cyrilzakka/clinical-trials huggingface dataset:
Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR

The primary objective of this pilot study is to program an opioid use disorder (OUD) clinical decision support (CDS) tool for use in an electronic medical record (EMR) and obtain high primary care physician (PCP) usability and acceptability. The OUD-CDS is based on the NIDA-Blending Initiative white paper, "Clinical Decision Support for Opioid Use Disorders: Working Group Report," which itself is based on national evidence-based guidelines (American Society of Addiction Medicine (ASAM 2015), VA (VA 2015). As such, this pilot study aims to help PCPs achieve accepted standards of care in OUD treatment. The secondary objectives of this pilot study are to evaluate the usefulness of the tool by comparing OUD case-finding, medication-assisted therapy (MAT) and referral patterns pre- and post-CDS deployment for PCPs with and without CDS access.


Eligibility Criteria:
Inclusion Criteria:

* Be an MD, Doctor of Osteopathy, Nurse Practitioner or Physician's Assistant engaged in independent primary care of adults at HealthPartners or Park Nicollet
* Have at least schedule 3 DEA prescribing privileges
* Voluntarily provide written informed consent to participate in this study

Exclusion Criteria:

* Less than half-time clinical primary care responsibilities
Yogurt Study in Children 2-4 Years Old Attending Daycare

The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare.

In this study, participants will be asked to:

1. Give their child 4 oz. of the test yogurt each day for 90 days
2. Keep a daily diary of their child's health
3. Collect 3 stool samples from their child at the start, middle, and end of the study
4. Speak with research personnel on a bi-weekly basis regarding their child's health
5. Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study


Eligibility Criteria:
Inclusion Criteria:

* Child aged 2 to 4 years of age
* Child attends daycare at least 3 days per week

Exclusion Criteria:

* Caregiver does not speak English or Spanish
* Caregiver does not agree to have their child refrain from cultured dairy products (yogurt) for the 105-day duration of the study
* Caregiver does not agree to collect a stool sample from their child on Day 0, 45, and 105 of the study
* Caregiver does not have a refrigerator to store the yogurt product at home
* Child is currently receiving breast milk
* Child has an allergy or hypersensitivity to milk proteins or other dairy food components such as lactose
* Child has an allergy or hypersensitivity to strawberry or red food coloring
* Child has a chronic disease
* Child has had an infection or been sick 7 days prior to starting study
* Child has had diarrhea or constipation 7 days prior to starting study
* Child has a special diet as prescribed by a medical professional
* Child has received antibiotics, antiseptics, antifungal, corticosteroids, anti-histamines, non steroidal anti-inflammatory drugs within 7 days prior to starting the study
* Child has a congenital anomaly or birth defect that requires medical care
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.

The Phase Ib dose escalation part was aimed at the determination of the MTD/RP2D of capmatinib in combination with 250 mg gefitinib in patients with NSCLC patients with epidermal growth factor receptor (EGFR) mutation and cMET dysregulation and showing disease progression following EGFR tyrosine-kinase inhibitor (EGFR TKI) therapy. Dose escalation started with a dose of 100 mg/day to a maximum of 1200 mg/day, as capsule or tablet formulation. Successive cohorts of patients were to receive increasing doses of capmatinib in combination with a 250 mg once daily (qd) dose of gefitinib until the MTD/RP2D of capmatinib had been determined. The Phase II dose expansion part consisted of 400 mg capmatinib twice daily (bid), as either capsules or tablets, in combination with 250 mg gefitinib.

Eligibility Criteria:
Inclusion Criteria:

* Documented EGFR mutation
* Documented c-MET dysregulation
* Prior clinical benefit on EGFR inhibitors and then subsequent progression

  -≥ 18 year old
* Life expectancy of ≥ 3 months
* ECOG performance status ≤ 2

Exclusion Criteria:

* Unable to swallow tables once or twice daily
* Previous treatment with c-MET inhibitor
* Any unresolved toxicity from previous anticancer therapy greater than grade 1
* History of cystic fibrosis
* History of acute or chronic pancreatitis
* Unable to undergo MRI or CT scans
* Known history of HIV
* Undergone a bone marrow or solid organ transplant
* Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
* Pregnant or nursing
Visual Rehabilitation and Depression in Visually Impaired Patients with AMD

Purpose: The aim of this study is to evaluate the impact of visual rehabilitation in visually impaired patients with advanced AMD by the use of questionnaires on the anxiety and depression status.

Study design: prospective observational study. The study is carried out at the IRCCS Fondazione G.B.Bietti and at the UO Visual Rehabilitation, S. Alessio - Margherita di Savoia.

Study procedures: Visit 1 (screening visit, at IRCCS Fondazione Bietti) After signing the informed consent, all patients received a complete ophthalmological examination, non-invasive diagnostic tests as optical coherence tomography, autofluorescence and microperimetry, and have to complete the questionnaires on the state of anxiety and depression (GAD-7 and PHQ-9).

Visit 2 (at the Sant'Alessio Institute) for a 60-day visual rehabilitation program scheduled in 5 group meetings.

Visit 3 (end-of-study visit, at IRCCS Fondazione G.B. Bietti) complete ophthalmological examination, as per clinical practice, non-invasive diagnostic tests such as microperimetry, optical coherence tomography and autofluorescence and administration of the Patient Health Questionnaire-9 (PHQ-9) questionnaires for depression and the General Anxiety Disorder (GAD-7) questionnaires for anxiety.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 55 years
2. Moderate and severe visual impairment (BCVA ≥1/10 and ≤2/10)
3. Diagnosis of advanced non-exudative age-related macular degeneration (AMD)
4. Informed consent freely granted and acquired before the start of the study
5. Ability to understand and willingness to follow the study instructions and procedures

Exclusion Criteria:

1. Visual impairment due to other ocular diseases
2. Mild visual impairment or partial or total blindness
3. Exudative age-related macular degeneration undergoing intravitreal drug treatment
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the initiation of this study, BG00012 was approved in several countries for the treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this study will receive the currently marketed dose of 240 mg BID.

Eligibility Criteria:
Key Inclusion Criteria:

-Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

Key Exclusion Criteria:

* Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
* Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
* Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples

This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.


Eligibility Criteria:
Inclusion Criteria:

No patients are enrolled. Use of tumor samples only.

* Histologically proven melanoma tumor sample
* Any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis
* Tumor samples must be fixed and paraffin-embedded.

Exclusion Criteria:

No patients are enrolled. Use of tumor samples only.

* Fixative unknown
Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis

The main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (RA) with that from individuals without RA.

The first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.

The secondary objectives of this study are :

* A. To compare between the two groups :
* a. The proportion of Proteus mirabilis in the intestinal microbiota;
* b . The proportion of species producing peptidyl arginine deaminase (PAD ) in the intestinal microbiota;
* c . The number of species found in the intestinal microbiota.
* B. To evaluate bacterial translocation (from the digestive tract) in newly diagnosed RA patients with and healthy volunteers without RA. (Bacterial translocation is a phenomenon in which live bacteria or a part of bacteria (e.g. LPS teichoïc acid) cross the intestinal barrier and reach the bloodstream.).
* C. To describe the ecology of the intestinal microbiota of newly diagnosed RA patients (characterization of species found according to their respiratory metabolism, according to their bacteriological characteristics, and according to whether or not the species are found significantly more frequently in patients with RA than in individuals without RA).

Eligibility Criteria:
Inclusion Criteria for RA patients:

* The patient was correctly informed
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* No antibiotic treatments within the 30 days preceding inclusion
* Absence of digestive pathology
* RA diagnosis made within the past 12 months

Exclusion Criteria for RA patients:

* The patient has participated in another study within the past 3 months
* The patient is under judicial protection, or any kind of guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has taken antibiotics in the 30 days preceding inclusion
* RA was diagnosed more than 12 months ago
* Digestive pathology

Inclusion Criteria for healthy volunteers (HV):

* The HV was correctly informed
* The HV must have given his/her informed and signed consent
* The HV must be insured or beneficiary of a health insurance plan
* Absence of digestive pathology
* No antibiotic treatments within the 30 days preceding inclusion
* Does not have RA

Exclusion Criteria for HVs:

* The HV has participated in another study within the past 3 months
* The HV is under judicial protection, or any kind of guardianship
* The HV refuses to sign the consent
* It is impossible to correctly inform the HV
* The HV is pregnant, parturient, or breastfeeding
* The HV has taken antibiotics in the 30 days preceding inclusion
* Digestive pathology
* Joint pathology of any kind (including inflammatory pathologies)
SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors

Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.

This study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining;
2. According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm);
3. Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
4. Estimated life expectancy \>3 months;
5. Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
3. Patients who have a history of other mesothelin-targeting therapy;
4. Patients who have a history of autoimmune disease;
5. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain

The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.

The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.

Eligibility Criteria:
Inclusion Criteria:

* postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy
* NRS score \> 4
* stable oral medication during the 1 month trial period
* volunteers with informed consent

Exclusion Criteria:

* pregnancy, breastfeeding, possibility of pregnancy
* pain from causes other than upper 3 indications
* hypersensitivity to lidocaine or other local anesthetics
* important disease of heart, kidney, liver or incurable disease that may affect the assessment of adverse effects, or may interfere with the completion of study
* severe conduction block
* history of other interventions that may affect the study
* Enrollment in other clinical trials within 30 days
* otherwise not suitable to study
Lipoprotein Kinetics in T1D

The purpose of this research study is to understand how type 1 diabetes (T1D) increases the risk for cardiovascular diseases (heart attack and stroke). To this end, the investigators will compare apolipoprotein and triglyceride kinetics in people wtih T1D and healthy control participants.

Not required

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 but ≤45 years
* premenopausal/eumenorrheic and not pregnant or breastfeeding
* non-obese (body mass index ≥18.5\<30.0 kg/m2)
* Fasting plasma triglyceride \<150 mg/dL

Additional inclusion criteria for control subjects:

* Fasting plasma glucose \<100 mg/dL
* Plasma glucose 2 h after a 75 g oral glucose challenge \<140 mg/dL
* HbA1c \<5.6%.

Additional inclusion criteria for subjects with T1DM:

* stable insulin regimen (multiple daily insulin injections or continuous subcutaneous insulin) for at least 8 weeks before screening
* no use of diabetes medications other than insulin
* HbA1c \<6.5%, basal (overnight fasted)
* no severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or a medical facility in the 6 months prior to screening or metabolic testing

Exclusion Criteria:

* more than 1.5 h of structured exercise/week
* use of tobacco products, excessive amounts of alcohol, or dietary supplements and/or medications known to affect lipid metabolism
* hypothyroidism or other disorders known to affect lipid metabolism
* conditions that would make it impossible to complete the study protocol
Avatrombopag to Promote Platelet Engraftment After Allo-HSCT

The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.

Patients with thrombocytopenia (PLT\<20×10\^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 18-60 years;
* PLT\<20×10\^9/L after 14 days of allo-HSCT;
* Expected survival time \> 3 months;
* ECOG performance status 0-2;
* Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form.

Exclusion Criteria:

* Pregnant or lactating;
* With severe and uncontrollable infection;
* With graft-versus-host disease (GVHD) with steroid resistance;
* With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation
* With detected disease recurrence due to chimerism by flow cytometry;
* With chronic active hepatitis B and C virus infection;
* With secondary or multiple transplantation, or multiple organ transplantation;
* With severe heart disease, lung disease, diabetes and metabolic diseases;
* HIV positive;
* With a history of PLT dysfunction or bleeding disorders
* With the active hepatic venous occlusion disease, or a history of clinically significant hepatic venous occlusion disease (The disease was defined as the abnormal condition of painful hepatomegaly after transplantation with bilirubin ≥ 6.0 mg/dL);
* With progressive solid tumor;
* With severe bleeding requiring transfusion of more than 2 units of red blood cells, or sudden drop of blood cell volume ≥10% within 7 days prior to screening;
* With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
* With treatment of thrombopoietin receptor agonist (TPO-RA) one month before enrollment;
* Deemed unsuitable for enrollment by the investigator.
Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer

The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.

Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel


Eligibility Criteria:
Inclusion Criteria:

1. Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
2. Patients who are older than 18 year-old;
3. Patients voluntarily join the study and give written informed consent for the study.

Exclusion Criteria:

1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
2. Large blood vessels or important structures on the puncture path of peripheral lung tumors；
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
US Cycle Control and Blood Pressure Study

Birth Control Patch Study


Eligibility Criteria:
Inclusion Criteria:

* Female subject requesting contraception
* Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
* Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
* History of regular cyclic menstrual periods

Exclusion Criteria:

* Pregnancy or lactation
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
Normative Values and Forming Regression Equations for One Minute Sit to Stand Test in Healthy Normal Indian Population

This study is to find relation between number of repetitions the volunteer able to sit and stand in an armless chair and their age, height, weight and gender. The investigators hypothesis there is a moderate relation between anthropometric characteristics and number of situps. This may partially define the ability of functional capacity and quadriceps ability.

Sit to stand is gaining importance as a functional capacity measurement tool in modern chronic diseases arena. Bu the reference values for normative population is not available. Hence the present study aimed at finding relation between the anthropometric variables (age, height, weight) and number of sit to stand repetitions. The volunteers will be asked to sit to stand in an arm less chair of 40 inches height. The number of repetition will be correlated and regression equations will be sought out relating number of repetitions and anthropometric variables through best fit regression equations

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* 30 - 80 years old
* Hospital staffs, relatives of patients volunteering the test
* Willing to give consent for the test

Exclusion Criteria:

* Chronic cardiovascular and pulmonary diseases
* On anticoagulants
* Cancer undergoing chemo, radiotherapy
* recent orthopaedic ailments (Osteoarthritis, Rheumatoid arthritis, surgeries less than 3 months)
* Balance impairments