cyrilzakka/clinical-trials huggingface dataset:
Interventional Radiology in Bony Lesions

To explore the capability of the interventional radiology techniques in management of the painful bony lesions .

Bone tumors may present as incidental findings, with pain or loss of function, or as fractures \[1\].

Interventional Radiology (IR) has experienced an exponential growth in recent years. Technological advances of the last decades have made it possible to use new treatments on a larger scale, with good results in terms of safety and effectiveness\[2\] .

Today, IR represents a minimally invasive option of treatment for benign bony lesions (osteoid osteoma \[OO\], osteoblastoma, periosteal chondroma, etc.) and for palliation of metastases involving bone and soft-tissue sites beyond the liver and lung in an always-increasing number of cases \[3\]\[4\].

The aim of minimally-invasive ablation treatment is addressing the biological pain due to the stretching and irritation of the periosteum secondary to tumor growth and due to osteoclast-mediated bone resorption with the release of neurostimulating cytokines. The purpose of cementoplasty is to treat the mechanical pain for the instability from pathologic microfractures \[5\] Radiofrequency ablation (RFA) and cementoplasty are safe, feasible, and promising clinical option for the management of painful bony tumors that are challenging for their morphology and location \[6\].

Also , there is a broad range of indications for transarterial embolization (TAE) in primary or metastatic bone tumors: to reduce operative haemorrhagic risks, to simplify or allow more definitive surgery, or in the context of pain palliation, fever, bleeding, or hypercalcemic and other rheological factors\[1\].

Eligibility Criteria:
Inclusion Criteria:

1. Painful primary bone tumors .
2. Bone secondaries not amenable to radiation therapy .
3. histopathologically radioresistant bony tumors.
4. Painful osteoporotic vertebral fractures.

Exclusion Criteria:

* 1- Contraindications to contrast media 2- Raised renal chemistry or chronic kidney disease . 3- Pregnant patients . 4- Abnormal coagulation profile . 5- Contraindications to anesthesia .
A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers

This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers

Exclusion Criteria:

* History of orthostatic hypotension
* History of prior radiation exposure for research purposes, or radiation therapy
Injectable Filler for Facial Soft Tissue Augmentation

The purpose of this study is to assess the safety and performance of Hydroxytite in all subjects who have received sub dermal or deep dermal injections.


Eligibility Criteria:
Inclusion Criteria:

* Patient is over 18 years of age
* Patient received Hydroxytite injection(s).

Exclusion Criteria:

• Patient declines to participate in the study
Remote Care: The Future of Cochlear Implants

The purpose of this study is to see if remote programming visits for cochlear implants are possible.


Eligibility Criteria:
Inclusion Criteria:

Pediatric Arm

1. English speaking patients (Parents can speak English and/or Spanish)
2. ages 1-17 years
3. current CI users with a Cochlear Americas device
4. minimum of 6-months of CI experience
5. maximum of 4 years of CI experience

Adult Arm

1. Postlingual patients
2. English speaking patients

2. ages 18-90 years 3. current CI users with a Cochlear Americas device 4. minimum of 3-months of CI experience 5. maximum of 18-months of CI experience

Exclusion Criteria:

1. Patients with physical neuropathy, abnormal anatomy (e.g., cochlear malformations), severe cognitive deficits, and/or severe mental health difficulties
2. Patients who do not speak English
3. Patients who do not have access to the internet
4. Patients who do not live in Florida
5. Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)

Hyperglycemia increases the risk of complications in surgical patients. Focus on poor glycemic control as a contributor to adverse outcomes in settings outside the intensive care unit (ICU) is often dismissed. Total parenteral Nutrition (TPN) has been used in providing surgical patients with nutrition to prevent deterioration of nutritional status. However, many diabetic patients receiving TPN develop exaggerated hyperglycemia that requires frequent insulin administration via sliding scale. Providing diabetic patient's receiving TPN basal insulin is a known strategy to aid in blood sugar control and prevention of high blood sugar spikes. Many strategies for basal insulin provision have been utilized clinically during the administration of TPN; this includes the incorporation of insulin with TPN solution or administration of long acting insulin such as glargine. However, no study has compared any of these strategies aiming for selecting the optimum modality for controlling blood glucose in diabetic surgical patient's receiving TPN. We will conduct a study to compare the efficacy of once daily insulin glargine versus continuous regular insulin incorporated TPN in controlling blood glucose in non-critically ill diabetic surgical patients receiving TPN.


Eligibility Criteria:
Inclusion Criteria:

* All adult diabetic patients undergoing abdominal surgery operated by the surgical oncology team at KFSH \& RC and required TPN therapy are possible subjects of the study.

Exclusion Criteria:

* Patients receiving octreotide or immunosuppressive agents including corticosteroids.
* Recipient of \< 3 units of regular insulin per day via subcutaneous insulin sliding scale after the third day of TPN recipient.
* Patients with clinically relevant hepatic disease (\> three times normal AST and ALT on admission to the hospital) or impaired renal function (GFR \< 60 ml/min), history of diabetic ketoacidosis.

Patients who get infected while on TPN as reflected with elevation of white blood cells and elevated temperature \> 37.5 C will be excluded as well.
CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy

RATIONALE: Imaging procedures such as CT scans help the doctor in detecting cancer or the recurrence of cancer. Increasing the number of times a CT scan is given may improve the ability to detect stage I testicular cancer.

PURPOSE: Randomized clinical trial to determine if there is a different result from two different schedules of CT scans in treating patients with stage I testicular cancer after undergoing orchiectomy.

OBJECTIVES:

* Determine whether there is a difference between two schedules of CT scan surveillance in respect to stage of disease at relapse, survival, the investigation determining relapse, and incidence of second malignancies in patients with stage I testicular teratoma after orchidectomy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence of vascular invasion.

After orchidectomy, patients are randomized into two schedules (arms I and II) of CT scan follow up.

* Arm I: Patients repeat chest and abdominal CT scans no later than 3 months after orchidectomy and again at 12 months to confirm that the patient is clear of disease.
* Arm II: Patients repeat chest and abdominal CT scans at 3, 6, 9, 12, and 24 months after orchidectomy.

Patients are followed monthly for the first year after orchidectomy, then every 2 months for the second year, then every 3 months for the third year, and then every 4-6 months thereafter.

PROJECTED ACCRUAL: There will be 400-900 patients accrued into this study over 3-6 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed nonseminomatous germ cell tumor of the testis Stage I disease:

  * No evidence of metastatic disease on clinical examination
  * Normal chest x-ray
  * Normal chest and abdominal CT scan
  * Normal serum tumor marker (AFP, HCG) after orchidectomy
* High risk patients should be considered for ongoing studies of adjuvant chemotherapy after orchidectomy, but those choosing not to take this option may enter this study
* Orchidectomy no greater than 8 weeks prior to randomization into this study

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other concurrent or prior malignancy except successfully treated nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
Analgesic Techniques for Rib Fractures

This study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). Patients will be randomly assigned to one of the following three groups: 1) ESP block with catheter using ropivacaine (bolus followed by continuous infusion); 2) lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids.

Our specific aims are:

1. To compare the opioid use and pain ratings over the first 72 hours after enrollment.
2. To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention.
3. To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use (exploratory).

Inclusion Criteria:

• Adult patients ≥ 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital.

Exclusion Criteria:

* Allergy to amide local anesthetics, lidocaine, or ropivacaine
* Pregnancy
* Bilateral rib fractures
* Coagulopathy (INR \> 1.5; PTT \> 1.5 times ULN, or platelets \< 75,000)
* Conduction block on EKG
* Total body weight \< 40 kg
* Painful distracting injuries: acute thoracic spine fracture, severe traumatic brain injury or spinal cord injury, unstable pelvic fracture, open abdomen
* Spine fracture at the level of intended ESP block
* Infection near the ESP insertion site or active bacteremia or sepsis
* Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded


Eligibility Criteria:
Inclusion Criteria:

* ≥ 55 years old
* Sustained 3 or more unilateral rib fractures and are admitted to the hospital

Exclusion Criteria:

* Allergy to amide local anesthetics or any study medications
* Pregnancy
* Bilateral rib fractures
* Coagulopathy (INR \> 1.5; platelets \< 100,000)
* Conduction block on EKG
* Spine fracture at the level of intended ESP block
* Infection near the ESP insertion site or active bacteremia or sepsis
* Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded
CP-690,550 And Oral Contraception Drug-Drug Interaction Study

This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis

Exclusion Criteria:

* Any medical reason which would contraindicate the administration of oral contraceptives
* Clinically significant infections within the past 3 months or history of febrile illness within 5 days
* Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus
* Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception
Supraclavicular Brachial Plexus Block During Upper Limb Surgeries

Comparative Study Between Ketamine-Bupivacaine Versus Bupivacaine With Intravenous Ketamine Infusion In Supraclavicular Brachial Plexus Block During Upper limb Surgeries The techniques of regional anesthesia have become very popular as they provide several advantages in comparison with general anesthesia and systemic analgesia.

They provide perfect pain control, decreased complications and reduced post-anesthesia care unit stay.

Regional anesthesia provides more patient safety and better outcomes, which leads to the fact that ultrasound-guided regional anesthesia became more popular.

Ultrasound provides clinicians with real-time images which are useful for better identification of the anatomical structures, safe needle placement and adequate local anesthetic spread.

Brachial plexus blocks are commonly achieved via an interscalene, supraclavicular, infraclavicular or axillary approach.

The supraclavicular level is an ideal site to achieve anesthesia of the entire upper extremity just distal to the shoulder as the plexus remains relatively tightly packed at this level, resulting in a rapid and high-quality block. For this reason, the supraclavicular block is often called the ''spinal of the arm'' Using the local anesthetics alone for supraclavicular brachial plexus block provide good operative conditions but have the disadvantage of shorter duration of postoperative analgesia. Various adjuvants such as opioids, dexmedetomidine, dexamethasone, midazolam, ketamine, etc., were added to local anesthetics in brachial plexus block to achieve quick and prolonged block.

Ketamine is a noncompetitive antagonist of the N-methyl-D aspartate receptor(NMDAR).

It is used as a premedication, and for sedation, induction and maintenance of general anesthesia.

Local anesthetic and analgesic properties have been reported for ketamine. Intravenous administration of low-dose ketamine decreases postoperative opioid use and improves analgesia.

Ketamine has been added to bupivacaine to prolong the duration of regional anesthesia and postoperative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years.
* ASA physical status I-II, scheduled.
* Patients of either sex.
* Unilateral elective upper limb surgeries undergoing under ultrasound guided supraclavicular brachial plexus block.

Exclusion Criteria:

* Patient refusal.
* Patients with peripheral neuropathy of the upper limb.
* Infection at the injection site.
* Uncontrolled diabetes, epilepsy, obstructive pulmonary disease and neuromuscular disease.
* Altered mental status.
* Hypersensitivity to bupivacaine and ketamine.
* Patients with coagulopathy.
Study on the Model of Smoking Cessation Intervention and Service Ability Improvement

This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.

This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.

To study the intervention methods of smoking cessation in a general hospital and to evaluate their effects. Four methods of specialist intervention of smoking cessation clinic, short-time intervention in out patients, free medical intervention and group intervention were adopted for different smokers, with health counseling, psychological intervention and drug treatment. The intervention effect was evaluated by standard methods.

The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each quitter received follow-up at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview, an expected average of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* current smoker aged 18 years or above, Chinese,
* agreed to participate in the follow-up and signed an informed consent form.

Exclusion Criteria:

* cognitively impaired and with severe diseases,
* occasional or daily smoker,
* Disagree and non-signed an informed consent form.
Comparing Impression Techniques for Maxillary Complete Denture Retention

The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Secondary objectives include assessing patient satisfaction with impression methods and denture satisfaction after a two-month adaptation and comparing post-delivery adjustment visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderately resorbed maxillary alveolar ridge
* Patients with bimaxillary edentulous arches
* Patients aged between 35 to 85 years willing to participate in the study
* Patients who could be available for follow up visits

Exclusion Criteria:

* Patients with palatal torus or bony exostoses or severe undercuts in the maxillary arch
* Patients with uncontrolled diabetes, osteoporosis, osteomalacia and osteopenia
* Patients with xerostomia
* Patients with mucosa covering the denture bearing area with signs of inflammation, ulceration, or hyperplasia.
* Patients undergoing radiotherapy or chemotherapy or maxillofacial surgery
* Patients suffering from maxillofacial trauma
* Patients with neuromuscular disorders
* Patients with clinical signs and symptoms of temporomandibular joint dysfunction
* Patients with highly resorbed maxillary ridge and/ or flabby ridge
* Patient with hypersensitivity to silicone materials
Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension

To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC).

Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (QoL) and survival. Treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic drugs are needed. The investigators have recently demonstrated that sleep related breathing disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly PH. There are even data suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA in the treatment of PH has not been conclusively studied. Therefore, the purpose of the current project is to investigate, the acute hemodynamic clinical effects of AZA in PH patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing RHC for a clinical indication and who are diagnosed with precapillary PH (mPAP ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)

Exclusion Criteria:

* Patients in whom a RHC is clinically not indicated
* pregnant women
* PH in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease.
Vitiligo Extent Score (VES) Score in Comparison to Vitiligo Area and Severity Index (VASI) Score

All patients with vitiligo attending dermatology outpatient clinic at Kasr Alainy Teaching Hospital will be enrolled in this study to compare VES and VASI scores and evaluate them as assessment methods


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18.
* Non-segmental vitiligo patients

Exclusion Criteria:

* Age \< 18
* Segmental vitiligo
Topical Treatment of Under Eye Dark Circles and Swelling

This study examines topical treatment of under eye circles and swelling.

This study examines topical treatment of under eyes dark circles and under eye swelling.

Eligibility Criteria:
Inclusion Criteria:

* Under eye dark circles and swelling

Exclusion Criteria:

* Under age 18
* Allergy to tested medicines
Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy

The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?

This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.

Eligibility Criteria:
* Subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures)
* Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy.
* Mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse.
* Mothers must be able to maintain an accurate seizure diary of major motor seizures
* Subjects must have an IQ greater than or equal to 70 points.
* Subjects must have a history of a negative RPR and HIV.
* Subjects must not have progressive cerebral disease or presence of other major medical illness
* Subjects must not have exposure to known teratogens during pregnancy, except AEDs.
* Subjects must not have poor compliance with prenatal care.
* Subjects must have adequate reading skills to perform the cognitive tests.
A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis

This was a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA.

The study aimed to enroll ninety-four (94) patients/care partners. The time period for enrollment was dependent on the uptake of KESIMPTA in the real-world.

Data collected for the study was obtained directly from the patient/care partner within the web-based database: De-identified data was stored on a secure server and transferred for analysis. Responses from the patient and care partner surveys were pooled for analysis of study endpoints.

Eligibility Criteria:
Patients with MS Inclusion Criteria:

* Adult aged eighteen (18) years of age or over at the time of the survey
* Prescribed KESIMPTA within the prior 12 months and currently self-administering treatment using the Sensoready® pen
* MS diagnosis based on 2017 McDonald criteria

Care Partner Inclusion Criteria:

* Adult aged eighteen (18) years of age or over
* Formal or informal care partner of patient with MS prescribed KESIMPTA within the prior 12 months
* Is currently administering KESIMPTA using the Sensoready® pen on their patient's behalf

Patients with MS Exclusion Criteria:

* Previously used injection as a part of inclusion in any ofatumumab (OMB) randomized clinical trial
* Active Hepatitis B virus (HBV)
* Cognitive impairment that would impact their ability to participate in a survey study
A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG or OHT
* Prescribed Lumigan® 0.01%

Exclusion Criteria:

* None