cyrilzakka/clinical-trials huggingface dataset:
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter \>5cm on brain image.
* Age between 18-65 years.
* American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
* Obtain written informed consent.

Exclusion Criteria:

* Allergic to tranexamic acid.
* History of thrombotic disease.
* History of chronic kidney disease
* Receiving other anticoagulation or antiplatelet treatment.
* Refuse to provide written informed consent
Subthreshold SCS or BMT

Given the substantial socioeconomic impact of Spinal Cord Stimulation (SCS) implantations and given that currently no direct high-quality evidence with a relevant outcome measurement is available to guide the treatment choice between subthreshold SCS versus best medical treatment in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), we here propose a scientifically well-constructed randomized controlled trial to answer this question.

The primary scientific objective is to examine whether subthreshold SCS, compared to best medical treatment, provided to patients with PSPS-T2 results in a higher percentage of clinical holistic responders at 6 months. The secondary objective of the study is to examine if subthreshold SCS compared with BMT is having more efficacy in improving patients' individual competencies for self-management, increasing the likelihood to return to work, work status and healthcare expenditure, improving pain relief, obtaining pain medication reduction, decreasing anxiety and depression, increasing quality of life and decreasing disability.

After filling in the questionnaires at the 6 months follow-up visit, patients could change treatment groups (in both directions). This decision will be a shared decisions between patient and treating physician in case the randomized intervention did not provided enough pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Persistent Spinal Pain Syndrome Type II (PSPS-T2)
* Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment.
* PSPS-T2 patients eligible for subthreshold SCS
* Age \> 18 years
* Patient has been informed of the study procedures and has given written informed consent
* Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

* Expected inability of patients to receive or properly operate the spinal cord stimulation system
* Evidence of an active psychiatric disorder
* Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
* Pregnancy
4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease

The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device.

The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).


Eligibility Criteria:
Inclusion Criteria:

* De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment
* Patient presenting with a score from 2 to 4 according to the Rutherford classification
* Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times
* Patient is \>18 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
* Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
* Patient is eligible for treatment with 4F compatible devices

Angiographic Inclusion Criteria:

* The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis.
* The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion
* Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
* Target vessel diameter visually estimated is =4 mm and =6.5 mm
* There is angiographic evidence of at least one-vessel-runoff to the foot

Exclusion Criteria:

* Presence of another stent in the target vessel that was placed during a previous procedure
* Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
* Previous bypass surgery in the same limb
* Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
* Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
* Perforation at the angioplasty site evidenced by extravasation of contrast medium
* Patients with known hypersensitivity to nickel-titanium
* Patients with uncorrected bleeding disorders
* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
* Life expectancy of less than 12 months
* Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30%
* Use of thrombectomy, atherectomy or laser devices during procedure
* Any planned surgical intervention/procedure 30 days after the study procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice

This is a multicentre, descriptive observational study of adult patients with primary HPT receiving cinacalcet in clinical practice in a number of countries in Europe. Patients will be enrolled within 1 month of initiating cinacalcet treatment, and data will be collected prospectively for up to 1 year from initiation. Data will continue to be collected from patients discontinuing cinacalcet before the end of this period.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age at the time of first administration of cinacalcet
* patients with primary HPT who have initiated cinacalcet within 1 month before enrolment in the study
* provision of informed consent (if required)

Exclusion Criteria:

* previous use of cinacalcet (other than within 1 month before enrolment)
* diagnosed secondary HPT
* other known aetiology of hypercalcaemia (eg, sarcoidosis, tuberculosis)
Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre

The first goal of this study is to map all the subtherapeutic, therapeutic and supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second objective is to optimize and validate guidelines for dose modifications in patients with too low or high plasma concentrations and to investigate if the same guidelines can be used in different patient populations.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with voriconazole
* at least 1 voriconazole plasma level measured during therapy

Exclusion Criteria:

* none
Retrospective Study to Assess Real-Life Use of The Long Acting GnRH Agonist as Prostate Cancer Treatment

It is a retrospective review of the electronic medical record of patients on long-acting triptorelin in Hong Kong.

Prostate cancer is the second most prevalent cancer in men worldwide. Analogues of natural gonadotrophin releasing hormone (GnRH) are currently available in clinical practice to induce castration in subjects with prostate cancer. While 6 month formulation of Triptorelin has been approved since 2018 for controlling tumor growth in subjects with prostate cancer living in Hong Kong, to date, there are no published clinical data regarding the use and efficacy of the 6 month formulation in Chinese subjects with Chinese heritage. To better understand the real-world experience of long-acting GnRH agonist, there is an unmet need for a retrospective, noninterventional review to collect data regarding the use of the long-acting formulation GnRH in clinical practice as a treatment for prostate cancer. The purpose of this study is to collect data on healthcare characteristics and the treatment patterns in the real-world setting, as well as to understand the profile of the subject population using long-acting formulation GnRH agonist.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Chinese heritage
* Prostate cancer patients with the following disease status:

  * High-risk prostate cancer having hormonal therapy as neoadjuvant / adjuvant treatment for prostatectomy or radiotherapy; or
  * Advanced / metastatic prostate cancer treated with long-term hormonal therapy; or
  * After primary therapy (surgery or radiotherapy) with biochemical recurrence; or
  * Castration-resistant prostate cancer status
* Received at least one dose of 6-month Gonadotropin-releasing Hormone Agonist triptorelin formulation
* Having at least 6 months of follow-up after administration of the 3-month to 6-month Gonadotropin-releasing Hormone Agonist triptorelin

Exclusion Criteria:

* Nil
VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination

To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells

This is an interventional study of vaccination related to infection with varicella zoster virus. We will enroll participants of two age groups. Cohort 1 will be persons between the ages of 30-40; Cohort 2 will be persons who are 70 years of age or older. All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.

Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: 30-40 years of age
* Cohort 2: 70 years of age or older
* HIV seronegative

Exclusion Criteria:

* Previous vaccination with Shingrix (RZV), Zostavax (ZVL, zoster vaccine live), or with the chickenpox vaccine
* VZV seronegative
* Active Hepatitis C infection or active Hepatitis B infection. Persons with serologic evidence of hepatitis C infection that has cleared spontaneously, or with a history of treated hepatitis C with a sustained virologic response, can be enrolled. Persons with a history of resolved hepatitis B infection (negative for hepatitis B surface antigen) can be enrolled
* History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to any component of the vaccine
* History of receipt of an organ transplant or hematopoietic stem cell transplant
* Significant autoimmune disease such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, scleroderma, dermatomyositis, or other condition which in the past has required significant immune modifying medication or which has a clinical course that is characterized by relapses
* Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
* Has long-term use of oral or parenteral steroids (\>7 days), or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed)
* Women of child-bearing potential only: pregnant, breastfeeding, or planning to become pregnant 3 months post vaccination
* Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
* History of coagulopathy or taking medication that may cause bleeding (long term high dose aspirin, heparin, coumadin). Aspirin doses \<100 mg daily allowed
* History of keloid formation or excessive scarring
* History of frequent cellulitis or boils (\>3 episodes in past 2 years) requiring antibiotic therapy
* Allergy to lidocaine, silver nitrate, or mupirocin
* Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Gulf War 1 Veteran Healthcare Satisfaction

The purpose of this study is to investigate Gulf War 1 Veteran (GW1V) patient perceptions of, and satisfaction with, their VA primary care treatment, and physician effectiveness in delivering improved point of service, in the Primary Care Clinics at the Veterans Administration (VA) Salt Lake City Health Care System.

Veterans of the 1990-1991 Gulf War1 (GW1) conflict are still experiencing a host of adverse health conditions at the present time. Many GW1 Veterans are still unhappy with their health care at the VA, and other stakeholders are critical of how the VA has dealt with GW1 Veterans' issues. For these reasons, the Gulf War Veterans' Illness Task Force (GWVI-TF) was set up to find ways to improve the situation.

The present survey study addresses one of GWVI-TF's missions, that is, to identify gaps in VA services, and to discover opportunities to better serve GW1V. Caring for GW1V is a top priority for VA health care providers, which is all the more pressing for the following reasons: 1. medical science of Gulf War Illness and environmental exposures is still at its infancy, 2. most providers have not received any focused education about how to take care of GW1V and the unique medical problems these veterans face, 3. a lack of provider knowledge that GW1V may receive may lead to decreased satisfaction on the part of GW1V and may result in GW1V perceived health service quality that is compromised.

In this pilot study, we focus on #2 and #3, to determine how we may understand veterans' perceptions of their medical treatment to ultimately improve GW1V medical health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* a gulf war Veteran who served during the Persian Gulf War (GW1) of 1990-1991
* currently treated by a primary care physician at the VASLCHCS

Exclusion Criteria:

* cannot read and write English
Study of ALXN1850 in Participants With Hypophosphatasia (HPP)

This is an open-label, dose-escalating study to assess safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of ALXN1850 when given intravenous (IV) and subcutaneous (SC) to adults with HPP.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of HPP
* Not anticipated to require further treatment with enzyme replacement therapy to treat participant's HPP after study completion
* Willing and able to follow protocol-specified contraception requirements
* Willing and able to give informed consent

Exclusion Criteria:

* Primary or secondary hyperparathyroidism or hypoparathyroidism
* Fracture within 12 weeks of screening
* Current or relevant history of unstable physical or psychiatric illness
* Significant allergies
* Asfotase alfa use within 6 months and/or positive for asfotase alfa antidrug antibody/neutralizing antibodies
Pain Neuroscience Education in Old Adults.

The primary objectives of this study are to:

* Evaluate the ability of the older adults to understand the biological processes underneath a pain experience.
* Evaluate their ability to modify their behaviors and beliefs about pain and health.

The purpose of this study is to test the effectivity of a single, group-based session of pain neuroscience education (PNE) on old adults. Participants will be 65 years or older, and they will be recruited from primary care medical clinics, public lectures, community centers and through the word of mouth. The intervention consist in one educational session of pain neuroscience education delivered by a physiotherapist. The study design is a single arm, crossover clinical trial, participants will be assessed in 3 different times (1 month before PNE ,pre-PNE, post-PNE) for knowledge of pain neuroscience, pain attitudes, pain catastrophizing and pain-related fear of movement.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 65 years old or more.
* Able to speak and read in Spanish.

Exclusion Criteria:

* Cognitive impairment. Global Deterioration Scale and Functional Assessment Staging (GDS-FAST) will be used for the screening, excluding the subjects with a level 3 or above in the GDS-FAST scale.
Effect of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Right-hemisphere on Picture Naming in Chronic Aphasia

There are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (RH) in language recovery following a left hemisphere damage. Transcranial direct current stimulation (tDCS) has received increasing attention as a potential complement to behavioural therapy.

This preliminary study aimed to examine the effect of excitatory (anodal) stimulation of right inferior frontal gyrus (IFG) on naming abilities of chronic people with aphasia (PWA) to examine the compensatory versus interference role of RH in language recovery, and to confirm the application of tDCS does not induce adverse effects on other cognitive and language functions.


Eligibility Criteria:
Inclusion Criteria:

* People with chronic aphasia following the stroke

Exclusion Criteria:

* history of seizure or epilepsy,
* previous adverse reactions to TMS/tDCS,
* having a pace-maker or a metal implanted in the brain
* being pregnant
A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven SCLC, extensive-stage
* Planned to receive chemotherapy of carboplatin or cisplatin plus etoposide every 3 weeks for 6 cycles
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy greater than or equal to 3 months
* Hemoglobin concentration greater than or equal to 9.0 g/dL and less than or equal to 13g/dL
* Adequate renal, liver and hematopoietic function
* Subjects must sign and date a written Institutional Review Board /Independent Ethics Committee-approved Informed Consent Form

Exclusion Criteria:

* Known primary hematologic disorder which could cause anemia
* Brain metastases that are either symptomatic or treated with medications
* Unstable or uncontrolled disease/condition, related to or affecting cardiac function
* Other known primary malignancy within the past 5 years with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma in situ cervical carcinoma or surgically cured malignancies
* Iron deficiency
* Known positive test for human immunodeficiency virus infection
* Received greater than 2 units of packed red blood cells within 4 weeks of randomization or any RBC transfusions within 2 weeks before randomization
* Received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
* Previous chemotherapy for SCLC
* Previous radiotherapy except as symptom palliation for bone or brain lesions and at least 24 hours since prior radiotherapy for symptom palliation providing extent of radiotherapy makes marked bone marrow suppression unlikely
* Less than 30 days since receipt of any drug or device that is not approved for any indication
* Pregnant or breast-feeding
* Not using adequate contraceptive precautions
* Previously randomized into this study
* Known hypersensitivity to recombinant mammalian-derived product or any other ingredients contained in the study drug
* Any medical, mental, or other conditions that makes the subject unsuitable for participation
NdYag Laser for Acne Keloidalis Nuchae

Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN.


Eligibility Criteria:
Inclusion Criteria:

* For inclusion, the subject must:

  1. Be at least 18 years old
  2. Be otherwise healthy
  3. Have a diagnosis of AKN with at least 10 papules/pustules and/or a non-keloidal plaque \> 7 cm2 in area.

Exclusion Criteria:

* Subject must not:

  1. Have AKN with a keloidal plaque \>3 cm in length
  2. Be using any other medications or undergoing any other procedures for the treatment of AKN
  3. Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment
  4. Have used any oral medications for AKN within 4 weeks of study enrollment:
  5. Have serious, uncontrolled medical conditions
  6. Be pregnant at any time during the study.