louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01006018: DPP-4 Inhibition and TZD for DM Prevention
Official title: DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prediabetic State
Keywords: Prediabetic State
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-11-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.


Eligibility criteria: Inclusion Criteria:

* Impaired glucose tolerance (IGT) by oral glucose tolerance test

Exclusion Criteria:

* History of diabetes mellitus
* History of congestive heart failure
* History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)
* History of liver disease (ALT or AST \>2.5 times the upper limit of normals)
* History of renal disease (serum creatinine \>1.5 mg/dl)
* History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)
* Current treatment with glucocorticoids
* History of immune disorder, including HIV
* Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures

Primary outcomes:
measure: Insulin Secretion
timeFrame: baseline, 6 months, 9 months (after a 3 month washout)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Mary Rhee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
Clinical trial NCT06486818: Clinical Predictors of Short Term Outcomes of Ablation of Idiopathic Monomorphic PVCs
Official title: Clinical Predictors of Short Term Outcomes of Ablation of Idiopathic Monomorphic PVCs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrythmia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 - 70

Brief summary: Clinical predictors of successful Pvcs ablation

Detailed description: Clinical predictors of short term outcomes of ablation of idiopathic monomorphic pre mature ventricular contractions

Eligibility criteria: Inclusion Criteria:

* patients with idiopathic monomorphic PVCs

Exclusion Criteria:

* patients with heart failure

Primary outcomes:
measure: Clinical predictors of short term outcomes of ablation of idiopathic monomorphic PVCs
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT02805218: PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy
Official title: The Multi-center,Open-label,Single Arm Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with age ≥ 18 years
* diagnosis of lymphoma(Hodgkin's lymphoma and non-Hodgkin's lymphoma) patients
* Karnofsky Performance Status Z70
* life expectancy of at least 8 months
* normal white blood cell count and platelet count
* Written informed consent are acquired

Exclusion Criteria:

* uncontrolled infection
* pregnancy
* Have accepted any other anti-tumor drug within 4 weeks before anticipated the study
* Other situations that investigators consider as contra-indication for this study

Primary outcomes:
measure: The occurrence rate of adverse event
timeFrame: up to 30 days after the patient study completion
measure: The severity of adverse event
timeFrame: up to 30 days after the patient study completion
Secondary outcomes:
measure: the occurrence rate of grade III/ IV neutropenia during chemotherapy cycles
timeFrame: through the study completion,an average of 5 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00000218: Pharmacotherapy and Intensive Treatment - 2
Official title: Pharmacotherapy and Intensive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: VA Office of Research and Development
First posted: 1999-09-21
Enrollment: 353
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric disorders.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Severity addiction
measure: Depression
measure: Depression, anxiety
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas
state: Missouri
Study officials:
affiliation: University of Kansas
name: William Haning, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05468918: Real World Perspectives on Advancements in Hearing Aid Technology
Official title: Real World Perspectives on Advancements in Hearing Aid Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.

Detailed description: Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.

This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.

Eligibility criteria: Inclusion Criteria:

* Moderate sensorineural hearing loss
* Experienced hearing aid user
* Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial
* Smartphone user for receiving study alerts

Exclusion Criteria:

* Cognitive impairment
* Not willing to wear hearing aid

Primary outcomes:
measure: Speech in Noise Test
timeFrame: Day 1 of study
measure: Subjective Perception of Listening Effort
timeFrame: Day 1 of study
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Phonak Audiology Research Center
state: Illinois
Study officials:
References:
Clinical trial NCT00172718: Using 3.3mm Screw Tap and Cutting Resistance to Evaluate Bone Quality Around Dental Implant
Official title: Using 3.3mm Screw Tap to Modify the Standard Implantation Procedure and to Measure the Cutting Resistance for Establishing a More Objective Method to Evaluate the Peri-Implant Bone Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Jaw, Edentulous, Partially
Mouth, Edentulous
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Osseointegrated root form implants have been applied successfully in treating fully and partially edentulous patients and patients with single tooth missing. However, the success rate of osseointegrated dental implants was not as good in patients with poor bone quality. The reasons are believed that poor bone quality reduces the initial stability of dental implants and then reduces the success rate. For increasing initial stability of dental implants, some technical modifications are suggested in literature. However, due to lack of an objective method to evaluate bone quality, they are controversial. The purposes of this clinical study are to develop a standard procedure which using cutting resistance measured by Osseocare in surgery to evaluate the bone quality and to compare with the clinical experiences of oral surgeons. The objective outcome, initial stability of dental implant, is measured with Osstell. The analyzed results are also helpful for less experienced surgeons.

Detailed description: Materials \& Methods:

1. Patient eligibility: Six implant surgeons will assist the experiment. The subjects are patient who will receive dental implant treatment in Dental department of NTUH. Sixty subjects are offered by six surgeons. They must fully fill the requirements as following

Eligibility criteria: Inclusion Criteria:

* No major systemic diseases
* Mouth opening: \> 35 mm
* Missing teeth at anterior or premolar area and willing to restored by implantation

Exclusion Criteria:

* Uncomfortable or other condition occurring in the surgical procedure make the measuring unacceptable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dept. of Dentistry, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University, School of Dentistry
name: Tong-Mei Wang, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University, School of Dentistry
name: Li-Deh Lin, DDS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01875718: A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)
Official title: A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Premenstrual Dysphoric Disorder
Lead sponsor: Umecrine Mood AB
Sponsor class: INDUSTRY
First posted: 2013-06-12
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1.

In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.


Eligibility criteria: Inclusion Criteria:

Part 1 -Essentially healthy

Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles

Exclusion Criteria:

* steroid hormonal treatment during the previous three months
* treatment with psychopharmaceuticals or other treatment for PMS
* history of or a significant medical condition ongoing
* be pregnant or plan a pregnancy within the study period

Primary outcomes:
measure: Premenstrual symptom severity
timeFrame: Daily Record of Severity of Problems (DRSP) measured during 4-5 months
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: During 1.5 month (starting from first dose)
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Umecrine Mood AB
Study officials:
References:
Clinical trial NCT05149118: Effect of PDRN in Post-operative Scars
Official title: Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scar
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aimed to evaluate the efficacy of PDRN administration in early wound healing phase on prevention of post-operative scars after open thyroidectomy.


Eligibility criteria: Inclusion Criteria:

• Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital

Exclusion Criteria:

* age younger than 20 years or older than 60 years
* history of keloid development
* requirement for modified radical neck dissection
* previous neck surgery
* current pregnancy or breast feeding
* allergy to PDRN
* taking medications that may affect inflammation and would healing such as isotretinoin, anti-cancer drugs, high dose corticosteroids, and anticoagulants
* uncontrolled medical diseases

Primary outcomes:
measure: modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up
timeFrame: at 3 months
Secondary outcomes:
measure: Subjective symptoms at the 3-month follow-up
timeFrame: at 3 months
measure: Erythema and pigmentation at the 3-month follow-up
timeFrame: at 3 months
measure: Scar Height (mm) at the 3-month follow-up
timeFrame: at 3 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung Won Shin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706718: Beetroot Enriched Bread, Blood Pressure and Vascular Function
Official title: The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Beetroot
Blood pressure
Vascular function
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. We evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.


Eligibility criteria: Inclusion Criteria:

* Male
* A signed consent form
* Age 18-64 years
* Body mass index - 18.5-30 kg/m2
* Non-smoking, healthy individuals
* Normal blood pressure at screening (\< 150/90)

Exclusion Criteria:

* Subjects with anaemia
* Sufferers of chronic illnesses
* Individuals with food allergies
* People with diabetes
* People with coeliac disease
* Women
* Vegetarians

Primary outcomes:
measure: Vascular reactivity
timeFrame: Change from baseline at 2, 4 and 6 hours after bread consumption
Secondary outcomes:
measure: Arterial stiffness
timeFrame: Change from baseline at 2, 4 and 6 hours after bread consumption
measure: Blood pressure
timeFrame: Change from baseline at 30 minute intervals for 7 hours
measure: Plasma nitrate
timeFrame: Every 30 minutes for 7 hours
measure: Plasma nitrite
timeFrame: Every 30 minutes for 7 hours
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References:
citation: Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
citation: Hobbs DA, Goulding MG, Nguyen A, Malaver T, Walker CF, George TW, Methven L, Lovegrove JA. Acute ingestion of beetroot bread increases endothelium-independent vasodilation and lowers diastolic blood pressure in healthy men: a randomized controlled trial. J Nutr. 2013 Sep;143(9):1399-405. doi: 10.3945/jn.113.175778. Epub 2013 Jul 24.
Clinical trial NCT00262418: Comparison of the Efficacy and Safety of Ivermectin to Permethrin
Official title: A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scabies
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2005-12-06
Enrollment: 160
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies

Detailed description: Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28

Eligibility criteria: Inclusion Criteria:

At least one of the following inclusion criteria:

* Scabies tunnels
* Positive microscopic examination (acarids, faeces or ova)

At least two of the three following inclusion criteria:

* Non-specific injuries with a typical distribution pattern
* Serious itching which increases during the night
* Family or contacts with similar complaints

Exclusion Criteria:

* Treatment for scabies \< 4 weeks ago
* Treatment with corticoids \< 1 week ago
* Pregnancy
* Breast-feeding
* HIV
* Serious immunodepressive patients
* Sensitivity or allergy to one of the components of the study medication
* Damage of the central nerve system

Primary outcomes:
measure: Clinical healing of the skin injuries
timeFrame: on day28
Secondary outcomes:
measure: Decrease of itching
timeFrame: on day28
measure: Amelioration of the life quality
timeFrame: on day28
measure: Number and gravity of adverse events
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Jean-Marie Naeyaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03117218: Correlation Between Quantitative Analysis of Coronary MRA and FFR
Official title: Quantitative Analysis of 3T Whole Heart Coronary Magnetic Resonance Angiogram Improves Detection of Functionally Significant Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Magnetic Resonance Angiography
Fractional Flow Reserve
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 89
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 coronary stenosis on coronary MR angiograms who were planned to undergo invasive coronary angiography.

Brief summary: This study aims to evaluate whether quantitative analysis of coronary MR angiogram would improve the detection of functionally-significant coronary artery stenosis.

Detailed description: Coronary MR angiography is performed with a 3.0-T imager with 32-channel coils. Qunatitative analysis of coronary MR angiogram is evaluated on the basis of the signal intensity (SI) profile along the vessel. Quantitative analysis of coronary MR angiogram (QCMRA) is calculated as \[1 - (SImin/SIref)\] x 100, where SImin is minimal SI and SIref is corresponding reference SI. Diagnostic performance of quantitative analysis of coronary MR angiogram for predicting functional significant coronary stenosis was evaluated by using fractional flow reserve (FFR) as the reference standard.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* 1 or more coronary stenoses in the major coronary artery with a vessel diameter ≥ 2mm on coronary MR angiogram
* Patient who were planned to undergo invasive coronary angiography and fractional flow reserve

Exclusion Criteria:

* clinically unstable patient
* a history of coronary revascularization
* infiltrative cardiomyopathy, hypertropic cardiomyopathy, myocarditis
* contraindication to use of adenosine
* complete occlusion of target lesion

Primary outcomes:
measure: Presence of functionally significant coronary stenosis
timeFrame: within 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hopsital
state: Gyeonggi
Study officials:
References: