cyrilzakka/clinical-trials huggingface dataset:
Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients

The purpose of this study is to investigate whether cells from a biopsy taken from the patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart muscle cells) when grown in a special culture medium outside of the body. The structure and function of these cells will then be studied to determine why some patients with breast cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age greater than 18 years
* Willing to participate in protocol procedures with signed informed consent
* Assessment of LVEE via echocardiogram, cardiac MRI, or MUGA

Subjects in the cardiotoxicity group (TOX) must meet the following criteria:

* History of HER2 positive breast cancer (stage I-IV)
* Prior/current treatment with anthracycline based chemotherapy followed by anti-HER2 directed therapy or anti-HER2 directed therapy alone
* Assessment of LVEF at baseline prior to initiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA
* Prior confirmed diagnosis of cardiotoxicity associated with anti-HER2 based therapy, defined as a decrease in LVEF \> 10% from baseline to \< 53% with symptoms of heart failure (NYHA class II-IV).

Subjects in the no cardiotoxicity group (NO-TOX) must meet the following criteria:

* History of HER2 positive breast cancer (stage I-IV)
* Completion of planned anthracycline and anti-HER2 therapy, or anti-HER2 therapy alone
* No symptoms of heart failure (NYHA class II-IV) during and at the end of anthracycline and anti-HER2 therapy
* Assessment of LVEF at baseline prior to innitiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA
* Normal LVEF \>53% at each assessment during and at the end of trastuzumab therapy.
* Maximum absolute decrease in LVEF \<5% from baseline during and at the end of trastuzumab therapy.
* LVEF assessment performed at baseline and at least two time points during trastuzumab therapy.

Exclusion Criteria:

* Unwilling or unable to give skin biopsies
* Contraindications to punch biopsy including but not limited to bleeding diathesis, as determined by the investigator.
* Known pre-existing CV disease prior to initiation of breast cancer therapy as determined by the investigator, including

  * Obstructive coronary artery disease (stenosis \>70%)
  * Arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (\>30 seconds), ventricular fibrillation, or cardiac arrest
  * Cardiomyopathy (EF \<53%)
  * Heart failure (NYHA class II-IV)
  * Valvular heart disease with equal to or greater than moderate stenosis or regurgitation
Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* unruptured cerebral aneurysm
* elective endovascular treatment
* stenting required
* dual antiplatelet therapy required

Exclusion Criteria:

-none
Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Patients with gastric or colon cancer with peritoneal carcinomatosis will receive a biopsy of the tumor during their primary curative surgery. The operation is performed according to standard and includes resection of the primary tumor and any metastases and followed by HIPEC (Intraperitoneal hyperthermic chemoperfusion) according to the respective hospital standard. Organoid cultures from the biopsies are established in the research laboratory.

Various chemotherapeutic agents are tested on these tumor organoids in the laboratory and the tumor organoids are analyzed in detail with regard to genetic alterations in order to find alterations that can be addressed, if necessary, by means of targeted drugs against peritoneal carcinomatosis.


Eligibility Criteria:
Inclusion Criteria:

* (Suspected) synchronous or metachronous peritoneal metastasis of adenocarcinoma of the stomach / gastroesophageal junction (GEJ) or of the colon or rectum
* intraoperative histological confirmation of synchronous or metachronous peritoneal carcinomatosis in gastric carcinoma (incl. GEJ) or colon carcinoma (incl. rectal carcinoma)
* Intraoperative peritoneal cancer index (PCI) ≤ 15 for gastric carcinoma and ≤ 20 for colon carcinoma.
* Possibility of surgical resection of peritoneal carcinomatosis (cytoreductive surgery) in curative intention with achievement of a Completeness of Cytoreduction Score (CCS) of 0-1
* No contraindication to surgery
* No contraindication against the performance of HIPEC
* Expected survival of 6 months at least
* ECOG ≤ 2
* Female and male patients ≥ 18 years of age
* Patient is able and willing to give written informed consent and comply with the study protocol

Exclusion Criteria:

* Presence of non-resectable distant metastases
* Patients with extensive metastasis (e.g., multiple bilobular liver metastases, hepatic and pulmonary metastases, multiple retroperitoneal lymph node metastases; oligometastasis is allowed)
* Patients with recurrence of peritoneal carcinomatosis (e.g., previous peritonectomy in the course of primary tumor resection)
* Patients after previous palliative chemotherapy or radiation of the tumor (exception: neoadjuvant and/or adjuvant therapies)
* Hypersensitivity/allergy to components of the planned intraperitoneal chemotherapy
* Patients not eligible for surgery/HIPEC (e.g., heart failure NYHA ≥III, myocardial infarction within the last 3 months before surgery, high-risk cardiac arrhythmias)
* Secondary malignant disease that occurred \<5 years ago (exception: early stage of a localized tumor with in-sano resection, for example in situ carcinoma of the cervix, Adequately treated basal cell carcinoma of the skin)
* Patients who are housed in a closed facility
* Pregnant or breastfeeding patients, or patients who plan to become pregnant within 7 Months after the end of treatment to become pregnant
Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire

validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.


Eligibility Criteria:
Inclusion Criteria:

* Femal patient aged \> 18 years
* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneal
* patients whose disease progresses or relapses
* patients having received at least a line of platinum-based chemotherapy
* patients whose treatment of relapse is envisaged to comprise paclitaxel
* patients who will receive EPO for treatment of their anaemia
* ECOG performans status \< 2
* life expectancy \> 16 weeks
* patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

* peripheral neuropathy grade \> 2
* history of ischemic cardiopathy, congestive heart failure (NYHA\>2), arrhythmia, hypertension or significant valvulopathy
* abnormal biological values
* A therapy or a serious disease which could involve a risk for the patient or interfere with the aims of the study
* patient who is pregnant, breast feeding or using inadequate contraception
* concomitant therapy by a potentially neurotoxic drug
* concomitant inclusion in another therapeutic trial which could interfere with the aims of the study
* patient who for familial, sociological, geographical or psychological condition could not be followed correctly
Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin

The Temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. The investigators wish to study the responsibility of Temocillin in the occurrence of adverse effects in patients in the hospital of Amiens receiving a treatment containing this molecule.

The study "Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumoniae: stability, compatibility, population pharmacokinetic studies and breakpoint selection, R. De Jongh, et al, 2007 ", the author states that no adverse effects were found following injection of Temocillin. In the study "Temocillin use in England: clinical and microbiological efficacies in infections caused by extentedspectrum and / or derepressed AmpC β-lactamase-producing Enterobacteriaceae, I. Balakrishnan, et al, 2011, the author faced two cases of Clostridium difficile with a positive toxin test. The first patient received three doses of Amoxicillin / clavulanic acid followed by one week's treatment with Temocillin. This one has developed Clostridium difficile diarrhea on the last day of antibiotic treatment. The second patient did not not received Temocillin in the 6 weeks prior to diarrhea but received 8 days of Meropenem just before this diarrhea. In all cases, Temocillin can not be clearly attributed to this adverse effect and no patient developed pseudomembranous colitis.

Eligibility Criteria:
Inclusion Criteria:

* documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to Temocillin

Exclusion Criteria:

* History of hypersensitivity to betalactamines (rash,...)
* Patient participating in another biomedical research on a drug to avoid the risk of interactions drug
* Grafted patient
* Immunocompromised patient
* Dialysis patient (except hemodialysis patient and dialysis patient peritoneal)
Vitamin D Receptor, Interleukin-1A and Interleukin-1B Gene Polymorphisms in Periodontitis

Background: The aim of the study is to find out the prevelance of VDR (rs731236), IL1B (rs1143634) and IL1A (rs1800587)gene polymorphisms in Turkish population and their association with stage III grade B / C periodontitis.

Methods: Individuals who were found to be systemically and periodontally healthy (N = 100) after clinical and radiographic examination and who were diagnosed with Stage III Grade B / C periodontitis (N = 100) were included in the study. Gingival index, Plaque index, bleeding on probing, clinical attachment level and pocket depths of the patients were recorded. subjects genotyped for rs731236, rs1143634 and rs1800587 gene polymorphisms with Real Time Polymerase Chain Reaction.

In this study we recruited 200 participants from the Periodontology Clinics. Periodontal clinical parameters such as plaque index, gingival index, probing depth and clinical attachment level were assessed. Genotyping rs731236, rs1800587 and rs1143634 gene polymorphisms was performed by Real Time Polymerase Chain Reaction.Statistical analysis was done by the statistical software package SPSS v16. SNPassoc.

Eligibility Criteria:
Inclusion Criteria:

systemically healthy, previously untreated periodontitis patients

Exclusion Criteria:

presence of systemic disease such as diabetes, rheumatic fever, liver or kidney diseases, neurologic deficiencies, immunologic diseases; pregnancy; smoking; receive of any medication which may affect periodontal tissues; used antibiotics for any purpose within 6 months.
Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1

A strength and endurance training program was conducted in adults with myotonic dystrophy type 1 (DM1). Participants underwent a 12-week/18-session supervised training program consisted of 6 exercises: elbow flexion/extension, shoulder horizontal adduction, leg press, and knee flexion/extension. To offer a complete training program aimed at improving function it was divided: the first 6 weeks were dedicated to strength-training, whereas the following weeks focused on endurance-training. To evaluate the effects of the training program, participants completed maximal strength, endurance and functional evaluations. Volunteers could also add a muscle biopsy at the beginning and the end of the program to evaluate physiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adults with DM1
* Walk without technical aid
* Muscle impairment rating scale (MIRS) of 3 or 4

Exclusion Criteria:

* Severe musculoskeletal disorders
* Any medical contraindication to physical exercise
* Any medical contraindication to muscle biopsies for the biopsy volunteers
ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder

The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.

This project aims to develop an objective diagnostic instrument for ADHD through an automatic voice-analysis system, which uses as input the natural speech of the participants. The underlying voice-analysis procedure was developed by J. Langner at Humboldt University of Berlin (Langner 2003). It ignores the semantic content of spoken words and extracts prosodic and sound features from the speech.

Aims of the study:

* deliver optimized multivariate logistic regression models of prosodic and sound properties of speech for ADHD.
* observe sensitivity and specificity of the voice-analysis procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50.
2. Written informed consent.
3. Adult ADHD / Non-ADHD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
4. Normal vocal functioning, negative history for voice or laryngeal disorders.
5. Currently euthyroid condition; in case of past history of thyroid disease and need for current pharmacological treatment, patient needs to be on stable medication for at least 4 weeks.

Exclusion Criteria:

1. Exclusion of borderline and antisocial personality disorder, assessed by the German version of the SCID-II (Fydrich et al., 1997).
2. Exclusion of schizophrenia and psychotic disorders not otherwise specified.
3. Exclusion of Epilepsia.
GRoup A StrePtococcus

The purpose of the research is to help understand why some children become carriers of strep and whether children who are carriers need to be treated with antibiotics.

The overall objective of this investigation is to understand the differences in Group A streptococci in children who are acutely infected from those who are carriers. The hypothesis is that when in the carrier state, GAS exhibits unique transcriptional profiles that differ from those of the acute infection state. The investigators expect transcriptional profiles of GAS to provide important information regarding the changes the organism undergoes when transitioning between acute infection and carriage.

The specific aims of this study are:

1. To collect longitudinal participant-samples from acute and carriage phases of GAS infection and compare transcriptomic profiles and whole genome sequences of GAS recovered from acute and carrier pharyngeal swabs obtained from the same participants.
2. To evaluate how identified differentially expressed genes, or observed genetic polymorphisms, influence GAS models of bacterial colonization and pathogenesis.

To do this, the investigators will to identify 12 children with acute pharyngitis due to Group A streptococcus (GAS) who are pharyngeal carriers of GAS. Thirty percent of children 4 to 16 years of age with acute pharyngitis occurring between October and May will have a positive culture or rapid antigen detection test for GAS. Approximately 8-10% of these children with pharyngitis and a positive culture or rapid antigen detection test (RADT) for GAS will be carriers. Therefore,180 participants will need to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 5-15 years
* Positive rapid antigen detection test for group A streptococcus
* Parent or legal guardian present and able to provide consent
* Provider prescribes treatment with a beta lactam antibiotic
* English speaking

Exclusion Criteria:

* Unable to take beta lactam antibiotics
* Other concurrent bacterial infection, i.e., pneumonia
A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults

The purpose of this study is to compare three finished products of PF-06954522 in terms of the uptake into the blood stream.

This study is seeking participants who are:

- Healthy male or female participants aged 18 years or older.

All participants in this study will receive PF-06954522 once by mouth. The participants may receive different tablets by mouth for PF-06954522.

The study will compare experiences of people receiving three different products of PF-06954522. This will help understand how much PF-06954522 is taken up into the blood for each product given.

Participants will take part into the study for about 77 days. During this time participants will have to stay onsite for 21 days. There will be one follow up (by telephone) study visit.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants of non-childbearing potential aged 18 years or older who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and electrocardiograms.
* Body mass index of 16-32 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or participants with suspected MTC per the investigator's judgement.
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of any prohibited prior/concomitant medication(s).
* A positive urine drug test at screening or admission.
Cognitive Development After Pediatric Liver Transplantation

The purpose of this study is to investigate the cognitive performance after pediatric live transplantation.

During the last 20 years, survival rates after pediatric liver transplantation (Ltx) have increased steadily. Today, pediatric Ltx is a well-established treatment for a variety of liver diseases in their final stage. Even in relative indications (i.e. certain metabolic diseases), liver transplantation is a promising treatment option that actually is becoming increasingly important in clinical practice .

Importantly, childhood cognitive ability is highly predictive for educational achievement and later occupational outcomes as well as health behavior . Current research indicates that liver transplanted children are at higher risk for developing cognitive deficits compared to the age-matched normal population .

The aim of present study is to evaluate the cognitive development after pediatric liver transplantation. The investigators expect to understand of the association between cognitive deficits and certain disease-related variables, which may be contribute to optimizing clinical care of these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients accepted Live Transplantation before 12 month, and now age between 2 and 7 years;
2. residency in China;
3. sufficient Chinese language skills;
4. at least 1 year post-Ltx;
5. no acute diseases;
6. no mental handicap.

Exclusion Criteria:

1. Re-transplantation
2. Patients with localized or systemic infection
3. Patients cor-morbid with auto-immune disease
4. Combined liver and kidney transplantation
5. Lack of informed consent
The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)

The aim of the study is to choose an optimal stent and to get further knowledge about the mechanisms of the engraftment of a stent.

The occurrence of a hyperplasia of neointima can be minimized by application of a coated stent and a concurrent safety four weekly dual thrombocytes therapy


Eligibility Criteria:
Inclusion Criteria:

* male and female patients with a severe dysfunction of liver
* patient is planned a coronary stent implantation
* adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
* written informed consent prior to study participation

Exclusion Criteria:

* younger than 18 years
* pregnancy and breast-feeding
* acute cardiac syndrome
* contraindication against an intracardiac catheter
* persons in dependence from the sponsor or working with the sponsor
* participation in a parallel interventional clinical trial
* patient has been committed to an institution by legal or regulatory order
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)

A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.


Eligibility Criteria:
Inclusion Criteria:

* Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study

Exclusion Criteria:

* Subject weighs less than 110 lbs.
* Subject has received treatment for hepatitis C virus infection in the 3 months before enrollment in this study or is anticipated to begin treatment with in 1 year after enrollment
* Subject has any history of anaphylaxis or allergy to vaccine components
* Subject has any history of anaphylaxis or allergy to Tetanus and Diphtheria Toxoids Adsorbed (Td)
* Subject has clinical signs suggestive of cirrhosis
* Subject has had a liver biopsy showing bridging fibrosis or cirrhosis
* Subject is HBsAg positive
* Subject has other known chronic liver disease
* Subject has evidence of hepatocellular carcinoma on liver biopsy
* Subject has had a liver transplant or is anticipated to have a liver transplant within 1 year of enrollment
* Subject has been vaccinated with a live virus vaccine in the past 30 days
* Subject has been vaccinated with an inactive virus vaccine in the past 14 days
* Female subject is pregnant or breast-feeding, Male subject is planning to impregnate
* Subject has active drug or alcohol abuse
* Subject is at high risk for HIV infection