cyrilzakka/clinical-trials huggingface dataset:
Study of SGB-3908 in Healthy Subjects and Mildly Hypertensive Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3908 in healthy subjects and mildly hypertensive subjects. The study will be a single ascending dose (SAD) phase.


Eligibility Criteria:
Inclusion Criteria:

* Has body mass index (BMI) ≥18 and ≤30 kg/m\^2 and has bodyweight ≥ 50 kg;
* Has Systolic blood pressure (SBP) ≥100 mmHg and ≤150 mmHg and diastolic blood pressure (DBP) ≥65 mmHg and ≤95 mmHg at screening;

Exclusion Criteria:

* Has mental illness, liver and kidney disease, gastrointestinal disease, nervous system disease, or other related systemic diseases that affect the trial;
* Has a history of hospitalization or other clinically significant diseases within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator;
* Has a history of orthostatic hypotension or syncope;
* Patients with clinically significant abnormalities confirmed by physical examination, 12-lead electrocardiogram, laboratory tests, etc., or those who meet any of the following conditions during screening need to be excluded:

  1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin higher than 1.5× upper limit of normal (ULN)
  2. Serum creatinine (Cr) higher than ULN
  3. Serum potassium higher than 5 mmol/L
  4. QT/QTc interval prolongation during screening (QTcF\>450 ms)
Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair

Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of intersphincteric fistula track (LIFT) procedure and the use of an anal fistula plug. The purpose of this study is to exam the rate of fistula closure between the LIFT procedure and the use of a fistula plug


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years of age or older.
* Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
* Has a documented diagnosis, confirmed by physical exam and/or endorectal ultrasound (if available), of a trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).

Exclusion Criteria:

* History or suspicion of Inflammatory Bowel Disease (Crohn's or Ulcerative colitis).
* History of connective tissue disease.
* Rectovaginal fistula.
* Presence of horseshoe fistula.
* History of immunosuppression therapy/treatment within previous six months.
* Presents of a proximal diversion and refractory fistula.
* Any physical conditions, disease, or disorder that would exclude subject from being a candidate for elective surgery.
* Known history of allergy to pork or pork products.
Bone Disease in Severely Burned Children

Bone metabolism is adversely affected by severe burns in children for a period of time.

More closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnormalities and possible therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Children age 5-18 years old with at least 40% or more of their body burned.

Exclusion Criteria:

* Anyone with a burn covering less than 40% of the body or whose burn covers the front of both hipbones.
* Anyone younger than 5 years old, anyone with a history of cancer or other metabolic disease process, or anyone who is pregnant or has an allergy to Tetracycline will also be excluded.
* Anyone who has participated in an investigational drug trial within the past 60 days from date of admission will be excluded from this study.
Efficacy of Hip Strengthening on Dynamic Knee Stability, Disability and Gait in Knee Osteoarthritis

this study will be conducted to investigate the role of hip strengthening in improving dynamic knee stability, gait parameter, lower extremity strength and disability in knee osteoarthritis

knee osteoarthritis accounts for more than 80% of the total burden of the diseases. patients with knee osteoarthritis had worse spatiotemporal gait parameter and dynamic instabitity. there are significant hip muscle weakness in knee osteoarthritis. hip muscle weakness leads to improper alignment and stress in knee joint. hip muscle strength can affect knee joint loading and disease progression in knee osteoarthritis. muscles of the lower extremity play a critical role in the preservation of normal knee joint function by providing dynamic knee joint stability and shock absorption, while maintaining safe transfer of forces across the joint.

Eligibility Criteria:
Inclusion Criteria:

age 40 to 65 years grade 2-3 on KL grade BMI 25 to 32 kg/m2 medial KOA

Exclusion Criteria:

* lateral KOA intraarticular corticosteriod injection into knee within pervious 3 months significant comorbidity individuals with known hip osteoarthritis previous trauma affection one or both hips history of other medical conditions affecting the knee joint previous replacement of any joint in the lower extremity low back pain cognitive impairment
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.


Eligibility Criteria:
Inclusion criteria

* Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
* In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

* Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
* Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
* Have not been registered by 3 months after the full code-breaking of the preceding study
* Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
* Treated surgically (except for local surgery) within 4 weeks before administration of the study drug
Evaluation of DCTclock™ as a Cognitive Assessment Aid

The overall objective of this study is to demonstrate the safety and effectiveness of DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults aged 55-95.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 55 to 95 years old.

Exclusion Criteria:

* Ineligible for written informed consent.
* Physical impairment of the writing hand.
* Impaired manual dexterity.
* Impaired vision.
* Under the influence of recreational drugs or alcohol at the time of the visit.
* Current or recent participation in a clinical trial that includes the use of a drug or intervention to alter cognitive function.
* Recent cognitive testing.
Comparison of End-tidal Carbon Dioxide (ETCO2) Measured by Transportable Capnometer (EMMATM) and the Arterial pCO2 in General Anesthesia

An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread use of capnometry on-site at emergency and trauma fields. So, portable device can be used usefully.


Eligibility Criteria:
Inclusion Criteria:

* patients who anticipated arterial gas analyze intraoperatively

Exclusion Criteria:

* patients who didn't get arterial line
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA

To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee arthroplasty.

The use of the saline-coupled bipolar sealing technology (Aquamantys® System, Medtronic Advanced Energy, LLC, Portsmouth, NH, USA) represents a modern approach to reducing perioperative blood loss in patients undergoing total joint arthroplasty. Unlike standard electrocautery, which use monopolar radiofrequency energy, this technology uses bipolar radiofrequency energy combined with a continuous-flow saline at the electrode tip to prevent tissue temperatures from exceeding 100 °C thus minimizing tissue charring. This eliminates the smoke and eschar formation seen with standard electrocautery. The temperature achieved is sufficient to induce a process called Transcollation(TM) which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.

Suction is used to remove the saline from the surgical field with the treated tissue turning a light tan color. With normal use, the depth of penetration of this effect is typically less than 2mm. The technology is cleared by the US FDA (510(k)) and EU (CE Mark) for use on soft tissue \& bone and will be used according to its intended packaging indications for use. The current assessment proposes a technique in which a disposable Aquamantys® hand piece is used to treat targeted areas which are bleeding or expected to bleed during surgery.

This postmarket study will assess the surgical and economic effectiveness of Aquamantys® System in managing intra-operative blood loss and transfusion rates in patients undergoing septic and aseptic revision TKA.

Eligibility Criteria:
Inclusion Criteria

* The patient is greater than 18 years of age
* Patients following failure of primary, unilateral TKA
* The degree of revision requires the use of an extended osteotomy for component removal
* Patient has participated in the informed consent process and has signed an Ethics Committee approved informed consent

Exclusion Criteria

* Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
* Patients presenting with an internal cardiac defibrillator
* Women who are pregnant
* Prisoner or transient
* Recent history of known narcotic abuse
* Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires
* Subject unwilling to undergo blood transfusion, if necessary
Accuracy of Mobile-Based Vision Charts.

Analyzing the accuracy of mobile-based distant vision charts in clinical practice as an economic alternative for standard vision charts.

Accuracy of mobile-based visual acuity testing in clinical practice is still debatable. The aim of this study was to analyze the accuracy of mobile-based distant vision chart in comparison to standard chart projector.

Eligibility Criteria:
Inclusion Criteria:

* Subjects visited ophthalmology clinic at Al-Nil Hospital, Banha, EGYPT for visual acuity assessment.
* Subjects that their best corrected visual acuity was ranged from 0.1 to 1.0 in decimal form measured on snellen's chart.

Exclusion Criteria:

* Subjects that refuse to measure visual acuity twice during the same visit.
* Subjects that their best corrected visual acuity is less than 0.1 in decimal form by the standard chart projector.
Efficacy of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Major Depressive Disorder

The aim of this study is to assess the efficacy of Transcranial Direct Current Stimulation (tDCS) as an Add-on Treatment for the drug-naïve Major depressive disorder. Meanwhile, evaluate the effect of tDCS on cognitive function of drug-naïve MDD patients. Furthermore, the investigators will examine the changes in cortisol, gut microbiome and some biomarkers. The hypothesis of this study is that tDCS alleviate the depressive symptoms and improve the cognitive function of drug-naïve Major depressive disorder patients with regulating inflammatory response.

This is a randomized, double-blind, sham-controlled study using transcranial Direct Current Stimulation (tDCS) for 4-week treatment. After the intervention of tDCS, there is a follow up visit at week 8 in order to understand the long-term effects of tDCS. Participants were randomly assigned 1:1 to tDCS group or sham-control group. Active tDCS comprised 20 min sessions of 2 mA direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 4 weeks. Sham was administered similarly, but with current turned off after 30s. Apart from studying the effects of tDCS on severity of depression and cognitive function, the secondary outcomes are to examine biomarkers related to inflammatory activity. Scale assessments are performed before the initiation of treatment, week 1, week 2, week 3, week 4 and week8. Collection of blood, excrement and saliva takes place at three time points, at the baseline, week 4 and week 8.

Eligibility Criteria:
Inclusion Criteria:

* a current episode of MDD diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* age between 18 and 50 years
* a total score of HAMD-17 ≥ 17
* take antidepressants less than 3 days
* Patients are compliant with treatment according to the judgement of the treating clinician.

Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised.

Exclusion Criteria:

* A history of manic episode
* Use of mood stabilizer
* History of substance abuse or dependence
* Severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma.
* Use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
* Use of immunosuppressive medication such as oral steroid hormones Women in pregnancy or lactation period
Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography

Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery. The purpose of the study is to compare these two methods of echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely performed simultaneously. The study will also compare the echocardiography data to a third technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.


Eligibility Criteria:
Inclusion Criteria:

* Elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries.
* 18 years or older

Exclusion criteria for thermodilution assessment are as follows:

* Moderate to severe tricuspid regurgitation
* Contraindications to pulmonary artery catheter placement based on the American Society of Anesthesiologist's 2003 Practice Guidelines for Pulmonary Artery Catheterization.

Exclusion criteria for performance of TEE:

* Contraindications to the performance of TEE based on the Journal of the American Society of Echocardiologists' 2011 recommendations and the American Society of Anesthesiologist Guidelines for Performance of Perioperative Transesophageal Echocardiography.
* Any degree of mitral regurgitation or aortic insufficiency above trace.

Exclusion criteria for performance of TTE, both 3D and 2D:

* Qualified echocardiographer absent or unavailable.
Sodium Glycididazole Reduces the Adverse Reactions of Concurrent Chemoradiotherapy

To evaluate the efficacy and toxicity of sodium glycididazole combined with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy.

1. To evaluate the efficacy and toxicity of concurrent chemoradiotherapy combined with sodium glycididazole in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy, and to explore sodium glycididazole as a new way to inhibit the occurrence of radiation esophagitis and reduce the occurrence of radiation pneumonitis and lymphopenia.
2. To evaluate the sensitization effect of sodium glycididazole in the anti-tumor activity during concurrent chemoradiotherapy, as well as the changes in the anti-tumor immune response in peripheral blood, in order to screen out the dominant population and the predictive biomarkers with fewer related toxic and side effects.
3. By exploring the correlation between the expression level of NLRP3 inflammasome activation related molecules and imaging changes in peripheral blood after radiotherapy and the toxicity of radiotherapy and chemotherapy, a risk model for predicting radiation esophagitis after concurrent radiotherapy and chemotherapy for non-small cell lung cancer was further constructed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed non-small cell lung cancer.
2. Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant therapy.
3. ECOG PS 0-2
4. Adequate organ and bone marrow function.

Exclusion Criteria:

1. History of previous radiotherapy.
2. The previous immune-related pneumonitis ≥ grade 2.
3. Local lesions require surgery.
4. History of another primary malignancy.
5. History of active primary immunodeficiency.
6. Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
7. For any unmitigated toxicity during pre-study chemoradiotherapy.
Sodiumhexametaphosphate as Pulp Capping Material for Primary Teeth

Sodiumhexametaphosphate will be tested as pulp capping material in comparison to MTA for primary teeth pulp therapy


Eligibility Criteria:
Inclusion Criteria:

* physical healthy children
* cooperative children
* primary molar with deep carious lesion
* absence of pain or transient momentary pain

Exclusion Criteria:

* Uncooperative children
* children with systemic disorders
* periapical lesions
* sever pain
Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.

The aim of our research was to define both in vivo and in vitro whether and to what extent an high-impact exercise program would affect bone cell turnover and improve the QoL in osteopenic postmenopausal women.

Subjects were selected among those attending the "Bone and Mineral Metabolism Disorders" Clinic of Perugia University, Italy, since May 2nd 2015 and January 31st 2016. A total of 33 post-menopausal women volunteered to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal
* bone mineral density T-score less than -1 but more than -2.5 in the total hip or lumbar spine (L1-L4) by dual energy x-ray absorptiometry
* be able to attend an exercise program 2 times per week over the 3-month period
* stated availability throughout the entire study period

Exclusion Criteria:

* secondary causes of bone loss such as osteomalacia, glucocorticoid medication
* co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
* physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
* a past vertebral fracture
* history of chronic diseases, such as renal, hepatic, cardiac, and rheumatic diseases
* current or prior use of drugs that could interfere with bone mass (i.e. glucocorticoids, antiresorptive drugs and hormonal replacement therapy)
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Inadequate response to Methotrexate
* Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
* American College of Rheumatology (ACR) global function status class 1-3
* Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
* High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

Exclusion Criteria:

* Previously received or currently receiving concomitant biologic therapy
Efficacy of Topical Capsaicin Cream for Stable Angina

The purpose of this study is to test the hypothesis that application of topical capsaicin in patients with stable angina will result in improved exercise tolerance and reduced cardiac ischemia.

Patients with stable angina on medical therapy who are capable of exercising on a treadmill and have an interpretable ECG for ischemia will be enrolled in the study, which entails performing two treadmill tests approximately one week apart following topical treatment with placebo cream or topical capsaicin (randomized in crossover fashion). Patients will be monitored for exercise tolerance, anginal symptoms, ECG for ischemia/arrhythmia, and hemodynamic responses.

Eligibility Criteria:
Inclusion Criteria:

* \> or = 3 month history of chronic, stable, angina triggered by physical effort or mental/emotional stress
* documented stress-induced ST depression, reversible perfusion imaging, or wall motion abnormality or CAD \>50%
* Canadian Cardiovascular (CV) Class I-III
* Receiving medical therapy for \> or = 2 months
* Ability to perform Bruce Protocol treadmill test
* non-pregnant female

Exclusion Criteria:

* unstable angina
* revasc within 2 months
* Myocardial infarction (MI) within 2 months
* congestive heart failure (CHF) hospitalization within 2 months
* New York Heart Association (NYHA) class III or IV
* left ventricular ejection fraction (LVEF) \< 25%
* abnormal ECG; Acute changes on ECG
* Currently receiving treatment with investigational drugs/devices
* Uncontrolled hypertension
* contraindication to exercise stress testing
* allergy to red peppers or capsaicin
* skin deformity, scar, or rash at application site
* abdominal surgery within 3 months