cyrilzakka/clinical-trials huggingface dataset:
The Effect of Tai Chi Exercise Among Elders With Sarcopenia

Sarcopenia has been defined as a disease which presented as low muscles strength, low muscle quantity or quality and low physical activity. The prevalence of sarcopenia is increasing with the age and it is also included in one of geriatric syndromes. Several criteria have been mentioned for diagnosis of sarcopenia, such as European Working Group on Sarcopenia in Older People (EWGSOP)、Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project (FNIH) and Asian Working Group for Sarcopenia (AWGS).

In European, the prevalence rate of sarcopenia is 9.25-18%; 5-7% Canadian and 14.4% Taiwanese elders have been diagnosed as sarcopenia, respectively. The sarcopenia has been found its relationship with adverse outcomes of fall down, fracture, disability, and death. The cytokines and decline in anabolic hormones play a role in the pathogenesis of sarcopenia. Tai Chi exercise is one of Qigong and well-popular in Chinese population, and is helpful to integration of body movements. Tai Chi exercise is less complicated and emphasized people's awareness of self-care which presented the relationship between human and nature. Tai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty. Furthermore, Tai Chi has been found that it also could improve the muscle power and power strength in sarcopenic elders by team training. Furthermore, immune makers of inflammation process have been noted their diminishments by Qigong intervention.

The aim of this study is to investigate the effect of Tai Chi exercise in sarcopenic elders through practicing at home. The differences of muscles strength, muscle quantity or quality and physical activity after interventions would be recorded and analyzed. The cytokines related to the sarcopenia process would also be sampled.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 or older;
* With a diagnosis of sarcopenia \[defined as EWGSOP-2\] (6);
* Without planned exercise program or unplanned admission in 6 months;
* Could tolerate tests of muscle power and strength.

Exclusion Criteria:

* Uncontrolled diabetes mellitus;
* Uncontrolled cardiovascular diseases;
* Uncontrolled hypertension;
* Knee or hip prosthesis, pacemaker, fracture in the previous 6 months,
* Critical cognitive (MMSE\<23)
* Mini Nutritional Assessment (MNA \<17)
* Physical dysfunctions that could not tolerate our tests
Prostate Cancer - Localized Adenocarcinoma Proton Therapy

A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma

For Proton therapy with prostate adenocarcinoma patients.

Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.

Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0
* ECOG performance status:0-1
* Signed study specific informed consent prior to study entry.

Exclusion Criteria:

* Postoperative residual or recurrent tumor
* Evidence of distant metastasis previous irradiation for the tumor in the same location
* Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
Ocular Surface Microbiome

The purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms.

"Dry eye" is a very common eye condition, which may or may not be caused by specific microorganisms that live on the surface of the eye. In this study, a combination of tissue culture and molecular biology techniques will be used to identify every microbe (bacteria, fungus, or virus) on the surface of eyes of people with dry eye syndrome, as well as a 'control' group of people who don't have dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with ocular surface discomfort with an Ocular Surface Disease Index score of greater than 60
* Subjects with and Ocular Surface disease Index score less than 30
* Males and females age 18 or older

Exclusion Criteria:

* Contact lens wear
* Use of oral or topical antibiotics in past 6 months
* Use of prescription eye medication in past 6 months
* Penetrating ocular or keratoplasty surgery in last 12 months
* Children under the age of 18
Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer

The purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).

The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx
* Patients who did not undergo surgery for the primary tumor location
* Patients with a Karnofsky performance score of 70% or more
* Written informed consent for participation in this trial

Exclusion Criteria:

* Other malignancy except for non-melanoma skin cancer
* Prior irradiation to the head and neck region
Group Intervention for Interpersonal Skills

The purpose of this study is to compare an individual state-of-the-art cognitive behavioral therapy (CBT) with CBT augmented by a group intervention for improving interpersonal skills, the Kiesler Circle Training (CBT+KCT), in patients with a depressive or anxiety disorder.

This study aims to test the effectiveness and feasibility of a transdiagnostic group psychotherapy to improve interpersonal skills, the Kiesler Circle Training (KCT). For this purpose, a prospective, bicentre, randomised clinical trial (RCT) blinded by evaluators and statisticians will be conducted on outpatients with diagnoses of anxiety and/or depressive disorders according to DSM-5. An individual state-of-the-art cognitive behavioral therapy (CBT) will be compared with CBT augmented by Kiesler Circle Training (CBT + KCT) in a sample of 156 patients (CBT: 78 patients, CBT + KCT: 78 patients). All participants will be assessed four times, at baseline (T1, week 2), at mid-treatment (T2, week 9), at post-treatment (T3, week 14) and at 3-months follow-up (T4, week 26). Outcome measurements include interpersonal problems as well as symptom change in regard to both the categorical approach (primary diagnosis) and the transdiagnostic approach. The two main hypotheses are:

1. the improvement of interpersonal problems in the experimental group (CBT + KCT) will be greater than the improvement in the control group (CBT).
2. the improvement of interpersonal problems will be associated with decreasing symptom severity related to the primary diagnosis, so that patients in the conjoint CBT+KCT treatment will reach higher symptom change scores than patients in the CBT only condition.

Furthermore, we assume that the course of interpersonal problems is moderated by childhood maltreatment and mediated by the quality and quantity of daily social contacts.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient knowledge of the German language (B2 level)
* Primary diagnosis of either depressive disorder or anxiety disorder according to DSM-5 at time of screening
* Interpersonal distress above average (IIP-32 \> 1.81) at time of screening
* Ongoing individual CBT at time of screening
* Signed informed consent regarding the study protocol

Exclusion Criteria:

* Acute suicidality at time of screening
* Active substance abuse at time of screening
* Borderline, antisocial, schizoid or schizotypic personality disorder at time of screening
* Inability to participate in outpatient treatment with additional weekly group appointment at time of screening
* Any kind of additional group treatment (including self-help groups) besides individual CBT during the entire study period
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children with Autism Spectrum Disorder: Raynor Cerebellum Project

The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).

The study will be randomized, double-blind, within subject crossover design. It will involve a group of 30-40 children and young adults with Autism Spectrum Disorder (ASD). We may recruit up to 60 subjects. Diagnosis of ASD will be confirmed with the Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule-2 (ADOS-2) by a research-reliable clinician. Each participant will undergo a sham condition and a transcranial direct current stimulation (tDCS) condition, the order of sham and tDCS conditions will be randomly assigned to each participant during baseline testing. Sham refers to participants only receiving 1 milliamp of tDCS stimulation for 1 minute, and tDCS stimulation refers to 20 minutes of tDCS stimulation. The study involves an initial screening visit followed by two sessions with three months between each session period. Each session includes the following: pre-testing and imaging, tDCS 3-week session, post-testing and imaging. Participants will complete an initial screening to confirm clinical diagnosis of ASD, determine baseline cognitive functioning, and complete a practice Magnetic Resonance Imaging (MRI) and Magnetoencephalography (MEG) session. At pre-testing, they will complete a psychometric battery, as well as undergo safety screening, and an MRI and/or MEG. Each 3-week tDCS sessions will be randomized, and each participant will undergo three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation. Neither the researchers nor the participants will know which group they are assigned during each three-week session.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5 to 21, male and female, with known autism spectrum disorder as diagnosed by a clinician

Exclusion Criteria:

* Pregnancy
* Brain implants
* Pacemakers
* Any biomedical or metal implants in any part of body
* Hearing or visual impairment
* History of brain injury
* Known brain or skull abnormality other than those that may be associated with ASD
Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease

In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral cavity of patients with Crohn's disease before and after ileocecal resection, so as to further explore the role of ileocecal region in inducing remission of disease.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Crohn's disease

Exclusion Criteria:

Serious oral diseases (e.g. dental caries, periodontal disease) Other acute or chronic gastrointestinal diseases Probiotics or prebiotic consumption and antibiotic use within 1 month
The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

This is a prospective comparative randomized controlled trial investigating the effect of two GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology.

Follicle maturation triggering is the final differentiation process of an immature egg before fertilization, either in normal or stimulated ovarian cycles in assisted reproductive techniques. This step has traditionally been accomplished by the administration of human chorionic gonadotropin (hCG) trigger which mimics LH activity. However, hCG is a primary cause of severe ovarian hyperstimulation syndrome (OHSS) in women and appears to initiate the complex cascade that leads to the development of serious medical complications. Numerous strategies have been suggested to prevent OHSS; one of these is the administration of a gonadotropin releasing hormone (GnRH) agonist trigger instead of hCG. Despite a high safety profile, the GnRH agonist trigger of follicle maturation was found to be associated with a decreased probability of clinical and ongoing pregnancy rates and very high miscarriage rates. A profoundly deficient luteal phase is believed to be the cause of compromised reproductive outcome. Our personal clinical practice at the AUBMC Fertility Center seems to indicate that a novel GnRH agonist administration protocol is associated with a comparable reproductive performance to standard hCG trigger. In this study, we aim to validate the above clinical impression and assess associated parameters of success. Therefore, a prospective comparative randomized controlled trial will be performed in order to investigate the effect of three repeated doses of GnRH agonist trigger "Triptorelin" accompanied by intensive Luteal Support on the ongoing pregnancy outcome in women who are hyper-responders to ovarian stimulation when undergoing assisted reproductive technology.

Eligibility Criteria:
Inclusion Criteria:

* Normal uterine cavity (as assessed by hysteroscopy or HSG).
* Normal hormonal investigation: TSH, PRL.
* More than 15 follicles (≥12 mm in diameter) on ultrasound, and/or estradiol level of \> 3500 pg/ml on the day of trigger.

Exclusion Criteria:

* History of three or more miscarriages.
* History of three or more previous IVF failures.
* Abnormal uterine cavity (Hysteroscopy or HSG).
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

The purpose of this study is to compare eritoran tetrasodium and placebo in patients with severe sepsis and to demonstrate a reduction of mortality from all causes.


Eligibility Criteria:
INCLUSION CRITERIA:

* Age \>= 18 years
* Confirmed early-onset severe sepsis, defined as:

  o---Objective evidence of infection likely to be caused by a bacterial or fungal pathogen

  o---Presence of at least 3 of 4 systemic inflammatory response syndrome (SIRS) criteria

  o---Sepsis-associated organ dysfunction
* Baseline Acute Physiology and Chronic Health Evaluation II (Apache II) Score of 21 to 37
* \< 12 hours between onset of the first qualifying organ dysfunction and expected administration of study drug
* A commitment to full patient support

EXCLUSION CRITERIA:

* Pregnancy or breastfeeding
* Extensive (\>20% Body Surface Area) third-degree burns
* Weight \> 150 kg at admission
* Patients whose death from sepsis is considered imminent
* Patients not expected to survive for at least 2 months due to a pre-existing and uncorrectable medical condition, or those in a chronic vegetative state
* Patients with severe congestive heart failure
* Patients currently receiving immunosuppressive therapy such as cyclosporine, azathioprine, or cancer chemotherapy
* Patients with granulocyte counts \< 1000/mm\^3 unless the decreased count is believed to be due to sepsis
* Patients that required cardiopulmonary resuscitation in the 4 weeks prior to evaluation for enrollment
* Human immunodeficiency virus (HIV)-positive patients with CD4 count \<= 50/mm\^3 within 4 weeks of enrollment, or end-stage processes
* Patients with significant hepatic impairment, portal hypertension, or esophageal varices
* Patients who are expected to be treated with endotoxin-removal devices
* Patients with active cancer
* Patients receiving polymyxin B or colistin
Leukemia and Lymphoma Society (LLS) Services Impact on Outcomes and Care

The purpose of this study is to learn about the impact that the services and programs provided by the Leukemia and Lymphoma Society have among patients with blood cancer, such as access to care, quality of life, and financial burden.


Eligibility Criteria:
Inclusion Criteria:

* Be currently receiving primary or relapse treatment for a diagnosis of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN)
* Report experiencing at least one unmet need addressed by the LLS Program (i.e., medical care including second opinions, travel for care, clinical trial access, financial and insurance needs, supportive programs, disease and treatment education)
* Not be currently participating in any LLS programs or services
* Be willing to be followed for 6 months
* Speak English or Spanish

Exclusion Criteria:

* Are not receiving primary or relapse treatment for a diagnosis of leukemia, lymphoma, myeloma, myelodysplastic syndromes (MDS), or myeloproliferative neoplasms (MPN)
* Are not experiencing unmet needs addressed by the LLS Program (i.e., medical care including second opinions, travel for care, clinical trial access, financial and insurance needs, supportive programs, disease and treatment education)
* Are currently participating in any LLS programs or services
* Are not willing to be followed for 6 months
* Do not speak English or Spanish.
Parallel Mapping for Ventricular Tachycardia

Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation.

In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedures can be helpful, however the recurrence rate of arrhythmias after ablation remains unacceptably high. The primary reason for this high recurrence rate is nonspecific mapping methodologies for identifying the heart area responsible for these arrhythmias. Therefore, new methods for increasing the specificity of mapping have been the subject of significant research for many years, however implementation of these methods in clinical practice has been challenged by limited technologies. Recently, a new mapping technology named "parallel mapping" has been developed, received FDA approval and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel mapping, and the efficacy of ablation using this technology have not been evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* History of scar-mediated sustained ventricular tachycardia
* Failure of therapy with Anti arrhythmic drugs
* Implanted ICD or a plan for ICD implantation after the ablation
* Willingness to adhere to the study restrictions and comply with all post procedural follow-up requirements
* Ability to understand the requirements of the study and sign an informed consent

Exclusion Criteria:

* Patients with reversible causes of ventricular tachycardia including ongoing ischemia or electrolyte abnormalities
* Contraindication to anticoagulation therapy
* Stroke within 30 days before enrollment
* Life expectancy \<1 year
* Individual has a known, unresolved history of drug use or alcohol dependency lacks the ability to comprehend or follow instructions or would be unlikely or unable to comply with study follow-up requirements
* Pregnant or breast feeding at time of signing consent
* Patient undergoing cardiac transplantation
* Enrolled or participates in other drug or device studies
Horizontal vs. Vertical Positioning of the iCare Rebound Tonometer and Effects on Intraocular Pressure Readings

The goal of this study is to evaluate the agreement between intraocular pressure (IOP) measurements taken by iCare, held in both vertical and horizontal positions. In addition, iCare measurements will be compared against pneumotonometry measurements to assess for accuracy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must be able to understand and sign and informed consent form that has been approved by an Institutional Review Board/Ethics Committee

Exclusion Criteria:

* Evidence of corneal epithelial defects or pathology affecting corneal rigidity
* Use of topical ophthalmic medications (except for artificial tears)
* History or corneal surgeries
* Any condition that would prevent or inhibit intraocular pressure measurements using iCare or pneumotonometry
* Evidence of ocular infection 30 days prior to enrollment
* Allergy to proparacaine or latex
Vascular Anomaly Pathology and Genomics Biopsy Study

The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.

Vascular anomalies or vascular malformations often are treated with minimally invasive sclerotherapy, embolization or ablation based on clinical and imaging features without acquisition of tissue. Over the last two decades there have been significant advancements in the understanding of the genetic basis for various vascular anomalies/malformations, which may guide use of therapies for individualized treatment.

As such, given the emergence of novel medications for treatment of vascular anomalies/malformations based on genetic information, acquisition of tissue for pathology and genomic characterization will be increasingly important as treatment of vascular anomalies/vascular malformations moves toward individualized medicine approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical and imaging diagnosis of a vascular anomaly.
* No prior treatment for the vascular anomaly.
* Subjects undergoing clinically indicated sclerotherapy, embolization and/or ablation.
* Male or female with age greater than or equal to 18 years.
* Capacity and willingness to provide a written informed consent..

Exclusion Criteria:

* Subjects with prior treatment for their vascular anomaly.
* Uncorrectable coagulopathy.
* Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure.
Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension

Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.

Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.

Design: A randomized, controlled clinical trial.

Setting: Single medical center from 5/2013 to 10/2014.

Patients \& Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.

Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.


Eligibility Criteria:
Inclusion Criteria:

* Parturient at full term.
* Must be elective cesarean section.
* Must be uncomplicated pregnancy

Exclusion Criteria:

* Body weight \<50 kg or \>90 kg
* Height ˂150 cm or \>170 cm.
* Pre-eclampsia.
* Any major systemic disease.
* Contraindication to regional anesthesia.
* Allergy to used medications.