cyrilzakka/clinical-trials huggingface dataset:
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.

The study design is a double blind placebo controlled trial that will enroll subjects between the ages of 8 - 30 who have had the diagnosis of Type 1 diabetes made 4 - 12 months prior to enrollment. A single 14 course of treatment with mAb hOKT3gamma1(Ala-Ala), Teplizumab will be given. The primary endpoint is the C-peptide response to a mixed meal at 12 months. A total of 60 subjects will be enrolled (30 in the drug treatment and 30 in the placebo groups) at 4 study sites: Yale University,the University of California at San Francisco, Children's Hospital of Philadelphia, and the Barbara Davis Diabetes Center.

Eligibility Criteria:
Inclusion Criteria:

* age 8 - 30,
* duration of diabetes 4 - 12 months,
* weight greater than 27.5 kg,
* stimulated C-peptide \>= 0.2 pmol/ml

Exclusion Criteria:

* asthma,
* history of hepatitis C, hepatitis B, HIV
Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit

An interventional, prospective study. It is estimated that up to 800 patient tissue samples (from approximately 650 patients enrolled at approximately 300 clinical trial sites), will be obtained as part of enrolment into Phase 3 of Clinical Study (Protocol No. 20190009), for testing using the therascreen® KRAS RGQ PCR Kit (KRAS Kit).

This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumour tissue biopsy samples (resected and core needle biopsy \[CNB\]/fine needle aspiration \[FNA\]) tumour tissue ) obtained from patients with Non-Small Cell Lung Cancer (NSCLC), using the KRAS Kit.

Up to 800 patient tissue samples (from approximately 300 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190009), will be tested using the KRAS Kit. The testing will be performed at the investigational device clinical testing sites, Q2 Solutions Laboratories in the four geographical locations: USA, Singapore, UK and China.

The primary objective of the Clinical Study (Protocol No. 20190009) is to evaluate tumour objective response rate (ORR) assessed by MODIFIED RECIST 1.1 criteria of AMG 510 as a monotherapy in patients using the Clinical Study Assay, KRAS Kit to assess whether to treat patients with KRAS G12Cmutated advanced tumours (NSCLC).

The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Eligibility Criteria:
Inclusion Criteria:

* All patients who provided consent (by signing and dating the ICF for Protocol No. 20190009), may be included in the Clinical Performance Study.

Exclusion Criteria:

* Patients whose tumour tissue biopsy samples are not Clinical Study Assay evaluable will be asked to provide further tumour tissue biopsy samples. Patients with samples identified for the study which have insufficient testing material will have their sample excluded, as will specimens which have undergone decalcification.
Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia: Comparison With a Control Group Without Intracranial Pathology

Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 - 80 years old
* Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial
* Scheduled for "procedure"
* ASA Class I, II or III as assigned by the anaesthesiologist

Exclusion Criteria:

* Allergy or inability to tolerate "product"
* Body weight less than 70% or more than 130% of ideal body weight
* Pregnant or nursing females
* Participation in a clinical trial within the past 30 days
* Congenital mental disability or congenital anatomical brain abnormality
* A medical history of cerebrovascular accident or thrombosis
* A medical history of carotic artery occlusive pathology
* A medical history of degenerative cerebral pathology (MS, Dementia, ALS, para-or tetraplegia due to a traumatic disruption of the spinal cord)
* A medical history of severe psychiatric pathology (Schizophrenia, severe depression, alcoholism, drug abuse) Mild depression evoked by coping with the diagnosis of cancer is not excluded
* Patients with a history of epileptic insults. Patients receiving preventive anti-epileptic treatment due to the tumoral process are not excluded.
* Patients with low cardiac output conditions due to pre-existing cardiac pathology (Cardiac insufficiency, valve pathology, dysrhythmia, myocardial infarction). Patients presenting with stable coronary artery disease with a normal myocardial function are not excluded)
* Arterial hypertension is not an exclusion criteria, nor is the use of antihypertensive medication, except beta blockers for their potential interfering effects on spontaneous EEG.
A Comparison of Two GlideScope Intubation Techniques

The aim of this study is to compare the hemodynamic response to tracheal intubations using the standard technique versus the alternative GS intubation technique. As secondary outcomes the investigators will analyze procedure time, success rate and injury rate.

The investigators hypothesize that the alternative intubation technique will have a shorter procedure time and lower injury rate when compared to the standard technique of GS intubation.

A Difficult intubation is still one of the most daunting challenges in anesthesiology. One of the tools used to assist with a difficult tracheal intubation is the GlideScope (GS) (Verathon, Bothell, WA, USA). The GS is a video laryngoscope that has a 60 degree angle blade with a built-in high-resolution camera and a light source assembled beside it. The image is transmitted onto a mobile bedside monitor. It has been widely used in medicine for over a decade. The GS was designed to provide an improved view of the glottis during difficult intubations without alignment of the oral, pharyngeal and tracheal axes, as it is able to "look around the corner" to facilitate the intubation.

The standard technique of the GS intubation involves a midline laryngoscopy followed by the insertion of a styleted endotracheal tube (ETT) once an adequate view of the vocal cords has been achieved. The ETT insertion process requires the operator to look away from the monitor during the laryngoscopy while maintaining the blade position in order to insert it into its initial position.

An alternative GS intubation technique has been described for cases in which there is limited mouth opening, a big tongue or other anatomical impediments. In these cases the ETT is inserted under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx.

There are several advantages to this alternative technique. The first advantage is that this technique of ETT insertion would minimize the laryngoscopy time as a part of it is performed before the blade is introduced and the stimulating effect occurs. This technique thus has the potential of reducing the sympathetic response. Minimizing oropharyngo-laryngeal stimulation time would theoretically attenuate the hemodynamic response.

Eligibility Criteria:
Inclusion Criteria:

* Patients of ASA physical status 1-2
* Patients aged 18 years and older
* Patients undergoing elective surgery that requires tracheal intubation

Exclusion Criteria:

* Patients in whom a rapid sequence intubation or alternative intubation method is indicated
* Patients with a known or suspected oral, pharyngeal or laryngeal mass
* Patients previously flagged as a difficult intubation
* Patients with hypertension (treated or untreated, poor dentition, symptomatic gastro-esophageal reflux or cervical spine instability
A Mobile Phone SMS Intervention to Increase Retention in HIV Care Among HIV-Positive MSM in Peru (WELTEL PERU)

We will use a web-based system in order to deliver a text messaging-based intervention and assess the efficacy to increase retention in HIV care among HIV+ gay men in Peru.

We will determine the efficacy of the SMS-based intervention delivered through a web-based system for increasing retention in HIV care when compared with standard-of-care. We will perform a randomized controlled trial. The main outcome will be retention in HIV care within 1 year after enrollment. Participants will be categorized as retained if they attend three medical appointments for HIV care that are separated by 90 days within a one-year period (at the study clinic). Otherwise they will be classified as not retained. The follow-up period will last 6 months. We will identify and recruit 208 HIV+ MSM over a 12-month period at the research site. Healthcare providers at the clinic will be trained to assess eligibility and obtain consent for this study. After enrollment, the recruiter, who will be masked to the group assignment, will obtain consent and give instructions to all participants on how they should interact if they start receiving SMS (text messages). Participants will be randomized after signing the consent form. They will be assigned a study ID and randomly assigned to the intervention or control arm, 1:1 ratio using computer generated random numbers. Allocations will be sealed in individual, sequentially numbered opaque envelopes. The trained providers in charge of delivering the intervention will be informed when a new participant in the intervention arm is enrolled. Because of the nature of the study, healthcare providers and participants will not be masked to group assignment during the delivery of the intervention. Participants allocated to the intervention arm will have their phones registered into the platform.

Eligibility Criteria:
Inclusion Criteria:

1. Be men who have sex with men;
2. Be 18 years or older;
3. Have been diagnosed HIV positive;
4. Own a cell phone which can send and receive text messages;
5. Reside in Lima, Peru;

Exclusion Criteria:

1) Be enrolled in an interventional trial using text messages.
Options for Lowering the Threshold to Brussels Out-of-hours Primary Care Services for Dutch Speaking Citizens

The purpose of this qualitative study is to find out which technological translation tools can be used to improve Dutch-speaking care in all Brussels out-of-hours primary care services.

Previous studies have shown that language barriers in healthcare can lead to communication problems between healthcare provider and patient. This can lead to a decrease in satisfaction, quality of care and patient safety. Dutch speakers are a minority in Brussels (a Dutch-French bilingual region in Belgium), and the majority of general practitioners (GPs) in the Brussels out-of-hours primary care services are French-speaking. Measures are already being taken to increase the number of bilingual (Dutch and French) GPs.

In addition, several technological tools (e.g. video interpreting, translation apps, ...) exist to overcome language barriers. The investigators want to explore which of these options can be used in Brussels out-of-hours primary care services to improve access for Dutch-speaking citizens. The objective of this study is to examine both barriers and facilitators to use these technological translation tools during language-discordant consultations with a French-speaking GP and a Dutch-speaking patient in Brussels out-of-hours primary care services.

To achieve this objective, the investigators aim to engage Dutch-speaking patients, Dutch- and/or French-speaking GPs, as well as Dutch- and/or French-speaking representatives from pertinent organizational and policy sectors.

There will be about 40 participants in total. Participants will answer questions during an online group session (focus group). There will be 4 focus groups, with a maximum of 10 participants in each focus group. Each focus group will last 60-90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients: adult, living in Brussels, Dutch-speaking
* GPs: adult, working in Brussels, Dutch- and/or French-speaking
* Employees of professional organization-regulatory bodies: adult, Dutch-and/or French-speaking

Exclusion Criteria:

* Subject is not capable of will
* Subject cannot express themself in Dutch or French
Covid-19 Virtual Recovery Study

The purpose of this study is to determine the effects of respiratory muscle training (RMT) and nasal breathing on patients who have been infected with the SARS-CoV2 virus and continue to have lingering symptoms.

This study will be conducted virtually and will be completed at home using a cell phone application. Study participation involves the use of a RMT device, and/or nasal breathing. The purpose of this research is to evaluate the impact of RMT and nasal breathing on chronic symptoms of COVID-19 in patients that have recovered from SARS-CoV2.

Subjects that have tested positive for the SARS-CoV2 infection and have completed a 14 to 30 day quarantine will be recruited.The RMT device will be used up to 2 times a day at a moderate intensity for 2 or 3 sets of 10 or 15 repetitions. Additionally, 2 sets of 10 nasal breathing techniques will be performed twice a day without the RMT device.

Subjects will complete several surveys examining symptoms, physical activity, cognitive function, and quality of life at baseline, 2 weeks, and 4 weeks. Subjects will also perform phonation (speaking/speech sounds) and sit to stand tests at baseline, 2 weeks, and 4 weeks. All data will be collected through the use of a cell phone application. The cell phone application will also provide subjects with the proper RMT protocol. Additionally, subjects will receive coaching and instructions on how to use the breathing device, as well as instructions on how to complete the phonation and sit to stand test.

Eligibility Criteria:
Inclusion criteria:

* Positive test for SARS-CoV2 within the last 3 months.
* Smartphone user.
* English speaker.
* Age 18 or above.
* US resident.

Exclusion criteria:

* Hemodynamic instability.
* Contraindications or inability to perform RMT.
* Inability to navigate study questionnaires or tasks.
* History of kidney disease, arteriosclerosis obliterans, and high calcium levels.
The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training

This project will investigate a novel strategy for enhancing cognitive training (CT). Specifically, the investigators aim to combine a non-invasive form of brain stimulation (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be administered either before or during CT.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy right-handed subjects aged 18 to 40 years.

Exclusion Criteria:

* Concurrent medication likely to affect mental performance,
* Current history of drug or alcohol abuse or dependence,
* Any psychiatric or neurological disorder,
* Recent head injury, or history of seizure or stroke.
A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer

This prospective, multi-center, non-interventional study will evaluate the efficacy and safety of trastuzumab in routine clinical practice in Chinese participants with gastric or gastro-oesophageal cancer. The study will be conducted in 5 cohorts and eligible participants will be enrolled and assigned to the various cohorts according to human epidermal growth factor receptor 2 (HER2) status, disease stage and treatment with trastuzumab according to physician's decision. Treatment patterns and clinical outcomes in participants with gastric cancer in China will be evaluated. The total study duration is 60 months.


Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria:

* Histologically confirmed cancer of the stomach or gastro-oesophageal junction or recurrent disease within 6 months before the date of recruitment
* Documented participant with trackable medical records
* HER2 status by immunohistochemistry (IHC) is known

Specific Inclusion Criteria:

* Cohort I/II/IV: Participants with mGC: with recurrent or metastatic disease or with inoperable locally advanced disease
* Cohort III/V: Participants with operable non-mGC: TxNxM0 (according to American Joint Committee on Cancer \[AJCC\] edition 7th)

Exclusion Criteria:

* Participants receiving regimen in a blinded trial
Effect of Exercise on Irisin Levels of Hypothyroid Rats

The aim of study was to evaluate the role of exercise on serum irisin levels in hypothyroid rats.

Contracting skeletal muscle acts as an endocrine organ, capable of secreting hormones called myokines, such as interleukin 1, Interleukin 15 and Irisin. Myokines are important for regulation of glucose and lipid metabolism. Among these, irisin, is an exercise induced polypeptide, secreted mainly by skeletal muscles and adipose tissue. Irisin is also secreted in small amounts from cardiac muscle, pancreas and sebaceous glands. It is cleaved and secreted from fibronectin type III domain-containing protein 5 (FNDC5 gene) and is regulated by the peroxisome proliferator-activated receptor-γ co activator 1-α (PGC1-α) .

The most important function of Irisin is thermogenesis, by inducing the browning of white adipose tissue, thereby increasing energy consumption, encouraging weight loss and decreasing dietary insulin resistance. Linking Irisin levels with obesity, its mechanism shows that after exercise there is up regulation of a thermogenin ,an Uncoupling Protein-1 (UCP-1) Thyroid hormone also plays an important role in glucose-lipid metabolism and energy homeostasis. Hypothyroidism, a decrease in thyroid hormone levels, can lead to obesity and metabolic syndrome. It has been found that thyroid hormone is also involved in thermogenesis by inducing browning of white adipose tissue, through thyroid hormone receptors. In hypothyroidism, many metabolic processes in the body are affected such as differentiation in the adipose tissue. Increased thyroid stimulating hormone (TSH) causes adipogenesis by stimulating pre-adipocyte differentiation directly through the receptors in the adipose tissue . Fatty tissue is increased by adipocyte hypertrophy as a consequence of previous adipogenesis, and newly formed adipocyte-8, resulting in clinical obesity.

FNDC5 (Fibronectin type III domain-containing protein 5), which is the precursor of irisin, is a protein that is encoded by the FNDC5 gene, is present in many tissues, including the thyroid tissue and therefore effects thyroid hormone.

Dysregulation of both Thyroid and Irisin hormones result in metabolic syndrome. The metabolic syndrome is a common metabolic disorder that has been linked to the increasing prevalence of obesity. By regulating thyroid hormone levels, irisin has a powerful impact on metabolism and thermogenesis. The association of irisin with the thyroid hormone in hypothyroidism still remains unknown and is controversial, and requires further confirmatory studies on experimental models.

Regular exercise is known to have significant beneficial effects on the metabolic health and this is mediated by skeletal muscle. Contracting skeletal muscle is the source of Irisin. Studies have shown an increase in post exercise Irisin levels

Eligibility Criteria:
Inclusion Criteria:

* Male adult rats weighing approx. 200-250gms
* 6 to 8 week old rats

Exclusion Criteria:

* Female rats will be excluded.
* Rats with any obvious pathology
* The rats weighing \>200gm
CO2 (Carbon Dioxide) - Cerebral Oxygenation

Several projects in high altitude research in environments with a low oxygen partial pressure (hypobaric hypoxia) leading to hypoxemia showed, that cerebral perfusion and cerebral performance could be improved by adding C02 (cabon dioxide).

The investigators hypothesize that adding 5% C02 to 02 (Oxygen) also under normobaric conditions increases the time until a significant cerebral hyopxia is measured by near infrared spectroscopy (NIRS) compared to the administration of 95% 02.

lf this hypothesis proves to be true, this approach might be used in situations in which individuals are prone to cerebral hypoxia. In bariatric surgery, patients that experience an apnea phase are more prone to (cerebral) hypoxia due to the fact, that they have a higher body mass index (BMI) leading to a reduced functional residual capacity (FRC), which serves as the oxygen reserve in the body.

On the day of surgery patients will be randomized. After induction of anesthesia and endotracheal intubation patients will be managed by the study team to perform the intervention and the measurements.

According to randomization, investigational medical product (IMP) or comparator will be administrated by ventilator 1/ventilator 2.

At time point 1 apnea will be performed by disconnecting the ventilator from the endotracheal tube until the NIRS value has dropped by 20% from baseline. After that, re-ventilation will be resumed immediately, until parameters have returned to baseline.

During apnea time NIRS and vital signs will be recorded permanently, blood samples will be drawn at definite time points.

Application of IMP (or comparator) will be performed in this cross-over study design in the same manner after the baseline level is reached again.

At the end of the study procedure, after the baseline level of end-expiratory CO2 is reached again, patient will be taken over by the clinical anesthesia team and surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are designated for bariatric surgery at the University Hospital Zurich (USZ)
* Informed Consent as documented by signature
* BMI \>35 kg/m2

Exclusion Criteria:

* Severe end-organ damage: chronic obstuctive pulmonary disease (COPD) GOLD (cassification) III and IV, known hepatic insufficiency or elevated liver enzymes, renal creatinine clearance \<30ml/min
* Severe cardiovascular disease (NYHA classification III and IV)
* Known pulmonary Hypertension
* Cerebrovascular disease
* Pregnancy and lactation
* Cardiac dysrhythmias
* acidosis, chronic pulmonary disease
* Known or suspected non-compliance, drug or alcohol abuse
Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users

The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.

The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes
* Transmetatarsal amputation
* Below-knee prosthetic user
* 2-5 years from surgery

Exclusion Criteria:

* No diabetes
* Other than transmetatarsal or below-knee amputation
* Below-knee amputation but not a below-knee prosthetic user
* Less than 2 years from the amputation
* Over 5 years from amputation