cyrilzakka/clinical-trials huggingface dataset:
Prospective Observation of the Fluoroscopy-guided Cervical Epidural Approach Using the Contralateral Oblique View

The aim of the present study is to investigate the safety and clinical utility of contralateral oblique view for fluoroscopic guided cervical epidural access.

A cervical epidural block is a widely used intervention to reduce pain in patients with cervicalgia or cervical radicular pain. To achieve a successful procedure, accurate access to the cervical epidural space is needed. However, careful attention is required for this cervical epidural procedure due to a possibility of serious complications such as spinal cord infarction and quadriplegia due to blood vessel damage, convulsion due to an intravascular drug administration, cerebral infarction due to vascular embolism, subdural or subarachnoid injection, hematoma, and spinal cord injury. Although the use of fluoroscopy improves the safety and accuracy of cervical epidural access, this technique still has significant drawbacks, such as false loss of resistance and difficulty in assessing the depth of the needle tip in lateral views in relation to the epidural space. To overcome this issue, cervical epidural access using the contralateral oblique (CLO) view has been introduced and the ideal angle of CLO view for the cervical spine is reported as 50 degrees.

However, it has not been reported on the safety and clinical utility of using the CLO view during cervical epidural access. Therefore, the investigators planned this study to observe the safety and clinical utility of the CLO view at 50 degrees for the cervical epidural block.

Eligibility Criteria:
Inclusion Criteria:

* Patients who need an epidural space access at C6-7 or C7-T1 level
* Patients who are expected to undergo cervical epidural block
* Patients who are expected to undergo cervical epidural neuroplasty
* 20 ≤ age \<80
* When obtaining informed consent voluntarily

Exclusion Criteria:

* Allergy to local anesthetics and contrast dye, and steroid
* Use of anticoagulants or antiplatelet medication, coagulopathy
* Infection at the insertion site
* Neurological or psychiatric disorders
* Prior spine instrumentation
* Pregnancy
* Not visible epidural space due to severe cervical spinal canal stenosis
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants

This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\^2) through 32.0 kg/m\^2, inclusive.

BMI = weight (kg)/(height \[m\])2.

* Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
* Any major surgery within 4 weeks of study intervention administration.

Other protocol-defined inclusion/exclusion criteria apply.
Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial

Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests \[namely International Normalised Ratio (INR) and Platelets count\] are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Rotational Thromboelastometry ( ROTEM) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study is to evaluate the efficacy of ROTEM as a guide for blood products transfusion in cirrhotic children undergoing invasive procedures.

Children with cirrhosis listed for invasive procedures and with deranged INR or deranged platelet count will be included in the study and will be block randomized into two groups. To prevent bleeding during the procedure, one group will receive prophylactic transfusion of either fresh frozen plasma (FFP),Platelet or Cryoprecipitate based on the values of INR, platelet and fibrinogen.The second group will undergo ROTEM based correction.

Following correction, the procedure will be done in both the groups. Patients randomized in the ROTEM group will undergo repeat ROTEM and INR, Platelet, Fibrinogen testing (depending on the component transfused), post the procedure, to look at the correction achieved. Similarly, patients randomized in the conventional group will undergo repeat INR, Platelet, fibrinogen testing depending on the component transfused.

Patients will be followed for 24 hours indoors for any evidence of bleeding or transfusion reaction.

Eligibility Criteria:
Inclusion Criteria:

•Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ≥ 1.5- ≤ 2.5 and/or Platelet count 20,000/mm3- 50,000/mm3 and who are listed for the following invasive procedures : Low risk of bleeding

1. Central venous cannulation
2. Haemodialysis catheter
3. Ascitic or Pleural tapping
4. Endoscopic variceal ligation (EVL)
5. Endoscopic sclerotherapy (EST)

High risk of bleeding 6. TIPPS 7. Endoscopic retrograde cholangiopancreatography (ERCP) with sphicterotomy 8. Percutaneous drain (PCD) Insertion 9. Biopsies other than liver biopsy

For children less than 18 years with liver cirrhosis and with a platelet count between 40,000-60,000/mm3 and INR between 1.5-2.0 who are listed for

1) Liver biopsy

Exclusion Criteria:

* Anti platelet or anti coagulant therapy in the previous 7 days
* Patients with clinical evidence of Disseminated intravascular coagulation (DIC) and/or active bleeding
* Hemodialysis in the past 7 days
Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial

This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule).

Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes.

There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients ≥ 18 and ≤ 65 years of age at Screening
* Patients with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured interview (MINI).
* Adequate organ function.
* Able to understand the study procedures and understand risks associated with the study, and sign written informed consent to participate in the study.
* Must be willing to refrain from more than 6 standard alcoholic drinks a week, more than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment period (6 weeks) and until the last study visit is complete.

Exclusion Criteria:

* Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder.
* Past or present bipolar disorder (DSM-5).
* Any lifetime history of suicide attempt.
* Once Informed Consent form is signed, not willing or able to stop any prescription or non-prescription ADHD medications.
* Use of investigational medication/treatment in the past 30 days.
* Patients with a positive urine drug screen with the exception of THC or its metabolites.
* Pregnant or nursing females.
Danish Angle Closure Prevention Trial

To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy.

Prospective, randomised paired-eye design clinical trial comparing peripheral laser iridotomy in one eye with observation in the other over 5-years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Primary angle closure suspect: ≥180 degrees (cumulative) irido-trabecular contact on darkroom gonioscopy, IOP\<21mmHg, no peripheral anterior synechiae, no glaucomatous optic neuropathy
* Best-corrected visual acuity (BCVA) \>0.8 on both eyes
* Caucasian

Exclusion Criteria:

* Pseudophakia
* Previous iridotomy
* Clinically significant cataract with indication for surgery,
* Gaucoma
* Uveitis
* Unstable retinal conditions
* Ocular malignancies
* PEX
* PDS
* Systemic or ocular corticosteroid treatment
Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory myeloma.
* Must have been exposed to at least 2 cycles of an IMiD containing regimen and PI containing regimen and must be refractory to at least one of the two.
* Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting antibodies.
* Active myeloma requiring systemic treatment.
* Measurable disease per protocol.
* ECOG performance status of 0 - 2.
* Life expectancy of at least 3 months.

Exclusion Criteria:

* POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis.
* History of select prior malignancies.
* Previous intolerance to daratumumab or any study drug.
* Received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant.
* Have an active infection or serious comorbid medical condition.
* Any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis B or hepatitis C.
* Female participants pregnant or breast-feeding.
* Screening chemistry and blood counts within protocol limits
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children

To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children.

Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.

Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.

Two doses, given by mouth, are evaluated: Three patients receive the lower dose, and 7 days after the third patient receives the lower dose, three additional patients receive the higher dose. After dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure blood levels of the drug.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines.

Patients must have the following:

* HIV infection.
* Parent or guardian must be available to give written informed consent.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Zidovudine (AZT).
* Steroid dependency.

Excluded within 1 hour before and 4 hours after study drug administration:

* Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine).
* Benzodiazepines.
* Alcohol-containing substances.

Concurrent Treatment:

Excluded:

* Requiring supplemental oxygen.

Patients with the following are excluded:

* Active opportunistic or serious bacterial infection.
* Lymphoid interstitial pneumonitis (LIP) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 \< 70 mm Hg.
* Pre-existing malignancies.

Prior Medication:

Excluded:

* Zidovudine (AZT) within 7 days prior to administration of study drug.

Excluded for at least 4 weeks prior to drug administration:

* Other approved or investigational antiretroviral agents. All other investigational agents. Biologic response modifiers (e.g., interferon) or immunomodulators. Immunosuppressive agents (including glucocorticoids). Coumadin and other anticoagulant medications.

Prior Treatment:

Excluded:

* Red blood cell transfusion within 4 weeks of study entry.

Patients may not have the following:

* Opportunistic or serious bacterial infection.

Zidovudine (AZT) \> 7 days prior to administration of study drug.

Active alcohol or drug abuse.
The Safety and Efficacy of the 4 Channel NMES on Swallowing

This study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders.

The purpose of this study is to investigate the difference in 4ch NMES and 2ch NMES, And to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

* Design: Prospective study
* Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study
* Intervention: Participants are divided into two group and applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)" in 4channel or 2channel Neuromuscular Electrical Stimulation.
* Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory

Eligibility Criteria:
Inclusion Criteria:

* patient who do not belong to the criteria excluded for subjects aged 19 years or older
* Patient who is confirmed to be dysphagia by videofluoroscopy
* Patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury
* Those voluntarily agreeing to the clinical trial

Exclusion Criteria:

* Patient who refuse inspection, do not agree
* Simple "Commend obey", first step is impossible
* When instructions can not be executed due to dementia, psychiatric disorders, etc.
* Dysphagia occurs due to respiratory failure, neck surgery, etc.,
* Pregnant women and lactating women
Dermal Wound Closure Using Silkam®

Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.

The prospective, monocentric, single-arm, observational Post Market Clinical Follow-Up (PMCF) study is done to continue to evaluate the safety and performance of Silkam® suture material for skin closure under clinical routine. Safety and effectiveness parameters commonly used in skin closure are to be used to evaluate the performance of the suture material.

The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Silkam® suture material under the daily routine clinical practice when used for skin closure as intended.

Eligibility Criteria:
Inclusion Criteria:

* Adult and paediatric patients undergoing skin closure using Silkam® as suture material.
* Written informed consent regarding the data collection for the PMCF study.

Exclusion Criteria:

* Pregnancy
* Visible dirty wounds
* Patients taking medication that might affect wound healing
* Patients with hypersensitivity or allergy to the suture material
Decision-making - the Benefit of Bedside CRP Within Ambulance Care

Patients with degreased (DGC) for ambiguous reasons receive low triage priority. Their death risk is triple. Tools are needed to identify the critically ill patients from this group. The triage used today is not effective. The bedside point-of-care measurements are CRP, lactate acid and suPAR (Soluble Urokinase Plasminogen Activator Receptor). Elevated values associate with the probability of critical illness and predict a risk of death.

Purpose: To improve identification and proper prioritization of patients with non-specific symptoms prehospitally, we intend to investigate whether Q-CRP, a rapid test for CRP, correlates with time-critical states in the above-mentioned patient group alone or together with CRP, lactate and suPAR. The primary endpoint is need for hospital care.

Material: Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Method: In patients with unspecified conditions, defined according to the inclusion template, a venous blood sample was taken prehospitally at the scene by the EMS.

Analysis: Significance tests and regression analyzes with 95% CI were used. The diagnostic accuracy of Q-CRP, lactate, suPAR and combinations thereof were compared with optimal boundary values.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Exclusion Criteria:

* Abnormal vitals
A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients

This study will be a prospective, non-interventional, single arm and open label study, in patients with contact dermatitis requiring systemic steroid therapy with a purpose to obtain the real life effectiveness and tolerability of Medrol in treating contact dermatitis in Indian patients. Patients with contact dermatitis who have been prescribed for Medrol will be enrolled into the study and will be followed up for the resolution of symptoms


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for enrollment in this study, patients must be prescribed oral Medrol tablets (4mg and 16 mg) for contact dermatitis as per the locally approved prescribing information
* Medrol tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol tablet will necessarily precede and will be independent of the decision to enroll patient into the study
* Only those patients, who are ready to sign an informed consent, will be included in the study
* Subject can be contacted through telephone

Exclusion Criteria:

* Patients who have any other dermatological or systemic condition that may interfere or confound with the study outcome measurements
* Patients taking any oral steroid preparation or immunomodulators or have taken any such oral medication during last 15 days before enrollment. NSAIDs (Non Steroidal Anti-Inflammatory Agents) are excluded from the list
* Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
* Participation in other studies within last 1 month before the current study begins and/or during study participation
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
A Behavioral Intervention for Pain Catastrophizing in Primary Dysmenorrhea

The purpose of this study is to test the feasibility and efficacy of a brief group therapy treatment program focused on reducing pain catastrophizing in adolescents and young adults (ages 16-25) with menstrual pain.


Eligibility Criteria:
Inclusion Criteria:

* Female ages 16-25 years
* Self-reported menstrual cycle averaging 24-32 days
* Menstrual pain rating of ≥4 on the Numeric Rating Scale for at least the previous three menstrual cycles prior to participation
* Written informed consent or assent (if a minor, parent must also provide written parental permission)
* Able to read and understand English

Exclusion Criteria:

* Use of oral contraceptives or any exogenous hormones in the previous 3 months
* Presence of persistent pelvic pain throughout the menstrual cycle
* Acute illness or injury that may impact lab performance or that affects sensitivity of the extremities
* Diagnosis of an underlying medical cause for dysmenorrhea symptoms
* No or minimal menstrual pain (NRS rating of ≤ 3) during any of the 3 previous cycles prior to study participation
* Daily use of opioids; participants using other analgesics will be included, but will be asked not to take these analgesics on the days of the lab sessions
* Developmental delay, autism, or significant anatomic impairment that may preclude understanding of study procedures
Briagen Observational Study

This research study is evaluating a study product called Briagen™ as a possible treatment for wound healing after Mohs procedure.

Briagen, the study product being used in this study, is a natural complex carbohydrate wound dressing for skin wounds created by Mohs surgery.

Briagen was developed with the intent to improve healing time and reduce scarring of skin wounds. Briagen seeks to match the mechanical aspects of your skin (thickness, stiffness, hydration, pore size) to assist in the healing process.

The purpose of this research study is to observe healing time of Briagen applied to wounds created as a result of Mohs surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient seeking treatment for wound created by Mohs or other full thickness skin excisions
2. Over 18 years of age
3. English-speaking
4. Presents for treatment within 24 hours of initial Mohs skin excision procedure.

Exclusion Criteria:

1. History of significant wound complications and non-compliance on wound maintenance instructions (infections, disturbing the wound during the healing process, etc.)
2. Known diagnosis of Diabetes
3. Active infection in the wound bed
4. Under 18 years of age
Impact of COVID-19 Pandemic on Perceived Exercise Benefits and Barriers

It is aimed to determine the physical activity level and exercise benefits and barriers caused by Covid-19 pandemic and reveal the relationship between them.

Study hypothesis that people are tend to be physically inactive while Covid-19 pandemic. It is aimed to determine the exercise benefits and barriers caused by Covid-19 pandemic and reveal the relationship among gender, age, marial status and physical activity level.

Eligibility Criteria:
Inclusion Criteria:

* being Turkish
* understanding Turkish
* being between the age of 15 - 65
* being literate
* have internet access

Exclusion Criteria:

* having a disable condition to exercise
* having missing value on outcome measures
* giving incomprehensible answering