cyrilzakka/clinical-trials huggingface dataset:
A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA

This main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and prescribing physicians regarding the risks and safe use of NATPARA. The survey will be done via internet, telephone, or paper and participants will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.


Eligibility Criteria:
Participant inclusion criteria:

• Participants who are 18 years of age or older and who have been approved for NATPARA and a part of the SUP Program prior to survey implementation are eligible to participate in the survey.

* A caregiver may participate in this survey on behalf of a participant who is a part of the SUP Program and who is eligible but unable to complete the survey.

Prescribing physician inclusion criteria:

• HCPs in the United States (US) who can provide a 10-digit NPI number and who are certified in the NATPARA REMS by successfully completing the NATPARA REMS Program Training Module for Prescribing Physicians, including the Knowledge Assessment, and submitting a NATPARA REMS Program Prescribing Physician Enrollment Form are eligible for participation in the survey and a part of the SUP Program.

Participant and Prescribing Physician exclusion criteria:

* Respondents who do not agree to participate in the survey will be excluded.
* Survey respondents who have been employed or whose immediate family members have been employed by NPS, Shire, Takeda, United BioSource LLC, (UBC), or the Food and Drug Administration (FDA) are not eligible to participate in the survey and will be excluded.
* Respondents who reported having a conflict of interest will be excluded.
* Respondents who are not part of the SUP program will be excluded.

Participant exclusion criteria:

* Participants who do not agree to participate in the survey will be excluded.
* Participants who have opted out of receiving communications will be excluded.
Adding Amantadine to Pregabalin on Occurrence of Post-thoracotomy Pain Syndrome

This study aims to evaluate the additive effect of Amantadine to Pregabaline in the development of post-thoracotomy pain syndrome.

Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the primary therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing, as well as the development of post-thoracotomy pain syndrome (PTPS).

Pregabalin is one of the drugs that can reduce the excitability of the dorsal horn neurons. It is a γ-aminobutyric acid analogue that binds to α2-δ subunits of the voltage-gated calcium channels in the central nervous system.

Amantadine (1-aminoadamantane) is NMDA receptor antagonists. NMDA receptors were found to have role in the development of central sensitization, acute opioid tolerance, and opioid induced hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

* Age (18-65) years.
* Both sexes.
* American Society of Anesthesiologists (ASA) Physical status II, III.
* Body mass index (BMI): (20-40) kg/m2.
* Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or other lung resection procedures.

Exclusion Criteria:

* Patients with known sensitivity or contraindication to drug used in the study.
* History of psychological disorders and/or chronic pain and drug abuse patients.
* Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Advanced liver or kidney disease.
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment

This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:

* Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement.
* Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* age ≥18
* currently on methadone
* persistent or recurring pain that has lasted for a duration of 3 months of longer.

Exclusion Criteria:

* severe cognitive impairment (score \>23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
* suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
* inability to attend or fully participate in intervention sessions or assessments
* previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).
Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster

OBJECTIVES:

I. Compare the efficacy and safety of two doses of oral valacyclovir in immunocompromised patients with uncomplicated herpes zoster.

II. Compare quality of life, pain, and medical resource utilization in patients treated with these 2 regimens.

PROTOCOL OUTLINE:

This is a randomized, double blind study.

Patients are randomized to one of two treatment arms.

Arm I: Patients receive standard dose oral valacyclovir three times a day on Days 1-7.

Arm II: Patients receive higher dose oral valacyclovir three times a day on Days 1-7.

Both arms: Patients begin treatment within 72 hours after onset of zoster rash.

Quality of life is assessed on Days 1, 14, and 28 during study and then every 4 weeks through Week 24. Pain is assessed on Days 1-28 during study, and then weekly through Week 24. Medical resource utilization is assessed on Days 1, 8, 14, and 18 during study and then every 4 weeks through Week 24.

Patients are followed every 4 weeks through Week 24.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within 72 hours after onset of zoster rash

No evidence of cutaneous or visceral dissemination of herpes zoster infection; cutaneous dissemination defined as at least 20 discrete lesions outside adjacent dermatomes

Must have immune dysfunction caused by any of the following: congenital immune deficiency; active malignancy of any type; collagen vascular diseases; organ or bone marrow transplantation; HIV infection; severe atopic dermatitis; received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within past 3 months

CD4 count at least 50%

--Prior/Concurrent Therapy--

Biologic therapy: Greater than 9 months since prior bone marrow transplantation

Surgery: Greater than 9 months since prior liver or heart transplantation

Other: At least 4 weeks since prior topical or systemic anti-varicella zoster virus (anti-VZV) medications; no concurrent systemic agents with anti-VZV activity from enrollment to Day 10; no concurrent probenecid from 24 hours before the first dose of study drug until Day 10

--Patient Characteristics--

Hepatic: AST or ALT no greater than 5 times upper limit of normal

Renal: Creatinine clearance at least 30 mL/min

Other: Not pregnant or nursing; negative pregnancy test; fertile patients must use effective contraception; no history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir
Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer

The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy with radiosurgery for locally advanced pancreas cancer.

The purpose of the trial is to test the efficacy of treating locally advanced pancreatic cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered single fraction of high-energy radiation using a radiosurgical technique.

Eligibility Criteria:
Inclusion Criteria:- Pancreatic tumors not to exceed 7.5 cm.

* Histologically confirmed malignancies of the pancreas, (ampulla of Vater or periampullary duodenum, tumors may be included when the head of pancreas is secondarily involved and unresectable criteria are met).
* Unresectable by CT criteria or unresectable at exploratory laparotomy or laparoscopy. CT criteria for unresectability include encasement of the superior mesenteric vein (SMV), portal vein (PV) or invasion of the celiac artery or superior mesenteric artery (SMA).
* Patients with metastatic disease may be treated if they are symptomatic from the primary tumor.
* Eastern Clinical Oncology Group performance status 0, 1 or 2. Exclusion Criteria:Chemotherapy within 1 month of registration.
Hypertensive Ambulatory Trial to Compare the Efficacy of HCTZ and Lisinopril

The purpose of this trial is to evaluate if an objective clinical decision of anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design.

Personalized medicine involves choosing the optimal treatment for a patient based on data gathered by the physician that is specific to that individual. The N-of-1 or single patient trial is a study design motivated by the new era of personalized medicine. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends a personalized medicine approach to hypertensive drug class choice based on compelling indications. However, the hypertensive decision algorithm is limited. With the advent of new technology the amount of data available to a physician has grown substantially improving the robustness of surveying a more complete picture of the patient's health care status. Medicine is quickly becoming data intensive with new technology decreasing the cost of data collection and analysis.

The typical standard care for patients with stage 1 hypertension first involves a non-pharmacological modification of lifestyle changes. Health care providers diagnose hypertension when the blood pressure is persistently elevated after three to six visits over a several month period. JNC 7 recommends thiazide-type diuretics for Stage I hypertension for most patients. In the United States, this recommendation results in most patients being given a dose of hydrochlorothiazide (HCTZ) at 12.5 to 25 mg per day. A patient would then return for follow-up and would be prescribed a few month supply of an antihypertensive medication (e.g. HCTZ or lisinopril). The choice of treatment by the physician is based on JNC 7 guidelines, patient's risk factors, and a provider's experience.

The objective of this trial will be to evaluate if an objective clinical decision of anti-hypertensive therapy can be made using an N-of-1 (single patient) trial design. In this study we propose to do a series of N-of-1 trials in patients with stage 1 hypertension who will be randomized to alternating courses of HCTZ and lisinopril.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Grade 1 Hypertension
* Treatment naïve
* GFR \> 60 within previous 3 months
* Urinary microalbumin level normal during previous 3 months

Exclusion Criteria:

* Pregnancy (Fetal morbidity and mortality may occur with the use of ACE inhibitors.)
* Uncontrolled Hyperthyroidism
* Sleep Apnea
* Primary Aldosteronism
* Renovascular Disease
* Cushing's Syndrome or steroid therapy
* No evidence of end organ damage
* EKG with evidence of LVH within previous 3 months
* Collagen Vascular Disease
* Current Smoker
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary Sjögren's syndrome
* ESSDAI score ≥ 6

Exclusion Criteria:

* Secondary Sjögren's syndrome
* Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimunab, other immunosuppressives.
* At significant risk for thromboembolic event
* Clinically significant systemic infection
* Significant elevated risk for infection
A Prospective Case Series Analysis of Initial Users of the Urovac Device

To document usage of the Urovac device among 30 initial users of the device in an acute rehabilitation facility, with analysis of whether and how patients benefitted, challenges encountered, and how benefits and challenges varied by patient type.

The Urovac device holds the promise of improving care for many of these patients in a manner that may also significantly decrease costs. The aim of the study is to determine if this device may increase quality of life for patients by reducing urine spills, reducing falls by avoiding urgent situations where patients try to ambulate to the bathroom to avoid wetting sheets, reducing skin breakdown by avoiding urine spills, reducing excoriation of the glans penis, and reducing urinary tract infections.

The Urovac is simply a regular plastic handheld urinal attached by tubing to a pump that evacuates urine to a reservoir. There is also a removable cloth-covered platform to reduce spills. Allowing for the evacuation of urine from the urinal significantly improves its functionality. The Urovac can be left in place without risk of overflow or other spillage, such that a patient with UI requires less assistance. Improving the handheld urinal in this manner should thus allow for reduced usage of diapers, catheterization, and institutionalization. For patients with UI requiring hospitalization or institutionalization for other reasons, the Urovac could potentially reduce the associated labor and complication costs. Despite the clear clinical promise of the Urovac, it has only been used by a small number of patients to date. This study will document usage of the Urovac among 30 of the initial users of the device to better understand the benefits and challenges.

Eligibility Criteria:
Inclusion Criteria:

* Male patients who identify as having difficulty with functional urinary incontinence, such that it may be difficult to get to the toilet in time to urinate
* Patients age 18 or older

Exclusion Criteria:

* Patients with leg wounds or dysfunction which could be worsened by Urovac device placement
* Patients under age 18
The Belgian Molecular Profiling Program of Metastatic Cancer for Clinical Decision and Treatment Assignment

PRECISION 1 will enroll patients with metastatic solid tumors. The local PI will verify if the candidate patient fits the inclusion/ exclusion criteria.

The participant will sign the PRECISION 1 informed consent. NGS data will be collected from local panel testing on DNA extracted from tissue samples or plasma.

Data will be collected from further molecular testing performed at the different laboratories: select rearrangements (fusion genes and translocations) by RT PCR, FISH or NGS; copy number variations of selected genes via the NGS platform (if possible) or using FISH or other technologies such as SNP arrays in case the NGS technology is incapable of giving this information.

Results will be stored in the Precision Belgium section of the Healthdata database.

Data on germline variants will also be collected in the Healthdata database whenever this information is available.

The cooperating clinical investigator will decide with the patient the treatment strategy, -guided by the best interest of the patient and the availability of respective options :

* " Empirical " available approved treatment (for example chemotherapy, immunotherapy)
* Genotype-driven standard of care
* Inclusion in a genotype-matched clinical trial (includes signing of trial-specific IC)
* Inclusion in PRECISION 2 if options 2/3 not available. Irrespective of treatment choice, the patient will be followed by the collaborating clinician and will have follow-up data collected every 6 months for determination of disease status and survival endpoints.

Clinical data will be collected and stored in the Healthdata database. Genomic data (somatic and germline whenever available) and clinical data (tumor type and stage, number of previous lines, treatment choice, response rate, PFS on chosen and previous treatments, ...) will be uploaded on the Healthdata platform and can be consulted via password-protected web access by the local PI at each participating center. European regulation protecting patient privacy will apply ("GDPR").


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic solid tumors that are candidates for systemic therapy (early lines are preferred).
* Patient showing an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
* Patients able to provide written informed consent prior to enrollment into a subsequent clinical trial.
* Patients agrees to provide NGS data (somatic and/or germline) as well as clinical data baseline and during follow-up.

Exclusion Criteria:

* Life expectancy of less than 12 weeks.
* Inability to comply with protocol procedures.
* Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI).
* Targeted gene sequencing on DNA extracted from decalcified bone biopsies is not accepted.
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.

Exclusion Criteria:

* Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
* Primary generalized seizures.
Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent and complete study assessments in written English
* Male or female age 18 to 75
* Patients having Saphenofemoral Junction (SFJ) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg
* Screening Symptom score of 7 points or more as measured by Question 1 on the modified VEINES-QOL/Sym questionnaire

Exclusion Criteria:

* Unable to comply with completing a daily diary for a total of 24 days
* Participation in any other investigational pharmaceutical product, or device study within the 3 months prior to Visit 1
* Current venous leg ulcer in either leg
The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome

To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. The included PSS patients were divided into experimental group and control group using simple randomization method. Among them, the experimental group was treated with FK-506 twice a day, and the control group was treated with prednisolone acetate ophthalmic suspension 1% 4 times a day.

For all PSS patients whose intraocular pressure is higher than 30mmHg, also add brinzolamide eye drops 3 times a day. Best corrected visual acuity, Goldmann intraocular pressure, anterior section photographs, corneal endothelial cells，corneal confocal microscope, Heidelberg retinal nerve analysis, Octopus visual field were examined on baseline and 1 week, 2 weeks, 3 weeks, 4 weeks after the treatment.


Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study

Exclusion Criteria:

- Fuchs syndrome
Evaluation of Educational Intervention to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes

The purpose of this study is to identify the effect of a short term educational intervention for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) to high-school biology students.

Shared decision making is increasingly demanded by patients in order to take part in health care decisions. However this demand for autonomy can only be used for shared decision making if the patient has basic skills in critical health literacy. To transfer health care literacy to young and healthy consumers educational intervention programs at high-school might be a feasible and effective way. This preliminary phase 2 study is designed to investigate the effect of an educational intervention to be integrated in a curriculum for upcoming teachers in biology.

Eligibility Criteria:
Inclusion Criteria:

* students becoming biology teachers at participating university during enrollment period

Exclusion Criteria:

* refusal to participate in study
Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients

A study comparing the effect of two doses of neostigmine on the gastric residual volume in critically ill patients on enteral feeding.

Participants were categorized into three groups: Group I and Group II received neostigmine 1 mg and 2 mg, respectively, and a control group received 10 ml of normal saline. All participants received an intravenous administration of 10 mg of metoclopramide. GRV was measured every 3 hours before enteral feeding. aspiration through nasogastric (NG) or orogastric (OG) tubes was done before the next due bolus of feeding.

Eligibility Criteria:
Inclusion Criteria:

* patients with a GRV \>120ml
* a normal heart rateExclusion Criteria
* absence of comorbidities such as diabetes and renal failure. exclusion Criteria:
* Patients exhibiting new-onset arrhythmias or heart block
* hypotension (systolic blood pressure less than 60 mmHg)
* experiencing active gastrointestinal bleeding or receiving prokinetic medications 8-12 hours before the intervention
* patients with a history of surgery in the gastrointestinal system in the past two weeks history of extrapyramidal manifestations
* patients with electrolyte imbalance
* pregnant patients,