louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01481649: Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure
Official title: Risk of Hepatitis B Reactivation After Hematopoietic Stem Cell Transplantation in Donors and Recipients With Prior HBV Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure to Hepatitis B Virus
Keywords: hepatitis B
anti-HBc
HBsAg
HSCT
recipients
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 69
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: Patients referred for hematopoietic stem cell transplantation (HSCT) in Hong Kong

Brief summary: The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation (HSCT).

Detailed description: Occult hepatitis B virus (HBV) reactivation has been documented in bone marrow transplantation recipients who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 50 such bone marrow transplant recipients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.

Eligibility criteria: Inclusion Criteria:

* Documented HBsAg-negative HSCT recipient with or without antibody to the hepatitis B surface antigen (anti-HBs).
* Documented anti-HBc (total)-positive.

Exclusion Criteria:

* Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
* Significant alcohol intake (\>30 grams per day)

Primary outcomes:
measure: HBV reactivation (defined as detectable HBV DNA >20 IU/mL)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wai-Kay Seto, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seto WK, Chan TS, Hwang YY, Wong DK, Fung J, Liu KS, Gill H, Lam YF, Lau EHY, Cheung KS, Lie AKW, Lai CL, Kwong YL, Yuen MF. Hepatitis B reactivation in occult viral carriers undergoing hematopoietic stem cell transplantation: A prospective study. Hepatology. 2017 May;65(5):1451-1461. doi: 10.1002/hep.29022. Epub 2017 Mar 22.
Clinical trial NCT01091649: Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics, Safety
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.

Detailed description: This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.

Eligibility criteria: Inclusion Criteria

* Overall healthy subjects
* Non-childbearing potential females included

Exclusion Criteria

* Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
* Use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
* Abnormal screening laboratory results that are considered clinically significant by the investigator
* Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
* Previous exposure to ABT-450

Primary outcomes:
measure: Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
timeFrame: 72 hrs post dose
measure: Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir
timeFrame: 72 hrs post dose
Secondary outcomes:
measure: To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir
timeFrame: Through 30 days post last dose.
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 27781
state: Illinois
Study officials:
affiliation: Abbott
name: Adebayo Lawal, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01921049: Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery
Official title: Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammatory Response Syndrome (SIRS)
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-08-13
Enrollment: 27
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: all patients undergoing major procedures in oral and maxillofacial surgery during the study period

Brief summary: Patients undergoing major procedures in oral and maxillofacial surgery more often develop a systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical care therapy than patients with a comparable major surgery in other regions. The reasons for this finding are unknown and have not been studied in depth so far. We hypothesize that surgical trauma in this region might activate pro-inflammatory pathways. By examining the proteome of patients at different stages (prior to the surgery, at ICU admission, on the second postoperative day and when SIRS has ended clinically), we aim to identify the involved pro-inflammatory pathways and identify possible target proteins that might be clues to modification of postoperative SIRS in the future.


Eligibility criteria: Inclusion Criteria:

* age 18-99yrs
* scheduled for elective surgery with risk for development of SIRS
* written and informed consent

Exclusion Criteria:

* age \<18yrs
* pregnancy
* emergency surgery
* failure to obtain patient consent

Primary outcomes:
measure: change of concentration of pro-inflammatory cytokines [µg/l]
timeFrame: up to 10 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
Study officials:
affiliation: Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
name: Wolfgang A. Wetsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01389349: Acupuncture for Tonsillectomy Pain
Official title: Acupuncture for Tonsillectomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Postoperative Pain
Tonsillar Hypertrophy
Obstructive Sleep Apnea
Chronic Tonsillitis
Keywords: tonsillectomy
adenotonsillectomy
acupuncture
children
postoperative pain
postoperative nausea
Lead sponsor: Children's ENT of San Diego, Inc.
Sponsor class: OTHER
Collaborators: name: Rady Children's Hospital, San Diego
First posted: 2011-07-08
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain after tonsillectomy can be severe and last ten days.

