cyrilzakka/clinical-trials huggingface dataset:
Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction

INDUCTION TREATMENT :Ara-C 100 mg/m 2 /day in continuous perfusion,days 1 - 7. Idarubicin 8 mg/m 2 /day, days 1 - 3 in bolus. GM-CSF (Leucomax) 5 mcg/kg subcutaneous or endovenous from day + 4 after finishing the chemotherapy until the recovery of neutropenia (\> 1.000/mm 3)

CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle, will receive a second cycle to consolidation. The patients who do not reach a complete response with the first cycle will receive a second cycle. If after two cycles,do not obtain the response, patient should leave the protocol.

INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation, or after two cycles of induction, will receive a treatment of intensification with: ARA-C 500 mg/m 2 /12 h in one hour infusion, days 1-4. Daunomycin 45 mg/m 2 /day bolu, days 5-7. GM-CSF (Leucomax): 5 mcg/kg from day to + 4 after finishing the chemotherapy until the recovery of neutropenia (\>1.000/mm 3)

Eligibility Criteria:
Inclusion Criteria:

* Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3)
* Over 65 years

Exclusion Criteria:

* Previous diagnosis of other malignancy hematopoietic disorder or myelodysplastic syndrome
* Previous treatment with antileucemic chemotherapy
* Psychiatric disorder
* Diagnosis of subtype FAB M3
* Creatinine \> 2.5 mg/dL
* Bilirubin , Alkaline Phosphatase or transaminases three times upper the limit
Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal

The present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a doubleblind, randomized and crossed manner.

The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal antiinflammatory drugs (NSAIDS). Studies have shown that NSAIDS exert their therapeutic effect by the inhibition of cyclooxigenases (COX) 1 and 2, which determines the inhibition of prostaglandins production whose effects potentiate the action of many inflammatory mediators. The present study aims to evaluate in a double blind, randomized and cross over manner the clinical efficacy of naproxen (500 mg) and naproxen in association with esomeprazol (500 mg and 20 mg), both administered by oral route every 12 h during 4 days, in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. The following parameters will be analyzed: 1) subjective postoperative pain evaluation, with the aid of a visual analogue scale, 2) mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal), 3) beginning and duration of the surgery after anesthetic administration, 4) incidence, type and severity of adverse reactions, 5) total amount of rescue analgesic medication (paracetamol), 6) facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery). The comparative analyses of the data along with the application of the adequate statistical tests will provide the basis for an evaluation of the clinical efficacy of both NSAIDS.

Eligibility Criteria:
Inclusion Criteria:

* Need of lower third molar surgeries in similar positions

Exclusion Criteria:

* Presence of systemic diseases;
* Presence of local inflammation and/or infection;
* Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
* Cardiovascular, kidney or hepatic diseases;
* Patients who are making use of antidepressants, diuretics or anticoagulants;
* Asthma and allergy to aspirin, naproxen or any other nonsteroidal antiinflammatory drug;
* Regular use of any nonsteroidal antiinflammatory drug,
* pregnancy or
* breast feeding.
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer

This is a prospective, open, randomized phase II trial.

Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate adenocarcinoma
* IR or HR in the NCCN definition
* N0M0 at staging with choline or (preferably) PSMA PET-CT;
* ECOG performance status between 0 and 2;

Exclusion Criteria:

* Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
* Previous radiotherapy to the pelvis
* Previous chemotherapy for malignancy in past 5 years
* Impossibility to implant fiducials for tracking purposes
* Impossibility to undergo MRI of the prostate
* Contraindication to short term AD
* Prostate volume \>90cc
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults

Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay, and mortality. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as diprospan as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity in knee osteoarthritis or in total knee arthroplasty. However, there has not been reported about local application of diprospan on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
* American Society of Anesthesiologists (ASA) physical status of I , II or III;
* Participates with an anticipated fully recovery within 2 hours postoperatively.

Exclusion Criteria:

* History of craniotomy;
* Expected delayed extubation or no plan to extubate;
* Participants who cannot use a patient-controlled analgesia (PCA) device;
* Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* Allergy to opioids, diprospan or ropivacaine;
* History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
* History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
* Pregnant or at breastfeeding;
* Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
* Preoperative Glasgow Coma Scale\< 15;
* Suspicion of intracranial hypertension;
* Peri-incisional infection;
* Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer

This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.

Introduction

* Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa).
* ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality.
* There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors.
* CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP), a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer.

Intervention:

* 24 Weeks
* Health Coaching Weekly
* Serum \& Urine Baseline, Week 12 and Week 24
* Anthropometric Measures
* Questionnaires
* Dual-energy X-ray absorptiometry (DXA) at Baseline and Week 24

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer Stage I, II or IV
* On androgen deprivation therapy with last 5 years
* Willing to participate in a lifestyle modification program
* Willing to modify diet and eating practices
* Willing to participate in blood collection, urine collection and measurements
* Minimum of 30 days since participating in another study/trial
* English speaking
* 40 years of age or older

Exclusion Criteria:

* Currently participating in another study or trial
* Currently in hospice
* Inability to walk two city blocks
* Inability to comprehend informed consent or procedural requirements
* Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake
Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury

This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview.

This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview (qualitative analysis).

Eligibility Criteria:
Inclusion Criteria:

* Individuals with subacute/chronic (\> 1 month after injury) spinal cord injury.
* Individuals with a mid-cervical/mid-thoracic (levels C5 to T6) spinal cord injury.
* Individuals with a complete or incomplete (ASIA Impairment Scale A, B, C, or D) spinal cord injury.

Exclusion Criteria:

* individuals with other disorders of the central nervous system (e.g., sequelae of traumatic brain injury, stroke);
* Individuals with psychiatric disorders that can interfere with adherence to study;
* Individuals with neuromuscular diseases;
* Individuals with history of substance abuse;
* Individuals with prior history of hypersomnias or sleep apnea under treatment;
* Individuals with prior history of chronic pain (e.g. fibromyalgia).
Vitamin D Repletion in Coronary Artery Disease

Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.

The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.

100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.

Eligibility Criteria:
Inclusion Criteria:

* Male and nonpregnant females greater than 18 years of age
* ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
* Serum 25-hydroxyvitamin D \< 20 ng/ml

Exclusion Criteria:

* confinement to a nursing facility, institution or home
* GFR \< 60 ml/min (by MDRD equation)
* presence of liver disease
* hypercalcemia
* NYHA class III or IV heart failure
* cardiogenic shock at time of presentation
* current planned or emergent CABG
* prior gastric or small bowel surgery
* pancreatitis
* malabsorption
* inflammatory bowel disease
* autoimmune disease
* active malignancy
* current use of \> 800 IU/day of vitamin D
* Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Effects of Marijuana on Neuropathic Pain and Spasticity in Spinal Cord Injury Patients

The goal of this clinical trial is to compare effects of marijuana or cannabis on neuropathic pain and spasticity in spinal cord injury patients. The main question is: Does the cannabis product from KhonKaen University reduce neuropathic pain and spasticity in spinal cord injury patients? The research design is a crossover study. The participants will be randomly into 2 groups: group 1 and group 2. The participants received either cannabis or placebo for 2 weeks. After completing treatment, participants were swapped to the other group for 2 weeks, a wash-out period is 2 weeks. The outcome measurements are pain and spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury more than 6 months
* Neuropathic pain
* Pain score \> 3
* Do not response to standard medical treatment
* Given inform consent

Exclusion Criteria:

* Allergy to cannabis
* Unstable cardiovascular and pulmonary diseases
* Chronic kidney and liver diseases
* Psychological disease
* Pregnancy or breastfeeding
Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)

The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research

Preoperative T1-MRI, functional MRI and diffusion MRI imaging data of iNPH patients were collected. The clinical assessment was performed before/after the lumbar puncture test and 6 months after VP shunt. Clinical assessment included Mini-mental State Examination (MMSE), gait scores, Kiefer score, and Modified Rankin Scale (mRS). The cerebrospinal fluid was collected by tap-test, and 6 months after surgery by puncturing in the VP device pump.

Methods- The primary methods used are:

1. The cerebrospinal fluid proteomic analysis of iNPH patients before and after VP shunt surgery.
2. The structral and functional MRI analysis of iNPH patients
3. The clinical assessment of MMSE, gait scores, Kiefer score, and mRS. Objective- To study the prognostic factors of VP shunt for iNPH.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years;
* Diagnosis of iNPH based on clinical assessment
* Participant is able to give written informed consent

Exclusion Criteria:

* Combining AD and Parkinson's disease and other nervous system diseases
* Participant is not medically available for shunt surgery
* Secondary NPH
Predictors of Heart Failure After ST-segment Elevation Myocardial Infarction (HF-EXPRESS)

Objective: The purpose of this project is to study the post miyocardial infaction (MI) damage and subsequently developed post-infarct cardiac repair process on the basis of cellular, molecular and imaging techniques. Besides this, whole genomesequencing and analysis (GWAS) will be performed to determine common varying genetic loci in order to anticipate whetherthese findings and its related pathways would be the predictors of adverse remodeling after MI or not.

A brief description of the issue and the original value of the subject: Epidemiological studies show a clear increase ininfarct-related complications due to increased survival after MI and aging population. Heart failure is the most prevalent complication after MI, which has reached epidemic proportions in western societies. For the period between 2010 and 2030,according to projections made in developed countries, about 10% increment in all cardiovascular disease is being predictedhowever increment in heart failure (HF) would be such a dramatic figure which is about 25%. HF is an increasing burden tosociety and healthcare systems, since its prevalence and incidence is dramatically increasing. There has not been aprospective study that assesses the exact cellular and geometric course after MI in human. This study will allow us tounderstand the behavior of cells involved in cardiac repair after MI. In addition, it will show us the exact functional andgeometric course after MI. Finally, the current study will also provide novel diagnostic and therapeutic targets via genomic andproteomic studies. All together, we envision to find new efficient ways to identify/treat patients at risk to develop HF after MI.

Eligibility Criteria:
Inclusion Criteria:

18-80 years old patients with myocardial infarction in the first 12 hours TIMI 3 flow following PCI

Exclusion Criteria:

Right ventiricular myocardial infarction Cardiogenic shock History of CABG, PCI or valvular disease History of Cardiomyopathy severe LV hypertrophy No reflow after PCI Chronic kidney disease (GFR\<60) Systemic inflammatory disease
Fiber Regimens for Constipation Symptoms

The objective of the current study is to compare the effects of bowel recipe with psyllium on symptoms associated with constipation.

Patients presenting to the urogynecology clinics at Parkland Health and Hospital System and UT Southwestern Medical Center at Dallas from July 2003 to July 2005 were screened for symptoms of constipation. Subjects were randomized to a 6-week course of either psyllium (Konsyl, Konsyl Pharmaceuticals, Easton, MD) or a special bowel recipe. The bowel recipe was a modification of that used by Behm and consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice. A validated constipation scoring questionnaire12 was administered to participants at the beginning and at the end of the six-week study period. During the six-week trial patients also kept a bowel diary recording characteristics of each bowel movement.

Eligibility Criteria:
Inclusion Criteria:

* fluent and literate in either English or Spanish.
* responds affirmatively to at least two symptoms according to Rome II criteria for functional constipation, for at least 12 weeks

Exclusion Criteria:

* pregnant or less than six weeks postpartum
* six weeks post abdominal surgery,
* colostomy
* history of bowel obstruction, inflammatory bowel disease, diagnosis of slow colonic transit time, spinal cord injury, neurogenic disease, myopathic disorders, or cognitive impairment, history of an allergic reaction to psyllium or any of the ingredients contained in the bowel recipe, such as wheat bran, prunes, or apples.
Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia

The goal of this study is to obtain data that well help inform the feasibility and design of a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES) technique in improving the swallowing function of young infants presenting with severe dysphagia.

Infants with severe neurologic disability often have difficulty in eating by mouth due to a disruption in the swallowing process. This swallowing dysfunction, also known as dysphagia, is often evident early in life and when severe can be permanent. Dysphagia can lead to an inability to take in enough food to maintain an adequate weight and result in malnutrition. It also can result in food going into the lungs instead of the stomach, resulting in an illness called aspiration pneumonia. Both of these complications may require feeding by tube either through the nose into the stomach or directly into the stomach via the abdominal wall, to bypass the swallowing process. This process is resource intense, can be associated with a number of complications and may result in a reduced quality of life for both the infant and caregivers. Currently, there are no effective treatments to change the natural course of dysphagia in this context.

Eligibility Criteria:
Inclusion Criteria:

* Infants with severe dysphagia on VFFS as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid).
* We will include children with dysphagia due to a central neurologic deficit. The neurologic diagnosis will be based on the diagnosis from the treating physician.

Exclusion Criteria:

* Infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for NMES treatment (tumours in the neck region and neck soft tissue infections).
* Children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder.