cyrilzakka/clinical-trials huggingface dataset:
Mixed-methods Protocol for the WiSSPr Study

WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH).

WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). We will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). We will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. We seek to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants' lived experiences. https://doi.org/10.1136/bmjopen-2023-080218

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: (1) identify as a cis-gendered or transgendered woman, (2) age ≥ 18 years, (3) earns a significant amount of income from exchanging sex for money or goods in the last 3 months, (4) HIV-negative status and eligible for PrEP according to national guidelines, (5) not planning to transfer care to another site within the next 30 days, (6) speaks English or ChiNyanja or IchiBemba and (7) willing and able to provide written informed consent

Exclusion Criteria:

* Exclusion criteria: (1) do not identify as a woman, (2) age \< 18 years old, (3) has not earned a significant amount of income from exchanging sex for money or goods or has earned for \< 3 months, (4) HIV-positive status or status is unknown or ineligible for PrEP, (5) planning to transfer care to another site within the next 30 days, (6) unable to speak English or ChiNyanja or IchiBemba and (7) not willing or able to provide written informed consent
TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients

The aim of this study is to establish the additional effectiveness and costs of routine thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT.

The technological advances in computed tomography (CT), with faster image acquisition resulting in higher resolution, result in making CT a more widely and intensively used imaging modality in trauma patient care. Thoraco-abdominal CT in addition appears to have additional diagnostic value compared to conventional radiography, especially in severely injured trauma patients.

Nowadays, both clinical data and conventional radiology are used to determine which patient should undergo body CT scanning. Currently there are no widely accepted guidelines for the use of a "standard" TRAuma CT (TRACT). Although many retrospective and several prospective cohort studies have been published on this topic, the data are not sufficient to sustain evidence-based practice in decision-making.

The aim of this study is, to establish the additional effectiveness and costs of routine thoraco-abdominal CT in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT.

Consecutive trauma patients, who are at least 16 years old and are suffering from severe injuries, undergo a standard trauma CT of the cervical spine, the thorax and abdomen after clinical evaluation and conventional radiological workup.

Clinical, conventional and computed tomographic radiological assessment, costs, therapeutic consequences and 6 months patient follow up are recorded and will be statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with life threatening vital problems: respiratory, circulatory (pulse \> 120/min, blood pressure \< 100 mmHg, refill \> 4 sec, exterior blood loss \> 500 ml) or neurologically (Glasgow Coma Score \< 14, abnormal pupils) compromised patients.
* Patients with a revised trauma score under 12
* Patients with signs of fractures from at least two long bones
* Patients with clinical signs of flail chest/multiple rib fractures
* Patients with a clinically evident pelvic rim fracture
* Patients with signs of unstable vertebral fractures or signs of neural cord compression
* Patients involved in a high-energy injury mechanism

  * Fall from height (\> 3 m)
  * As declared by prehospital emergency medical services

Exclusion Criteria:

* Patients suffering from a shock Class IIIB/IV
* Patients who need immediate neurosurgical intervention
* Pregnant patients
* Patients referred from other hospitals
* Patients who die at the emergency department
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Functional precision medicine (FPM) is a relatively new approach to cancer therapy based on direct exposure of patient- isolated tumor cells to clinically approved drugs and integrates ex vivo drug sensitivity testing (DST) and genomic profiling to determine the optimal individualized therapy for cancer patients. In this study, we will enroll relapsed or refractory pediatric cancer patients with tissue available for DST and genomic profiling from the South Florida area, which is 69% Hispanic and 18% Black. Tumor cells collected from tissue taken during routine biopsy or surgery will be tested.

PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on Functional Precision Medicine (FPM), the combination of ex vivo drug sensitivity testing (DST) and genomic profiling.

SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with FPM-guided therapy as compared to non-FPM guided (conventional) therapy.

EXPLORATORY OBJECTIVE: To explore associations between tumor molecular characteristics (genomic and transcriptomic variation) and ex vivo drug response with respect to patient ethnicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity.

Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing Subjects or their parents or legal guardians willing to sign informed consent Subjects aged 7 to 17 willing to sign assent

Exclusion Criteria:

* Subjects who do not have malignant tissue available and accessible The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.

Patients with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.
Ulnar Nerve Neurotization After Ulnar Nerve Injury

This study will evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve

* ulnar nerve injuries result in loss of both the sensory and motor elements within the hand. these injuries can be classified by the site of injury into low injuries and high injuries. In low ulnar nerve injuries, the nerve is injured distal to the motor branch of the Flexor carpi ulnaris (FCU) and motor branch to the Flexor digitorum profundus (FDP) of the ring and little fingers. In low injuries, sensation is lost in palmar ulnar hand and paralysis occurs usually to all 7 interossei, the ulnar 2 lumbrical, the 3 hypothenar, the adductor pollicis, and the deep head of the flexor pollicis brevis muscles .
* After peripheral nerve lesion axonal regeneration is at a rate of 1-2 mm/day. Because muscle fibers undergo irreversible changes after 12 months of denervation, it is important that treatment be undertaken as early as possible for successful functional recovery .
* "Babysitting" nerve fiber transfers can be defined as giving fibers from a healthy donor trunk to a denervated recipient trunk, in order to allow these fibers reach the distal effectors to avoid atrophy; such a procedure has originally been described together with partial neurotomy and has been found to be efficient both in experimental and clinical studies
* As far as it concerns proximal ulnar nerve injuries, babysitting by end-to-side nerve transfer has proven effective in 1 of the 3 series reported, where Colonna et al. analyzed an alternative Martin Grubertype( type of of operation) connection created by a bridge nerve graft between median (donor) and ulnar (recipient) trunks in the distal forearm, which gave interesting, but not ideal results ; "supercharged" reverse end-to side nerve transfers have been reported in latter studies . another person reported 7 cases of distal anterior interosseous to ulnar nerve end-to-end coaptation together with palmar cutaneous branch of the median nerve to the ulnar nerve above the wrist in a previous paper . it has not yet been well-established whether end-to-end or end-to-side gives better results.

nowadays, surgeons performing this type of surgery complain inconsistent outcomes, maybe as an effect of the discrepancy between the number of fibers in donor nerves and those in the recipient one

Eligibility Criteria:
Inclusion Criteria:

1. Site of the injury: at or proximal to level of the elbow
2. Nature of the injury; post traumatic injury.
3. Sex; both males and females.
4. Age; any age.
5. Time of presentation of injury: less than 6 months from injury.

Exclusion Criteria:

1. Any patient with non-post traumatic injury either inflammatory or tumor caused palsy or idiopathic.
2. Any distal injury below origin of FCU branch.
3. Delayed presentation after 6 months of injury.
4. Any patient refusing participation in this study.
Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients (0954A-322)

Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).


Eligibility Criteria:
Inclusion Criteria:

* ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period
* Be able to carry out his or her own daily activity
* - Be at least 50 years old at inclusion in the study Be diagnosed with mild to moderate hypertension, treated or untreated
* Literate
* Not taking any cognitive-enhanced agent at baseline
* Present with a memory complain ( spontaneous or informed by caregiver)

Exclusion Criteria:

* Congestive heart failure with NYHA class \>2
* Renal failure or renal insufficiency with serum creatinine \>1.4mg/dl
* chronic severe liver disease with abnormal GPT and GOT \>2 times of upper normal limits
* Diagnosed with major depression when entering the study
* Foreign language as his or her mother tongue so that the test results will not be reliable
* History of stroke or transient ischemic attack (stroke is defined as focal neurological sign progressing stepwise)
* Hypersensitive to the active ingredient and any other component of losartan potassium and indapamide tablets
* Major hearing loss/deafness and/or major visual impairment/blindness preventing from performing the tests
* Myocardial infarction within the past 6 months
* Single functioning kidney
* Anuria
Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ILD than those with normal vales.50 subjects will be enrolled from the Rheumatology practice at NJH and followed with phone interviews or Electronic Medical Record (EMR) record review yearly times 5 to determine if they have subsequently developed evidence of ILD or pulmonary artery hypertension.

50 scleroderma patients without evidence of lung disease who have been seen by an NJH Rheumatologist will be invited to participate. They will have their medical records reviewed to determine eligibility and then perform hand held spirometry and LCI testing. This measures evidence of small airway airflow obstruction and requires normal breathing while first on room air followed by inhaling a gas mixture of 100% oxygen. The Oxygen concentration in exhaled breathing and the number of breaths needed to return to room air concentration of Oxygen will be analyzed by a computer. Medical information from the EMR will be recorded and placed in a secure database, REDCap, for statistical analysis to determine if LCI results or other clinical features are predictive of which Scleroderma patients are most likely to subsequently develop evidence of Interstitial Lung disease (ILD) based upon yearly phone call interviews and EMR record reviews within 5 years of baseline testing.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of systemic sclerosis (SSC) by an NJH Rheumatologist
* age 21-75
* No evidence of Scleroderma related Lung disease (ILD)
* Able to comprehend and sign an Institutional Review Board (IRB) approved consent form.

Exclusion Criteria:

* Patients without a Rheumatologists confirming a diagnosis (DX) of SSC
* Patients with evidence of lung involvement based upon; Thoracic imaging, abnormal Pulmonary Function Tests (PFTs); Forced Vital Capacity( FVC), Forced Expiratory Volume in 1 second (FEV1) or a Diffusion Capacity for Carbon Monoxide (DLCO) \< the Lower Limit of Normal (LLN) or Saturation of Oxygen in arterial blood (SaO2) \< 90% .
* Cardiac echocardiogram or right heart catheter evidence of Pulmonary Arterial Hypertension (PAH).
* \< 21 or \> 75 years of age
* Must not be pregnant or had eye surgery within 2 weeks of LCI testing
* Must be able to comprehend and sign an IRB approved consent form and complete LCI testing
Predictors of Motor Progression in Parkinson's Disease

Treatment resistant motor features, such as postural instability and freezing of gait are common in people with Parkinson's disease and major contributors to morbidity and mortality. This project will use sleep studies, quantitative motor assessments and magnetic resonance imaging to examine the relationship between abnormally increased muscle activity during rapid eye movement sleep and the development and progression of treatment-resistant postural instability and gait disturbances. Specifically, the investigators will test the hypothesis that anticipatory postural adjustments (weight and pressure shifts) during gait initiation are significantly reduced in people with Parkinson's disease who have abnormally elevated muscle activity during rapid eye movement (REM) sleep compared to individuals will Parkinson's disease whose REM sleep muscle activity is normal. In addition, the investigators will test the hypothesis that the level of RSWA at baseline is predictive of measures of motor decline (postural stability and gait) and alterations in the structure and function of locomotor brainstem networks. Since sleep disorders can emerge years before a diagnosis of Parkinson's disease, establishment of a link between sleep and treatment-resistant posture and gait disorders will help identify individuals at risk of developing these disabling motor features of disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's Disease (PD).
2. Age 21-75 years
3. Able to ambulate independently without the use of an assistive device (e.g. cane)

Exclusion Criteria:

1. History of Dementia
2. History of musculoskeletal disorders that adversely affects walking and/or balance
3. Other significant neurological disorders
4. Implanted deep brain stimulator(s) (DBS) or other neurosurgeries to treat PD
5. MRI exclusion for 7 tesla scans: presence of any metallic clips or implantable medical devices
6. Pregnant women
Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery

Tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces bleeding. It is routinely given intravenously in many surgical situations where there is a risk of major bleeding. Concerns regarding possible adverse effects from intravenous use prevents a more widespread use, even in smaller surgeries. Topical application - using the drug directly on the wound surface- may give a higher concentration at the site of bleeding but a lower concentration in the rest of the body, and hence a lower risk of adverse effects. Here it will be investigated to what extent a defined dose of the drug is absorbed systemically - into the blood stream - when it is applied topically. This will then be compared to the concentration in the blood stream when administered intravenously. Blood samples will be obtained at defined time intervals after administration from patients receiving topical and patients receiving intravenous administration of the same single dose of tranexamic acid. Will less of the drug enter the blood stream if it is applied directly to the wound?


Eligibility Criteria:
Inclusion Criteria:

* planned for major skin reduction surgery (abdominoplasty/panniculectomy) after massive weight loss, or
* planned for orthopaedic hip replacement surgery

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy to tranexamic acid/Cyklokapron®
* ongoing or former thromboembolic event
* known kidney failure, as defined by estimated glomerular filtration rate (eGFR)\<60 ml/min
Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the prevention of radiodermatitis in patients with breast cancer or head and neck cancer undergoing radiotherapy.

Prophylactic Trial will consist of a control group and two experimental groups, namely control group (usual care), Experimental Group 01 (usual care + topical application of the gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based cream).

The doses used in the different compounds are being in test since february 2014 by a dose-response curve study, using 6 groups with three doses of urea cream and three doses of C. recutita gel.

The study will be conducted at the Center for High Complexity Oncology at University Hospital of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according to established criteria to classify the effects of radiotherapy, which identifies grades 0, 1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use of cream based urea three times a day, concomitant radiotherapy, would present the following hypotheses:

* Null: equal incidence and severity of radiodermatitis when compared to the control group (usual care);
* Alternative 1: low incidence and severity of radiodermatitis when compared to patients who comprised the control group (usual care).
* Alternative 2: lower incidence and severity of radiodermatitis between the experimental groups (urea and chamomile).

Eligibility Criteria:
Inclusion Criteria:

* Being an adult, over the age of 18 years old;
* Owning diagnosis of malignant breast or head and neck;
* Being first referred to the radiotherapy protocol;
* Agree to participate, expressing his acceptance by signing the Informed Consent Form (ICF);
* Present absence of dermatitis to initiation of radiotherapy;
* Demonstrate understanding of and conditions to continue the intervention in their home environment when needed.

Exclusion Criteria:

* Reports of previous hypersensitivity reaction or presentation, during the research, adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or urea;
* Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis;
* Withdrawal of the patient to remain in the study, independent of time.
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction

A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Radiographically (CT or EUS) distal malignant bile duct obstruction
* Histology or cytology proven malignancy of the primary tumour or metastasis; onsite cytology evaluation after EUS guided fine-needle sampling that is highly suspected of a malignancy suffices
* Indication for biliary drainage; in case of a resectable tumour this should be discussed during a clinical multidisciplinary meeting
* Written informed consent

Exclusion Criteria:

* Age \< 18 year
* Surgically altered anatomy after previous gastric, periampullary or duodenal resection
* Cancer extending into the antrum or proximal duodenum
* Extensive liver metastases
* WHO performance score of 4 (in bed 100% of time)
* Uncorrectable coagulopathy, defined by INR\>1.5 or platelets \< 50 x 10\^9/L\*
* Clinically relevant gastric-outlet obstruction
* Unable to complete sign informed consent

  * Inclusion is allowed after corrective treatment measures are taken, according to local protocol and treating physician.
PSMA PET/CT for Prostate Cancer

Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.

Exclusion Criteria:

* Age: \<18 years
* Physically or mentally unfit to perform the sequential procedures
* Refusal of patient to be informed about accidental findings on scans
* Patients with heart failure if ejection fraction \< 45% (phase 2 trial)
* History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)