louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02314637: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
Official title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: DPP-IV inhibitor
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.


Eligibility criteria: Inclusion Criteria:

* In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes over 12 weeks before administration of investigational drug
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* HbA1c criteria:

  * monotherapy: 6.9% - 10.5%
  * combination therapy with Sulfonylurea: 7.4 - 10.5%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients who are accepting treatments of arrhythmias
* Patients with serious diabetic complications
* Patients who are the excessive alcohol addicts
* Patients with severe hepatic disorder or severe renal disorder
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Fasting Plasma Glucose at Week 52
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
city: Shikoku
country: Japan
facility: Reserch site
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, Professor
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.
Clinical trial NCT01970137: A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinocerebellar Degeneration
Keywords: Spinocerebellar degeneration (SCD)
Thyrotropin-Releasing Hormone (TRH)
Spinocerebellar Ataxia (SCA)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)


Eligibility criteria: Inclusion Criteria:

* Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
* Discontinuations in another clinical trials caused by side effects

Primary outcomes:
measure: SARA (Scale for the Assessment and Rating of Ataxia)
timeFrame: 24 weeks
Secondary outcomes:
measure: SF-8 (QOL)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese Cities
country: Japan
Study officials:
References:
Clinical trial NCT02991937: Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Official title: Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.


Eligibility criteria: Inclusion Criteria:

* first episode of appendicitis
* Pain \< 48 hours
* White blood cell count \< 18,000
* temperature \< 103º F
* radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation
* appendiceal diameter \< 11 mm
* ability to take oral antibiotics

Exclusion Criteria:

* Prior antibiotic treatment for appendicitis
* presence of medical condition prohibiting surgical therapy
* radiographic or clinical evidence of abscess or perforation
* appendiceal mass, positive pregnancy test
* other diagnosis equally as likely as appendicitis
* pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm
* inability to take oral antibiotics.

Primary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent
timeFrame: 1 Year
Secondary outcomes:
measure: Readmission Rates
timeFrame: 1 Year
measure: Incidence of Long-term Complications in Medical Therapy Group
timeFrame: 1 Year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jason Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03474237: A Prospective Cohort Study for Patients With Adrenal Diseases
Official title: A Prospective Cohort Study for Patients With Adrenal Diseases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adrenal Adenoma
Cushing Syndrome
Pheochromocytoma
Adrenal Incidentaloma
Adrenocortical Carcinoma
Primary Hyperaldosteronism
Keywords: algorithms
adrenal adenoma
cushing syndrome
pheochromocytoma
adrenal incidentaloma
adreocortical carcinoma
primary hyperaldosteronism
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study population of this study is the patients who are newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma

Brief summary: The purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.

Detailed description: The investigators will recruit 150 patients annually for 10 years (adrenal incidentaloma 100 patients, pheochromocytoma 15 patients, primary aldosteronism 25 patients, adrenal cushing syndrome 10 patients, adrenocortical carcinoma 2 patients) and perform hormonal, biochemical, imaging exam according to each disease's clinical guidelines. Based on this, the investigators will identify pathologic features, complications, and prognostic factors of each disease.

Eligibility criteria: Inclusion Criteria:

* Adults, male or female aged 19 years or older
* newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma

Exclusion Criteria:

* previous or current history of adrenal diseases
* using oral or intravenous steroids
* history of major depressive disorder
* history of chronic alcoholics
* history of any cancer with suspicious adrenal metastasis
* those with acute illness (ex- patients with acute coronary syndrome within 4 weeks, acute febrile disease)

Primary outcomes:
measure: Number of participants in remission
timeFrame: Up to 10 years
Secondary outcomes:
measure: Complication of adrenal disease
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung Hee Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922337: The Israeli MGuard Registry
Official title: A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Acute Coronary Syndrome
Acute Myocardial Infarction
Keywords: distal embolization
thrombotic lesions
AMI
ACS
SVG
Lead sponsor: InspireMD
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication for coronary stent implantation according to the Israeli regulatory approval of the MGuard Coronary Stent System. All patients who receive one or more MGuard Coronary Stent System in one or more target lesions should be included.

