cyrilzakka/clinical-trials huggingface dataset:
Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia

Prospective, randomized, controlled, three-arm, open-label, blinded analysis. Patients admitted with stroke diagnosis and with suspected dysphagia that meet the initial inclusion and exclusion criteria will be consented into the clinical investigation. Patients who meet the second set of inclusion criteria (dysphagia confirmed by VFS) will be randomized to either active (motor or sensory) or standard treatment (control group) arms.

Subjects included in this clinical investigation will be evaluated at screening, 1-week, 3-months and at 12-months post treatment.

The main aim of the study will be to assess the effect of VitalStim therapy on improving the safety of swallow according to the VFS, after the treatment and at 1-year follow up, on patients with chronic post-stroke OD.


Eligibility Criteria:
Inclusion Criteria:

* Subject is over 18 years of age.
* Subject is suspected of having oropharyngeal dysphagia.
* Subject is able to comply with videofluoroscopy protocol.
* Subject diagnosed with stroke.
* Subject has no previous history of dysphagia.
* Subjects who are able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained/ or a consultee has consented on the subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves.
* Subject is not currently participating in any other interventional clinical study.
* Subject is able to comply with the protocol requirements
* Subject scores 0 or 1 on question 1a of NIHSS

Randomization Inclusion Criteria:

• Subject has confirmed dysphagia (PAS of 2 or more on VFS screening or pharyngeal residue).

Exclusion Criteria:

* Subject stroke event occurred less than 3 months ago.
* Subject is pregnant or a nursing mother.
* Subject, in the opinion of the investigator, has advanced dementia
* Subject fitted with a pacemaker or implantable cardiac defibrillator
* Subject is dysphagic from conditions other than stroke
* Subject has been diagnosed with a progressive neurological disorder, such as Parkinson's disease or Multiple Sclerosis.
* Subject with active neoplasm or infection process.
RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors

The scope of the RecoveryFun study is to test a new personalised home rehabilitation solution to leverage the telehealth paradigm and increase the possibility for seniors to perform remotely supervised home-rehabilitation.

This study was designed to test the usability and acceptability of the RecoveryFun system by a group of subjects, aged 60 years or older, within one year after an acute event with upper limb hemiplegia (Fugl- Meyer \> 33). The patient, once the acute and intensive phase of rehabilitation is over, should also continue from home the process begun. However, this often creates difficulties for the patient. The study was carried out at the three recruitment sites (ZURZACH Care, TRAINM and INRCA)

The study was structured in two phases:

* A pilot in protected environment;
* A trial with the system used at the patient's home. The inclusion/exclusion criteria for the two steps were the same and the tools used to evaluate the result were the same too.

The two phases had different specific objectives and to avoid any bias due to previous experience the participants recruited in the two phases were different.

The RecoveryFun system comprehended Three tools: a Virtual reality headset for rehabilitation purposes, a set of Exergames and an app installed on caregiver's smartphone to motivate and support the end user in the therapy. The clinical personnel had access to the Clinical platform provided as a secured web app. The system administrator could differentiate access rights to each clinical user group (e.g: doctors, physiotherapists, nurses). An Innovative biosensing wireless sensor (wristband) was integrated in the connected ecosystem to measure physiological parameters (Heart Rate and Electrodermal Activity) of end users during the rehabilitation session. The patient performed the rehabilitation session according to the rehabilitation plan defined by the clinician. To have coherent results the rehabilitation plan included at least two weekly rehabilitation sessions lasting between 10 and 30 minutes, with the support of the caregiver, if necessary. Each session was planned and scheduled by the therapist remotely via the dedicated clinical platform.

After 4 weeks the assessment of usability and acceptability of the RecoveryFun system were performed by validated tools.

Eligibility Criteria:
Inclusion Criteria:

* No more than 12 months from acute event (for example stroke or brain injury)
* Trunk Impairment Scale (TIS) ≥20
* Fugl-Meyer Assessment Upper Extremities: Motor function for upper extremities (section A-D): a minimum Score of ≥33 is requested.

Exclusion Criteria:

* Technical Requirements based on the safety manual of the "Pico" headset
* Presence of pathology that could impact on the ability of using VR system or can be worsened by the use of VR system
* Montreal Cognitive Assessment (MoCA) score \<24
Velcade for Proliferative Lupus Nephritis

The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.

This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.

Eligibility Criteria:
Inclusion Criteria:

1. ACR criteria for lupus (minimum 4 out of 11).
2. Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.
3. GFR must be greater or equal to 30 cc/min/1.73 m2.
4. Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.
5. Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.

Exclusion Criteria:

1. Serum creatinine of more than 3.0 mg/dL on repeated testing.
2. Greater than 50% fibrosis on renal biopsy.
3. Platelet count of less than 30× 109/L.
4. Absolute neutrophil count of less than 1.0 × 109/L.
5. Greater than or equal to Grade 1 peripheral neuropathy.
6. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.
7. Hypersensitivity to Velcade, boron or mannitol.
8. Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.
9. Known history of untreated positive PPD.
10. Serious complications from systemic lupus such as cerebral lupus and severe active infections.
11. Diagnosed or treated for another malignancy within 3 years of enrollment.
12. Greater than 1.5x upper limit of normal total bilirubin.
A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer

This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.


Eligibility Criteria:
Inclusion Criteria:

1. Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist.
2. Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.
3. Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)
4. Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at screening.
5. Adequate bone marrow, renal, and hepatic function.
6. QTc interval \< 480 milliseconds (msec) on the baseline electrocardiogram.

Exclusion Criteria:

1. Participant has untreated brain or meningeal metastases.
2. Participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1.
3. Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
4. Symptoms of gross hematuria or gross hemoptysis.
5. Exhibits symptomatic or persistent, uncontrolled hypertension (BP \> or = to 140 and/or diastolic pressure of \> or = to 90 mm Hg).
6. History of long QT syndrome.
7. Peripheral neuropathy greater than or equal to grade 2.
Performance of the ID-Cap System, an Ingestion Event Marker, in the Clinical Setting as an Aid to Measure Medication Adherence

The ID-Cap System is classified as an ingestion event marker (IEM), a Class II medical device. The system is intended to record time-stamped ingestions with the ingestible sensor, ID-Tag which transmits a signal to a wearable device, the ID-Cap Reader. In this study, 12-18 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting.


Eligibility Criteria:
Enrollment will be stratified to include at least two study participants in each BMI-Gender category. The BMI-Gender categories will be: Normal/Underweight (BMI\<25), Overweight (BMI 25.0 to \<30), and Obese (BMI\>30.0); and Male/Female.

Inclusion Criteria:

* Men and women 18 years of age or older.
* For females of childbearing potential, negative urine pregnancy test at time of entry and assurance that a medically-accepted means of contraception will be used for the duration of the study.
* Able and willing to provide informed consent.
* Willing to adhere to all protocol requirements and study procedures.
* Adequate organ function at screening.

Exclusion Criteria:

* Unable to take oral medications.
* Women who are pregnant, breast-feeding, or plan to become pregnant during the study, and females of childbearing potential who are not using a medically-accepted means of contraception.
* Medical condition which may affect passage through the gastrointestinal tract (including, but not limited to, small bowel tumors, symptomatic intestinal adhesions, symptomatic active ulcerations, and radiation enteritis).
* Known hypersensitivity to any component of the ingestible ID-Capsule (including, but not limited to, gelatin, polyimide, magnesium, or silver).
* Significant medical condition, psychiatric condition, current alcohol or drug abuse, or other condition which may preclude the study participant from being able to follow study procedures or to safely participate in the opinion of the investigator.
* Participation in an investigational product study (e.g., medical device or drug study) within 30 days prior to screening, or prior participation in an Ingestion Event Marker study.
* Presence of an active implantable electronic medical device.
* Positive screen for drugs of abuse (detection of drug for which a valid prescription exists is not exclusionary).
* Any laboratory test result deemed clinical significant by the Investigator.
Iron Supplementation for Geriatric Hip Fractures

Geriatric hip fracture is an important disease that affects the health life of the elderly in China. Geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. And anemia is a common comorbidity. At present perioperative management of geriatric hip fracture, transfusion is only indicated for moderate and severe anemia, while no special medical intervention for mild anemia in China. More and more studies have found that iron can not only correct anemia, but also improve cardiac function, patients' quality of life and function. This study investigated the effect of perioperative iron supplementation on activity tolerance in elderly patients with hip fracture complicated with iron deficiency anemia. The study was a randomized, parallel controlled clinical study. Due to the requirements of the ethics committee, the unblinded setting was cancelled due to ethical considerations. Research will be grouped according to whether to accept iron supplementation treatment, are divided into 2 groups, respectively, iron treatment group and the traditional method. The method of randomization was stratified block randomization. The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. The outcomes include 6-minute walk distance, Harris score, EQ-5D score six months after surgery, perioperative blood transfusion rate, and so on in the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. \>65 years old patients with hip fracture
2. Patients with iron deficiency or anemia,

   * preoperative hemoglobin \<13g/ dL in males and \<12g/ dL in females, and \>9g/ dL,
   * serum ferritin \< 100 ng/ mL or serum ferritin 100-299 ng/ mL or transferrin saturation (TSAT) \<20%

Exclusion Criteria:

1. Coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days
2. Acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery;
3. Refused to sign the consent form to be included in the clinical trial group;
4. Can't walk before injury;
5. Use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(\> 100 mg/ day)
6. Patients with liver and kidney dysfunction
7. Other conditions that the researchers considered inappropriate for inclusion
Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Colon Surgery

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing colon surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).

All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number).

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.

All statistical analyses will be performed after the 30th patient's discharge and data acquisition


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colon surgery
* Patients provided a written informed consent.
* Patients with preoperative serum hemoglobin concentration \>13 g/dL (male) and \>12 g/dL (female)
* Patients with PaO2/FiO2 ratio \>150

Exclusion Criteria:

* Patients with history of anemia, dyspnea, active infection.
* Patients with endocrine disease
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing and capable to provide written informed consent
* Patients with frequent symptomatic VPB and/or nonsustained VTs with burden ≥ 5% on 24 hour Holter monitor AND
* Absence of structural heart disease (excluded by echocardiogram) AND
* Absence of underlying cardiac ischemia (ruled out by treadmill test, CT coronary arteries, nuclear scintigraphy or coronary angiography) AND
* Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician.
* For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2-week washout period before entry to the study

Exclusion Criteria:

* Age \>75 years
* Previous catheter ablation therapy for VPB/VT
* Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
* Wolff-parkinson-white (WPW) syndrome
* Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol.
* Left ventricular dysfunction (LV ejection fraction \<55%)
* Estimated glomerular filtration rate \< 50 ml/min/1.73 m2
* Hepatic impairment defined by a total bilirubin ≥ 2 times the upper limit (ULN) of normal, or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 3 times ULN at screening
* Untreated hypo- or hyperthyroidism or electrolyte imbalance
* Untreated obstructive sleep apnea
* Patients with history of myocardial infarction or bypass surgery
* More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe)
* Contraindication for any of the antiarrhythmic drugs used in this study
* Enrolment in another clinical study
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age
* Mental or physical inability to participate in the study
* Life expectancy ≤ 12 months
Can Mindful Eating Improve Cholesterol and Glucose Level

This study aims to explore the effectiveness of mindful eating and its effect on cholesterol and glucose level. The participants will be required to get tested for their fasting total cholesterol and blood glucose level for two times. At the first visit, they will be required to complete the survey given and be tested for their fasting total cholesterol and blood glucose level. A recommendation on healthy food intake will be sent to participants. At the end of each week, participants will be required 1) to submit THREE photos of the meals that they are most satisfied with in terms of healthiness and 2) using the photos to answer a questionnaire about their diet. The photos and completed questionnaire must be submitted to the research investigator each week for a total of 8 weeks. After 8 weeks, participants will be required to get tested for their fasting total cholesterol and blood glucose level in the appointed pharmacy for the second time. It is estimated to require 15-30 minutes of their time weekly.

Consistently high cholesterol or/and glucose level pose harmful threat to the body that may cause lethal health conditions (e.g. stroke, cardiovascular diseases). In addition, 3.6 million Malaysians are suffering from diabetes, the highest rate of incidence in Asia and one of the highest in the world. There is crucial need to find ways to improve the situation. Tele-health interventions and mindful eating behaviours are proposed to be effective in improving the levels of cholesterol and glucose. To investigate and explore the intervention, a small-scale randomised controlled trial will be conducted by comparing the effectiveness of mindful eating and the effect on cholesterol and glucose level. Students will collect and analyse both quantitative and qualitative data.

A small-scale randomised controlled trial will be conducted to compare the effectiveness of mindful eating and the effect on lipid level. Subjects will be randomly assigned to intervention or control group. For intervention group, subjects will be required to snap picture of every meal that they consume. At the end of the day, they are required to actively recall and reflect on how healthy they consider their meals to be. The reflection will be submitted to the research team daily together with the taken pictures of meal. As for the control group, subjects will only snap and submit the picture of their meals but without active recall and reflection.

Subjects are required to return to the community pharmacy after two months to follow-up on their glucose and lipid levels post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Total fasting cholesterol of at least 5.2mmol/L

Exclusion Criteria:

* Familial hypercholesterolaemia or Pregnant women.