louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01337791: Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Pregnancy Complications
High Viral Load
Elevated Alanine Aminotransferase Levels
Keywords: chronic hepatitis B
hepatitis B virus
perinatal transmission
Telbivudine
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.


Eligibility criteria: Inclusion Criteria:

* age between 20-40 years
* gestational age between 12-30 weeks
* serum HBsAg and HBeAg positivity
* HBV DNA levels \>6log10 copies/mL
* ALT \>1x ULN (40 IU/mL) and \< 10x ULN.

Exclusion Criteria:

* co-infection with hepatitis A, C, D, E or HIV
* evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity
* concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
* clinical signs of threatened miscarriage in early pregnancy
* evidence of fetal deformity by 3-dimensional ultrasound examination
* the biological father of the child had CHB

Primary outcomes:
measure: The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety
timeFrame: From late pregnancy to 28 weeks of postpartum
Secondary outcomes:
measure: Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg
timeFrame: From late pregnancy to 28 weeks of postpartum
Other outcomes:
Locations:
city: Nan Jing
country: China
facility: Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University
state: Jiang Su
Study officials:
References:
citation: Pan CQ, Han GR, Jiang HX, Zhao W, Cao MK, Wang CM, Yue X, Wang GJ. Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B. Clin Gastroenterol Hepatol. 2012 May;10(5):520-6. doi: 10.1016/j.cgh.2012.01.019. Epub 2012 Feb 14.
Clinical trial NCT03486691: Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery
Official title: Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty

Detailed description: the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the other group ultrasound not routinely done.

Eligibility criteria: Inclusion Criteria:

* Morbidly obese patient with BMI more than 40 with or without co-morbidity
* Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria:

* Unfit patients for laparoscopy
* patients refuse to share in the study
* revisional surgery for obesity
* previous upper abdominal surgery

Primary outcomes:
measure: intraoperative maximum diameter of left lobe of the liver
timeFrame: 4 hours
measure: score of difficulty
timeFrame: 6 hours
Secondary outcomes:
measure: operative time
timeFrame: 6 hours
measure: incidence of intraoperative complications
timeFrame: 3 days
measure: early postoperative complications
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Minia University
name: Alaa M Sewefy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04568291: CTC in Lung Caner Patients With Bone Metastases
Official title: Clinical Reasearch on Three Dimensional Bionic Capture Network Circulating Tumor Cell in Lung Caner Patients With Bone Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Bone Metastases
Single Cell Sequencing Technology
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Evaluate the feasibility of single cell sequencing technology based on three-dimensional bionic capture network;
2. To build a risk prediction model of bone related events based on single cell sequencing;
3. To verify the risk prediction model of bone related events by single cell sequencing;
4. To verify the comprehensive treatment of non-small cell lung cancer ( NSCLC) bone metastases.


Eligibility criteria: Inclusion Criteria:

1. age 18-75 years
2. pathology-proven diagnosis of lung cancer and radiographical/pathological evidence of BM
3. no previous treatment for BM
4. good general condition (Eastern Cooperative Oncology Group, ECOG Performance scores: 0-2) with an estimated survival time \> 3 months.

Exclusion Criteria:

-

Primary outcomes:
measure: SREs（Skeletal related events）
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People'S Hospital
state: Other (Non U.s.)
Study officials:
References:
Clinical trial NCT02737891: Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Official title: A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Two-center, Safety and Efficacy Study of Co-administration of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Saniona
Sponsor class: INDUSTRY
Collaborators: name: Profil Institut für Stoffwechselforschung GmbH
First posted: 2016-04-14
Enrollment: 60
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: TREATMENT

Brief summary: Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus

Detailed description: This is a double-blind, randomized, placebo-controlled, multiple-dose, two-center, safety and efficacy study of co-administration of tesofensine/metoprolol treatment in subjects with T2DM. Study medication will be administered for ninety (90) days (+2 days after the final assessments with half-dose of metoprolol). Following all baseline assessments, eligible subjects will be randomly assigned to one of the two arms (1:1).