Various new surgical instruments have been developed over the years in an attempt to reduce postoperative pain with mixed results and increased costs; no single tonsillectomy technique is superior to the rest. Patients are discharged to home usually on the day of surgery and often suffer significant pain and nausea. Pain medication is often prescribed which can cause nausea, vomiting and constipation. Children in pain are reluctant to take in fluids and may require intravenous hydration at an emergency department.

"Battlefield acupuncture " has been recently developed by the US Air Force and is now being used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma. This protocol consists of five acupuncture points on the outer ear.

A recent study has demonstrated decreased pain and agitation in children undergoing ear tube insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are able to attend school the next day.

The investigators have been encouraged by the benefits of acupuncture during surgery for ear tube patients and also wounded warriors recovering from their injuries. These findings motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and nausea.


Eligibility criteria: Inclusion Criteria:

* Children 2 to 17 years of age who need tonsillectomy with or without adenoidectomy with or without myringotomy tube(s)

Exclusion Criteria:

* Developmental Delay

Primary outcomes:
measure: Pain Response
timeFrame: Postoperative days 1 and 6
Secondary outcomes:
Other outcomes:
Locations:
city: El Centro
country: United States
facility: Children's Specialty Clinic
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
Study officials:
References:
Clinical trial NCT02235649: Exploring the Feasibility of Social Skills Training in People With Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reduced social and community functioning is a predominant and enduring feature in people experiencing severe mental illness such as psychosis. The large majority of interventions (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and delusions) but poorly address functional and social consequences of the illness.

This study attempts to fill this gap by assessing the feasibility and acceptability of a psychological intervention targeting social cognition deficit in people with psychosis. The intervention is a group psychological treatment facilitated by a clinical psychologist targeting competencies such as emotion recognition, social situation appraisal and guessing people's intentions and mental states. The group therapy takes advantage of audiovisual material to illustrate strategies and thinking styles that may help participants to overcome difficulties in social settings.

A second objective of this study is to test a new method to measure social cognition. Recent research showed that interview and performance based tests are poorly associated with every day activity of people with schizophrenia. This study is planning to evaluate the feasibility of new assessment methods for social cognition in everyday life using portable electronic devices (Experience Sampling Method and an activity watch). These devices will be carried by participants in their everyday life and will ask about feelings and levels of social activities at random times and record basic physiological and activity levels.


Eligibility criteria: Inclusion Criteria:

Diagnosis part of the psychosis spectrum (according to DSM-IV or DSM-V or ICD-10); age 18-65 yrs; good command of the English language; social engagement problems as evidenced by care coordinator report and number of hours spent in social activities per week lower than 10.

Exclusion Criteria:

Primary diagnosis of substance abuse disorder; change in antipsychotic medication in the last six weeks; significant learning difficulties (premorbid IQ lower than 70).

Primary outcomes:
measure: Feasibility and Acceptability
timeFrame: 10 weeks
Secondary outcomes:
measure: Effectiveness (i.e. social behaviour and social cognition)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, King's College London
Study officials:
References:
Clinical trial NCT05967949: A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.
Official title: A Retrospective (Non-interventional) Clinical Study on the First-line Maintenance Treatment of Peripheral T-cell Lymphoma (PTCL) With Chidamide.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PTCL
Keywords: chidamide
maintenance treatment
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults diagnosed with PTCL, who have undergone first-line treatment and are using chidemide as maintenance therapy.

Brief summary: The efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be assessed through a retrospective case analysis.

Detailed description: The study design belongs to a retrospective study, collecting information on patients with PTCL who were diagnosed and treated with chidamide as maintenance therapy at our center. The collected data includes age, gender, previous treatment regimens, results of auxiliary examinations (such as blood routine, biochemistry, bone marrow cytology, pathology, flow cytometry, NGS, etc.), as well as PET-CT images. The safety and efficacy of Chidemide as first-line maintenance therapy in PTCL will be analyzed.

Eligibility criteria: Inclusion Criteria:

* (1) Age: 18 years and older; (2) Gender: Male/Female; (3) Diagnosed with PTCL; (4) Received chidamide as maintenance therapy after first-line treatment.

