cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma

To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell leukemia-lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Positive for serum anti-HTLV-I antibody
2. Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
3. Positive for CCR4
4. Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
5. Received at least one prior chemotherapy
6. Subjects with an interval of four weeks or more between the last day of the previous treatment and the scheduled day of the first KW-0761 treatment
7. PS of 0 to 2
8. Negative for HBs antigen and for HBV-DNA by a real-time PCR

Exclusion Criteria:

1. A history of transplantation such as hematopoietic stem cells
2. Positive for HCV antibody or HIV antibody
3. Active multiple cancers at the time of starting this clinical study
4. Previous history of allergic reactions after receiving antibody products
5. Requiring continuous systemic treatment with a steroid
6. Requiring such radiotherapy after starting this clinical study
7. Treated with any investigational drug other than KW-0761 within three months
Validation of a Smart Phone App to Non-invasively Measure the Size of Children

Smart phones are omnipresent. Apps exist to calculate size of medical equipment and doses of medication if a valid weight or age is entered. During emergency situations, these values are often unknown. An App has been developed to measure the size of a child noninvasively. This App is now to be validated in clinical practice. App measured size is calculated and compared to the real size of a child. Via known percentiles of age/weight of the child is calculated upon the App measured size. This value is compared to the mother's, physician's and nurses estimation of the size and weight.

Depending on the size multiple algorithms exist to estimate weight, age and medical values. ("Kindersicher ®", "Notfalllineal ®" and "Broselow Tape ®"). These estimations by the calculations will also be compared to actual weight and age.

Children from 0-12 years of age are included in the emergency Department of the Children's Hospital of the University of Zurich after informed consent obtained by the parents. No therapy decisions from these calculations will be made. The therapy is independent of this study.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients 0-12 years of age (45 per age group)
* obtained informed consent
* admitted to the emergency department of the Children's Hospital of the University of Zurich

Exclusion Criteria:

* physically or mentally unable for measurement
* denial of informed consent
Predictors of Response to Combined Pegylated Interferon and Ribavirin in Chronic Hepatitis C Infected Egyptian Patients

Retrospective prospective cohort study aimed at Assessing the predictors to the response to the antiviral combined therapy with pegylated Interferon (Both types: Alfa 2 A and Alfa 2 B) in hepatitis C virus infected Egyptian patients.

Retrospective prospective cohort study conducted on HCV infected patients treated with Interferon alpha therapy, the retrospective part of the study includes the data of the patients retrieved from medical records from the period from September 2006 till January 2011. Then from January 2011 the study became prospective national study. Responders to therapy were defined by normalization of serum alanine aminotransferase (ALT) and absence of detectable serum HCV RNA at the end of treatment (48 weeks). Relapsed responders to therapy were defined by normalization of serum ALT and absence of detectable serum HCV RNA at the end of treatment but with an increase of the serum ALT and the presence of HCV RNA at follow-up 72 weeks). Non-responders were defined by elevated serum ALT and the presence of HCV RNA at the end of treatment. All patients will sign a written informed consent to share in this clinical registry by their data and biological samples. Sub-studies will be conducted on subgroups of patients sharing in this main study after signing a written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Age: above eighteen years and below 60

  * Detectable HCV RNA in serum by PCR
  * ALT level ranged from normal to three fold elevation.
  * Minimum hematological values of hemoglobin of 10.5 g/dl for females, 12g/dl for males; white blood count 3×109/L; platelet counts not less than 100,000/mm3.
  * Bilirubin, albumin, prothrombin time and creatinine within normal limits.
  * A suitable method for assessment of fibrosis lik liver biopsy or fibroscan will be done before the start of treatment to assess the degree of necroinflammatory response to HCV, which was further subgrouped by HAI scoring system into mild, moderate \& severe.

Exclusion Criteria:

* Decompensated cirrhosis
* Other causes of liver diseases
* Autoimmune disorders
* Uncontrolled diabetes
* Thyroid dysfunction
* Neurological or cardiovascular disease
* Malignancy
The Contact Activation System and Ulcerative Colitis

The study aims to describe alterations in the contact activation system during active and inactive ulcerative colitis.

Contact activation system measures are compared in a cross sectional (healthy controls vs. active disease) and longitudinal (active diasese vs. inactive disease) fashion.

We include and follow up on 102 adults with active ulcerative colitis. Visits are week 0 (inclusion), 6, 12 and 26 (end of study). We obtain plasma and fecal samples at each visit. Whereas we obtain colonic tissue samples only at inclusion and end of study.

Registered data are:

* Demographics realate to UC and general wellbeing.
* Clinical parametres used for UC evaluation are PRO2, SCCAI, CRP, fecal calprotectin, Mayo endoscopic subscore and Nancy index.
* The contact activation system is characterised by FXII, prekallikrein, kallikrein generation, HK, cHK (specific to plasma kallikrein), cHK (specific to tissue kallikrein), C1 inhibitor and Kallistatin.
* Polymerized alpha-1-antitrypsin is characterised by the degree of polymerization and the capacity to activate the contact activation system.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill diagnostic criteria of ulcerative colitis
* SCCAI score ≥ 5
* Mayo Endoscopic Subscore ≥ 1
* Age ≥ 18 years
* Most understand written and oral information in Danish
* Informed consent must be given

Exclusion Criteria:

* Pregnancy
* Infection at inclusion
* Any existing disease at inclusion:

  * liver disease or defect in CAS
  * inflammatory rheumatologic or dermatologic disease
  * cardiovascular or renal disease
  * immunodeficiency or hematologic diseases
  * malignancies
* Medication with

  * Systemic corticosteroids at inclusion
  * ACE-inhibitor
  * Acetylsalicylic acid/NSAID
  * Warfarin, Phenprocoumon, NOAC and heparins
Assessing the Impact of Front-of-package Nutrient Labels

This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info with each scheme having (1) a version with colors (i.e., green, yellow, and/or red) indicating level of nutrient content and (2) a black-and-white version. Additionally the Nutrition Info scheme will have a version that includes the percent Daily Value in black and white. Labels will be compared against a no-label control and one another.

This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info. The labels will have variations, such as color, and will be compared to a no-label control and one another. There will be a total of 6 experimental conditions: 1) High In label with color; 2) High In label in black and white; 3) Nutrition Info label with color; 4) Nutrition Info in black and white; 5) Nutrition Info label in black and white with percent Daily Value listed; and 6) a no-label control.

Participants will view a series of food-and-beverage products labeled (or not) according to condition. The three primary outcomes are: (1) correct assessment of high nutrient contents in food-and-beverage products, (2) perceived healthfulness of packaged foods and beverages, and (3) selection of at least one item high in at least one nutrient of concern (saturated fat, sodium, added sugar) in a shopping task. Perceived message effectiveness will be examined as a secondary outcome.

All statistical analyses will use two-tailed tests with a significance level of \<0.05. Per CONSORT Guidelines, all models comparing labels will be bivariate, regressing outcomes on indicators for labeling condition. For continuous outcomes, linear regression models will be used, and for dichotomous outcomes, risk ratios (or probability ratios) will be estimated using Poisson regression with a robust error variance.

Effect modification of the labels on primary outcomes will be explored for type 2 diabetes status and sociodemographic variables important for health equity using interaction terms and stratified models.

Additionally, differences in the primary outcomes between each of the 6 unique conditions will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Equal or greater than 18 years of age
* English-speaking
* U.S. residents
* Have eaten restaurant food at least once in the last month
* Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age

Exclusion Criteria:

* Failing the attention check question
* Completing the survey in less than 33% of the median completion time
Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation

Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters.

LVAD candidates satisfying the inclusion criteria will undergo vasodilator challenge with sodium nitroprusside (NTP) infusion following the study protocol.

Thereafter, we will evaluate all data in order to determine which variables significantly correlate with RHF onset after LVAD implantation.

Inclusion criteria

* Age over 18 years old.
* Diagnosis of advanced heart failure with an indication for LVAD implantation.
* Mean Arterial Pressure (MAP) \> 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) \> 20 mmHg; Pulmonary Artery Wedge Pressure \>15 mmHg.
* Vasodilator Challenge performed through NTP infusion.

Exclusion criteria

* State of pregnancy.
* Inability to perform vasodilator challenge
* Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.
* Planned right ventricular assist device implantation in the peri-procedural setting.

Right heart catheterization (RHC) RHC will be performed under optimal medical therapy within 90 days before LVAD implantation.

Vasodilator challenge will be performed through intravenous nitroprusside administration and titration (by 5 minutes intervals) until symptoms (flushing or hypotension) onset or systolic systemic pressure drops below 85 mmHg.

Dobutamine or phosphodiesterase inhibitors infusion could be performed at clinician's discretion.

All haemodynamic measurements will be repeated after nitroprusside infusion and titration.

Right heart failure (RHF) Post-operative RHF will be evaluated according to the definition proposed by the 2020 consensus statement of the mechanical circulatory support academic research consortium (1).

Eligibility Criteria:
Inclusion criteria

* Age over 18 years old.
* Diagnosis of advanced heart failure with an indication for LVAD implantation.
* Mean Arterial Pressure (MAP) \> 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) \> 20 mmHg; Pulmonary Artery Wedge Pressure \>15 mmHg.
* Vasodilator Challenge performed through NTP infusion.

Exclusion criteria

* State of pregnancy.
* Inability to perform vasodilator challenge
* Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.
* Planned right ventricular assist device implantation in the peri-procedural setting.
With Continuity of Covid-19 Pandemic, Have Our Anethetic Choices for Caesrean Section Changed ?

This retrospective analytic study will be petformed to investigate if there was a change in the choice of anaethetic technique for caesarean sections with continuation of the COVID-19 pandemic .

The number of regional and general anethesia techniques used with detailed number ofspinals epidurals as well as combined spinal epidurals that were provided .

Eligibility Criteria:
Inclusion criteria:

* pregnant women
* suspected or infected with covid-19
* women undergo cesarean section .

Exclusion criteria:

* normal delivery
* abortion
Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population

There is tremendous curiosity about medical marijuana and the treatment of epilepsy. In a specific genetic epilepsy known as Dravet Syndrome, a mutation occurs affecting the SCN1A gene. A specific strain of marijuana known as Charlotte's Web, available in Colorado, may have activity in this catastrophic epilepsy syndrome. Anecdotal reports suggest both success and lack of response with this therapy. Genetic analysis of the differences between Dravet responders and non-responders may prove useful for identifying patients likely to be helped by this therapy, as well as shed light on the putative mechanisms by which marijuana may exert any antiepileptic effect.


Eligibility Criteria:
Inclusion Criteria:

* age 1-50 with gene confirmed Dravet Syndrome
* uncontrolled epilepsy, having failed at least 2 prior treatments (including appropriate Anti-epileptic drugs, ketogenic diet, vagus nerve stimulation Therapy)
* Seizure frequency should be more than 2 visually countable motor seizures per week (tonic clonic, tonic, clonic, myoclonic, or astatic)
* care providers able to identify convulsive seizures, drop attacks, or tonic seizures, or any combination of countable seizure types
* self- seeking therapy with Charlotte's Web strain of medical marijuana with the assistance of a medical marijuana doctor, but are still naïve to therapy
* care provider able to complete seizure count diary
* able to obtain oral swab sample from subject with Dravet Syndrome
* agree to forfeit any right to results of genetic analysis

Exclusion Criteria:

* subjects having non-epileptic seizures that are not distinguishable from epileptic seizures by the care provider
* prisoners
* pregnant women
* failure to forfeit right to results of genetic analysis
The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetro and Tc-99m Mibi

Research Questions:

1. Is there a significant difference between the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi?
2. Is there a significant difference in the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?
3. Is there a significant difference in the quantitative diagnostic measures reported between the original and the acceptable repeated studies?

There are two commonly used Tc-99m based radiopharmaceuticals useful in the diagnosis and localization of regions of reversible myocardial ischemia in the presence or absence of infarction under exercise and rest conditions. One is Tc-99m tetrofosmin (Tc-99m-1,2-bis\[bis(2-ethoxyethyl) phosphino\] ethane), the other is Tc-99m sestamibi (Tc-99m- methoxyisobutylisonitrile). When performing a myocardial perfusion SPECT (MPS) study, extracardiac subdiaphragmatic activity adjacent to the myocardium can cause artifacts in the inferior wall and can be detrimental to the accuracy of the study1,2. Following acquisition, MPS studies are routinely checked for potential imaging artifacts. When a separation between the extracardiac activity cannot clearly be distinguished from the myocardium, the study should be repeated. Repeating the SPECT study can affect the efficiency of a lab as well as having a negative influence on patient comfort and overall satisfaction. The goal of this study is to determine if there is a significant difference in the number of studies that should be repeated between the two commonly used radiopharmaceuticals.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving sestamibi MPI study or tetrofosmin MPI study

Exclusion Criteria:

* Thallium or dual isotope MPI study
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring

Investigate the efficacy of the inercial Flywheel training protocol in modifying the architecture and function of the hamstrings in patients with a history of structural muscle injury vs conventional training.

The researchers hypothesize that inercial Flywheel training protocol will be a useful strategy in the modification of the architecture and function of the hamstring in patients with a history of indirect structural muscle injury and decrease the recurrence.

Randomized controlled intervention study

Eligibility Criteria:
Inclusion Criteria:

* Adults with history of structural muscle injuries type 3 of the Munich Consensus classification for muscular injuries, confirmed by imaging diagnosis no more than 2 years ago.
* The patient must have performed conventional medical and physiotherapy treatment
* Have Returned to their usual sporting activity
* With good mental health.

Exclusion Criteria:

* Suffer from a systemic pathology that could alter the healing biology of the muscle.
* Present other lesions in the muscular group of extrinsic characteristic or not encompassed within type 3 structural lesions such as, for example, proximal or distal insertion tendinopathy, use of semitendinous as anterior cruciate ligament graft.
* Prior knee or hip surgery.
* Having been infiltrated with platelet rich plasma in the posterior thigth region in the previus 3 months before startin the study
Distress Related to the Feeling of Loss of Dignity in Patients With Rheumatic Diseases

Rheumatic diseases (RD) are an important group of different clinical entities and specific diseases that affect a significant proportion of the world population. In Mexico, the RD have a relevant representation in the adult population.

Dignity is a construct characterized by the representation of the self, of the self from others' point of view, and of the interaction of the individual with the environment and social context.

Living with a chronic illness can threaten experiences of dignity for the sick person and their families. Various studies have demonstrated the direct impact of the disease on dignity in terms of physical and psychological symptoms and loss of function. Some efforts have been made to operationalize the concept of perceived dignity in the context of chronic diseases

The perceived dignity of patients and the distress related to the feeling of loss of dignity (DRFLD) are outcomes that the patient can report and that the doctors can evaluate to be incorporated into the considerations of comprehensive care. Both outcomes are closely related, perceived dignity refers to a complex phenomenon, while distress related to the feeling of loss of dignity identifies those patients with a perceived dignity compromise of such magnitude that it generates anguish.

The Patient Dignity Inventory (PDI) is an instrument originally written in English made up of 25 items integrated into 5 factors that include: symptoms, existential anguish, dependency, peace of mind and social support. Has a Likert-type response system with a 5-point scale, ranging from 1 ''not a problem'' to 5 ''very serious problem"; higher scores indicate greater dignity-related distress.

The PDI has been translated and validated into different languages, including validation in Spanish. The PDI instrument was validated in Mexico by Rodríguez-Mayoral et al., in 290 cancer patients. It had very good reliability with an alpha of 0.95 and a 4-factor structure that explained 64% of the variance (loss of meaning in life, loss of autonomy, dependency, and social support).

The primary objective of the study is the association between the presence of distress related to the feeling of loss of dignity and quality of life in patients with RD

Eligibility Criteria:
Inclusion Criteria:

* Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

Exclusion Criteria:

* Patients with a not confirmed rheumatic disease
Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus who are taking metformin only.
* Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only.
* Male and/or female patients (females will be women of non childbearing potential)
* Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs).
* HbA1c between 7.0% and 10.0%.

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). Patients who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible).
* Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 mL/min
* Any condition possibly affecting drug absorption (eg, gastrectomy)
* History of stroke or transient ischemic attack or myocardial infarction within the past 6 months
* History of coronary artery bypass graft or stent implantation.
* Clinically significant peripheral vascular disease (eg, manifested by claudication).
* Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV.
* One or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months.
* Current history of angina/unstable angina.
* Milk or soy allergy