Eligibility criteria: Inclusion Criteria:

1. Males and females
2. Confirmed diagnosis of T2DM
3. 18-70 years of age
4. HbA1c ≥7.0%

Exclusion Criteria:

1. Hypersensitivity to tesofensine/metoprolol
2. Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure
3. History of myocardial infarction or stroke within 12 months prior to enrolment
4. History of coronary revascularisation or angioplasty in the last 12 months prior to enrolment
5. Patients reporting angina in the last 6 months prior to enrolment
6. Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs
7. Any clinically significant cardiac arrhythmia

Primary outcomes:
measure: Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
timeFrame: Baseline to Day 90
Secondary outcomes:
measure: Change From Baseline to End of Treatment in HbA1c
timeFrame: Baseline to Day 90
measure: Change From Baseline to End of Treatment in Body Weight
timeFrame: Baseline to Day 90
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Saniona
name: Jørgen Drejer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05356091: Quality of Recovery of Remimazolam Versus Sevoflurane in Transurethral Bladder Resection.
Official title: Comparison of Postoperative Recovery Quality Between Sevoflurane and Remimazolam for General Anesthesia for Transurethral Resection of Bladder Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Recovery
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Hana Pharm Co., Ltd.
First posted: 2022-05-02
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was designated to investigate the quality of recovery after transurethral bladder resection. Because, patients undergoing transurethral bladder resection are mostly old age, and because of catheter-related bladder discomfort are common after transurethral bladder resection, study on the quality of recovery after transurethral bladder resection seems to be meaningful. In general, sevoflurane is commonly used as an anesthetic agent for general anesthesia of transurethral bladder resection. The purpose of this study is to investigate whether remimazolam is not inferior to sevoflurnane in terms of quality of recovery after transurethral bladder resection.


Eligibility criteria: Inclusion Criteria:

* adult patients aged from 19 years
* Americaln Society of Anesthesiologist's class I, II, and III
* scheduled to undergo elective transurethral bladder resection under general anesthesia

Exclusion Criteria:

* refuse to participate in the study
* cannot read, or sign the consent form (e.g., iliterate, foreigner, eye disease)
* history of allergy to benzodiazepines
* decreased liver, kidney, or heart function
* pregnant women or breastfeeding patients
* history of drug or alcohol abuse
* obesity (body mass index \> 30kg/m2)

Primary outcomes:
measure: Quality of recovery -15 score at postoperative day 1
timeFrame: postoperative day 1
Secondary outcomes:
measure: Catheter related bladder discomfort
timeFrame: 5 minutes, and 1 hour after post-anesthesia circuit unit arrival.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eunah Cho
Study officials:
affiliation: KangbukSamsung Hospital
name: Eunah Cho, Pf.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00999791: Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diffuse Diabetic Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-10-22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.

Detailed description: Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.

Eligibility criteria: Inclusion Criteria:

* patients with clinically significant macular edema and diffuse macular edema

Exclusion Criteria:

* any history of focal photocoagulation
* any prior intra ocular injection
* history of glaucoma with high pressure
* history of ophthalmic surgery
* high rish PDR
* active PDR

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT04830891: A Volunteer Study to Collect Imaging Data for the Development and Validation of ScanNav Anatomy PNB
Official title: A Volunteer Study to Collect Imaging Data for the Development and Validation of Intelligent Ultrasound ScanNav Anatomy PNB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Imaging of Anatomical Structures
Lead sponsor: IntelligentUltrasound Limited
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers will be sourced initially from Intelligent Ultrasound's employees. If additional volunteers are required, adverts will be placed online. Intelligent Ultrasound will make cash payments of up to £40 to non-employee volunteers, to compensate them for their time

Brief summary: This is a single-centre, prospective, non-randomised volunteer study to be undertaken in Intelligent Ultrasound's offices at Hodge House, 114-116 St Mary Street, Cardiff, CF10 1DY, UK.

Detailed description: This is a single-centre, non-randomised, prospective study involving up to 100 participants. The data collected in this study will augment the data collected in ML2018_AG_01, ML2018_AG_02, IU2019_AG_03, and IU2020_AG_04.

Phase I Collect data from participants for each indicated block area. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.

Phase II Validation will proceed by feeding the videos into the ScanNav AnatomyGuide system and recording the output anatomy highlighting, overlaid on the original ultrasound image. The overlaid video will be examined by experts to identify safety and performance issues.

Eligibility criteria: Inclusion Criteria:

Potential participants who meet the following criteria will be considered eligible for the study:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

Potential participants who meet the following criteria will NOT be eligible for the study:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent;
3. Previous surgery or trauma to the affected area.

Primary outcomes:
measure: Change in per-class Mean Intersection over Union (IoU) scores of deep-learning segmentation models compared to baseline models
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Intelligent Ultrasound Limited
state: Wales
Study officials:
affiliation: Clinical consultant, University of Oxford & Royal Gwent Hospital
name: James Bowness
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01259791: Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Official title: Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Statin Myopathy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy.


Eligibility criteria: Inclusion Criteria:

* history of muscle symptoms occuring within 3 weeks of starting a statin
* need for statin therapy to achieve LDL target according to the 2009 Canadian Lipid Guidelines
* willingness to re-try statin therapy

Exclusion Criteria:

* currently tolerant of statin therapy
* metabolic or inflammatory myopathy
* known neuropathy
* CK elevation \>3 times upper limit of normal (ULN) previously on a statin or history of rhabdomyolysis
* pregnant, breastfeeding, or wanting to become pregnant in the near future
* participation in another clinical trial
* other medical condition associated with decreased life span
* inability to adhere to stringent regimen
* unwilling to stop consumption of grapefruit juice

Subset of 5 patients also completing neuromuscular testing:

Inclusion Criteria:

- same as above

Exclusion Criteria:

* same as above but also:
* angina III of IV
* decompensated heart failure
* history of orthopedic problems
* have any skin ulcers or other non-healed skin areas or infections in the arm or leg

Primary outcomes:
measure: To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.
timeFrame: Duration of study September 2010 to August 2013
Secondary outcomes:
measure: To delineate the relation of objective changes in non-invasive neuromuscular testing to subjective symptoms during the first exposure to active or placebo therapy, in subset of 5 patients with prior history of statin myopathy.
timeFrame: September 2010 to August 2013
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care, UWO
name: Tisha Joy, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joy TR, Monjed A, Zou GY, Hegele RA, McDonald CG, Mahon JL. N-of-1 (single-patient) trials for statin-related myalgia. Ann Intern Med. 2014 Mar 4;160(5):301-10. doi: 10.7326/M13-1921.
Clinical trial NCT00302991: Quality of Life and Adverse Effects in Epilepsy Patients (EPIKA)
Official title: Quality of Life and Adverse Effects in Epilepsy Patients According to Treatment Group (EPIKA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Observational
cross-sectional
health-related quality of life
adverse effects
Baker´s AEP scale validation
epilepsy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-03-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: Observational, multicentre, epidemiological study to determine the HRQOL of patients with epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (AED), patients receiving a "classic" AED; patients receiving combination therapy.


Eligibility criteria: Inclusion Criteria:

* Epileptic adult patients treated at a stable dose with one or more AEDs for ≥ 3 months

Exclusion Criteria:

* Symptomatic epilepsy due to malignant brain tumour or progressive brain disease.
* Confirmed diagnosis of a concomitant chronic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial M. Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02419391: Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
Official title: A Randomized, Single-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV Vaccines
Respiratory Syncytial Virus Vaccines
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A total of 63 subjects will be recruited into three groups (18 subjects per group will receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen suspension of MVA BN RSV.

Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per 0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.


Eligibility criteria: Inclusion Criteria:

* signed and dated an informed consent form
* Body mass index ≥ 18.5 and \< 35.
* Women of childbearing potential (WOCBP) must have used an acceptable method of contraception

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
* History of any serious medical condition.
* History of or active autoimmune disease.
* Known or suspected impairment of immunologic functions.

Primary outcomes:
measure: Occurrence of serious adverse events
timeFrame: Screening up to week 34 after first vaccination
measure: Occurrence of grade 3 adverse events
timeFrame: Screening up to week 8 after first vaccination
measure: Solicited local adverse events
timeFrame: day of vaccination and the following seven days
measure: Unsolicited non-serious adverse events
timeFrame: within four weeks after each vaccination
measure: Solicited general adverse events
timeFrame: day of vaccination and the following seven days
Secondary outcomes:
measure: Vaccinia-specific cellular immune responses.
timeFrame: cellular immune response measured up to week 4 after 2nd vaccination
measure: RSV-specific humoral immune response
timeFrame: humoral immune response is measured up to week 34
measure: RSV-specific humoral immune response
timeFrame: humoral immune response is measured up to week 34
measure: RSV-specific humoral immune response
timeFrame: humoral immune response is measured up to week 34
measure: Vaccinica-specific humoral immune response
timeFrame: humoral immune response is measured up to week 34
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clin-Trials (JCCT)
state: Kansas
Study officials:
affiliation: Johnson County Clin-Trials (JCCT)
name: Casey Johnson, DO
role: PRINCIPAL_INVESTIGATOR
References: