cyrilzakka/clinical-trials huggingface dataset:
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome

Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis, decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or benzodiazepines.

Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly despite evidence of safety and efficacy. To demonstrate the utility and safety of physostigmine, the investigators propose a randomized clinical trial of physostigmine compared to benzodiazepine for antimuscarinic toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=10 and \< 18 years
* Present to the Emergency Department or Intensive Care Unit for an antimuscarinic toxidrome from either a pharmaceutical agent such as antihistamine overdose, or natural toxins or products such as Datura stramonium
* Antimuscarinic toxidrome will be defined with at least one central nervous system agitation effect (agitation, delirium, visual hallucinations, mumbling incomprehensible speech), and at least 2 peripheral nervous system adverse effect (mydriasis, dry mucus membranes, dry axillae, tachycardia, decreased bowel sounds).
* Patients will also be required to have a RASS score of +2 to +4 on initial assessment.

Exclusion Criteria:

* History of seizures or seizure during acute clinical course
* History of asthma or wheezing during clinical course Bradycardia (Heart Rate \<60)
* Concomitant use of atropine or choline ester or depolarizing neuromuscular blocker during present illness and hospital course
* Diabetes gangrene, known intestinal obstruction or urogenital tract, vagotonic state
* QRS interval \> 120 ms on electrocardiogram
* Known to be pregnant at the time of enrollment
* Known ward of the state
An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

This study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.

The investigators will enroll pairs of Veterans and one adult family member who lives with them. Veterans will be beginning a course of PTSD-focused treatment at the Boston VA; Veterans' treatment will not be limited or changed by their participation in this study.

Family members will receive or not receive (depending on which Phase of the study they are recruited in) the BFI. The BFI consists of 2 sessions in which the family member meets one-on-one with a clinician to discuss PTSD, PTSD treatment, and how families can be most helpful to patients in treatment.

Veterans and family members will also be interviewed about their opinions and experiences regarding family-inclusive treatment for PTSD. Clinicians will be recruited and enrolled to obtain their information and feedback (via qualitative interviews), and to deliver the intervention in Phase II.

Eligibility Criteria:
Inclusion Criteria:

* Veterans must have a diagnosis of PTSD and be beginning a course of Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) at the Boston VA.
* Must also have an eligible family member who is willing to participate.

Exclusion Criteria:

* Current diagnosis of unstable bipolar disorder, substance dependence, past or present psychosis, or organic mental disorder
* Clear and current suicidal risk
* Current participation in family/couples therapy
Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer

The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.

The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.

Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably.

Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the "change of life"). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* History of breast cancer who have received hormonal therapy
* Personal history of hot flashes
* Patients will be accepted if receiving therapy with traditional allopathic medicines if their hot flashes have persisted after two months

Exclusion Criteria:

* Receiving therapy with traditional allopathic medicines for hot flashes
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment

The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe hepatic impairment.


Eligibility Criteria:
Key Inclusion Criteria:

* Screening laboratory parameters within defined thresholds
* Creatinine clearance must be ≥ 60 mL/min

Key Exclusion Criteria:

* Females who are pregnant or nursing or males who have a pregnant partner
* Infection with hepatitis B virus (HBV) or HIV
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Probiotic Sport Study

We investigate the impact of a probiotic-based dietary supplement on oxidative stress and endotoxemia before and after strenuous exercise.

Hypotheses (H1):

* Supplementation has an influence on oxidative stress parameters before and post exercise
* Supplementation has an influence on parameters of endotoxemia and inflammation before and post exercise
* Strenuous exercise has an influence on parameters of oxidative stress, inflammation and endotoxemia


Eligibility Criteria:
Inclusion Criteria:

* trained men
* 30 - 45 years
* non-smokers
* 4wk wash out of all dietary supplements

Exclusion Criteria:

* untrained people (VO2max \< 55 ml x kg-1)
* female
* all people not matching this age group
* smokers
* all men taking dietary supplements
* all men that fail in ergometric exercise eligibility testing, refering to the standards in sports medicine (e.g.: significant ST-decrease or increase, blood pressure \> 240 mmHg, tachycardia, polymorphic extrasystolia, cyanosis, bradyarrhythmia..)
* all people that are not adjudged as "Healthy"
Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.

The radial approach for a coronary angiography is currently adopted by several centers because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in intra-arterial have been widely studied in prevention of this spasm. No studies have compared the different routes of administration of nitrates as a patch and a continuous intravenous injection.

The radial approach is favored for coronary angiography due of several advantages: reduction of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and time reduction of hospitalization, improved patient ulterior comfort. However, this approach is subject to an immediate major complication that is the radial artery spasm (RAS) which, according to the criteria used, has an average incidence of 30%. The administration of a vasodilator just before coronary angiography procedure enables an increase of the radial artery diameter and thus a decrease of friction probes. Theoretically this prevents the occurrence of the RAS.

