cyrilzakka/clinical-trials huggingface dataset:
Anti-PD-1therapy Combined With Thermal Ablation for Advanced HCC

The inhibition of programmed cell death protein 1 (PD-1) has shown promising antitumor activity in advanced hepatocellular carcinoma (HCC). Unfortunately, less than 20% of HCC have response. The effect of PD-1 blockade and incomplete thermal ablation in patients with advanced HCC is not yet clearly understood. This study aimed to analyze outcomes of advanced HCC treated with anti PD-1 inhibitors in combination with incomplete thermal ablation.

Hepatocellular carcinoma (HCC) is ranked as the third leading cause of cancer death both worldwide and in the China. In the past decade, survivals of patients with advanced HCC or those who have progressed diseases following locoregional treatments can be increased with the multi-kinase inhibitor sorafenib, the first evidence identified drug for HCC. Recent clinical trials further verified some novel tyrosine kinase inhibitors such as regorafenib and cabozantinib, and two programmed cell death protein-1 (PD-1) immune checkpoint inhibitors (ICIs), nivolumab and pembrolizumab, as useful therapies in second line setting following sorafenib.

Advances in programmed cell death protein 1 (PD-1) blockade have shown an ORR of 15-17% and median survival time of 12.9-15.0 months among patients with advanced HCC. Of these, nivolumab and pembrolizumab have been accelerated approved as second-line treatment of advanced HCC. Notably, patients who have tumor responses maintain long-lasting disease control for 9.9-17months and still a large proportion of patients (81-83%) do not respond to mono PD-1 blockade, which emphasizing the need to explore strategies to increase the efficacy of immunotherapy.

An approach to expanding the benefit of ICIs may involve combinations with locoregional therapy like radiofrequency ablation (RFA) and transarterial chemoembolization (TACE), such treatments have been shown to boost tumor-specific T-cell response through release of TAAs from HCC cells. The intent-to-treat population of this study was a subset of patients receiving ongoing ICIs therapy for advanced HCC and is with stable disease or atypical responses in different lesions of the same individuals.

Eligibility Criteria:
Inclusion Criteria:

Eligible patients had pathological diagnosis of HCC by either surgical resection tissue or core needle biopsy; and had advanced stage of disease that is refractory to or is with unacceptable toxicity of sorafenib. Other eligibility criteria included: Child-Pugh A or B7 classification; Eastern Cooperative Oncology Group-performance status score 0-2; adequate bone marrow (leukocyte count \>3.0 ×109/L, hemoglobin \>8.0 g/L, and platelet count \>60 ×109/L), liver (alanine aminotransferase and aspartate aminotransferase \<200 IU/mL), renal (creatinine \<1.5 times the upper limit of the normal range) and coagulation (international normalized ratio \<2.3) function.

Exclusion Criteria:

* Exclusion criteria included a history of treatment with immune checkpoint inhibitors, allergies to immunetherapeutics, systemic immunosuppressive therapy, and ongoing or active infection, or an active autoimmune disease.
Acupuncture for Diabetic Gastroparalysis: a Randomized Controlled Trial

The purpose of this study is to determine whether the different combination of acupoints have different effect on diabetic gastroparalysis.


Eligibility Criteria:
Inclusion Criteria:

* individuals who meet the diagnostic criteria of diabetes gastric paralysis.
* individuals between the ages of 18 and 60 years.
* individuals who meet blood glucose control standards: Fasting plasma glucose (FPG) ≤7. 8mmol/L; 2 hours plasma glucose (2hPG)≤13.6mmol/L.
* individuals who suffered for more than 3 years.
* individuals who treated with diet control or exercise or using hypoglycemic drug (except for α-glucosidase Inhibitor) on the basis of diet or exercise therapy and the dose stability must be last at least 3 months.
* individuals who receive no other treatments in the first 3 months.
* women who is at the age of childbearing age and take contraceptive measures.
* individuals who voluntarily agree with a study protocol and sign a written informed consent.

Exclusion Criteria:

* individuals who have reflux esophagitis;
* individuals who have gastroparesis after surgery;
* individuals who have acute complications with ketoacidosis and nonketotic hyperosmolar coma;
* individuals who have Acute cardiovascular and cerebrovascular diseases or Severe trauma or surgery, severe infection. Or who are pregnant or breastfeeding;
* individuals who have a history disease of myocardial infarction, acute coronary syndrome or coronary revascularization;
* individuals who have serious hepatobiliary disease, or AST and/or ALT 2 times greater than the upper limit of normal patients;
* individuals with kidney damage, and serum creatinine exceeds 140umol/L;
* individuals who have obvious blood system diseases (Any one of which can not be caught in line: Hb: male\<110g/L, women\<100g/L,WBC\<3.5×109/L,PLT\<80×109/L).
* individuals who have a problem of blood press:SBP≥180mmHg,DPB≥100mmHg;
* individuals who have cancer or other serious progressive wasting disease, and easy to infection and bleeding;
* individuals who have peptic ulcer or other organic disease confirmed by esophagogastroduodenoscopy;
* individuals unwilling to meet the testing and exacerbations,or have serious complications in the test;
* individuals who have taking α-glucosidase inhibitor drug in the past four weeks.
Evaluate Efficacy and Safety in Chinese Patients With Infantile-Onset Pompe Disease With One Year Alglucosidase Alfa Treatment

Primary Objective:

To evaluate effect of 52-week treatment with Alglucosidase Alfa in the extension of survival and improvement of cardiomyopathy measured by Left Ventricular Mass Index in Chinese patients with infantile-onset Pompe Disease.

Secondary Objectives:

* To observe the improvement of physical growth, motor and cognitive development of 52-week treatment with Alglucosidase Alfa in infantile-onset Pompe Disease from the baseline.
* To observe the efficacy on survival free of invasive ventilation, use of any ventilation support of 52- week treatment with Alglucosidase Alfa in Chinese patients with infantile-onset Pompe Disease.
* To evaluate the safety and tolerability of Alglucosidase Alfa in Chinese patients with infantile-onset Pompe Disease.

Total of 56 weeks in the study period, including an up to 28-day screening period and 52-week treatment period, followed by 30-day post-treatment observation period.

After the end of 52-week treatment, patients' guardians could choose to participate in a patient assistance program (PAP) sponsored by Sanofi and launched before first patient out (FPO) or reimbursement from social insurance for continued treatment.

Eligibility Criteria:
Inclusion criteria:

* Subject's parents or legal guardians must provide written informed consent prior to any study-related procedures.
* Documented onset of Pompe disease symptoms up to 12 months of age (corrected for gestation if born before 40 weeks); diagnosis of Pompe disease confirmed by acid alpha-glucosidase enzyme deficiency from any tissue source and acid alpha-glucosidase gene mutations.
* Age 0-12 months at enrollment, defined as at the time of providing written informed consent.
* Cardiomyopathy (abnormal left ventricular mass indices \[LVMIs\], measured by echocardiography, abnormal value is defined as ≥65 g/m2 for patients up to 12 months old) confirmed by cardiologist at study site.

Exclusion criteria:

* Patient who has previously been treated with acid alpha-glucosidase.
* Patient who is participating in another clinical study using any investigational therapy.
* Conditions/situations such as:
* Clinical signs of cardiac failure with ejection fraction \< 40%.
* Respiratory insufficiency (oxygen saturation \< 90% or carbon dioxide partial pressure \> 55 mm Hg \[venous\] or \> 40 mm hydrargyrum \[arterial\] in room air or any ventilator use).
* Patients who are dependent on invasive or non-invasive ventilator support.
* Patients with major congenital anomaly or clinically significant intercurrent organic disease unrelated to Pompe disease.
* Patients not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections

The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.

All females ages 18-55 presenting to the University of Maryland Medical Center Emergency Department or Urgent Care whose provider suspects sexually transmitted infection will be offered study enrollment and be randomly assigned to either the control or the experimental group. Both groups will have a urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of the standard PCR. Data will be collected regarding provider decision making, length of stay in the emergency department, patient satisfaction, clinician satisfaction, further healthcare sought by patient, and cost surrounding each treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female patients age 18-55
* Signs or symptoms consistent with sexually transmitted infection
* Medical provider willing to consider the result of the rapid turnaround test in decision to treat for gonorrhea/chlamydia
* Must have a urine specimen obtained and a pelvic exam performed as part of the anticipated standard of care evaluation
* Provides informed consent

Exclusion Criteria:

* Signs of systemic infection
* Patient in whom the provider is unwilling to consider the result of the rapid turnaround test
* Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3 months
* Patients undergoing evaluation for sexual assault
* Patients that are known to be pregnant or express concern that they may be pregnant
* Incarcerated patients
* Students/Employees of the facility
* Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
Ventralex Vs Stratafix for Primary Ventral Hernias

Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.

Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery.

Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery.

The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.

Eligibility Criteria:
Inclusion Criteria:

* Defect 1-4 cm
* Primary ventral hernia in the midline
* BMI\<35

Exclusion Criteria:

* Defect \>4cm
* BMI\>35
* Recurrent hernia
Acupressure for the Treatment of Raynaud's Phenomenon

The use of acupressure will be compared to targeted Raynaud's education and will evaluate the' frequency, duration and pain of Raynaud's attacks.

Using a Raynaud's condition score, severity of tingling, numbness and pain of attacks, the number of attacks and patient and physician visual analog scale we will assess the effect of acupressure.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Have Raynauds phenomenon, with at least 4 attacks in the last week
* on stable medications
* Willing to attend study visits

Exclusion Criteria:

* smoker
* have a history of stroke, heart attack or irregular heart rhythm
* uncontrolled blood pressure
* physical or mental illness that would interfere with participating in the study
13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.

The objective of the study is to investigate the metabolism of cells in the ascites tumour microenvironment of ovarian cancer patients. This observational study involves intravenous infusion of \[U-13C\]glucose into patients during standard paracentesis.

Participants and Location:

This study will recruit up to 10 patients of at least 18 years of age with ascites due to diagnosed ovarian cancer. Eligible study patients will be screened and recruited at BC Cancer - Victoria. Paracentesis procedure and patient consent will occur at the Island Health - Royal Jubilee Hospital.

Study Design:

Participants meeting the inclusion criteria will be fitted with a continuous glucose monitor (FreeStyle Libre) before proceeding to their scheduled appointment for paracentesis. Labeled glucose will be administered via I.V. at dose of 8g of labeled glucose in 60 mL over 10 min. This is followed by 4g of labeled glucose in 30 mL over an hour.

Sample collection and processing:

During \[U-13C\]glucose infusions, the ascites specimens will kept on ice. Samples will be collected and analyzed by flow cytometry and mass spectrometry for states of metabolism and metabolite profiles respectively. The ascites fluid will be monitored for changes in metabolite levels.

\[U-13C\]glucose Product Information:

\[U-13C\]glucose clinical grade will be compound BC Cancer Pharmacy.

Eligibility Criteria:
Inclusion Criteria:

* Ovarian cancer
* Any stage or grade of disease
* Ascites fluid that requires draining
* Any treatment regimen
* Primary or recurrent ascites
* Understands the concept of the study and give informed consent.

Exclusion Criteria:

* Participants must not have diabetes or abnormal hemoglobin A1C levels.
* The patient's glucose levels must be between 4 - 11.1 mM before administering an infusion. This is to ensure that patients are within normal blood glucose levels, as described by Diabetes Canada.
* Participants cannot receive chemotherapy treatment during the 5 hour duration of the experiment as it may compromise the integrity of the data.
Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic

This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.


Eligibility Criteria:
Inclusion Criteria:

Patients are included in the study if they meet all the following criteria:

* Exclusively breastfed healthy infants of both sexes, aged ≤ 7 weeks.
* Diagnosis of IC according to Rome III criteria.
* Written informed consent of the parent/tutor.

Exclusion Criteria:

Patients are excluded from this study if they meet any of the following criteria:

* Birth weight \< 2500 g.
* Gestational age \< 37 weeks.
* APGAR 5 minutes \< 7.
* Formula feeding.
* Stunting/loss of weight (\< 100 g/weeks from birth to the last reported weight).
* Neurological diseases.
* Known or suspected food allergy.
* Gastroesophageal reflux disease.
* Use of substances that alter gut microbiota (probiotics, prebiotics, antibiotics, gastric acidity inhibitors) in the last 2 weeks prior the enrollment.
* History of fever and/or infectious diseases in the last 2 weeks prior to enrollment.
* Ongoing systemic infections.
* History of congenital infections.
* Chronic intestinal diseases (cystic fibrosis or other forms of primitive pancreatic insufficiency)
* Primitive or secondary malformations of the gastrointestinal tract (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation).
* Metabolic diseases.
* Genetic diseases and chromosomal abnormalities.
* Primary or secondary immunodeficiencies.
* Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol.
* Previous participation in this study.
Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®

This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).


Eligibility Criteria:
* Have never received smallpox vaccine or previously received an experimental smallpox vectored vaccine (for vaccinia-naive cohorts only)
* Have been previously vaccinated within the last 10 years (vaccinia-experienced cohort only)
* Must agree to have blood samples banked for future research testing
* Have not participated in any clinical trial using investigational product within past month
* No current or past history of exfoliative skin problems
* Not have regular contact with children under 3 years of age until scab at site of vaccination has fallen off (around 21 days or 3 weeks after vaccination)
* Do not have a positive test for HIV virus, hepatitis C virus, or hepatitis B surface antigen
* Are not a health care worker caring for newborns, patients that are immunocompromised or have skin that is adversely altered
* Will not engage in direct patient care until immunization scab falls off (around 21 days or 3 weeks after vaccination) if health care worker
Ear Acupuncture for Acute Sore Throat.

The purpose of this study is to compare ear acupuncture plus standard of care versus standard therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral anti inflammatory medication use, hours lost from work in acute sore throat.


Eligibility Criteria:
Inclusion:

* Male and female subjects (DoD beneficiaries), 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat.
* Minimum pain score of 5 points on an 11 point scale (0-10 with 10 being the worst pain)

Exclusion:

* History of significant gastrointestinal bleed
* Previous documented history of stage 2 kidney disease or worse
* Known Pregnancy
* History of gastric bypass surgery
* Known Peritonsillar abscess (PTA)
* Throat, mouth or esophageal cancer
* Chronic oral steroids use
* Absence of one or more ears
* Active cellulitis of ear
* Ear anatomy precluding identification of acupuncture landmarks
* Non-English speaking
* Use of Hearing Aids that preclude the use of ear acupuncture
* Allergy to Ibuprofen
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer

This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation.
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm).
* Suitable for either treatment regimen.
* Prior chemotherapy for metastatic colorectal cancer is not allowed.
* WHO performance status 0-1.
* Adequate hematological, renal and hepatic function.
* Age 18 years or older.
* Willing and able to provide written informed consent.
* Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

* Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
* Previous radiotherapy delivered to the upper abdomen.
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
* Peripheral neuropathy \> grade 1 (NCI-CTC).
* Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
* Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
* Pregnant or breast-feeding.
* Other active malignancy.
A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics

To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of Advanced solid tumors,lack of the standard treatment or treatment failure.In expanding stage,enroll the Non-small Cell Lung Cancer with EGFR+(except exon 20)
* 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:

* 14 Days or more from the last cytotoxic therapy
* Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
* Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥470ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification)
* Patients with non-healing wounds or fractures
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment