louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01798667: Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Premature Ejaculation
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 220
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.

The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).

Design:

Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design


Eligibility criteria: Inclusion Criteria:

* Male patients aged with premature ejaculation for more than 6 months.
* PEDT score ≥ 11

Exclusion Criteria:

* IIEF-EF domain ≤ 21
* Serum Creatinine ≥ 2.5 mg/dl
* AST, ALT \> 3\*Upper limit of normal
* Subjects with hypotension(SBP/DBP\<90/50mmHg) or uncontrolled hypertension(SBP/DBP\>180/100mmHg)
* Subjects with chronic depression, psychiatric or schizophrenia,
* Subjects with alcohol, drug or substance abuse

Primary outcomes:
measure: average IELT change
timeFrame: From 0 week(baseline) to 8 week(end of treatment)
Secondary outcomes:
measure: PEP, PGI
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Sae Woong Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Du Geon Moon
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Nam-Cheol Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Jae-Seung Paick
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Tai-Young Ahn
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Sung Won Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeongnam University Hospital
name: Ki Hak Moon
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Kwangsung Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Jong Kwan Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong Sacred Heart Hospital
name: Dae Yul Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01403467: Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation
Official title: Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Asthma
Keywords: Bronchial disease
asthma
continuous positive airway pressure (CPAP)
Bronchoconstriction
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This current study aimed to demonstrate the effectiveness of the addition of CPAP to the current conventional therapy in terms of airway obstruction improvement in acute asthma patients.

Detailed description: Continuous positive airway pressure (CPAP) is widely used in providing ventilator support. However, its role in an acute asthmatic attack is uncertain. The purpose of this study was to compare the efficacy of CPAP when used in addition to conventional therapy with conventional therapy alone in the management of acute asthma exacerbation.

Eligibility criteria: Inclusion Criteria:

* aged over 18 years
* known asthmatic patients visiting ED with acute exacerbation
* had given their written informed consent.

Exclusion Criteria:

* smoking history
* chronic obstructive pulmonary disease
* required intubation
* instability of hemodynamic or arrhythmia
* unable to perform PEFR
* facial abnormality
* pulmonary infiltration
* pregnancy.

Primary outcomes:
measure: an improvement in PEFR, as % predicted
timeFrame: 75 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University
name: Yuda Sutherasan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327167: Digital Intervention for Ethnic Groups in Transplantation (DIGIT)
Official title: Digital Intervention for Ethnic Groups in Transplantation (DIGIT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Live Donors, Ethnic Minorities, Transplantation
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Study Title Digital intervention for Ethnic Groups in Transplantation (DiGiT)

Internal ref. no. (or short title) DiGiT Study Design Observational cohort study Study Participants 90 Planned Size of Sample (if applicable) 30 Follow up duration (if applicable) 2 years Planned Study Period 2 years Research Question/Aim(s)

1. To produce, test and pilot a video-based intervention about living donor kidney transplantation in Black, Asian \& Minority ethnic (BAME) community in United Kingdom. Embedded within this is an ambassador training.
2. Study the long term psychological impact of BAME donors following donation.


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years of age
* Belong to a BAME community only for phase 1-3, in phase 4 all past and future donors regardless of ethnicity would be eligible.
* Be a community member, past donor, past recipient of a transplant, healthcare professional or be on the waiting list for a transplant.

Exclusion Criteria:

* Anyone less than 18 years of age
* Unable to consent

Primary outcomes:
measure: Magnitude of the change in score assessing knowledge of LDKT by study questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Magnitude of change in QOL score pre donation to 1 year post donation
timeFrame: 2 years
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Shafi Malik
state: West Midlands
Study officials:
References:
Clinical trial NCT03215667: Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites
Official title: Ridge Preservation With Hardening Calcium Phosphate Bone Substitutes and Resorbable Membrane for Implant Site Development on Non-containable Extraction Sites: A Clinical and Histological Prospective Case Series in Humans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alveolar Ridge Preservation
Dental Implants
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.


Eligibility criteria: Inclusion Criteria:

* adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study
* minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)
* single-rooted tooth to be extracted
* American Society of Anesthesiologists (ASA) Physical Status Classification I or II
* age \>18 years old
* subjects who had \>50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study
* adjacent teeth to extraction site will be present during healing period
* willingly sign informed consent and authorization.

Exclusion Criteria:

* do not meet any inclusion criteria
* pregnancy or nursing woman
* subjects with active systemic or localized infection (exclude chronic periodontitis)
* subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c\>7%)
* subjects with smoking habit (more than 10 cigarettes per day)

Primary outcomes:
measure: Change in Radiographic Measurements of Bone Ridge Dimensions
timeFrame: Change from Baseline at 3 months
Secondary outcomes:
measure: Change in Digital Measurements of Soft Tissue Dimensions
timeFrame: Change from baseline at 5 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
References:
Clinical trial NCT06478667: The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity
Official title: The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myocarditis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 50
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: SUPPORTIVE_CARE

Brief summary: To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity

Detailed description: Aluminum phosphide (ALP) is a well-known fumigant known also as rice pill or wheat pill. It is considered an ideal pesticide since it is effective to preserve stored grains against insects and rodents without leaving residues, in addition to its availability and low cost. In Egypt, it has become a common method of suicide over the last few years because it is cheap and easily accessible. Cardiomyocytes are one of the main targets for ALP. ALP-induced cardiotoxicity involves detrimental effects such as direct myocardial tissue damage, hypoperfusion, myocarditis, pericarditis, and arrhythmias leading to circulatory failure. Levosimendan, an inotropic agent, enhances cardiac contractility through calcium sensitization with minimal oxygen demand and, in turn, decreases the risk of arrhythmia. However, limited studies have investigated the role of levosimendan in the treatment of ALP induced cardiotoxicity.

Eligibility criteria: Inclusion Criteria:

Patients with acute ALP intoxication admitted to ICU of PCC-ASUH and developed cardiotoxicity with Poisoning Severity Score (PSS) 2 (moderate) or 3 (severe) that led to cardiogenic shock and necessitated administration of vasoactive medications

Exclusion Criteria:

* Pregnant patients
* The presence of pre-existing diseases such as hematologic, pulmonary, hepatic, renal, immunologic, central nervous system, or endocrine system disorders that made patients unsuitable for the present study.
* Patients with underlying cardiac disease and ECG changes, especially prolonged QTc intervals.
* Patients co-ingested drugs or toxins with cardiovascular toxicity.
* Patients had been previously administered with inotropic agent other than agents under the current study as a preconsultation treatment.
* Patients had received any other investigational medicinal products within 30 days or were enrolled in any other interventional trials with the potential to interact with Levosimendan or affect ALP induced cardiotoxicity

Primary outcomes:
measure: systolic blood pressure
timeFrame: acute phase of myocarditis in 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Poison Control Center
Study officials:
References:
Clinical trial NCT06656767: Somatic Mutation in Chronic Liver Disease
Official title: Understanding the Evolution of the Somatic Mutational Landscape in Chronic Liver Disease Across Aetiologies and Disease States
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Liver Disease
Somatic Mutation
Keywords: Somatic mutations liver
Lead sponsor: The Wellcome Sanger Institute
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic liver disease

Brief summary: Deaths from chronic liver disease are rising in the UK and around the world. The leading causes are alcohol-related liver disease, metabolic-dysfunction associated steatotic liver disease (MASLD, formerly known as 'non-alcoholic fatty liver disease') and viral hepatitis. Chronic liver disease puts people at significantly increased risk of liver cancer, which in the UK has a 5 year survival of under 15%. Little is understood about how liver cells acquire genetic changes, called somatic mutations, as they progress from healthy cells, to disease, to cancer development. This study aims to investigate these somatic mutations across different causes of chronic liver disease, and different stages of liver disease. The investigators hope this will help us to understand how different insults to the liver put the liver cells under different pressures, resulting in varying genetic changes. By understanding these changes specific to disease aetiology and stage, novel genetic targets may be identified which assist to focus research in identifying specific prognostic, diagnostic and therapeutic tools in chronic liver disease, and improve outcomes for patients.

Tissue, surplus to clinical requirement, from patients were undergoing liver biopsy, liver resection or liver transplantation (tissue sampling from explanted liver) collected by collaborators at University of Texas Southwestern will undergo genomic sequencing at the Wellcome Sanger Institute.


Eligibility criteria: Inclusion Criteria:

Pre-collected cohorts of liver tissue collected from adults (male and female) with consent and ethical approval for use in research.

Exclusion Criteria:

Anything outside of the above including samples other than liver tissue, samples where there is no consent or ethical approval for use in research and/or samples from children.

Primary outcomes:
measure: Somatic mutations in chronic liver disease
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Wellcome Sanger Institute
Study officials:
affiliation: Wellcome Sanger Institute
name: Peter Campbell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00135967: Mycophenolate Mofetil in Membranous Nephropathy
Official title: Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glomerulonephritis, Membranous
Keywords: membranous nephropathy
mycophenolate mofetil
cyclophosphamide
prednisone
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.

In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.


Eligibility criteria: Inclusion Criteria:

* Membranous nephropathy
* Serum creatinine (Screat)\> 1,5 mg/dl or ECC \< 70 ml/min or increase Screat \> 50%
* Proteinuria \> 2 g/day

Exclusion Criteria:

* Systemic diseases
* Pregnancy wish
* Active infection
* Liver dysfunction
* Abnormal hematology lab
* Unstable angina
* Nonsteroidal anti-inflammatory agents (NSAIDs)

Primary outcomes:
measure: renal function (serum creatinine)
measure: proteinuria
Secondary outcomes:
measure: side effects
measure: relapse rate
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of Nephrology Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Jack F Wetzels, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56. doi: 10.1053/j.ajkd.2007.05.015.
Clinical trial NCT02345967: Function of Implanted Glucose Sensor 2
Official title: Function of Implanted Glucose Sensor 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus requiring insulin
Lead sponsor: GlySens Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Profil Institute for Clinical Research, Inc.
name: AMCR Institute
First posted: 2015-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.


Eligibility criteria: Inclusion Criteria:

* Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant
* Diabetes diagnosis of type 1, or type 2 using insulin
* Under the routine care of a physician for diabetes treatment
* Able to understand and follow directions
* History of compliance with diabetes care regimen
* Able to comply with study requirements regarding planned clinical visits and exams
* In good physical condition without major medical concerns or blood chemistry abnormalities

Exclusion Criteria:

* Mental disorders that might affect compliance to protocols
* Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone
* History of intolerance or sensitivity to any of the device materials
* History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures
* History of recurrent skin infections

Primary outcomes:
measure: Number of Adverse Events
timeFrame: From enrollment to 2-weeks post-explant
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: Profil Institute for Clinical Research, Inc.
name: Linda Morrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03911167: An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer
Official title: An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of rectal cancer

Brief summary: A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Afﬁliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related costs of the three groups.


Eligibility criteria: Inclusion Criteria:

* endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative CT, MRI examination did not see the tumor directly invaded the surrounding organs;
* blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications;
* without distant metastasis such as liver, lung, bone, and abdominal cavity.

Exclusion Criteria:

* there is distant organ transfer or extensive abdominal metastasis;
* emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.;
* combined with other primary malignant tumors;
* other colonectomy and combined with other organ resection;
* patients with severe basic diseases unable to tolerate surgery;
* pregnant and lactating women;
* patients who underwent neoadjuvant radiotherapy and chemotherapy before surgery;
* those who underwent palliative surgery.

Primary outcomes:
measure: Postoperative complication rate，%
timeFrame: 2 weeks
Secondary outcomes:
measure: Urine tube time,days;
timeFrame: 2 weeks
measure: operation time,minutes;
timeFrame: 2 weeks
measure: intraoperative bleeding,ml;
timeFrame: 2 weeks
measure: number of lymph node detection,
timeFrame: 2 weeks
measure: exhaust time,days;
timeFrame: 2 weeks
measure: intake time, days;
timeFrame: 2 weeks
measure: postoperative hospital stay,days;
timeFrame: 2 weeks
measure: hospitalization expenses,yuan
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References: