cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fasting Conditions in Healthy Volunteers

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1015" and co-administration of "BR1015-1" and "BR1015-2" under fasting conditions in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of the first administration of the investigational products to 14 days after the last administration and disagrees to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Effects of rTMS on Human Brain Activity Measured With fMRI

This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Leveraging our expertise in application of TMS methodology during concurrent single neuron recording techniques in non-human primates and imaging and scalp potential techniques in humans, the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-30.
2. Use of effective method of birth control for women of childbearing capacity.
3. Willing to provide informed consent.

Exclusion Criteria:

1. Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).
2. Current serious medical illness (self report).
3. History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator); \[TMS Adult Safety Screening (TASS) form\].
4. Subjects are unable or unwilling to give informed consent.
5. Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
6. Subjects with a clinically defined neurological disorder including, but not limited to:

   1. Any condition likely to be associated with increased intracranial pressure
   2. Space occupying brain lesion.
   3. History of stroke.
   4. Transient ischemic attack within two years.
   5. Cerebral aneurysm.
   6. Dementia.
   7. Mini Mental Status Exam (MMSE) score of \<24.
   8. Parkinson's disease.
   9. Huntington's disease.

   i. Multiple sclerosis.
7. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.
8. Subjects with cochlear implants
9. Subjects not willing to tolerate the confinement associated with being in the MRI scanner.
10. Women who are pregnant or breast-feeding (urine test).
11. Blindness.
12. Inability to read or understand English.
Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

A randomised double-blinded study, in which the patients either get methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary breast cancer.

After mastectomy, up to 90 % of patients develops seroma in the cavity. The treatment is puncture, which is a small operation, but many patients have to come several times, and there is a risk of infection. In some cases further treatment can be postponed.

Preventing seroma to develop would be an improvement in the treatment of breast cancer patients operated with mastectomy.

An earlier study found that the seroma production was significant lower in the group who had Prednison injected directly into the cavity.

In this study the patient are divided into two groups: patients who have mastectomy and axillary dissection and patients who have mastectomy and Sentinel Node operation. Each group are examined separately.

Using Prednison in patients after operation could be a potential risk, but correct injection into the cavity will seldom give systemic side effects.

Eligibility Criteria:
Inclusion Criteria:

* women with primary breast cancer or Ductal carcinoma in situ, mastectomy plus either Sentinel Node or Axillary dissection, signed consent form

Exclusion Criteria:

* dissection of the axilla in les than 4 month, treatment with steroids, pregnancy, if the patient don't speak danish, allergy towards steroid, other medical conditions which the investigator find contradict participating
Examination of Implant´s Safety in an Electronic and Magnetic Field Environment

The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades. This has been paralleled by an increase in the number of sources of electromagnetic fields in daily life and occupational circumstances.

To date it remains unclear whether patients are at risk of device failure when being subjected to these fields. There are currently no general guidelines available to help clinicians informing their patients about safety levels and behavior around these electromagnetic fields.

This study aims to identify the thresholds of safe use of these devices and potential failures under worst-case conditions in 50/60 Hz fields (i.e.

power line frequency). Device implanted patients will be exposed to electric, magnetic and combined fields of different intensity at various device programming (e.g. nominal and maximum sensitivity). The results will show whether patients are safe in public or occupational environments, which medical relevant disturbances can occur and if a correlation exists between disturbances and device type or patients physique.


Eligibility Criteria:
Inclusion Criteria:

* men and women between 18 and 80 years
* Implantation of a Pacemaker (SM)-/ ICD-assembly at least four weeks ago
* signed informed consent

Exclusion Criteria:

* enduring addiction of implant
* thyroid disease
* electrolyte imbalance on the trial day
* pregnancy and breastfeeding
* acute myocardial infarction (\<30 days)
* Comorbidity, which complicates an emergency assistance, e.g. morbus bechterew, glaucoma, micturition disturbance
Comparative Effects of Methylprednisolone and Prednisolone on the Risk of Acute Decompensated Heart Failure - An Emulated Target Trial

The investigators aim to emulate a target trial to compare the risk of acute decompensated heart failure in users of methylprednisolone compared to prednisolone. The exposure is prescriptions of methylprednisolone or prednisolone tablets and the primary outcome is heart failure hospitalizations within the following 6 months, i.e. acute contacts with secondary or tertiary health care resulting in a primary diagnosis of heart failure. Secondary outcomes include broader heart failure diagnoses and the initiation of loop diuretics. Data preparation includes an initial observation period of 2 years, inclusion criteria such as age, corticosteroid formulation types / dosages and prescription codes, as well as removal of duplicate prescriptions and measures to reduce potential carry-over effects.


Eligibility Criteria:
1. Individuals aged \< 18 years in January 2008 will be excluded
2. Analyses will be restricted to tablets, as prednisolone is only available in this form.
3. To allow for equipotent dose comparisons, we will focus only on 4 mg and 16 mg methylprednisolone and their counterparts in prednisolone at 5 mg and 20 mg, respectively. Patients with other doses will be excluded.
4. To facilitate comparisons of treatments prescribed for similar conditions, we will only include prescriptions with an International Classification of Diseases, 10th Edition (ICD10) or International Classification of Primary Care, 2nd Edition (ICPC2) refund code.
5. Patients with prescriptions for diagnosis codes including palliative care, cancer symptoms, medical complications, and organ transplants will be excluded. This exclusion aims to reduce the inherent heterogeneity within these groups, allowing for a more comparable baseline risk.
6. An initial 2-year observational period, spanning from January 2008 to December 2009, will be used to establish comorbidities. Accordingly, only prescriptions of methylprednisolone or prednisolone dispensed from January 2010, onward, will be eligible for analyses.
7. To minimize the risk of carry-over effects, we will exclude all prescriptions prescribed \< 6 months after another prescription for a corticosteroid. Accordingly, the same patient can contribute data on several treatment courses, provided that there was \> 6 months since the last prescription was dispensed (See section 7 for justification for why a 6-month interval was chosen).
8. Duplicate prescriptions (same date, drug and dosage) will be kept in the analyses as a single treatment course. Cases of duplicate prescriptions on the same date, but where the drug or dosage is different will be excluded.
9. Baseline of the treatment course will be defined as the date when the prescription of either methylprednisolone or prednisolone was dispensed.
Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

I. To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.

II. To study the incidence of infections for up to 1 year following activated T cell infusion.

III. To study the overall response rates.

OUTLINE:

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.

Patients who have been previously treated on study, and subsequently need additional infusions, may be retreated with previously cryopreserved expanded cells at the same or lower dose level 6-12 months after the first infusion.

After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by immunophenotyping and flow cytometry analysis of blood or bone marrow

  * Patients must meet criteria for treatment based on the criteria proposed by National Cancer Institute (NCI)-sponsored CLL Working Group to include at least one of the following:

    * Weight loss of more than 10% over the preceding 6 months; or
    * Extreme fatigue attributable to progressive disease; or
    * Fever or night sweats without evidence of infection; or
    * Worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or
    * Massive lymphadenopathy (\> 10 cm) or rapidly progressive lymphocytosis (lymphocyte doubling time \< 6 months); or
    * Prolymphocytic or Richter's transformation; or
  * Patients with CLL who have received at least one prior line of therapy; or
  * Patients with CLL who have frequent infections and/or recurrent secondary cancers
* No active central nervous system (CNS) disease
* All patients must have a Karnofsky performance score \> 60%
* Calculated creatinine clearance (by Cockcroft-Gault) of \> 50 ml/min
* Patients must not have untreated or uncontrolled life-threatening infection
* Patients must sign informed consent

Exclusion Criteria:

* Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration
* Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes

Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have little effect in one person but a large effect in another. Understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower nonresponse rates.

This study will examine the physiological mechanisms and potential clinical/biomarker predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering medication and answer fundamental methodological questions for the future study of variation in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy for up to 2 weeks with assessment of baseline characteristics and glycaemic response. Participants will then enter an optional extension where they receive sulphonylurea or DPPIV inhibitor therapy in crossover fashion.

Participants will withdraw sulphonylurea therapy for up to 2 weeks (part 1) followed by an optional cross-over extension (part 2)where they are randomized to 4 weeks of treatment with Gliclazide (DPP-IV thera) or Sitagliptin (sulphonylurea), followed by 4 weeks of the second treatment with a 2 week wash-out period in between.

Part 1 will allow assessment of response rates to long standing sulphonylurea treatment in clinical practice and potential predictors of this, as well as whether a very brief period (1 week) of treatment withdrawal is a valid assessment of an individual's response to therapy. Part 2 will allow comparison of the approach in part one with response to the same treatment in a trial setting and will allow assessment on whether response is consistent across therapies with different mechanisms of action.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and \<80
* Clinical diagnosis of Type 2 Diabetes
* Currently treated with sulphonylurea tablets
* No change in diabetes treatment (new treatments or dose change) within last 3 months
* Last HbA1c (taken within last 12 months) of ≥42 mmol/mol and ≤75 mmol/mol (6-9%)
* Able and willing to monitor home blood glucose
* Able and willing to give informed consent

Exclusion Criteria:

* Current treatment includes: insulin, GLP-1 agonists, DPP-IV inhibitors, glinides
* Renal impairment (eGFR \<30 ml/min/1.73m2)
* Active infection (any infection requiring antibiotics at present)
* Recent (within 3 months) surgery or planned surgery
* Cardiovascular disease (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months
* Previous history of pancreatitis
* Pregnant, breastfeeding or planning a pregnancy over the study period
* Unable/unwilling to monitor home blood glucose
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).

ECU-MG-302 was an extension study designed to provide the participants who completed Study ECU-MG-301 an opportunity to receive eculizumab and collect clinical data to provide long-term safety and efficacy information on eculizumab in participants with refractory gMG.

After receiving blinded study treatment (eculizumab or placebo) in Study ECU-MG-301 for 26 weeks, participants were eligible to enroll in the ECU-MG-302 extension study. Participants were to enter Study ECU-MG-302 within 2 weeks after completing their Week 26 visit in Study ECU-MG-301.

Study ECU-MG-302 consisted of a 4-week Blind Induction Phase to preserve the blinded nature of Study ECU-MG-301, an Open-Label Maintenance Phase (up to 4 years), and a Safety Follow-up visit 8 weeks after the last dose for participants who withdrew from the study or discontinued eculizumab treatment at any time and for any reason after receiving any amount of eculizumab.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has completed Study ECU-MG-301.
2. Participant has given written informed consent.
3. Participant was willing and able to comply with the protocol requirements for the duration of the study.
4. Female participant of childbearing potential must have had a negative pregnancy test (serum human chorionic gonadotropin). All participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.

Exclusion Criteria:

1. Participants who withdrew from Study ECU-MG-301 as a result of an adverse event related to study drug.
2. Female participants who were pregnant, breastfeeding, or intended to conceive during the course of the study.
3. Unresolved meningococcal infection
4. Hypersensitivity to murine proteins or to one of the excipients of eculizumab
5. Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.
Inhalation Intervention for Nausea in the Emergency Department

Randomized controlled trial comparing inhalation of isopropyl alcohol vs placebo (normal saline) pads to treat nausea in emergency department patients.

This study is to investigate if inhaling the scent of a typical medical alcohol prep pad will alleviate nausea as compared to a identically packaged normal saline prep pad for the Emergency Department patient with nausea. The study length will be 10 minutes long. The subjects will take several deep nasal inhalations at the 0, 2, 5 minute marks. Level of nausea will be recorded during these times and at 10 minutes. The investigators will also assess satisfaction of the intervention. As in previous post operative unit studies,the hypothesis is that there will a significant difference in levels of nausea between the alcohol pad group versus the normal saline pad group.

Eligibility Criteria:
Inclusion Criteria:

* age range of 18-65 years of age
* complaint of nausea and or vomiting
* ability to breathe through nose
* ability to read and write English

Exclusion Criteria:

* allergy to isopropyl alcohol
* pregnancy or pregnancy status unknown to subject. Pregnancy test only if part of clinical course.
* recent upper respiratory infection
* recent intake of cefoperazone, disulfiram, or metronidazole or any other medications that are known produce nausea when exposed to alcohol.
* use of antiemetic or psychoactive drug within 24 hours
* alcohol abuse
* nicotine within last 4 hrs
STUN (STop UNhealthy) Alcohol Use Now! Implementing Evidence-Based Services for Unhealthy Alcohol Use in Primary Care

STUN Alcohol Use Now is an intervention designed to use primary care practice support services (practice facilitation) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. The original recruitment goal was 135 primary care practices in North Carolina, which we were unable to meet due to pandemic-related barriers.

STUN Alcohol Use Now is an intervention designed to use primary care practice support services (practice facilitation or PF) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. 135 primary care practices in North Carolina will be recruited.

Specific Aim 1 will evaluate the effect of PF on uptake of evidence-based screening and brief intervention (SBI) for unhealthy alcohol use. The investigators hypothesize that PF will increase screening for unhealthy alcohol use and provision of brief counseling. The secondary hypothesis is that practice-level and contextual factors (capacity for quality improvement, organizational readiness to implement change, and implementation climate) will moderate the effect of PF on use of evidence-based screening and brief intervention (SBI) for unhealthy alcohol use.

Specific Aim 2 will evaluate whether PF increases provision, among those identified as having an alcohol use disorder (AUD), provision of medication assisted treatment (MAT) or referral to specialty care.

Aim 3 (effect of providing embedded telehealth services) will not be evaluated due to lower enrollment than anticipated and delayed data collection (both related to the COVID-19 pandemic) which have prevented randomization among practices with slower uptake of SBI after 6 months of PF.

In Aim 4 the investigators will evaluate the effect of PF on the implementation of clinical practice and office systems changes to improve evidence-based SBI and MAT. The primary hypothesis is that PF will increase implementation of clinical practice and office systems changes to improve evidence-based SBI and MAT. The secondary hypotheses are that (a) practice capacity for quality improvement (QI), organizational readiness to implement change, and contextual factors will moderate the effect of PF on the implementation of clinical practice and office systems changes and (b) embedded telehealth services will increase implementation of clinical practice and office systems changes among practices with slower uptake.

Eligibility Criteria:
Inclusion Criteria:

* Small-to-medium sized primary care practices (10 or fewer providers) in North Carolina

Exclusion Criteria:

* Practices with fewer than 100 adult patients (18+ years) or more than 10 providers;
* practices unwilling to implement evidence-based screening and management of patients with unhealthy alcohol use.