cyrilzakka/clinical-trials huggingface dataset:
Physical Training on Patients With Breast Cancer

The treatment of breast cancer at any given time can be through surgery, as well as adjuvant treatments (radiotherapy, chemotherapy and hormone therapy) alone or together. And with this the patient tends to lose weight, he becomes depressed, resulting in an increasingly debilitating picture. Therefore, the present study aims to investigate the relationship between physical exercise and its effects on quality of life in patients with breast cancer, those who underwent surgery for at least 6 months, patients who are still with the Tumor using the adjuvant treatments submitted to physical exercises and not submitted. The sample will consist of 25 to 50 female patients aged 18 to 75 years. Patients will be submitted to the initial quality of life evaluation (SF - 36 reduced version, Anxiety and depression (HAD Scale), Fatigue (Piper Fatigue Scale), Pain (Brief Inventory of Pain), Body Composition (Bioimpedance BYODINAMICS 450 ) And oxidative stress markers (oxidized and reduced glutathione, TBARS / MDA, Myeloperoxidase and Creatinine), inflammatory markers (IL1, IL6, IL8, IL10, MCP-1 and TNF-α), hormones Estrogen, progesterone), blood test (complete blood count) 24 hour food recall (24hs food recall), and perform the maximum repetition test to find the initial workload that will be adjusted every 4 weeks with the evaluation of the load and Completing the 12 weeks of training will be reevaluated following the initial evaluation. The data collected will be treated statistically with an α=5% using the software Stata 12.0.

The patients will be allocated into two groups: exercise group (intervention) and conventional treatment group (active comparison). Intervention: The combined training program consisted of 12-week aerobic, resistive and flexibility exercises, with 3 sessions per week of aerobic and resistive training in the same session (supervised by physical exercise coaches) and 2 sessions per week of Flexibility training (unsupervised). As stretching sessions were interspersed with sessions of aerobic and weathered training in the daytime period.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients;
* Sedentary;
* Currently at treatment and clinical follow-up.

Exclusion Criteria:

* Musculoskeletal injuries or disorders;
* Mental illnesses;
* Enrolled in other exercise program.
Pulmonary Hypertension: Assessment of Cell Therapy

The primary objective is to establish the safety of autologous progenitor cell-based gene therapy of heNOS in patients with severe Pulmonary Arterial Hypertension(PAH) refractory to conventional treatment.

This is a two centre, phase I clinical trial. A total of 18 patients will be studied using an open-label, dose escaling protocol; three patients will be entered into each of the five dosing panels. An additional three patients will be entered into the final dose panel to establish safety at the maximum tolerated dose.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic Pulmonary Arterial Hypertension
* Familial PAH or anorexigen induced PAH
* Specified 6-minute walk distance

Exclusion Criteria:

* Intra or extra cardiac communication between the right and left sided circulations
* Hemodynamic instability
* Left ventricular ejection fraction \< 40%
* Thromboembolic event or recent hospitalization for worsening right sided heart failure in past 3 months
* CVP\>20mmHg at time of research heart catheterization
* Pregnancy
* Concurrent hepatitis or HIV
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

We initiate a study with research grant from department of health and Taoyuan mental hospital and choose risperidone and olanzapine as study medications. We compare the effects of these 2 drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that these two medications have different effects in improving tardive dyskinesia.

Objective: First generation antipsychotics would induce tardive dyskinesia in some schizophrenic patients. Second generation antipsychotics were the choices for these patients. But which one of second generation antipsychotic was the better choice did not have definitive results. We compared risperidone and olanzapine in schizophrenic patients with neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive dyskinesia.

Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to December 2003. Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV) patients who met the research criteria of neuroleptic-induced tardive dyskinesia research criteria of DSM-IV and no less than moderate severity (\> or =4) of global impression of extrapyramidal syndrome rating scale (ESRS). 60 patients were random assignment to risperidone or olanzapine for 24 weeks. The primary outcome was to compare the change of total scores of abnormal involuntary movement scale from baseline to study endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18-70 y/o
* Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age
* Meet schizophrenia, schizophreniform or schizoaffective disorder criteria of DSM-IV
* Fulfill DSM-IV neuroleptic-induced tardive dyskinesia research criteria, the severity of tardive dyskinesia was no less than moderate degree (\> or =4) assessed by global impression of Extrapyramidal System Rating Scale (item 42 of ESRS)
* Patients or legal responsible people agree to join study and sign informed consent

Exclusion Criteria:

* Had other axis I diagnosis of DSM-IV
* Unstable major systemic diseases
* Had neurological disorder influenced to EPS assessment
* Substance abuse or dependence other then coffee or tobacco within 6 months before study
Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery

The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta in patients undergoing coronary artery bypass graft surgery for treatment of coronary artery disease. Patients in the study will have a coronary angiogram approximately 9 months following surgery to determine the patency of vein grafts created using either the automated PAS-Port or hand sewn methods. Safety will be evaluated by documenting the occurence of adverse clinical events and evealuating possible association with either method.


Eligibility Criteria:
PRE-OPERATIVELY

Inclusion Criteria:

* Able to give informed consent, able to understand the intent and clinical meaning of the study as well as its implications. Patient is legally competent.
* Assessment that the patient is willing and able to have follow-up visits and examinations
* Age greater than or equal to 50 years and less than 85 years
* Ejection fraction of \>30%
* Can tolerate radiographic contrast media
* Requires non-emergent coronary artery bypass with at least two vein bypass grafts intended
* Coronary artery targets intended for bypass index grafts must have \>70% native stenosis
* Life expectancy \>1 year

Exclusion Criteria:

* Patient is participating in other clinical trials that would conflict with this protocol
* Unable to meet study requirements (travel, general health)
* Pregnancy
* Previous cardiac surgery
* Requiring preoperative use of an intraaortic balloon pump
* Congestive heart failure / NYHA Class IV
* History of thromboembolic disease requiring ongoing anticoagulation therapy or the presence of a bleeding disorder
* Acute or chronic dialysis
* Creatinine of greater than 200 µmol/L (2.3 mg/dL) in the last 30 days
* Documented acute or suspected systemic infection
* Need for ongoing immunosuppressive therapy
* Recent (less than 2 weeks) history of cerebrovascular accident
* Aspirin allergy or other contraindications to aspirin use

INTRA-OPERATIVELY

Inclusion Criteria:

* Patient is hemodynamically stable
* Open chest reassessment of the revascularization strategy confirms that two vein bypass grafts are still intended
* Target vessel wall properties that are suitable for performing both a hand-sewn and a PAS-Port anastomosis
* Target vessel is greater than 1.8 mm in diameter at sites where anastomoses are planned
* Target vessel at sites where anastomoses will be placed are free from severe calcifications or severe atheromas
* The length of the vein graft(s) is adequate for both of the planned index graft revascularization strategies
* Vein outside diameter and double wall thickness are between 4 and 6 mm(inclusive) and less than or equal to 1.4 mm, respectively, at the graft site intended for the PAS-Port proximal anastomosis
* The vein(s) is of suitable quality to be used as a bypass graft conduit

Exclusion Criteria:

-Any of the Intra-operative Inclusion Criteria not met
Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder

The study aims to determine the effects augmented reality game-based training on social communication of children with autism spectrum disorder.

Augmented Reality allows children to see a representation of imaginary content and pretend play overlaid on the real-world environment. Today, technology can be a safe and motivating way of engaging children with autism in social interaction activities. Current research in therapeutic technology for autism is aimed toward improving behavior and psychomotor activities that impact social communication. The aim of this research project is to help teachers, parents, practitioners, and researchers to understand the unique strengths of their children with autism along with technology based educational and therapeutic activities for home and classroom.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.

Exclusion Criteria:

* Sensory issues and patients on medication.
A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinoconjunctivitis Following Exposure in the Allergen BioCube

The objective of this study is to evaluate ocular and nasal signs and symptoms in patients with seasonal allergic rhinoconjunctivitis following allergen exposure in the Allergen BioCube.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age;
* if female, cannot be pregnant or nursing;
* have a history of ocular and nasal allergy and a positive skin test reaction to one of the allergens tested within the past 24 months;

Exclusion Criteria:

* have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood and Lung Institute classification;
* have a compromised lung function;
* have any ocular condition that could affect the subject's health or the study parameters;
* have any presence of active ocular or sinus infection;
* have significant nasal conditions;
* have any significant illness that could be expected to interfere with the subject's health or with the study parameters
* use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period;
* have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
Serum MicroRNAs as Diagnostic Biomarkers of Colorectal Cancer

evaluation the diagnostic value of certain MicroRNAs as biomarkers of Colorectal cancer by comparing its expression levels in Colorectal cancer patients and normal individuals.

Colorectal cancer (CRC) is the second commonest cause of cancer deaths and the third most common cancer worldwide. Five year survival of patients with stage 1 CRC is 92%, and decreases to 10% at stage 4 CRC. So, CRC diagnosing at an early stage is the most important factor influencing disease prognosis. Most CRC patients are diagnosed after being symptomatic, but studies show that once the symptoms are present it mostly signifies late-stage disease. colonoscopic screening of asymptomatic patients has been shown to pick up early-stage CRC. However, this is limited by cost issues and patient attitudes. Therefore, more efforts could be done to view to early diagnosis of CRC in asymptomatic patient. Biomarkers are molecules that can serve as signals of disease activity and pathological processes. CRC biomarkers can help in early diagnosis. MicroRNAs (miRNAs) are non-coding molecules that impact the expression of target genes in cell. Also, they exist in highly stable, cell free form in peripheral blood. They are detected by quantitative real time polymerase chain reaction (qRT-PCR). Data also shows that certain miRNAs are elevated in the plasma and tissues of CRC patients and decrease in plasma levels after operative treatment. There are over 2000 different miRNAs and they are estimated to regulate 30% of the human genome. miRNA dysregulation is also associated with multiple cancers. miRNAs seem to show significant promise with high sensitivity and specificity for CRC, but with limiting factors of limited data for high risk polyps and significant heterogeneity in test media and non-standardisation of test panels. Further research would be required to bridge these knowledge gaps. Interestingly, miR-15b and miR-21 appears to be the best diagnostic accuracy values for CRC.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18-75) diagnosed with primary CRC (histopathologically confirmed).
* CRC patients who have not received prior treatment (i.e., chemotherapy or radiation).
* Age-matched healthy controls without colorectal disease

Exclusion Criteria:

* Patients with secondary tumors or metastasis originating from non-colorectal sources.
* Patients with prior history of CRC.
* Patients who refuse to contribute in this study.
Group Education to Improve the Iodine Nutrition in Pregnancy: Cluster Randomized Trial

The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women

BACKGROUND: It is a priority to achieve an adequate nutritional status of iodine during pregnancy since iodine deficiency in this population may have repercussions on the mother during both gestation and post partum as well as on the foetus, the neonate and the child at different ages. According to the WHO, iodine deficiency is the most frequent cause of mental retardation and irrreversible cerebral lesions around the world. However, few studies have been published on the nutritional status of iodine in the pregnant population within the Primary Care setting, a health care level which plays an essential role in the education and control of pregnant women.

AIMS: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the factors associated with its appearance during pregnancy.

METHODS/DESIGN: We will perform a cluster randomised, controlled, multicentre trial. Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of 17 years attending consultation to a midwife during the first trimester of pregnancy in the participating primary care centres. Outcome measures: consumption of iodine-rich foods and iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group education during the first trimester of gestation on healthy hygiene-dietetic habits and the importance of an adequate iodine nutritional status. Statistical analysis: descriptive analysis of all variables will be performed as well as multilevel logistic regression. All analyses will be done carried out on an intention to treat basis and will be fitted for potential confounding factors and variables of clinical importance.

DISCUSSION: Evidence of generalised iodine deficiency during pregnancy could lead to the promotion of interventions of prevention such as how to improve and intensify health care educational programmes for pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women in the first trimester
* Over the age of 17
* Receive routine care in their respective health center

Exclusion Criteria:

* Pregnant women who are in the second or third trimester.
* Pregnant women with diagnostic of thyroid disease.
* Pregnant women who do not have a phone.
* Pregnant women with communication difficulties (cognitive or sensory deterioration, language barrier).
* Pregnant women who do not consent to participate in the study.
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
* Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
* Subject has a history of sensorineural hearing loss
* Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy
Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome

A total of 93 suitable patients will be randomly allocated into three groups: Group A will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, Group B will receive only low-energy extracorporeal shock wave therapy, and Group C will receive only the tailored exercise program.

Patients were randomly assigned to one of three groups: Group A, which received a low-energy extracorporeal shockwave treatment and a tailored exercise program; Group B, which received only a low-energy extracorporeal shockwave treatment; and Group C, which received only the tailored exercise program. The randomization process was done using a computer-generated table of random numbers concealed by sealed opaque envelopes. The patients' shoulder range of motion, pain intensity, upper extremity activities, and echogenicity, thickness, and disorganization were assessed using a digital inclinometer, visual analogue scale, quick DASH scale, and diagnostic ultrasound, respectively. The randomization process was overseen by a professional physical therapist who was not involved in the study procedures.

All outcomes were measured at the baseline and four weeks post-intervention. The outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.

Eligibility Criteria:
Inclusion Criteria:

* female
* between the ages of 40 and 65 years

Exclusion Criteria:

* metastases of any kind
* lymphedema,
* a traumatic injury to the targeted upper extremity
* a musculoskeletal disorder
* taking any anticoagulants
* had undergone bilateral breast cancer surgery
* experienced locoregional recurrence
* had vascular problems in the affected upper extremity
SHIFT-Hospital in Motion (Hospital Implementation Study)

The goal of this monocentric observational study involving hospitalised patients is to assess the integration of activity sensors into routine clinical practice.

Patients in hospitals spend the majority of their time inactive, sitting or lying down. Not being active is a common problem for patients in hospitals, often causing complications and impairing recovery, as it can lead to issues such as reduced blood volume, unsteady blood pressure when standing, weaker muscles, and a higher risk of infections, blood clots, and other health issues. The inactivity-related changes in the body in combination with the natural ageing process, the stress of being in the hospital, a poor nutritional status, and possibly troubles with thinking, memory, and understanding or depression diminish the ability to regenerate with overall compromised physiological resilience.

A pilot study (NCT06403826) involving 40 patients demonstrated the feasibility and effectiveness of using activity sensors in clinical settings. A subsequent validation study (NCT06396676) validated a classification model based on activity data from 65 patients, which can distinguish between different activities with 89% accuracy.

The integration of activity sensors into routine clinical practice requires a comprehensive infrastructure to support interdisciplinary collaboration. Therefore, the primary objective of this observational, single center study is to evaluate the additional time expenditure associated with using activity sensors in routine clinical practice by physiotherapy and clinical care over a 10-week period. Secondary objectives include assessing the comfort of extended sensor use, the feasibility and benefits for healthcare professionals, the reliability and accuracy of the sensor data, and the optimization of the activity classification algorithm.

The results of this study will contribute to improving patient care through the use of activity sensors, enabling more personalized care.

Eligibility Criteria:
Inclusion Criteria:

* at least 3 days inpatient on the medical ward 6.1 (Monday to a maximum of Thursday or Tuesday to a maximum of Friday)
* at least restricted bed rest
* patient must be able to walk
* patient must be cognitively able to follow instructions (normal Observation Screening Scale (DOS) und modified Confusion Assessment Method (mCAM))
* ≥ 18 years
* signed informed consent

Exclusion Criteria:

* planned discharge within the next 3 days
* planned surgery during the measurement
* isolated patient
* inability or contraindications to participate in the study or to follow the study procedures, e.g. due to certain neurological disorders, speech problems, mental disorders, or cognitive impairments
* prior inclusion in the study