cyrilzakka/clinical-trials huggingface dataset:
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).


Eligibility Criteria:
Inclusion Criteria:

* Participants chronically infected with HCV Genotype 4
* HCV RNA viral load of ≥ 10,000 IU/mL
* No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
* Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted

Exclusion Criteria:

* Evidence of decompensated liver disease
* Documented or suspected Hepatocellular carcinoma (HCC)
* Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients

Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib

This is a single-arm, multi-cohort, multi-center, open-label, phase IIIb clinical study. The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations. The study involves a Screening Period, a Treatment Period and a Follow-up Period. There are 53 study sites initiated and enrolled 203 advanced or metastatic NSCLC patients with MET exon 14 mutations

Eligibility Criteria:
Inclusion Criteria:

1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
2. Age ≥18 years;
3. Histologically diagnosed locally advanced or metastatic NSCLC with MET exon 14 mutation;
4. Cohort 1: disease progression or intolerable toxicity after previous therapy with platinum-based chemotherapeutic regimen (for the patients who have received platinum-based adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy previously or radical radiochemotherapy for progressive disease, if the disease progression occurred \< 6 months after the end of the last therapy, the patient belongs to failure after the first-line therapy); Cohort 2: no any previous systematic antitumor therapy for advanced diseases; Cohort 3: no any previous systematic antitumor therapy for advanced diseases;
5. Having measurable lesions (in accordance with RECIST 1.1 criteria);
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, or Karnofsky performance status ≥80;
7. Survival is expected to exceed 12 weeks;
8. Adequate functionality in bone marrow, liver, kidney
9. Able to take or swallow the drug orally.
10. Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 30 days after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug;

Exclusion Criteria:

1. Having gene mutations sensitive to targeted drugs for EGFR, ALK and ROS1;
2. Previous anti-MET therapy (including but not limited to crizotinib, Onartuzumab, etc.)
3. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled;
4. Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment;
Clinical Assessment of Injectable Flowable Composite with Giomer Technology Vs High Viscosity Glass Ionomer Restorations in ART for Cancer Patients

Aim of the Study:

This study will compare between injectable flowable composite (Beautifil flow plus x) and high viscosity glass ionomer (Equia Fil) by ART caries preventive protocol in high caries risk patients receiving chemotherapy and/or radiotherapy

Statement of the problem:

Chemotherapy and radiation therapy may cause changes in the lining of the mouth and the salivary glands. This can upset the healthy balance of bacteria. These changes may lead to mouth sores, infections, and tooth decay.

Rationale:

Patients under chemotherapy treatment and radiotherapy are systemically compromised and undergo hospital manipulations and residency, increasing their caries risk, fear, and anxiety. That's why they need specific caries preventive protocols designed for high-risk patients. Atraumatic restorative treatment (ART) is recommended for these patients to decrease pain and anxiety.

Atraumatic restorative treatment (ART) and interim therapeutic restoration (ITR) have had increased interest in the past few years. ART and ITR are comparative approaches and are performed utilizing the same material, but they contrast within the reason of their utilize. ART is very effective as a restorative technique since it is more conservative than conventional treatment. Also in this technique, we avoid using rotary equipment and dental anaesthesia, which increase anxiety during the dental procedure. ITR, on the other hand, is used as a temporary restoration that will be replaced with a more definitive one.

Injectable flowable Giomer composites are a material used for direct filling techniques has been developed over the past years. It has the property of Giomer technology that is able to release and recharge fluoride and other beneficial ions for the life of the restoration and induce remineralization of the underlying hard dental tissues. Injectable flowable Giomer composite (Beautiful flow plus x) has a long-term clinical performance like conventional composite., it also aids in decreasing acid production and formation of an antiacid resistant layer, helps in the reduction of tooth mineral solubility also has a high survival rate and wear resistance in high stress-bearing areas in posterior teeth.

Beautiful Flow Plus X also helps to remineralise the tooth structure for sustainable caries prevention and easily polishes for long-lasting lustre

Eligibility Criteria:
Inclusion Criteria:

* existing caries in permanent posterior teeth
* Permanent posterior teeth with active carious lesion class I and class II without any signs and symptoms of pulp disease.
* Teeth in normal occlusion
* Absence of any active periodontal disease.

Exclusion Criteria:

* Patients whose systemic involvement was too advanced to allow dental manipulation, such as those who were admitted to the intensive care unit
* Patients with parafunctional habits
* Presence of any sign or symptoms of irreversible Pulpitis or necrotic pulp
* Partially erupted teeth
Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women

This is a phase II study evaluating the efficacy and safety of the pre-operative use of letrozole plus PD 0332991 (combination therapy)


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Primary tumor greater than 2 cm in diameter
* Histologically proven invasive breast cancer
* Positive estrogen receptor
* Negative HER-2 receptor
* ECOG performance status ≤ 1 or Karnofsky performance status ≥ 70%
* Laboratory values must be follows:

Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); Serum Creatinine ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2 × ULN; AST and ALT ≤ 2 × ULN; Normal finding of ECG - QTc ≤ 470 msec (based on the mean value of the triplicate ECGs); Left ventricular ejection fraction (LVEF) ≥ 60%.

* Able to give written informed consent form
* Able to follow prescription instructions reasonably well

Exclusion Criteria:

* Male
* Severe psychiatric disorder
* Prior history of other malignancy within 5 years of study entry, aside from basal cell carcinoma or the skin or carcinoma-in-situ of the uterine cervix
* Locally advanced breast cancer (T3N1 or Any T4 or Any N2, N3), or distant metastasis
* Multifocal or multicentric breast cancer except that the largest lesion is greater than 2cm
* Major surgery within 3 weeks of first study treatment
* Current use or anticipated need for:

Food or drugs that are known strong CYP3A4 inhibitors; drugs that are known strong CYP3A4 inducers

* Severe cardiovascular diseases in the previous 6 months
* Active inflammatory bowel disease or chronic diarrhea
* Renal Impairment
* Poor adrenal function
* Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function)
* Known human immunodeficiency virus infection
* Known hypersensitivity to anti-aromatase drugs or any cell cycle inhibitor
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Vaccine Attitudes and Practices of Hospital Specialists

This study aims to evaluate the perceptions and knowledge of hospital specialists regarding vaccine recommendations targeting their patients, to study their behavior with respect to these recommendations and to quantify their vaccine hesitancy.


Eligibility Criteria:
Inclusion Criteria:

* To be a physician in one of the participating institutions
* Or to be a contract physician in participating institutions

Exclusion Criteria:

* Interns
* Attached practitioners
* Emergency physicians
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM. This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents.

The study includes dose escalation and dose expansion phases. This study will enroll subjects with RRMM who received at least 3 prior lines of treatment including at least one proteasome inhibitor (PI), one immunomodulator (IMiD), and an anti-CD38 antibody.

Eligibility Criteria:
Principal Inclusion Criteria:

* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
* Eastern Cooperative Oncology group (ECOG) performance status of ≤ 2.
* Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria.
* Participants must have one or more of the following measurable disease criteria:

  1. Serum M-protein level ≥ 0.5 g/dL.
  2. Urine M-protein level ≥ 200 mg/24h.
  3. Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP.
* Participants must have received at least 3 prior lines of treatment which include a proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and an anti-CD38 antibody (e.g., daratumumab).

Principal Exclusion Criteria:

* Participants exhibiting clinical signs of central nervous system involvement of MM.
* Participants with known COPD, or previous history of ILD.
* Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification.
* Participants who have severe cardiovascular disease which is not adequately controlled.
* Participants who have a history of immunodeficiency disease.
* Participants with peripheral neuropathy ≥ Grade 2.
* Primary refractory MM.
* Participants who have previously received anti-GPRC5D or MMAE-containing treatment.
* Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention.
Electrical Stimulation vs. Static Stretching in the Leg Muscles

The retraction of the posterior leg muscles consists of a shortening of the muscle fibers that limits ankle dorsiflexion. The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology is to evaluate the short-term effect of electrostimulation associated with muscle stretching (electrical muscle elongation technique or EME) compared to static stretching in adult subjects with shortening of the posterior leg muscles.

The main questions it seeks to answer are:

* Are there significant differences in the short-term effect of electrical muscle elongation versus static stretching exercises on the gastrocnemius complex and Achilles tendon in young adults?
* Does the ankle\&#39;s range of motion increase in both weight-bearing and non-weight-bearing positions?
* Does muscle strength increase in ankle plantar flexion?

The researchers will compare the group receiving electrical muscle elongation with interferential current to the group receiving passive static stretching to assess whether there are significant differences in the effects on the ankle\&#39;s range of motion and the muscle strength of the posterior leg muscles.

Participants in this study will perform the following tasks:

* Receive a session of electrical muscle elongation with TENS and static stretching performed by the researcher.
* Follow the instructions during the intervention.
* Undergo evaluations of ankle range of motion and plantar flexor muscle strength
* Record their level of satisfaction after the study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects affiliated with or related to the University of Seville.
* Those with muscular shortening of the posterior chain of the limb.

Exclusion Criteria:

* Subjects who engage in sports activity above the average of the sample or who follow an organized stretching program for the posterior leg muscles.
* Hyperlaxity
* History of musculoskeletal, neuromuscular injuries, joint disease, surgery on the lower leg, or serious illness.
NAVA vs PSV Ventilation During Weaning From Mechanical Ventilation in Children After Liver Transplantation

Liver transplantation is the treatment of choice for acute and chronic end-stage liver disease. Neurally Adjusted Ventilator Assist (NAVA) may be a feasible solution to guide the liberation from mechanical ventilation reducing asynchronies between patient and ventilator, and optimizing ventilator cycling. Cardiovascular and respiratory effects during NAVA ventilation are very limited after major abdominal surgery. The purpose of this application is to explore the efficacy of NAVA to reduce the asynchronies between the ventilator and pediatric patient admitted in Pediatric Intensive Care Unit (PICU) after major abdominal surgery, and the relationship between an optimal level of NAVA and cardiac and pulmonary function.

Twelve pediatric patients underwent liver transplantation and admitted during postoperative period in PICU will be studied. They will be endotracheally intubated and spontaneously triggering the mechanical ventilator. In each patient enrolled a specially manufactured nasogastric tube will be inserted. This nasogastric tube is equipped with ten electrodes. The correct position of the nasogastric tube (and of electrodes) will be confirmed checking the good quality of Edi trace with the P waves displayed by the central electrodes on monitor of Servo I Ventilator (Maquet). All the patients will be ventilated using ventilators with NAVA option (Servo-I, Maquet Critical Care, Sweden). After a stabilization period in Pressure Support Ventilation (PSV) according with the attending physician, each patient will be studied for a duration of 2 hours, divided in three trials of 40-minutes (first 30 minutes to washout from the effects of previous ventilation mode and during the last 10 minutes the results will be recorded). Each patient will be randomized for ventilation mode sequence (PSV/NAVA/PSV or NAVA/PSV/NAVA). The patient tracings of flow, airway pressure, electrical activity of diaphragm for the patient-ventilator interaction analysis, blood gas analysis and cardiovascular parameters will be recorded during each trial.

Eligibility Criteria:
Inclusion Criteria:

* Liver recipients (from cadaveric or living donor)
* Invasive Mechanical ventilation

Exclusion Criteria:

* Neurological impairment
* Neuromuscular, mitochondrial, metabolic, or chromosomal diseases with baby hypotonia
* Lesions of medulla
* Hemodynamic instability requiring inotropes/vasopressors (dopamine \> 6 mcg/kg/min, norepinephrine, epinephrine, dobutamine, milrinone) or volume load.
* Congenital cardiovascular disease
* Patient extubated
* Need of controlled mechanical ventilation
* Intravenous infusion of benzodiazepines or propofol
* Pneumonia, pneumothorax, massive pleural effusion
* Patient placed on extracorporeal circuit
* Contraindications to insert nasogastric tube
* Not expected to survive beyond 24 hours
* Parental/legal guardian refusal
Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors

Fat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors.

Chemical shift encoding-based water-fat magnetic resonance imaging (MRI) is a non-invasive method that provides quantitative information about the biochemical water-fat composition of bone marrow and skeletal muscle in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Pathological biopsy of a patient with diagnosed spinal tumor lesion, and preoperative examination Chemical shift encoding-based water-fat MRI was performed.

Exclusion Criteria:

* Recurrent neoplasms; Lesion diameter \< 1 cm; Poor image quality.
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

PRIMARY OBJECTIVE:

I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.

SECONDARY OBJECTIVE:

I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ANTIBIOTIC): Patients receive ertapenem Intravenously (IV), levofloxacin, or clindamycin IV at induction per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

GROUP II (CONTROL): Patients receive ertapenem IV, levofloxacin IV or clindamycin IV at induction per standard of care.

After surgery, patients are followed up to 120 days.

Eligibility Criteria:
Inclusion Criteria:

* Any patient that electively chooses to have a cystectomy is eligible to participate in the study. Indications for a person who may undergo a cystectomy include having a diagnosis of muscle-invasive bladder cancer (MIBC) or refractory non-muscle invasive bladder cancer (NMIBC)
* Any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Patients with a history of myasthenia gravis
* Patients with a history of QT prolongation or taking other drugs that prolong corrected QTc (QTc) should be excluded
* Patients with renal dysfunction, creatinine clearance (mL/min) \< 30
* Pregnant or nursing female participants
* Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)
* Unwilling or unable to follow protocol requirements
* Patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea

The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.

Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.

Eligibility Criteria:
Inclusion Criteria:

1. children with acute non-bloody diarrhea (≤ 2 weeks)
2. mild to moderate dehydration

Exclusion Criteria:

1. mucous bloody stools
2. major systemic illness
3. severe malnutrition (Weight for age \<60% and Weight for height \<70 %)
4. history of antibiotics receiving
Effect of Ursolic Acid of Loquat Extract on Function of Muscle

This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks.

This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks. Change over time in muscle fuction was evaluated by four outcomes: assessment of appendicular skeletal mass using DEXA (dual energy X-ray absorptiometry); quadriceps muscle power by Biodex; hand grib power; and Short Physical Performance Battery, SPPB.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-30KG/M2

Exclusion Criteria:

* \> SERUM creatinine 1.2mg/dL
* \> AST or ALT 60IU/L
* DM Patients