cyrilzakka/clinical-trials huggingface dataset:
Starter Kit Study in Insulin naïve Patients

The concept consists of an initial period (two weeks) of intensive data capture by use of continuous glucose monitoring (CGM) during basal insulin initiation, followed by a second period (variable duration) of basal insulin titration guided by self monitored blood glucose. Data captured during the first period are used as input to an algorithm that estimates the optimal daily dose for the individual patient. The estimated optimal daily dose is used to guide the titration of the basal insulin during the second period. The goal is to safely and successfully achieve blood glucose targets. The concept is based on the use of basal insulin degludec (Tresiba, Novo Nordisk A/S).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Age 18-75 years
* HbA1c 53-86 mmol/mol (7.0-10.0%)
* BMI 20-40 kg/m2
* Insulin-naïve
* Willingness to use CGM consistently during the study period and send/receive data and dose advice to/from HCP via a mobile phone
* Signed informed consent prior to any study procedures

Exclusion Criteria:

* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* Active proliferative retinopathy
* Mean blood glucose \> 15 mmol/l the week prior to screening
* Blood glucose \> 20 mmol/l on the screening day
* Non-fasting ketones \> 0,5 mmol/l on the screening day
* Use of sulfonylurea within 14 days prior to or during the study period
* Change in other antidiabetic medicine than basal insulin during the study period
* Use of corticosteroids within 30 days prior to or during the study period
* Marked change in lifestyle within 30 days prior to or during the study period as assessed by the investigator
* People with type 2 diabetes that suffer from conditions which make tight diabetes control undesirable, e.g. severe cardiovascular disease, according to the investigator
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
* Overall treatment
Tablet-based Cognitive Training

Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One recommended intervention is cognitive stimulation. We try to develop serious games as a further treatment option, also usable in pre-dementia as well as early stages of dementia and for a long period of time.

The main objective of this study is to test, if the computerized-cognitive training (CCT) is able to improve the performance in a score quantifying an "AD-specific" component score. Additionally, the neurobiological effects of the training are investigated.

The study intervention consists of a computer-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months the intervention group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site.

Primary endpoint will be the change in an "AD-specific" component score, quantified by episodic memory, semantic memory and visuospatial abilities. Secondary endpoints are changes in task related brain networks and changes in resting state networks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease
* Patients with increased risk for developing dementia
* Must be able to give their consent

Exclusion Criteria:

* Contra-indications for MRI scanning
* Substance abuse
* Severe medical conditions
Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)

This clinical trial studies how well the Decision Counseling Program works in increasing patient-physician shared decision making and participation in clinical trials for lung cancer patients. Decision aids help provide patients with information that may help them select a course of action related to their cancer care when more than one alternative is available. It also encourages shared decision making allowing patients and their providers to make health decisions together. Determining how patients make decisions about participating in a clinical trial may help doctors facilitate patient decision making and improve participation in lung cancer clinical trials.

PRIMARY OBJECTIVES:

I. Facilitate patient deliberation about participation in a lung cancer clinical trial using the Decision Counseling Program (DCP).

SECONDARY OBJECTIVES:

I. Document the extent to which patient values and preferences are incorporated into physician-patient shared decision making (SDM) about cancer clinical trials.

II. Assess changes in patient knowledge, anxiety, and decisional conflict related to clinical trial participation.

III. Characterize patient and physician experience with intervention exposure.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lung cancer (Stages 0, 1, 2, 3, 4)
* Lung cancer patients for which there is an available interventional clinical trial open at Jefferson Kimmel Cancer Center
* Patients being treated by a lung medical oncologist on the Center City Campus of Thomas Jefferson University
* Able to provide informed consent
* English-speaking

Exclusion Criteria:

* Inability to communicate in English
* Unable to provide informed consent
* Not eligible for an open, actively accruing interventional trial at Jefferson
The Development of a Personalized Decision Aid: Perspectives of Patients and Health Care Professionals on Shared Decision Making and Informational Needs on Radiotherapy for Breast Cancer

Background: The Dutch guideline on breast cancer treatment shows several grey areas, where no clear recommendation is given on the radiotherapy options, but where the advice is to discuss the treatment of choice with the patient. Currently, patients are exposed to different information given by the professionals' personal styles of informing patients. The challenge for all oncological professionals is to give clear, structured, and neutral information on the pros and cons of the treatment option(s) in the context of the natural course of the disease to the patient; to elicit patients' needs and preferences. How and which information should be shared in a decision aid is up for investigation, as well as how this should best be implemented.

Research goals: Qualitative assessment of patients' and health care professionals' informational needs and perspectives on breast cancer radiotherapy and shard decision making.

Methods: Semi-structured interviews will be held with both breast cancer patients and health care professionals. To reach as heterogeneous groups as possible patients of different ages, with different education levels and who underwent different treatments or chose not to get radiotherapy at all will be selected . Data will be collected til saturation is reached. Interviews will be transcribed verbatim and analysed using thematic analysis.

Results: Results of the qualitative study are expected at the beginning of 2017.

Hypothesis: Investigating the patients' and health care professionals' perspectives on shared decision making and informational needs on radiotherapeutic options will help the development of a personalized decision aid eligible for broad implementation.

semi-structured interviews with breast cancer patients and health care professionals.

Eligibility Criteria:
Inclusion Criteria:

* 2-3 months after facing decision or \> 1 year after decision
* able to speak and understand Dutch
* Written informed consent

Exclusion Criteria:

* recurrence of breast cancer prior to interview
Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery

Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been published. The aim of this prospective study is to compare the achievement of diaphragmatic function depending on the type of surgery (abdominal and head and neck surgery).


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Upper abdominal or head and neck surgery
* written consent

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* History of neuropathy or myopathy,
* History of diaphragm paralysis, thoracic surgery, pneumothorax, pneumomediastinum
VERtebral Fracture Treatment Comparisons in Osteoporotic Women

The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD), i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women
* A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required

Exclusion Criteria:

* Increased risk of osteosarcoma
* History of unresolved skeletal diseases that affect bone metabolism
* History of atypical subtrochanteric or diaphyseal femoral fractures
* Abnormally high or low calcium levels
* Abnormally high parathyroid hormone (PTH) levels
* Severe vitamin D deficiency
* Abnormal thyroid function not corrected by therapy
* History of malignant neoplasms in the last 5 years
* Active liver disease, clinical jaundice
* Significant impairment of hepatic or renal function
* History of nephro- or urolithiasis
* Previous or planned kypho- or vertebroplasty
* Active or risk for osteonecrosis of the jaw
* Active or recent history of upper gastrointestinal disorders
* Unable to stand or sit in the upright position for at least 30 minutes
A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib

A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.

An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers when 100 and 150mg of Fostamatinib are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet.

Treatment sequences will be determined using two 2-2 crossover designs in sequence, 1 for treatments A and B, and 1 for treatments C and D. The order of the designs containing AB/BA and CD/DC within the overall design, as well as the order of treatments within each design, will be randomized. This gives a total of 8 possible treatment sequences as follows: ABCD, ABDC, BACD, BADC, CDAB, CDBA, DCAB, DCBA.

Eligibility Criteria:
Inclusion Criteria:

* Males and nonlactating, non childbearing potential females from 18 to 55 years, inclusive and with a weight of at least 50 kg and BMI between 18 and 30 kg/m2, inclusive
* Females must have a negative pregnancy test at screening and on admission to the study center of each period, must not be lactating and must be of non childbearing potential
* Non childbearing potential can be confirmed by being postmenopausal defined as amenorrhea for a least 12 months following cessation of all exogenous hormonal treatments and with FSH and LH levels in the laboratory-defined postmenopausal range
* Non childbearing potential can be confirmed by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.

Exclusion Criteria:

* History of any clinically significant disease or disorder, including GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
* Known or suspected history of drug abuse, as judge by the investigator
* Any clinically significant abnormalities on 12-lead ECG as judged by the Investigator
* Current smokers, or those who have smoked, used nicotine-containing products, or used smoking cessation treatments within the previous 1 month prior to enrollment
Morphological and Functional Evaluation of Irvine-Gass Syndrome

Purpose: To evaluate morphological and functional characteristics of Irvine Gass syndrome

Methods: 30 patients suffering on Cystoid macular edema (CME) secondary to Cataract surgery will be observed and evaluated by fluorescein-angiography, SD-OCT, reading performance, contrast sensitivity and microperimetry in a fixed time schedule


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* St.p Cataract surgery
* able to read
* informed consent
* with fluorescein angiography and SD-OCT diagnosed Irvine Gass syndrome

Exclusion Criteria:

* \< 18 years
* CME of other origin
* diabetic macular edema
Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System

Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* DOAC administered for a minimum of 7 days

Exclusion Criteria:

* Genetic Bleeding disorders. Known or subsequently discovered inherited defects of coagulation (e.g. hemophilia or Von Willebrand disease)
* Not known when last two DOAC doses were administered prior to blood draw
* DOAC first administered (or resumed after temporary cessation) less than 7 days prior to blood draw
* DOAC dosage outside of manufacturer's recommended range (e.g. study subject with renal impairment and supratherapeutic dose)
* Heparin or LMWH administered within 7 days prior to blood draw
* On any medications known to affect coagulation status and listed below
* Bruising, wounds or scarring in the area of venipuncture

List of medications known to affect coagulation status

1. Vitamin K Antagonists \[VKAs\] Warfarin Phenprocoumon Acenocoumarol Tecarfarin \[ATI-5923\] Phenindione Anisindione Elinogrel Vorapaxar Atopaxar
2. Heparin and Heparins Unfractionated Heparin \[UFH\] LMWH Fondaparinux Idraparinux Danaparoid
3. Vasopressin Analogues DDAVP
4. Direct Thrombin \[IIa\] Inhibitors Hirudin Lepirudin Bivalirudin Argatroban
5. Defibrinating Agents Ancrod
Single Dose Study of Tulisokibart (MK-7240) in Healthy Chinese Participants (MK-7240-002)

The goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

* Be in good health
* Has a body mass index (BMI) ≥18 and ≤28 kg/m\^2 and weight ≥40.0 kg
* Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the dosing of study drug

Exclusion Criteria:

Exclusion Criteria include, but are not limited to:

* History of cancer (malignancy)
* Has positive serum test for human immunodeficiency virus (HIV), hepatitis C or hepatitis B virus infection
Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels

Prospective observational study to determine predictors that related to cardiac troponin I (cTnI) release, malondialdehyde (MDA) and high sensitivity C Reactive Protein (hs-CRP) after Tour de Borobudur (TdB) 2017

Eligible Criteria:

1. minimum sample size of 80 men, non-athlete, participants of TdB
2. Classified into two groups: 160kms cycling and 100kms cycling participation
3. 25-55 years old
4. voluntary participate in the research
5. eligible in pre participatory physical examination and ECG test by the doctor
6. have no history of the previous acute coronary syndrome (ACS)

Measurements:

Interview for determining predictors of sports participation history, medical history, family medical history and Rate of Perceived Exertion Measurement and examination to determine: anthropometry parameters, clinical conditions (Systolic BP, Diastolic BP, hemoglobin levels, T-cholesterol and HDL-C levels, the intensity in cycling activities (mileage, velocity, duration, and time for resting), hemodynamic responses (average and maximum heart rate, Karvonen Index), and Hydration status

Other outcome measurements; pre and post-TdB 2017 measurements of cTnI, MDA, and hs-CRP

Eligibility Criteria:
Inclusion Criteria:

* minimum sample size of 80 men, non athlete, participants of TdB
* Classified into two groups: 160kms cycling and 100kms cycling participation
* 25-55 years old
* voluntary participate in the research
* eligible in pre participatory physical examination and ECG test by doctor have no history of previous acute coronary syndrome (ACS)

Exclusion Criteria:

* stop cycling before finish line due to mechanical or bicycle related errors
* (subjects who stop cycling due to any physical symptoms and health related problem included in analysis)
Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid

The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female over 18 years;
2. Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
3. Suitable for the medical history and physical examination like the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.

Exclusion Criteria:

1. Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
2. Have history or active dermal diseases, inflammation, or any related disease;
3. Had invasive aesthetic treatments or surgeries history 6 months before the treatments;
4. Had physical or chemical aesthetic treatments 1 months before the study starts;
5. Have a known history of allergic reactions like hypersensitivity to hyaluronic acid;
6. Patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule;
7. Pregnant or lactating;
8. Use of drugs;
9. Patients with preoperative results considered inadequate.
A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)

This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (PS). This is an extension of other miransertib studies (MK-7075-002 \[NCT03094832\] or ArQule CU/EAP \[NCT03317366\]), and may also enroll participants who are approved for MK-7075-002 but have not yet started miransertib therapy.


Eligibility Criteria:
Inclusion Criteria:

* Has PROS or PS and has been screened in Study MK-7075-002 (or has been approved by the Sponsor to screen for MK-7075-002) or is currently being treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's CU/EAP (NCT03317366)
* For males, agrees to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic during the study period and for ≥90 days after the last dose of study intervention
* For females, is not pregnant or breastfeeding, and is either not a participant of childbearing potential (POCBP) or is a POCBP and is abstinent or uses a highly effective method of contraception

Exclusion Criteria:

* Has previously discontinued miransertib due to related SAEs or other intolerance of miransertib
* Has received other investigational agents, if any, that were administered between leaving Study MK-7075-02 or ArQule's CU/EAP and entering this trial
* Is receiving systemic inhibitors of the mechanistic target of rapamycin (mTOR) pathway (eg, sirolimus, everolimus)
* Is receiving immunosuppressive therapies
* Is receiving continuous high dose steroids
Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia

our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

This randomized controlled study will compare the effect of Lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* ASA status I or II

Exclusion Criteria:

* Unexpected difficult laryngoscopy
* Surgery\>3 hours
Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis

To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mononuclear cell in 22 patients with neurological sequelae due to encephalitis or meningitis at Vinmec International Hospital, Hanoi, Vietnam

Eligibility Criteria:
Inclusion Criteria:

* Neurological sequelae due to encephalitis or meningitis

Exclusion Criteria:

* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
Signaling Pathway Activation After Exercise in Patients With Chronic Obstructive Pulmonary Disease

Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD). Although resistance exercises increase strength and muscle mass in patients with COPD, the response to training appears to be suboptimal in these individuals. A dysregulation in the signaling pathways involved in the regulation of muscle mass could play an important role in this phenomenon.

Hypothesis: Proteins involved in muscle mass regulation will be less activated in the quadriceps of patients with COPD following the acute bout of resistance training exercise compared to healthy age-matched controls.

Our objective is to investigate the impact of an acute bout of resistance training on key signaling pathways involved in the regulation of muscle mass in moderate to severe COPD (FEV1 under 60% of predicted). Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured before after 72 contractions of the quadriceps. The exercise protocol was designed to match the actual exercise prescription model use in the context of pulmonary rehabilitation. A squat, leg press and leg extension will be done at 80% of max with one minute rest between sets. A biopsy of the quadriceps will be done before and after exercise in order to measure phosphorylated kinases, total protein content and mRNA expressions. All our patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition.

Eligibility Criteria:
Inclusion Criteria:

* Male
* COPD with an FEV1 of under 60% of predicted
* non-smoker
* Between 50 and 75 years old

Exclusion Criteria:

* All inflammatory disease (HIV, Cancer, renal and cardiac deficiency)
* Hormonal dysregulation
* Inferior limb pathology
* Neuromuscular pathology
* History of tabacco or alcool abuse
* Oxygen dependent
* Recent exacerbation (2 months) of the symptoms of COPD