Brief summary: the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System

Detailed description: A Prospective, Observational, Multicenter Registry The primary objective of this registry is to document the safety and overall clinical performance of the MGuard Coronary Stent System in a "real world" patient population requiring stent implantation.

The secondary objective is to assess the event rate in patient subgroups with specific clinical indications and/or vessel and/or lesion characteristics.

Eligibility criteria: Inclusion Criteria:

* Patient is \> 18 years of age
* The patient has consented to participate by signing the "Patient Informed Consent Form"
* Patient is suitable for implantation of one or more MGuard Stent System in one or more target lesions
* Target lesion(s) are according to the Indications for Use and Israeli regulatory approval of the MGuard Stent System
* The patient is willing and able to cooperate with registry procedures and required follow up

Exclusion Criteria:

* Heavily calcified target lesions
* Target lesions with side branch bigger then 2.5mm
* Target lesions which are distal to newly stented lesion (less than 1 month).
* Women with known pregnancy
* Current medical condition with a life expectancy of less than 12 months
* Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits study participation

Primary outcomes:
measure: Major Cardiac Adverse Events rate (MACE)
timeFrame: 1 month
Secondary outcomes:
measure: Major Cardiac Adverse Events rate (MACE)
timeFrame: 6 months
measure: Lesion success rate
timeFrame: 1 day
measure: Bleeding complications
timeFrame: 6 months
measure: Stent thrombosis rate
timeFrame: 6 months
measure: Any death
timeFrame: 6 months
Other outcomes:
Locations:
city: Natanya
country: Israel
facility: Laniado Hospital
city: Zrifin
country: Israel
facility: Asaf Harofe Medical Center
Study officials:
affiliation: InspireMD
name: Elad Yaacoby
role: STUDY_DIRECTOR
References:
Clinical trial NCT03040037: Cryoballoon Atrial Fibrillation Ablation Registry
Official title: Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
Collaborators: name: RUSSIAN SOCIETY OF CARDIOLOGY
First posted: 2017-02-01
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patient with Indications for Catheter Ablation of Atrial Fibrillation

Brief summary: This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label

Detailed description: The purpose of this Registry is to describe characteristics of patients undergoing cryoballoon ablation, diversity of cryoablation techniques among different centers; to evaluate efficacy and safety of the procedure in the centers with different levels of experience.

Eligibility criteria: Inclusion Criteria:

* The indications for catheter ablation of atrial fibrillation
* Signed informed consent to participate in the Register
* Patients undergoing cryoballoon ablation

Exclusion Criteria:

* Left atrial thrombosis

Primary outcomes:
measure: Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring
timeFrame: 1 Year
Secondary outcomes:
measure: Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)
timeFrame: 1 Year
measure: Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)
timeFrame: 1 Year
measure: Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)
timeFrame: Above parameters will be assessed only during the procedure of cryoablation
measure: Number of participants with antiarrhythmic drug treatment at 12 months
timeFrame: 1 Year
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation
Study officials:
References:
Clinical trial NCT04880837: Human Papillomavirus Education Programs
Official title: Human Papillomavirus Education Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to implement a culturally-tailored educational outreach actives with the goal of increasing knowledge of human papillomavirus (HPV) types that can lead to cancer and uptake of the available vaccine. The initiative also addresses barriers to vaccination and refer people to sites where they can get the HPV vaccine (e.g., private doctor offices, community health clinics, school-based health centers, and health departments). The HPV education program may help increase HPV vaccination rates and ultimately prevent HPV-related cancers.

Detailed description: PRIMARY OBJECTIVE:

I. To implement culturally tailored educational outreach activities with the goal of increasing knowledge of HPV types that can lead to cancer and uptake of the available vaccine.

OUTLINE:

Participants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. Participants participate in surveys over telephone or face-to-face at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* From Ohio

Primary outcomes:
measure: Change in human papillomavirus (HPV) knowledge
timeFrame: Baseline up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra D Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06196515: Anti-bacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication
Official title: Evaluation of the Antibacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Endodontic Disease
Pulp Disease, Dental
Keywords: intracanal medication
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the anti-bacterial potential of Nano Calcium Hydroxide as an intracanal medication in primary endodontic treatment of permanent molars.

Detailed description: This study is conducted to evaluate the bacterial reduction capability of hydrogel loaded with Nano Calcium Hydroxide and paste form of nano and conventional calcium hydroxide as an intracanal medication. The hydrogel will be synthesized in a new rapid in situ form that can turn from liquid into gel when reaching body temperature. The efficacy of bacterial reduction will be compared with Nano Calcium Hydroxide and conventional Calcium Hydroxide in paste form. The evaluation is to be done by quantitative microbiological assessment of samples which are gained from the root canal before and after intracanal medication placement in roots of permanent molars, having PAI score ≥ 2.

Eligibility criteria: Inclusion Criteria:

* healthy males and females.
* age range between 21-49.
* patients with no physical disability or psychological problems.
* patients presenting with single permanent molar with signs and/or symptoms of apical periodontitis, and having Periapican index ≥ 2.

Exclusion Criteria:

* pregnant women.
* patients with immune-compromised disease.
* patients with complicated systemic diseases.
* patients who took antibiotics within a period of 1 month.
* patients with known sensitivity to the medicaments or pharmaceuticals used in this study.
* Non-restorable teeth including root fractures, and/or advanced periodontal involvement.

Primary outcomes:
measure: bacterial count
timeFrame: on the seventh day from intercanal medication placement appointment
Secondary outcomes:
measure: periapical healing
timeFrame: participants will be recalled after 6 months from the obturation for radiographic examination
measure: incidence and intensity of pain
timeFrame: Pain intensity will be assessed each day for three days following initial treatment
measure: incidence of flare up
timeFrame: incidence of flare up will be recorded each day after the intracanal medication placment visit until the next visit (after seven days)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: british university in Egypt - dentistry collage
Study officials:
affiliation: British University In Egypt
name: Shehab Eldin M Saber, doctoral
role: STUDY_DIRECTOR
References:
Clinical trial NCT01816815: Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in 60 Healthy Tubal-ligated Women Aged 18 to 45 Years Investigating the Pharmacodynamic Effects of 5 Different Doses (0.1 - 5 mg) BAY1002670 After Daily Oral Administration Over 84 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leiomyoma
Keywords: PK/PD
BAY1002670
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-03-22
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects
* Sterilized by tubal ligation
* Age 18-45 years
* Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
* At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
* Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy

Exclusion Criteria:

* Regular use of medicines (incl. anabolics)
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Amenorrhea for more than 3 months within the last 6 months before the first screening examination
* Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
* Clinically relevant findings (e.g. blood pressure, electrocardiogram \[ECG\], physical and gynecological examination, laboratory examination)

Primary outcomes:
measure: Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
timeFrame: After three months
Secondary outcomes:
measure: Return of menstrual bleeding after treatment
timeFrame: Up to two months after last treatment
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Neu-Ulm
country: Germany
state: Bayern
city: Neuss
country: Germany
state: Nordrhein-Westfalen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Belfast
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Schutt B, Kaiser A, Schultze-Mosgau MH, Seitz C, Bell D, Koch M, Rohde B. Pharmacodynamics and safety of the novel selective progesterone receptor modulator vilaprisan: a double-blind, randomized, placebo-controlled phase 1 trial in healthy women. Hum Reprod. 2016 Aug;31(8):1703-12. doi: 10.1093/humrep/dew140. Epub 2016 Jun 10.