cyrilzakka/clinical-trials huggingface dataset:
Effect of Branched Chain Amino Acids on Muscle

With aging, there is a decrease in muscle mass and function especially in the energy storehouses of cells called mitochondria. Amino acids, the building blocks of protein, and insulin have been shown to increase muscle mitochondrial protein synthesis and thereby function. Branched chain amino acids which can only be provided in the diet seem to be key in this process. Therefore in our study, our aim is to study the effect of branched chain amino acids on muscle mitochondrial protein synthesis in both the young and elderly. By doing so, we can then elucidate if branched chain amino acid supplementation has future potential in improving quality of life and performance in the elderly. The study will involve blood sampling and needle muscle biopsy.

Skeletal muscle mito ATP production in young people are stimulated by insulin when infused with a mixture of amino acids while clamping blood glucose at the basal level. Our preliminary results indicate that this effect on mito ATP production is directly related to amino acid levels. Recent publications indicated that infusion of insulin with amino acids specifically stimulate muscle mitochondrial protein synthesis with no effect on synthesis or contractile proteins or sarcoplasmic proteins. The recent publications also indicated that intracellular amino acid anabolic sensors are stimulated by amino acids. It appears that BCAA, especially leucine has a specific effect in stimulating intracellular signaling or translation of mRNA to protein synthesis. It has been shown that amino acids, especially leucine, stimulate protein synthesis by activation of the mTOR pathway in mTOR phosphorylates p70S6 kinase which in turn phosphorylates the ribosomal S6 protein, resulting in increased activity of the protein synthesis complex. Activated mTOR also phosphorylates eIF4E-BP1 and activates the protein synthesis initiation complex. It is the abundance of specific mRNAase that determines synthesis of which specific proteins are promoted. Our preliminary data supports that amino acids selectively promotes muscle mitochondrial protein synthesis by enhancing the abundance of transcripts of genes that encode mitochondrial proteins. Administration of an amino acid mixture, specifically BCAA, is proposed as a stimulant of muscle mitochondrial ATP production. Secondary measurements will be performed to understand the underlying mechanism of enhanced muscle ATP production. These results are likely to contribute to our understanding of the basic mechanisms of the regulation of mitochondrial biogenesis in humans which will have potential future application.

This is a cross-sectional study between young and old. The study will use the new proteomic techniques established in our laboratory to profile and quantify mitochondrial protein synthesis in the participants. The combination of metabolic labeling with stable isotope and measuring synthesis rates of specific mito proteins by tandem mass spectrometry will determine whether actual stimulation by BCAA occurs differentially in young and elderly.

Eligibility Criteria:
Young (age 18-30) or old (age 65-80) Body mass index \<30
Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

The purpose of the study is to compare the effects of recombinant factor VIIa (NovoSeven) on restoring coagulation activation between patients with hemophilia A and antibodies to factor VIII and normal subjects (controls) by use of an in vivo method.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hemophilia A and current antibodies to factor VIII -

Exclusion Criteria:

* Life-threatening hemorrhage
* Severe liver failure
* Any other severe co-morbidity (including diabetes mellitus, renal failure, cancer, septicemia, disseminated intravascular coagulation, crush injury)
* Exposure to other haemostatic drugs during the previous 7 days
* Hypersensitivity to hamster, mouse or bovine proteins
* Known or suspected allergy to NovoSeven or any of its components
Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training and Decision-making

This study aims to (i) assess the effects of combined tDCS and cognitive training on decision-making on a trained task (Iowa Gambling Task; IGT); and (ii) test generalization to a closely related cognitive domain, namely motor impulsivity. It is hypothesized that combined anodal tDCS and cognitive training will result in more advantageous decisions and better impulse control than combined sham tDCS and cognitive training.

Impaired decision-making under conditions of uncertainty and risk has been implicated in maladaptive personality development and violent behaviour. There is a dearth of studies that examined the effects of combined tDCS and cognitive training on decision-making under conditions of uncertainty and risk. It is also unclear if these effects are generalizable to tasks in other domains such as response inhibition (motor impulsivity).

To examine these issues further, a single blind parallel arms randomized controlled trial will be conducted, involving a sample of healthy volunteers aged between 18 and 40. This will entail applying either active or sham tDCS over the anterior frontal cortex (including the vm-PFC) while participants undertake decision-making training using the Iowa Gambling Task. Decision-making will be assessed using the IGT, which is a computerized gambling task used to assess decision-making under conditions of uncertainty and risk. IGT is sensitive to damage to the ventromedial prefrontal cortex (vmPFC), which is considered to play a key role in decision-making. Motor impulsivity will be measured using the Stop Signal Task (SST). The UPPS+P Impulsive Behaviour Scale will be used to index trait impulsivity. The Profile of Mood States will be used to measure state emotion before and after tDCS.

Eligibility Criteria:
Inclusion Criteria:

* Consenting volunteers aged between 18 and 40.

Exclusion Criteria:

* Individuals with epilepsy, other neurological conditions and history of significant head injury will be excluded.
* Individuals with a history of substance misuse, major mental disorder and those receiving psychotropic medication will be also excluded.
Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)

The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's disease (HD) treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate (MTX).


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic proof of HD who are in relapse and have failed \> or = to 2 prior chemotherapy regimens.
* Patients must have a life expectancy of at least 8 weeks.
* All patients must have ECOG performance level rating of \< or = to 2.
* Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study.
* Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of CT.
* Patients must have adequate liver function (bilirubin \< or = to 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine \< or = to 1.5 mg/dl, creatinine clearance \> or = to 60 ml/min/1.73 m2).
* Patients should have a granulocyte count \> or = to 500/gL and a platelet count \> or = to 100,000/uL (unless due to disease involvement of the bone marrow).
* Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.

Exclusion Criteria:

* Patients with active infections or significant medical conditions other than their malignancy shall be excluded.
* Patients with HD who had prior MTX or 6-TG should be excluded.
The Effectiveness of Visual Training in Convergence Insufficiency Patients

Convergence insufficiency (CI) is one of the most common binocular vision disorders. The prevalence of CI ranges from 3% to 6% in school-aged children. CI symptoms include visual fatigue, headache, blurred vision, and diplopia and could be caused while using near-distance viewing. These symptoms might become more severe with increasing need to perform near-distance tasks. Long-term visual symptoms could result in a negative impact on learning behaviors and work performance in patients. Nowadays, visual training is the main type of management for CI patients clinically; however, the existing training protocol required patients to make several visits to the clinic for visual training, which might increase the burden for patients and result in higher failures in training. Therefore, this study will use a simple training method by utilizing prisms for CI patients to train at home, then compare visual symptoms and binocular vision after the training. In stage I of this study, investigators will recruit 60 symptomatic CI participants aged 9 to 30 years old to do a 6-week visual training with the prisms (15 min/time, 3 times/week). The post-training outcomes will be collected at week 4 and week 6. In stage II, all of the participants will be randomly divided into the "stop training group" and the "continue training group." The participants in the "continue training group" will have the same 6-week prism training and in the "stop training group" will stop all the prism training during this period. The final post-training outcomes of all the participants will be collected again at week 12. In this study, investigators will investigate the effectiveness of the prisms training for 6 weeks and for 12 weeks on visual symptoms and binocular vision in CI patients, and evaluate whether the training effect will be affected by stopping training after 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. The overall score of CI symptom survey ≥ 16 (9-18 years old) or ≥ 21 (19-30 years old)
2. The break point of near point of convergence (NPC) ≥ 6 cm
3. Exophoria at near distances be at least 4∆ higher than at far distances
4. Near positive fusional vergence (PFV) ≤ 15∆ or failing Sheard's criterion at near.

Exclusion Criteria:

1. The best corrected visual acuity (BCVA) of \< 20/25 in each eye at far and near distances
2. Amblyopia patients or the difference of BCVA between the two eyes ≥ 2 lines
3. Constant strabismus patients
4. History of strabismus surgery or refractive surgery
5. Systemic diseases that would affect binocular vision
6. Acquired brain injury or neurological disorder.
Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training

Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide, lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or preventive measures are lacking.

There is evidence that physical activity strategies are able to address existing CIPN symptoms and potentially increase quality of life in affected patients. CIPN symptoms involves restrictions of sensory and sometimes motor modalities, for example, deficits in plantar perception and dysfunction of postural control and one study in type II diabetes patients also suggested that structured exercise might have a preventive potential with regard to peripheral neuropathy incidence.

Based on these findings, we aim to investigate the preventive potential of a sensorimotor intervention vs. machine-based resistance training vs. usual care (wait-list control group) in a randomized controlled three-arm intervention trial among cancer patients undergoing chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to include 82 patients per intervention arm resulting in a total patients number to be enrolled of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via questionnaires (EORTC QLQ-CIPN20 \& FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the effectiveness of the selected interventions will be objectively evaluated by spectral analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are: physical performance, sleep quality and chemotherapy compliance.


Eligibility Criteria:
Inclusion Criteria:

diagnosed with cancer and assigned to receive a chemotherapeutic regimen containing at least one of the following agents:

* a platinum analog, e.g., cisplatin, carboplatin, oxaliplatin
* a vinca alkaloid, e.g., vincristine
* a taxane, e.g., paclitaxel, docetaxel
* suramin
* thalidomide or lenalidomide
* bortezomib

Physical capability that allows the performance of the training program implemented within the experimental intervention or the control intervention arm

Exclusion Criteria:

* Known polyneuropathy of any kind or any polyneuropathic signs or symptoms at baseline
* Abnormal electroneurographic findings at baseline
* Known metastasis to the central or peripheral nervous system
* Any physical or mental handicap that would hamper the performance of the training program implemented within the intervention arms
* Family history positive for any hereditary polyneuropathy
* Known history of alcohol or illegal drug abuse or any constellation of lab values suggesting alcoholism
Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients

Aim of the study is to assess the effect of quetiapine treatment in neuroleptic naive, first-episode schizophrenic patients on aspects of functional and structural neuroplasticity assessed by means of transcranial magnetic stimulation and voxel-based morphometry. Main outcome measure is a change in gray matter density under quetiapine treatment from baseline to steady-state-treatment after 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of first episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criteria and no history of neuroleptic medication
* Females and/or males aged 18 to 65 years
* Mild to moderate schizophrenia

Exclusion Criteria:

* Neuroleptic treatment prior to study enrollment
* Pregnancy or lactation
* Any DSM-IV Axis I disorder not defined in the inclusion criteria
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
* Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
* Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
* Any history of neuroleptic treatment
* Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
* Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
* Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
* Involvement in the planning and conduct of the study
* History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery
* Concomitant treatment with psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics) except benzodiazepines or hypnotics
Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer

Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal, defined by the absence of periods for the past 12 months;
* Breast cancer diagnosis stages 1 to 3;
* The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors
* No abnormalities on screening physical or any health problems that contraindicate study participation;
* No contraindications for treadmill testing or entry into a training program, including any of the following:
* Myocardial infarction within the past 6 months
* Pulmonary edema
* Myocarditis Pericarditis
* Unstable angina
* Pulmonary embolism or deep vein thrombosis
* Uncontrolled hypertension (i.e., blood pressure \> 200/100 mm Hg)
* Uncontrolled arrhythmia
* No significant mental illness
* Have medical certificate to perform exercise testing and participate in combined training
* Able to answer Questionnaires
* No concurrent participation in any other organized exercise program;
* Live in Presidente Prudente
* Sign the consent form and formal clarification for participation in the study.

Exclusion Criteria:

* Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.
ADI-PEG in Patients With Metastatic Melanoma

This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life.

In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed metastatic melanoma
* Nonresectable disease
* Measurable or evaluable disease
* Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy
* Recovered from prior surgery
* Karnofsky performance status 70 or higher
* Expected survival of at least 12 weeks
* Bilirubin less than 2.0 mg/dL
* Albumin greater than 3.0 g/dL
* SGOT less than 5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 5 times ULN
* Ammonia less than 55 microg/dL
* Glucose greater than 60 mg/dL
* Amylase less than 1.5 times ULN
* Absolute neutrophil count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3
* Patients must use 2 forms of effective contraception

Exclusion criteria:

* Prior therapy within the past 4 weeks
* Ascites or pleural effusion
* Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease)
* Pregnant or nursing
* Concurrent enrollment in another IND study
* Serious infection requiring antibiotics
Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer.

PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men.

OBJECTIVES:

* Estimate dietary heterocyclic amine (HA) exposure in African American men who use HA-forming meats and cooking methods.
* Correlate dietary HA exposure with prostate-specific antigen and digital rectal exam screening results (i.e., higher HA exposure with increased abnormality in prostate cancer screening results) in these participants.

OUTLINE: This is a prospective study.

Participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption, cooking preferences, and other factors that may be associated with prostate cancer risk. Participants then undergo a digital rectal exam (DRE) and blood collection for prostate-specific antigen (PSA) testing (total PSA and % free PSA). Results of PSA testing and DRE, including follow-up instructions (if needed), are sent to the participant 3-4 weeks later.

Blood samples are also examined by phenotypic assays for UV-damage induced nucleotide excision-repair capacity.

PROJECTED ACCRUAL: A total of 800 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* African American male
* No previous diagnosis of prostate cancer
* Desires prostate cancer screening as a routine preventative medical service

PATIENT CHARACTERISTICS:

* Lives in or near Oakland, California
* Speaks English
* No medical or other disability (e.g., blindness, psychological dysfunction, or amputation) that would preclude study participation

PRIOR CONCURRENT THERAPY:

* Not specified
Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.

Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.

Rectal prolapse is a disabling condition, which is more common in females and increases in frequency with age.

There are two types of rectal prolapse; external and internal. External rectal prolapse is a circumferential protrusion of all layers of the rectum through the anal sphincter. Internal rectal prolapse, also referred to as rectal intussusception.

The majority of patients with a RP suffer from symptoms of fecal incontinence and constipation, causing a significant negative impact on quality of life.

The aims of the surgical treatment are to correct the anatomical abnormality and to cure the accompanying symptoms of incontinence, constipation and pain, with the lowest rate of complications as possible and an acceptable rate of recurrence.

Since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment for RP have been applied in patients of all ages.

Eligibility Criteria:
Inclusion Criteria:

* all patients with rectal prolapse either external or internal prolapse

Exclusion Criteria:

* Age below 18 years.
* Pregnancy or breast-feeding.
* Recurrence of rectal prolapse.
* patients with previous complicated abdominal surgery.