cyrilzakka/clinical-trials huggingface dataset:
Testing the Effect of the InsuPad Device in Daily Life Conditions

This is the test protocol for the InsuPad device. The aim of the study is to show economical benefit when using the InsuPad device, by testing the effect of the InsuPad device on reducing injected insulin dose while keeping the same overall glycaemic control.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 75 years (including 18 and 75 years old).
* Type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of \> 60 IU/day.
* HbA1c \>=6.0% and =\< 8%
* Use of short-acting prandial insulin analogues with multiple daily injections. The analog insulin brands to be used will be either insulin Lispro (Humalog, Liprolog) or insulin Aspart (NovoRapid) or insulin Glulisin (Apidra).
* Subject agrees to sign consent form before any study-specific tests or procedures are to be performed.
* Study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book.

Exclusion Criteria:

* Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
* Known gastro- or enteroparesis.
* Unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start.
* Severe hypoglycaemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
* Hypoglycaemia unawareness (Score \> 4 in the Hypoglycaemia Awareness Questionnaire)
* Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
* Any known life-threatening disease
* Pregnant women, lactating women or women who intend to become pregnant during the observation period
* Any other condition or compliance issues that might interfere with study participation or results
* Subjects with heat sensitivity
* Subjects involved in or planned to participate in other studies
* Subjects who are incapable of contracting or under guardianship
Metabolic Effects of Rowing Multi-races Events

The aim of this study was to assess the relevance of NRI or athletes' NRI (ANRI) utilization to detect nutrition-related risks of failure in competition in the particular population of rowers.

In the morning, 60 to 90 minutes before the first race of a national level multi-races competition (three races for each subjects), body weight were measured and blood samples were collected with subjects at rest and in post-absorptive condition (last meal at least 2.5 hours before blood collection). Body weight was also recorded in the same conditions six weeks before the competition to calculate weight state (actual weight /usual weight ´ 100) and subjects were asked to identify the date of diet beginning. Body weight was measured using a floor scale (Mettler-Toledo floor scale, France), body mass index (BMI) was calculated from the ratio of weight (in kg) by height squared (in meters) and training volume (total duration of training in a week) was determined after discussion with athletes and coaches.


Eligibility Criteria:
Inclusion Criteria:

Competitors, volunteers

Exclusion Criteria:

non competitors
Trial of Bilateral tDCS for Depression

Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be measured during the trial.


Eligibility Criteria:
Inclusion Criteria:

1. Participant meets criteria for a DSM-IV Major Depressive episode.
2. MADRS score of 20 or more.

Exclusion Criteria:

1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
3. Inadequate response to ECT in the current episode of depression.
4. Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
5. Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
6. Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
7. Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
9. Participants who are not fluent in English will not be included in the trial for safety reasons.
Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma

Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18 to 32 kg/m2
* A diagnosis of moderate asthma (according to GINA 2015) for a period of at least 2 years prior to screening.
* Patient must use a stable medium daily dose level of inhaled corticosteroids (ICS) as defined by GINA guidelines, ie, total daily dose of ICS \>400 μg and ≤800 μg/day of budesonide or equivalent for at least 1 month prior to screening and during the study
* A pre-bronchodilator forced expiratory volume in the first sec (FEV1) ≥60% and ≤90% of the predicted normal values at screening and pre-dose at screening
* A documented positive response to the reversibility test at the screening, defined as improvement in FEV1 ≥12% and ≥200 mL over baseline after 400 μg salbutamol Pmdi
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent.

Key Exclusion Criteria:

* Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening.
* Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to screening.
* History of life-threatening asthma
* Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening.
* Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2016); or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease).
* Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening.
* Use of oral antibiotics/anti-infectives within 2 weeks prior to screening.
* Known sensitivity to doxycycline or tetracyclines, or to any of the components of the investigational product formulation.
* Recent (within the previous 2 months) bacterial, protozoal, viral, or parasite infection.
* History of tuberculosis or systemic fungal diseases
* Patients treated with a monoclonal antibody based therapy (such as an anti-IgE, anti-IL-5), a biologic therapy or immunotherapy (subcutaneous immunotherapy \[SCIT\], sublingual immunotherapy \[SLIT\], or oral immunotherapy \[OIT\]) in the previous 12 weeks prior to screening and during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib

Upon determination of eligibility, patients will be receive:

* Bortezomib

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Multiple Myeloma
* Received no more than 2 previous treatment regimens for multiple Myeloma
* ECOG performance status 0, 1, or 2
* Serum creatinine \< 2.0mg/dL
* calculated or measured creatinine clearance \> 30ml/minute
* Measurable or evaluable disease
* Provide written informed consent prior to receiving protocol therapy.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Moderate or severe peripheral neuropathy
* Other serious medical conditions
* Other active malignancies
* history of treatment for other invasive cancers
* Women who are pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Study on Serum Cystatin C and PET-DAT in Patients With Parkinson's Disease

To investigate the relationship between serum cystatin C and dopamine receptor(DAT) loss in patients with parkinson's disease(PD)

Number of people suffered from Parkinson disease (PD) is increasing every year. PET imaging of dopamine transport receptors（DAT） serves as the gold standard for the diagnosis and monitoring of PD development. However, due to high costs and radiation reasons, it is not suitable for long-term follow-up. Serum cystatin C can be easily obtained and cheap as an indicator. In recent years, studies have gradually found that it is related to the progression of H\&Y staging of Parkinson's disease. To this extent, we want to further explore whether it can reflect the loss of DAT in the brain. Explore whether it can partially replace the role of DAT imaging for future clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 20 and 80 years and whose laboratory results included the levels of serum Cystatin C within a month from the PET-DAT were recruited.

Exclusion Criteria:

* To make the study cohort more homogeneous, PD patients with either a long-standing duration (≥5 years) or advanced Hoehn and Yahr (H\&Y) staging (≥3) were excluded.
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up.

Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of stable or unstable angina or a positive functional study
* Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with positive functional test or symptom of ischemia)
* Successful lesion preparation (no flow-limiting dissection or a residual stenosis \> 30%)

Exclusion Criteria:

* Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
* Intolerance and / or allergy to Sirolimus
* Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:

iopromide)

* Patients with an ejection fraction of \< 30 %
* Reference vessel diameter (RVD) \< 2.5 mm
* Contraindication for whichever necessary accompanying medication
The Role of Point-of-care Polymerase Chain Reaction in Managing Nosocomial Pneumonia

The study compares a device that is used for the detection of bacteria and MDR pathogens from skin, soft tissue and nose with the gold-standard (microbiological lab). It is a novel use for this device because it has been used in samples from the lower-respiratory tract.

The purpose of this study is to find out if a POC-PCR device can be use in the diagnosis of hospital acquired pneumonia and ventilation-associated pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* patients that are admitted for at least 48 hours
* radiological findings typical for pneumonia
* signs of infection

Exclusion Criteria:

* patient or patient relatives doesn't accept to enter the study
Detection of Sepsis Occurrence by Using Blood Fluorescence

This study adopted a case-control study method to explore a reagent-free, highly sensitive, and frequently screened blood fluorescence metabolite analyzer for sepsis, which can detect the emergence of inflammatory free radicals before organ damage and shorten the diagnosis time of sepsis.

Currently, clinical practice lacks an effective screening method for early detection and prediction of sepsis. This gap hinders timely differential diagnosis, leading to severe shock and increased mortality rates. Although the qSOFA score is highly specific, it is not devoid of false negatives. Typically, by the time sepsis is confirmed using the qSOFA (≥ 2) and SOFA (≥ 2) scores as gold standards, the patient may already be suffering from organ damage, thus escalating the risk of death. Early-stage septic patients exhibit a surge in inflammatory free radicals, altering the optical characteristics of their blood compared to that of healthy individuals. Based on this, we hypothesize that a blood fluorometer could detect these early changes in septic patients, enabling rapid and accurate diagnosis to mitigate mortality rates. This study will conduct a case-control investigation, collecting blood from both admitted and discharged patients, with the aim of developing a reagent-free, highly sensitive blood fluorescence metabolite analyzer. This device will be capable of frequent sepsis screenings, detecting inflammatory free radicals before organ damage occurs, thereby reducing the time to sepsis diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy control group: Individuals who are physically healthy with no underlying diseases and have not been hospitalized within the past two years. Recruitment for healthy volunteers will be conducted through notices and online media.
2. Sepsis Experimental Group: Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, will be screened and confirmed by a physician to meet the inclusion criteria.
3. Non-septic Severe Control Group: Patients with suspected or confirmed infections, having a SOFA score of 1, will be screened and confirmed by a physician to meet the inclusion criteria.

Exclusion Criteria: minors, pregnant, individuals with mental illnesses, and other vulnerable groups.
A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexible sigmoidoscopy.

It is not currently known if procedures used to observe the lining of the distal colon, such as endoscopy with or without pinch biopsy, may cause mucosal trauma and thus alter colonic permeability. Additionally, the application of topical HIV microbicides (to prevent HIV transmission) and shearing forces associated with rectal intercourse might also adversely affect the epithelial layer, and thus alter colonic permeability. In order to appropriately interpret testing of the effects of topical HIV microbicides on the mucosal lining of the distal colon, it is essential to understand whether these procedures themselves, adversely affect the epithelial layer. If changes in permeability can be detected, this method may be developed to help determine microbicide distribution/toxicity in early phase studies, thus improving the selection of candidate microbicides for study in larger scale clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 21 years of age
* Prior history of receptive anal intercourse (RAI)
* Subjects must have a history of using commercially-available personal lubricants for RAI.
* Ability to provide signed informed consent.
* Willingness to abstain from lubricant use and anal receptive intercourse for 48 hours prior to and 48 hours after Phases A and B.
* Willingness to use a single dose of rectally-applied N-9.

Exclusion Criteria:

* Mental handicap or impaired cognitive performance status as judged by the investigator.
* Coagulation abnormality which would put the subject at risk for bleeding as judged by the Principal Investigator.
* History of anorectal surgery within the last month or the presence of any anorectal disease or condition that in the judgment of the investigator could affect permeability of the rectal mucosa.
* Presence of any painful anorectal conditions or anorectal lesions that would be tender to manipulation.
* History of occupational radiation exposure.
* History of acute or chronic diarrhea defined as three or more loose stools per day.
* History of any allergic response to rectal lubricants.
* History of sleep apnea, or airway problems with previous sedation procedures.
* History of significant adverse reaction to sedation medications.
Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology

Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and chronic cardiac conditions whose clinical presentation, mimicking the onset of acute myocardial ischemia in absence of epicardial coronary disease, has progressively gained the interest of the scientific community. However, despite significant progress, their underlying pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial dysfunction and autonomic imbalance have both been individually implied in their puzzling pathogenesis.

The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and healthy volunteers with the following primary objective: to assess the response of endothelial function (through the Endopat score) to the autonomic tone activation induced by a 10-minute stress mental test. The assessment of autonomic tone during activation through the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with endothelial function (Endopat score) will represent secondary objectives.

Our study will enroll 15 patients with TTC at least six months after the event, 15 patients with classic CSX and 15 healthy volunteers who will serve as control.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the Mayo Clinic's criteria established diagnosis of TTC at least 6 month after the acute event
* Patients with CSX defined by the presence of anginal pain, positive exercise stress testing and negative coronary angiography.
* A comparable cohort of healthy volunteers age and sex-matched with patients

Exclusion Criteria:

* Short-term life-threatening pathology (life expectancy \< 6 months)
* Physically unable to participate in the study
* Compliance not guaranteed
* Pregnancy
* Conditions that make BRS and Endopat measurements impossible
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen).

EA may still be available in countries outside of the United States.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologically or cytologically confirmed SCLC
* Extensive-stage, unable to be encompassed in a tolerable radiation plan
* Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
* Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
* Minimum life expectancy of 12 weeks

Exclusion Criteria:

* Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology
* Symptomatic central nervous system (CNS) metastases
* Active hepatitis B or hepatitis C virus infection
* Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product
* Currently or previously enrolled in a prior tarlatamab study
* Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab
* Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception
Study to Validate Novel Seizure-Detection Algorithm

The specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (Motor Seizure Detection Algorithm \[mSDA\]) installed on a wearable device to be worn by the subject. The software will be tested using subjects from a patient population in an epilepsy monitoring unit (EMU) undergoing video and electroencephalograph (VEEG) observation. The number of generalized major motor seizures detected by the mSDA will be compared with those detected by VEEG.

Seizures are paroxysmal, abnormal behaviors which usually are associated with altered awareness and amnesia. The frequency of seizures is not easily documented. The individual who suffers from seizures may be unaware that a seizure is occurring. Many seizures, including generalized major motor seizures, have stereotyped, vigorous motor activity associated with the events.

Currently, accurate seizure detection relies on EEG and video which are limited by time, size and mobility. Seizure detection can also use biomarkers such as movement patterns described by gyroscopes. These devices can monitor patterns of movement which correspond to the activity during seizures and kept in a log of seizures without patient input. The log can be used to notify patients or caregivers of seizures.

This study is to determine the accuracy of a system using a commercial, wearable device linked to a computer algorithm based in the cloud which stores the movement pattern and notifies the patient and others of a generalized major motor seizure. The accuracy will be determined by a comparison of the system detections to simultaneously recorded video electroencephalogram, considered the "gold standard" of seizure detection.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Meets the standard of care criteria for admission to an epilepsy monitoring unit (EMU).
4. Male or female.
5. Aged 18 and above.
6. The patient has experienced at least one generalized major motor seizure prior to admission.
7. Agreement to wear a wristwatch throughout the duration of the study on the left wrist.
8. Ability to cancel false positive alarms via interaction with the application on the watch.

Exclusion Criteria:

1. Concurrent physiological diseases with movement disorders (Parkinson's, tremor, ataxia, Huntington's, paralysis of the upper body, pseudo-seizures).
2. Known allergic reactions to components of the (watch materials).
3. Treatment with another investigational drug or other intervention within the study
4. Children under the age of 18.
5. Women who are pregnant or nursing.
6. Inability to give consent to the study.
7. Active skin infection or rash on the upper extremities