cyrilzakka/clinical-trials huggingface dataset:
Study of Taste Deficits

This study will explore the genetics of taste and taste deficits. The sense of taste plays a crucial role in food choices, allowing people to identify beneficial foods (those with high caloric value, which are typically sweet) and foods likely to be toxic (usually bitter substances). The loss of sense of taste in older people plays a role in decreased appetite and poor nutrition. Taste deficits may adversely affect people in ways that are not well understood. This study will examine why some people (about one-fourth of all people in the United States) cannot taste a substance called phenylthiocarbamide (PTC). The inability to taste PTC is due to inherited factors that are not yet clear.

Individuals age 18 and older who can taste PTC and individuals who cannot taste PTC may be eligible for this study. Participants will taste a number of liquid solutions until they find one with a clear taste. Then they will taste another group of solutions and decide which ones have that taste and which have no taste. Finally, they will taste a third group of solutions until they find one with a different taste. About 2 tablespoons of blood will be drawn from participants for genetic tests related to the sense of taste.

The primary goal of this study is to identify the underlying cause of deficits in the ability to taste different commonly consumed substances, including the bitter compound phenylthiocarbamide (PTC) as a model. Individuals will be tested to identify those who can and cannot taste PTC, as well as for their ability to taste a variety of sweet, sour, salty, and savory substances. Individuals will have 20 cc of blood drawn to obtain DNA. These DNA samples will then be analyzed for variation in genes whose products are known to be involved in taste perception pathways. Information about individuals DNA sequence variation will then be correlated with their taste phenotype to identify the specific genetic variation that causes phenotypic variation, providing molecular structure-function information in taste sensory pathways.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Individuals age 18 years and older.
* Subjects must be medically healthy, with no cognitive impairment or physical swallowing inability or impairment
* Must be able to provide informed consent
* Must be able to read and understand English.
* NIH employees or staff may participate in this study if they meet the eligibility criteria.

EXCLUSION CRITERIA:

* Cannot be younger than 18 years of age
* Subjects with suspected or known cognitive impairment or physical swallowing inability or impairment
* Subjects who are unable to provide informed consent
* Subjects who are taking any pyschoactive medications or medications that affect their nervous system, such as antidepressants or anti-psychotics.
* Subjects who have known problems with these sense of taste
* Subjects who are currently using tobacco
Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens

To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany.

The study is conducted in the areas of Tuebingen, Freiburg and Saarbruecken in Germany. In total, 10.000 ThinPrep® LBC cervical samples were collected from June 2009 to May 2012. Liquid based cytology (LBC) was performed by a central laboratory in Saarbruecken. Human papilloma virus (HPV) testing with the HR HPV HC2® test and APTIMA® HPV Assay were performed at the Section of Experimental Virology, Institute of Medical Virology, University Clinic of Tuebingen, Germany (UKT).

Within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years.

Study close out visit: In addition, approximately 5 years after baseline ThinPrep® LBC cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value (NPV) and HPV related disease after a 5 year period. Women who tested positive in any test will undergo colposcopy.

Eligibility Criteria:
Inclusion criteria:

* Women aged 30 - 60 years
* Women attending gynaecological practices for routine screening
* Women who gave informed consent to participation in the study

Exclusion criteria:

* Women with hysterectomy or known destructive therapy to the cervix
* Women who are pregnant
* Women with an abnormal cytology result during the previous 6 months
* Women with known HIV infection or history of transplants
* Women vaccinated against HPV
* Women participating in another research protocol
Measure of the Potential Evoked by Electric Stimulation

This study is about an experimental biomedical monocentric search concerning twelves patients presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on the site of the CHU of Montpellier.

The objective of this search is to understand exactly how the electric impulses, delivered by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by tumors infiltrates of low rank, propagate in this one and to identify the nervous networks inhibited by these electric impulses.

Having verified the eligibility of the patients and having obtained their consent, they will be included in the study. Before the beginning of the surgery, the electroencephalography activity of the brain of every patient will be recorded. Before and after the surgical resection, the electrocorticography activity will be recorded.

The collected data will then be analyzed, after the operation. Analyses will try to identify what we call potential evoked by the stimulation and which are small electric waves which appear after the electric stimulation was delivered.

All the surgical operations will be realized by Professor Hugues DUFFAU. The DEMAR-INRIA team will assure the collection and the data processing electrophysiological, the management of the data and the methodological follow-up, as well as the writing of the report and the distribution of the results.

The quality assurance will be assured by a "minimal" monitoring by an assistant of clinical research for the department of the research and the innovation, to Montpellier, which will verify principally the consents.

The electrophysiological data digitized will be stored in the form of computer files via PowerLab.

All the analyses of treatment of signals required to highlight the potential evoked will be realized with the software Matlab.

Eligibility Criteria:
Inclusion Criteria:

* Patient carrier of a low-rank infiltrative glioma (OMS Type II) and presenting the indications to benefit from a surgical care in condition awakened for the first time.
* Patient capable of understanding the nature, the purpose and the methodology of the research.
* Having signed an informed consent writes before the inclusion in the research.
* Membership or beneficiary of a national insurance scheme

Exclusion Criteria:

* Systematic pathology with neurological appearance
* Psychiatric disorders
* History of psychotic disorders
* History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology
* Major protected by the law (supervision or guardianship)
* Loss of liberty by court or administrative order
Bariatric Surgery, Hormones, and Quality of Life

The purpose of this study is to characterize the hormonal status in fertile women undergoing laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation between health-related quality of life and proposed hormone changes post-operatively.

Sex hormone levels in women with obesity are altered in comparison to normal weight subjects. Most previous studies have focused on questionnaire surveys, and on the emotional/psychological aspect of health-related quality of life (HRQoL). It has been shown that bariatric surgery can affect reproductive ability, but the relationship between hormonal changes and HRQoL has been sparsely studied.

Hormone balance is affected by fat allocation, insulin levels and liver function, and these factors are all influenced postoperatively. Also body image and altered body mass composition can influence sexuality in diverse ways.

This leads us to theorize that liver production of SHBG will change after surgery and impact serum concentrations of sex hormones. Normalized levels of testosterone and estrogen may lead to reduced symptoms of hyperandrogenism, restitution of normal menstrual cycles and changes in sexual functioning.

The focus of this study is to analyze sexual and health-related quality of life through questionnaire analyses, and to investigate levels of sex hormones pre- and postoperatively in women undergoing bariatric surgery. Results from questionnaire analyses and hormone data will be tested for possible correlations.

Eligibility Criteria:
Inclusion Criteria:

* Premenpausal women
* BMI \>30
* Undergoing laparoscopic gastric bypass surgery

Exclusion Criteria:

* Smoking
* Liver disease
* Concomitant hormone treatment including all forms of hormone-based contraception
A Prospective Double-blind Interventional Study of Tissue Reaction to Polyglycolic Acid Sutures in Human Skin

Objective

To investigate the tissue reaction produced by implanted polyglactin suture material in normal human skin and to determine the effect of suture gauge on this response.

Design

A prospective, double blind, randomized clinical trial using a novel ethical study design. Both the patient and clinician analyzing the histology were blinded to the suture gauge used.

Participants

A total of 42 consecutive patients presenting to an oculoplastic clinic with involutional entropion and horizontal eyelid laxity, who provided written consent to participate, were enrolled in the study.

Intervention

Patients were randomly allocated to 5/0 or 7/0 Vicryl™ test suture groups. Patient symptoms were alleviated during the wait for definitive surgery by the placement of temporary eyelid everting sutures including a test suture. After 28 days, entropion correction was achieved by a Quickert procedure which includes excision of an eyelid wedge. Histological analysis was carried out, blind to the suture gauge used, on the excised eyelid containing the test suture.

Main outcome measure

Defined histological parameters of suture-related granulomas were measured at multiple levels. Data included granuloma outer diameter, central cellular diameter, giant cell number and area of fibrous coat (calculated from the coat diameter and thickness at multiple levels) and a statistical comparison made between the 5/0 and 7/0 suture gauge groups.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients
* Involutional lower eyelid entropion
* Horizontal eyelid laxity associated
* Informed consent

Exclusion Criteria:

* Inability to provide informed consent
* Previous eyelid surgery
* Poorly controlled diabetes
* Oral steroid use
* Addisons disease
An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy

Children and young people with epilepsy are at increased risk of poorer outcomes related to emotional and psychological adjustment, peer relationship problems, lower academic attainment and mental health problems across the lifespan. Despite the well understood risks, there continues to be a lack of psychological and psychosocial support for young people with epilepsy, and a corresponding lack of evidence regarding the effectiveness of psychosocial interventions. This study aims to evaluate a manualised psychosocial group intervention for adolescents with epilepsy. A cognitive behaviour therapy approach is used, aimed at increasing awareness of how epilepsy may impact upon thoughts, feelings and activities and to develop strategies for improved psychological adjustment. In addition, an epilepsy knowledge component aimed at improving a sense of control and epilepsy self-management is included. A group delivery format allows an opportunity for social modelling, and social problem solving, helping others and relating to other young people with similar experiences. The social learning context and availability of knowledgable facilitators (an epilepsy nurse specialist and clinical psychologist) are also key aspects of the intervention. The study will allow us to establish a standard manualised group intervention that can be used throughout the UK which aims to; establish the effectiveness and desirability of this approach; improve the overall quality of life, psychological health and social integration of young people with epilepsy; and to improve epilepsy knowledge and selfmanagement skills aimed at maximising seizure control and overall management.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Diagnosis of epilepsy (controlled or refractory) of at least 6 months duration
* Between the ages of 1217 years old
* Have a reasonable level of expressive and receptive English language abilities to enable them to fully participate and contribute to the group process
* In mainstream schooling.

Exclusion Criteria:

* Formal diagnosis of Learning Disability or attendance at a school for children with Special Educational Needs
* Complex and severe mental health problems;
* Diagnosis of nonepileptic seizures in the absence of epileptic seizures
* Epilepsies occurring in the context of:

  1. Postnatally acquired structural lesions (e.g. TBI or neurooncological conditions)
  2. Immune mediated disorders (e.g. limbic or antiNMDAR encephalopathy)
  3. Metabolic disorders (e.g. GLUT1 deficiency)
Characterization of Gut Microbiota in Chronic Liver Disease With Decreased Muscle Mass

The purpose of this study was to confirm the presence of specific gut microbiota observed in patients with sarcopenia among patients who agreed to analyze gut microbiota through stool among multi-center chronic liver disease cohort patients.

The effect of gut microbiota on liver disease is also well known and many studies are ongoing. A recently published study summarized the differences in the composition of gut microbiota in non-alcoholic fatty liver, steatohepatitis, and cirrhosis, and reported that metabolites from the changed gut microbiota may be a factor influencing non-alcoholic fatty liver disease (NAFLD) progression. These changes in gut microbiota composition have been reported to affect clinical outcomes in patients by causing an increase in endotoxin, a change in bile acid metabolism, and a decrease in short chain fatty acid. In particular, the reduction of short chain fatty acid is known to be associated with the occurrence of sarcopenia. Sarcopenia, which is common in patients with cirrhosis, which is a representative chronic liver disease, is well known as a poor prognostic factor for patients. Therefore, this study aims to analyze the distribution of gut microbiota observed in patients with sarcopenia through the gut microbiota investigated in the chronic liver disease cohort patient group and the characteristics of the distribution of gut microbiota for each disease corresponding to chronic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who have chronic liver disease (chronic liver disease cohort): alcohol liver disease, non-alcoholic liver disease, liver cirrhosis 2. Patients who consented to a study confirming the gut microbiota 3. Patients with abdominal computed tomography scan taken one month before or after submitting stool for gut microbiota analysis

Exclusion Criteria:

* Patients whose height and weight records are missing from the chart review
A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors

This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).

This is a multi-center, open-label, dose finding, phase I study of single agent CGM097, administered in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. Patients' tumors must be characterized by p53wt status.

The study consists of a dose escalation part, where cohorts of three to six newly enrolled patients will receive escalating doses of CGM097, and a dose expansion part, in which patients are given CGM097 the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Novartis and the site investigators will jointly decide on each dose escalation step based on the recommendation from an adaptive Bayesian logistic regression model (BLRM). If safety data should indicate a lower increment than suggested by the BLRM, the next dose level (DL) will be adjusted accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Patient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
* Tumor of the patient is p53wt
* Evaluable disease as determined by RECIST 1.1
* WHO performance status 0-2

Exclusion criteria:

* Prior treatment with CGM097 or other p53/HDM2-interaction inhibitor
* Patient with symptomatic or growing CNS metastatic lesions
* Concurrent other malignancy
* Clinically significant cardiac disease as defined in the protocol
* Diagnosis of acute or chronic pancreatitis
* Concomitant therapy that precludes enrollment, as defined in the protocol
* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.
A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)

Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery

This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.

This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts, with 3 to 6 patients enrolled at each dose level, and a minimum of 6 patients enrolled at the highest dose level, for a total of approximately 12-18 patients in the dose escalation portion of the study.

SRG-514 doses will be escalated based on safety and potential dose-limiting toxicities (DLTs) within the 14-day period following SRG-514 administration. Patients who do not complete the DLT period for reasons other than study drug related toxicity would be considered non-evaluable for DLT assessment and may be replaced.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Body weight \>50kg
* Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer.
* Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed.
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
* Have adequate organ and bone marrow function at screening

Exclusion Criteria:

* Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs)
* Patients anticipated to require the use of a drain after breast-conserving surgery (BCS)
* Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure.
Cerebrospinal Fluid Collection and Repository Storage

Background:

- Cerebrospinal fluid (CSF) is the liquid around the brain and spinal cord. Many diseases can only be diagnosed by examining the CSF. A lumbar puncture is used to collect and test CSF. Once someone is already having a lumbar puncture, a small extra amount of CSF can be collected at the same time. This fluid can be used to study brain, nerve, and related health issues. Researchers want to collect CSF and blood samples from people who are scheduled to have a lumbar puncture.

Objectives:

- To collect cerebrospinal fluid and blood samples from individuals who are having a lumbar puncture.

Eligibility:

- Individuals between 2 and 100 years of age who are scheduled to have a lumbar puncture for clinical or research purposes.

Design:

* Participants will have a lumbar puncture for clinical or research purposes.
* During the procedure, an additional sample of CSF will be collected. They will also provide a blood sample, if one is not taken at the time of the procedure.
* Treatment will not be provided as part of this study.

In this study we are planning to establish a repository of cerebrospinal fluid (CSF), serum, and plasma. We are planning to collect a small amount of additional CSF and blood on subjects who are already going to have a lumbar puncture as part of their research or clinical care at the National Institutes of Health (NIH). This will allow us to study whether there is an association between neurological diseases and biomarkers, help identify novel pathogens infecting the central nervous system, and better enable us to understand the immune response to infections under future protocols. CSF and blood as well as clinical data associated with the samples will be stored securely.

Eligibility Criteria:
* SUBJECT INCLUSION CRITERIA:
* Subjects (patients and healthy volunteers) 2 years of age and older identified to undergo LP for research or for clinical care purposes at the NIH Clinical Center.

SUBJECT EXCLUSION CRITERIA:

-Subjects (patients and healthy volunteers) with the inability to provide informed consent either directly or via a legally authorized representative.

Inclusion of Vulnerable Subjects - Research Involving Adults Who Are Or May Be Unable To Consent:

-The risks to all subjects involved in this research project are no more than minimal risk as we are only collecting additional CSF and plasma during a LP procedure that is already being performed under a separate research protocol or as a clinically indicated procedure. At the time of the LP it will already be determined if the subject is able to give informed consent and if not a legally authorized representative will have been appointed who will decide if the additional CSF and plasma can be obtained from the individual.