louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963130: Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study
Official title: Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Mechanism
Drug Usage
Keywords: Vildagliptin
Portal Vein Pressure
Hepatosteatosis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 Diabetes Mellitus (DM)

Brief summary: This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.

Detailed description: Group 1 used metformin (1000 mg bid) and gliclazide (60 mg qd); Group 2 used the same amounts of metformin and gliclazide, with the addition of vildagliptin (50 mg bid). The patients were prospectively assigned to each of these two groups for the purpose of this study. Using Doppler ultrasound, all cases were measured for portal vein flow velocity, portal vein flow and portal vein diameter. Degree of hepatosteatosis was also recorded.

Eligibility criteria: Inclusion Criteria:

-type 2 DM cases and at least 3 months used the same drugs (metformin and gliclazide or metformin and gliclazide and vildagliptin)

Exclusion Criteria:

* used alcohol and cigarettes
* chronic liver disease,
* chronic renal failure,
* active infection
* patients using certain drugs which may affect portal pressure such as propronalol,
* calcium channel blockers,
* angiotensin-converting enzyme inhibitors,
* angiotensin receptor blockers and isosorbit monohydrate

Primary outcomes:
measure: This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on portal hemodynamics.
timeFrame: at least 3 month (mean 7.8 months)
Secondary outcomes:
measure: This study investigated the effect of the used type 2 DM drug, vildagliptin, a DPP-4 inhibitor, on hepatosteatosis.
timeFrame: followed for at least 3 months (mean 7.8 months)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem VU
Study officials:
affiliation: Bezmialem VU
name: Cumali Karatoprak, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00709930: Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Fields in Mild and Moderate Essential Hypertension
Official title: Randomized Placebo-Controlled Trial of Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Field in Mild and Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Ages: 20 years to 74 years
* Genders : Both
* The severity of hypertension: mild and moderate (WHO/ISH criteria stage I-II) Systolic blood pressure (SBP) \>/= 140 and/or diastolic blood pressure (DBP)\>/= 90 (untreated hypertension cases)

Exclusion Criteria:

* Any of the following medical conditions:
* Severe essential hypertension (DBP \>110)
* Secondary or malignant hypertension
* History or symptoms of cerebral vascular disease
* History of myocardial infarction
* History of angina pectoris, atrial fibrillation, heart failure and arrhythmia
* Renal dysfunction (serum creatinine \> 2.1mg/dl)
* Severe hepatic dysfunction
* Uncontrolled diabetes
* Allergy, drug sensitivity or chronic skin disease
* Peptic ulcer disease
* Current pregnancy or lactation
* Depression that needs to be treated
* Hypertension controlled with antihypertensive medication

Primary outcomes:
measure: The difference between the ELF-EMF and sham groups with respect to the absolute change in SBP value between baseline and the end of the exposure regimen (the age of the pre-exposure values for the last two sessions).
timeFrame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
Secondary outcomes:
measure: The difference between the ELF-EMF and sham groups with respect to the change in DBP value between baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
timeFrame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
measure: The change in both SBP and DBP values between pre-exposure and post-exposure for each session (averaged over the regimen)
timeFrame: for each session
measure: The incidence of adverse events
timeFrame: during exposure and at the end of the exposure period and at six months after exposure
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Masanori Fukushima
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06284330: CHARGE Study: CHoice ARchitecture Genetic tEsting
Official title: CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hereditary Cancer
Keywords: cascade genetic testing
hybrid type I
feasibility
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care.

Detailed description: CHARGE study contains two arms: Arm 1) Usual care, comprising of standard genetic counseling and education to probands regarding cascade testing; and Arm 2) Direct mailing of a home genetic testing kit to probands' at-risk relatives that can be returned directly to a commercial genetic testing laboratory, including educational information on the importance and cost of cascade testing

Eligibility criteria: Proband Inclusion Criteria:

* Have a newly reported pathogenic or likely pathogenic variant in one or more of the following genes: APC, ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, MLH1, MSH2, MSH6, PMS2, PTEN, TP53
* 18 years of age or older
* English fluency
* Have at least 1 adult living genetically related relative who resides in Texas

Proband Exclusion Criteria:

* Referred for genetic testing by a relative with a pathogenic variant
* Unwilling to be randomized to a study arm

Relative Inclusion Criteria:

* 18 years of age or older
* English fluency
* Residing in Texas

Primary outcomes:
measure: Rate of cascade genetic testing
timeFrame: 3-6 months
Secondary outcomes:
measure: Change in probands' family communication about genetic test results as measured by Proband survey
timeFrame: Baseline and 4-7 months
measure: Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months
timeFrame: Approx. 4-7 months
measure: Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale
timeFrame: 4-7 months
measure: Proband's reaction to intervention materials as measured by proband survey.
timeFrame: 4-7 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Sukh Makhnoon, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04521530: Immediate Functional Versus Non Functional Implant Loading in the Mandible
Official title: A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Edentulous Alveolar Ridge
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).

