cyrilzakka/clinical-trials huggingface dataset:
QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors

This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be conducted in the United States and Spain.

Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479 that is safe and tolerable.

Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Histologically or cytologically confirmed, locally advanced or metastatic, treatment-refractory solid tumors
* Part 2: Histologically or cytologically confirmed, locally advanced or metastatic: NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens), Colorectal Cancer (up to 2 prior treatment regimens), Pancreatic Cancer (up to 1 prior treatment regimen), Ovarian cancer (up to 2 prior treatment regimens), or Sarcoma (up to 2 prior treatment regimens), according to cohort availability
* Eastern Cooperative Group (ECOG performance status of 0 or 1
* Women or men ≥16 years of age
* Adequate hematology, renal, hepatic, coagulation and glycemic function.

Exclusion Criteria:

* Presence of uncontrolled central nervous system (CNS) disease
* Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved anticancer proteins/antibodies therapy ≤28 days before enrollment.
* Prior treatment with death receptor agonists (including but not limited to rhApo2L/TRAIL \[AMG951\], apomab, mapatumumab, lexatumumab, CS-1008)
* Prior treatment with IGF receptor antagonists (including but not limited to CP-751, 871, MK0646, AVE1642 or IMC-A12)
Presenting Summary Information From Cochrane Systematic Reviews to Physicians

The objective of this study is to evaluate the efficacy of infographics, compared to standard PLS and scientific abstract format, in presenting information, in terms of understanding and remembering research results by physicians.

The investigators will conduct a randomized controlled trial (RCT) with three different formats of the same systematic review summary (Infographics, PLS, scientific abstract). The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation in plain language, plain language only, and text with scientific abbreviations. The interventions will be delivered online in January 2016, with physicians who are currently working at Clinical Hospital Split. The trial will be preformed online, and it will be voluntary and anonymous. The survey will consist of 5 parts, in the following order: 1) one format of the summary (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the information given in the summary, and 5) user friendliness of information and overall satisfaction with the given summary assessed by survey.

Eligibility Criteria:
Inclusion Criteria:

* physicians who are working at Clinical Hospital Split

Exclusion Criteria:

* none
Multi-slice CT Coronary Angiography in Patients With Stable Angina

early identification of vulnerable plaques by remodeling index prior to rupture and development of acute event is of considerable importance especially by a reliable non-invasive method as CT coronary angiography.

single-center, cross section, observational study included 150 patients with stable angina with normal resting ECG, negative markers, normal systolic function by 2D echocardiography (EF\>50%) and without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree.

Eligibility Criteria:
Inclusion Criteria:

* first attack, low to intermediate risk stable angina
* normal resting ECG,
* negative markers
* normal systolic function by 2D echocardiography (EF\>50%)
* without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree.

Exclusion Criteria:

* previous acute coronary syndrome or revascularization, those with renal impairment or dye hypersensitivity, patients with morbid obesity (BMI\>40kg/m²), rhythm other than sinus rhythm inability to hold breath for 10sec to acquire the image lesions with heavy calcium score.
An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants

The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
* Male and female participants of age 18 to 45 years, both inclusive
* Serum potassium, calcium, and magnesium values within normal ranges

Key Exclusion Criteria:

* Median QTcF\>450 msec on triplicate 12-lead ECGs
* History of conduction abnormalities

Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients

This clinical investigation addresses the performance of a re-designed The current study aims to investigate the next version of the TW speaking valve, in combination with both a 15mm and 22mm HME cassette.

This clinical investigation addresses the performance of a re-designed (updated) speaking valve with Heat and Moisture Exchangers (HME) for tracheotomized patients (project development name 'TW', commercial name 'DualCare'). Study participants trial the new device for 2 weeks after which they can choose to discontinue using the device or continue in the 3 month follow-up part of the study. Clinical feasibility is assessed using structured questionnaires addressing voice and speech, quality of life, breathing, swallowing, olfaction, sleeping, and respiratory symptoms. This is an exploratory, observational study and no specific hypotheses have been formulated.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* has a tracheostomy
* is spontaneously breathing
* has a cuffless tracheostomy tube
* has a tracheostomy tube with inner and outer cannula
* currently uses an HME and/or speaking valve

Exclusion Criteria:

* patient unable to handle or remove the device him/herself when needed, e.g. has decreased level of cognition or reduced mobility of the arms and/or hands
* is mechanically ventilated in any way
* has a tidal volume of less than 100 ml
* is suffering from severe aspiration
* is laryngectomized: the device will block the possibility to exhale if speaking mode is unintentionally activated
* has severe upper airway obstruction, this may cause air trapping
* has thick and copious secretions which might block the device
Computerized Psychoeducation for Anxiety Sensitivity

This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology.


Eligibility Criteria:
Inclusion Criteria:

* Elevated Anxiety Sensitivity Cognitive Concerns and indicated by the anxiety sensitivity index-3

Exclusion Criteria:

* History of epilepsy or seizures
Pregnancy With Morquio Syndrome - What Are Patients' Perspectives and Has ERT Changed Them?

The present study seeks to interview women with Morquio A and Morquio B syndrome, to explore their concerns surrounding pregnancy and the impact of ERT on their perspectives, in comparison with the control group of Morquio B subjects for whom no ERT treatment exists.

Interviews will be conducted by a health psychologist, in-person or over the telephone. Data will be analyzed using MAXQDA 12.0 software and Grounded Theory. Differences in thematic trends between Morquio A subjects, for whom treatment exists, and a control group of Morquio B subjects, for whom there is no treatment, will be compared.

The present study seeks to interview women with Morquio A and Morquio B syndrome themselves, to explore and discover their perspectives and concerns surrounding pregnancy and having biological children, the impact of the advent of ERT for Morquio A on their perspectives and concerns in comparison with the control group of Morquio B subjects for whom no ERT treatment exists, as well as what each group is being told by the medical community and others in their lives in this regard.

Interviews will be conducted by a health psychologist, either in-person or over the telephone. We will interview 1) those women with Morquio syndrome who are known to have been pregnant and 2) those women with Morquio syndrome who have not been pregnant and/or chose to adopt children. All information will be kept confidential, except as in accordance with Georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent.

Data will be analyzed using MAXQDA 12.0 software to develop code which can be used to describe and compare the data using Grounded Theory. Differences in thematic trends between Morquio A subjects, for whom treatment exists, and a control group of Morquio B subjects, for whom there is no treatment, will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Documented clinical diagnosis of either MPS IVA or MPS IVB, based on clinical signs and symptoms, documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis.
2. Subject is at least 15 years old.
3. Subject is female.
4. Subject is fluent enough in English to complete in-depth interview with PI.

Exclusion Criteria:

1. Patient has a clinically significant disease other than Morquio which would confound the effects of Morquio upon study variables.
2. Any condition that, in the view of the Investigator, places the patient at high risk of poor compliance or of not completing the study.
Early SARS-CoV-2 Tracheostomy

Objective of this case series was to evaluate the characteristics of early COVID-19 tracheostomy and its effect on laboratory parameters. A series of 17 patients with COVID-19undergo surgical tracheostomy in our intensive care unit. Demographic parameters, duration indicators, and laboratory parameters before and after tracheostomy were analyzed in patients. Of the 17 patients, 4 were men and 13 women with a mean age of 59 years. The average length of total hospitalization were 12 days, the length of stay in intensive care were 10 days, the length of endotracheal intubation were 9 days, with the seventh day of tracheotomy. Neurological and thyroid diseases and withdrawal had a statistically significant difference (p \<0.05), with laboratory parameters without statistically difference. Critically ill COVID-19 patients undergoing early tracheostomy has a lower possibility of weaning from mechanical ventilation, and early tracheostomy itself has no significant effect on renal parameters, lactate and D-Dimer.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 postive patients
* surgery tracheostomy patients

Exclusion Criteria:

* trachestomy before admission in the ICU
A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC

To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.

To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.

Eligibility Criteria:
Inclusion Criteria (Patients)

1. Male and female outpatients 18-55 years of age
2. A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
3. Patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. Subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. If fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)).
4. If on non-stimulant medications, dose must have been stable for at least 4 weeks.

Exclusion Criteria (Patients)

1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
2. Active substance dependence (except for tobacco).
3. Pregnant or nursing females.
4. Inability to participate in testing procedures.

Inclusion Criteria (Healthy Control)

1. Male and female outpatients 18-55 years of age

Exclusion Criteria (Healthy Control)

1. Diagnosis of psychiatric of neurological disorder
2. Ongoing treatment with any psychotropic medications.
3. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
4. Active substance dependence (except for tobacco).
5. Pregnant or nursing females.
6. Inability to participate in testing procedures.
Rectal Indomethacin vs Intravenous Ketorolac

Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.


Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)
* Age 6 month- 21 years old
* Does not meet exclusion criteria

Exclusion Criteria:

* \< 10 kg
* Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy.
* High risk for bleeding (Example: Planned liver biopsy)
* Gastrointestinal bleeding in previous 3 days
* Acute pancreatitis (within 3 days) at the time of ERCP
* Use of NSAIDs in the previous 5 days
* Peptic ulcer disease
* Acute kidney Injury or Known Chronic Kidney Disease per KDIGO
* Pregnancy (Pregnancy tests are administered prior to ERCP as standard of care)
* Lithium therapy
* Allergy to ketorolac or indomethacin
* Organ Dysfunction or SIRS
MAP to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

The purpose of this Cohort Treatment Plan is to allow access to nilotinib for eligible patients diagnosed with relapsed or refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

Currently, preliminary responses of nilotinib monotherapy in adults with refractory or relapsed Ph+ ALL show limited clinical benefit in this population of patients with a high unmet medical need. Remissions induced by imatinib are of short duration and resistance to imatinib represents a major clinical challenge. The exact benefit and role of nilotinib in this leukemia remains to be determined and requires further analysis. Until further data is available patients with Ph+ ALL should be treated with nilotinib through the Individual Patient Program.. Studies to date indicate that nilotinib may provide clinical benefit to Ph+ ALL patients and may represent a novel treatment option for these patients.

Eligibility Criteria:
Inclusion Criteria:

The following criteria must be fulfilled for the provision of Managed Access and will vary depending on the stage of the product lifecycle:

* An independent request should be received from the Treating Physician (in some instances from Health Authorities, Institutions or Governments);
* The patient to be treated has a serious or life threatening disease or condition, and no comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition;
* The patient is not eligible or able to enroll in a clinical trial;
* There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated;
* Provision of the investigational product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program and
* Such access provision as described above is allowed as per local laws and regulations.

Exclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:

1. Male or Female patients age ≥ 18 years
2. WHO Performance Status of 0, 1 or 2
3. Relapsed or refractory Ph+ ALL
4. Imatinib (or dasatinib) must be discontinued at least 5 days prior to beginning therapy
5. Normal organ, electrolyte and marrow functions as described below:

   * Absolute Neutrophil Count (ANC) ≥ 1.0 x 1000000000/L
   * Platelets 50 x 1000000000/L
   * Potassium ≥ LLN (Lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of nilotinib
   * Total calcium (corrected for serum albumin) ≥ LLN
   * Magnesium ≥ LLN or corrected to within normal limits with supplements prior to the first dose of nilotinib medication
   * AST and ALT ≤ 2.5 x ULN or ≤ 5.0 x UL:N if considered due to tumor
   * Alkaline phosphatase ≤ 2.5 x ULN
   * Serum bilirubin ≤ 1.5 x ULN
   * Serum amylase and lipase ≤ 1.5 x ULN
Empowerment and Support for the Diabetic Patient

CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.

Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.

Research Group 300 type 2 diabetics: 150 from Jewish sector and 150 from Arab sector will be recruited from 7-10 clinics in each district: North District and Haifa District A personal coaching intervention will be tailored from the offered tools: Face to face, group, telephone Participants will be monitored for clinical and self treatments outcomes Comparison Group 300 patients with similar characteristics to the research group will receive Clalit's standard of care Participants will be monitored for clinical and self treatments outcomes like the research group

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* At least one oral anti diabetic drug
* HbA1c above 7.5% ot above 0.5% of personal target
* Preparedness for change
* Fluent Hebrew or Arabic

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Incompetency to sign consent
* Participation in another clinical trial
* Unstable psychotic disease
* Complex health condition
Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)

The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18 to 80 years of age at Visit 0
* Women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the Risk Evaluation Mitigation Strategies (REMS) guidance
* Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a pulmonary vascular resistance (PVR) \>300 dyn\*sec\*cm-5, mean pulmonary artery pressure (PAP mean) ≥25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤15 mmHg as assessed by right heart catheterization within 6 months prior to Screening (Visit 0)
* PAH of the following types:

Idiopathic (IPAH) Familial (FPAH)

Associated with PAH (APAH) due to:

Connective tissue disease Congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment Anorexigen or amphetamine use Portal hypertension with liver cirrhosis

* Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit 0)
* 6MWD between 150 meters and 450 meters

Exclusion Criteria:

* Patients who are pregnant
* Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)
* Non-WHO group 1 Pulmonary Hypertension
* Severe restrictive lung disease
* History of uncontrolled high blood pressure or hypotension
* A medical disorder, condition, or history that in the opinion of the Investigator would impair their ability to participate or complete this study
* Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization