cyrilzakka/clinical-trials huggingface dataset:
The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults

The study is a randomized clinical trial that is assessing the effects of sensory training on pain modulation, cognition, and physical endurance (time to fatigue) in healthy participants


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent to participate in the study
* Able to perform physical activities such as cycling
* 18-40 years old
* BMI\<27
* Practice of moderate intensity aerobic physical activity less than 150 minutes per week

Exclusion Criteria:

* Hypertension
* Diabetes
* Cardiovascular disease
* Subjects with pacemakers, and/or implantable cardioverter-defibrillators
* History of asthma with active symptomatology in the past year, pulmonary disease or use of inhalers
* Physical disability, neurological and/or psychological disorder that precludes safe and adequate testing
* Conditions that may impair the ability to feel pain
* Mental impairment with limited ability to cooperate
* Uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, or hyperthyroidism
* Pregnancy or trying to become pregnant in the next 6 months
* History of alcohol or drug abuse within the past 6 months as self-reported
* Epilepsy
* Suffering from severe depression (with a score \>30 in the Beck Depression Inventory)
* History of unexplained fainting spells as self-reported
* Head injury resulting in more than a momentary loss of consciousness
* History of neurosurgery as self-reported
* Use of antiepileptic and/or hypnotic medications like carbamazepine, valproate acid, gabapentin, zolpidem, etc.
* Use of medication with potential cardiovascular influence
* Active smoker, or history of smoking in the last 6 months
* Skin lesion or open wounds around or in area of electrode application
* Tattoos in upper limb or along the nerve tract
Interventions on Non-prescription Dispensing of Antibiotics in Community Pharmacies

This study was a randomized controlled trial conducted in community pharmacies. Empirical data were collected primarily using standardized patient methods. In Hubei Province, 400 community pharmacies were randomly selected and assigned to the intervention group and the control group according to the ratio of 1:1. A one-month intervention was conducted in community pharmacies in the intervention group, which included both social surveillance and health education. First, on-site training was provided to community pharmacy staff. Respiratory physicians and pediatricians were invited to give health education lectures on disease diagnosis and treatment, medication use, etc. Second, signs were posted or hung in the community pharmacies of the intervention group, saying that "antibiotics need to be purchased with a prescription, and you are welcome to call the 12315 hotline to report if you find any sales without a prescription", in order to open up the channels of social supervision and to form a social surveillance intervention. The control group only received the regular drug supervision and management measures in Hubei Province. The primary outcome is to observe the proportion of community pharmacies selling antibiotics without a prescription.


Eligibility Criteria:
Inclusion Criteria:

* The qualification of retail pharmacies to sell antimicrobial drugs complies with relevant regulations and requirements, ensuring that the study participants operate legally within the regulatory framework.
* Pharmacies located in Hubei Province.

Exclusion Criteria:

* The retail pharmacy plans to undergo major changes during the study period, such as relocation, renovation, shutdown, or closure;
* Retail pharmacies that refused to respond to the call for training from the Hubei Provincial Drug Administration;
* Participants had poor compliance and do not participate in the intervention as required by the trial on multiple occasions;
* Subjects withdrew from the study on their own or were lost to follow-up.
Psychiatric Care Via Videoconferencing

The purpose of this project is to compare the effectiveness between face-to-face consultations and consultations via videoconferencing among patients treated in the Institute of Psychiatry (IPq).

Introduction: Within the emergence of the Internet and for the purposes of providing psychiatric services across distances, the provision of mental health service via video counseling has become a possible way of mental health service delivery. An appropriate systematization of the propaedeutic methods in psychiatry, according to the interactive resources of telemedicine, and a standardized assessment based on clinical records turn this method to a viable alternative for service delivery all over the world. The main benefit of video counseling is an increased access to care services. But, so far, there is still limited research regarding to the effectiveness of telepsychiatry in the management of mental illnesses.

Objective: To verify the applicability of psychiatric attendance via Interned-based videoconferencing, comparing various quality characteristics between this method and face-to-face attendance, on the basis of a one-year follow-up study with a randomized clinical trial (RCT) design.

Material and methods: 100 patients of the Institute of Psychiatry (IPq) between 18 to 55 years old with depressive disorders are randomly allocated to a control (monthly face-to-face consultation with the attending psychiatrist) or intervention group. The intervention group will have consultations with the attending psychiatrist through internet-based videoconference. For reasons of patient safety, consultations at baseline, and after 6 and 12 months will be realized in a face-to-face form for all patients. At baseline, and after 6 and 12 months mental health, satisfaction with treatment, therapeutic relationship, and medical compliance will be assessed. Depression will be assessed at baseline, and after 3, 6, 9 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* depressive disorder
* between 18 to 55 years
* broadband Internet access

Exclusion Criteria:

* Hamilton Depression Rating Scale total score \> 15
* severe cognitive limitations
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (\<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.

The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:

* BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:

  * at least 1 moderate (semiquantitative grade \[SQ\]2) or severe (SQ3) vertebral fracture OR
  * at least 2 mild (SQ1) vertebral fractures OR
* BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:

  * at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
  * a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.

Exclusion Criteria:

* History of metabolic or bone disease (except osteoporosis)
* Use of agents affecting bone metabolism
* Vitamin D insufficiency
* History of solid organ or bone marrow transplants
* Hyper- or hypocalcemia
* Hyper- or hypothyroidism
* Hyper- or hypoparathyroidism
* Possible signs of intolerance to alendronate
Renal Denervation in Patients With Advanced Heart Failure

Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.

Primary Outcome Measures:

• Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events

Secondary Outcome Measures:

• Ventricular function,NYHA functional Class, 6 min walking test, biochemical test and Renal function as measured by Glomerular Filtration Rate (GFR)

Eligibility Patients population: Volunteers, NYHA Class III-IV heart failure patients. Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure patients NYHA Class III or IV
* Left Ventricular Ejection Function \< 35%
* GFR \> 45 mL/min/1.73m2
* Optimal stable medical therapy

Exclusion Criteria:

* Do not eligible renal artery anatomy for treatment as determined by Angiography, and
* History of prior renal artery intervention
* Single functioning kidney.
* Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
* Systolic BP \< 110mmHG Hospitalisation because of heart failure in last 3 weeks.
Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years

The glenohumeral joint has the highest rate of dislocation of the whole body, due to its high mobility and the special characteristics of its anatomy. It is estimated that every year between 1-2% of the population will suffer from glenohumeral dislocation. The vast majority of studies are based on young patients under the age of 40, given that at this age they have the higher incidence and at the same time, they have higher redislocation index. However, the investigators are in front of a more active population with a longer life expectancy. That is why the cases of anterior glenohumeral dislocations are increasing in people older than 40 years. Given that most studies focus on younger patients, the investigators lack knowledge about which injuries are associated with dislocation at this age and whether these influence its clinical evolution.


Eligibility Criteria:
Inclusion Criteria:

* More than 40 years old
* First episode of traumatic anterior gelnohumeral dislocation seen in Rx
* Acceptance to be checked over 2 years
* Acceptance to be submitted to TAC, NMR, EMG and Bilateral Ultrasound

Exclusion Criteria:

* Previous fractures in this extremity
* Previous neurovascular lesions in this extremity
* Other associated lesions
* Cognitive alterations or dementia which prevent completing the protocols. Patients with \<14 points in Mini-mental test.
Korean Stroke Cohort for Functioning and Rehabilitation

Korean Stroke Cohort for functioning and rehabilitation (KOSCO) is a large, multi-centre prospective cohort study for all acute first-ever stroke patients admitted to participating hospitals in nine distinct areas of Korea. This study is designed as a 10-year, longitudinal follow-up investigating the residual disabilities, activity limitations, and quality of life issues arising in patients suffering from first-ever stroke. The main objectives of this study are to identify the factors that influence residual disability and long-term quality of life. The secondary objectives of this study are to determine the risk of mortality and recurrent vascular events in patients with acute first-ever stroke. Investigators will investigate longitudinal health behaviors and patterns of healthcare utilization, including stroke rehabilitation care. Investigators will also investigate the long-term health status, mood, and quality of life in stroke patient caregivers. In addition, investigators will identify baseline and ongoing characteristics that are associated with secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. First-ever acute stroke (ischemic stroke or intracerebral hemorrhage) with corresponding lesion and/or evidence of acute arterial occlusion on CT (A)- or MRI/A-scan.
2. Age ≥ 19 years at onset of stroke.
3. Onset of symptoms within seven days prior to inclusion.

Exclusion Criteria:

1. Transient ischemic attack.
2. History of stroke.
3. Traumatic intracerebral hemorrhage.
4. Not Korean.
Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment

The aim of this work is to compare between early (3days) and late(7days) removal of urinary catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under Tamsulosin treatment.

This is a prospective randomized study, Men with acute urinary retention secondary to benign prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days, After that the catheter was removed and the ability to void unaided assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients having first attack of acute urinary retention secondary to BPH.

Exclusion Criteria:

* Renal impairment.
* Suspected urethral stricture.
* Neurogenic bladder.
* Cancer prostate.
* Medically induced retention.
* Previous use of alpha blockers.
* History of drug hypersensitivity or allergy to Tamsulosin.
A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies

The purpose of this study is to evaluate the plasma concentration and pharmacodynamics effects of warfarin 5 mg, in the presence or absence of belinostat 1,000 mg/m².

Pharmacokinetic evaluation of belinostat 1,000 mg/m² and metabolites in the presence of warfarin 5 mg.

This is an open-label, single center, pharmacokinetic and pharmacodynamic study in patients with solid tumor or hematological malignancies. Upon providing informed consent and satisfying screening procedures, eligible subjects will report to the clinic for Part I of the study 14 days before the first dose of belinostat (Day -14) for clinical laboratory tests, warfarin (5mg) single dose and a series PK collections. On days 1-5 of each 21-day cycle patients will receive belinostat 1000mg/m\*2 and will have a series of subsequent PK samples collected. On day 3 of cycle 1 only, the patient will also receive warfarin 5mg single dose prior to belinostat infusion. PK samples, urine samples, electrocardiogram (ECG) and safety measurements will be collected from Day 1 through Day 10 of cycle one. If it is in the interest of the patient, belinostat can be continued during Part II- extension phase for 5 additional cycles of belinostat treatment on days 1-5 of each subsequent cycle, or until disease progression, patient withdraws consent or if unacceptable toxicity occurs. During the extension phase routine physical exams, laboratory tests and safety and efficacy assessments will be performed. Disease evaluations will be conducted per standard of care. Patients who discontinue for reasons other than disease progression will be followed until new anti-cancer treatment is initiated or death.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Histological or cytological confirmed diagnosis of malignant disease
* Age ≥18 years old
* Adequate organ function
* ECOG 0-2
* Estimated life expectancy \>3months
* Negative pregnancy test for women of child bearing potential

Exclusion Criteria:

* Low dose anticoagulation therapy within 2 week prior to study treatment
* Anticancer therapy within 2 weeks prior to study treatment
* Investigational therapy within 4 weeks of study treatment
* Major surgery within 2 weeks of study treatment
* Coexisting active infection or other medical condition likely to interfere with trial procedures
* Significant cardiovascular disease (NYHA Class III or IV)
* Baseline prolongation of QT/QTc
* Clinically significant CNS disorder, altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completing trial procedures
* Symptomatic or untreated CNS metastases
* Pregnant or breast feeding women
* Patients not willing to use effective contraception
* Known infection with HIV, Hep B or Hep C
Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws

The study aims to compare the anchorage control during canine retraction using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion

The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars.

After leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed.

* In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar.
* In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws

Lastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs.

Eligibility Criteria:
Inclusion Criteria:

* Post-pubertal female patients.
* Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.
* Full permanent dentition (not necessitating third molars).
* Good oral hygiene.

Exclusion Criteria:

* Medically compromised patients.
* Active periodontal disease or obvious bone loss in the maxillary arch.
* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
* Smoking or any systemic diseases.
* Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement
* Previous orthodontic treatment.
* Missing teeth.
The Effect of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Lean and Normal Weight Patients With Nonalcoholic Fatty Liver

Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no evidence for patients with normal or low body mass index (BMI).

The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD patients with normal or low BMI.

Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups will be advised to follow an energy balanced diet and physical activity recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) below 25
* Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery

The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).


Eligibility Criteria:
Inclusion Criteria:

* The patient is scheduled to undergo an elective colorectal surgery (open or laparoscopic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
* The patient is willing to comply with protocol-specified follow-up evaluations
* The patient signed Informed Consent

Exclusion Criteria:

* Pregnant or nursing female subjects
* Patient surgical treatment is acute (not elective)
* Patient has infections at the time of intervention
* Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
* Patients with ASA (American Society of Anesthesiologists) classification \> 3
* diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
* Patient is participating in another clinical trial within 30 days of screening
* Patient has been taking regular steroid medication in the last 6 months
* Contraindications to general anesthesia
* Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis
* Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
* Blood loss (\> 500 cc)
* Leak test failure during surgery
* Any condition or surgical incidence where the device deployment can jeopardize the patient's safety or interferes with study outcome per the discretion of the investigator
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability

The purpose of this study is to explore the connection between gait variability parameters and balance performance in children with physical disability

Step length and step time variability will be measured with an electronic walkway, strength of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer, walking performance as will be assessed by the 2 minute walk test, energy expenditure index (EEI) and rating of perceived exertion (OMNI scale).

Eligibility Criteria:
Inclusion Criteria:

3 years of age and older Ambulate, with or without an aid

-

Exclusion Criteria:

-
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Male or female
* Must meet Attention-Deficit/Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria

Exclusion Criteria:

* Comorbidity with major psychiatric disorder
* Clinically significant depression or anxiety
* Patients with significant medical conditions
* Current alcohol/drugs abuse/dependence
* Concomitant excluded medications