cyrilzakka/clinical-trials huggingface dataset:
Investigating Patient Characteristics of Intermediate Stage Hepatocellular Carcinoma Patients Treated With Nexavar and Their Distribution to Different Treatment Groups as Well as Determining Effectiveness and Safety

The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma (BCLC-B) for whom the decision has been taken by the investigator to prescribe Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients with large/multifocal HCC who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread).

Exclusion Criteria:

- Prior targeted therapy for hepatocellular carcinoma.
Dose Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction Cause Less Cost?

The investigators tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.

The relationship between the quality of care and costs has been discussed widely. Higher costs of care did not bring better outcomes, vice versa. However, as the rising spending of health care, the health care providers, insurance payers, governments, and consumers begin to pursue the higher quality of cares with lowest costs. In surgical experiences, improving the process of care succeeded to improve the quality of care and reduce the costs.

In patients with acute ST-Segment elevation myocardial infarction (STEMI), A Door-to-Balloon (D2B) time of less than 90 minutes has been established as the gold standard for primary percutaneous coronary intervention (PCI) and was associated with lower in-hospital mortality.9 Only less literatures discussed the costs and the quality of care in acute STEMI, and whether improving processes of care associated with lower costs was still controversial. The Premier Hospital Quality Incentive Demonstration (PHQID) in United State improved the processes of care but had not a significant effect on cost. Another single hospital experience in Indiana, USA, showed that the reducing D2B time in STEMI decreased the insurance payments as well as the total hospital costs. However, this study design was before-and-after intervention analysis, did not actually measure the impact of D2B time. Besides, the payment system in this study was prospective payment, not fee-for-service payment in Taiwan.

In this study, we tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.

Eligibility Criteria:
Inclusion Criteria:

* self visit
* acute STEMI by ECG definition

Exclusion Criteria:

* non-diagnosis on first ECG
* transferred
* diagnostic angiogram only
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer

Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50% in HER2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients. With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pCR rate exceeding 50% for our novel regimen.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented adenocarcinoma of the breast
* ANC \> 1000 cells
* Female; age \> 18; Zubrod PS 0-1
* Platelets \> 100,000
* Stage IIA-IIIB disease
* Total bilirubin \< or = ULN
* No evidence of metastatic disease Not pregnant or lactating
* No prior systemic therapy for this breast cancer
* Serum Creatinine \< 1.5 mg/dl or Creat Cl \> 30 ml/min
* Serum ALT \< 2.5 x ULN
* ER, PR and HER2 status required
* LVEF (MUGA/echo)WNL
* No baseline \> 2 neuropathy
* Hemoglobin \> 9.0 gm/dl
* HER2+, defined by IHC 3+ or FISH ratio \> 2.0
Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients

A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.

Pancreatic cancer has a poor prognosis for its high malignancy. Radical surgical resection is an effective means for prolonging survival. However, only a few patients can be directly treated with surgical resection. Neoadjuvant therapy can reduce the tumor size, improve the relationship between the tumor and adjacent blood vessels，to gain surgical opportunities and prolonging patients' survival.

Nutritional treatment of cancer has been valued by more and more researchers. As an important branch of nutrition therapy, immunonutrition plays an important role in regulating the immune. Studies have shown that immunonutrition can reduce antitumor treatment related toxicity among patients with head and neck cancer, esophageal cancer. At present, most studies on immunonutrition therapy focus on perioperative patients, and there is no study on patients with pancreatic cancer undergoing radiotherapy.

This prospective, single-arm clinical trial aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. A total of 98 pancreatic cancer patients will be enrolled. All of the patients will receive oral immunonutrition therapy for 6 weeks from one week before radiotherapy. The total follow time is 4 months.

Eligibility Criteria:
Inclusion Criteria:

* 1. Pathologically confirmed pancreatic ductal epithelial malignant tumors;
* 2. Resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy;
* 3.Nutritional Risk Screening 2002 (NRS2002) ≥3 and Patient-Generated Subjective Global Assessment (PG-SGA) performance status B;
* 4. Age 18 years and older;
* 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* 6. Expected survival time more than 3 months;
* 7. History of antineoplastic therapy;

Exclusion Criteria:

* 1. Known allergy or intolerance to any component of investigational Oral Immunonutrition;
* 2. History of Oral Immunonutrition use within one month prior to enrollment;
* 3. Tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis;
* 4. Patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases;
* 5. Liver, kidney and blood coagulation function failure;
* 6. Patients with hemopathy;
* 7. Patients with active infections;
* 8. Patients with other primary tumor;
* 9. Patients with other medical diseases that seriously affected nutritional status;
* 10.Subjects deemed by the investigator have other factors that may be ineligible for enrollment;
Lidocaine-prilocaine Cream Versus Rectal Meloxicam on Relief of Post-episiotomy Pain

Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Early pain management is thus relevant to provide relief and prevent chronicity.

Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum


Eligibility Criteria:
Inclusion Criteria:

1. Primiparas
2. Normal vaginal delivery
3. Mediolateral episiotomy
4. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

1. Patients who had postpartum hemorrhage
2. Patients who had manual removal of the placenta
3. Patients with contraindications to non steroidal drugs
4. Patients with a multiple perineal lacerations
A New Technique for Determining Limb Occlusion Pressure

This study evaluates a novel technique for measuring the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). Patients will have tourniquets applied to their arms and legs and LOP will be measured using the new technique and a gold standard Doppler ultrasound technique.

Optimal tourniquet safety depends on accurately determining the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). However, LOP is not yet routinely measured in all patients due to limitations of current techniques. This study evaluates a novel technique for measuring the LOP through the tourniquet cuff that overcomes many limitations of current LOP measurement techniques.

The goal of the study is to determine if the LOP measured by the new technique is statistically or clinically different from the LOP measured by a gold standard Doppler ultrasound technique in adult and pediatric patients

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a visit to one of four surgical clinics in Vancouver, Canada
* Agreed to participate in the study and provide informed consent

Exclusion Criteria:

* Unable to give informed consent on their own behalf or by a legal guardian
* Lack of parental agreement in the case of consent from a legally competent minor
* Standard contraindications to tourniquet use
* Vascular disease or circulation problems in the extremities
* History or indication of deep vein thrombosis
Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects

The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if there are differences in these parameters when HQK-1001 is administered in a fed versus a fasted state.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Between the ages of 18 and 45 years old
* Able and willing to give informed consent
* Able to comply with all study procedures
* If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and throughout the study: hormonal (i.e., oral, transdermal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (6 months minimum); or abstinence
* Male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate, throughout the course of the study
* Not receiving medications within the 2 weeks before the first dose of study medication, except for multivitamins and contraception
* Complete blood count (CBC) with white blood cell (WBC) count hemoglobin, hematocrit, reticulocyte count and platelet count within normal range for the testing facility or not clinically significant
* Serum ferritin level \> 50 ng/ml in Cohort 1
* Serum ferritin level \> 30 mg/ml in Cohorts 2, 3, 4 and 5
* Serum chemistry values, coagulation tests and urinalysis values within the normal range for the testing facility or not clinically significant
* Negative urine test for substances of abuse including marijuana, cocaine, opiates, and methadone

Exclusion Criteria:

* Prior participation in HQP 2007-001
* Clinically significant abnormal vital signs
* Blood donation within 2 months of study medication administration
* Blood transfusion within 3 months of study medication administration
* An acute febrile illness or upper respiratory tract illness within 72 hours prior to administration of study medication
* Received another investigational agent within 4 weeks before administration of study medication
* Receiving any other investigational agent during this study
* Any acute or chronic disease (e.g., history of hepatitis B or C or HIV-1)
* Heart disease including an abnormal electrocardiogram, clinical significant, (ECG) or cardiac arrhythmia
* History of neurological disease, such as a seizure disorder
* Currently pregnant or breast feeding a child
* A smoker in the past 12 months
* Body Mass Index (BMI) \>33 kg/m2
An Open-Label Food Effect Study of Telotristat Etiprate

This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects aged ≥18 to ≤55 years of age at screening
* Body mass index ≥18.0 to ≤32.0 kg/m\^2
* Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
* Able and willing to ingest an entire high fat/high caloric breakfast meal within 30 minutes
* Willingness to adhere to the restrictions outlined in the protocol
* Able to comprehend and sign the Informed Consent Form

Exclusion Criteria:

* Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
* Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of study start
* Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening
* Receipt of any protein- or antibody-based therapeutic agent within 3 months prior to Screening
* Prior exposure to telotristat etiprate
* Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening
* History of major surgery within 6 months prior to Screening
* History of any GI surgery that may induce malabsorption
* History of renal disease, or significantly abnormal glomerular filtration rate (\<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening
* History of hepatic disease, or significantly abnormal liver function tests at Screening
* History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality
* History of any active infection within 14 days prior to Screening
* History of alcohol or substance abuse within 2 years prior to Screening
* Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
* Concurrent conditions that could interfere with safety and/or tolerability measurements
* Donation or loss of \>500 mL of blood or blood product within 3 months prior to Screening
* Women who are breastfeeding or are planning to become pregnant during the study
* Positive serum pregnancy test (females only)
* Positive urine screen for selected drugs of abuse and cotinine
* Consumption of alcohol within 48 hours prior to study start
* Consumption of caffeine- and/or xanthine-containing products within 72 hours of study start
* Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start
* Unable or unwilling to communicate or cooperate with the Investigator for any reason
Blunt Thoracic Trauma: Definition of a Standard Operating Procedure

Rib fractures are the most frequent injury after blunt thoracic trauma. It is very important to choose the most appropriate interventions to prevent complications. But who will benefit most of those interventions remains a challenge.

This study analyses the correlation between chest X-Ray and CT scan. We also analyse different scores to predict respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Polytrauma patients admitted to de ICU with a thoracic CT scan in the first 24h of arrival

Exclusion Criteria:

* Penetrating trauma
* Patients referred from other hospitals
Cross-cultural Adaptation and Validity of Mini Bestest in Balance Disorders in the Autonomous City of Buenos Aires: Validation Study Protocol

The objective of this study is to carry out the cross-cultural adaptation of the Mini BESTest (a balance assessment scale) into Argentine Spanish, as well as to study its validation in patients with peripheral vestibular disorders in the autonomous city of Buenos Aires.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>18 years of age,
* With vestibular alterations of peripheral etiology, within the second year of evolution
* Time of evolution of symptoms ≤ 2 years
* Independent walking with or without walking assistance device
* Who are at the beginning of a VR program
* No diagnoses of psychiatric disorders or cognitive impairment,
* Sign the informed consent

Exclusion Criteria:

* Who have suffered amputation in one of their lower limbs,
* History of neurological pathologies (stroke, multiple sclerosis, neuromuscular disease)
Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy

The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Women aged more than 18 years
* Histologically proven breast carcinoma
* Neo-adjuvant chemotherapy with anthracyclines and/or taxanes
* No prior chemotherapy
* Written informed consent

Exclusion Criteria:

* Metastatic disease
A Phase I Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients

The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.


Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of Advanced solid tumors( Non-small Cell Lung Cancer.Soft Tissue SarcomaMedullary. Thyroid Carcinoma)
* At least one measurable lesion (by RECIST1.1)
* Lack of the standard treatment or treatment failure
* 20≤BMI≤25
* 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Clear allergies to the study drug or its ingredients
* Had the disease to affect drug absorption and metabolism
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
* Brain metastases patients with symptoms or symptoms controlled \< 1 months
* Used any drugs inhibit or induce hepatic drug metabolic enzymes in 30 days before the study
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* Patients participated in other anticancer drug clinical trials within 4 weeks
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Reliability and Acceptability of Real-time Virtual Video Pediatric Gait, Arms, Legs and Spine (V-pGALS)

The use of telemedicine in musculoskeletal assessment has been historically low. The current COVID 19 global pandemic has forced a paradigm shift with many centers rapidly adopting virtual visits to conduct care resulting in rapid expansion of use of telemedicine amongst practices. Mayoclinic has published The Telemedicine Musculoskeletal Examination for adults. Paediatric Musculoskeletal Matters (PMM) has put video Pediatric Gait, Arms, Legs and Spine (V-pGALS) assessment sheet on their website. However, there is a lack of the acceptability and reliability of these tools. The aim of this study is to investigate acceptability and reliability of real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) assessment for musculoskeletal assessment of children for telemedicine visits.

The use of telemedicine in musculoskeletal assessment has been historically low. The current COVID 19 global pandemic has forced a paradigm shift with many centers rapidly adopting virtual visits to conduct care resulting in rapid expansion of the use of telemedicine amongst practices. Mayoclinic has published The Telemedicine Musculoskeletal Examination for adults. 'Paediatric Musculoskeletal Matters' (PMM- www.pmmonline.org, is a free, evidence-based, and peer-reviewed open e-resource for pediatric musculoskeletal (MSK) medicine targeting non-MSK specialists. They have also published video Pediatric Gait, Arms, Legs and Spine (V-pGALS), an assessment sheet for telemedicine visits on their webpage. However, there is a lack of the acceptability and reliability of these tools. The aim of this study is to investigate acceptability and reliability of real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) assessment for musculoskeletal assessment of children for telemedicine visits. For this purpose, children at between the ages of 7-18 who admitted the Pediatric Rehabilitation outpatient clinic of Department of Physical Medicine and Rehabilitation of Marmara University School of Medicine will be recruited to the study. They will be evaluated via V-pGALS face to face on the day of admission and the physiatrist will record the diagnosis if there is. Within 24 hours the child will be reevaluated via V-pGALS by using Zoom application virtually. The acceptability of V-pGALS examination to the child and parents in terms of the duration and additional discomfort caused was evaluated using visual analog scale with smiley faces (0-10, 0 for full acceptability).

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 7-18 who admitted the Pediatric Rehabilitation outpatient clinic of Department of Physical Medicine and Rehabilitation

Exclusion Criteria:

* Non-ambulatory children
* Children with poor cooperation
* Being severe ill and unable to tolerate examination
* Children and parents who do not give oral and written permission for study enrollment
Gabapentin Treatment of Cannabis Dependence

This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 18-65 with cannabis dependence
* Meets DSM-IV-TR criteria for Cannabis Dependence
* Smoked marijuana at least once a week in the 90 days prior to study participation
* Willing to attend 12 weekly study visits and 1 follow-up visit

Exclusion Criteria:

* Currently meets DSM-IV-TR criteria for dependence on illicit substances other than cannabis
* Significant medical disorders that will increase potential risk or interfere with study participation
* Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Treatment with an investigational drug in the last month