cyrilzakka/clinical-trials huggingface dataset:
Providing Access to an Alternative Nurse Call

To address the needs of the many patients who cannot access the standard nurse call systems Iowa Adaptive Technologies has developed the Noddle, a smart switch that can take the smallest intentional gesture a patient can make (e.g. tongue click, wink) and allow the patient to access the nurse call system and control a speech-generating device. This study will assess how patients and their nurses as well as family members perceive the impact of having a device that would allow them to summon the nurse and to be able to effectively communicate. Patients will be provided a Noddle and will be free to use it as much or a little as they like during their hospitalization. Patients will either use the Noddle just to access the nurse call system or they will use it to access the nurse call system and a speech-generating device. Patients, nurses and family members will be asked to complete an exit questionnaire prior to discharge from the hospital.

The study will evaluate the responses of patients, nurses and family members to the use of the Noddle switch to enable the patients to access the nurse call system and a speech generating device. Patients who cannot access the standard nurse call and who may not be able to speak due to mechanical ventilation will be recruited to the study and provided the opportunity to use the Noddle switch as long as they want while they are hospitalized at UIHC. Prior to their discharge or when they no longer need or want to use the Noddle switch, they along with their nurses and family members (if present) will be asked to complete a survey to assess their ability to effectively communicate. The data from the study participants will be compared to data from two groups of patients from a previous study who were either able to or unable to access the nurse call system and communicate with caregivers.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be conscious, able to produce an intentional gesture and appropriately respond to yes/no questions.
2. Patients must be severely limited in their mobility and unable to access the nurse call system and/or must be unable to use normal modes of oral and written modes of communication.

Exclusion Criteria:

1. Patients who are sedated or unconscious (patients who are sedated for limited time may be considered).
2. Can access the nurse call and speak without other assistance
Pleth Variability Index and Fluid Management During Surgery

Pleth Variability Index (PVI) seems to be an ideal parameter to guide fluid management: dynamic parameter and non-invasive. PVI could guide fluid management during surgery and optimization of the plethysmographic-derived parameter could improve hemodynamics of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery

Exclusion Criteria:

* Refusal or inability to understand the protocol
* Arrythmia
* \<18 years
* Contraindication to normal mechanical ventilation
Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).

This protocol describes procedures for the collection of blood samples for the intent of determining genetic contribution to the safety and efficacy of CPT/FU/LV.


Eligibility Criteria:
Inclusion Criteria:

* Participation in studies employing treatment with irinotecan and a signed informed consent.

Exclusion Criteria:

* None.
A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Has been postmenopausal for at least 5 years
* Has taken or is taking alendronate
* Agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion Criteria:

* Has a history or evidence of hip fracture
* Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
* Has active parathyroid disease
* Has a history of thyroid disease not adequately controlled by medication
* Is taking anti-seizure medication and has abnormal calcium metabolism
* Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
Efficacy and Safety of COVID-19 Convalescent Plasma

Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection

There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for donation according to the Institutional protocol. Recipients will be COVID-19 patients requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be infused and recipients will be followed up.

Eligibility Criteria:
Inclusion Criteria

Blood donors:

1. Age: \>18 and \<60 years
2. Body weight : \>55 kg
3. Confirmed previous SARS CoV-2 infection
4. Minimum 28 days after the last symptom or finishing of the isolation, or
5. 21 day without symptoms from the date of the negative SARS CoV-2 test
6. Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
7. Concentration of COVID-19 IgG antibodies more than 5 AU/ml (Because measurement of neutralizing antibody titers is not available now, storing of retention sample from the convalescent plasma donation is performed for determining antibody titers at a later date)
8. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
9. Individuals who meet all regular voluntary donor eligibility requirements

Patients/recipients:

1. Age: \>18 years
2. Admitted to an acute care facility for the treatment of COVID-19 complications
3. Patients with severe or immediately life-threatening COVID-19, or
4. Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
5. Informed consent provided by the patient or healthcare proxy

Exclusion Criteria:

Blood donors:

1. Age : \<18 or \>60 years
2. Female subjects who are pregnant
3. HIV1,2 hepatitis B,C or syphilis infection
4. Donors ineligible for regular voluntary blood donation

Patients/recipients:

1. Age : \<18 years
2. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
3. Patients who received in the past 30 days immunoglobulin therapy
4. Females who are pregnant or breastfeeding
META Trial - a Mixed Methods Process Evaluation

The aim of this study is to conduct a mixed methods process evaluation of the META trial. Semi-structured interviews, focus groups, and brief questionnaires will be conducted with a purposive sample of participants (patients and healthcare providers) who were involved in the trial to explore the feasibility, acceptability and perceived effectiveness of the trial intervention.

The META trial was a phase II randomised double-blind placebo-controlled trial that is being conducted in Dar es Salaam, Tanzania to evaluate the use of metformin in HIV-positive persons on antiretroviral therapy (ART) with pre-diabetes.

This study aims to explore the feasibility, acceptability and perceived effectiveness of the META trial intervention by conducting qualitative interviews, focus groups, and brief questionnaires with a purposive sample of participants (patients and healthcare providers) in Tanzania who are involved in the META trial.

Data collection will commence during June-July 2025 with a purposive sample of patients and health care professionals who were involved in the trial (n=50-60).

Eligibility Criteria:
Inclusion Criteria:

* Participants who participated in the META Trial
* Participants who have the capacity to provide written informed consent
Ocular Blood Flow in Colorectal Cancer Patients

In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of treatment regimens in the metastatic setting. Addition of bevacizumab to conventional chemotherapeutic combination regimens has improved the median overall survival of advanced colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit from anti-angiogenic approaches, would be highly desirable in order to optimize treatment strategies. Changes in ocular blood flow may be an attractive biomarker for predicting treatment response. In light of the given alternative first line treatment options such a predictive biomarker would be of clinical benefit. In the proposed study the investigators will assess potential changes in the ocular blood flow of mCRC patients after treatment with standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of treatment response as assessed by standard CT-scan


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients (age 18 and over) suffering from mCRC.
* Normal findings in ophthalmic examination (except the investigator finds an abnormality irrelevant for the purpose of the study.)
* Patients, which are scheduled for standard of care treatment with chemotherapy plus bevacizumab

Exclusion Criteria:

* Refusal to give informed consent
* Severe hypertension (RR ≥180/110)
* Epilepsy
* Pregnancy and breastfeeding women
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)

This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™ whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish the recommended infusion schedule of Troxatyl™.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies.
* Subjects must have adequate organ and immune function as indicated by the following laboratory values: \*Creatinine clearance ≥5 L/hr (83mL/min), \*Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), \*AST(SGOT) and ALT(SGPT) ≤3 x ULN

Exclusion Criteria:

* Clinical evidence of active central nervous system (CNS) leukemic involvement
* Active and uncontrolled infection
* Uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
* Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
* Known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
* Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
* Females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
SepsisFLAGS ( FLuidAndGender)

In this single-center study the investigators will analyze gender differences among patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. About 11 000 patients will be included. Patient data including fluid therapy will be drawn from the electronic medical record; Take Care and Clinisoft. In the logistic regression analysis, the investigators will adjust for age, gender, comorbidities, vital signs, preliminary focus of infection, level of care and renal replacement therapy. The aim is to analyze gender differences in fluid treatment and the response to fluid treatment and if the treatment is associated with differences in mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency department with suspected sepsis (defined by blood culture taken and intravenous sepsis-antibiotics prescribed within 48 hours) and fulfilling sepsis-3 definition of sepsis (sequential organ failure assesment score of 2 or more)

Exclusion Criteria:

* Patients transferred from other hospitals or treatment clinics.
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm

Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm.

Vanoxerine has important antiarrhythmic properties and may prove effective in converting AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized, double-blinded, placebo-controlled, dose-modifying study in subjects who have been in symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral administration.

Eligibility Criteria:
Inclusion Criteria:

* provide written informed consent,
* male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
* symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
* AF/AFL documented by ECG at the start of study drug administration

Exclusion Criteria:

* Systolic blood pressure \<100 mmHg.
* Average heart rate \<50 bpm.
* Average QTcF (Fridericia correction) \>440 ms.
* Average QRS interval \>140 ms.
* Paced atrial or ventricular rhythm on ECG.
* Serum potassium \<3.5 meq/L (may be corrected prior to randomization).
* Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
* received amiodarone (oral or IV) in prior 3 months.
* Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
* Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.
* Rheumatic mitral stenosis with valve area of \<1.5 cm2.
* Untreated hyperthyroidism.
* Acute pericarditis.
* AF/AFL as a result of surgery within the last 7 days
* History of failed electrical cardioversion
* History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).
* History or family history of long QT syndrome.
* History of ventricular tachycardia requiring drug or device therapy.
* History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
* Ejection fraction (EF) of 35% or less.
BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care


Eligibility Criteria:
Inclusion Criteria:

* complex cryptoglandular transsphincteric anal fistula undergoing surgical repair by LIFT or advancement flap procedure
* English or Spanish speaking and capable of providing informed consent
* Willing to undergo temporary anal seton drainage for requisite time prior to repair
* Participating surgeons will only be eligible if they perform at least 3 repair procedures/year

