cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Incidence of Dyskinesia in Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist

The purpose of this study is to compare the onset time and severity of dyskinesia in amantadine or Dopamine agonist initial treated groups in Parkinson's disease.

1. Dopamine agonist can delay the risk of dyskinesia by initiating treatment rather than levodopa. Amantadine is typical antidyskinetic drug. There is no data about comparison of risk of dyskinesia in amantadine and dopamine agonist by initiating treatment.
2. Prospective , randomized, open label study compare the onset time and severity of dyskinesia between groups randomized assigned order of amantadine and dopamine agonist

Eligibility Criteria:
Inclusion Criteria:

* 30\<age\<60
* IPD
* H \& Y\<3

Exclusion Criteria:

* previous dopaminergic medication history
* dyskinesia
* Parkinson plus
* clinically significant or unstable medical or surgical condition
Provigil (Modafinil) Study by Taiwan Biotech Co.

The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.


Eligibility Criteria:
Inclusion Criteria:

* Polysomnographic findings of shortened sleep latency less than 5 minutes average of Multiple Sleep Latency Test, and two or more SOREM should be fulfilled.
* Age of 12 y/o to 55 y/o.
* The liver and kidney functions are within normal limits.
* Meeting the strict criteria of narcolepsy described above.
* Wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments.
* Willingness to comply with the protocol and signed the written Informed Consent.

Exclusion Criteria:

* Patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper.
* Patients with concomitant neurological disorder and psychiatric disorders.
* Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above.
* Patients with Restless Leg Syndrome \& Periodic Limbs Movements whose index was more than 5 per hour.
* Patients who are pregnant or breast-feeding.
Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2

Edible parts of the artichoke plant (Cynara cardunculus, Cynara scolymus) are traditionally known in folk-medicine for lipid lowering and choleretic effects. Furthermore, antidiabetic effects are described. In the past year's research attributed health promoting effects to the main active compounds chlorogenic acid, luteolin and apigenin. Present literature indicates potential antidiabetic effects by different mechanisms like downregulation of gluconeogenesis, increased GLP-1 secretion and modification of insulin signalling. Up to now only few human clinical trials provide insufficient data to conclude the therapeutic potential of cynara scolymus extract in the treatment of type 2 diabetes.

The primary objective is to evaluate the antidiabetic effect and the mechanisms of glucose lowering by a 12-week treatment with a highly-standardized extract of cynara scolymus in subjects with diabetes mellitus type 2 compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years old.
* Diagnosis of diabetes mellitus type 2 ≥ 90 days prior to screening
* HbA1c-level between 6.5-9%
* Body mass index of ≥ 28 kg/m2
* Stable daily dose (for at least 30 days) of 1-3 oral antidiabetic drug (metformin, sulfonylurea, SGLT-2 inhibitor, thiazolidinedione or DPP-IV-inhibitor)

Exclusion Criteria:

* Subjects with diabetes mellitus type 1 or history of ketoacidosis,
* Uncontrolled diabetes, defined as fasting plasma glucose ≥20mmol/l or recurrent hypoglycemia (defined as capillary glucose values ≤3.5mmol/l)
* Use of insulin or GLP-1-receptor agonists
* Women wanting to become pregnant
* Pregnant or breast-feeding women
* Known hepatic disorder
* Severe renal insufficiency (GFR ≤30ml/min)
* History of inflammatory bowel disease
* History of gastric bypass or gastric sleeve surgery
* Anticoagulation with vitamin K-antagonists
Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.

People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffering certain psychological disorders.


Eligibility Criteria:
Inclusion Criteria:

* Be able to understand and comply with protocol requirements, instructions, and restrictions.
* Understand the long-term commitment to the study and be likely to complete the study as planned.
* Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.).
* Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.
* Plasma HIV-1 RNA \<50 copies/mL at screening.
* A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test at screen and a negative urine hCG test at randomization) and not lactating

Exclusion Criteria:

* Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blips are allowed (increased viral load ≥50 copies/mL but \<200 copies/mL preceded and followed by a viral load less than 50 copies/mL)
* Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
* Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as a confirmed plasma HIV-1 RNA measurement ≥200 copies/mL after initial suppression to \<50 copies/mL while on first line HIV therapy regimen)
* Subjects who are currently participating in or anticipate being selected for any other interventional study. Observational studies and intervention studies that do not include treatments are allowed unless they interfere with scheduled visits.
* Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication
Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy

This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia.

Anesthesia for lower limb revascularization consists of general anesthesia, neuraxial anesthesia and peripheral regional block. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus and it blocks femoral nerve, LFCN, and limited numbers of nearby nerves such as ilioinguinal, genitor femoral.

Eligibility Criteria:
Inclusion Criteria:

* scheduled femoral thrombectomy,
* both sexes,
* aged between 40-65 years,
* American Society of Anesthesiologists (ASA) II-III. Patients Criteria:

Exclusion Criteria:

* ASA status Grade IV, patient
* refused to participate,
* patients with contraindications to neuraxial anesthesia, such as systemic infection or history of allergy to anesthetic drugs
* infection at the site of injection.
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

Distal humeral fractures can be difficult to treat, in particular when the joint surface is affected (intra-articular fractures). If rigid internal fixation with plates and screws can be obtained it is considered to be the treatment of choice. In elderly patients, poor bone quality (osteopenia) and fragmentation of the articular surface can make rigid internal fixation non-reliable or even impossible. Total elbow arthroplasty has been shown to be of value in this type of situation. Elbow hemiarthroplasty has been proposed as an alternative to total elbow arthroplasty. The theoretical advantages as opposed to total elbow arthroplasty are: no restriction in the weight allowed to be lifted, complications related to polyethylene wear debris are avoided as there is no polyethylene liner and there is no ulna component that can loosen. Wear of the native ulna and instability are potential complications of elbow hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that elbow hemiarthroplasty gives better elbow function than total elbow arthroplasty for irreparable distal humeral fractures.


Eligibility Criteria:
Inclusion criteria

* Intra-articular distal humeral fracture with two or more displaced joint surface fragments devoid of soft tissue attachment
* Osteopenia
* Fracture deemed unsuitable for internal fixation
* Low-energy trauma
* Closed fracture
* Independent living

Exclusion criteria

* Comorbidity that affects elbow rehabilitation considerably
* Severe pre-existing elbow disease
* Concurrent injury that affects elbow rehabilitation considerably
* Pathologic fracture
* Vascular injury
* Inability to participate in follow-up
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia

Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia?

Bladder and Prostate Sonomorphology as a Useful tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia?

Eligibility Criteria:
Inclusion Criteria:

male patients with LUTS/BPH prostate size \> 25 g

Exclusion Criteria:

urinary retention diabetes mellitus neurologic deficit LUTS medications prior lower urinary tract surgery concomitant bladder pathology small bladder capacity (\< 150 ml) urethral stricture evident prostate carcinoma.
Stenting of Haemodialysis Acces Trial

The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years of age
* Patients have a life expectancy of at least 2 years
* Signed informed consent
* Recurrent stenosis at the venous anastomosis or in the draining vein of a loop arterio venous fistula, within 2 cm from the anastomosis.

Exclusion Criteria:

* Patient unsuitable for administration of contrast agent
* Pregnancy
* Dementia or altered mental status that would prohibit giving conscious informed consent
* Need for adjunctive major surgical or vascular procedures within one month
Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

The purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.


Eligibility Criteria:
Inclusion Criteria:

* Neonates \<44 weeks corrected age at seizure onset
* Seizures due to acute brain injury
* Parent(s) who are English or Spanish literate (with assistance of interpreter)

Exclusion Criteria:

* Neonates at risk for adverse outcome independent of seizures and underlying brain injury
* Neonates with mild, temporary causes for seizures
* Newborns with neonatal-onset epilepsy syndromes
* Neonates who do not survive the initial hospital admission
* Neonates will not be excluded based on race, ethnicity, gender or gestational age
Meibomian Gland Dysfunction (MGD) and Tear Cytokines After Cataract Surgery According to Preoperative Meibomian Gland Status

To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular surface parameters after cataract surgery according to the preoperative MGD grade.


Eligibility Criteria:
Inclusion Criteria:

* males or non-pregnant females aged between 55 to 80 years-old.

Exclusion Criteria:

* had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease, as well as patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.
Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms

In the weeks prior to menstruation, many individuals experience mood and physical symptoms that negatively impact their quality of life and functioning. Approximately 5% of women and menstruating individuals have such severe symptoms that they meet criteria for Premenstrual Dysphoric Disorder (PMDD). Further, of those with underlying mood disorders (i.e., depression, bipolar disorder) about 60% have cyclical worsening of symptoms classified as premenstrual exacerbation (PME). Both PMDD and PME are associated with significant impairment, yet limited effective options exist to treat these conditions. In this project, the investigators will adapt and evaluate an Acceptance and Commitment Therapy (ACT) group for PMDD and PME, entitled ACT-Premenstrual (ACT-PM), delivered virtually to maximize accessibility. The investigators will examine whether ACT-PM is feasible to deliver and whether it is acceptable to group participants and those facilitating the group. The study will lay the groundwork for future research to determine if the group is effective. If effective, the intervention could be scaled up to improve quality of life and outcomes for individuals suffering from PMDD and PME.


Eligibility Criteria:
Inclusion Criteria:

* (1) diagnosed by the psychiatrist who conducted the initial assessment with either Premenstrual Dysphoric Disorder (PMDD), or a bipolar or depressive disorder where there is Premenstrual Exacerbation (PME), after 2-3 months of mood tracking using a validated evidenced based scale for premenstrual mood symptoms (McMaster Premenstrual And Mood Symptom Scale (MAC-PMSS) or similar;
* (2) have internet access and a video-enabled device;
* (3) residing in Ontario for the duration of the study, necessary because MDs and therapists who could deliver the intervention are all licensed provincially;
* (4) regular menstrual cycles (\~21-35 days); and
* (5) have a regularly treating physician (e.g. psychiatrist or primary care provider).

Exclusion Criteria:

* (1) active alcohol or substance use disorder in the previous 12 months;
* (2) active suicidal ideation, mania, psychosis, or violence;
* (3) current pregnancy or planning a pregnancy during the duration of the study
* (4) inability to complete group and/or study measures in English, necessary as the pilot group is only available in English at this time.
Bauhinia Forficata in Diabetic Patients

Among the plants most used in folk medicine for the treatment of diabetes are the species of the genus Bauhinia (Fabaceae), popularly known in Brazil as "pata-de-vaca". Of these, Bauhinia forficata has the highest number of studies regarding the hypoglycemic activity. Due to this fact it is included in the Medicinal Plants List of the Brazilian Public Health System. Extracts of pata-de-vaca (B. forficata) have been explored both in relation to its chemical composition and its pharmacological potential. From the chemical point of view the main components identified in hydro alcoholic extract of the leaves are O-glycosylated derivatives of kaempferol and quercetin. Regarding pharmacological properties preclinical studies have confirmed the hypoglycemic effect and antidiabetic of the hydroalcoholic extract of the leaves of B. forficata. The search for evidence of the alleged anti-diabetic activity of B. forficata in clinical level was performed in only two studies, both with few patients, and questionable methodological quality that used tea as a pharmaceutical form, a fact that allows us to question the validity of data considering the risks of no dose reproducibility ingested by patients during the study. Thus the investigators here intend to determine the effects of a standardized extract of B. forficata in the control of patients with diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetic patients
* Using oral antidiabetic treatment for at least 3 months
* Glycated hemoglobin levels \> 7.5% or
* Fasting glucose levels \>=100mg/dl

Exclusion Criteria:

* Type 1 diabetes patients
* History of cancer under treatment
* Major cardiovascular event during the last 90 days (eg. stroke, myocardial infarction)
* Pregnancy
* Lactation
* Serious diseases presenting limited short-term prognosis (eg stage IV COPD end-stage heart failure)
* Child B or C cirrhotic patients
* Patients with chronic renal failure on dialysis
Effects of Camelina Sativa Oil in Free-living Older Adults

The present study aims at evaluating the anti-inflammatory effects of a novel food in older adult volunteers. Briefly, this randomized, double-blind and placebo-controlled study is performed on 91 apparently healthy older adults (age≥65 years) before and after 12 weeks' consumption of a snack enriched with camelina Sativa oil. Subjects were randomized into two groups (active group vs placebo group).

Ninety-one volunteers (26M/65F) are enrolled according to the following inclusion criteria i) free-living older adults ≥ 65 years; ii) apparently healthy subjects; iii) subjects who do not take vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids; iv) subjects without food allergies.

All volunteers are informed about the purpose of the study and the potential risk and provide their informed consent.

Subjects are randomized into two groups: active group (13M/36F) vs placebo group (13M/29F).

The main objective of this project is to test the efficacy of the 12-weeks consumption of a novel food (snack enriched with camelina Sativa oil) on the inflammatory status in older adults.

The primary and secondary endpoints are:

i) Investigation of changes in serum CRP levels and serum levels of pro- and anti-inflammatory cytokines, in the active group (volunteers consumed enriched snack with camelina Sativa oil) and placebo group, after 12 weeks of snacking (T1), compared to baseline (T0) (primary endpoint).

ii) Evaluation of changes in serum lipid panel parameters after the consumption of the novel food in both the active and placebo groups (secondary endpoint).

iii) Evaluation of changes in glucidic status after the consumption of the novel food in both the active and placebo groups (secondary endpoint).

iv) Evaluation of changes in the levels of omega 3 polyunsaturated fatty acids in both the active and placebo groups (secondary endpoint).

v) Evaluation of the nutritional status at T0 and at T1 in both the active and placebo groups (secondary endpoint).

Eligibility Criteria:
Inclusion Criteria:

* Age over 65
* Free-living
* No food allergy
* Apparent good health
* Acceptance and sign of informed consent

Exclusion Criteria:

* Age under 65
* Living in a nursing home, extended care
* Hospitalized
* Presence food allergy
* Without acceptance and sign of informed consent
* Taking vitamin supplements/integration and/or omega 3 polyunsaturated fatty acids
Assessment of Proprioceptive and Functional Characteristics in Patients With Hemophilia

Analyze and evaluate the skeletal muscle of patients affected with hemophilia in the Region of Murcia.

* Describe the periarticular muscular deficit of the lower limbs, depending on the degree of injury: acute and chronic, or subacute.
* Identify the range of motion of joints with higher prevalence of hemophilic arthropathy.
* Detect the biomechanical changes of the lower limbs and their impact on gait in patients with hemophilia.
* Assess the factors that influence the perception of illness and quality of life of patients with hemophilia.

Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis in lower limbs.

Descriptive study of alterations in the strength of the periarticular muscles of lower limbs as a result of acute conditions or the development of chronic articular sequelae.

Descriptive study of the biomechanical alterations in weight-bearing joints of lower limbs and their impact on gait in patients with hemophilia.

Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A and B
* Patients of all ages (from 6 to 70 years).
* With or without joint damage clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
* Residents in the Autonomous Community of the Region of Murcia.

Exclusion Criteria:

* Patients without ambulation
* Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
* Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)

This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella

Exclusion Criteria:

* Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
* Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
* Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
* History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX® or M-M-R II®
* Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
* Received salicylates within 14 days prior to study vaccination
* Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
* Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
* History of seizure disorder, including febrile seizure
* Fever illness (\>=102.2 °F \[39.0 °C\] within 72 hours prior to study vaccination
* History of thrombocytopenia
* Born to a human immunodeficiency virus (HIV)-infected mother
* Has a diagnosis of active untreated tuberculosis
* Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.