cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.

Xueshuanxinmaining tablet is a Chinese patent medicine composed of Ligusticum chuanxiong, Salvia miltiorrhiza, borneol and Toad puff, etc. It has been widely used in cardiovascular diseases in China. Clinical application suggested that Xueshuanxinmaining tablet was safe and effective in the treatment of stable angina pectoris. However, it still needs to be further confirmed by high-quality, large sample randomized controlled trials. This randomized, double-blind, placebo-controlled clinical trial is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.

Eligibility Criteria:
Inclusion Criteria:

* Participants are aged between 40 and 75 years.
* Meet the diagnostic criteria of stable angina pectoris.
* Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome.
* Voluntarily participate and sign informed consent.

Exclusion Criteria:

* Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases.
* Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year.
* Any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases.
* Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value.
* With a history of alcohol and drug abuse.
* Pregnant or lactating women.
* Patients who have participated in clinical trials of other drugs within 3 months before enrollment.
Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission

Hospital rehospitalizations within 30 days are frequent and represent a burden for the patients, but also for the entire health care system. This study evaluates the impact of an intervention targeted to high-risk medical patients in order to reduce their risk of rehospitalization. Half of the patients will receive a set of interventions before and after their hospital discharge, while the other half will receive usual care.

Background: Hospital readmissions within 30 days are frequent, with rates varying usually between 12 and 20%. Is it therefore recognized as important to improve the quality of the transition of care period in order to avoid as much as possible hospital readmissions. There are however still several gaps in current knowledges. First, most trials to reduce hospital readmission have been performed on specific patient populations such as patients with diabetes or heart failure, and therefore the findings may not be well generalizable to other high-risk population. Second, while some specific interventions have been showed to reduce readmission, these were complex and resources demanding, and no trial targeted these interventions to the patients who are most likely to benefit for better effectiveness, using a widely validated prediction tool, such as the "HOSPITAL" score. Finally, most studies tested unimodal interventions instead of more promising multimodal interventions.

Specific aim: the goal of this proposal is to evaluate the effect of a multimodal transitional care intervention prioritized to higher-risk medical patients on the composite of 30-day unplanned readmissions and death.

Methods: the investigators will conduct a multicenter randomized controlled trial in medical inpatients discharged home or nursing home, who are identified as having a higher risk for 30-day readmission. Risk of readmission will be predicted using the simplified HOSPITAL score, which includes 6 variables routinely available before hospital discharge and which has been previously validated in more than 200,000 patients across 6 countries in its original version, and in nearly 120,000 patients in its simplified version. Patients will be randomly assigned to the intervention group or usual care group. The primary outcome will be the first 30-day unplanned readmission or all-cause mortality. The primary analysis will be a comparison between two groups according to the intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients planned to be discharged home/nursing home from a medical department.
* Hospital stay of at least 24 hours.
* Patient at higher risk of 30-day readmission based on the simplified HOSPITAL score.

Exclusion Criteria:

* Previous enrolment in this trial.
* Patient is not living in the country in the next 30 days.
* No phone to be reached at.
* Not speaking the local language.
* Refusal to participate, or unable to give consent.
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation

This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation of patients for surgical upper eyelid repair.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with ptosis undergoing conjunctival Muller's muscle resection evaluation.
* Individuals who can tolerate and have no hypersensitivity to phenylephrine 2.5% ophthalmic solution.
* Individuals who can tolerate eye-drop medications.
* Individuals who are physically able to take a tangent screen visual field test.
* Age: Adults who can comprehend the instructions and procedures (18-90 years old).

Exclusion Criteria:

- This study will not incorporate any of the following at-risk populations: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.

* This study will not include participants who refuse to consent.
* This study will not include participants who are too tired or unable to take a tangent screen visual field test (see Risk to Subjects).
* This study will not include individuals who may not be able to tolerate phenylephrine 2.5% ophthalmic solution.
* Specifically, those with a past medical history of bradycardia, hypotension, autonomic dysfunction, or severe cardiovascular disease
* This study will not include individuals who consume drugs contraindicated in phenylephrine use: Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates), Iobenguane Radiopharmaceutical Products, Kratom, Lisuride, Monoamine Oxidase Inhibitors
Life-long Monitoring of Frail Patients With Chronic Diseases

The purpose of this study is to evaluate whether telemonitoring of frail patients with chronic diseases produces benefits in terms of reduced readmissions, improved health related quality of life, and improved health status. In addition, the trial evaluates the economic and organisational impact of the telemonitoring service and examines its acceptability by patients and health professionals.

The study is designed to evaluate the impact of telemonitoring on the follow-up of elderly patients with one or more chronic diseases among heart failure, chronic obstructive pulmonary disease and diabetes. The particular target of patients selected has the particularity of being "frail" according to a set of social eligibility criteria, agreed by the clinicians participating at the study. General practitioners are the first clinicians in charge of managing these patients during the trial follow-up. The term of comparison is represented by a control group, followed by outpatient usual care.

From a clinical point of view, the trial will investigate how the remote monitoring of some clinical parameters contributes to reduce the access to healthcare facilities (emergency and planned hospitalization, bed-days, ER, specialist and GP visits), to improve the patients health-related quality of life and to reduce the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Diagnosis of one or more of the following chronic diseases:

  * Heart failure - diagnosis confirmed by echocardiogram or by a specialist assessment
  * Type 1 or 2 diabetes - with HbA1C of 7.5 or greater in the previous 15 months
  * Chronic Obstructive Pulmonary Disease (COPD) - diagnosis confirmed by spirometry and FEV1 ≤ 70% of predicted normal and/or FEV1/FVC ratio ≤ 70% or by a specialist assessment
* and at least one of the following Social inclusion criteria:

  * Have had a fall in the previous year or who are considered at high risk of falling
  * Need home social care
  * Have a caregiver who have difficulties to take care of him/her properly
  * Cognitive impairment/confusion, but with caregiver able to use devices.

Exclusion Criteria:

* Patient unable to use the telemonitoring equipment (alone and assisted)
Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.

The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.

Eligibility Criteria:
Inclusion Criteria:

Infants are eligible if they meet all the following inclusion criteria except 4.

1. ≥36 weeks gestation
2. Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \<7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
3. Moderate to severe encephalopathy (Sarnat II to III)
4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
5. Up to 24 hours of age
6. A person with parental authority must have consented for the study.

Exclusion Criteria:

1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases
2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
3. Severe growth restriction, with birth-weight less than 1800 g
4. Severe infectious disease, such as sepsis
5. Infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia by the attending neonatologist
Bioavailability of Golden Rice Carotenoids in Humans

This investigation protocol uses an isotope reference method to evaluate bioavailability of ß-C in rice and its bioconversion to vitamin A.

A well-nourished population will be fed hydroponically grown Golden Rice containing \~ 1 mg of β-carotene at day 8 after a reference dose of vitamin A at day 1. The blood samples will be collected up to 33 days after the doses. The absorption kinetics will be determined by tracking both vitamin A and β-carotene in human serum. Blood responses to Golden Rice β-carotene will be determined and evaluated. The vitamin A value of Golden Rice can thus be quantitatively determined.

Recently, scientists have genetically engineered "golden rice" that contains 1.6 ug ß-carotene in a gram of dry rice (12). Since the vitamin A equivalency varies from 2 ug (oil dose) to 27 ug (vegetable) carotene to 1 retinol equivalent and the equivalency is matrix dependent, it is necessary to know what the vitamin A equivalency of golden rice beta-carotene is. The determination of the absorption and conversion of golden rice beta-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.

To evaluate the absorption and intestinal conversion of rice beta-carotene after an acute dose of golden rice, an intrinsically labeled Golden Rice with a labeled reference dose of vitamin A are used. We propose to conduct a pilot study on the US adults with normal vitamin A status (n = 15).

The specific aims of this pilot study are:

1. To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or 10 g fat (butter);
2. To determine retinol kinetics from the golden rice and from the labeled vitamin A dose;
3. To determine vitamin A value of golden rice ß-carotene in adults with normal vitamin A status. The determination of the absorption and conversion of golden rice ß-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.

Eligibility Criteria:
Inclusion Criteria:

* healthy health

Exclusion Criteria:

* GI track problems
Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions

Purpose: To determine unmet functional needs in patients referred to the Palliative Care Unit at Rigshospitalet, Copenhagen University Hospital will be asked to fill out self reported questionnaires regarding problem intensity, problem burden and felt needs, physical functioning, emotional functioning, fatigue, sleep, distress. Furthermore patients physical function will be evaluated.

Physical functioning is found to be an important predictor for survival and physical ability 'to do what one wants' affects quality of life in cancer patients in palliative care and their spouses. Despite this, physical functioning is reported as a neglected dimension in palliative care quality of life outcome measures, and advanced cancer patients report that they do not receive the help they need. The vast majority of patients with advanced cancer described unmet palliative care needs, and with the most frequently reported problems being; fatigue (73%), limitations doing physical activities (65%), limitations in work and daily activities (58%), worry (58%), difficulties with sexuality (54%), pain (52%) and problems with concentration (43%). Furthermore, limitations in physical functioning and physical activity is a leading cause of distress and psychological problems a rehabilitative approach in palliative care integrated in the interdisciplinary interventions to the patients must be maintained throughout the entire illness trajectory from diagnosis through treatment, rehabilitation and palliative care to address such problems.

However, prevalence of patient unmet needs and reported physical functioning and performance is reported to differentiate largely between palliative units.

In order to address the functional needs of patients receiving specialist palliative care studies of their specific needs are required. Therefore, the aim of this study is to investigate the patient reported unmet needs for function and supportive occupational- and physiotherapy rehabilitation interventions in the palliative unit at Copenhagen University Hospital, Rigshospitalet. Furthermore, we aim to investigate if observations, additional disease-specific patient reported outcomes and assessment of physical function and performance can support the unmet needs.

Eligibility Criteria:
Inclusion Criteria :

All adult patients (≥ 18 years) referred to the Palliative Care Unit at Copenhagen University Hospital, Rigshospitalet.

Exclusion Criteria:

Inability to read and understand Danish
Study of Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer.

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.

OBJECTIVES:

Primary

* To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.

Secondary

* To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.

OUTLINE: This is a multicenter study.

Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following advanced metastatic malignancies:

  * Malignant melanoma
  * Lung cancer
  * Breast cancer
  * Pancreatic carcinoma
  * Colorectal cancer
* Advanced and/or metastatic disease
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Validation And Turkish Cross-Cultural Adaptation of Treatment Expectation Questionnaire (TEX-Q) Tool

The general treatment expectations of patients play a significant role in determining the outcomes of the different treatments they undergo. When it comes to physiotherapy programs, these expectations act as non-specific treatment components, capable of triggering subjective psychological changes and eliciting mechanisms that resemble placebo effects. When theory-based, multidimensional measurement tools that evaluate patients' expectations from various treatments are examined, the Treatment Expectation Questionnaire (TEX-Q) questionnaire stands out. The aim of this study is to ensure the validity and reliability of the Turkish version of this form, which can be answered by every patient receiving various treatments, as an objective alternative and to be included among other treatment expectancy measurement tools.

This study includes the translation of the form after obtaining the relevant permissions, examining the internal consistency of the Turkish version, explanatory and confirmatory factor analysis, convergent validity and test-retest reliability processes.

The Turkish version of TEX-Q was applied to 200 patients who applied to the clinic for physiotherapy in the examination of internal consistency and exploratory factor analysis of the questionnaire. For convergent validity, 46 independent participants answered the Turkish version of the TEX-Q, the Positivity Scale, and the Hospital Anxiety and Depression Scale. The test-retest reliability within a 2-weeks interval was analysed in 63 of patients seeking physiotherapy program.

Eligibility Criteria:
Inclusion Criteria:

* ages between 18-65
* who would receive physiotherapy for at least 2 weeks for any indication

Exclusion Criteria:

* insufficient level of Turkish
* having any mental problems that would prevent participation in the study
* receiving another applied treatment other than the physiotherapy program
Understanding How Anaesthesia Affects ECT Outcomes

This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus, and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a recording of brain activity during ECT and is used to judge the quality of a seizure and to guide individual patient dosing).

This study aims to examine how the time interval between administration of anaesthetic agent and ECT stimulus delivery impacts upon measures of EEG quality (seizure quality).

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with a course of ECT

Exclusion Criteria:

* Use of non-standard anaesthetic agents in ECT (e.g. ketamine)
Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery

Surgery for colorectal cancer is a major surgery. People above the age of 60 tend to have a higher risk of complications. Some studies indicate that senior cancer patients might benefit from a home support after surgery by a geriatric nurse practitioner and a team, beside their usual post-operative care. The investigators team is planning a large study to assess whether this approach could help patients with colorectal cancer recover better from their surgery, get better cancer treatment after that (e.g. chemotherapy), and possibly live longer. This study you are asked to take part in is a pilot for this large study.

Our key background data come from the randomized study conducted by McCorkle et al.

After evaluation testing, patients will be randomly assigned (similarly to a coin toss) to one of two possible follow-up groups. One would be a regular post-surgery care group (control group), the other will have in addition a support by geriatric nurse practitioner (intervention group).

Patients who are assigned to the intervention group: once they arrive home, in addition to their normal post-surgery care, will receive a once a week home visit by a geriatric nurse practitioner (GNP). The GNP will also call the patient once a week in between. The GNP will check any problem patients may have during their recovery and provide or organize care for it. The GNP has a checklist of problems to address so that we can reliably reproduce our intervention in other patients. The GNP will work together with the patient's various doctors and caregivers, as well as a geriatric team. Some of the visits or the telephone calls maybe tape-recorded so that the research team can evaluate the information provided to the patient. We will record any complication patients might have from surgery.

No matter which treatment group the patient is assigned to, at the end of a 4 weeks period, we will repeat the tests we did at the beginning to see how they change.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer, stage III or IV, confirmed by histology
* Abdominal surgery by a University of South Florida (USF) surgeon at Moffitt Cancer Center or Tampa General Hospital (TGH)
* Age 60 years and older
* Informed consent
* Living within a one (1) hour radius of Moffitt

Exclusion Criteria:

* Discharge planned to a rehabilitation facility or a nursing home
* Unable to answer the questionnaires (e.g. because of cognitive impairment, blindness, deafness)
* Post-operative inpatient stay \>one (1) month