Exclusion Criteria:

* Unable to reliably complete follow up for 12 months postoperatively
* Primary platelet disorders
* Thrombocytopenia \< 150 plt/microliter
* Inability to stop anti-platelet agent \> 5 days preoperatively
* Fistula associated with inflammatory bowel disease (IBD), malignancy or pelvic/perineal radiation
Remimazolam Besylate in Sedation of Postcardioperative Patients

Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation，in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (\> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally，the investigators will compare the sedation effect and safety between the 2 groups ，to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years ;
2. admitted to the intensive care unit after cardiac surgery with techanical ventilation；
3. expected to extubation within 48hours ；
4. participant has given informed consent

Exclusion Criteria:

1. pregnant or lactating women
2. known or suspected hypersensitivity to the study drug
3. history of impaired consciousness or psychiatric illness
4. severe bradycardia with a heart rate of \< 50 beats per minute
5. systolic blood pressure \< 90 mmHg with fluid resuscitation and vasopressor maintenance
6. atrioventricular block（II or III degree）, Left ventricular ejection fraction(LVEF) \<30%
7. participated in other clinical studies within 3 months
Virtual Reality (VR) Paediatric Tracheostomy Training

This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare student
* Clinical experience needed
* Healthcare staff
* Based at Manchester University Foundation Trust, or The University of Manchester

Exclusion Criteria:

* Not a healthcare student
* Not a healthcare student - have no clinical experience
* Not healthcare staff but working in the National Health Service
* Not based at Manchester University Foundation Trust, or The University of Manchester
"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"

Retrospective study to collect data from Patients with advanced/metastatic renal cell carcinoma previously treated with Axitinib under standard clinical practice, to describe the clinical profile of the patients with a long response to Axitinib and to try to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients

To describe the clinical profile of patients with a long response to Axitinib and to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients.

For this study are defined as "long responder", those patients who has a Progression Free Survival (PFS) of at least 9 months since the initiation of Axitinib treatment, and "refractory patients" those who have Progression Disease (PD) in the first response assessment since the initiation of Axitinib treatment (estimated PFS ≤3 months\]

Secondary Objectives

* To describe the efficacy of Axitinib treatment in the long responders group, and in relation with the treatment received before Axitinib, in terms of PFS, ORR, CB, OS, TTP ...
* To describe the tolerability and drug management of Axitinib in this population.
* To describe treatment received after Axitinib in this population.

Study procedures:

For the recruitment, the Investigator should review the inclusion / exclusion criteria. In case of patients alive at the moment of the inclusion, the investigator will require them to sign the IC.

With the data available in the medical records, the information requested will be recorded in the electronic data collection tool.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

  * Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment
  * Patients who had received Axitinib treatment in second or further line with a PFS ≥9 months or DP (disease progression) at the first tumor assessment.
  * For the patients alive at the moment of the inclusion, patients must have a signed informed consent document

Exclusion Criteria:

* Axitinib received out of the approved indication Patients who do not meet any of the inclusion criteria
CoA-Z in Pantothenate Kinase-associated Neurodegeneration (PKAN)

The purpose of this study is to learn more about how people with the condition pantothenate kinase-associated neurodegeneration (PKAN) respond to a specialized study product. We are hoping to find out if the study product is safe, what effects-good and bad-the study product causes, and whether the study product changes certain measures of disease in PKAN.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of PKAN confirmed by: a) genetic testing confirming 2 pathogenic or likely pathogenic mutations, or (b) typical findings on exam and brain MR imaging with only one pathogenic mutation +/- a second likely pathogenic or VOUS in PANK2, or (c) typical findings on exam and brain MR imaging with a single likely pathogenic or VOUS in PANK2, or (d) be a symptomatic sibling of a proband subject meeting a, b or c.
* Be between 3 months old and 89 years old.
* Be able to take study product by mouth or feeding tube.
* Be willing and able to complete study procedures / telephone visits / blood draws independently, OR have a caregiver / parent willing and able to assist with these tasks.
* Be enrolled or willing to enroll in the PKANready natural history study (eIRB 10832).
* Be resident in North America (US or Canada) for the duration of the trial.

Exclusion Criteria:

* Have had exposure to a putative PANK2 bypass therapeutic agent in the 30 days prior to screening.
* Be concurrently enrolled in another interventional clinical trial.
* Have concurrent medical or other condition expected to preclude completion of study procedures of confound the assessment of clinical and laboratory measures of safety.