cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Levetiracetam in Essential Tremor

Essential tremor poses one of the greatest therapeutic challenges to neurologists. This study will examine the effectiveness of the drug, levetiracetam or keppra, for the treatment of essential tremor.

Currently available pharmacological treatments for essential tremor are hampered by relatively low efficacy and intolerable side effects. Recent evidence indicates that levetiracetam (LEV) may modulate the dopaminergic system. In this regard LEV has been shown to reduce L-dopa-induced dyskinesias, tardive dyskinesia and myoclonus, and is relatively well-tolerated in the elderly. Previous studies examined the efficacy of LEV for the treatment of essential tremor. However, these were either open label or relatively short duration studies. A longer term study of LEV for the treatment of essential tremor is therefore warranted. In this randomized, double-blind, placebo-controlled crossover study, ten subjects with essential tremor will be randomly assigned to receive either LEV up to a maximum dose of 3000 milligrams (mg) per day or placebo. Study drug will be titrated up over 6 weeks and continued at 1500 mg twice daily for an additional 6 weeks. Following a 4 week washout period subjects will cross over to the other arm and continued for an additional 12 weeks. Subjects will be evaluated monthly by a blinded examining neurologist and research coordinator. At each study visit subjects will receive a neurological examination and will be evaluated using a 16-item scale for tremor and medication side effects. The data derived from study drug vs. placebo groups will be compared using the Mann-Whitney U and Wilcoxon W tests.

Eligibility Criteria:
Inclusion Criteria:

* History of tremor for 5 or more years
* No other neurological problems

Exclusion Criteria:

* Prior stroke or other neurological disease, psychiatric problems
* History of renal disease
* Pregnancy
Wearable Monitor in Patients With Syncope

The main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.

Background While ECG monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. Conventional ambulatory blood pressure (BP) monitoring (ABPM) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of BP measurements (usually every 15-20 min).

The main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.

Method The study is a prospective intrapatient comparison during tilt testing between BP measured by mean of a wearable watch-type BP monitor (Omron HeartGuide 6410T, Omron Healthcare, Kyoto, Japan) and by mean of the standard methods for continuous finger BP monitoring (Finometer®, Finapres Medical Systems, Enchede, The Netherlands, and Task Force® monitor, CNSystem, Graz, Austria), based on the photoplethysmographic volume clamp method .

Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the HeartGuide device and will be compared with the standard of reference of BP. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of impeding syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients,
* \>18 years of age, referred for tilt testing because affected by suspected reflex syncope

Exclusion Criteria:

* Arrhythmias or the inability of HeartGuide to measure BP supine at rest.
A Study of Carbon-14-Labelled [14C] LOXO-305 (Pirtobrutinib) in Healthy Male Participants

The main purpose of this study is to evaluate the absorption, metabolism, and excretion (AME) profiles of pirtobrutinib (LOXO-305), to identify and characterize metabolites of pirtobrutinib (LOXO-305), and to assess the safety and tolerability of \[14C\] LOXO-305 in Part 1. To determine the absolute bioavailability of pirtobrutinib (LOXO-305), to evaluate the plasma concentration of total radioactivity, to evaluate the urinary excretion of \[14C\] LOXO-305 and total radioactivity, to evaluate the fecal excretion of \[14C\] LOXO-305 and total radioactivity, and to assess the safety and tolerability of pirtobrutinib (LOXO-305), and \[14C\] LOXO-305 in Part 2. Blood tests will be performed to check how much pirtobrutinib (LOXO-305) and \[14C\] LOXO-305 gets into the bloodstream and how long it takes the body to eliminate it.

The study will last up to approximately 60 days for Part 1 and approximately 47 days for Part 2.


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) within the range of 18.5 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Participants who are capable of fathering a child must agree to use contraception from the time of the dose administration through 6 months after the last dose of LOXO-305 administration
* History of a minimum of 1 bowel movement per day

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening
* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening or Check-in (Day -1)
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
* Part 1 only: Participation in a radiolabeled drug study where exposures are known to the Investigator (or designee) within the previous 4 months prior to Check-in (Day -1) or participation in a radiolabeled drug study where exposures are not known to the Investigator (or designee) within the previous 6 months prior to Check-in (Day -1).
* Part 2 only: Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in (Day -1). Any previous radiolabeled study drug must have been received more than 12 months prior to Check-in (Day -1).
Brain Oxygenation During Prehospital Anesthesia

The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. The study does not affect the treatment of the patient. The study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.


Eligibility Criteria:
Inclusion Criteria:

* sedation or anesthesia provided to facilitate endotracheal intubation, performed by HEMS team regardless of the reason

Exclusion Criteria:

* Cardiac arrest at the time of intubation
* Physical barrier for NIRS measuring (e.g. forehead laceration)
* HEMS physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion)
* Workload too high to ensure standard level of clinical care during the study
* Known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients.
* Known or evident pregnancy
Project TEAM: Teaching HIV Prevention in the HIV Clinic

The purpose of this study is to determine if the TEAM prevention intervention delivered by a physician and an HIV-positive counselor is effective. It is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition.


Eligibility Criteria:
Inclusion Criteria:

* 1) 18 years or older, 2) HIV-infected, 3) Sexually active, 3)Receiving HIV primary care at participating clinic, 4) Can communicate in English or Spanish, 5) No previous enrollment in the TEAM study or intervention.

Exclusion Criteria:

* 1) Participation in a similar study run by the TEAM PI.
AFT: Introduction of a Full Breast Reconstructive Method

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age of 18 years and older
* History or in candidate for a mastectomy procedure in the near future
* Patients undergoing preventive mastectomy
* Patients' choice to undergo a breast reconstruction
* Wanting to participate in this study
* Patient is able to wear the external expansion device

Exclusion Criteria:

* Active smoker or a history of smoking 4 weeks prior to surgery
* Current substance abuse
* History of lidocaine allergy
* History of silicone allergy
* 4 weeks or less after chemotherapy
* History of radiation therapy in the breast region
* Oncological treatment includes radiotherapy after mastectomy
* Kidney disease
* Steroid dependent asthma (daily or weekly) or other diseases
* Immune-suppressed or compromised disease
* Uncontrolled diabetes
* BMI\>30
* Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
* Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
* The treating plastic surgeon has strong doubts on the patient's treatment compliance
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up

This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.

This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have had an implant of the OCT System.

Exclusion Criteria:

* No exclusion criteria.
Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection

Although Prostate Specific Antigen (PSA) is a useful marker for early detection of the prostate cancer, its specivity is not sufficient. Several PSA variations were defined in order to increase the specivity of the test, but they aren't much more effective than the PSA alone for detection of disease.

In older studies reported that, serum and prostatic tissue zinc levels decreased in prostat cancer disease.

In our study we aimed to establish the utility of serum zinc, PSA, free PSA/PSA (fPSA/tPSA), zinc/PSA, levels for early detection of the prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients with LUTS and elevated serum PSA levels and/or suspicious rectal examination

Exclusion Criteria:

usage of zinc included drugs, older prostatic operations, older prostatic radiotherapy, older prostatic biopsies, chronic rectal diseases (anal fissure, hemorrhoid, etc..), PIN(prostatic intraepithelial neoplasia) and ASAP(atypical small acinar proliferation) in pathologic evaluation.
Histiocytic Disorder Follow-up Study

The purpose of the study is to describe the burden of chronic health conditions, psychological dysfunction, chronic pain, healthcare utilization, worse health-related quality of life, overall mortality, and cause-specific mortality among individuals with histiocytic disorders

Background

Over the last decade, major advances have occurred in histiocytic disorders with the discovery of MAPK-ERK pathway mutations leading to targeted therapeutics using BRAF- and MEK-inhibitors. However, there is a lack of large studies informing the burden of morbidity and mortality among people with histiocytosis. Institutional studies in pediatric LCH suggest that survivors suffer from long-term impairment of health related quality of life, cognitive dysfunction, pituitary dysfunction, and hearing difficulties in 20-50% cases. Studies from the investigative team and others have also shown a high incidence of acute myeloid leukemia and other second primary malignancies in pediatric and adult LCH. Chronic medical conditions may arise as a function of the disease biology or due to cancer therapy, as seen in other hematologic malignancies.

Design

Retrospective cohort study aimed at determining the risk of chronic health conditions and cause-specific mortality in pediatric and adult patients with histiocytic disorders. The study will include patients from the Histiocytosis Association registry and other institutions including UAB (n\~6000). The participants will complete a validated questionnaire capturing details of chronic health conditions, health related quality of life, cognitive/psychological function, and healthcare utilization.

Future directions

The results from our study will be instrumental in formulating follow-up guidelines for histiocytic disorders and developing targeted survivorship programs to improve overall outcomes.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of histiocytic disorder at any age

  1. Langerhans cell histiocytosis,
  2. Erdheim-Chester disease,
  3. Rosai-Dorfman disease,
  4. Xanthogranuloma,
  5. Mixed histiocytosis
  6. Malignant histiocytosis (Histiocytic sarcoma, langerhans cell sarcoma, interdigitating cell sarcoma)
  7. Hemophagocytic lymphohistiocytosis

Exclusion Criteria:

* None
Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia

This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).


Eligibility Criteria:
Inclusion Criteria:

* Treated with a statin - Fasting LDL-C \>=70mg/dL and triglycerides \<=400mg/dL

Exclusion Criteria:

* Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block

This double-blind dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anesthetic administered to each patient depends on the response from the previous one. The TQL block is performed preoperatively, and the first patient recruited receives 20 mL of ropivacaine 0.75%. In case of block failure, the next patient will receive a higher volume (defined as the previous volume with an increment of 2 mL). Given a successful block for the first patient, the next patient will be randomized to either a lower volume (defined as the previous volume with a reduction of 2 mL) or the same volume as the previous patient. The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume. Block success is defined as patient reported numeric rated scale (NRS) pain (NRS value ≤ 3 (0-10/10)), 30 minutes after arrival in the post anesthesia care unit (PACU). The NRS pain value is our primary and only outcome in the evaluation of the block. A minimum of 25 eligible patients are needed to achieve precise estimation of MEV90 with narrow 95% confidence intervals derived by bootstrapping. Following inclusion of 25 patients early termination is considered when interim analysis shows sufficiently stabilization of MEV90 estimate. The final sample size is not known a priori, but a maximum of 40 patients will be enrolled in the trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for the trail must comply with all of the following requirements to be included:

  * Scheduled for elective PNL surgery in general anesthesia with propofol and remifentanil
  * Age \> 18 years at the date of inclusion
  * Have received thorough information, oral and written, and signed the "informed consent" form on participation in the trail
  * ASA score 1-3

Exclusion Criteria:

* Inability to speak and understand Danish
* Allergy to local anesthetics or opioids
* Daily intake of opioids (evaluated by the investigators)
* Drug and/or substance abuse
* Local infection at the site of injection or systemic infection
* Difficult visualization of muscular and fascial structures necessary for successful block administration
* Pregnancy or breastfeeding
Burden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers

This study is an online (web-based) or paper-based survey for patients with transthyretin familial amyloidosis polyneuropathy (TTR-FAP) and caregivers. The results will be used to describe the emotional, physical, and financial impact of having TTR-FAP or caring for someone who has the disease.

Convenience sample of patients and caregivers recruited through patient advocacy groups. Convenience sample.

Eligibility Criteria:
Inclusion Criteria:

* Adults (ages 18-85 years inclusive) diagnosed with TTR-FAP or TTR-CM and experiencing symptoms or currently providing care for a patient with TTR-FAP or TTR-FAP

Exclusion Criteria:

* Caregivers who formally care for a TTR-FAP or TTR-CM patient as part of their job description and receive payment for their services.
Attentive Eating for Weight Loss

This trial examined whether a smartphone application designed to encourage a more attentive eating style could help people to lose weight, compared to a control group.

There is evidence that enhancing memory for recent eating and focusing attention on food being consumed influences later energy intake. Studies have shown that attending to food being eaten can reduce food intake. This has since been implemented into a smartphone based 'attentive eating' application. In a feasibility trial of this mobile phone application, adults with overweight or obesity were encouraged to eat attentively by photographing their meals and making satiety ratings after they had eaten. Participants were also required to review what else they had eaten that day before entering their next meal, with an overall aim of encouraging a more attentive eating style. Adherence data and qualitative interviews suggested that the mobile phone app was generally acceptable to participants and easy to use. Participants reported that they felt the application increased their awareness of what they had been eating. There was also an average weight loss of 1.5kg across the 4 week period that participants used the application for. Given that the previous feasibility trial included no control condition, the aim of the current trial was to examine initial proof of concept for effectiveness of an attentive eating smartphone weight loss application.

In the current study the investigators hypothesised that participants randomised to the attentive eating smartphone based condition (experimental condition) would lose significantly more weight than participants randomised to the control condition.

The study is a single centre, parallel, two arm, individually randomised 8 week controlled trial in adults with overweight and obesity in the Merseyside area of England.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25.0 kg/m2
* Self-report would like to lose weight by changing their dietary behaviour
* 18-65 years
* Fluent English
* Own an Android/Apple smartphone

Exclusion Criteria:

* History of eating disorders or food allergies
* Medication that affects appetite
* Pregnant
* Scheduled for weight loss survey during the trial
* Currently on a structured weight loss programme (e.g. Weight Watchers)
"Core Stabilization Strenght and Pelvic Floor Functions in Primary Sjogren's"

This study aims to explain the comparison of core stabilization strength and pelvic floor functions between individuals diagnosed with Sjogren syndrome and a healthy control group.

(Sjogren syndrome group n=27; control group n=27)


Eligibility Criteria:
Inclusion Criteria:

Sjogren syndrome group:

* Diagnosed by a rheumatologist
* Being 18 years of age or older,
* Agreeing to participate in the study

Control group:

-Being 18 years of age or older,

Exclusion Criteria:

Sjogren syndrome group and control group:

* Presence of neurological disease
* Presence of any orthopedic problem that would affect functionality
* Presence of a history of orthopedic surgery
Misoprostol For Nulliparous Women Before Hysteroscopy

To compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

There is no consensus on the effect of misoprostol on cervical ripening for nulliparous women. The aim of the study is to compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment.

Exclusion Criteria:

* women with a known allergy to misoprostol.