cyrilzakka/clinical-trials huggingface dataset:
The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs

The goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs.

The main questions it aims to answer are:

* What are the cost-savings of redispensing unused oral anticancer drugs?
* What is the environmental impact of redispensing unused oral anticancer drugs?

Researchers will compare redispensing unused oral anticancer drugs to the standard practice of disposal.

Participants will receive their oral anticancer drugs in a sealed bag with a temperature indicator if needed. They will be asked to return any unused oral anticancer drugs to the pharmacy during their next visit to the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* A clinical diagnosis of cancer using an oral anticancer drug that requires storage at room temperature according to the Summary of Product Characteristics (SmPC).

Exclusion Criteria:

* Patients that do not understand the Dutch or English language, in written or spoken.
* Patients receiving prescriptions that contain an amount of tablets that deviates from the regular package size, resulting in the pharmacy dispensing an opened package
Androgens for Poor Responders in In Vitro Fertilization

it has been shown that androgens in non human primates may favour follicular growth in the ovaries when animals are treated with gonadotropins which are the hormones used in patients receiving treatment with in vitro fertilization. Therefore, this study investigates the potential usefulness of testosterone treatment preceding gonadotropin administration in in vitro fertilization patients having a previous poor response to gonadotropins alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving the second IVF treatment attempt having the first treatment cycle cancelled because of poor ovarian response to gonadotropins

Exclusion Criteria:

* Previous ovarian surgery
* Clinical or laboratory profile suggesting premature ovarian failure
Use of a Multimedia Presentation for Informed Consent

This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process. The goals include determining if parents prefer a multimedia consent process and evaluating the effectiveness of multimedia consent process.

BACKGROUND: Informed consent (IC) is an ethical process for ensuring patient autonomy. Multimedia presentations (MMP) often aid the IC process for research studies. Thus, it follows that MMP would improve IC in clinical settings.

OBJECTIVE: To determine if MMP for the IC process for ketamine sedation improves parental satisfaction and comprehension as compared to standard practice.

DESIGN/METHODS: This two phase study compared two methods of IC for ketamine sedation of pediatric patients. Phase one was a randomized, prospective study that compared the standard verbal consent to a MMP. Phase two implemented the MMP into daily work flow. Parents completed a survey evaluating their satisfaction of the IC process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the IC process and knowledge of ketamine sedation.

Eligibility Criteria:
Inclusion Criteria:

* Receiving ketamine sedation for fracture reduction
* Less than 18 years of age
* English as primary language

Exclusion Criteria:

* patients who received medications in addition to ketamine for sedation
* Families where English was not the primary language
Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy

Cerebral palsy (CP) is the most common motor disability in childhood. Among these, hip luxation represents the most frequent and clinically relevant one, affecting 72% of non-ambulatory CP children. Reconstructive surgical treatment is debated in severe CP children, for whom it is crucial to identify an effective preventive approach. The aim of our study is to verify if keeping a sitting position centering femoral heads is more effective than usual postural management (sitting with the trunk aligned and hips abducted), in preventing hip luxation in quadriplegic CP children. It's a multicenter randomized controlled study (13 sites involved). A total of 102 quadriplegic CP children, aged 1-6 years-old, classified as Gross Motor Function Measure System 4 or 5, will be recruited and randomized to usual or experimental sitting, at least 5 hours a day, for 2 years. The primary outcome will be the degree of luxation, measured by means of the Migration Percentage (MP), on pelvic radiography, at 12 and 24 months. Secondary outcomes will include compliance and Health Related-Quality of Life, using validated tools, hip pain, device cost, MRI lesions, concurrent direct neuromotor treatment, use of standing devices and spasticity treatments (botulinum toxin, per os or intrathecal baclofen, selective dorsal rhizotomy). Experimental sitting is expected to reduce the MP change compared to usual care. It will be of interest to compare compliance, QoL and costs in either groups: aspects affecting the effectiveness. Furthermore to evaluate correlations between MP and spasticity treatments, MRI lesion type, and other clinical features.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy spastic or dyskinetic
* GMFCS 4 or 5
* MP\<41%
* Informed Consent acquired

Exclusion Criteria:

* muscle contracture overcoming defined passive Range Of Motion (ROM)limits
* anterior hip luxation
* previous reconstructive hip surgery
* preventive surgery in previous 12 months
* lumbar scoliosis \>20° Cobb
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.

A prospective, multicenter, open-label Phase I safety study of Anginera. Adults with Left Ventricular Dysfunction and reversible myocardial ischemia who are undergoing a CABG procedure, who have at least one graftable vessel and at least one coronary vessel not amenable to bypass or PCI (Percutaneous Coronary Intervention)will be recruited. Three pieces of Anginera will be placed on the area of the surface of the ventricle, including the area supplied by the vessel or vessels that cannot be bypassed, as well as surrounding myocardium. Patients will be followed for 12 months after the surgery at which Anginera is implanted.

The primary objective is to determine safety. The secondary objectives are to determine regional myocardial perfusion and regional left ventricular performance and to investigate the utility of measures of patient perception of improvement.

Eligibility Criteria:
Inclusion Criteria:

* Patients have been referred for CABG
* Left ventricular ejection fraction (LVEF) greater than 20%
* Patients have CAD involving at least two (2) coronary arteries, with at least one or more vessel(s) having disease not amenable to bypass grafting or PCI
* There is a region of myocardium served by the vessel(s) defined above that has objective evidence of multi-distribution reversible ischemia based on a 17-segment assessment of reversible defects on SPECT/Thallium.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

1. Patient undergoing valve replacement or valve modification
2. Patient with significant or malignant ventricular arrhythmias, defined as a patient being treated for ventricular tachycardia and/or ventricular fibrillation with an implantable cardioverter/defibrillator (ICD) or a patient being treated with Amiodarone for these same tachyarrhythmias. (Note: having an implantable cardioverter/defibrillator (ICD) per se, in a patient who does not have significant or malignant ventricular arrhythmias, does not exclude the patient from this study.)
3. Patient requires urgent coronary artery bypass surgery
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer

Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms develops.

Patients undergoing LAR for recto-sigmoid cancer is subjected to peritoneal microdialyses during the postoperative period until discharge. Subcutaneous microdialysis serve as control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

Patients undergoing abdomino-perineal rectal resection will serve as a control group.

A total of 50 patients will be included in this pilot study. The results of the peritoneal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. This will be compared to results from patients with various complications.

The study is approved by the local scientific ethical committee No. ------

Eligibility Criteria:
Inclusion Criteria:

* Histological verified cancer
* The cancer must be located in rectum or the sigmoid colon
* Diverting stoma is allowed
* Perioperative radio-chemotherapy is allowed

Exclusion Criteria:

* Disseminated cancer
* ASA-group 4 ore higher
Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients

Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can prevent the increase in Hepatic Glucose Production (HGP) following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and A1c.

Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content.

Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure.

Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can prevent the increase in HGP following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and A1c. We will examine this hypothesis by comparing the effect of administration of liraglutide alone, canagliflozin alone, and the combination of liraglutide plus canagliflozin on:(i) the rate of HGP; (ii) decrease in fasting plasma glucose concentration; (iii) counter-regulatory hormone response and (iv) A1c. We anticipate that the addition of liraglutide to canagliflozin will prevent the increase in plasma glucagon concentration, augment insulin secretion, and blunt/block the increase in HGP in response to canagliflozin, resulting in a greater decrease in fasting plasma glucose concentration and A1c than observed with each therapy alone.

Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content.

Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 18-70
* Subjects with Type 2 Diabetes Mellitus (T2DM)
* Drug naïve or on stable dose (more than 3 months) of metformin with or without sulfonylurea
* Have an HbA1c levels ≥7.0% and \<10.0%
* Stable weight (± 3 lbs) over the preceding 3 months

Exclusion Criteria:

* Subjects taking drugs known to affect glucose metabolism (other than metformin) will be excluded.
* Individuals with evidence of proliferative diabetic retinopathy or plasma creatinine \>1.4 females or \>1.5 males or estimated Glomerular Filtration Rate (eGFR)\< 60 ml/min.172m2 will be excluded
* Unstable body weight (change of greater than ±3 lbs over the preceding 3 months)
* Participates in excessively heavy exercise program
Comparison of Tai Chi and Frenkel's Exercises in Patients With Stroke

The main objective of this study is to compare the effectiveness of Tai Chi and Frenkel's exercises to improve balance, fall risk and activities of daily living in patients with stroke.

A total of 44 patients will be recruited after inclusion and exclusion criteria. Patients will be recruited through nonprobability convenience sampling technique and will be randomized through Lottery method into either a Group A or a Group B, and for each group, the number of patients will be identical. Group A will receive Tai Chi exercises for 1-hour class, 3 times per week for 12 weeks along with routine physical therapy. Routine treatment includes range of motion (ROM) exercise, stretching \& strengthening exercises, passive movements \& gait training. Group A will receive the Tai Chi exercise with conventional treatment and Group B will receive Frenkel's exercise with conventional treatment. Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks. Patients will be assessed at baseline and after the treatment using a variety of measurement scales. After the completion of this time period, the assessment of balance, activities of daily living and fall risk will be performed again and will be compared to baseline assessment to check the comparison between 2 interventions. The risk fall will be measured by Stratify Risk Assessment Tool, Activities of daily will be measured by The Barthel Index (BI) , while balance will be assessed by using berg balance scale (BBC). Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling survivors of stroke who were aged ≥50 years
* Both genders can participate in the study
* ≥3 months poststroke
* The vital signs were stable
* Survivors of both hemorrhagic and ischemic stroke
* Modified Rankin Scale 14 score of three or less
* Short Physical Performance Battery 15 score of 3 to 9
* Mini-Mental State Exam 16,17 score of 18 or greater.

Exclusion Criteria:

* The subject is unable to perform exercises.
* Subjects with diagnosed vestibular disease.
* The subjects included in the experiment were normal elderly without stroke diseases.
* The subjects had dyskinesias and could not complete Tai Chi exercises.
* Serious medical condition (e.g. active cancer treatment.
* Stroke survivors whom had no disability that would interfere with study participation.
* Subject taking medications that increases the incidence of fall.
* Subjects who undergoes strength and balance training in the past 3 months.
Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis

The purpose of this study is to evaluate the validity and reliability of the Mastitis-score (M-score) and the Breast Inflammatory Symptom Severity Index (BISSI) as measures for assessing symptom severity in non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). This research aims to provide a valid and reliable tool for evaluating both symptom severity and treatment efficacy in NL-GLM/PDM.

Non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM) are inflammatory breast diseases with unclear etiology, usually manifested as palpable breast mass, accompanied by breast pain and abscesses, erythema or fistula formation. There is no well-recognized assessment tool for evaluating the symptom severity and treatment efficacy of NL-GLM/PDM. In our previous studies with NL-GLM, we used the Mastitis-score (M-score) as a physician-directed measure of the symptom severity. However, there were no patient-reported outcome measure for NL-GLM/PDM. The Breast Inflammatory Symptom Severity Index(BISSI) was reported as a valid patient-reported outcome measure for lactational mastitis. Its clinical validity as a measure of Symptom Severity for NL-GLM/PDM are still unclear.

In this multicenter, prospective cohort study, we will validate the validity and reliability of the M-score, a physician-directed measure, and the Breast Inflammatory Symptom Severity Index (BISSI), a patient-reported outcome (PRO) measure, for assessing symptom severity in patients with non-lactational granulomatous lobular/periductal mastitis (NL-GLM/PDM). Establishing the validity of these two approaches will facilitate the objective measurement of treatment efficacy for NL-GLM/PDM in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Female, age between 18 and 65 years;
2. Clinically considered as Non-Lactational mastitis;
3. Clinically and Pathologically confirmed NL-GLM/PDM;
4. Patients planning to receive treatment or observation alone;
5. Signed the informed consent form

Exclusion Criteria:

1. Patients with confirmed or suspected malignant breast tumors
2. Patients with bilateral mastitis (including those with bilateral Non-Lactational Mastitis occurring simultaneously or successively)
3. Pregnant.
Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction

The investigators aims to evaluate the effect of multicomponent supervised tele-rehabilitation, compared to home-based self-rehabilitation, on range of motion (ROM), pain, muscle strength, and function in patients following ACLR. The hypothesis is of superiority for the effects of multicomponent supervised tele-rehabilitation over home-based self-rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 50 years at the time of recruit;
2. BMI between 16 and 28 kg/m²;
3. acute unilateral ACL rupture;
4. plan for an ACLR surgery (with autologous hamstrings tendon reconstruction) under arthroscopy;
5. ACL rupture to ACLR within 3 months;
6. Patients can independently use mobile software and WeChat mini programs, and can operate related software through the "Huajiantong" mini program under the guidance of staff;

Exclusion Criteria:

1. With synthetic tendon reconstruction;
2. Concomitant meniscus lesion which needs operation;
3. Concomitant other ligaments injury which needs operation;
4. Concomitant intra-articular knee fracture;
5. Concomitant fracture or injury which may affect postoperative exercise;
6. Previous history of knee infection, fracture, and surgery;
7. Participate in knee exercises and/or rehabilitation programs in the past three months;
8. Living outside the city, regular return to the hospital for follow-up cannot be guaranteed;
9. Serious cardiopulmonary disease and unable to participate in rehabilitation exercise;
10. Other reasons for exclusion (mental disorders, stroke, pregnancy, etc).
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block

The aim of this study is to determine the minimum effective volume of local anesthetic (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.

The study is based on biased coin design, and the volume of LA for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2ml. Conversely, block success will result in either a reduction in volume by 2ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 65 years
2. ASA 1-3
3. body mass index between 18 and 35kg/m2

Exclusion Criteria:

1. inability to consent to the study
2. pregnancy
3. allergy to local anesthetics
4. preexisting neuropathy or coagulopathy
5. prior surgery in the supraclavicular region
Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months

This is an open label trial, involving a total of 28 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 6\* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, x-ray, MRI tests and arthroscopy will be performed. \*If tissue samples can be collected at screening visit, there will be only 5 visits.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult men and women over 15 and less than 65 years of age 2. Applicable to patients who have a partial cartilage defect in their ankle based on an MRI (defect size: for a single lesion, less than 15 cm2; and for multiple lesions, less than 20 cm2) 3. Patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance 4. Patients which surrounding cartilage are normal 5.Patients with a Grade III or IV cartilage defect size on the ICRS (International Cartilage Repair Society) 6. Patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form

Exclusion Criteria:

* 1. Patients hypersensitive to bovine protein 2. Patients hypersensitive to gentamicin antibiotics 3. Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis 4. Patients with arthritis related to autoimmune disease 5. Pregnant, breast-feeding patients or those who have a possibility of pregnancy 6. Patients with accompanying diseases other than articular cartilage defects, including tumors 7. Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years 8. Patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded) 9. Patients who are administering antibiotics and antimicrobial agents due to infection 10. Patients who receive steroid hormone therapy 11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager