cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma

The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy combination programme originally introduced by GMALL (the German cooperative group for adult acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free survival rates of adult patients with Burkitt's leukemia and lymphoma.

The therapy includes a maximum of six chemotherapy courses (two with high doses of methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses), supplemented by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy.

Cycle A1: prednisone-cyclophosphamide pre-phase (5 days), Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, iphosphamide, vincristine, high-dose methotrexate, triple intrathecal therapy).

Cycle B1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vincristine, cyclophosphamide, high-dose methotrexate, adriamycin, triple intrathecal therapy) Cycle C1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vindesine, high-dose methotrexate, etoposide, high-dose cytarabine).

Cycle A2: like cycle A1, without pre-phase. Cycle B2: like cycle B1. Cycle C2: like cycle C1. Cycle C2 is followed by two additional Rituximab injections.

Notes:

1. patients with stage I-II disease without mediastinal tumor or extranodal involvement receive only the first 4 cycles (A1 to A2).
2. patients aged \>55 years do not receive cycles C (sequence: A1, B1, A2, B2, A3, B3 or A1, B1, A2, B2 if limited stage, with reduced-dose methotrexate).

Eligibility Criteria:
Inclusion Criteria:

* Burkitt's leukemia or lymphoma (new diagnosis)
* Written informed consent
* Age \> 15 years

Exclusion Criteria:

* pre-treated Burkitt's leukemia or lymphoma
* psychiatric disorders
* active second malignancy
* pregnancy
* absence of patient's written informed consent
* participation in other studies that interfere with the study therapy
Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy

This is a clinical study with a medical device that bears the CE mark (approval for marketing in the EU) and is applied within its intended use. It is a prospective, single-centre, single-arm, open-label, observational post-market clinical follow-up (PMCF) study using the "Colon Hydromat" system for bowel preparation prior to colonoscopy. The patients will be treated according to the clinical routine and in accordance with the current IFU.

Aim of the study is to confirm safety and performance (effectiveness) of colon hydrotherapy as bowel preparation for colonoscopy. Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation, especially for patients, who cannot tolerate oral preparations or want to have alternatives because they have experienced the current oral preparations as a burdensome process.

This observational study is intended to answer the question, if the colon hydrotherapy (colonic irrigation with the "Colon Hydromat") works in real-life practice.

Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. The advantage of colonic irrigation is that there is no unpleasant taste, it avoids the discomfort of diarrheic episode and there is no need to drink a large volume of water or fluids. The patient will receive the bowel irrigation with the "Colon Hydromat" directly before colonoscopy, at the same day. Aim of this study is to confirm performance (effectiveness), in terms of an adequate bowel preparation and safety of the "Colon-Hydromat", as alternative bowel cleansing device prior to colonoscopy. The primary performance (effectiveness) endpoint for this study is the colonic cleanliness, defined as overall quality of bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS). The primary safety endpoints for this study are adverse device events (ADE) and serious adverse device effects (SADE), product and procedure related.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication of colonoscopy: inclusion is considered if patients require a colonoscopy and
* desire an alternative bowel preparation method to standard of oral polyethylene glycol or other orally taken purgatives, or do not tolerate the oral preparations, or had an inadequate colon cleansing following traditional oral preparation, in order to complete the colonoscopy at the same day.
* Adult patients (≥ 18 years old) having signed the informed consent.
* Being able to respond to the self-administered questionnaire.

Exclusion Criteria:

* Psychiatric conditions and inability to provide informed consent
* Emergency colonoscopy
* Off-label use (application is not within the IFU)
* Pregnancy and lactation period
* The patient has one of the contraindications listed in the IFU.
Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhalation of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will provide an understanding of the levels of nicotine obtained with use of the company's 1.7% and 5% ENDS products.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 60 years of age inclusive.
* Current smoker or e-cigarette user:
* Able to participate, and willing to give written informed consent and to comply with the ° study restrictions.

Exclusion criteria:

* Clinically significant abnormality on screening ECG.
* Sustained blood pressure recordings at screening of \< 90 mmHg or \> 150 mmHg for systolic blood pressure, or \< 50 mmHg or \> 90 mmHg for diastolic blood pressure.
* Sustained resting heart rate of \> 100 or \< 40 beats per minute at screening.
* Positive result for urine drugs of abuse test or alcohol breath test at screening.
* Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
* Positive urine pregnancy test at screening or Assessment Days in female subjects of child bearing potential.
* Any clinically significant concomitant disease or conditions.
Pharmacogenetics Informed Tricyclic Antidepressant Dosing (PITA)

Tricyclic Antidepressants (TCA's) are the cornerstone of treatment for patients with severe Major Depressive Disorder (sMDD). Current dosing is guided by repeated measurements of blood levels. Compared to patients with a normal metabolization function, for those with increased CYP450 enzyme activity it takes longer to reach a therapeutic drug level. The consequent delay of drug efficacy is associated with a prolonged treatment period, increased risk of suicidal behaviour and eventually lower remission rates. For those with reduced CYP450 activity higher rates of side effects are expected. An innovative TCA dosing strategy, taking the genetic variants of CYP2D6 and CYP2C19 into account may help to reduce the above mentioned problems. Up till now, the current guidelines for CYP450 pharmacogenetics based TCA dosing have not been systematically evaluated for effectiveness and cost-effectiveness in larger groups of patients. Such evaluation is necessary before broad implementation of these guidelines can be advocated. In the present study 200 patients with sMDD who are treated with nortriptyline, clomipramine or imipramine are randomized over two strategies: dosing based both on CYP450-genotype and blood level measurements and dosing as usual (standard doses plus blood levels). We hypothesize that genotype informed dosing results in faster attainment of therapeutic drug levels, lower rates of side effects, earlier symptom relief and lower levels of health- and working related costs.


Eligibility Criteria:
Inclusion Criteria:

Patients are in- and outpatients, having a primary diagnosis of severe major depressive disorder (SCID-I diagnosis in agreement with DSM-5 criteria and a Hamilton Rating Scale for Depression score ≥ 19 (HAM-D-17-item version), aged 18-65 years, who, according to their physician, are eligible for treatment with a TCA (Nortriptyline (NOR), Clomipramine (CLOMI) or Imipramine (IMI)). The choice of the specific TCA is at the discretion of the physician in attendance.

Exclusion Criteria:

1. Psychotic depression
2. Bipolar I or II disorder.
3. Schizophrenia or other primary psychotic disorder.
4. Drug or alcohol dependence in the past 3 months.
5. Mental Retardation (IQ \< 80).
6. For women: pregnancy or possibility for pregnancy without adequate contraceptive measures.
7. Breastfeeding.
8. Serious medical illness affecting the CNS, including but not restricted to M Parkinson, SLE, brain tumour, CVA.
9. Relevant medical illness as contra-indication for TCA use, such as recent myocardial infarction.
10. Other drugs influencing the pharmacokinetics of the TCAs as based on a list of interacting drugs. In case of psychotropic co-medication only a benzodiazepine in a dose equivalent up to 4 mg lorazepam will be allowed.
Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor

Prolonged labor is associated with adverse maternal and fetal outcomes including infection, postpartum hemorrhage and increased NICU admission. One of the most common indications for cesarean section in the US is prolonged labor. Maternal positioning through labor facilitated by birthing balls is believed to help facilitate labor. Current data is inconclusive on whether or not the use of birthing balls is advantageous in a statistically significant manner.

In this prospective randomized controlled trial, participants will be randomly selected to receive either the experimental intervention (repositioning peanut ball during labor) or the control intervention (the standard therapy of traditional repositioning during labor).

Primary outcome: Time of active labor to delivery with and without use of the peanut ball.

Secondary outcome: Cesarean section frequency.


Eligibility Criteria:
Inclusion Criteria:

* Fetus must be vertex in position at the time of admission to L\&D
* Pregnant patients age 16 years old and above
* Singleton pregnancy (ie. one fetus)
* Patients who receive induction and augmentation of labor may be included
* Include both nulliparous and multiparous women
* Patients with HTN, diabetes, and obesity at any point in their pregnancy may be included
* Patients may be included in the study regardless of whether or not they received an epidural
* Patients who have been randomly assigned to receive a peanut ball must be placed on the peanut ball at 6cm dilation, not earlier.
* Patients who present to L\&D dilated to 4cm may be included

Exclusion Criteria:

* TOLACs and VBACs will be excluded
* Multiple gestation will be excluded
* Category 3 fetal tracing will be excluded
* Chorioamnionitis will be excluded
* Patients who present to L\&D at 6cm cervical dilation will be excluded
* Patients placed on the peanut ball before 6cm cervical dilation will be excluded
* Patients with fetal malpresentation will be excluded
Long-term Outcome of HER2-amplified Metastatic Breast Cancer: A Retrospective Analysis

The aim of this study is to analyze cases of human epidermal growth factor receptor (HER) 2-positive metastatic breast cancer (MBC) of the last 10 years at the University Hospital of Zurich to assess the efficacy of the treatment with trastuzumab in HER2-positive MBC and to find out associations between different variables and the outcome. The aim is to find out probable prognostic factors and patterns of disease progression. Prognostic factors could optimize treatment approaches and result in a delay of disease progression.

Human epidermal growth factor (HER2) is a receptor tyrosine kinase and regulates diverse functions in normal cells such as growth, differentiation and survival of cells. In 25-30 per cent of breast cancer HER2 gene is amplified, what result in abnormally high levels of encoded HER2 protein in malignant cells. Overexpression or amplification of HER2 is associated with an aggressive form of breast cancer seen by significantly shortened disease-free survival and overall survival.

Trastuzumab, a humanized monoclonal antibody against the extracellular domain of HER2, inhibits the growth of breast tumor cells by receptor internalization, inhibition of cell-cycle progression and recruitment of immune-effector cells. Trastuzumab, as the first anti-HER2 therapy, is approved since 1998 in the United States and since 2000 in European countries for the treatment of HER2-overexpressing metastatic breast cancer (MBC). Single therapy as well as combination with chemotherapy has significantly improved the outcome of these women. Shown by longer time to disease progression, longer duration of response, lower rate of death at 1 year, longer survival and a 20 per cent reduction in the risk of death.

But still is little known about the long-term outcome nor patterns of disease progression of HER2-positive MBC. A few case reports showed a prolonged complete remission in HER2-positive MBC under an anti-HER2 treatment (trastuzumab, T-DM1, pertuzumab). These cases had some common characteristics such as negative hormone receptor status and metastasis to the live. Another hypothesis is a worse prognosis for patients with early development of CNS metastases.

Eligibility Criteria:
Inclusion Criteria:

* Received at least 1 dose of trastuzumab in metastatic setting at the University hospital of Zurich from 01/2004 to 12/2014.
* HER2+ status confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) ≥ 2.

Exclusion Criteria:

-
Chymase Angiotensin-(1-12) Axis In Hypertensive Disease

Determine the presence of the human sequence of Angiotensin-(1-12) in plasma of ten untreated hypertensive subjects and after 4 week with Lisinopril 40 mg every day. Determine the blood pressure reduction with Lisinopril 40mg.

Determine the presence of the human sequence of Ang-(1-12) in the plasma of ten normal male and female hypertensive patients at baseline and after 4 weeks on Lisinopril 40mg every day. Measure concentrations of Ang-(1-12) in either spot urine collections from ten male and female hypertensive patients at baseline and after 4 weeks of Lisinopril 40mg every day.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of reading, comprehending the consent process and providing written informed consent to participate in the study
2. Subject willing to comply with all study visits/procedures and be available for the duration of the study
3. Male or female 40 years of age to 75 years of age
4. Male and female subjects naive to anti-hypertensive medications or receiving no anti-hypertensive medication for at least 6 months prior to visit 1
5. Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 90 mm Hg and equal/less 109 mm Hg and/or Systolic blood pressure equal/over 140 mm Hg and equal/less 179 mm Hg on visit 1
6. Women may be enrolled if all three of the following criteria are met:

Have a negative urine pregnancy test at visit 1, for females of childbearing potential Are not breastfeeding Do not plan to become pregnant during the study And if one of the following three criteria is met Have had a hysterectomy or tubal ligation at least six months prior to signing the informed consent form Have been postmenopausal for at least one year Are of childbearing potential and will practice one of the following methods of birth control though out the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. Abstinence, partner's vasectomy are not acceptable methods of contraception

Exclusion Criteria:

-
Pediatric Teduglutide Registry

Pediatric specific post-marketing registry to evaluate the long-term safety and efficacy of teduglutide.

This will be a multi-center post-marketing pediatric registry study evaluating the efficacy and safety of teduglutide. This is an observational longitudinal registry of pediatric SBS patients who are using FDA approved teduglutide as per standard of care.

Eligibility Criteria:
Cohort A:

Inclusion Criteria:

1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days
2. Received teduglutide after FDA approval
3. Age ≥ 1 years and ≤ 18 years at start of teduglutide initiation
4. Weight ≥ 10 kg at start of teduglutide initiation
5. Dependent on PS at the time of teduglutide initiation
6. Subject data for primary outcome (PS energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit.
7. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry.

Exclusion Criteria:

1. Participation in the pediatric clinical trial studies of teduglutide (TED-C13-003, TED-C14-006 or SHP633-303, SHP633-304).
2. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.

Cohort B:

Inclusion Criteria:

1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days
2. Participated in clinical trial study (TED-C13-003, TED-C14-006) and/or extension study (SHP633-303, SHP633-304)
3. Currently receiving teduglutide
4. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry.

Exclusion Criteria:

1. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.
Interest of TTC for the Early Diagnosis of Acute Myocardial Infarction at Autopsy

Ischemic heart disease is the leading cause of death worldwide and the leading cause of sudden cardiac death. However, its post-mortem diagnosis is particularly difficult because the gross examination of the heart is usually normal at the autopsy . The diagnosis is therefore often based on a set of indirect arguments, such as the patient's medical and clinical history and the degree of occlusion of the coronary arteries. The formal diagnosis of acute myocardial infarction (AMI) currently relies on standard histological examination. However, histological findings often require a prolonged survival time of several hours to be highlighted. Triphenyltetrazolium chloride (TTC) is a salt that reacts with lactate dehydrogenases contained in still viable myocardial cells, forming a red pigment visible to the naked eye, (1,3,5 triphenylformazan). Ischemia-induced cell death, which occurs within minutes of the causative event, is responsible for the leakage of lactate deshydrogenase into the extracellular medium and thus results in the absence of formazan formation in the infarcted area, which displays an easily identifiable pale unstained color. It has been suggested that the use of TTC would allow the identification of MI as early as one hour of survival in animal models, before the usual macroscopic and microscopic signs are visible. It could therefore represent an attractive forensic tool for the early diagnosis of AMI at the autopsy.


Eligibility Criteria:
Inclusion criteria:

* Adult patients autopsied at the Forensic Institute of the CHU of MONTPELLIER whose ante-mortem (medical history, cardiovascular risk factors, clinical history) and autopsy data (significant coronary stenosis associated or not with an endoluminal thrombus, scars of old infarction, absence of other identified cause of death) suggest AMI as the cause of death.
* Known survival time and postmortem interval.

Exclusion criteria:

- Putrefied bodies
TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Randomized, double-blind study of the tolerability of three different doses of rifapentine

Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.

Eligibility Criteria:
Inclusions:

1. Drug susceptible culture-positive tuberculosis
2. Adequate induction therapy
3. Age \>18
4. Normal screening labs
5. Karnofsky \>=60
6. Informed consent
7. Birth control if of child bearing potential

Exclusions:

1. SilicoTB
2. Skeletal or CNS TB
3. Pregnant or breastfeeding
4. Intolerance to INH or rifamycins
5. Over 70 days TB treatment just prior to enrollment