-control studies exist examining the use of intrathecal opioids on outcomes in OSA patients is inconclusive. The primary objective of this study is to compare the post operative respiratory effect after single dose intrathecal morphine and intrathecal fentanyl on orthopedics patients who suspected or undiagnosed obstructive sleep apnea.

Hypotheses

Undiagnosed OSA patients who received intrathecal morphine are more likely to have respiratory events post-operatively.

Detailed description: This is a prospective, randomized study to compare the post operative respiratory effect after single dose intrathecal morphine (0.1mg) and intrathecal fentanyl (40mcg) on orthopedics patients who suspected or undiagnosed obstructive sleep apnea.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. ASA I - II
3. Patients who admitted for orthopedic surgery and consented for regional anesthesia
4. STOP - BANG score ≥ 5

Exclusion Criteria:

1. Refused to give informed consent
2. Previous diagnosis and treatment of OSA or any sleep-related breathing disorder
3. Allergic to morphine / fentanyl / Local anesthetic
4. Contra-indicated for regional anesthesia
5. Pregnant woman
6. Contraindication to either of the oral analgesia as in protocol

Primary outcomes:
measure: Respiratory Rate (RR)
timeFrame: 72 hours post operatively
measure: Heart Rate (HR)
timeFrame: 72 hours post-operative
measure: Oxygen Desaturation Index (ODI)
timeFrame: 72 hours post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: University of Malaya
name: Wang Chew Yin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155414: Tolerance of Healthy Term Infants Fed Infant Formulas #4
Official title: Tolerance of Healthy Term Infants Fed Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Term Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 168
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.


Eligibility criteria: Inclusion Criteria:

* Singleton full term birth in good health
* Birth weight was \> 2490 g.
* Between 0 and 8 days of age.
* Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria:

• An adverse maternal, fetal or infant medical history and treatment with antibiotics

Primary outcomes:
measure: GI tolerance via stool consistency
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Dothan
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance
state: Florida
city: Coralville
country: United States
facility: University of Iowa
state: Iowa
city: Dubuque
country: United States
facility: Medical Associates Clinic, PC
state: Iowa
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Hershey
country: United States
facility: Pediatric Clinical Research Office
state: Pennsylvania
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02360514: Study to Evalutate Long-term Immunity of Hantavax in High Risk Population of HFRS
Official title: Non-comparable and Open Clinical Research to Evaluate Long-term Immunity by Neutralizing Antibody Test of Adults in High Risk Population of HFRS (Hemorrhagic Fever With Renal Syndrome) After Vaccination and Booster Vaccination of Hantavax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2015-02-10
Enrollment: 226
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .

Detailed description: This clinical trial was designed as a multicenter, non-comparable, open-label clinical trial.This trial was conducted written informed consent form by voluntary agreement, negative result of hantaanvirus antubidy by neutralizaing antibody test, test drug was administrated 0, 1, 13 months according to drug label.

For antibody test, Sampling was conducted pre-dose(T0), 1 month after vaccination(T1), 1 year after vaccination(before booster vaccination, T2) and 1 month after vaccination(T3). Also, 1 month after vaccination (T3) after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted, and the antibody test every year.In conclusion, sampling was conducted 12 months(T4), 24 months(T5), 36months(T6) after the booster vaccionation.

However, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.

Eligibility criteria: Inclusion Criteria:

* The subjects who have the vaccination history of ah the time of screening
* The subjects whose Hantaan virus virus's antibody shows negative using Neutralizing antibody test at the time of screening

Exclusion Criteria:

* The subjects who have a history of hemorrhagic fever with renal syndrome
* The subjects who have a fever or significant dystrophy

Primary outcomes:
measure: Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates
timeFrame: 13 months
Secondary outcomes:
measure: The antibody seroconversion rates and its retension rates by neutralizing antibody test
timeFrame: 13 months
measure: The antibody seroconversion rates and its retension rates by fluorescent antibody technique
timeFrame: 13 months
measure: The antibody titers by neutralizing antibody test and fluorescent antibody technique
timeFrame: 13 months
measure: Number of adverse events after vaccination of Hantavax to adults in high risk population.
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02034214: Shaping the Health of Adolescents in Zimbabwe
Official title: Economic Opportunity for Zimbabwean Adolescent Orphans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
adolescents
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: UZ-UCSF Collaborative Research Programme
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-01-13
Enrollment: 367
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The SHAZ! study was a randomized trial that compared a package of life skills education, reproductive health care services, and economic livelihood development to a control package of life skills education and reproductive health care services alone. SHAZ! enrolled young women 16 to 19 years old who had been orphaned and who were currently out of school and not infected with HIV. Individuals participated in the project for up to two years.


Eligibility criteria: Inclusion Criteria:

* 16 to 19 years old
* out of school
* orphaned
* willing to participate in intervention activities
* living in Chitungwiza

Exclusion Criteria:

* HIV infection
* currently pregnant

Primary outcomes:
measure: Intervention completion
timeFrame: Within 2 years of follow up
Secondary outcomes:
measure: Unintended pregnancy
timeFrame: during 2 year follow up
measure: Incident viral infection with HIV or HSV-2
timeFrame: During 2 years of follow up
Other outcomes:
Locations:
city: Chitungwiza
country: Zimbabwe
facility: South Medical
Study officials:
affiliation: Pangea Global AIDS Foundation
name: Megan Dunbar, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunbar MS, Maternowska MC, Kang MS, Laver SM, Mudekunye-Mahaka I, Padian NS. Findings from SHAZ!: a feasibility study of a microcredit and life-skills HIV prevention intervention to reduce risk among adolescent female orphans in Zimbabwe. J Prev Interv Community. 2010;38(2):147-61. doi: 10.1080/10852351003640849.
citation: Kang M, Dunbar M, Laver S, Padian N. Maternal versus paternal orphans and HIV/STI risk among adolescent girls in Zimbabwe. AIDS Care. 2008 Feb;20(2):214-7. doi: 10.1080/09540120701534715.
citation: Krishnan S, Dunbar MS, Minnis AM, Medlin CA, Gerdts CE, Padian NS. Poverty, gender inequities, and women's risk of human immunodeficiency virus/AIDS. Ann N Y Acad Sci. 2008;1136:101-10. doi: 10.1196/annals.1425.013. Epub 2007 Oct 22.
citation: Dunbar MS, Kang Dufour MS, Lambdin B, Mudekunye-Mahaka I, Nhamo D, Padian NS. The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe. PLoS One. 2014 Nov 21;9(11):e113621. doi: 10.1371/journal.pone.0113621. eCollection 2014.
Clinical trial NCT02043314: A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
Official title: New Strategy for Treating Latent Tuberculosis Infection in Brazil: A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tuberculosis
Lead sponsor: Oswaldo Cruz Foundation
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The recommended treatment for latent tuberculosis infection for adults is a daily dose of isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested the development of a new 300mg isoniazid formulation. The aim of the study is to compare the bioavailability of the isoniazid 300mg new formulation and three 100mg tablets of the reference formulation.

The study is a randomized, single dose, open label, fasting, two-phase crossover bioequivalence study with a wash out period of 7 days (\>7 half-life) in 28 healthy human volunteers. For the determination of isoniazid in human plasma, the investigators developed and validated a sensitive, simple and rapid HPLC-MS/MS method.

This will support the strategy adopted by the Brazilian National Program for Tuberculosis for the treatment of latent tuberculosis. The new formulation will increase patients' adherence to the treatment and quality of life. Medical doctors in Brazil should become aware of the new formulation and the new treatment strategy in order to prescribe the right medication and avoid errors that could result in a high frequency of adverse events. Future research studies should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact on the cure rate.


Eligibility criteria: Inclusion Criteria:

* healthy men and women
* aged between 18 and 50 years
* BMI between 18.5 and 29.9 kg/m²

Primary outcomes:
measure: Average bioequivalence based on the 90% CI
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Synchrophar - Ass. e Desenv. de Projetos Clínicos Ltda.
state: São Paulo
Study officials:
affiliation: Fundação Oswaldo Cruz
name: Eduardo W Barroso, Dr
role: PRINCIPAL_INVESTIGATOR
References: