cyrilzakka/clinical-trials huggingface dataset:
3D Echocardiographic Assessment of Epicardial Pacing After Cardiopulmonary Bypass.

This study evaluates the usefulness of 3D echocardiography to guide pacemaker therapy in the operating room in cardiac surgical patients. Each patient will serve as his own control, following a paired design.

Cardiac surgical patients sometimes require temporary pacing wires to optimize cardiac function during weaning from cardiopulmonary bypass (CPB), and/or to treat hemodynamically significant brady-arrhythmias. The available patient series report that 8.6% to 23.9% of patient undergoing coronary artery bypass grafting (CABG) or valve surgery require temporary pacing at some time after CPB. The site of pacemaker wire placement seems to be a crucial determinant of cardiac output. In non-surgical patients isolated right ventricular (RV) pacing seems to induce electromechanical dyssynchrony of the RV and the left ventricle (LV). A normal ventricle in sinus rhythm displays a simultaneous contraction of all segments of the heart, so that regional minimal volume (i.e. maximal contraction) will occur at the same time. Isolated RV pacing seems to result in a left bundle branch type electrical activation sequence, with delayed contraction of some of the segments. The LV, but not the RV, seems to negatively affected by this state of dyssynchrony, resulting in decreased cardiac output. In surgical patients however, there is not such data available yet. Since isolated RV epicardial wire placement is still widely practiced in cardiac surgery, and in our own institution, we would like to study the effect of RV pacing on LV synchrony and LV output.

Again from studies in non-surgical patients receiving resynchronization therapy, we know that real-time three-dimensional (3D) echocardiography is very useful to pick up subtle changes in LV synchrony and thereby guide synchronization of ventricular contraction. However, to date the usefulness of real-time 3D echocardiography to guide pacemaker therapy in cardiac surgery is unknown. In the present feasibility study in cardiac surgical patients, we want to investigate the acute effects of isolated RV pacing on LV synchrony, and LV output.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient scheduled to undergo elective cardiac surgery by means of full sternotomy and use of cardiopulmonary bypass
* Preoperative moderate to good LV function, ejection fraction \> 30%
* Age \> 18 yrs. old
* Preoperative sinus rhythm
* Pacemaker lead inserted by cardiac surgeon during surgery
* Underlying sinus rhythm after cardiopulmonary bypass before the end of surgery
* Able to understand written and verbal patient information
* Signed informed consent

Exclusion Criteria:

* Emergency cardiac surgery
* Minimally invasive surgery
* Contraindication to TEE
* Redo surgery
* Hemodynamic instability after CPB (late exclusion criterium)
* No pacemaker lead inserted by cardiac surgeon (late exclusion criterium)
* No sinus rhythm during chest closure towards the end of surgery (late exclusion criterium)
Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

The combined ultrashort flare GnRH agonist /GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This is a protocol combining the effect of the microdose flare on endogenous FSH release with the benefit of an immediate LH suppression of the GnRH antagonist.

A major disadvantage of the use of a GnRH antagonist protocol is the limitation for programming cycles, as the drugs administration is started on day 2 of the menstrual cycle and is strictly followed until the hCG criteria are met.

The purpose of the study is to perform oestradiol pre-treatment with the combined ultrashort flare GnRH agonist /GnRH antagonist protocol aiming to

1. better programme an antagonist cycle and
2. improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients with poor or no response in previous COH for IVF cycles
* Patients with AMH \< 1 and/or FSH \>12
* Poor quality of embryos in previous cycles
* Age of patients up to 44 years

Exclusion Criteria:

* Patients with normal ovarian reserve
* Patients with sonographically detected hydrosalpinges
* Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome
* Women with thrombofilia disorders
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer

This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced or metastatic pancreatic cancer (PC),
* histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,
* failed to second-line chemotherapy for PC,
* 18-75 years of age,
* an Eastern Cooperative Oncology Group performance status score of 0 to 1,
* adequate organ functions

Exclusion Criteria:

* had received PD 1 /CTLA 4 antibody treatment
* had received anti-VEGFR inhibitors or antibodies
Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis

The aim of this clinical study was to evaluate the clinical efficacy of using perio flow adjunctively with mechanical instrumentation on periodontal parameters and halitosis.

Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur compound (VSC) values were measured by a halimeter at the baseline, immediately after treatment, and at 7 days, 14 days and 1 month.


Eligibility Criteria:
Inclusion Criteria:

* In the present trial, patients who had at least three teeth with 4-6-mm periodontal pockets.

Exclusion Criteria:

* acute infectious oral lesions,
* furcation defects,
* using antibiotics for any reason in the last 4 weeks,
* periodontal treatment in the last 6 months and
* pregnant or lactating patients.
A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)

The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy.


Eligibility Criteria:
Inclusion Criteria:

* Have symptomatic and/or progressive MM that was previously treated with at least 1 and no more than 3 prior lines of therapy
* Have measurable disease
* Have given written informed consent prior to any study-specific procedures
* Have adequate organ function
* Treatment with prior autologous transplant is permitted

Exclusion Criteria:

* Are enrolled in or discontinued from a clinical trial of any drug or device within 21 days prior to the first dose of assigned study treatment
* Have had less than a minimal response or have had progressive disease within 60 days of most recent therapy with a proteasome inhibitor
* Plan to proceed to autologous transplant for consolidation after participation in this trial
* Have an active infection or ongoing treatment for systemic infection ("ongoing treatment" does not include prophylactic anti-infectives),, chest x-ray suggestive of tuberculosis, or history/risk of chronic/latent infection that may reactivate in the presence of study therapy
* Have any of the following:

  * positive test results for human immunodeficiency virus (HIV)
  * positive test for hepatitis B, defined as positive for hepatitis B surface antigen (HBsAg+), OR positive for anti-hepatitis B core antibody AND positive for hepatitis B deoxyribonucleic acid (HBV DNA), OR positive for anti-hepatitis B surface antibody (HBsAb+) AND positive for hepatitis B deoxyribonucleic acid (HBV DNA)
  * positive test results for hepatitis C virus (HCV), defined as positive for hepatitis C antibody (HepCAb) AND confirmed positive via the hepatitis C recombinant immunoblot assay
* Have had significant allergy to human/humanized monoclonal antibodies that, in the opinion of the investigator, poses an unacceptable risk to the participants
* Have known hypersensitivity or contraindication to any of the study therapies or excipients
* Prior allogeneic hematopoietic stem cell transplant
* Prior therapy with experimental agents targeting B-cell activating factor (BAFF), including LY2127399
* Have corrected QT (QTc) interval \>500 millisecond (msec) on baseline 12-lead electrocardiogram (ECG)
* Have Waldenstrom's macroglobulinemia
* History of malignancy with adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, are eligible regardless of the time of diagnosis/treatment
Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence

The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.

Experimental: After obtaining informed consent, 100 patients with bipolar I, or II disorders and alcohol abuse/dependence confirmed by a structured clinical interview (SCID) will be enrolled. from referral sources in the community we have developed over the past 3 years. A medical history and physical examination, including an eye exam with an ophthalmoscope, will also be performed at baseline to rule out serious medical illnesses and cataracts. Baseline labs including a liver panel and CBC will be obtained. Women of child-bearing potential will be given a urine pregnancy test. Baseline measures of psychiatric symptoms will be assessed with the HRSD, YMRS, and Barratt Impulsiveness Scale. Alcohol cravings will be assessed with the Obsessive Compulsive Drinking Scale (OCDS). Alcohol use including number of drinks/2 weeks, days used in the past two weeks, and days of heavy use will be obtained as will a urine drug/alcohol screen. Alcohol use and cravings will also be recorded throughout the study. Side-effects will be assessed with a general side effects scale, the Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Barnes Akathesia Rating Scale (BARS). GGT levels will also be repeated at weeks 6 and 12. The subjects will be randomized and receive quetiapine or identical appearing placebo add-on therapy in a double-blind fashion for 12 weeks. Subjects will return every two weeks for reevaluation with the above outcome measures and for upward titration of study drug. All subjects will be given the option of receiving open-label quetiapine for an additional 4 weeks (with continuing assessment of mood and alcohol use/cravings every 2 weeks) at the end of the study or discontinuing medication.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar I or II
* Ages 18-70

Exclusion Criteria:

* Life threatening medical condition causing participation in the study hazardous
* Alcohol abuse within the past 2 weeks
* History of cataracts or likely cataracts on baseline eye exam
* History of hepatic cirrhosis or AST or ALT more than three times normal limit
* Current active suicidal or homicidal ideation
* History of allergic reaction, poor response or intolerable side effects to quetiapine
* Antipsychotic use within 7 days of beginning quetiapine therapy
* Mental retardation, dementia or other severe cognitive impairment
Comparison of Two Techniques for Placement of Perineural Femoral Catheters.

The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.

The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.

Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).

Eligibility Criteria:
Inclusion Criteria:

* adults
* BMI less than 30

Exclusion Criteria:

* known allergies to local anesthetics or other drugs used
* patient refusal
* any local or systemic contraindication to the use of popliteal block
Efficacy and Safety of Fecal Microbiota Transplantation

In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.


Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of any of following diseases:

* Irritable Bowel Syndrome
* Ulcerative colitis
* Crohn's disease
* Constipation
* Clostridium Difficile Infection
* Functional Dyspepsia
* Parkinson's Disease
* Metabolic Syndrome
* Non-Alcoholic Fatty Liver Disease
* Autism Spectrum Disorder
* Radiation Enteritis
* Atopic Dermatitis
* Food Allergic
* Graft-versus-Host Disease
* Obesity
* Diabetes mellitus
* Multi-Drug Resistant Infection
* Hepatic Encephalopathy
* Enteric Dysbacteriosis
* Multiple Sclerosis
* Pseudomembranous Enteritis
* Acute Pancreatitis
* Chronic Fatigue Syndrome
* Acute-on-chronic Liver Failure with HBV Infection
* Alcoholic Liver Disease
* Anorexia
* Decompensated Cirrhosis
* Henoch-Schonlein Purpura
* Autoimmune Liver Disease
* Systemic Lupus Erythematosus
* Rheumatoid arthritis
* IgG4-Related Disease
* Celiac Disease
* Protein-losing Enteropathy
* Asperger Syndrome
* Rheumatoid arthritis
* Psoriasis
* Ankylosing spondylitis
* Immune checkpoint inhibition-related colitis
* Autoimmune enteropathy
* Drug-induced diarrhea
* Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc.
* The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.

Exclusion Criteria:

* Current pregnancy or breast-feeding;
* Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
* Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
* Any conditions that may render the efficacy of FMT or at the discretion of the investigators.
Sex Steroids, Obesity and Lipids in Adolescent Females

To prospectively explore the relationships of endogenous sex steroid hormones and obesity and their interactions with lipoprotein cholesterol and apolipoprotein levels in nine and ten year old Black and white adolescent girls for five years during puberty.

BACKGROUND:

In 1987, there was growing evidence that androgens, particularly when elevated, had an unfavorable effect on lipo/apo levels, tending to lower HDL cholesterol (HDLC) and raise LDL cholesterol (LDLC). Previous studies confirmed that although pre-pubertal boys and girls had similar lipo/apo levels, post-pubertal boys had a higher ratio of LDLC/HDLC than girls, in part because of their androgen levels. Such lipo/apo levels had been associated with an increased risk of coronary heart disease. There was also evidence that obese girls tended to be hyperandrogenic and thus had unfavorable lipo/apo levels and a higher risk of coronary heart disease. This study sought to elucidate whether high androgen levels preceded or were a consequence of obesity.

DESIGN NARRATIVE:

The longitudinal study was ancillary to the National Growth and Health Study (NGHS), a multicenter study which investigated the occurrence of obesity in Black and white adolescent girls, predictors of the transition to the obese state, the correlates of the transition, and the relationship of the transition to other coronary heart disease risk factors. As part of the NGHS, participants from the Cincinnati, Ohio and Washington, D.C. public and parochial schools received physical examinations with attention to pubertal staging and anthropometric measurements including weight, height, and skinfold thickness. Along with NGHS blood samples, additional blood was obtained in years 1, 3, and 5 for measurements of lipids, lipoprotein cholesterols, apolipoproteins A1, A2, and B, and sex steroid hormones including plasma total and free testosterone, dehydroepiandrosterone sulfate, estradiol, and testosterone estrogen binding globulin.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Eye Alignment and Eye Control Changes Through Follow up Period After Application of Eye Exercises Post Strabismus Surgery

The aim of this study is to determine the patient status through its follow up period and weather the eye alignment and eye control are as the same as the last physiotherapy treatment session or there is any deterioration of them.

This study is quantitative cohort observational study. The study depends on following a group of participants over a period of time ( 2 months after completed physiotherapy training program for 3 months to improve eye alignment and eye control post strabismus surgery ).

Through the study, there is observation to the changes in certain quantitative variables ( eye alignment and eye control ).

Eligibility Criteria:
Inclusion Criteria:

* Patients are both males and females.
* Their age will range from (5-15) years.
* All Patients received physiotherapy training for improving eye alignment and eye control.
* Patients applied the physiotherapy rehabilitation program for 3 months with the physiotherapist.
* All Patients complete their physiotherapy training sessions for improving eye alignment and eye control
* All Patients have a history of strabismus surgery.
* Intermittent exotropia was the type of strabismus which included to the study.

Exclusion Criteria:

* - Patient who didn't receive physiotherapy training program for improving eye control and eye alignment post strabismus surgery.
* Patient who didn't complete the physiotherapy training program for 3 months.
* Muscular disorders that will impair performance during training.
* Any organic lesion in the eye.
* Neurological disorders.
* Malignant conditions.
* Psychiatric illness, severe behavior or cognitive disorders.
Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.

OBJECTIVES:

* Determine the efficacy of imatinib mesylate, as measured by response rate, in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens.
* Determine the clinical and laboratory toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease subtype.

Patients receive oral imatinib mesylate twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 60-120 patients (6-12 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma

  * Eligible subtypes:

    * Ewing's family (e.g., primitive neuroectodermal tumor)
    * Osteosarcoma
    * Synovial sarcoma
    * Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic)
    * Liposarcoma (all variants)
    * Malignant fibrous histiocytoma
    * Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor, neurofibrosarcoma, or schwannoma)
    * Fibrosarcoma
    * Angiosarcoma (all variants)
  * Failed standard therapy with no available salvage regimens
* Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination

  * Must be outside prior irradiation fields or have documented disease progression at least 6 weeks after completion of prior radiotherapy

PATIENT CHARACTERISTICS:

Age:

* 10 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 3 times upper limit of normal (ULN)
* ALT and AST less than 2.5 times ULN

Renal:

* Creatinine less than 1.5 times ULN

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 1 week after study participation for female patients and for at least 3 months after study participation for male patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No hormonal birth control

Radiotherapy:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered

Surgery:

* Not specified

Other:

* At least 28 days since any prior systemic therapy