cyrilzakka/clinical-trials huggingface dataset:
High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy

The purpose of this study is to determine the differences in stone free results, patient side effects, and patient satisfaction between dusting vs. basket extraction for kidney and ureteral stones (a kidney stone located in the tube between the kidney and bladder) 6 mm and greater in size undergoing ureteroscopic treatment.

Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. Basket extraction is when a small wire basket is used to remove stone fragments.

On the day of surgery, the treatment assigned to the patient will be determined by chance, like flipping a coin. Neither the patient nor the study doctor will choose the treatment type. Each patient will have an equal chance of being given either surgical treatment. One group will have stones treated with high-powered laser dusting and the dust produced will pass spontaneously through the urine. The other group will have stones treated with low power laser fragmentation and stones will be removed using a basket. The surgical procedure will not differ from the treatment a patient would receive if he/she were not in this study.

After surgery, participants will complete a pain assessment questionnaire in the outpatient recovery area before being discharged to go home. Participants will also receive a daily email or text message to assess pain and daily activities. Participants will answer these questions daily until pain has resolved and daily activities have returned to baseline levels.

Six weeks after surgery, participants will undergo an ultrasound to assess for swelling of a kidney due to a build-up of urine (called hydronephrosis), which is standard of practice after ureteroscopy. Participants will also return to the urology clinic 12 weeks after surgery for a standard of care follow up visit. At this visit, participants will undergo standard of care procedures known as renal bladder ultrasound and kidney ureter bladder abdominal x-ray to evaluate for stones. Participants will also complete another pain assessment questionnaire at this appointment.

Researchers will review the medical record to evaluate the effectiveness of the surgery at removing kidney stones and preventing kidney stone recurrence as well as to track quality of life outcomes.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* undergoing ureteroscopic stone extraction
* Stone size 6mm stones or greater and the location to mid ureter or higher
* Willing to sign informed consent form
* Able to read, understand, and complete patient questionnaires, and pain questionnaires

Exclusion Criteria:

* \< 18 years of age
* Inability to provide informed consent
* Concomitant surgery (i.e. Percutaneous nephrolithotomy, Holmium laser enucleation of the prostate
* Solitary kidney
* Nephrocalcinosis
* Members of vulnerable patient populations
* Patients without access to a phone that can receive txt messages
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

Eligibility Criteria:
Inclusion criteria

* At least 18 years of age
* End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor
* Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

* Planned antibody induction
* Multiple organ transplants
* Patients at high risk of acute rejection
Kinesiotaping and Stretching on SKM and Upper Trapezius Muscle in TMD Patients

Purpose: This study determined the effects of Kinesiotaping and Stretching on pain, cervical joint range of motion and functional status in patients with myofascial pain due to temporomandibular joint disorder.

Methods: 33 patients with myofascial pain due to temporomandibular joint disorder were included in the study. The patients were divided into three groups by simple randomization (Kinesiotaping group, Stretching group and Control group). Patients in the Kinesiotaping and Stretching groups received application for their Upper Trapezius and Sternocleidomastoid muscles twice a week for two weeks by the same physiotherapist. No application was made to the Control group. Cervical joint range of motion, muscle strength and pain were evaluated. Additionally, algometry tests and functional evaluation were performed. The tests were performed in the Kinesiotaping and Stretching groups before the applications and at the end of week 1 and week 2, on the other hand Control group evaluated before the application and at the end of week 2.

This study is my master's thesis that I conducted in 2018. Our prospective clinical study was approved by the Non-Interventional Ethics Committee. The study was conducted at Dentistry Prosthetic Odontotherapy Outpatient Clinic between February 2018 and April 2018. Volunteering 33 patients between the ages of 18 to 60 years and who applied clinics and were diagnosed with myofascial pain due to TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) classification were included in the study. The patients were divided into groups using simple randomization method. There are 11 patients in groups. Blinding was ensured by patients and dentist were unaware the type of physiotherapy treatment application. Patient evaluation was repeated 3 times: before the treatment, at the end of week 1, and at the end of week 2 of the treatment.

In our study, the effects of conservative treatment options used in 'treatment of TMD on 'disease symptoms were examined compared with the control group. A 2-week follow-up was foreseen for the acute impact outcomes of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* Myofascial pain according to RDC/TMD
* Natural posterior occlusion and volunteering
* Being informed and signing the consent to participate in the research.

Exclusion Criteria:

* Presence of dentofacial anomalies
* Arthralgia
* Disk displacement
* General inflammatory connective tissue diseases (e.g. rheumatoid arthritis)
* Psychiatric disease
* Tumor
* Orofacial disease symptoms (neuralgia, migraine, etc.)
* Local skin infection
* Using regular analgesic
* Fibromyalgia
* History of TMJ-related surgery
* Findings of allergy related to Kinesiotape.
Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients

The investigators propose to use clinically validated patient avatar technology ("PDXovo") that can test multiple drugs against patients' cancers to identify the most promising systemic therapy for each individual.

The primary goal of this feasibility study is to determine the percentage of patients for whom PDXs are successfully generated within 7-10 days. This will give the investigators an indication of the success rate for providing patients with actionable information if this PDX technology were to be implemented in the clinic. Since the PDXs will also receive the same drug as the patient, there is an opportunity to assess the agreement between the clinical response and the PDX response.

As a secondary goal, the response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate at 12 weeks +/- 4 weeks (ORR, measured using RECIST 1.1 criteria).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18+.
2. Metastatic breast cancer irrespective of subtype.
3. Measurable disease as per RECIST 1.1 criteria.
4. Metastatic disease involving the lymph nodes and/or visceral organs is required.
5. Willingness to undergo a biopsy prior to the start of planned systemic therapy.

Exclusion Criteria:

1. Lack of feasibility to obtain a core biopsy of a metastatic site other than the bone (e.g. a metastatic lesion cannot be safely sampled due to proximity to vasculature).
2. Inability to provide informed consent.
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.

Eligibility Criteria:
Inclusion Criteria:

* Adult subject and pediatric subjects (aged greater than or equal to two (2) years).
* Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure.
* Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI.
* Has been fully informed about the study, and has consented to participate.

Exclusion Criteria:

* Having acute or chronic grade IV or V renal insufficiency.
* Known class III/IV congestive heart failure.
* Suffering from long QT syndrome.
* Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
* Having any contraindications to MRI such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field.
* Known allergy to Gadolinium chelates.
* Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration.
* Pregnant, breast feeding, or planning to become pregnant during the trial.
* Previously participated in this trial.
* Having participated within 30 days in another clinical trial involving an investigational drug.
* Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
* Inability or unwillingness to cooperate with the requirements of this trial.
Antibacterial Effect of Probiotic Yogurt Compared to Xylitol

This study will be conducted to evaluate the antibacterial effect of probiotic bacteria in yogurt in decreasing streptococcus mutans count in saliva and plaque, decreasing bacterial adherence and increasing salivary pH compared to xylitol-containing chewing gum after three months.

The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months. The probiotic yogurt is (Activia; Danone, Egypt) containing Bifidobacterium (7x107 CFU/g). The subjects assigned to probiotic yogurt group will be instructed to eat 100 g of the provided yogurt 10 minutes after dinner and not to brush their teeth until one hour later. The subjects assigned to the xylitol-chewing gum group will be instructed to chew the provided gum three times daily for five minutes after each meal.

Eligibility Criteria:
Inclusion Criteria:

* Above 50 years old.
* Have sufficient cognitive ability to understand consent procedures.
* Males or Females.
* Co-operative patients.
* High caries risk patients (≥105 CFU for streptococcus mutans count)

Exclusion Criteria:

* Under antibiotic treatment
* Milk intolerant
* Consuming any other probiotic product
* Habitual consumers of xylitol products
* Use antibacterial mouthwash
* Lack of compliance
* Any systemic condition affecting salivary secretion
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.


Eligibility Criteria:
Inclusion Criteria

* The subject must be 20 and older years of age.
* The subject must have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non-squamous to be eligible.
* The subject must have advanced or metastatic (Stage IV \[According to American Joint Committee on Cancer (AJCC) staging manual, 7th edition\]) disease that is not amenable to surgical resection or radiation with curative intent.
* The subject must have not received prior chemotherapy for NSCLC.
* The subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
* The subject has an Easter Cooperative Oncology Group (ECOG) Performance Score of 0-1.
* The subject must have adequate bone marrow, renal and hepatic function.

Exclusion Criteria

* The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
* The subject has received any anti-cancer therapy for treatment of NSCLC including investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies, hormonal, "targeted" agents (i.e., erlotinib, imatinib), biologic therapy or cytotoxic chemotherapy (i.e., alkylating agents, microtubule inhibitors, antimetabolites).
* The subject has a history of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.
* The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
* The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
* The subject is pregnant or breast feeding.
* The subject has NSCLC with a predominant squamous cell histology.
Physiotherapy to Improve Feeding Skills in Preterm Infants

INTRODUCTION: Suction problems are very common in premature children due to a lack of maturation and orofacial control, the manifestation of a low muscle tone and the incoordination during sucking-swallow-breathe. In addition, there are some problems in different systems that get it worse.

AIM: compare oral stimulation programme with a neurodevelopmental stimulation intervention programme combined with an oral stimulation programme, evaluating its effectiveness on feeding development, neuromotor development and other aspects of development.

METHODOLOGY: we proposed a prospective parallel group clinical trial with two randomized and independent experimental groups. All preterm infants born between 2022-2023 at University Hospital Torrecárdenas, with nasogastric tube and gestational age between 27-32 weeks will be included.

EXPECTED BENEFITS: to have better results when the preterm infant is approached globally, also considering the postural situation of the preterm infant. In addition, it is expected that the development of children treated by combining oral stimulation with neurodevelopmental stimulation will be equated or close to healthy and born-to-term child.

RESULTS APPLICABILITY: Improved eating performances will reduce length of hospital stay as well as a greater autonomy improving family situation. It will also allow the reduction of hospital costs and the creation of a new way to attend this problem in preterm children.


Eligibility Criteria:
Inclusion Criteria:

Premature infants with a gestational age between 27 and 32 weeks, with an adequate weight for their gestational age, admitted to the unit of Neonatology, hemodynamically stable and with enteral nutrition

Exclusion Criteria:

* Neurological disorders
* Invasive mechanical ventilation
* Congenital disorders
* Necrotising enterocolitis
* Metabolic diseases
* Intraventricular hemorrhage grade 3-4
* Genetic disorders
* Oral disorders that make this process difficult(cleft palate, cleft lip...)
* Serious illnesses according to medical criteria
CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study

In this observational, prospective study, patients affected by B-cell Lymphoma and candidate to chimeric antigen receptor-T (CAR-T) cell infusion will be evaluated at three timepoints to establish the rate of cardiac dysfunction, defined according to 2022 European Society of Cardiology Cardio-Oncology guidelines. Echocardiography, physical examination and cardiac/inflammatory biomarkers will be performed prior to CAR-T cell infusion and followed at 7 days and 1 month.

Patients will perform clinical evaluation, transthoracic echocardiogram with speckle tracking analysis and blood samples (including cardiac biomarkers of damage and fibrosis) prior to CART infusion, after 7 days and 1 month following CART infusion. Rate of Cytokine Release Syndrome and use of interleukin-6 inhibitors will be also registered.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old;
* Patients affected by relapsed and/or refractory diffuse large B-cell lymphoma, follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma or B-cell lymphoblastic leukemia, candidate treatment with chimeric antigen receptor-T cell therapy at the Hematology division of Policlinico Universitario Agostino Gemelli, Rome;
* Patients with left ventricular ejection fraction \>50%.

Exclusion Criteria:

* Age\<18 years old;
* Patients who denied to participate to the study;
* Patients with left ventricular ejection fraction\<50%.
Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects

To determine the relief of GI discomfort after overfeeding with a high caloric meal.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Age ≥ 25 and ≤ 70 years
* BMI: 19-30 kg/m2
* Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
* Male or female
* Written consent to participate in the study
* Subject is able and willing to follow the study protocol procedures
* If applicable, stable intake of chronic medication of at least 3 months

Exclusion Criteria:

Criteria for inclusion:

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Age ≥ 25 and ≤ 70 years
* BMI: 19-30 kg/m2
* Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
* Male or female
* Written consent to participate in the study
* Subject is able and willing to follow the study protocol procedures
* If applicable, stable intake of chronic medication of at least 3 months

Criteria for exclusion:

* Relevant history, presence of any medical disorder (e.g. cancer, severe liver disease, severe renal disease, severe cardiovascular disease)
* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or use of PPI (proton pump inhibitors) or other digestive auxiliaries potentially interfering with this study at screening
* Intake of antibiotics in the last 4 weeks
* Women suffering from distinct PMS symptoms
* Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
* Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
* Vegetarian or vegan nutrition style
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
* Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
* Subject who according to the study staff's opinion is not suitable for participation in the study
The Effect of a Smartphone-assisted Hybrid Cardiac Rehabilitation Program in Patients With Heart Failure.

The aim of this randomized controlled trial is to compare the impact of a case manager-led smartphone-assisted hybrid cardiac rehabilitation program with usual care in patients with HF. Participants will undergo a 12-week program led by a case manager and assisted by a smartphone. The study aims to answer two main questions:

1. Is the novel cardiac rehabilitation model feasible for patients with HF?
2. Does the intervention group show a significant improvement in exercise capacity and adherence compared to the usual care group?


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure between the ages of 18 and 80 years old.
* NYHA (New York Heart Association) functional classification of 1 to 3.
* Patients must be in a stable condition and under outpatient follow-up.

Exclusion Criteria:

* Patients who have contraindications for exercise according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
* Patients who are unable to complete cardiopulmonary exercise testing.
* Patients who are unable to follow verbal instructions.
* Patients who are unable to walk independently or pedal a stationary bicycle.
* Patients who are unable to use communication app on a smartphone.
* Patients who already engage in physical activity exceeding the recommended moderate intensity of 150 minutes per week or are currently participating in cardiac rehabilitation.
* Patients who do not provide consent to participate in the trial.