louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02011932: Prospective Observational Study of Disease Progression in Chronic Hepatitis C
Official title: Observational Study of Disease Progression and Risk Factors in Chronic Hepatitis C Caused by Plasma Donation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatitis C, Chronic
Disease Progression
Liver Cirrhosis
Lead sponsor: Beijing YouAn Hospital
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The plasma donors were primarily chosen from healthy farmers and agricultural workers living in a remote small city in the Northwest China.

Brief summary: The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.


Eligibility criteria: Inclusion Criteria:

* All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions.
* The Hepatitis C Virus antibody was positive.
* All patients did not receive interferon therapy before being recruited.

Exclusion Criteria:

* Patients with evidences for other forms of liver diseases.
* The coinfection with hepatitis B virus or other virus.

Primary outcomes:
measure: Fibrosis progression rate
timeFrame: 20 years
measure: The incidence of cirrhosis
timeFrame: 20 years
measure: Risk factors for the occurrence of cirrhosis
timeFrame: 20 years
Secondary outcomes:
measure: The incidence of hepatocellular carcinoma
timeFrame: 20 years
measure: Number of participants with chronic hepatitis C-related complications
timeFrame: 20 years
Other outcomes:
Locations:
Study officials:
affiliation: Beijing YouAn Hospital
name: Zhongping Duan, Ph.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. doi: 10.1053/jhep.2002.36806.
citation: Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
citation: Ghany MG, Kleiner DE, Alter H, Doo E, Khokar F, Promrat K, Herion D, Park Y, Liang TJ, Hoofnagle JH. Progression of fibrosis in chronic hepatitis C. Gastroenterology. 2003 Jan;124(1):97-104. doi: 10.1053/gast.2003.50018.
citation: Seeff LB, Miller RN, Rabkin CS, Buskell-Bales Z, Straley-Eason KD, Smoak BL, Johnson LD, Lee SR, Kaplan EL. 45-year follow-up of hepatitis C virus infection in healthy young adults. Ann Intern Med. 2000 Jan 18;132(2):105-11. doi: 10.7326/0003-4819-132-2-200001180-00003.
Clinical trial NCT00760032: Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients
Official title: Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cirrhosis
Ascites
Infections
Keywords: Cirrhosis
Ascites
Lipopolysaccharide binding protein
Infections
Cytokines
Ciprofloxacin
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Laboratorios Senosiain, S.A. de C.V.
First posted: 2008-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis
* Ascites
* No history of spontaneous bacterial peritonitis and/or \< 1 g of protein in ascites
* No antibiotic use in previous 6 weeks
* Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
* Absence of GI bleeding or encephalopathy
* Signature of informed consent

Exclusion Criteria:

* Ciprofloxacin contraindication
* Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
* \> 13 Child-Pugh points
* Inability to attend to regular visits
* Current alcohol intake
* Terminal disease with \< 24 week expected survival

Primary outcomes:
measure: Lipopolysaccharide binding protein plasma levels
timeFrame: 24 weeks
Secondary outcomes:
measure: Severe infection
timeFrame: 24 weeks
measure: Pro- and anti-inflammatory cytokine secretion by PBMN cells
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: D.f.
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Florencia Vargas-Vorackova, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04877132: Compassionate Use Program for Olipudase Alfa Enzyme Replacement Therapy for Patients With Chronic Acid Sphingomyelinase Deficiency (ASMD)
Official title: Compassionate Use Program for Olipudase Alfa Enzyme Replacement Therapy for Patients With Chronic Acid Sphingomyelinase Deficiency (ASMD)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Sphingomyelin Lipidosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-05-07
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The objective of this program is to provide access to enzyme replacement therapy (ERT) with olipudase alfa for certain patients with ASMD, a severe, life threatening disease, that could not participate in the olipudase clinical trials. The program will provide access to olipudase alfa prior to registration and the availability of commercial product (including reimbursement where applicable) in the country of the patient.


Eligibility criteria: Inclusion Criteria:

All patients (adult and pediatric)

* Unsolicited request for the patient from a site with at least 3 years of experience in administration and safety management of ERT.
* Written informed consent signed by the patient or the patient's parent(s)/guardian(s), where applicable.
* Documented deficiency of acid sphingomyelinase in peripheral leukocytes, lymphocytes, or cultured fibroblasts.

Adult patients

* Age ≥ 18 years.
* Clinically documented advanced disease evidenced by defined thresholds for lung, spleen, liver, and hematologic parameters.

Pediatric patients

- Age \>3 years and \<18 years or clinical diagnosis consistent with ASMD Type A/B or Type B.

Exclusion Criteria:

All patients (adult and pediatric)

* Active serious intercurrent illness which will preclude enrollment, significant liver disease with etiology other than ASMD, Malignancy with poor prognosis, serious medical or psychiatric condition that may preclude participation, or circumstances that may interfere with compliance in this compassionate use program, requirement for recurrent dose adjustment of anticoagulation treatment over the last 6 months.
* Pregnancy or breastfeeding.
* For female patients of childbearing potential, a positive serum pregnancy (β human chorionic gonadotropin \[HCG\]) test result.
* For female patients of childbearing potential and sexually active male patients, unwillingness to abstain from heterosexual intercourse in accordance with their preferred and usual lifestyle, or to use 2 acceptable, effective contraceptive methods, while participating in this program and for 15 days after the last infusion of olipudase alfa.
* For pediatric patients, clinical diagnosis, or suspicion of infantile onset ASMD. Genotype compatible with ASMD type A.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT02331732: Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Lead sponsor: The Behavioural Insights Team
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial aims to increase the wellbeing of tuberculosis patients and their adherence to medication in Chisinau, The Republic of Moldova. The design is an individually randomised controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of treatment. The trial will have two arms; 200 patients will form the control group and receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually Observed Treatment (VOT).

VOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video messages rather than in-person. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. VOT allows patients to take their treatment in the comfort of their home and means they don't have to travel to their polyclinic every day.

There will be a central VOT observation centre where VOT observers will view and respond to video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health app. The VOT observers will also respond to the patients by sending feedback to the patients. The trial duration will depend on the recruitment rate of eligible patients but is expected to take 16 months.


Eligibility criteria: Inclusion Criteria:

1. Consent to being part of the trial
2. Live in Chisinau and no plans to move away from Chisinau during the four months
3. Aged 18 or over
4. At least four months of care remaining

Exclusion Criteria:

1. Having MDR-TB
2. Homeless
3. Is not homeless
4. Suffer from alcoholism or drug misuse
5. In prison
6. Has a treatment regimen with injections

Primary outcomes:
measure: Adherence to medication
timeFrame: 2 weeks
Secondary outcomes:
measure: Adherence 80%
timeFrame: 2 weeks
measure: Patient wellbeing
timeFrame: Collected at 4 months
measure: Patient satisfaction
timeFrame: Collected at 4 months
measure: Travel and time cost of treatment borne by patient, self reported.
timeFrame: Collected at 4 months
measure: Employment, self reported
timeFrame: Collected at 4 months
measure: Treatment success
timeFrame: Collected at 4 months
measure: Body mass index (BMI)
timeFrame: Collected at 4 months
measure: Side effects reported during treatment
timeFrame: Collected at 4 months
Other outcomes:
Locations:
Study officials:
References:
citation: Ravenscroft L, Kettle S, Persian R, Ruda S, Severin L, Doltu S, Schenck B, Loewenstein G. Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova. Eur Respir J. 2020 Aug 6;56(2):2000493. doi: 10.1183/13993003.00493-2020. Print 2020 Aug.
Clinical trial NCT02951832: Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphocyte Subsets in Women of Child-bearing Age
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy women of child-bearing age

Brief summary: The investigators are going to select the normal child-bearing period women as the study subjects and draw their peripheral blood to observe and analyze the change of quantity and percentage of lymphocyte subsets along with the change of menstrual cycle.

Recording their BMI\\menstrual history\\and childbearing history, the investigators would select 300 healthy women in 6 different age groups which are aged 20-24, aged 25-29, aged 30-34, aged35-39, aged 40-44 and aged 45-49, then draw 1-2 ml blood form their peripheral vein (adding EDTA for anti-coagulation). The investigators are going to perform routine examination on the blood samples and detect T\\B\\NK lymphocyte through flow cytometry (FCM), thus calculating the absolute number of every species of lymphocyte. The investigators make assessment for the cellular immune function of the women during child-bearing period via comparing distinction in percentage and absolute number of every lymphocyte subset among reproductive-age women in different ages.


Eligibility criteria: Inclusion Criteria:

* Women aged 20-49;
* Having a regular menstrual cycle of which the menstrual period is between day 3-7, and the period between day 25-35;
* Excluding internal and surgical disease (after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine).

Exclusion Criteria:

* Having experienced severe allergies, trauma history and/or operation history within 3 months;
* With a history of mental illness and/or family history of mental illness;
* Limb disabled;
* Taking medicine within one month;
* Suffering major events or having mood swings.

Primary outcomes:
measure: the percentage of lymphocyte subsets
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai first Maternity and Infant health hospital, Tong Ji University
Study officials:
affiliation: Shanghai First Maternity and Infant Hospital
name: Tao Duan
role: STUDY_CHAIR
References:
Clinical trial NCT06519032: Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI
Official title: Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacterial Infections
Lead sponsor: GramEye
Sponsor class: INDUSTRY
Collaborators: name: Osaka University
name: Keio University
name: Fukujuji Hospital
First posted: 2024-07-25
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specimens for microbiological testing, such as acid-fast bacilli(AFB) smear test , ordered at the hospital.

Brief summary: The goal of this observational study is to develop AI that detects and classifies Acid-Fast Bacilli from microscope images using anonymized and fixed glass slides.


Eligibility criteria: Inclusion Criteria:

* Patients in whom acid-fast bacilli(AFB) smear test was ordered

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Rate of concordance between AI-estimated results with actual culture results regarding the presence or absence of acid-fast bacteria
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Osaka University Medical Hospital
name: Satoshi Kutsuna, PhD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00207532: Dosage Effects of Folic Acid on Blood Folates of Honduran Women
Official title: Dosage Effects of Folic Acid on Blood Folates of Honduran Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spina Bifida and Anencephaly
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Ministry of Health, Honduras
name: Project Healthy Children
First posted: 2005-09-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: CDC staff at the National Center on Birth Defects and Developmental Disabilities have been working closely with a Honduras-based organization, Project Healthy Children (PNS) and the Ministry of Health, on a folic acid supplementation study among female maquila workers. Participants are divided into two groups. One group receives a 1.0 milligram pill daily while the other group receives a 5.0 milligram pill weekly. The aim of this study is to assess serum blood folate levels measured at baseline, midpoint, and endpoint of the study. Hypothesis: Folic acid (5mg)given once weekly is as effective as folic acid (1mg)given daily in raising blood folate levels.


Eligibility criteria: Inclusion Criteria:

minimum employment in factory 6 mths

-

Exclusion Criteria:

* pregnant
* currently consuming folic acid
* prior birth-defect affected pregnancy
* chronic disease
* currently taking folic acid antagonist

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Pedro Sula
country: Honduras
facility: PROTEXSA
Study officials:
affiliation: Project Healthy Children (Honduras)
name: Gayle Milla
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837732: Effectiveness of Relational Touch in Painful Elderly
Official title: Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
elderly
relational touch
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 74
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to investigate the feasibility and efficacy of a relational touch / relational intervention on persistent pain in a long term geriatric hospital care ward population. The main issue is the pain reduction. The hypothesis is that this type of intervention is very useful on pain reduction in old people even with physical or mental disability.

Detailed description: The first 74 patients wanting to participate are randomly assigned to 2 groups: relational- touch or relational. Inclusion criteria are : patients with chronic pain; age \>65y and informed consent. Where patients had mental impairment the family's agreement is solicited. The regional Ethics Committee agreement was granted. The intervention consists of 6 Relational versus Relational- Touch sessions (twice a week) .Evaluation takes place after the second, 4th and 6th sessions and in the 4th week following the intervention. The main outcome is the pain reduction.

The primary outcome measure is the pain reduction according to the DOLOPLUS scale and the VRS; the secondary outcomes measures are : patient's participation rate; pain related symptoms variation; overall benefit.

Eligibility criteria: Inclusion Criteria:

* Age \>65 y
* Chronic pain \> 3 months
* Follow up 4 weeks
* Patient's speak french
* Patient's or representative's agreement to participate and to the informatics treatment of the data

Exclusion Criteria:

* acute pain
* unstable clinical status

Primary outcomes:
measure: SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)
timeFrame: change from baseline to 4th week
Secondary outcomes:
measure: Scale of Guy (Pain related symptoms)
timeFrame: at 3th week and 4th week
measure: Global benefit questionary
timeFrame: 2 sessions per week for 4 weeks and one after the 6 sessions
measure: Acceptability rate at each session
timeFrame: 2 sessions per week for 3 weeks and in 4 th week
measure: score variations of Verbal Rating Scale (VRS)
timeFrame: change from baseline to 4th week
measure: Global benefit questionary (nurse, doctor, carer)
timeFrame: after the 6 sessions
Other outcomes:
Locations:
city: Sevran
country: France
facility: Hopital René Muret - Head of department Long Term hospital ward
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe JOSEPH-SYLVESTRE, Nurse
role: STUDY_DIRECTOR
References:
Clinical trial NCT01644032: Telemedically Supported Analgesia in the Emergency Medical Service
Official title: Telemedically Supported Analgesia in the Emergency Medical Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indication for Analgesia
Emergency Medical Service
Teleconsultation
Keywords: telemedicine
teleconsultation
analgesia
emergency
prehospital
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the safety and efficacy of telemedically supported and delegated pain therapy in the Emergency Medical Service (EMS).

Detailed description: Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team and can delegate the application of morphine and other analgesics. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene.

All regular ambulances of the five districts are not allowed to administer analgesics without an physician on-scene. They have to call an Advanced Life Support response unit, staffed with an EMS physician, who carries out all kinds of ALS interventions.

The safety, efficacy and the quality of analgesia should be compared with regular EMS.

Eligibility criteria: Inclusion Criteria:

* Verbal consent obtained or patient is unable to consent due to the severity of the emergency
* Indication for analgesia

Exclusion Criteria:

* Refused consent
* No indication for analgesia

Primary outcomes:
measure: Rate of complications
timeFrame: 2 hours
Secondary outcomes:
measure: Pain level
timeFrame: average 1 hour
measure: Incidence of nausea and vomiting
timeFrame: 2 hours
measure: Time intervals
timeFrame: average 1 hour
measure: Medications and dosages
timeFrame: average 1 hour
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
affiliation: University Hospital Aachen, Germany, Department of Anesthesiology
name: Rolf Rossaint, Prof. Dr.
role: STUDY_CHAIR
affiliation: University Hospital Aachen, Germany, Emergency Department
name: Jörg Brokmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References: