cyrilzakka/clinical-trials huggingface dataset:
Promoting Recovery After STroke with Amantadine

The investigators aim to examine whether amantadine can help patients recover from stroke. This will be a blinded randomized clinical trial (RCT). Patients will be randomized post-ischemic or hemorrhagic stroke either to the placebo arm or amantadine arm. Patients will be on study drug or placebo for 1 month but will be enrolled for 3 months total. At various time points patients will be examined and fill out questionnaires to determine level of stroke recovery.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 85 years old, male and female
2. Modified Rankin Score (mRS)\<=2 prior to stroke
3. Ischemic or hemorrhagic stroke as diagnosed by vascular neurologist or as proven on magnetic resonance imaging (MRI) or non-contrast head computed tomography NCHCT)
4. 24 hours to 3 weeks after stroke onset or time last known well prior to detection of symptoms
5. National Institute of Health Stroke Scale (NIHSS)\>=3 and NIHSS\<=15
6. Creatinine Clearance of greater than or equal to 60 mL/min using the Cockroft- Gault equation.
7. Have passed a swallow evaluation prior to drug administration
8. The patient is an acute rehabilitation candidate or candidate for the Homeward Stroke Program
9. Able to participate in administered tests

Exclusion Criteria:

1. Any degree of receptive aphasia
2. Moderate or severe expressive aphasia
3. Currently pregnant or plans to get pregnant
4. Currently breastfeeding
5. Any patient admitted with primary SubarachnoidH emorrhage (SAH )on either non-contrast head CT or MRI brain
6. Diagnosis of dementia or mild cognitive impairment prior to index stroke
7. Prior limb amputation
8. Currently prescribed or taking a primary anticholinergic medication
9. Currently enrolled in any other investigational pharmacologic or procedural clinical trial
10. Malignancy with active treatment
11. History of prior stroke with residual impairment
12. Current or prior neuroleptic use
13. History of suicidality or psychosis (The Columbia Suicide Severity Ratings Scale (C-SSRS) will be administered at the screening visit to assess depression and suicidal thoughts for subject eligibility. Any subjects who indicate severe depression or suicidal thoughts and/or attempts within the last year will not be eligible)
14. Prior history of seizures
15. Prior treatment with amantadine
16. Parkinson's disease
17. Amantadine allergy
18. Elevated liver function tests (aspartate aminotransferase and alanine aminotransferase above the upper limit of normal) -
Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery

The aim of this study is to assess if treatment with Lacrimera® eye drops (Croma-Pharma GbmH, Leobendorf, Austria) during and/ or after cataract surgery has a positive effect on the ocular surface compared to control group.

Prior to surgery, pre-assessment measurements will be performed in the same fashion as for non-study patients. Patients will be randomized to one of the 3 groups in a 1:1:1 fashion using an online randomization tool (www.randomizer.org, list randomizer).

Surgery is performed in topical anaesthesia. Right after topical anaesthesia, patients allocated to Group 3 will receive 1 drop of Lacrimera® in the study eye. Injection of viscoelastic substance (OVD), capsulorhexis, phacoemulsification, and coaxial irrigation/ aspiration of cortical material are performed as standard procedure. After IOL implantation the OVD will be removed and at the end of the surgery, stromal hydration will be performed to the incision as a routine procedure to seal the wound. Right after the wound is sealed, patients allocated to group 2 and group 3 will receive 1 drop of Lacrimera® in the study eye. Postoperative standard medication (Bromfenac gtt., twice a day for 4 weeks) will be prescribed for all groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 22 or older
* Scheduled for cataract surgery
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Written informed consent prior to surgery

Exclusion Criteria:

* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathology (e.g. corneal scars, etc.)
* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
* Previous ocular surgery or trauma in the study eye within 6 months of the cataract surgery
* Active ocular infection or inflammation
* Pregnancy (pregnancy test will be taken in women of reproductive age)
* Subjects with surgery longer than 30 minutes will be excluded and replaced
Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia

Varicose veins are irreversible and abnormal enlargement of the veins. These veins appear and there are curled swellings under the skin in the feet and legs. Complaints increase when standing and sitting for long periods. For varicose veins in the initial stages, medical treatment methods such as compression socks (elastic socks) and elevating the feet as much as possible can be tried. For widespread varicose veins in more advanced stages, invasive procedures such as sclerotherapy and endovascular ablation are performed. These procedures can be performed under local, spinal or general anesthesia.

Spinal anesthesia; It is a type of neuraxial type of regional anesthesia characterized by injecting local anesthetic drugs into the subarachnoid space alone or together with other drugs, resulting in temporary sensory block, motor block, and sympathetic block. The local anesthetic volume administered during spinal anesthesia may affect the anesthesia levels and discharge times of the patients. For varicose vein surgeries, low-dose local anesthetic is sufficient for spinal anesthesia and can also provide early discharge.

This study will compare the peri-operative effects of different doses of spinal anesthesia in patients undergoing varicose vein surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II
* Body Mass Index (BMI) between 18-30 kg/m2
* Patients who underwent spinal anesthesia (bupivacaine 4 mg or 6 mg) for varicose vein surgery in the operating theatre

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* ASA score III and above
* Patients with a history of bleeding diathesis
* Patients with infection in the area to be treated
* BMI below 18 or above 30 kg/m2
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Partial Menisectomy

A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be conducted.

Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial menisectomy. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.


Eligibility Criteria:
Inclusion Criteria:

* Young adults aged between 18 and 40 years;
* Recreational athletes;
* Unilateral partial meniscal tear;
* Partial meniscectomy by video-arthroscopy within 90 days after injury;
* Male subjects;
* Classification of body mass index up to pre-obese (25.0 - 29.9 kg / m2);
* Not undergoing any strength training program for the lower limbs in the six months prior to the study;
* Acceptance of individuals in participating in the procedures proposed by the research.

Exclusion Criteria:

Repeated meniscal tear; Associated ligament injuries; Previous history (\<6 months) of musculoskeletal lesions in the thigh; Patellar tendinopathy; Patellofemoral pain syndrome; Respiratory or cardiovascular conditions that limit the performance of exercises; Users of dietary supplements or anabolic steroids
Echocardiographic Characteristics of High Endurance Israeli Athletes

The purpose of this study is to characterize the cardiac adaptive changes of professional Israeli bicyclists by using echocardiography.

Adaptive cardiac changes, such as enlargement of left ventricle mass and enlargement of left ventricular wall was observed in athletes. The physiological limit of remodeling changes in accordance to sex, type of activity, intensity of activity, genetics and race.

Although many studies were conducted on this subject, it is still impossible to predict if an athlete from a certain sport will develop cardiac changes and their what will those changes characteristics will be.

Sudden cardiac death is the leading cause of death among young athletes, this is because of high physical activity in the presence of a hidden heart disease, therefore there is much debate about the needed screening tests for athletes.

In Israel, there is only one study in this subject that showed no significant cardiac changes in Olympic athletes of various types of sports. the study didn't focused on high endurance sport athletes such as professional bicyclists although cardiac endurance is a main factor in cardiac changes.

Eligibility Criteria:
Inclusion Criteria:

* Known athletes of the bicyclists organization of Israel or any other known organization for 2 year at least.
* Participated in at least one contest recognized by the bicyclists organization of Israel.
* Had been in training for the last 3 months at least, which included minimum of 8 hours a week in average

Exclusion Criteria:

* Do not suffer any known cardiac disease
* Had declared that they are not using drugs which are forbidden by the Olympic committee
Registry of Patients With Chronic Thromboembolic Pulmonary Hypertension in Novosibirsk Region

There will be assessment of patients after acute pulmonary embolism for the development of CTEPH

There will be assessment of patients after acute pulmonary embolism for the development of CTEPH.

There will be analysis of case histories of 40 patients with acute pulmonary embolism. All this patients will be clinically assessed by local cardiologist. Also echocardiography, lung VQ scans (perfusion and ventilation) will be performed.

Patients with chronic thromboembolic pulmonary hypertension will be assessed by local team experienced in CTEPH treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients who had episodes of acute pulmonary embolism
* 3-4 months of anticoagulation treatment after acute pulmonary embolism
* informed consent

Exclusion Criteria:

* pregnancy
BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects

The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.

This study was a randomized, open-label, single-dose, two-period, crossover study which included 34 healthy adult male and female subjects under fasting conditions. A single dose of experimental drug or comparator was administered in each of the two study periods (separated by a washout period of 1 week). Serial blood samples were collected up to 36 hours post-dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUCt), were determined by non-compartmental analysis. The geometric mean ratios and associated 90% confidence intervals (CIs) of log-transformed Cmax and AUCt were calculated to evaluate pharmacokinetic equivalence.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
* Acceptable medical history, physical examination, laboratory tests and EKG, during screening
* Subjects who has signed a written informed consent voluntarily

Exclusion Criteria:

* History of clinically significant medical history or current disease
* Hypotension (SBP ≤ 90 mmHg or DBP ≤ 60 mmHg) or hypertension (SBP

  ≥ 140 mmHg or DBP ≥ 90 mmHg).
* AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit
* Total bilirubin \> 2.0 mg/dl
* Volunteers considered not eligible for the clinical trial by the investigator
* Administration of other investigational products within 6 month prior to the first dosing.
Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series of downstream effector pathways. KIT is an established therapeutic target in cancer with activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate. Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic targets in melanoma. Additional information is required to characterize the functional role of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid cancers were reported to have KIT mutation even in low frequency. A molecular profiling of the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center showed KIT mutation in 7 patients in total of 431 patients (2%).

Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib to various types of cancers harboring KIT mutation or amplification.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 20
2. advanced, refractory cancer patients who failed standard of care (SOC)
3. KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score\<-1) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy
4. ECOG performance status of 0\~2
5. measurable or evaluable lesion per RECIST 1.1 criteria
6. adequate marrow, hepatic, renal and cardiac functions

   * Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
   * Total serum bilirubin ≤ 1.5 x ULN
   * Absolute neutrophil count(ANC) ≥ 1,500/uL
   * Platelets ≥ 100,0000/uL
   * Hemoglobin ≥ 9.0 g/dL
7. provision of a signed written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. history of major surgery or radiotherapy within 4 weeks
4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
5. known history of hypersensitivity to study drugs
Effectiveness Study of the Guardian RT in Type 1 Diabetics

The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.

The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes for at least 12 months
* HbA1c must be 8.1% or above at study entry
* Intensive Insulin Therapy 3 months prior to study entry

Exclusion Criteria:

* Impaired hearing or vision (must see screens and hear alarms)
* Unable to comply with protocol
* Chronic debilitating or psychiatric disturbances
VX-770 for the Treatment of Chronic Bronchitis

This research study will test how well a new drug affects bronchiectasis or chronic bronchitis. The new drug, Ivacaftor (KALYDECO), is a drug that has recently been approved by the U.S. Food and Drug Administration (FDA) for patients with a lung disease called Cystic Fibrosis (CF). It has not been approved for use in patients with bronchiectasis or chronic bronchitis.

The study is an open label study of orally-administered ivacaftor in subjects with chronic bronchitis and/or bronchiectasis. Subjects will be administered the study drug ivacaftor 150 mg twice daily (BID). The study drug is commercially available and will be purchased by the participant.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 18 years
* A Clinical diagnosis of Bronchiectasis and/or Chronic Bronchitis in the investigators opinion
* Exhibit symptoms of chronic bronchitis as defined by the Medical Research Council
* FEV1 percent predicted greater than 40 percent Post Bronchodilator
* Clinically stable in the last 4 weeks with no evidence of exacerbation
* Weight of 40 kg to120 kg
* Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives
* Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy
* Element of CFTR Dysfunction, as defined by Sweat Chloride

Exclusion

* Daytime use of Oxygen Therapy
* Documented history of drug abuse within the last year
* Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
* Cirrhosis or elevated liver transaminases \> 3X ULN
* GFR \< 50 estimated by Cockroft-Gault
* Any illness or abnormal lab finding that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Pregnant or Breastfeeding
* Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit juice. (Excluded medications and foods including the drugs and foods are provided in the appendix document)
* Uncontrolled Diabetes
* Clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator that affect patient safety
A Comparative Analysis of Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups

Factors affecting the success of the treatment of infertility can evaluate before and after embryo transfer in two stages. Most of the patients reach the embryo transfer stage. Unfortunately, the investigators are able to intervene very few of the factors that will affect the success of the post-transfer. All factors and treatments that affect the implantation is vital to identify. Basically, healthy vasculature is essential for a successful implantation. The investigators will try to understand relationship between vascular resistance and type of infertility. The investigators will examine whether the effect of the ovarian uterine and spiral artery resistance over infertility.

In this study the investigators will examine whether the alterations of doppler indices in the uterine, ovarian and spiral arteries can help to explain tubal or unexplained infertility as a standard screening method. Patients in unexplained-tubal infertility groups were treated in our IVF clinic. Patients will be invited to the hospital according to the criteria of the study. Fertile patients will be selected according to the criteria for patients who have come for the annual smear control. The study hypothesis is that the resistance in ovarian, uterine and spiral artery doppler will be higher in cases with tubal and unexplained infertility as opposed to low resistance in fertile women.Ovarian, uterine and spiral artery pulsatility index (PI = (peak systolic velocity - end diastolic velocity) / time averaged velocity and resistance index ( RI= (peak systolic velocity - end diastolic velocity) / peak systolic velocity ) will measure with doppler ultrasonography in the mid-luteal phase ( 21th day). Measured values are to be compared.

Eligibility Criteria:
Inclusion Criteria:

* unsuccessful infertility treatment
* normal prolactin levels
* normal thyroid stimulation hormone levels
* no ovarian or pelvic surgery history

Exclusion Criteria:

* To have systemic diseases
* receive medical treatments which may influence the clearance or excretion of gonadotropins and sex steroids
Balance Training Vs Pilates Training

Many pathologies present balance disturbances, however, other types of therapies such as Pilates are increasingly used within the Physiotherapy profession. It is therefore necessary to know the effects that this type of exercise has compared to the traditional method of balance training in order to make good use of this type of therapy.

The objective of the study will be to know if there are differences between both types of training on the balance of the participants.


Eligibility Criteria:
Inclusion Criteria:

* University students between 18 and 35 years.

Exclusion Criteria:

* Diseases or patologies that affect balance.
* Professional sportmen.
* Having suffered an injury 6 months prior to the intervention.
A Study of Sustained-Release Desvenlafaxine Hydrochloride for the Treatment of Major Depressive Disorder

A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Adult with primary diagnosis of Major Depressive Disorder
* Aged from 18 years to 65 years
* A primary diagnosis of Major Depressive Disorder based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features
* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of ≧ 20
* Clinical Global Impressions Scale-Severity (CGI-S) score of ≧4

Exclusion Criteria:

* Known hypersensitivity to desvenlafaxine or venlafaxine
* Significant risk of suicide based on clinical judgment
* Women who were pregnant,breast-feeding,or planning to become pregnant during study
* Had a history of seizure disorder
* History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs
* Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
* Cancer
A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne

A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).


Eligibility Criteria:
Inclusion Criteria:

* Severe facial acne (acne vulgaris)

Exclusion Criteria:

* History of significant anemia or hemolysis
* History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
* History of lupus, rosacea, or seborrheic dermatitis