louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05556252: The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life
Official title: The Effect of Hydrogen-rich Water Consumption on Premenstrual Symptoms and Quality of Life in Students With Premenstrual Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of hydrogenated water on premenstrual symptoms and quality of life in students with premenstrual syndrome.

Research Hypotheses H1 1 Hydrogenated water consumption reduces premenstrual symptoms in students with premenstrual syndrome.

H1 2 Hydrogenated water consumption increases the quality of life in students with premenstrual syndrome.

The research will consist of intervention and control groups. Individuals consuming hydrogen-rich water will be included in the intervention group, whereas individuals consuming normal water will be in the control group. The block randomization method will be used to randomly assign participants who meet the research criteria to the groups. Participants will be provided with hydrogenated water for three cycles.


Eligibility criteria: Inclusion Criteria:

* The length of the menstrual cycle is within normal limits (21-35),
* Getting a score of 132 or more from the Premenstrual Syndrome Scale,
* Not receiving medical treatment for PMS,
* Not having any psychiatric diagnosis.

Exclusion Criteria:

* • Irregular menstruation in the last three cycles

  * Having received a psychiatric diagnosis,
  * Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
  * Using contraceptive medication.
  * Individuals' refusal to participate in the study,
  * Participants' non-compliance with the research plan,
  * Participants start receiving PMS treatment during the study period.

Primary outcomes:
measure: Change in premenstrual symptoms assessed by The Premenstrual Syndrome Scale
timeFrame: immediately before the intervention, immediately after the intervention, and 1 month after the intervention
measure: Change in quality of life assessed by World Health Organization Quality of Life
timeFrame: immediately before the intervention, immediately after the intervention, and 1 month after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Altindağ
country: Turkey
facility: Ankara University Faculty of Nursing
state: Ankara
Study officials:
References:
Clinical trial NCT01692652: Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular symptoms, which are all associated with the constant release of inflammatory mediators. To our knowledge, there has been no study on tear cytokine levels in MGD patients treated with topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine the concentration of inflammatory tear cytokines in patients with MGD and to compare the changes in tear cytokine levels between topical loteprednol etabonate and warm compress treatment group and warm compress only treatment group.


Eligibility criteria: Inclusion Criteria:

(1) stage 3 or 4 meibomian gland dysfunction

Exclusion Criteria:

1. history of previous ocular or intraocular surgery
2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
3. history of intolerance or hypersensitivity to any component of the study medications,
4. wearing contact lenses during the study period, presence of current punctal occlusion,
5. pregnancy, lactating women, and children.
6. Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears

Primary outcomes:
measure: Changes of inflammatory cytokines in the tears of moderate and severe MGD
timeFrame: 1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References:
citation: Lee H, Chung B, Kim KS, Seo KY, Choi BJ, Kim TI. Effects of topical loteprednol etabonate on tear cytokines and clinical outcomes in moderate and severe meibomian gland dysfunction: randomized clinical trial. Am J Ophthalmol. 2014 Dec;158(6):1172-1183.e1. doi: 10.1016/j.ajo.2014.08.015. Epub 2014 Aug 13.
Clinical trial NCT03234452: Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
Official title: Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disbiosis
Abdominal Pain
Constipation
Diarrhea
Stress
Keywords: Lactoflorene plus
Bifidobacterium animalis subsp. lactis, BB-12®
Lactobacillus acidophilus, LA-5®
Lactobacillus paracasei subsp. paracasei, L. CASEI 431®
Inflammation
gut permeability
disbiosis
probiotic
IgA
IL10
Lead sponsor: Montefarmaco OTC SpA
Sponsor class: INDUSTRY
First posted: 2017-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.


Eligibility criteria: Inclusion Criteria:

Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.

Exclusion Criteria:

Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.

