cyrilzakka/clinical-trials huggingface dataset:
Psychosocial Risks in Liver Transplant Recipients

A retrospective chart review in which the information in the standard psychosocial evaluations done pre-transplant for liver transplant recipients will be coded, recorded, and correlated with posttransplant outcomes of the same recipients. Evaluated outcomes include rejection episodes and adherence to tacrolimus, calculated through the MLVI (Medication Level Variability Index). The researchers will evaluate the degree to which both single elements in the evaluation as well as a cumulative score derived by a structured review of the chart using the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) model can predict posttransplant outcomes.

The research team will perform a chart review and extract data without identifiers from paper charts and electronic charts and data tracking system. This data will be obtained from OTTR /EPIC as well as paper charts if needed. Those charts will be accessed to obtain demographic data (age, gender, income, employment status, marital/relationship status, insurance payer); transplant specific data (primary diagnosis, transplant year, tacrolimus blood levels, rejection episodes (yes/ no and number of), graft loss (yes/no), re-transplantation (yes/no); related medical data (creatinine levels, dialysis dependence (yes/no), ICD diagnoses; and psychosocial variables (social worker risk assessment before transplant, presence of social and family support, conviction history (yes/no), psychiatric history (diagnoses yes/no).

Variables will be obtained from the psychosocial pretransplant evaluation write-up (which in different years was attached to OTTR or EPIC datasets, or may be present in paper form, and from electronic datasets (OTTR / EPIC).

The data extraction as well as dataset building and data entry will be performed in office spaces at ISMMS. No patient contact is anticipated for this study. The predictive model will include evaluations of single variables as well as an evaluation of the predictive ability of a pre-defined scoring system (the SIPAT) which will be applied to existing data.

Eligibility Criteria:
Inclusion Criteria:

* Received a liver transplant in the year 2012 or earlier
* Received Tacrolimus
* Had at least 3 Tacrolimus blood tests
* Received their transplant at RMTI

Exclusion Criteria:

* Patients who received more than 1 solid organ transplant
* Patients who were not prescribed Tacrolimus
* Patients who died within the first year after transplant
* Patients with cognitive impairment
Robotic Bronchoscopy for Peripheral Pulmonary Lesions

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

Successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Capable and willing to give informed consent
2. Acceptable candidate for an elective, non-emergent bronchoscopic procedure
3. Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure
4. Lack bleeding disorders

Exclusion Criteria:

1. Medical contraindication to bronchoscopy
2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
3. Patients with endobronchial involvement seen on chest CT
4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
5. Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study
6. Uncontrolled or irreversible coagulopathy
7. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement
Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia

This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.

CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
2. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
3. ECOG Scores: 0\~2
4. CD19 positive and CD22 positive were detected by immunohistochemistry or flow cytometry;
5. Estimated survival time\>3 months;
6. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
7. For patients with only extramedullary recurrence of B-ALL, there must be at least one assessable lesion.

Exclusion Criteria:

1. Serious cardiac insufficiency；
2. Has a history of severe pulmonary function damaging;
3. Presence of other malignant tumors.
4. Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management.
5. Presence of other severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]);
7. Known positive serology for human immunodeficiency virus (HIV) or syphilis。
8. Has a history of serious allergies on biological products (including antibiotics);
9. Female patients who are under pregnancy and/or lactation, or planing on pregnancy for the next 12 months.
10. Any other situations that the researchers believe will affect the results of the study.
Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty

Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.

  * Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
  * Patients must be willing to comply with the pre and post-operative evaluation schedule

Exclusion Criteria:

* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
Nortriptyline for the Treatment of Functional Dyspepsia

Functional dyspepsia (FD) is a common functional gastrointestinal disorder characterized by upper abdominal discomfort/pain and/or symptoms of meal-related fullness/satiety. There is currently no definitive therapy that is beneficial for all FD patients. Accumulating evidence suggests efficacy of tricyclic antidepressants (TCAs) in FD. However, no firm conclusion can be drawn currently due to the relatively small amount of studies and large heterogeneity between studies. In addition, TCAs are often associated with side effects, which occur early after initiation of therapy preceding the therapeutic effect and often result in discontinuation of the therapy. These side effects are related to drug metabolism, which depend on polymorphisms of the cytochrome P (CYP) enzyme system. It is therefore hypothesized that pre-treatment assessment of CYP genotype and subsequent exclusion of abnormal metabolizers limits the occurrence of side-effects and as such improves compliance and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years;
* A diagnosis of FD according to the Rome IV criteria;
* Predicted CYP2D6 extensive metabolizer phenotype on the basis of CYP genotyping
* Insufficient effect of first line treatment with proton pump inhibitors (twice daily) or prokinetics;
* In the presence of alarm symptoms, patients are required to have undergone an upper gastrointestinal endoscopy (without evidence of organic disease), and have tested negative for Helicobacter pylori 2 years prior to inclusion;
* Women in their fertile age (\<55 years old) must use contraception or be postmenopausal for at least two years.

Exclusion Criteria:

* Predicted CYP2D6 poor, intermediate or ultrarapid metabolizer phenotype on the basis of CYP genotyping
* Evidence of current anxiety and/or depression disorder as defined by a score ≥ 10 on the GAD-7 and/or PHQ-9 questionnaire;
* Current use or any previous use of psychotropic medication in the last 3 months prior to inclusion;
* Inability to discontinue prokinetics, NSAIDs or opioids;
* Using drugs of abuse;
* Using more than 2 or 3 units of alcohol per day (females and males respectively)
* Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:

  1. Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
  2. Other surgery upon judgment of the principle investigator;
* History of gastric ulcer;
* History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system;
* History of epilepsy
* History of glaucoma
* Pregnancy or lactation.
A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients

PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis.

SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.

Forty patients are randomized to receive either BACI or placebo (bovine colostrum from non-immunized cattle) for 1 week. The double-blind portion of the study will be followed by an open-label phase in which all 40 patients receive BACI for 1 week.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antidiarrheal compounds (if dose remains stable).
* Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry).

Patients must have:

* AIDS.
* Cryptosporidium parvum enteritis.
* Chronic diarrhea.
* Life expectancy of at least 4 weeks.
* Ability to tolerate food by mouth.
* Ability to take the histamine H2-receptor antagonist famotidine (Pepcid).

Prior Medication:

Allowed:

* Antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry).
* Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose has remained stable for at least 4 weeks prior to study entry).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening.
* Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis.
* Grossly bloody diarrhea.
* Known allergy to milk or milk products (other than lactose intolerance).

Prior Medication:

Excluded:

* Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry.
Genomic Signatures to Predict Treatment Response

A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively evaluate the microarray-based, genomic test as a predictor of axillary lymph node response. Also, to determine whether the probability of achieving negative axillary nodes, is sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to support omitting axillary dissection.


Eligibility Criteria:
Inclusion Criteria:

* Clinical status of lymph nodes must be available
* Sonographical status of lymph nodes must be available
* Patients must consent to documentation of cancer treatment
* Histologic diagnosis of invasive breast cancer, clinical stage T1-4, M0 (non-inflammatory T4c)
* Patients scheduled for neoadjuvant chemotherapy
* Treatment with a 3-weekly FEC or AC regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel.
* Local HER2 status of tumor biopsy must be negative.

Exclusion Criteria:

* The patient has a prior history of invasive or metastatic breast cancer.
* The patient had prior excisional biopsy of the primary invasive breast cancer.
* The patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer.
* The patient cannot safely or feasibly undergo biopsy of the primary tumor.
* The patient has a diagnosis of Stage IV (distant metastatic) breast cancer.
* The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.
Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)

This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation


Eligibility Criteria:
Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -

Exclusion Criteria:

-
Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism

Background:

Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.

As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be considered a good candidate tool in the diagnosis of PHPT.

AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the diagnosis of PHPT.

Study design: Retrospective, observational, cross-sectional, case-control clinical trial will be carried out.

Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.


Eligibility Criteria:
Inclusion Criteria:

* elevated parathormone serum levels
* normal or elevated calcium serum levels

Exclusion Criteria:

* age younger than 18 years
* renal and liver failure and insufficiency
* active metabolic bone disease (such as Paget's disease of the bone, osteomalacia, rickets, etc)
* any type of cancer
* malnutrition, severe obesity (BMI \> 40 kg/m2) and malabsorption
* transplantation
* sarcoidosis
* endocrinological disorders such as hypercortisolism, diabetes insipidus, hyperthyroidism, pseudohypoparathyroidism
* familial hypocalciuric hypercalcemia
* hypophosphoremia sustained by genetic causes or secondary to other causes.
Predictive Factors of Long Term Outcome in MMN

The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). The aim of this study is to identify prognostic factors of poor outcome.

Data were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group and a poor outcome group. Demographic, clinical, biological and nerve conduction study features of MMN patients were analyzed. Identification of prognostic factors in MMN could help develop personalized treatment.

The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). However, 10% of patients progress despite treatment. The aim of this study is to identify prognostic factors of poor outcome.

Data were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group (patients in remission without IVIg or with spaced IVIg courses), and a poor outcome group (patients dependent on continuous IVIg treatment or deteriorating despite IVIg). Investigators searched predictive factors of long-term outcome in MMN. They studied demographic, clinical, biological and nerve conduction study features of MMN patients.Identification of prognostic factors in MMN could help develop personalized treatment by selecting patients eligible for immunosuppressive drugs before IVIg dependence or progression.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MNN following the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Guideline criteria 2010

Exclusion Criteria:

* missing data
* clinical progression features suggested another inflammatory neuropathy,
* immunosuppressive agents for another pathology.
Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine

To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)

All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.

Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

Exclusion Criteria:

* Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
* Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Comparison of Infusion Methods for Hysteroscopic Procedures

This study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional pump infusion method to clarify if the manual syringe infusion method really needs less amount of distension medium.

Hysteroscopy is frequently used for diagnosing abnormal uterine bleeding, endometrial polyp or submucous myoma. However, hysteroscopic procedure can cause morbidity and even mortality related to infusion distension medium. We had used a manual syringe infusion method to infuse fluid for distending the uterine cavity in our institute without significant morbidity, and it seems that this method need less amount of distension medium, and possible result in less possibility of hyponatremia. Therefore, the aim of this study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional infusion pump method to clarify if the manual syringe infusion method really needs less amount of distension medium during hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.

Exclusion Criteria:

* Female patients of less than twenty years-old.
Inferior Vena Cava Indexes in Positive Pressure Supports

Collapsibility (CI-IVC), distensibility (dIVC) and delta (ΔIVC) indices, which are dynamic measures of inferior vena cava (IVC) diameter, are used to assess the intravascular volume status in critically ill patients. Positive pressure support (PS) has been shown to induce IVC diameter distention by increasing intrathoracic pressure, and high positive expiratory pressure (PEEP) decreases the CI-IVC percentage (4). During Triggered positive pressure support it is necessary to clarify which IVC index is valid for measuring the volume status.it is aimed to compare the IVC indexes (CI-IVC, DIVC, ΔIVC), positive rate of change with pressure, correlation with central venous pressure and accurate prediction of volume status in patients with different positive pressure support.

The IVC diameters at different pressure supports were measured by the same clinician after obtaining a clear image of where the US and IVC measurements were made and the probe stabilization was achieved. He performed the procedure of changing the pressure supports, a blind independent intensive care physician without working, and recorded the applied pressure supports respectively. The different pressure supports applied are as follows:

1. PS 10 mmHg-PEEP 5 mmHg,
2. PS 0 mmHg- PEEP 5 mmHg
3. PS 10 mmHg- PEEP 0 mmHg.
4. T-tube (PS 0 mmHg-PEEP 0 mmHg)

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Current use of mechanical ventilation through an endotracheal tube.

Exclusion Criteria:

* Profound Hypoxia defined as a fraction of inspired oxygen requirement \>90% or a PEEP \>10 mmHg
* Patient-ventilator desynchrony or active agitation
* Unstable O2 requirement
* Cardiovascular instability
* Current PEEP requirements of \>10 mmHg
* Current oxygen saturation (SpO2) of \<88%.
* High intra abdominal pressure
* Right cardiac failure
* Morbid obesity