Detailed description: Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss.

Implants of the BioInfinity system were placed in 16 subjects divided into two groups.

Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants.

Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used.

The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged (20-40) years old.
* Missing Posterior tooth or teeth indicated for implant placement.
* Residual alveolar ridge at least 10 mm high and at least 4 mm wide.

Exclusion Criteria:

* Systemic diseases that will contraindicate the surgery.
* Poor Oral Hygiene.
* The patient refuses to undergo the surgery.
* Parafunctional habits.

Primary outcomes:
measure: Pain score
timeFrame: immediately Postoperatively
measure: Change in crestal bone loss
timeFrame: immediately Postoperatively and after 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT05928130: Efficiency in 4-week Plyometric Training: Lower Limb Improvement in Sedentary Adults
Official title: Determining the Minimum Effective Volume of Plyometric Training for Inducing Changes in Lower Limb Strength, Power, and Muscle Electrical Activity During Functional Performance Testing in Sedentary Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plyometric Exercise
Sedentary Behavior
Keywords: Plyometric exercise
Lower extremity
Sedentary behavior
Muscle strength
Electromyography
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the effects of different volumes of plyometric training on lower limb muscle strength, power, and muscle activity in sedentary individuals. The main question\[s\] it aims to answer are:

* What is the minimum volume of plyometric training that can induce changes in lower limb strength and power variables?
* How does muscle activity in the lower limbs vary with different volumes of plyometric training?

Participants will be asked to:

* Complete questionnaires to determine their level of physical activity.
* Attend pre and post-evaluations of lower limb muscle activity, strength, and power during an instrumented sit-to-stand test.
* Perform lower limb plyometric exercises, such as jumps, hops, and bounds.
* Attend supervised training sessions three times a week for a duration of 4 weeks.

Researchers will compare three groups to see if the minimum volume of plyometric training can be identified.


Eligibility criteria: Inclusion Criteria:

* Subjects without lower limb musculoskeletal injuries in the past six months.
* Without previous lower limb surgery in the past two years
* Being sedentary

Exclusion Criteria:

* Medical conditions that could compromise their participation (including cardiovascular disease).

Primary outcomes:
measure: Change from baseline muscle strength at 4 weeks
timeFrame: Baseline (pre-intervention), and two days after the last training session
measure: Change from baseline muscle power at 4 weeks
timeFrame: Baseline (pre-intervention), and two days after the last training session
measure: Change from baseline muscle activity at 4 weeks
timeFrame: Baseline (pre-intervention), and two days after the last training session
Secondary outcomes:
Other outcomes:
Locations:
city: Valdivia
country: Chile
facility: Universidad San Sebastián, sede Valdivia.
Study officials:
References:
Clinical trial NCT05167630: Prognosis Factors in Patients With Primary Central Nervous System Lymphoma
Official title: Prognosis Factors in Patients With Primary Central Nervous System Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PCNSL
Survival Analysis
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical data of PCNSL patients were collected retrospectively, such as sex, age, physical state (ECOG score), cell source classification, number of lesions, whether the lesions involved deep structure, etc. The data of laboratory examination include the protein content in cerebrospinal fluid, lactate dehydrogenase (LDH), β2- macroglobulin (β2-MG), IESLG score, ALC and Ki-67.

Brief summary: Primary central nervous system lymphoma (PCNSL) is a rare extranodal non-hodgkin's lymphoma confined to the central nervous system. It accounts for about 4% of all intracranial tumors and 4% to 6% of all non-Hodgkin's lymphomas . Among them, the most common type is diffuse large B cell lymphoma (DLBCL), accounting for about 95% of all cases. High dose methotrexate (HD-MTX) based chemotherapy can improve the prognosis of patients, but only 30% to 40% of patients can achieve sustained remission, and the overall prognosis is very poor\[4, 6\]. Currently, the International Extranodal Lymphoma Study Group (IESLG) prognostic scoring system and the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic index are widely used to evaluate the prognosis in patients with PCNSL. However, IESLG model has some limitations such as the relatively small number of patients and short follow-up period. MSKCC model may have an inherent selection bias because retrospective data were collected from a single large institution. Therefore, there is a urgent need to identify novel indicators for prognosis evaluation and risk stratification in PCNSL patients.


Eligibility criteria: Inclusion Criteria:

(i)The pathological biopsy and immunohistochemistry diagnosis were PCNSL according to WHO diagnostic criteria for PCNSL in 2016. (ii) No treatment has been received. (iii)There were no diseases with malignant tumor, serious infection, other blood system diseases, immune system diseases and other conditions which may have great influence on peripheral blood lymphocyte count. (iv) The clinical data were complete.

Exclusion Criteria:

-

Primary outcomes:
measure: Overall survival
timeFrame: from September 1, 2013 to June 1, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou university
state: Henan
Study officials:
References:
Clinical trial NCT02918630: E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Official title: E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Keywords: E-cigarettes
Schizophrenia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 7
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: PREVENTION

Brief summary: The purpose of this study is to assess if access to an electronic nicotine delivery device, or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among individuals diagnosed with schizophrenia compared to nicotine patch alone.


Eligibility criteria: Inclusion Criteria:

* Be diagnosed with schizophrenia
* Be in stable medical condition (DSM-V)
* report smoking ≥10 tobacco cigarettes/day
* present a breath CO ≥10 ppm
* report wanting to reduce their cigarette smoking
* be fluent in English
* have a stable living situation

Exclusion Criteria:

* be currently pregnant or breastfeeding
* report wanting to quit smoking in the immediate future
* test positive for illicit drugs except THC
* have any illness, medical condition, or use of medications, which in the opinion of the study physicians would preclude safe and/or successful completion of the study

Primary outcomes:
measure: Change in Smoking as Assessed by Breath Carbon Monoxide Levels
timeFrame: Baseline, Week 5
measure: Change in Smoking as Assessed by Urinary Cotinine Levels
timeFrame: Baseline, Week 5
measure: Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
timeFrame: Baseline
measure: Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
timeFrame: week 5
Secondary outcomes:
measure: Feasibility as Assessed by Percent of Participants Who Completed the Study
timeFrame: week 5
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jin Ho Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806130: Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
Official title: Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients, a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Failure
Renal Dialysis
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2008-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage renal disease and in active dialysis treatment in the Norwegian county of Sør-Trøndelag.

Brief summary: The purpose of this study is to assess health related quality of life and its predictors among chronic dialysis patients and to assess cognitive function using 3 different tests.

(undergraduate medical student research project; not published)


Eligibility criteria: Inclusion Criteria:

* Chronic kidney failure
* Active dialysis treatment
* Aged over 18 years
* Able to read and answer the quality of life questionaire

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
state: Sør-Trøndelag
Study officials:
affiliation: Norwegian University of Science and Technology
name: Inger Karin Lægreid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05921630: Patient Compliance With the Spirometry Protocol
Official title: Impact of Pre-Test Information on Patient Compliance With the Spirometry Protocol: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TEST COMPLIANCE
Keywords: Patient education
respiratory function tests
spirometry
test failure
lung function
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: OBJECTIVE: In this study, the effect of brochure-based and video-assisted information given before spirometry on patient compliance will be evaluated.

PATIENTS AND METHODS: This is a randomized controlled clinical trial. Before the test, subjects in the intervention groups will be shown a brochure explaining the steps of the spirometry protocol and a video prepared for the same purpose. Standard routine information will be given to the control group by the technician before spirometry.

RESULTS: 450 patients will be included in the study. It will be investigated whether there is a difference in terms of test compliance between compliance status and age, gender, smoking status, presence of lung disease, spirometry indication, having spirometry for the first time and those receiving brochure, video and brochure-video information. Multivariate analyzes will be performed among the parameters found to be significant.


Eligibility criteria: Inclusion Criteria:

* Patients sent to the spirometry laboratory for forced vital capacity maneuver

Exclusion Criteria:

* illiterate and had communicational, hearing and visual impairment were excluded

Primary outcomes:
measure: Patient spirometry test compliance
timeFrame: One year
Secondary outcomes:
measure: Number of spirometry test repetitions
timeFrame: One year
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: University of Gaziantep
Study officials:
References: