cyrilzakka/clinical-trials huggingface dataset:
The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

This study is an investigational study of the ELG medical device to monitor glucose blood level in diabetes mellitus Type 1 and 2 without blood samples in comparison to blood testing methods."Investigational" means the ELG medical device is subjected by the FDA (Food and Drug Administration) for premarket testing requirements. The purpose of this study is to collect data comparison values between ELG testing device to current blood testing methods.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 1 or 2 diabetes
* Be 25 - 65 years of age
* Male or female
* Various ethnicities are desired
* Must be available for 2 visits within a 2-4 week period and willing to spend up to 1-2 hours/visit
* Must have daytime availability for visits
* Able to have 1 venous blood draw \& up to 4 fingersticks for complete blood testing at each visit
* Must be willing and able to fast (for at least 6 hours) prior to first visit

Exclusion Criteria:

* Taking drugs of abuse (illegal and/or prescription)
* Have been in another research study in the last 30 days
* Have had a blood transfusion or severe blood loss in the last 14 days
* Have Sickle Cell Anemia
Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD)

The objective of the study is to observe the effect of adherence to once-daily administered long-acting bronchodilators (long-acting ß2-agonists \[LABAs\] / long-acting muscarinic antagonists \[LAMAs\]) on patients health related quality of life (HR-QoL) and to assess the relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease (COPD) maintenance therapy


Eligibility Criteria:
Inclusion criteria:

1. Male or female, above 40 years of age
2. Patients clinically diagnosed of COPD with no history suggestive of asthma:

   1. by scores \>=5 in the COPD Population Screener,
   2. by a clinical diagnosis of COPD made by pulmonologists or internists,
   3. by a Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC6) ratio of \<=0.70 and a FEV1 \<=80% of the predicted value as assessed by copd-6 (Vitalograph, UK);
3. Maintenance treatment-naïve COPD patients who have been prescribed once daily long-acting bronchodilators (LABAs / LAMAs) for the first time at enrolment into the study
4. Patients who are able to provide signed informed consent
5. Patients who agree to be contacted for telephone/ SMS reminders via call center

Exclusion criteria:

1. Patients with contraindications to the prescribed medication
2. Patients with any disorder that would prevent the patient from being able to complete questionnaires either verbally or by self-completion
3. Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception
Cocaine, Lidocaine/xylometazoline and Saline for Nasal Analgesia

When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck. The procedure can be deemed necessary due to the nature of the surgical procedure or considerations in regard to the patient's comorbidities. For a certain group of patients with expected difficult airways, the procedure is done whilst they are awake and aided by fiberoptics.

For these awake patients, extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort. The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion, providing more space within the nasal cavity. For these purposes, several drugs in varying combinations and dosages are used, but no single drug choice is universally recommended.

Cocaine is one of these appropriate drugs. It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties. Concerns have though been raised regarding cocaine's potential toxicity and alternative medications are continuously sought after.

A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation. Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor.

The investigators wish to compare the analgesic effects of cocaine and lidocaine/phenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Proficient in spoken and written Danish
* Healthy volunteers (no active diagnoses)
* Negative hCG (human chorionic gonadotropin) urine stix for women of childbearing potential

Exclusion Criteria:

* Known nasal malformation
* Known coagulopathy
* Current antithrombotic treatment
* Self-reported epistaxis occurring more than once a month
* Symptoms of a common cold within the past week
* Hypersensitivity to local anaesthetics of amide type or any of the excipients
* Hypertension
* Narrow-angle glaucoma
Axillary Reverse Mapping

We hypothesize that variations in anatomic location of the arm lymphatic drainage system put the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the drainage of the arm during the procedure would decrease the likelihood of inadvertent disruption of the lymphatics and the subsequent development of lymphedema. A combination of radioactivity and blue dye will be used.

Mapping Procedure:

Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor.

If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye will be used in the breast either in the subareolar plexus or peritumorally at the discretion of the surgeon. For this contingency (expected to occur \<3% of the time), the blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the SLN for staging.

If the blue dye is unnecessary to find the sentinel node draining from the breast, then it will be injected dermally in the upper inner arm along the Biceps groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in either the subareolar plexus, peritumorally (intraparenchymal or dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-100 years old
* Not pregnant or breastfeeding
* Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral breast OR prophylactic mastectomy
* Willing participation following an informed consent process

Exclusion Criteria:

* Patient \< 18 y/o or \> 100 y/o
* Pregnant or breastfeeding
* If a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis.
Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation

The purpose of this study is to investigate the prevalence germline pathogenic BRCA1/2 mutation in a large group of potential candidate of PARP inhibitors, among the unselected patients with HER2-negative unresectable locally advanced or metastatic breast cancer.

This is a multicenter, prospective, non-interventional study on the prevalence of germline pathogenic BRCA1/2 mutation (Blood) and somatic pathogenic BRCA1/2 mutation (Tissue, optional) in patients with HER2-negative unresectable locally advanced or metastatic breast cancer.

1. For the assessment of germline mutational status of BRCA1 and BRCA2, (1)Collect peripheral blood from each subject. (2) Extract DNA from the collected blood. (3)From the extracted DNA, germline BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) using NGeneBioBRCAaccuTest®
2. For the assessment of somatic mutational status of BRCA1 and BRCA2, (1)Collect FFPE from about 100 subjects. (2) Extract DNA from the FFPE. (3)From the extracted DNA, somatic BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) using NGeneBioBRCAaccuTest®
3. Collect variables on the patients and compare clinical outcomes (Overall survival, Invasive Disease-free survival, Distant Disease-free survival, Progression free survival) that can be affected by clinicopathologic characteristics and type of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years old
* Histologically confirmed, unresectable locally advanced or metastatic breast invasive carcinoma
* Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
* Germline mutational status of BRCA1 and/or BRCA2 can be known or unknown
* Signed written informed consent
* The patient is regarded as good candidate for active palliative management at time of enrollment. The patient with terminal cancer which is not appropriate for further endocrine treatment or chemotherapy cannot be enrolled to this study.

Exclusion Criteria:

* HER2 positive breast cancer
* Amenable to curative surgery
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)

In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD). The trial is based in previous results with autologous MSC (Orozco et al., Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective, randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing Practice (GMP)-compliant expanded bone marrow MSC (MSV, Investigational medicinal product Num. 10-134). The assay consists of two arms with 12 patients each one. Patients in the experimental arm will be given a single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We shall follow the evolution of pain, disability and quality of life as well as disc fluid content by Magnetic Resonance Imaging (T2-calibrated).


Eligibility Criteria:
Inclusion Criteria:

* Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.
* Fibrous ring capable of holding the cell implantation, demonstrated by Magnetic resonance imaging (MRI) image (stages 2, 3 and 4 of Adams).
* Decrease of disc height of more than 20% (radiographic measurement in side image).
* Absence of spinal infection.
* Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.
* The patient is able to understand the nature of the study.
* Informed written consent of the patient.

Exclusion Criteria:

* Age over 75 or under 18 or legally dependent
* Allergy to gentamicin, or to bovine, cattle or horse serum.
* Congenital or acquired diseases leading to spine deformations that may upset cell application.
* Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
* Modic III changes on MRI images (31).
* Overweight with body mass index (mass in Kg/size in m2) greater than 35 (obesity grade II).
* Pregnancy or breast-feeding
* Neoplasia
* Immunosuppression
* Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
* Other conditions that may, according to medical criteria, discourage participation in the study.
Determining Patterns In Trial Experiences of Parkinson's Disease Patients

Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.

This study will invite several participants to gather a wide range of information on clinical trial experiences for Parkinson's Disease patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of Parkinson's Disease.

The data collected from this study will help improve future outcomes for all Parkinson's Disease patients as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient plans to participate in an interventional clinical trial for the condition of Parkinson's Disease
* Patient has been diagnosed with a type of Parkinson's Disease
* Patient is at least 50 to 80 years of age
* Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

* Patient has an ECOG score of 4 or higher
* Patient is not able to provide consistent digital updates as per study requirements
* Patient does not complete or agree to terms outlined in the Informed Consent Form
Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering

\*Ketamine:\* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.

- \*Tramadol:\* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.

Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.

Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:

* Reduced discomfort and anxiety for the patient
* Improved patient satisfaction
* Reduced need for additional medications or interventions
* Faster recovery times

Eligibility Criteria:
Inclusion Criteria:

* Pateint for elective cesarean section
* Age 18 to 40 years
* ASA 1 and 2

Exclusion Criteria:

* ASA 2 and 3
* Cesarean section requiring general anesthesia
* Hypersensitivity to Ketamine, Tramadol and Opiods
* History of cardiovascular disease
Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19

The GW Medical Faculty Associates recently launched a remote monitoring program for patients diagnosed with COVID-19. Patients are provided with a home pulse oximeter and thermometer. Participants complete daily surveys about their symptoms and vital signs and are escalated to receive phone calls and video visits if responses are abnormal.

Investigators would like to complete a study of the program to understand:

1. Operational parameters of program performance, such as how many patients were enrolled and how many patients completed monitoring
2. Clinical course of patients, including their reported symptoms over time and clinical endpoints such as hospitalization or ICU admission
3. Patient satisfaction with program

The SARS-CoV-2 that emerged in late 2019 has been noted to have a wide range of presentations, from asymptomatic and mild cases to those requiring intubation, ECMO, and critical care. As it is a novel pathogen, clinicians and scientists are only beginning understand when and who will require hospital-based resources such as oxygen, hospitalization, or ICU admission. The Medical Faculty Associates (MFA) COVID-19 Remote Monitoring Program (RPM) was developed to provide a daily touchpoint for patients during their COVID-19 course, including ready connection to paramedics and physicians when needed. The program was launched with the goal of identifying clinical decompensation early, maximizing available healthcare capacity, and minimizing nosocomial COVID-19 spread and healthcare worker exposure.

Investigators would like to perform analyses to test multiple hypotheses, including:

1. Patients discharged with a diagnosis of COVID-19 will be able to participate in a remote monitoring program.
2. A COVID-19 remote monitoring program will benefit patients.
3. Patients will be satisfied with their experience of a remote monitoring program and will have lower anxiety about their COVID-19 illness.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed coronavirus infection
* Age \>=18
* Primary language English or Spanish

Exclusion Criteria:

* Dementia
* Pregnant \> 16 weeks gestation
Diffusion-weighted Imaging Study in Cancer of the Ovary

This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across multiple centres and platforms, assessing reproducibility of the measurement in patients planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning measurements will be correlated with histopathological markers in tumour samples in order to link the biomarker with response mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed ovarian, primary peritoneal or fallopian tube cancer stage III or IV
* Scheduled to receive neoadjuvant chemotherapy (carboplatin/cisplatin)with planned debulking surgery.

Exclusion Criteria:

* Life expectancy of less than 6 months
* MRI contraindications
* Low grade or heavily calcified disease
Effect of Cervical Collar in Cervical Radicular Pain.

Objectives:The purpose of this study is to determine if use of nech collar (stiff or soft)will improve the possibility to obtain painrelief in patients with cervical radicular pain. We will compare short term (six weeks and three months) and long term ( one year) effect of six weeks use of neck collar (stiff or soft)together with "neck school information" with "neck school information" alone.


Eligibility Criteria:
Inclusion Criteria:

* cervical radicular pain caused by herniated disc og spondolytic spurs
* written consent from patient

Exclusion Criteria:

* previous necksurgery
* whiplash or other necktrauma
* serious diseases somatic or psychiatric
* patients not able to speak and read Norwegian well
* insufficient correlation between clinical and radiological findings
Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States

The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice setting.

The secondary objectives of this study are as follows:

* To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.
* To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.


Eligibility Criteria:
Key Inclusion Criteria:

* Decision to treat with DMF must precede enrollment.
* Naïve to DMF or fumaric acid esters.
* Resides in the US and has a confirmed diagnosis of a relapsing form of MS.
* Satisfies the approved therapeutic indication(s) for DMF.

Key Exclusion Criteria:

* Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.
* History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies.
* Is participating in any other interventional clinical trial.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges

Comparison of Piezoelectric split-crest technique versus expansion using Hand Driven Ridge Expanders in treatment of Maxillary Narrow Ridges


Eligibility Criteria:
Inclusion Criteria:

* Participants are free from any systemic diseases.
* Participant have missing one or two premolars or molars with sufficient alveolar ridge height and insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement.
* The minimum BL ridge width included in the study will be 3.5 mm to facilitate ridge splitting and expansion

Exclusion Criteria:

* Patients with residual infections in the edentulous areas.
* Medically compromised groups.
* Smokers and patients with poor oral hygiene.
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection

The main objective of this trial is to assess whether a sequential therapy strategy based on molecular antibiotic susceptibility testing (including clarithromycin and fluoroquinolone) for H. pylori infection will improve the eradication rate compared to an empirical therapy.

This trial is designed as a prospective, randomised, open-label, active-controlled and single-centre study. For empirical therapy group(control group), Bismuth quadruple therapy will be an empirical first-line therapy, and high dose dual (proton-pump inhibitor + amoxicillin) treatment will be for rescue therapy if the first-line empirical treat failure. For the susceptibility-guided sequential therapy group, regimens were selected based on H. pylori susceptibility to clarithromycin and levofloxacin. The primary outcome is the first-line eradication rate in both groups, and the overall (including first- and rescue therapies) H. pylori eradication rates in both groups is one of the secondary outcomes. The eradication rates of H. pylori will be analysed by intention-to-treat analysis, modified intention-to-treat analysis and per-protocol analysis.

Eligibility Criteria:
Inclusion Criteria:

* H. pylori infection was determined using at least one of the following tests: 13C/14C-urea breath test (UBT), stool H. pylori antigen test, rapid urease test, and histological analysis within 4 weeks.
* Patients were naïve to H. pylori treatment.

Exclusion Criteria:

* Allergy to any drug administered.
* Pregnancy and lactation.
* Major systemic diseases, such as severe cardiopulmonary or liver dysfunction.
* Complicated with active peptic ulcer disease, gastric cancer, or prior gastrectomy.