cyrilzakka/clinical-trials huggingface dataset:
Advagraf/Prograf Conversion Trial

Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant or Renal Pancreas patients who are \> 12 months post transplant
* Stable allograft function defined as eGFR \> 30-60ml/min
* Renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; Renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months
* Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent

Exclusion Criteria:

* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* Treated rejection within 3 months of randomization.
* Increased serum creatinine \> 20% within 3 months of randomization.
* Subject is pregnant or breastfeeding
* Subject has significant co-morbid disease (eg. Malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol
Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule

The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* Weight\>50kg, BMI of \>18kg/m2 and \<27kg/m2 subject

Exclusion Criteria:

* Acute disease within 28 days prior to start of study drug administration
* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Has a severe medical history of hypersensitivity to fibric acid derivative
* Participation in another clinical study within 30 days prior to start of study drug administration
Walnut Oral Immunotherapy for Tree Nut Allergy

The purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their immune system.

Tree nut

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 45 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (\> 3mm) or serologic evidence of allergic sensitization (defined as specific IgE \> 0.35 kU/L) to walnut and at least one other tree nut.
* A positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut.
* Written informed consent from participant and/or parent/guardian
* Written assent from all subjects as appropriate
* All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

* History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2 \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence).
* Known allergy to oat
* Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put the subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge.
* Poor control or persistent activation of atopic dermatitis
* Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years.
* Participation in any interventional study for food allergy in the past 6 months
* Participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing).
* Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2) or poorly controlled mild or moderate asthma
* Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
* Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
* Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
* Pregnancy or lactation
Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia

Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an indication for esophageal POEM for achalasia
* Patient with all types of achalasia with Eckardt score \> 3
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* Patient with contraindications to PPIs
* Patient with mediastinal and esophageal neoplasia
* Patient with a history of Heller myotomy surgery
* Patients requiring any type of anti-reflux valve surgery
* The subject is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding
Intrapleural Urokinase for Retained Hemothorax

Intrapleural thrombolytic treatment with urokinase for retained hemothorax is effective and safe. However, previous study was limited in prospective observation study without control group.

We will recruit 32 patients in this study. The patients with retained hemothorax will be randomly divided into the urokinase group and the placebo group. In the urokinase group, urokinase 100,000 IU in 100 mL NaCl will be injected into the intrapleural space. We will record the daily drainage amount and evaluate the therapeutic effect by the chest X-ray. The therapeutic effect, safety, hospital stay, and medical cost between the two groups will be compared. This study will be done in four medical centers in northern Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Retained hemothorax: it is defined as chest X-ray revealing obvious blood clot in pleural cavity after tube thoracostomy drainage for 3 days. The chest tubes are in good location and have no obstruction. The physician thinks the blood clot is difficult to drain.
2. Age: full 18 year-old

Exclusion Criteria:

1. Pregnancy
2. Active bleeding
3. Coagulopathy, e.g. congenital or acquired coagulation abnormality, platelet count less than 100,000 /μL, international normalized ratio (INR) more than 1.5, or partial thromboplastin time, PTT, more than 50 seconds after treatment.
4. Cerebrovascular accident within 30 days
5. History of intracranial tumor or vascular abnormality
6. Have received thoracic surgery
7. Have received pleurodesis
8. Wish to receive thoracoscopic surgery for hematoma evacuation directly
9. Allergy to urokinase
10. Sepsis
11. Shock
12. People who are less than 18 years of age, prisoners, aborigines.
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia

The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.

Inclusion criteria

* Healthy infants ≥ 35 weeks
* Neonates 36-96 hours old
* Exclusively breastfeeding
* TSB 0.1-3 mg/dl below AAP-recommended PT threshold
* TSB \< 6 hours ago
* Mothers English-speaking or Spanish-speaking

Outcome Measures

* Primary outcome: Total Serum Bilirubin
* Secondary clinical outcomes: Phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants ≥ 35 weeks
* Neonates 36-96 hours old
* Exclusively breastfeeding
* TSB 0.1-3 mg/dl below AAP-recommended PT threshold
* TSB \< 6 hours ago
* Mothers English-speaking or Spanish-speaking

Exclusion Criteria:

* Infants who have already received formula
* Infants who have received or are receiving Level II or Level III
* Infants who have already lost ≥ 10% birth weight
* Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
Molar Potency Study of HM12470 in Healthy Subjects

This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Females must be non-pregnant and non-lactating
* Males must be surgically sterile or using an acceptable contraceptive method

Exclusion Criteria:

* Participation in an investigational study within 30 days prior to dosing
* Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing
Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function

Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and initially presenting renal anomalies alone.

Biologic analysis and renal ultrasonography once a year.

After puberty or before kidney transplantation

* Abdominal and pelvic MRI
* Intravenous Glucose Tolerance Test

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting an anomaly of renal development due to TCF2 mutation
* Age\<18 years old

Exclusion Criteria:

* Anomaly of renal development without TCF2 mutation
* Age≥18 years old
* Parents or patients refusing to participate to the study
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT

This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ T cell will be separated from peripheral blood of the same donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation；
2. Age criteria: 18-65 years;
3. Weight criteria: \> 40kg;
4. Organ function criteria:

   Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN;
5. Life expectancy of at least 4 months;
6. ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
7. Patients able to understand and sign written informed consent.

Exclusion Criteria:

1. GVHD (graft versus host disease) ≥ grade Ⅱ；
2. Thrombotic microangiopathy；
3. Posttransplant lymphoproliferative disorders；
4. Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
5. Patients with chronic diseases that require treatment with immune agents or hormones;
6. Suffering from systemic autoimmune disease or immunodeficiency disease;
7. Systemic use of steroids;
8. Allergic constitution;
9. Hemorrhagic disease or coagulation disorders;
10. Patients participating in other clinical trials within 30 days prior to enrollment;
11. Patients receiving radiotherapy within 4 weeks prior to enrollment;
12. Pregnant or breastfeeding women;
13. According to the researcher's judgment, the patient has other unsuitable conditions.
Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting

The POKAL-PSY project is a study that monitors participants for five years. The goal of the study is to identify distinguishable subtypes of depression on the basis of biomarkers and to gain insight into their prognostic significance.


Eligibility Criteria:
Inclusion Criteria:

* (PHQ\>8) if depressed
* Subjects of any sex aged between 18-70
* Sufficient ability to speak and understand the german language
* Ability to understand and sign the informed consent form

Exclusion Criteria:

* Cognitive impairment that interferes with reliable completion of questionnaires or answering questions
* Presence of manic episode, bipolar disorder, Schizophrenia or schizoaffective disorder (as well as other diseases in the F2 domain in the ICD), active eating disorder, active drug or alcohol dependence syndrome
* Presence of uncontrolled systemic disease (e.g. autoimmune disease), uncontrolles somatic (other than metabolic or cardiovascular)/ neurologic diseases, current or recent (last month) physical trauma
* Patient with acute suicidal ideation
* known deficiency of alpha-1-antitrypsin
* pregnant or lactating women
Assessment of Rheological Parameters of Human Sputum.

This is a proof of concept study. The aim of this study is to assess a device measuring rheological properties of human sputum of four populations :

* 10 patients with Broncho Chronic Obstructive Pulmonary Disease (COPD)
* 10 patients with asthma
* 10 patients with cystic fibrosis
* 10 healthy volunteers.

This study includes two visits to 48 hours apart.

During the first visit :

* Patients with COPD or cystic fibrosis will have a spontaneous expectoration
* Then all study participants will have an induced expectoration with hypertonic salin solution (4.5%).

During the second visit :

* Patients with COPD or cystic fibrosis will have a spontaneous expectoration
* Then, patients with COPD, asthma and healthy volunteers will have an induced expectoration with hypertonic salin solution (4.5%). Patients with cystic fibrosis will have a spontaneous expectoration 1 hour after an RhDNAse nebulization.

A control spirometry will be perform before each expectoration and during induced expectoration if necessary.

All sputum sample collected will be homogenized and then divided into two equal volumes in order to perform two separate rheological measurements of 15 minutes.

Eligibility Criteria:
Inclusion Criteria of healthy volunteers:

* 18\>BMI\>29
* No smoker
* No acute disease in the previous month

Exclusion Criteria of healthy volunteers:

* asthma, COPD, cystic fibrosis
* contraindications for spirometry
* pregnant woman
* legal exclusion criteria

Inclusion Criteria of patients with cystic fibrosis:

- cystic fibrosis with bronchial disorder. Diagnosis confirmed by a reference center

Exclusion Criteria of patients with cystic fibrosis:

* Forced Expiratory Volume in 1 second (FEV1 ) ≤ 40%, contraindications for RhDNAse, patient with chronic impairment of lung function (PaO2\<60 mmHg at rest). Patient who is unable to perform a spontaneous expectoration.
* case of acute exacerbation during the last month
* contraindications for spirometry
* pregnant woman
* legal exclusion criteria

Inclusion Criteria of patients with COPD:

- COPD with FEV1/Forced Vital Capacity (FVC) \<70% after administration of a beta-2 agonist

Exclusion Criteria of patients with COPD:

* Patient with chronic impairment of lung function and/or FEV1≤ 40%. Patient who is unable to perform a spontaneous expectoration.
* case of acute exacerbation during the last month
* contraindications for spirometry
* pregnant woman
* legal exclusion criteria

Inclusion Criteria of patients with asthma:

- diagnosis of asthma confirmed by a Pulmonologist

Exclusion Criteria of patients with COPD:

* Patient with chronic impairment of lung function and/or FEV1≤ 50%.
* Very unstable Asthma
* case of acute exacerbation during the last month
* contraindications for spirometry
* pregnant woman
* legal exclusion criteria
Pressure Support Ventilation With the Anesthetic Conserving Device

Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation. These effects could be of interest in intensive care patients ventilated in pressure support ventilation mode. The purpose of this study is to evaluate mechanical respiratory effects of sevoflurane administered through a new specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®) in pressure support ventilation in intensive care patients. In fact, dead space and resistance generated by the device could cancel and even deteriorate the potential positive effects of sevoflurane on ventilation.

Pharmacological sedation is often necessary in mechanical ventilated intubated patient. Since a little time, sevoflurane can be used in the intensive care unit via a specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®, SedanaMedical AB, Uppsala, Sweden) placed between the Y piece of the ventilatory circuit and the endotracheal tube. Sevoflurane is known to have ventilatory interesting effects such as bronchodilatation that can be useful in the treatment of severe asthma. These effects could be of interest in the intensive care ventilated patients. On the other hand, the AnaConDa® device could have negative influence on ventilatory mechanics caused by the increased dead space and the resistance to air flow. This negative effect with worsening of work of breathing (WOB) was demonstrated with classic heat and moister exchanger compared to heated humidifiers in pressure support ventilation (PSV). In this way, we would like to study the mechanical effects of the sevoflurane administered with the AnaConDa® compared to a classic management with a heated humidifier and sedation with intravenous remifentanil in PSV consecutive intensive care patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults ICU patients who are no more in acute state, intubated and ventilated in pressure support ventilation with intravenous sedation by remifentanil, with light sedation (RASS -1 to -2).

Exclusion Criteria:

* Respiratory distress.
We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare

The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care.

The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation.

Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants for the pilot RCT will be patients
* aged 18-49 years (childbearing age)
* residing in a Central Brooklyn zip code
* self-reporting as Black,
* who speak English or Haitian Creole, and
* plan to deliver or present for delivery at University Hospital at Downstate (UHD).
* In NYC, SMM increases incrementally with later entry into prenatal care (1st trimester: 208/10,000 deliveries; 2nd trimester: 252/10,000; 3rd trimester: 297/10,000; None: 575/10,000). 3 Accordingly, in order to capture the full range of SMM risk profiles for our pilot study, any pregnant patient/client visiting our clinics will be eligible for enrollment from 13 weeks gestation through delivery, thus allowing follow-up to 3 months post-partum within the 2-year study timeline.

Exclusion Criteria:

* Patients planning to move outside of New York City in the ensuing 3 months post-partum
* Patients demonstrating an impairment that limits their ability to provide informed consent.
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers

Local anesthetic resistance is commonly reported by patients with EDS. However, there are no objective data on the occurrence of local anesthetic resistance in EDS patients and in healthy volunteers. We propose to collect such objective data on the frequency of drug resistance and whether any problems with local anesthesia are due to initial ineffectiveness or due to its effects dissipating too soon.

There was a prior large online questionnaire to better understand the issues around local anesthetic resistance. By November 2018, 933 EDS patients (total 1059 respondents) completed the survey, 99.2% of which had previously received local anesthetics. Among these patients, 88% reported that they have "had a problem with local anesthetic injection not working adequately or properly," while only 54% of respondents without EDS reported a similar problem. These data suggests that local anesthetic resistance might be more prevalent in patients with EDS than in the general population. If these findings are true, then this might have significant implications for the appropriate management of these patients during minor surgery and dental procedures.

This study aims to assess the frequency and related issues around local anesthetic resistance in EDS patients, including whether the problem is a lack of analgesia or a timing effect (short duration of action or delayed onset of action), and whether the problem relates only to some local anesthetics or whether there is a problem with the whole class of local anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* EDS patients, clinically diagnosed hypermobile EDS based on 2017 criteria
* EDS patients with genetically proven non-hypermobile EDS
* Healthy participants, no EDS
* Able and willing to provide informed consent

Exclusion Criteria:

* Known allergy to Lidocaine or Bupivacaine
* Unable to provide informed consent