louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05683951: Clinical Trial to Evaluate the Efficacy and Safety of DWKH
Official title: Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Infection
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 186
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, Double-blind, Parellel, Multicenter, Active-controlled


Eligibility criteria: Inclusion Criteria:

* Male and female aged between 19 and 80.
* Patients whose BSS score is over 5.

Exclusion Criteria:

* Patients allergic to any ingredients of the study drugs.
* Moderate liver disease (ALT or AST \> UNLx3).
* Moderate lung disease.
* Uncontrolled HTN.
* Uncontrolled DM.
* Uncontrolled thyroidism.
* Patients who is needed antibiotics during the study period.
* In the case of women, pregnant(Urine-HCG positive) or lactating women.

Primary outcomes:
measure: Bronchitis severity score (BSS)
timeFrame: 0,4,7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
Clinical trial NCT01590251: Yoga for Pain and Opioid Dependence
Official title: Yoga for Pain and Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pain
Opioid Addiction
Keywords: Pain
Addiction
Buprenorphine
Counseling
Methadone
Yoga
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.

Detailed description: This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD).

Specific Aims:

1) To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Prescription opioid addiction or heroin addiction
* Moderate to severe chronic pain,
* Understands English

Exclusion Criteria:

* Current suicide or homicide risk
* Life threatening or unstable medical condition
* Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician
* Pregnancy

Primary outcomes:
measure: Pain reduction
timeFrame: 8 weeks
measure: Reduce illicit opioid use
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: MRU
state: Connecticut
Study officials:
affiliation: Yale University
name: Declan T Barry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00902551: DNA Cytometry for Cervical Cancer Screening in China
Official title: Comparison of DNA Image Cytometry and Conventional Cytology for Cervical Cancer Screening in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: DNA cytometry
Cytology
Diagnosis accuracy
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 25000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women

Brief summary: Very few screenings of any kind will be possible during a woman's lifetime in most low-resource regions, where 80% of the half-million global cases of cervical cancer occur every year. Although a single round of human papillomavirus (HPV) testing was associated with a significant decline in the rate of advanced cervical cancers and associated deaths, whether other methods like as DNA image cytometry can be used as an more accurate means than others in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both DNA image cytometry and conventional cytology is not well known. The investigators hypothesized that DNA image cytometry was superior in screening cervical cancer than conventional cytology.


Eligibility criteria: Inclusion Criteria:

* Currently or had been married
* Not pregnant
* Had an intact uterus with no prolapse
* Had no history of cervical cancer
* Living in China

Exclusion Criteria:

* Not willing to participate or finish the study at any time
* History of cervical surgeries

Primary outcomes:
measure: The incidence of cervical cancer.
timeFrame: From the testing performed by the investigator (0h) to one year follow-up period
Secondary outcomes:
measure: The rate of death.
timeFrame: One year follow-up period after screening.
measure: The incidence of cervical intraepithelial neoplasia.
timeFrame: From the screening (0h) to one year follow-up period
measure: Cervical inflammation
timeFrame: From the screening (0h) to one year follow-up period
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
citation: Tong H, Shen R, Wang Z, Kan Y, Wang Y, Li F, Wang F, Yang J, Guo X; Mass Cervical Cancer Screening Regimen Group. DNA ploidy cytometry testing for cervical cancer screening in China (DNACIC Trial): a prospective randomized, controlled trial. Clin Cancer Res. 2009 Oct 15;15(20):6438-45. doi: 10.1158/1078-0432.CCR-09-1689. Epub 2009 Oct 13.
Clinical trial NCT04164251: Inpatient Screening Mammography for Non-adherent and High Risk Women
Official title: Inpatient Screening Mammography for Non-adherent and High Risk Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer Screening
Mammography
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Maryland Cigarette Restitution Fund
name: EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)
First posted: 2019-11-15
Enrollment: 101
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to pilot a program that will evaluate the feasibility of an inpatient screening mammography for non-adherent and high risk hospitalized women age 52-74 admitted to the medicine services at Johns Hopkins Bayview Medical Center and Howard County General Hospital. The two key activities include: inpatient breast care education with educational handouts and offering inpatient screening mammography. Inpatient screening mammography will be offered to non-adherent (last screening mammogram more than 24 months ago) and high risk (Gail 5-year risk of breast cancer 1.6 or greater) women. This pilot program will thus evaluate the feasibility of an inpatient screening mammography as an innovative approach to increase breast cancer screening among non-adherent and high risk women.


Eligibility criteria: Inclusion Criteria:

* women between 50 and 74 years of age who were non-adherent to breast screening guidelines

Exclusion Criteria:

* Patients with a history of breast cancer or mastectomy
* history of other cancers (except skin)
* serious comorbidities making patient's life expectancy \<10 years

Primary outcomes:
measure: Proportion of women who underwent a screening mammography during hospitalization
timeFrame: Prior to hospital discharge, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Waseem Khaliq, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khaliq W, Siferd C, Kantsiper ME, Jacobs L, Howell EE, Wright SM. Capturing the Rest: Inpatient Mammography for Nonadherent Hospitalized Women. Am J Prev Med. 2021 Nov;61(5):709-715. doi: 10.1016/j.amepre.2021.04.026. Epub 2021 Jul 4.
Clinical trial NCT06363851: Single-ascending Dose Study of Kylo-11 in Healthy Subjects
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cardiovascular Diseases
Lead sponsor: Kylonova (Xiamen) Biopharma co., LTD.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 55 years old, inclusive;
* Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive;
* Protocol-defined elevated serum Lp(a) level;
* Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
* Willing to comply with protocol required visits and assessments, and provide written informed consent.

Exclusion Criteria:

* History or evidence of a clinically significant disorder, condition or disease;
* Received an investigational drug, vaccine or device within 3 months before dosing;
* History of evidence of malignant tumor or Gilbert syndrome;
* Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
* History of alcohol abuse within 12 months before dosing;
* History of drug abuse within 3 months before screening;
* History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
* History of stroke or myocardial infarction within 6 months before sceening;
* Pregnant or breast-feeding women;
* Other exclusion criteria applied per protocol.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: up to Week 24
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: up to week 48
measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
timeFrame: up to Week 48
measure: PK parameter of time of maximum observed concentration (Tmax)
timeFrame: up to Week 48
measure: PK parameter of area under the concentration time curve (AUC)
timeFrame: up to Week 48
measure: Change in serum Lp(a) over time
timeFrame: up to Week 48
measure: Percent change in serum Lp(a) over time
timeFrame: up to Week 48
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT03618251: Automated Volume Assessment of Acute Stroke
Official title: Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-08-07
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we will include all adult patient with ischemic stroke which have MRI for stroke diagnosis

Brief summary: Stroke is a common disease. It is increasingly managed in non-specialized centers.

The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.

There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.

The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.

Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.


Eligibility criteria: Inclusion Criteria:

* Patients admitted for a recent neurological deficit (less than 24 hours), suspected for a stroke.

Non inclusion criteria :

* Pregnant or breastfeeding women
* Patients with absolute contraindications to MRI

Primary outcomes:
measure: Automated volume assessment of acute stroke
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A De Rothschild
Study officials:
References:
Clinical trial NCT02509351: Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?
Official title: Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postpartum Haemorrhage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
* The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin

Detailed description: Research question:

In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?

Research hypothesis:

pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section

Eligibility criteria: Inclusion Criteria:

* 38-41 weeks of amenorrhea
* scheduled for elective lower segment cesarean section

Exclusion Criteria:

* confirmed intrauterine fetal death
* more than previous 2 ceserean sections
* multiple pregnancy
* antepartum haemorrhage
* self-reported maternal heart disease
* current diagnosis of severe malaria or acute bacterial infection

Primary outcomes:
measure: volume of intraoperative blood loss
timeFrame: 30 minute
Secondary outcomes:
measure: maternal mortality
timeFrame: 6 months
measure: mean measured blood loss
timeFrame: 1, 2, and 24 h postpartum
measure: placental retention
timeFrame: 30 minutes
measure: requirement for blood transfusion
timeFrame: 24 hours
measure: requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures
timeFrame: 24 hours
measure: postpartum hemoglobin
timeFrame: 24 hours
measure: mean postpartum hematocrit
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: Helmy Dr metawe, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01452451: Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Official title: A Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 2 Study to Determine the Tolerability, Pharmacokinetics, and Pharmacodynamics of the GLP 1 Agonist HM11260C in Adult Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 72
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: The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy.


Eligibility criteria: Inclusion Criteria:

* Is male or female and 18 to 65 years of age, inclusive, at screening
* Has a history of T2DM and a stable dose of metformin
* Has HbA1c levels at screening between 7% and 10%

Exclusion Criteria:

* Is pregnant or lactating
* Has type 1 diabetes
* Has a significant change in body weight in the 3 months before screening
* Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening
* Has an estimated glomerular filtration rate rate \<75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 \<estimated glomerular filtration rate \<90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio \>30 mg/g.
* Has alanine aminotransferase or aspartate aminotransferase values \>2.0 × upper limit of normal or total bilirubin \>1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome
* Has fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) or \>250 mg/dL (\>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded.
* Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding
* Has any acute illness within 5 days before first study drug administration
* Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis
* Is a heavy tobacco user(more than 10 cigarettes a day)
* Is a heavy alcohol user
* Has a positive screen for drugs of abuse

Primary outcomes:
measure: Number of subjects with adverse events as a measure of safety and tolerability
timeFrame: Up to 106 days
Secondary outcomes:
measure: The pharmacokinetics in repeat-dose
timeFrame: Day 1 up to Day 92
measure: The pharmacodynamics in repeat-dose
timeFrame: Up to 106 days
Other outcomes:
Locations:
city: Ohio
country: United States
state: Ohio
Study officials:
References:
Clinical trial NCT01998451: The Discovery of the Double Sphincter in Gallbladder
Official title: The Discovery of the Double Sphincter in Gallbladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gallstone
Keywords: double sphincter in gallbladder
recurrence rate of gallstones
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We found a new Double sphincter which located in the neck of gallbladder，we supposed it may be related to control pressure of bile duct.Its formation is related to genetic factors.

Detailed description: To contrast the recurrence rate of gallstones between patients with gallbladder double sphincter and patients with general gallbladder sphincter who underwent the treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation. Method:Patients with gallbladder double sphincter and patients with general gallbladder sphincter who underwent the treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation in The Affiliated Hospital of Guiyang Medical College from May 2012 to December 2015. We collect these patients' bile during surgery.Patients with gallbladder double sphincter as trial group, patients with general gallbladder sphincter as control group.the overall follow-up period is 3 years. Then the investigators statistically analyze improvement of cholecystolithiasis symptoms, thickness of gall bladder wall, the gallbladder function and the rate of the recurrence of cholesterol gallstone in 2 groups.we also analysis of the genetic differences from bile between two groups.

Eligibility criteria: Inclusion Criteria:

- people with gallbladder double sphincter

Exclusion Criteria:

- people without gallbladder double sphincter

Primary outcomes:
measure: The Discovery of The Double Sphincter in Gallbladder
timeFrame: All the patients will be follow-up for an expected average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The Discovery of the Double Sphincter in Gallbladder
state: Guizhou
Study officials:
affiliation: The Affiliated Hospital of Guiyang Medial College
name: Chengyi Sun, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00516451: Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors
Official title: Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.

Primary outcomes:
measure: To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514
timeFrame: administered orally every day 28 days
Secondary outcomes:
measure: Evaluate safety, exposure levels of BMS-690514 in the body & anticancer activity of BMS-690514 administered orally every day for 28 days.
timeFrame: throughout the study
measure: Safety evaluations and laboratory assessments will be performed
timeFrame: throughout the study
measure: Preliminary markers of efficacy will also be assessed
timeFrame: throughout the study
Other outcomes:
Locations:
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Nokihara H, Yamamoto N, Yamada Y, Yamada K, Hirata T, Goto Y, Tanioka M, Ikeda Y, Tamura T. A phase I study of BMS-690514 in Japanese patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol. 2012 Oct;70(4):559-65. doi: 10.1007/s00280-012-1932-9. Epub 2012 Aug 10.