cyrilzakka/clinical-trials huggingface dataset:
Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

Administration of cyclosporine has been found to have a myocardial protective effect, improving post-operative cardiac function in patients undergoing percutaneous coronary interventions by diminishing infarct size. The purpose of the proposed study is to conduct a randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery, or coronary artery bypass surgery. Specifically the investigators will evaluate the cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors will be treatment group and cyclosporine versus placebo.

The specific aim of this study is to perform a randomized controlled study to compare the effects of cyclosporine v. placebo on changes in myocardial functioning associated with open heart surgery for isolated valvular or coronary artery bypass procedures.

The research question is:

Compared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of:

* Transthoracic ECHO (TTE) assessment of ejection fraction
* Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR)
* Length of stay
* 30-d mortality
* Angina Scale
* SF-36 measure of quality of life
* Measures associated with myocardial function:

  1. Cardiac Index
  2. Blood glucose level
  3. Serum Troponin I level
  4. Free Fatty Acid levels
  5. Serum CPK-MB levels
  6. Serum phosphoratase levels

Eligibility Criteria:
Inclusion criteria:

* Men and women, 18 years of age or older
* Patients with multi-vessel coronary artery disease
* Patients undergoing isolated valvular heart surgery (aortic/ mitral)
* Patients undergoing CABG

Exclusion Criteria:

* Patients with cardiac arrest
* Patients with ventricular fibrillation
* Patients with cardiogenic shock
* Patients requiring circulatory arrest
* Patients with known hypersensitivity to cyclosporine
* Patients with known renal failure or a GFR \<50 ml/min/1.732
* Patients with liver failure
* Patients with uncontrolled hypertension
* Women who are pregnant or who are of childbearing age and not on contraception
* Patients with a serum bilirubin level greater than 3 mg/100 mL
Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy

The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age\>20 years
* Histopathology-proven prostate adenocarcinoma
* Non-metastatic localized disease
* Subjects have chosen their curative, definitive treatments for prostate cancer prior to enrolling for the study
* Subjects are willing to sign the informed consent and agree to comply with the study procedures

Exclusion Criteria:

* Chronic use (\> 2 weeks) of \> 10 mg/day of prednisone or prednisolone within 2 months of the screening (topical or inhalational corticosteroids are permitted)
* Concurrent use of immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry
* Other conditions the investigators think may affect subjects' compliance
Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

This study evaluates the efficacy and safety of intravenous administration at regular intervals of Ustekinumab. It consists of escalation treatment period (Week 0 to 52); and safety follow up visit (24 weeks after last dose). Study assessments will include Harvey-Bradshaw index (HBI), Physician Global Assessment Score (PGA), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate in the study
* With active Crohn's disease
* Undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician
* HBI ≥ 5 before Ustekinumab therapy
* Over 18 years of age

Exclusion Criteria:

* Who had received Ustekinumab for an indication
* Pregnant or nursing
* L4 type
* History of enterectomy or enterostomy related to disease
* Who used total enteral nutrition for more than 2 weeks due to complications such as obstruction, abscess and perforation after starting Ustekinumab therapy
* Pregnant and lactating women
Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer

The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30).

The test article is extracted from many natural herbals, in which most or their components have been shown to have anti-tumor activity. A study in 2004 showed the test article could have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations (RAU) patients and suggested that it might be a potential immunoceutical agent for treatment of RAU. Subsequent study in 2005 also suggested the test article as a potential immunoceutical agent for treatment of RAU because the result showed it could modulate the antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study in 2005 showed the test article also had a broad-range tumor killing function and provided a molecular basis underlying therapeutic activity. It was also suggested in this study will could be a potential and promising cancer therapeutic or preventive agent.

The aim of this current study is to explore the safety and efficacy of the investigational product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the patients with metastatic breast cancer refractory to conventional treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed breast cancer with clinical evidence.
* Life expectancy of at least 4 weeks.

Exclusion Criteria:

* Any Uncontrolled infection.
* Lupus erythematosus.
* Malignant tumor.
Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).


Eligibility Criteria:
Inclusion Criteria:

* Stage V Chronic Kidney Disease
* Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

Pathological confirmed rectal adenocarcinoma.

Clinical stage T3-4 or T any N1.With or without MRF positivity, with or without EMVI positivity, R0 resection is estimated.

No metastasis

No signs of intestinal obstruction; or intestinal obstruction has been relieved after proximal colostomy surgery.

Age ranged from 18 to 75

No previous radiotherapy，surgery and chemotherapy.

Exclusion Criteria:

Multiple primary tumor

Cachexy
Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes

The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed type 2 diabetes
* No previous anti-diabetic medications

Exclusion Criteria:

* Heart failure
* Renal disease
* Liver disease
* Life-threatening diseases
Yoga Program in Respiratory Function

This study tested the hypothesis that yoga practice can improve respiratory function in the elderly.

Maximal inspiratory and expiratory pressure (IPmax and EPmax) were assessed by a manovacuometer and tidal volume (VT), vital capacity (VC) and minute ventilation (VE) were assessed by a ventilometer. The yoga program comprised 70 min sessions, 3 times/week during 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary women

Exclusion Criteria:

* Physical impairment
IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.

The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.

This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 test.

Eligibility Criteria:
Inclusion Criteria:

* Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing.
* Age \>/=18 years old.
* Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
* Able to read/write/speak English or Spanish fluently.
* Subjects must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
* Hospitalized at the time of consent or recently discharged with leftover blood stored at hospital laboratory

Exclusion Criteria:

* Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy

This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy.

Our program used and evaluated the mHealth program, which has pregnant women using APP and wearable devices to help prevent excessive gestational weight gain, and it continued to promote physical activity for overweight and obese pregnant women.

Eligibility Criteria:
Inclusion Criteria:

pregnant women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2

Exclusion Criteria:

high risk pregnancy, such as pre-clampsia, pregnancy induced hypertension, preterm contraction
PlayPhysio: Making Physio Fun

A study to examine if the gamification of routine airway clearance can improve the quality of live for young people living with chronic health conditions.

CF experts agree that there is a discrepancy between objective and self-reported adherence. Thus, an intervention focusing on both long-term, sustainable monitoring as well on enhancing and sustaining an efficient rate of respiratory physio is urgently needed. The device under investigation here is devoted exactly to this twofold task. Playphysio®(Pp) is a gamification system developed by Will Jackson, who has a background in product and software design but more importantly is the father of an adolescent girl with CF. The Pp is an electronic monitor which can be attached to the outside of an OPEP device. It senses patients' use of the OPEP device to enable the individual completing their existing airway clearance therapy to play mobile games throughout their treatment. Pp enables the individual to pick from a number of games to play whilst completing their normal prescribed airway clearance treatment. The games have been designed so that the ideal treatment technique is encouraged and the individual's treatment routine is supported with the counting of treatment breaths and prompting a pause to carry out their FET and cough. The aim of Pp is to enhance treatment adherence through its innovative element: gamification. It also offers objective monitoring of CF physio adherence through its technology. The Pp app offers positive feedback following the completion of treatment sessions, keeps a record of treatments done and shares this information with the CF physiotherapy team.

A previous study of an earlier Pp device have found good adherence over a 24 week period, however only 17/30 participants completed the trial. Qualitative data found positive outcomes with 2 participants making the following observations. This was an earlier prototype and changes have been made since that time to both the device and the games.

"I rely on the Playphysio for breathing into his PEP device properly. I can't imagine having to go back to the continuous monitoring and timing that used to be required before having Playphysio®" "I rely on Playphysio®. it has reduced my stress and time to get him to do it properly".

Children with CF who are using a play physio device, compared with those not using a play physio, will have a better experience of airway clearance leading to improved quality of life.

Eligibility Criteria:
Inclusion Criteria:

Subject has confirmed diagnosis of cystic fibrosis as determined by the investigator Under care of Alder Hey Cystic Fibrosis Team (local or network care) Subjects 6 years-11 years, 8 months of age, inclusive, on the date of the informed consent Using a compatible OPEP device for daily airway clearance

Exclusion Criteria:

Incompatible device for airway clearance Outside of recruiting age
Pregabalin (Lyrica) for the Treatment of Essential Tremor

This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with essential tremor diagnosed by a movement disorder specialist.
2. Age 18 years to 80 years.
3. Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
5. Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
6. Serum creatine kinase, complete metabolic blood count, liver function tests, renal function tests, and platelets are within normal limits (blood drawn within the past year).
7. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
5. Legal incapacity or limited legal capacity.
6. Presence of severe renal disease (BUN 50% greater than normal or creatine clearance \<60 mL/min) or hepatic disease.
7. Presence of severe daytime sleepiness.
8. Abnormal creatine kinase and/or platelet count in the past year.
9. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
10. Previous lack of response to other ET therapies (propranolol AND primidone).
11. Patients who have had deep brain stimulation (DBS).
12. Concomitant treatment with gabapentin.
Genetic Markers of Cardiovascular Disease in Epilepsy

Epilepsy is a common condition which affects over 3 million people in the US. Patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which is greatest in those under 40 years of age. The exact mechanisms and causes are not understood but can be due to underlying conditions which affect the heart and brain, which may lead to dangerous heart rhythms and death. Some of these conditions which affect heart and brain have an identifiable genetic cause. This study aims to identify known genetic causes of heart rhythm and sudden death related disorders in patients with epilepsy.

The overall goals are to determine whether patients with epilepsy who have the highest risk of SUDEP have an underlying genetic cardiovascular disorder. The investigators are seeking patients with epilepsy who have a high risk of SUDEP identified by using a risk scoring tool called SUDEP-7 and/or have blood-relatives with a history of epilepsy, seizure, cardiac arrest, sudden death, drowning/near-drowning, syncope or heart rhythm disorder. The investigators may also include blood-relatives of patients with epilepsy and invite them to participate by providing a blood sample and/or buccal cells (from a swab or saliva) for genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 - 50 with a diagnosis of epilepsy or seizures, or syncope or drowning or cardiac arrest or sudden death or an abnormal ECG suggestive of an arrhythmia
* Blood-relatives (Aged 18+) of a patient with a history of epilepsy, seizure, cardiac arrest, sudden death, drowning, syncope or arrhythmia

Exclusion Criteria:

* Those who are unable to provide written consent.
* Prisoners (vulnerable population)
* Seizures secondary to ischemic events
* Traumatic brain injury resulting in seizures
* History of cranial surgery
* History of brain tumor
The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS

Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).

Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.

We want to investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).

PCOS is characterized by menstrual deregulation, high testosterone, mail hair growth and increased stress hormones from the adrenals. Furthermore there are changes similar to those seen in diabetes.

Cipralex is known to decrease stress hormones. But no investigations are on the effect of cipralex on PCOS, or how the increased stress hormones affect the PCOS condition.

We will examine 2x20 women with PCOS. They will be randomized to Cipralex or placebo. Treatment duration is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>25 and \<50
* Age \< 50
* PCOS

Exclusion Criteria:

* Epilepsia
* use of metformin or oral anticonceptives
* pregnancy/breastfeeding
Oxaliplatin and 5-Fluorouracil With or Without Docetaxel in Elderly Patients (>65 y) With Stomach and Esophagus Cancer

In this trial, FLOT will be evaluated as therapy option for elderly patients (\>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.

Patients with locally advanced, potentially operable or metastatic gastric cancer or adenocarcinoma of the esophagogastric junction without prior therapy in the palliative setting are treated with:

* Arm A: FLO
* Arm B: FLOT

max. 12 cycles

Evaluation of quality of life by standard forms at baseline and then every 2 months until progress of disease. Pharmacogenetic analyses will be done to evaluate a risk profile for platin-based therapies. 140 patients will be treated (70 per arm)

primary endpoint:

* Response Rate

secondary endpoints:

* Prospective Validation of a pharmacogenetic risk profile for patients with advanced GC under first-line therapy with platin/docetaxel
* Evaluation of quality of life
* safety and tolerability
* progression free survival (PFS), time to treatment failure (TTF), overall survival (OS)

Eligibility Criteria:
Inclusion Criteria:

* metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
* no prior chemotherapy in metastatic state
* adequate blood and biochemistry parameters

Exclusion Criteria:

* hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
* KHK, cardiomyopathy or cardiac insufficiency
* malignancy \<5 years ago
* brain metastases
* severe internal disease or inadequate blood and biochemistry parameters