Primary outcomes:
measure: NK activity
timeFrame: 45 days
Secondary outcomes:
measure: IgA, IL8, TNF-Alpha, IL10
timeFrame: 45 days
measure: Cortisol, alpha-amylase , chromogranin A
timeFrame: 45 days
measure: microbiota composition investigation
timeFrame: 45 days
measure: Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
timeFrame: 45 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Centro Ricerche Cliniche di Verona Srl,
state: (Vr)
Study officials:
References:
citation: Soldi S, Tagliacarne SC, Valsecchi C, Perna S, Rondanelli M, Ziviani L, Milleri S, Annoni A, Castellazzi A. Effect of a multistrain probiotic (Lactoflorene(R) Plus) on inflammatory parameters and microbiota composition in subjects with stress-related symptoms. Neurobiol Stress. 2018 Nov 7;10:100138. doi: 10.1016/j.ynstr.2018.11.001. eCollection 2019 Feb.
Clinical trial NCT01475552: Tailored Antiplatelet Therapy During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus
Official title: The Effect of Point-of-care Platelet Function Assay Guided Antiplatelet Therapy on the Periprocedural Increase of Cardiac Enzymes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: platelet reactivity
platelet function assay
abciximab
tailored therapy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers aimed to investigate the effect of point-of-care platelet function assay on the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.

All patients who are supposed to undergo coronary angiography were loaded with clopidogrel (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP (Accumetrics). If patients have \>270 unit in the assay, they are randomized to abciximab or control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are assessed at 1 month.


Eligibility criteria: Inclusion Criteria:

* Patients who were determined to implant drug-eluting coronary stent
* Diabetes mellitus (type 1 or 2)

Exclusion Criteria:

* Age \<18 years or \>80years
* Patients with acute myocardial infarction
* Patients with history of cerebral hemorrhage ever or ischemic infarction within 2 years
* Patients with history of major surgery (abdominal, thoracic, intraocular) within 6 months
* Patients who have have allergy to antiplatelet medications (aspirin, clopidogrel, abciximab)
* Patients who are on anticoagulation therapy
* Serum creatinine \>2.0mg/dl or ALT/AST \> 3 times of upper normal limit (120 U/L)

Primary outcomes:
measure: Peak cardiac enzyme level (CK-MB,troponin-I)
timeFrame: within 24 hrs
Secondary outcomes:
measure: major adverse cardiovascular events (MACE): a composite of cardiac death, myocardial infarction, ischemic stroke
timeFrame: 1 month
measure: Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints)
timeFrame: 1 month
measure: The rate of periprocedural myocardial infarction
timeFrame: 8hr, 16hr, 24hrs
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Dong-Ju Choi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05679700: The Effect of Rigid Taping in Chronic Stroke Patients With Knee Hyperextension
Official title: The Effect of Rigid Taping in Chronic Stroke Patients With Knee Hyperextension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: Gait Analysis
Stroke
Knee Hyperextension
Rigid Taping
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, it is aimed to examine the effect of rigid taping on hyperextension control in stroke patients with knee hyperextension in the stance phase of gait.

Hypothesis Ho: Rigid taping has no effect on the control of knee hyperextension in stroke patients.

H1: Rigid taping has an effect on the control of knee hyperextension in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Having had a stroke at least 6 months ago
* Ambulation with or without a walking aid (walker, cane or tripod)
* To be between 0-3 points according to the Modified Rankin Scoring
* Presence of spasticity in any of the lower extremity muscles with a value of at least 1 according to the Modified Ashworth Scale
* Getting a score of 24 or higher on the Mini Mental Test
* Presence of hyperextension in the stance phase of gait

Exclusion Criteria:

* Having more than one stroke history
* Being diagnosed with dementia
* Having a previous diagnosis of orthopedic, psychiatric or other neurological disease
* Having a situation that prevents communication
* History of surgery or joint contracture involving the lower extremities and gait

Primary outcomes:
measure: Vicon Motion Capture System
timeFrame: Baseline
measure: Blade Software System
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Hacettepe University
state: Ankara
Study officials:
affiliation: Hacettepe University
name: Kadriye Armutlu, Prof. Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Süleyman Korkusuz, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Mehmet Akif Topçuoğlu, Prof. Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Serdar Arıtan, Asst.Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Nihat Özgören, MSc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ali Naim Ceren, Msc
role: STUDY_CHAIR
References:
citation: Cooper A, Alghamdi GA, Alghamdi MA, Altowaijri A, Richardson S. The relationship of lower limb muscle strength and knee joint hyperextension during the stance phase of gait in hemiparetic stroke patients. Physiother Res Int. 2012 Sep;17(3):150-6. doi: 10.1002/pri.528. Epub 2011 Dec 7.
citation: Geerars M, Minnaar-van der Feen N, Huisstede BMA. Treatment of knee hyperextension in post-stroke gait. A systematic review. Gait Posture. 2022 Jan;91:137-148. doi: 10.1016/j.gaitpost.2021.08.016. Epub 2021 Aug 24.
Clinical trial NCT00475800: Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
Official title: A 39-week, Open-label Extension to CCOX189A2360, a 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
lumiracoxib
celecoxib
Cox-2
knee
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.


Eligibility criteria: Inclusion Criteria:

* Have completed the core CCOX189A2360 study
* Males and females over the 18 years old

Exclusion Criteria:

* Treatment in the extension study is not considered appropriate by the treating physician
* Non-compliance or major protocol violation of the core study

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.
Secondary outcomes:
measure: Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit
measure: Patient's global assessment of disease activity by visit
measure: Physician's global assessment of disease activity by visit.
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Brooklyn Park
country: United States
state: Minnesota
city: Albuquerque
country: United States
state: New Mexico
city: Sioux Falls
country: United States
state: South Dakota
city: San Antonio
country: United States
state: Texas
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
Study officials:
References:
Clinical trial NCT01003652: Clinical Trial on Harmonic Focus Shears
Official title: Harmonic Focus Shears Versus Clamp-and-technique for Total Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multinodular Goiter
Keywords: goiter
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 68 patients candidate to total thyroidectomy for multinodular goiter in an academic hospital

Brief summary: The purpose of this study is to evaluate the technical benefits, advantages and limits of the use of the Harmonic Focus curved shears in total thyroidectomy.

Detailed description: According to a randomized sequence, total thyroidectomy was performed in 34 patients using Harmonic Focus and in 34 patients using clamp-and-tie technique.

In this randomized prospective trial, differences in the duration of surgery, intraoperative bleeding and post-operative complications were analysed.

Eligibility criteria: Inclusion Criteria:

* Total thyroidectomy for multinodular goiter in adults patients

Exclusion Criteria:

* Redo surgery, malignancy.

Primary outcomes:
measure: Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy
timeFrame: day one after surgery
Secondary outcomes:
measure: Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis
timeFrame: during the operation
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study officials:
affiliation: St Luc
name: Michel Mourad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03073252: The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise
Official title: The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Cardiovascular Risk Factor
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 121
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to explore the effect of high versus normal egg-based protein meals on acute exercise-induced elevated blood pressure.

Detailed description: This study is designed to assess BP changes during and post- exercise after consumption of a test breakfast. The design consists of three visits. The first visit will assess each participants aerobic exercise capacity (VO2 max). Visit 2 and 3 will be clinical testing days where the subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner and perform the exercise intervention. BP changes will be monitored before and after breakfast consumption, during the exercise intervention,

Eligibility criteria: Inclusion Criteria:

* Pre-hypertensive (systolic, 120-139 mm Hg; diastolic, 80-89 mm Hg
* Age ≥ 21
* Body weight \<300 lb (136 kg)
* BMI between 20 and 34.9 kg/m2
* Fasting plasma glucose \<6.1 mmol/L,
* total cholesterol \<6.7 mmol/L
* LDL cholesterol \<4.1 mmol/L
* TG \<4.5 mmol/L
* No pre-existing or history of cardiovascular, renal or liver disease
* Not currently or previously (past 6 mo) consuming a weight-loss diet or other special/non-balanced diets
* No weight loss/gain (±4.5 kg) within the past 6 mo
* No physical impairments preventing properly exercise execution
* No caffeine intake the day of testing

Exclusion Criteria:

* Hypertensive
* Body weight ≥ 300 lb
* BMI \<20 or \>35 kg/m2
* Pregnant or planning pregnancy
* Unwilling to consume study foods and beverages
* Fasting plasma glucose ≥6.1 mmol/L
* Total cholesterol ≥6.7 mmol/L
* LDL cholesterol ≥4.1 mmol/L
* TG ≥4.5 mmol/L
* acute illness
* smoking
* diabetic
* pre-existing or history of cardiovascular, renal or liver disease
* currently or previously (past 6 mo) consuming a weight-loss diet or other special/non-balanced diets
* weight loss/gain (±4.5 kg) within the past 6 months
* physical impairments preventing properly exercise execution
* caffeine the day of testing

Primary outcomes:
measure: Blood Pressure Changes
timeFrame: 6hr testing
Secondary outcomes:
measure: Vasoactive Molecules
timeFrame: 6 hrs
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References: