cyrilzakka/clinical-trials huggingface dataset:
Modified Exercise Programme in Individuals With Parkinson's Disease

A feasibility study using measures of turning function derived from Inertial Measurement Unit sensory before, and after, a modified exercise programme approach.

Participants will be patients diagnosed as having idiopathic PD by a neurologist. Patients will be recruited from the Movement Disorder Clinic, Division of Neurology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand. Participants will be classified into two groups; the treatment and the control groups. All participants will be asked to sign an informed consent form approved by the ethical committee of Mahidol University Institutional Review Board, Mahidol University, Thailand. Only patients with PD who meet the inclusion and exclusion criteria will be invited to participate in the study. All participants will be assessed for daily activity and motor skill using the Unified Parkinson's Disease Rating Scale (UPDRS). At pre- and post- assessments, eye movement and turning characteristics will be assessed using Inertial Measurement Unit sensors and Electroocculography (EOG). The treatment group will receive a rehabilitation program by the physiotherapist. The rehabilitation sessions will take place at the Faculty of Physical Therapy, Mahidol University, Thailand. The control group will receive a diary for recording their daily activities during the duration of participation in this study. In addition, the researcher will phone participants once per week to remind then to maintain their diary records.

Data Processing \& Analysis: this study will be used the outcome measures and processing data in MATLAB.

Statistical analysis: Kolmogorov Smirnov Goodness of Fit Test will be used to test the data distribution. If the data are normal or non-normal distribution, data comparisons will be tested as the following;

* Normal distribution: Mixed model ANOVA will be used to compare outcome measures between pre- and post- and between the treatment and the control groups
* Non-normal distribution: The Mann-Whitney U test will be used to compare outcome measures between the treatment and control groups. Wilcoxon Signed-Rank test will be used to compare outcome measures between pre- and post- assessments within group.

Eligibility Criteria:
Inclusion Criteria:

* Presenting clinical diagnosis of Parkinson's disease stage 2 to 3 by modified Hoehn and Yahr Scale assessment
* Age ranges from 50-75 years
* Having stable PD medication usage at least 1 month
* No wearing-off phenomenon
* Able to walk independently without using any assistive device
* Able to follow commands and instruction

Exclusion Criteria:

* Presenting clinical diagnosis of dementia
* Having other neurological, cardiopulmonary, or lower extremities musculoskeletal problems which influence the test performance.
* Having high blood pressure \[more than 140/90 mmHg\]
* Having hemodialysis
* Having visual problems which cannot be adjusted by the lens or glasses
CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer

TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological confirmed adenocarcinoma;
2. Clinical stage T3-4 and/or N+;
3. The distance from anal verge ≤ 12 cm;
4. Without distance metastases;
5. Age 18-70 years old, female and male;
6. KPS ≥ 70;
7. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;
8. With good compliance and signed the consent form.

Exclusion Criteria:

1. Pregnancy or breast-feeding women;
2. Known history of other malignancies within 5 years;
3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;
4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
7. Uncontrolled infection which needs systemic therapy;
8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
10. Allergic to any component of the therapy.
Oral Zinc Therapy for the Prevention of Mucositis

Zinc is an intracellular mineral with important enzymatic cofactor activities for cell membrane stability, DNA and RNA structure. Zinc deficiency is associated with delayed wound healing and immune dysfunction. In patietns with hematological malignancies an inverse correlation was found between disease stage and zinc level. Patients undergoing high dose chemotherapy for hematologic malignancies are predisposed to develop oral and gastrointestinal complications, in particular oral mucositis. These patients may have relative zinc deficiency, therefore oral zinc therapy may be benefical in the prevention of these complications.

Patients candidate for High dose chemotherapy with stem cell support for the diagnosis of relapsed/resistant Hodgkins or NHL or MM will be screened for enrollment in the study.

Patients will be randomized in a 1:1 ratio to therapy with either zincol 1 Tab TID or placebo 1 Tab TID.

Therapy will start on the morning before commencing chemotherapy and will continue untill the first of either discharge day or day 21.

Response assesment will include:

1. Mucositis assesment using NCI-CTC and OMAS scores- to be done eod from baseline and untill day 21/discharge day if before day 21
2. Evaluation of zinc levels in the serum, PBMC and saliva- to be done at baseline, day 6/7 and day 21/discharge day if before day 21.
3. Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia,use of antibacterial and antifungal medications,

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing high dose chemotherapy with stem cell support for relapsed or resistant Hodgkins or NHL (treated with BEAM protocol) or MM (treated with high dose melphalan).
* ECOG performance less than or equal to 2
* Adequate renal and hepatic function

Exclusion Criteria:

* Presence of any other active malignancy other than BCC of the skin
Computational Assessment of Hand Motor Skills in Stroke Patients

This is a two phase prospective observational study that aims to validate the use of a motion capture software (Leap Motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. The objectives of this study are:

1. To compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
2. To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
3. To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
4. To analyze changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients: clinically stable, with hand functional deficit at the momment they consent to participate in the study. Signed consent to participate.
* Healthy subjects: similar age to stroke patients, without previous clinical history of stroke or any disease that could affect hand motor skills. Signed consent to participate.

Exclusion Criteria:

* Aphasia or cognitive impairment, confusional syndrome or other conditions that could prevent comprehension and acomplishment of the task.
* Plegia or severe paresis of the hand that could prevent adecuate performance of the task.
* Previous stroke.
* Previous dependance.
* Previous diagnosis of any other neurologic disease or condition that could affect hand motricity.
* Life expectancy below three months.
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.

The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute.
* those who have failed previous treatment including over-the-counter analgesics and activity modification
* have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder.

Exclusion Criteria:

* Patients will be excluded from the study for any of the following reasons:
* Post traumatic osteoarthritis
* Inflammatory osteoarthritis
* Imaging confirmed rotator cuff tear
* Prior ipsilateral shoulder surgery
* Memory loss or inability to complete study measures
* History of allergy to injection medications
* Diabetic patients with patient-reported fasting blood glucose \>200
* Prior injection in the ipsilateral shoulder within three months
Echocardiography in Men With Erectile Dysfunction

Cardiovascular disease is the leading cause of morbidity and mortality in the world. To curb disease development, there is, therefore, a need to identify more people at increased risk. This can be done by advanced echocardiography, where the exact contraction pattern and dimensions of the heart are measured.

One group of patients who are already considered to be at increased risk for later development of heart disease are men with erectile dysfunction.

The investigators goal is to study the early detection of cardiac dysfunction in men with erectile dysfunction using both conventional and advanced echocardiography to analyze the possibility of preventing serious cardiovascular disease.

Cardiovascular disease is the leading cause of morbidity and mortality across the globe. About 524,000 Danes live with cardiovascular disease and it affects approx. 56,400 people. In addition, many people live with heart problems without knowing it. These figures emphasize the importance of early identification of more people at increased risk of developing cardiovascular disease to prevent morbidity and mortality.

This can be done using advanced echocardiography, where the heart's precise contraction pattern, as well as structure and dimensions, are measured. One group of patients who are already considered to be at increased risk for later development of cardiovascular disease are men with erectile dysfunction (ED). ED is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Approximately 30% of men over the age of 40 are affected by ED, and the incidence increases with age. ED is thought to be a precursor to cardiovascular disease, where it has been proven that after the onset of erection problems, over 3-5 years, there is an approximately 50% increased risk of cardiovascular disease.

The investigators hypothesize that cardiac structure and function assessed by conventional and advanced echocardiography together with cardiac biomarkers are abnormal in patients diagnosed with erectile dysfunction and can identify patients at high risk for cardiovascular complications. Echocardiography can serve as an important tool in risk assessment in these men who do not necessarily have symptom-causing problems.

Eligibility Criteria:
Inclusion Criteria:

* Men above 40 years old diagnosed with ED will be eligible to participate if none of the exclusion criteria below are present.

Exclusion Criteria:

* Patients not able to cooperate
* Patients unable to understand and sign "informed consent"
* Previous pelvic surgery (including prostatectomy, cystectomy and rectal surgery)
* Neurological diseases (e.g. multiple sclerosis, spinal cord injury)
* ED following pelvic trauma
Antibiotics in Free Flaps Reconstructions

The purpose of this study is to monitor and compare peri-operative problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics.

Study Design and Patient Recruitment All clinical investigations have been conducted according to the principles expressed in the Declaration of Helsinki. Patient consent was written. Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps was eligible. Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history were not included in this study as the protocols available are not comparable in doses and effect on the irradiated tissue.14 A prospective study was initiated from July of 2007 to June 2012. All patients were prospectively evaluated.

Postoperative Care The investigators standard regimen was to keep the patient sedated for one night on the intensive care unit and then transfer to the surgical ward. The specific intravenous antibiotic therapy was started 30 minutes before the operation and administered for 10 days.

Data Analysis Recorded parameters included: age, sex, preoperative medical history, American society of Anesthesiologists classification of preoperative status 15, diagnosis, stage of disease, defect localisation, type of microvascular free flap, choice of recipient vessels, flap success, rate and number of operative revisions, primary or secondary reconstruction, type of previous treatment (radiation or surgery), type of previous neck dissection (if any), microvascular complications, the total operative time, wound healing disturbances subdivided into dehiscence and infection at the neck, region of reconstruction, or donor site, and prophylactic antibiotic agent, if used. Infection was defined as a purulent discharge at the wounds.

Descriptive statistics for quantitative variables are given as the mean ± standard deviation. The data were analyzed with the "Statistical Package for the Social Sciences" software (IBM® SPSS® Statistics for Windows, Version 22.0; IBM Corp., Armonk, NY, USA). Figures are generated with SPSS and Microsoft® Office Excel (Microsoft Excel for Windows, release 11.0, 2003, Microsoft Corporation, Redmond, WA, USA). Multiple linear regression analyses were used to determine factors independently associated with the dependent variable wound infection or wound healing disturbances. 95% confidence intervals (95% CI) are also given. Differences were considered to be statistically significant for a two-sided p-value of less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps.

Exclusion Criteria:

* Healthy humans.
* Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history.
Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn

The objective of this study is to determine the impact of early post-operative feeding on splanchnic blood flow, cardiac output and end organ perfusion, and the patients overall clinical outcomes.

Neonates with critical congenital heart disease (CHD) undergoing surgery often have postoperative decreases in cardiac output. These hemodynamic changes can result in varying levels of organ dysfunction, ranging from the subclinical to the more overt. Although this low cardiac output syndrome (LCOS) and accompanying multiorgan dysfunction syndrome (MODS) is in large part transient, the rapidity and completeness of resolution can vary greatly.

During postoperative care in the intensive care unit, knowledge of this phenomenon must be balanced against the desire to initiate enteral nutrition. Many studies have demonstrated that timely initiation of enteral feeds in the intensive care can reduce mortality, morbidity and costs. Practically speaking, the decision to initiate feeds is made based on the patient's postoperative hemodynamic status, a normal lactate, absence of vasopressor agents and presence of bowel sounds. Trophic enteral feeding can usually commence 24h postoperatively, even after complicated neonatal heart surgery,

The vast majority of postoperative neonates suffer no apparent ill effects from this management strategy. However, recent data have demonstrated an exceedingly high incidence (3.3-6.8%) of necrotizing enterocolitis (NEC) in CHD patients; a disease for which diminution in splanchnic blood flow and disruption of the mucosal barrier are felt to play an important role. These data suggest the combination of diminished cardiovascular reserve, cyanosis and increased myocardial oxygen demands may promote the development of NEC.

Preliminary data from Sickkids (Chanthong and Sivarajan, 2008) demonstrates an NEC incidence of 8% in CHD patients. Patients with NEC also accounted for 25% of all cardiac arrests in Cardiac CCU.

Eligibility Criteria:
Inclusion Criteria:

* neonates ≤ 30 days of postnatal age at time of operation
* birthweight \> 2.5 kg
* gestational age at birth ≥ 35 weeks
* Patients requiring cardiac surgery who are expected to remain intubated in the CCIU for \> 48 hours
* informed consent by parent or guardian
* approval by treating critical care staff physician

Exclusion Criteria:

* patients with heterotaxy or pre-existing renal or abdominal pathology (eg. preoperative diagnosis of NEC).
* need for ECMO after repair within the study period (data up to that point will be recorded and analyzed).
* Parent refusal of formula for purposes of study
* Patient on vasopressin or norepinephrine infusion
* Parent or legal guardian refuse consent
Ketamine For Acute Treatment of Pain in Emergency Department

The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department.

The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.

The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and older presenting with acute generalized pain
* Describes pain to be greater than or equal to 3 on the Visual Analogue Scale (VAS)
* Provides informed consent

Exclusion Criteria:

* Patients who are admitted to the hospital
* Severe hypertension(≥180/100)
* Presence of or suspected for traumatic head injury with or without loss of consciousness
* Presence of or suspected for myocardial ischemia
* Presence of or suspected alcohol intoxication
* Hemodynamic instability
* History of schizophrenia
* History of Sickle cell crisis / presenting with acute sickle cell crisis
* History of or suspected recreational substance abuse
* History of or suspected diagnosis of headache or migraine
* History of or suspected diagnosis increase in intracranial/intraocular pressure
* Known or suspected pregnancy
* Allergy to ketamine or morphine
* Administration of opioids in previous 4 hours
* Patients with language barriers or in altered mental status who are unable to describe pain
* Patients weighing over 166kg
Lower-Cost Contingency Management in a Group Setting - 1

The purpose of this study is to evaluate the efficacy of prize contingency management (CM) in enhancing attendance, reducing drug use, and improving health among clients attending two HIV drop-in centers. Specifically, 172 clients are randomly assigned to one of two 6-month treatment conditions: standard 12-step oriented group treatment, or CM group treatment. In the CM group, clients earn the chance to win prizes for submitting clean urine specimens and for complying with steps toward their treatment goals. Activities related to improving health will be emphasized, such as attending medical appointments, recording daily medication consumption, getting prescriptions filled, and attending medication adherence support groups. Group attendance, drug use, medical problems, services received, and risky drug use and sexual behaviors will be measured pre-treatment and at months 1, 3, 6, 9 and 12.


Eligibility Criteria:
Inclusion criteria:

* HIV-positive and a member of The Living Center or the Manchester Area Network on AIDS
* DSM-IV diagnosis of current opioid or cocaine abuse or dependence
* willingness to accept random assignment to one of the two treatment groups

Exclusion criteria:

* inability to comprehend the study (Mini-mental status score \<21; Folstein \& Folstein, 1975; or inability to pass an informed consent quiz)
* severely disruptive behavior
* in recovery for pathological gambling (due to potential similarity between the CM procedure and gambling)
* non-English speaking