cyrilzakka/clinical-trials huggingface dataset:
Reliability and Validity of the Turkish Version of Sensory Hypersensivity Scale

Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system. Patient history and physical examination, quantitative sensory testing(QST), imaging methods, neuroinflammatory marker levels, electrodiagnostic studies and clinical scales can be used in the diagnosis of CS, but there is no standardized method yet. Among these methods, clinical scales are preferred because they are practical, inexpensive and do not require experience. The Sensory Hypersensitivity Scale was developed by Dixon et al. for investigate the personal hypersensitivity and CS. The aim of this study is to investigate the Turkish validity and reliability of the sensory hypersensitivity scale.

The term central sensitization (CS) was first used by Wolf in 1988 and was explained as the increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. With the development of CS, a decrease in the pain threshold and an increase in generalized sensitivity occur. There is no method for the diagnosis of CS is accepted as a gold standard. Clinical scales and quantitative sensory testing (QST) is used for this purpose widely. In addition, the well-known scale used for the evaluation of CS is the Central Sensitization Inventory (CSI), developed for detect CS in chronic pain patients. The use of CSI, which is more practical to use, is becoming widespread because QST takes time, is costly and requires experienced practitioners. Considering the place of sensory hypersensitivity in the diagnosis of CS and the application difficulties of QST, the Sensory Hypersensitivity Scale was developed in 2016. This scale includes 25 questions in the form of a Likert scale and questions the increase in modality-specific (touch, taste, hearing, etc.) sensitivity as well as the general sensitivity increase. Especially in chronic pain conditions, there is an increase in the evidence regarding the development of CS day by day, and the need for auxiliary tools in diagnosis is increasing in parallel. In this study, it was planned to show the Turkish reliability and validity the Sensory Hypersensitivity Scale.

Eligibility Criteria:
Inclusion Criteria:

* Have musculoskeletal pain that lasts for at least 3 months
* Accepting to participate in the study

Exclusion Criteria:

* Refuse to participate in the study
MK0954A-264 Filter Study (0954A-264)(COMPLETED)

To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)

Exclusion Criteria:

* Systolic BP \> 200 mmHg
* Secondary or malignant hypertension
* Taking more than 2 antihypertensive medications
* Hypertension induced by oral contraceptives
* Hx of cerebral vascular accident within 6 months
* Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months
* Clinically significant AV conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope
* History of angioedema
* Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney function
* Pregnancy or lactation.
Bosentan in Children With Pulmonary Arterial Hypertension

The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by the parents or the legal representatives.
* Males or females \>= 2 and \< 12 years of age.
* Idiopathic PAH or familial PAH diagnosed by right heart catheterization (Clinical classification of pulmonary hypertension, Venice 2003).
* World Health Organization (WHO) functional class II or III.
* Oxygen saturation (SpO2) \>= 88% (at rest, on room air).
* PAH treatment-naïve patients or patients already treated with either:

  * Bosentan monotherapy
  * Intravenous epoprostenol monotherapy
  * Intravenous or inhaled iloprost monotherapy
  * Combination of bosentan and intravenous epoprostenol
  * Combination of bosentan and intravenous or inhaled iloprost.
* All patients should start the study drug (bosentan pediatric formulation) at 2 mg/kg twice daily (b.i.d.), whether or not they were previously treated with bosentan.
* PAH therapy stable for at least 3 months prior to Screening.
* Stable treatment with calcium channel blockers, if any, for at least 3 months prior to Screening.
* Patient's PAH condition stable for at least 3 months prior to Screening.

Exclusion Criteria:

* PAH associated with conditions other than idiopathic or familial PAH.
* Non-stable patients, e.g., history (in the last 3 months prior to Screening) of recurrent syncope, or signs and symptoms of non-compensated right heart failure.
* Need or plan to wean patients from intravenous epoprostenol, or intravenous, or inhaled iloprost.
* Body weight \< 4 kg.
* Systolic blood pressure \< 80%, the lower limit of normal range, according to age and gender.
* AST and/or ALT values \> 3 times the upper limit of normal ranges.
* Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
* Hemoglobin and/or hematocrit levels \< 75% of the lower limit of normal ranges.
* Pregnancy.
* Known intolerance or hypersensitivity to bosentan or any of the excipients.
A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants

The main purpose of this study is to determine the effect of selpercatinib on the levels of dabigatran in the blood stream and how long it takes the body to remove dabigatran. This study will also look at how safe and well-tolerated of dabigatran when administered in combination with selpercatinib in healthy participants. This study will last approximately 22 to 25 days.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females, as determined by medical history, physical examination and vital signs.
* Body mass index (BMI) within the range of 19 to 35 kilograms per meter squared (kg/m²)
* Male participants are not required to adhere to contraceptive requirements and female participants of childbearing potential must agree to be either remain abstinent or stay in a same sex relationship without sexual relationships with males or must agree to use a highly effective method of contraception and who underwent bilateral salpingectomy. The Female participants not of childbearing potential are not required to use contraception.

Exclusion Criteria:

* Have a positive pregnancy test at screening or Day -1, where applicable
* Are planning to become pregnant during the study or within 1 month of study completion
* Are women who are lactating
* Have known allergies to selpercatinib- or dabigatran-related compounds or any components of the formulation of selpercatinib or dabigatran, or history of significant atopy
* Have a history of allergic reactions to medications or food products
* Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator
* Have known bleeding disorder including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder
* Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF \>450 msec on more than 1 ECG obtained during screening only
* Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib
* Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have an average weekly alcohol intake that exceeds 21 units per week (males ≤65 years old) and 14 units per week (females); 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirit(s)
* Are smokers of more than 10 cigarettes or e-cigarettes, or 3 cigars or 3 pipes, per day
* Consume excessive amounts of coffee, tea, cola, or other caffeinated beverages per day
Differences in Evoked Intracellular Interferon Signaling Pathways Using Single Cell Phosphoprotein Profiling

Purpose:

The purpose of this exploratory study is to evaluate phosphoprotein profiling to determine differences in the intracellular actions of interferon or interferon stimulated genes among people with different treatment outcomes to interferon based therapy for hepatitis C (HCV). Participants: Patients with genotype 1 HCV who have had interferon based therapy at the University of North Carolina (UNC). Procedures: Thirty patients with varied responses to treatment will be given a single subcutaneous injection of interferon alpha 2b. Prior to the injection and at 30 minutes, 1,2,4,6,12 and 20 hours after injection, blood will be drawn for analysis of phosphoprotein profiling and changes in serum cytokines.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for this study, subjects must meet the following inclusion criteria:

* Willing and able to provide informed consent
* Males or females age 18 - 65 years
* For women of childbearing potential, negative blood pregnancy test documented within the 24-hour period prior to IFN-α administration
* History of genotype 1 HCV infection previously treated with peginterferon and ribavirin and with a virological response that can be determined from retrospective review of medical records
* A washout period of \>12 weeks between the last dose of prescribed peginterferon and ribavirin and the screening visit

Exclusion Criteria

Subjects with any of the following will not be eligible for participation:

* Neutrophil count \<1500 cells/mm3, Hgb \<12 g/dL in women or 13 g/dL in men, or platelet count \<75,000 cells/mm3 at screening
* Serum creatinine level \>1.5 times the upper limit of normal at screening
* Poorly controlled psychiatric illness, as determined by the study physician, which can be exacerbated by interferon therapy
* Infection requiring antibiotics, symptomatic viral infection, inflammatory process requiring therapy, or allergic reactions in the week immediately preceding the inpatient study visit
* Use of medications that affect the immune system (e.g. glucocorticoids, chronic NSAIDs daily) in the week immediately preceding the inpatient study visit
* History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, psoriasis, rheumatoid arthritis)
* Women with ongoing pregnancy or breast-feeding
* History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
* History of a seizure disorder or current anticonvulsant use
* History of major organ transplantation with an existing functional graft
* History of thyroid disease poorly controlled on prescribed medications
* History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Attachment-Based Family Therapy for Adolescents With Binge Eating

The purpose of this study is to examine whether Attachment-Based Family Therapy (ABFT), a well-validated treatment for adolescents with depression and suicidality, is feasible and acceptable for adolescents with binge eating and their families.

This study involves a phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 16 weeks of ABFT treatment. The treatment primarily focuses on improving communication and relationships within the family, and will also address disordered eating behaviors (e.g., binge eating, laxative use, self-induced vomiting). All participants enrolled in the study will receive the same treatment. Participants will also complete research assessments throughout treatment, at the end of treatment, and 3-months after the end of treatment. Research assessments include a battery of questionnaires and interviews.

Eligibility Criteria:
Inclusion Criteria:

* Speak, write, and understand English
* Age 12-22 years old
* Have a diagnosis of DSM-5 AN, BN, BED, or OSFED
* Medically stable for outpatient treatment
* Must have a parent, guardian, or primary caregiver who is willing to participate in the study and treatment

Exclusion Criteria:

* Acute suicide risk
* No parent or guardian agreement to participate
* Are currently receiving psychological treatment for an eating disorder
* Are currently receiving weight loss treatment
* Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
* Diagnosis of intellectual disability
Study of the Need for Temperature Probe Covers for Newborn Babies on Radiant Warmers

The purpose of this study is to examine the need for reflective heat shield covers over the temperature probes applied to the skin of newborn babies who are being nursed under a radiant warmer.

Servocontrolled radiant warmers are widely used for infants' temperature maintenance. Covering the attached skin temperature (or thermistor) probe with a reflective shield may prevent inadvertent warming of the probe by the radiant heat source. However the shield itself might cause falsely elevated or lowered measured skin temperatures, and the use of such shields, while widespread, is not universal nor standard of care. This study aims to document the effects of a reflective shield on the measured skin temperatures of neonates nursed under radiant warmers.

Stable newborn infants in the Maimonides NICU who are being nursed under a radiant warmer will be studied. As part of routine care, the thermistor probe will be applied and the desired servocontrolled skin temperature set. Once stabilized, a trimmed reflective shield to cover only the probe itself will be placed over the thermistor probe. Changes in measured skin temperature and warmer power output will be recorded non-invasively, as well as the time taken to reestablish baseline status. A full-sized reflective shield will then be placed over the thermistor probe and the same observations recorded, then repeated 15 minutes later. At the time of a subsequent routine change in thermistor position, the same procedure will be followed, but omitting the intermediate step of using the smaller trimmed shield. Continuous core temperatures will be monitored via a short rectal probe during the study periods.

The effect of the use of the different size temperature probes will be examined by analyzing the effect on measured skin temperature.

Eligibility Criteria:
Inclusion Criteria:

* Stable newborn infants greater than 1000g birth weight
* On room air or on CPAP in 21% oxygen
* Being nursed under radiant warmer

Exclusion Criteria:

* Major congenital anomalies
* Significant dermatological pathology or abnormalities
* Documented or suspected sepsis
Effect of Microbial Exposure on Health, Particularly Immune System

The effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses.

The effect of microbial exposure on healthy human subjects will be investigated. The volunteers will either receive material containing a microbial inoculum, or they will receive nothing. Changes in cytokine and IgE and vaccine response will be measured. Subjective well-being will be recorded. Changes in microbial community will be followed. The hypothesis is that microbial exposure increases the measured responses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults that live in urban conditions; that do not own a furry pet; that do not have HIV or other condition that weakens immune system; that do not use drugs chilling immune system; that do not have a history of five active infections that caused hospitalization within 2 years; that do not have a condition affecting immune response (e.g. rheumatoid, colitis ulcerosa, Crohn disease); that do not have dementia, acute depression or psychosis; that do not have cancer within 2 years; that do not have sore skin in arms or hands; that do not have diabetes; that do not have incompetency; that have not received earlier vaccine against Pneumococcus sp.; that do not have unwillingness to receive the vaccine; that do not live in countryside.
An Additional Analysis of Data from the PARADIGM Exploratory Study (NCT02394834) in Patients with Advanced/Recurrent Colorectal Cancer

The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer.

In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.

This is a non-interventional study to do additional exploratory analysis of biomarkers from the PARADIGM Exploratory Study (NCT02394834), which is conducted for participants with advanced/recurrent colorectal cancer. 757 patients have enrolled in the PARADIGM Exploratory Study.

Eligibility Criteria:
Inclusion Criteria:

1. Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent.
2. Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.

Exclusion Criteria:

Participants who are considered inappropriate for participation in this study by the research institution.
Laparoscopic Sacrocolpexy Versus Lateral Suspension

Surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal vault. Most of studies shows a success rate of 80% of this procedure.

However, access to the promontory could be difficult in patients because of adherences or anatomical reasons. This step of the procedure also exposes to risk of ureteral or vascular injuries. Recent issues have also found spondylodiscitis cases.

The technique of laparoscopic lateral suspension with mesh was developed by Dubuisson in 1998 allows not to have to approach the promontory and avoids both the risk of vascular injury and ureteral damage of laparoscopic sacrocolpopexy. Instead of attach the mesh to the promontory, the procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall. The aim of this study is to compare the clinical and functional efficiency of the lateral suspension versus laparoscopic sacrocolpopexy.

It is a prospective, randomized, monocentric study compared two groups The study hypothesis is that the lateral suspension would provide correction than the laparoscopic sacrocolpopexy.

The primary outcome is the comparison of anatomic correction rates at 1 year Success is defined as 1 year Ba et C points \< -1 centimeter in POP-Q international score.

Secondary endpoints are improve of quality of life evaluated with the validated P-QOL questionnaire, and complications rates, including post-operative posterior prolapse.

Number of subjects required is 72 patients, 36 in each group having a laparoscopic sacrocolpopexy or lateral suspension.

Outcomes will be evaluated at 1 month and 1 year post-operative consultation


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old.
* Patients who agreed to participate in the study and signed informed consent.
* Patient affiliated to a social protection system.
* Surgical indication by laparoscopy of prolapse cure symptomatic of the anterior stage and / or isolated medium.

Exclusion Criteria:

* Minor patient.
* Patient refusing to sign the consent or unable to receive the necessary information to give informed consent.
* Patient not affiliated to a social protection system.
* Presence of one or more contraindication (s) to laparoscopy
* Presence of posterior prolapse requiring surgical treatment
* Need for an associated surgical procedure.
* Major people under legal protection
Electronic Pediatric Emergency Ruler vs the Broselow Tape.

Comparison of two different pediatric emergency rulers for length-based body weight estimation in pediatric emergencies.

Primary outcome is the time needed to identify four defined parameters from the pediatric emergency rulers during a low-fidelity pediatric emergency scenario (cardiac arrest). Secondary outcome is the correctness of the identified parameters and the percentage deviation from the correct value.

Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich Switzerland were asked to participate in this study. If they were not familiar with one of the three devices written informed consent was obtained and the participant included in this study. This exclusion criteria was necessary to prevent a bias by already knowing where to find the information of interest.

The pediatric emergency rulers investigated were the electronic Pediatric Emergency Ruler (ePER) and the Broselow Tape (BT)

All participants were instructed for the use of the two pediatric emergency rulers and were given time to practice with each device using one training manikin (Sim-Baby)

After they felt comfortable using the devices the participants were randomly assigned to use each device only once with one of two different manikins:

Resusci Baby, Laerdal/Dräger Medical Switzerland AG, Liebefeld, Switzerland Ambu® Junior, Ambu® GmbH, Bad Nauheim, Germany

Each manikin was only used once for the same participant. This guaranteed that the participants were blinded for the manikins.

The low-fidelity pediatric emergency scenario simulated was a cardiac arrest and the participants were asked to identify the following information from the pediatric emergency rulers:

Estimated body weight Joule suggested for defibrillation Recommended epinephrine dose Suggested endotracheal tube size

Participants stood aside from the manikin with a pediatric emergency ruler in their hand. After they stated they were ready, the facilitator started a countdown from three and gave the command to start. This setting was identical for all two pediatric emergency rulers and all two manikins. The time until each parameter was identified and the value of the parameter were recorded.

Primary outcome was the time needed to identify the four above defined parameters. Secondary outcome was the correctness of the identified parameters and the percentage deviation from the correct value.

Eligibility Criteria:
Inclusion Criteria:

* Medical team members (Paramedics, EMT) of Schutz und Rettung Zurich, Zurich, Switzerland
* Written informed consent

Exclusion Criteria:

* Having worked with one of the pediatric emergency rulers and knowing where to find the defined parameters