cyrilzakka/clinical-trials huggingface dataset:
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore, according to a 0, 1 to 2-month schedule. Routine vaccinations are given concomitantly with the study vaccines at 2 or 3 and 4 months of age according to each local country regulation. Whenever OPV is used, a minimum 2-week interval should be observed between HRV vaccine and OPV doses.

Eligibility Criteria:
Inclusion criteria:

* Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Child is unlikely to remain in the study area during study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
* First or second degree of consanguinity of parents.
The Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)

This is a single arm, open-label, single center, exploratory clinical study to evaluate the safety and efficacy of CD19 UCAR-T Cells in Patients With CD19+ B-cell acute lymphoblastic leukemia (B-ALL).

This study did not set up a control group. The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD19 UCART cells per treatment course. The dose escalation test was designed to evaluate the three dose levels of CD19 UCART (1 × 10 \^ 6 cells/kg,3 × 10 \^ 6 cells/kg,5 × 10 \^ 6 cells/kg). Each CD19 UCART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects between 6 and 70 years of age, inclusive.
* 2. Subjects diagnosed as relapsed or refractory B cell acute lymphocytic leukemia (B-ALL):

  1. Relapse as defined by 2nd or greater BM relapse or Any BM relapse after allogeneic SCT, naive lymphocytes in BM≥5%；
  2. refractory as defined by not achieving a CR after 2 rounds of standard chemotherapy.
* 3. Life expectancy \> 12 weeks.
* 4. ECOG score between 0 and 1.
* 5. Liver, Renal, Heart and Lungs function defined as:

  1. Creatininec≤1.5 ULN;
  2. ALT/AST ≤2.5 ULN;
  3. Total Bilirubin≤1.5×ULN;
  4. Pulse oxygenation≥92%;
  5. Left Ventricular Shortening Fraction (LVSF)≥50%;
* 6. Subjects could comprehend the clinical study and able to provide written consent at the time of consent or assent.

Exclusion Criteria:

* 1. Pregnant or lactating women, or men or women with pregnancy plans within 6 months.
* 2. Subjects with contagious disease，such as HIV, active HBV and HCV, and syphilis, etc.
* 3. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
* 4. Subjects with severe autoimmune disease and long-term use of immunosuppressants.
* 5. Subjects with active or uncontrollable infections requiring systemic treatment within 14 days prior to enrollment.
* 6. Subjects with any unstable systemic disease including, but not limited to, active infection (except for local infection), unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III).
* 7. subjects combined with dysfunction of vital organs such as lung, brain and kidney.
* 8. subjects that Participated in other similar clinical trials within 6 months.
* 9. subjects currently receiving treatment for other gene therapy.
* 10. subjects combined with graft versus host disease (GVHD).
* 11. Other subjects judged by the researchers to be unsuitable for admission to the study.
Effect of Electroacupuncture in Diabetic Patients With Gastroparesis

In this study, we aim at evaluating the effect of electroacupuncture in diabetic patients with gastroparesis. Patient-based symptom severity measure, serum parameters and solid-phase gastric emptying time are measured to evaluate the effectiveness of electroacupuncture.

Initially, we will collect 30 patients with type 2 diabetes with a ≧ 3-month history of dyspeptic symptoms. An upper GI endocopy will be obtained to rule out possibility of organic obstruction. Cardiac arrhythmia and pregnancy will be excluded. None of them ever received abdominal surgery. Patients are then randomized to one of two treatment arms. Arm I: 15 patients received EA stimulation on acupoints St-36 (Zusanli) and Li-4 (Hegu). Arm II: 15 subjected to EA stimulation on non-acupoints around St-36 and Li-4 with the same electrical pulse and amplitude. Gastroparesis Cardinal Symptom Index (GCSI) and solid-phase gastric emptying time will be measured on baseline and after EA. In addition, serum gastrin, motilin, human pancreatic polypeptide, fasting blood sugar, and postprandial glucose levels will be also monitored.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Dyspetic symptoms for more than 3 months
* Symptoms include nausea, vomiting, upper abdominal discomfort, early satiety, bloating and anorexia

Exclusion Criteria:

* Organic gastrointestinal obstruction
* Previous surgery of gastrointestinal tract
* Cardiac arrhythmia
* Pregnancy
Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

The prevalence of Taiwan's population with amblyopia is 2-5%. Amblyopia affects the daily life and learning ability. The human visual system can be developed normally with exposure of clear images on the retina, which often drive the development and projection of optic nerves progressively. In general, the visual acuity progresses gradually with age. A normal vision is relatively mature until 8 years old. Several types of amblyopia (strabismic amblyopia, refractive amblyopia, and deprivation amblyopia) are identified. The refractive amblyopia and deprivation amblyopia must be corrected by wearing glasses or surgeries. Otherwise, amblyopia is often corrected by occlusion of the dominant eye or amblyopia training. The Cambridge Stimulator (CAM) with rotating grating is commonly used in clinic in Taiwan. The principle of the CAM allows subjects to draw pictures on the plate in coincidence with occlusion of the dominant eye. The parents have to go with their children to a hospital weekly. The CAM training is a stereotyped visuomotor behavior, which usually causes fatigue and uninteresting results for children.

Recently, some computer games have been incorporated with CAM training. However, their clinical impact on amblyopia is largely unknown. Moreover, most of studies don't have long-term tracking, and they only use limited assessments. In this project, a home-based training would be built for children with amblyopia. A CAM training with a hierarchical structure with story-based organization would be implemented in the tablet. It will save time for children and parents for traffic between the home and hospital. The CAM training with organized structure would increase acceptability and create subjects' motivation for long-term training. In addition, a stochastic resonance theory would be incorporated with the CAM training to potentiate the learning curve of a visuomotor skill in young children. Five systematic assessments, including visual acuity, grating acuity, contrast sensitivity, and 2 measurements of visual evoked potentials (VEPs), would be used. The investigators hypothesized that the rotating grating stimulation and stochastic resonance stimulation groups showed significant enhancement of the visual functions compared with the control group and performance of the VEPs toward better eye through the home-based training apparatus.


Eligibility Criteria:
Inclusion Criteria:

1. Participants were 4-8 years old.
2. Participant had binocular or monocular best-corrected visual acuity (BCVA) of ≤0.8, or they exhibited binocular BCVA difference of ≥0.2.
3. Participant had the wearing of optimal spectacle correction.

Exclusion Criteria:

1. Children with deprivation amblyopia were excluded.
2. Children with ptosis were excluded.
The Effect of Low-Intensity Resistance Exercise Training

It was to compare the effect of low-load resistance training with blood flow restriction (LL-BFR) and high-intensity resistance training (HI-RT) on muscle strength, endurance and volume, functional performance, and delayed onset muscle soreness (DOMS).

The study included 13 young women. It is a controlled study designed for individuals to perform two different exercise protocols unilaterally. The persons were randomly allocated into two groups as LI- BFR (Group I, n = 13) and HI-RT (Group II, n = 13). Both groups received training for 6 weeks and 3 days a week. Blood flow restriction was performed only in group I.

Both sides triceps muscle thickness, triceps and biceps strength and endurance, functional performances (upper extremity Y balance test (UQYBT)), delayed-onset muscle soreness (DOMS) were evaluated before and after training.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-26,
* Do not have a chronic disease history and do not use medication,
* Female individuals were included.

Exclusion Criteria:

* People who made resisted exercise in the last 6 months,
* Smoker,
* BMI above 30 kg / m2,
* Individuals with hypertension were excluded.
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)

This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Dry Eye Disease
* Objective Signs (Schirmer's II test \<10 mm at 5 min; Tear Break-Up time (TBUT) of \<10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive \>=4 in at least 1 eye)
* Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy

Exclusion Criteria:

* History of Diabetes
* History of ocular surgery, corneal infection, or corneal injury within the last 3 months
* Active ocular allergies
* Active ocular infection
* Allergic to benzalkonium chloride
Open-Label Extension of LOCKCYST Trial

Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available.

Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.

van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the LOCKCYST trial
* 18 yrs-of age
* Multiple cysts \> 20
* Cooperating patient
* Is willing and able to comply with the study drug regimen and all other study requirements.
* Willingness to give written informed consent

Exclusion Criteria:

* Use of oral anticonceptives or estrogen suppletion
* Females who are pregnant or breast-feeding
* History or other evidence of chronic pulmonary disease associated with functional limitation
* History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
* History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Symptomatic gallstones (lanreotide decreases gall bladder volume)
* Renal failure requiring hemodialysis
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I

Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).

Patients with suspected primary breast cancer on mammography and clinical examination will be assessed for eligibility by having a needle core biopsy to confirm invasive carcinoma.

A fresh unfixed tumor specimen, incisional or core biopsy will be sent to Agendia to determine the MammaPrint risk profile, the BluePrint molecular subtyping profile, the TargetPrint ER, PR and HER2 single gene readout, the 56-geneTheraPrint Research Gene Panel and the additional genes as measured on the whole genome (44k) array.

Surgical Protocol:

1. Determination of nodal status:

   * For clinically node-negative patients: Axillary ultra sound, followed by Sentinel Lymph Node (SLN) biopsy
   * For clinically node-positive patients: ultra sound-guided Fine Needle Aspirate (FNA), followed by core biopsy
2. Neo-adjuvant chemotherapy
3. Definitive surgery:

   * For node-positive patients: lumpectomy, repeat SLN biopsy, Axillary Lymph Node Dissection (ALND)
   * For node-negative patients: lumpectomy, repeat SLN biopsy (optional), no ALND

Response will be measured by pathological Complete Response (pCR) and by centrally assessed Residual Cancer Burden (RCB).

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically proven invasive breast cancer and no distant metastases and;
* Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level.
* Age ≥ 18 years.
* At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response.
* Adequate bone marrow reserves (neutrophil count \>1.5 x109 /l and platelet count \>100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).
* Signed informed consent of the patient

Exclusion Criteria:

* Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer.
* Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control criteria.
* Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer.
* Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS

The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit.

Two of those strategies are based on electrical impedance tomography (EIT) monitoring.


Eligibility Criteria:
Inclusion Criteria:

* patients with moderate to severe ARDS, defined by the Berlin consensus, at 12 to 48h from diagnosis
* PaO2/FiO2 ratio \< 150 mmHg
* Patient affiliated to or beneficiary of a health care plan
* Consent obtained from patient's SDM

Exclusion Criteria:

* Pneumothorax
* Contraindication to the insertion of a nasogastric tube with an esophageal balloon
* Contraindication to the use of Electrical impedance tomography
* Pregnancy, lactating or parturient woman
Research of Predictive Factors of in Vitro Fertilization (IVF) Outcome AI-IVF Study

Infertility is the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected intercourse, while subfertility means a delay in achieving pregnancy. Several factors can contribute to these conditions, such as autoimmune diseases like systemic thyroid and celiac diseases, rheumatoid arthritis, systemic lupus erythematosus, and endometriosis. Some of them may overlap, sharing a common immunological milieu.

In this scenario, medically ART can help women carry on pregnancies if they are in stable disease remission and receive adequate treatment. However, the number of oocytes that can be ovulated under stimulation is highly variable, so the outcome of any IVF is linked to many factors, not only biological but also connected to the mean success rate of the fertility center.

For these reasons, the need to find methods for identifying the best gametes and embryos to guarantee a successful pregnancy is becoming pressing. AI can be essential to develop prediction models for pregnancy outcomes for patients undergoing ART treatments.

AI currently represents a modern way to obtain algorithms from a set of observable data that could help clinical decisions


Eligibility Criteria:
Inclusion Criteria:

* Women with age below 43 years old
* IVF cycle with fresh semen sample that could be used
* progressive motile spermatozoa expected count of minimum 1 million following density gradient purification on the day of oocyte pick up

Exclusion Criteria:

* Women with uterine abnormalities
* Women with chromosomal and genetic abnormalities
* Positivity to serological test (HCV, HBV, HIV, VDRL-TPHA)
Improving Colonoscopy Surveillance for Patients with High Risk Colon Polyps

This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.

PRIMARY OBJECTIVE:

I. To increase completion of surveillance colonoscopy within 3.5 years of high risk neoplasia (HRN) diagnosis.

OUTLINE:

AIM 1: Participants complete an interview over 20-30 minutes.

AIM 2: Primary care clinics are randomized to 1 of 2 arms.

ARM I: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records. Clinics also call patients to schedule their colonoscopy. Providers receive reminders and pending orders for the colonoscopy in the electronic health record. Patients receive a reminder 6 months in advance via their patient portal and mail to schedule a colonoscopy, and also receive a phone call from the patient communication center.

ARM II: Patients receive care according to the clinics' usual care practices.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1 PATIENTS: Patients between age 45 and 75 with a HRN diagnosis in the past 5 years
* AIM 1 PATIENTS: 12 patients who did and 12 patients who did not have surveillance colonoscopy
* AIM 1 PROVIDERS: Primary care providers (PCPs) and gastroenterologists (GIs)
* AIM 1 ADMINISTRATORS: Administrators who are involved in care processes related to CRC screening, HRN surveillance, and/or colonoscopy scheduling
* AIM 2: Patients age 45 to 75 diagnosed with a HRN during the pre-specified two-year HRN diagnosis period

Exclusion Criteria:

* AIM 2: Individuals with a personal history of colorectal carcinoma (CRC), inflammatory bowel disease (Crohn's, ulcerative colitis), or polyposis syndrome
* AIM 2: HRN cases not confirmed by chart review (human-in-the-loop)
The Relationship Among, Serum Uric Acid, Left Ventricular Hypertrophy and Metabolic Syndrome

Hyperuricemia is associated with the prevalence of metabolic syndrome and cardiovascular risks in diverse of the population. Whether the dose-response effects on the prevalence of metabolic syndrome and cardiometabolic risks is unclear. The present study is conducted to investigate the relationship between serum uric acid and the prevalence metabolic syndrome and left ventricular hypertrophy.

Apparently healthy individuals with an estimated screening number of approximately twenty-thousand individuals undergo an annual health exam in the investigators' hospital. The routine exam includes measurements of body height, body weight, blood pressure, visual and acoustic acuity, physical examinations, basic blood tests, urine analyses, chest radiography, and electrocardiography. The blood tests were performed after individuals fasted for at least eight hours. Individuals with any abnormal results underwent a clinical examination at an outpatient department for safety issues, ensuring the accuracy of the data. All data were registered prospectively. The investigators retrospectively collected data from the annual exam.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with ages of 20-65 years underwent the annual health exam at the investigators' hospital.

Exclusion Criteria:

* The individual had no data to define metabolic syndrome, including waist circumference, office blood pressure, serum uric acid, triglyceride, high-density lipoprotein cholesterol, fasting glucose.