The literature re-counts several vasodilator product tests (DN calcic blocker, magnesium sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct intravenous route (IV), subcutaneous injected route, direct intra-arterial route (IA)). Overall intra-arterial DN appears to be more efficient. The downside is a brief, painful thermal sensation but intense and notably unpleasant. IV injection is better tolerated but it was a direct injection and without proof of its superiority over IA. The para-radial subcutaneous injection has only been studied to facilitate access to the radial artery. The investigators randomized study compares, for the first time, the effectiveness of the transdermal administration of trinitrine (D) and continuous intravenous of dinitrate isosorbide (V) to dinitrate isosorbide intraarterial (A) standard.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 ans.
* Patients with hemodynamic stability.
* Patients informed consent was signed by each individual. The study obtained approval from the local ethics committee.

Exclusion Criteria:

* 'Test d'Allen' negative
* Pregnancy.
* STEMI
* Hemodynamic Instability : PAS \< 100 mmHg, FC \> 100 bpm, tachycardia uncontrollable.
* Allergy of nitrates.
Virtual Reality for Anxiety in Interventional Radiology Procedures

The goal of this clinical trial is to learn if virtual reality works to reduce anxiety in patients undergoing interventional radiology procedures. The main questions it aims to answer are:

Does virtual reality lower anxiety in patients undegoing minimally invasive procedures? Can it help the platient's compliance and operators' satisfaction? Researchers will compare virtual reality to usual preoperative care to see if virtual reality is effective.

Participants will:

Use virtual reality for 20 minutes before the intervention starts. Complete questionnaires before and after the procedure.

Patients enrolled and assigned to group 1 will wear the virtual reality visor in the induction room, before entering the Angio Suite in which the procedure will take place. The study requires that before and at the end of the procedure, a measurement of blood pressure and heart rate in order to measure the change in the patient's anxiety state. At the end of the procedure, they will be administered satisfaction tests to interventional radiologists and patients. The viewers in question are Meta Quest 2. Through the use of these viewers, the patient will will watch a VR video containing music and natural images that can promote relaxation in preparation for the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Indication to CT-guided biopsy in local anesthesia
* Informed consent signature

Exclusion Criteria:

* Lack of patient consent to trial.
* Lack of eligibility to perform CT-guided needle biopsy, or eligibility to perform the procedure but with administration of general anesthesia or sedation.
* patients who do not speak Italian or English will be excluded;
* patients with visual and/or hearing impairment;
* patients on analgesics or anxiolytics;
* patients with the following conditions: dementia, psychiatric disorders; headache, dizziness, recent head injury, epilepsy, and other conditions in which the application of VR glasses has been judged to be potentially harmful; and when the topical anesthetic (lidocaine and prilocaine \[eutectic mixture of local anesthetic (EMLA)\]) or tetracaine (Ametop) was not properly applied before surgery.
Microwave Coagulation in Partial Nephrectomy Protocol

Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney) tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most common technique is to clamp the blood supply to the entire kidney during removal and to surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood supply to the entire kidney including the healthy tissue, which can cause damage to the remaining tissue due to a shortage of oxygen if left clamped too long.

This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading to the remaining tissue, clamping and a shortage of oxygen can be avoided.

The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage of bleeding during partial kidney removal.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must have a solitary, polar, clinical T1 renal mass
2. Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation.
3. Women of child-bearing potential must have negative serum or urine pregnancy test
4. Patient must be able to give written informed consent
5. Patient must be 18 years or older
6. No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery

Exclusion Criteria:

1. T stage greater than clinical T1
2. Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
3. Prior surgery or radiation therapy to the region of interest
4. Patient has a single functioning kidney
5. Patient has an uncorrectable coagulopathy
6. Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition
Effect of Motor Relearning Programme and Mirror Therapy Along for Improving Hand Function In Patients With Stroke.

Study was conducted Effectiveness of Motor Relearning Programme and Mirror Therapy along with Conventional Physiotherapy treatment for improving Hand Function In Patients with stroke. study was an experimental study conducted on 12 stroke patients using convenient sampling method .Subjects were divided into two equal groups (n=6). Group A was given conventional physiotherapy and Motor Relearning Programme exercises for the affected hand and Group B received conventional physiotherapy for the affected hand and mirror therapy for the unaffected hand. Chedoke arm and hand inventory (CAHAI) was used as primary outcome measure for evaluation of hand function before and after application of therapeutic Intervention

Title: Effectiveness of Motor Relearning Programme and Mirror Therapy along with Conventional Physiotherapy treatment for improving Hand Function In Patients with stroke.

Background Upper extremity complications are common following stroke. Individuals who have sustained stroke are often left with residual motor deficits of the upper limb. These deficits restrict functional use of the limb in everyday activities and can result in increased dependen cy upon others to engage in some tasks.

Objectives Present study aims to see effectiveness of mirror therapy and Motor Relearning Programme for improving hand functions in stroke.

Materials and Methods Present study was an experimental study conducted on 12 stroke patients using convenient sampling method .Subjects were divided into two equal groups (n=6). Group A was given conventional physiotherapy and Motor Relearning Programme exercises for the affected hand and Group B received conventional physiotherapy for the affected hand and mirror therapy for the unaffected hand. Chedoke arm and hand inventory (CAHAI) was used as primary outcome measure for evaluation of hand function before and after application of therapeutic Intervention

Eligibility Criteria:
Inclusion Criteria:

* experienced one episode of stroke only,
* Both ischemic \& hemorrhagic stroke individuals
* Duration of stroke between 1 to 6 months,
* Mini mental status examination (MMSE) (score \> 23),
* Brunstrom Stage 4 \& 5.

Exclusion Criteria:

* any musculoskeletal Disorders,
* neurological disorder other than stroke,
* visual impairment, systemic disease,
* Non co-operative patients
* psychological problems.
Temperature Evaluation by MRI Thermometry During Cervical Cooling

The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients who were resuscitated following cardiac arrest but who remained comatose. Induced mild hypothermia is now the standard of care for post-resuscitation patients in the intensive care unit (ICU) setting. The use of cooling has recently moved to pre-hospital and emergency department (ED) application as more current studies show that early initiation of cooling significantly improves neurologic outcomes and survival rates instead of waiting until the patient arrives in the ICU to initiate cooling. In the pre-hospital setting chilled saline (4°C) and packing the body in ice have been the primary methods to initiate induced mild hypothermia The Excel Cryo Cooling System is a non-invasive cervical collar (C-collar) that provides cooling to the carotid arteries, the main blood supply to the brain, and allows for the rapid initiation of selective cerebral cooling. The investigators are planning to use MRI-thermometry to see how quickly the Excel Cryo Cooling Collar can drop brain temperature when applied by itself.

Healthy volunteers will be used for this study to provide important temperature data on the effectiveness of the Excel Cryo Cooling System. The investigators will be able to use the data from this project to further the current clinical research in induced mild hypothermia after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Understands the risks involved, as detailed in the informed consent
* No MRI risk factors

Exclusion Criteria:

* \< 18 years of age \& \> 60 years of age
* Pregnant
* Any known medical problems that limit activity or decrease blood flow: underactive thyroid (hypothyroidism),poor nutrition, stroke, severe arthritis, Parkinson's disease, dementia, significant mental illness besides clinical depression, spinal cord injuries, recent serious burn, disorders that affect sensation in the extremities (e.g., diabetic neuropathy)dehydration, and any condition that limits activity or restrains the normal flow of blood.
* Taking any medications (except seasonal allergy medication, over-the-counter NSAIDs, acetaminophen, or contraceptives)
* Oral medications that inhibit the body's ability to respond to cold: Antidepressants, antipsychotics/neuroleptics, including phenothiazines, beta blockers, clonidine, meperidine, sedative-hypnotics.
* History of cardiac condition in a family member younger than 40 years
* Inability to fit in the MRI scanner (BMI \> 30 kg/m2)
* MRI risk factors (e.g., claustrophobia, heart condition, metal implants, etc), as detailed in the MRI safety questionnaire Heart rate, blood pressure, respiratory rate, or temperature outside of acceptable ranges.
Perfusion Index Parameter

To evaluate the association between the Perfusion index parameter and an independent measure of perfusion.

Perfusion index parameters measured with an Investigational Pulse Oximetry PCBA, paired with Market Released sensors, will be compared to perfusion levels measured by a FDA-cleared device equipped with a laser Doppler technology-based device for blood perfusion measurements. Continuous Perfusion index measurements will be taken during the test sequence.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥18 years of age
2. Subject is able to participate for the duration of the study
3. Subject is willing to sign an informed consent
4. Subject weighs \>40kg

Exclusion Criteria:

1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect the ability to test sensors
2. Physiologic abnormalities that prevent proper application of pulse oximetry sensor
3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes.
4. Raynaud Syndrome
5. Repeated systolic blood pressure \> 140mmHg -
Acute Caffeine Ingestion on Futsal Performance

Caffeine supplementation has been recognized such as an useful strategy for improving performance in intermittent sports, however caffeine ingestion in futsal has been barely studied. In this randomized placebo-controlled study, we investigated the effects of acute caffeine supplementation in improving neuromuscular performance and physical match activity in futsal players.

To date, no previous investigation has studied the effect of acute caffeine ingestion on futsal performance during futsal-specific testing and during a simulated match. Therefore, the aim of this investigation was to establish the effects of acute caffeine intake on futsal-specific tests (e.g. futsal kicking velocity) and match-play running performance in male futsal players.

Eligibility Criteria:
Inclusion Criteria:

* Sub-elite men futsal players

Exclusion Criteria:

* Intolerance to caffeine,
* Suffering from any chronic pathology or an injury in the month prior to the investigation
* Use of medicines or dietary supplements during the study.
A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma

The purpose of this study was to determine clinical efficacy and safety of ruxolitinib (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory or relapsed multiple myeloma.

The protocol was originally designed as a Simon two stage but after it was determined that the initial 13 patients enrolled did not meet the definition of a 'responder' according to the International Uniform Response Criteria for multiple myeloma the protocol was amended to allow patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma with evidence of measurable disease.
* Relapsed or refractory disease with at least one line of prior therapy.
* Adequate bone marrow reserve.

Exclusion Criteria:

* Received anti-cancer medications or investigational therapy in the past 28 days.
* Intracranial disease or epidural disease.