Exclusion Criteria:

* (1) Patients with other types of lymphomas; (2) Pregnant women.

Primary outcomes:
measure: PFS
timeFrame: 2 years
Secondary outcomes:
measure: OS
timeFrame: 2 years
measure: CR
timeFrame: 2 years
measure: DOR
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hematological Department, People's Hospital of Jiangsu Province
state: Jiangsu
Study officials:
References:
Clinical trial NCT02134249: Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Official title: Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: infertility
ICSI
OHSS
Diosmin
Cabergoline
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Detailed description: Two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.

Eligibility criteria: Inclusion Criteria: infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin syndrome (PCO) with one of the following:

1. Presence of more than 20 follicles by ultrasound
2. E2 more than 3000 pg/ml
3. Retrieval of more than 15 follicles

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of participants with ovarian hyperstimulation syndrome (OHSS)
timeFrame: every week for eight weeks
Secondary outcomes:
measure: pregnancy rate
timeFrame: 14 days after embryos transfer
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha Universty
state: El Qalubia
city: Benha
country: Egypt
facility: Benha univesity hospital
state: El Qualyobia
Study officials:
affiliation: Department of Obstetrics and Gynecology, Benha University Hospital
name: khalid mohamed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Benha University Hospital
name: ahmed samy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.
Clinical trial NCT02886949: The Association Between Autoimmune or Inflammation and Thyroid Disease
Official title: The Relationship of Vascular Cell Adhesion Molecule 1, C-reactive Protein, Brain-derived Neurotrophic Factor, Orexin and Depressive Symptoms in the Subjects With Thyroid Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: THYROTOXICOSIS
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with a suspicion of thyroid disease.

Brief summary: This study aims to evaluate the effects of thyroid functions on energy homeostasis and inflammation.

Detailed description: The subjects were enrolled for evaluation of thyroid functions. The associations between thyroid function and energy homeostasis and inflammation will be assessed.

Eligibility criteria: Inclusion Criteria:

* Subjects visits outpatient department due to a suspicion of thyroid disease

Exclusion Criteria:

* Psychological disorders, severe inflammatory or infection diseases.

Primary outcomes:
measure: brain-derived neurotrophic factor
timeFrame: 3 months
Secondary outcomes:
measure: vascular cell adhesion molecule 1 (VCAM-1)
timeFrame: 3 months
measure: C-reactive protein (CRP)
timeFrame: 3 months
measure: Orexin
timeFrame: 3 month
measure: Zung Self-Rating Depression Scale (Zung SDS)
timeFrame: 3 month
measure: Body composition
timeFrame: 3 month
measure: ankle brachial index (ABI)
timeFrame: 3 months
measure: pulse wave velocity (PWV)
timeFrame: 3 months
measure: mean arterial pressure (MAP)
timeFrame: 3 months
Other outcomes:
Locations:
city: Taichang
country: Taiwan
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: I-Te Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357849: Fluoxetine vs Aripiprazole Comparative Trial (FACT)
Official title: The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Attenuated Psychosis Syndrome
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.

Detailed description: To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects

Eligibility criteria: Inclusion Criteria:

* consent obtained from patients and their parents (assent for patients under 18);
* age 12-25 years (inclusive);
* English-speaking;
* at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.

Exclusion Criteria:

* lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features;
* current psychosis (any positive symptom SOPS score of 6, i.e., extreme);
* current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features;
* current stimulant treatment;
* history of neurological, neuroendocrine or other medical condition known to affect the brain;
* any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine;
* past or current substance dependence; sunstance abuse within the last 4 weeks;
* IQ \< 70.

Primary outcomes:
measure: Time to Treatment Failure
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Prodromal Symptoms (SOPS) Total Scores
timeFrame: 24 weeks
measure: Number of Patients With Specific Adverse Effects
timeFrame: 24 weeks
measure: Change in Social and Role Functioning Scores
timeFrame: 24 weeks
measure: Subjective Well-being Questionnaire
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: North Shore LIJ
name: Christoph U Correll, MD
role: PRINCIPAL_INVESTIGATOR
References: