cyrilzakka/clinical-trials huggingface dataset:
Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

The primary objective of this study is to determine the safety \& efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.

This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Age \> 50 years
* Definite characteristic signs of age related macular degeneration including drusen
* Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion Criteria:

* Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
* Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
* Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
* History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
Topical Steroids & Bacterial Decolonization for Radiation Dermatitis

The purpose of this study is to determine whether bacterial decolonization of the nares and skin, topical steroid therapy, or a combination of the two regimens prior to treatment with radiotherapy (RT) for breast and head and neck cancer patients can prevent grade 2 or higher grade radiation dermatitis (RD) graded via the Common Terminology Criteria for Adverse Events (CTCAE) scale and improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Diagnosis of a breast or head and neck cancer with plans for fractionated RT (greater than or equal to 15 fractions in 40 Gy (Gray)) with curative intent, including post-operative patients deemed eligible for RT by their surgeons and radiation oncologists

Exclusion Criteria:

* Prior RT to the region of interest
* Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds; known allergy to intervention therapies)
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* Clinical diagnosis of DVT or PE

Exclusion Criteria:

* Contraindications for enoxaparin or warfarin
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Significantly impaired kidney or liver function
Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck

Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.

Before Treatment:

The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the FACE-Q Appraisal of Neck scale score

Treatment:

The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200\~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.

Post-Treatment:

All subjects will visit the Institution at 12 weeks from the day of procedure, and will take photos of the neck. Efficacy evaluation will performed by the Photographic Evaluator.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Subject in good health
* Subjects who desire improvement in neck skin

Exclusion Criteria:

* Presence of an active systemic infectious disease
* general disease or skin disorder in the area to be treated
* Pregnant or lactating subjects
* Previous episode of facial or neck surgery for wrinkle correction
* Subjects who have aesthetic addiction, drug abuse, alcohol abuse
* Subjects who were treated Botox or Filler at the neck area
* Subjects who had Auto-Immune disease
Comparison of Sedation by Esketamine and Sevoflurane

Pediatric diseases，including congenital cataract,，corneal injury，corneal ulcer, usually need suture removal and ophthalmic examination after Surgery for several days. Unfortunately, it remains a great challenge to achieve successful sedation due to children's noncooperation. Sevoflurane is one of the most often used anesthesia agents to provide deep sedation. Although sevoflurane has been used for pediatric anesthesia with successful keep spontaneous breathing without intubation, it should be noted that sevoflurane often results in air pollution under the open airway background and postoperative agitation.

Esketamine is the S (+) isomer of ketamine, which produces a dissociated state with minimal risk of airway compromise or apnea. It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause delirium during the recovery time. Based on these experiences on ketamine, we compared the effectiveness of esketamine and sevoflurane for short ophthalmological procedure in pediatric patients.

Pediatric diseases，including congenital cataract,，corneal injury，corneal ulcer, usually need suture removal and ophthalmic examination after Surgery for several days. Unfortunately, it remains a great challenge to achieve successful sedation to avoid body movement and keep perfect eye position due to children's noncooperation. Thus, appropriate sedative agents therefore need to be administrated to perform this minor surgery. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been used for successful keeping spontaneous breathing without tracheal intubation. It should be noted that sevoflurane often results in air pollution under the open airway background and emergence agitation. High concentrations of sevoflurane may causes respiratory depression due to the decrease in tidal volume during spontaneous ventilation.

Ketamine is widely used for procedural sedation, which produces a dissociated state with minimal risk of airway compromise or apnea. Esketamine is the S (+) isomer of ketamine, It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause agitation during the recovery time. Based on these experiences on ketamine, we compared the effectiveness of esketamine and sevoflurane for short ophthalmological procedure in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* patient who needed suture removal and ophthalmic examination

Exclusion Criteria:

* previous coronary heart disease,hypertension, arterial aneurysm, epilepsia, intracranial mass of benign or malign nature
Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

The purpose of this study is to evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.

WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Eligibility Criteria:
Inclusion Criteria:

1. 70 years\>=Aged \>=18 years
2. diagnosed with high-risk LPL/WM according to the ISSWM criteria
3. untreated or mild treated without standard regimens
4. suitable for ASCT
5. with life-expectancy more than 3 months.

Exclusion Criteria:

1. diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)
2. transformed lymphoma
3. liver or renal function lesion unrelated to lymphoma
4. serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
5. HIV positive or active HBV infection or other uncontrolled systematic infection
6. clinical central nervous dysfunction
7. serious surgery within 30 days
8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.
Pediatric Patients With Metabolic or Other Genetic Disorders

Background: Some patients with unusual genetic conditions are referred to the National Institutes of Health (NIH). They may not be eligible to join current research studies. Testing such patients is a good way to improve the skills of research staff. The findings could lead to new processes and research.

Objectives:

To recruit a diverse group of pediatric subjects with genetic disorders. To give clinic staff hands-on experience working with these patients.

Eligibility:

Children any age with a known or suspected genetic disorder.

Design:

Participants will be screened with medical history and physical exam. They may have lab and other tests.

Family members may give DNA samples.

Participants will have:

Medical history

Physical exam

Height, weight, and other measurements taken.

A clinical evaluation of their disorder.

They may have:

Blood, urine, and saliva samples taken

Imaging tests. These may include x-rays, scans, ultrasound, or skeletal survey.

A sleep study

A visit with other specialists at NIH

A genetic test from a commercial lab

Medical photographs taken

Other tests

Participants may have follow-up visits. They may get medical or surgical treatment.

The aim of this protocol is to allow genetic-related evaluations for patients with a variety of known or suspected genetic disorders.) If not eligible for a specific NICHD research protocol, patients with genetic-related conditions may be evaluated under the auspices of this protocol to provide stimuli for new clinical research initiatives. Standard medically-indicated laboratory or radiological studies may be performed to confirm a diagnosis or to aid in the management of the patient. Clinical data and excess biospecimens collected as part of clinical care will be analyzed for research purposes. In some cases, the subjects may receive medical or surgical treatment for their disorder at the NIH CC according to current clinical practice. The overall purpose of genetic evaluations under this protocol is to support our research missions, generate hypotheses bank specimens for analysis or future use as controls. Family members of subjects evaluated on this protocol (who have informative meiotic inheritance relationships to the proband or index case) may also be enrolled.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Subjects of any age with known or suspected genetic disorder
* For relatives of subjects with a genetic disorder: Subject is a family member of the proband

EXCLUSION CRITERIA:

-Presence of a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation
A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX120 in subjects with relapsed or refractory multiple myeloma.


Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥18 years.
2. Relapsed or refractory multiple myeloma, as defined by IMWG response criteria and treatment with at least 2 prior lines of therapy.
3. Eastern Cooperative Oncology Group performance status 0 or 1.
4. Adequate renal, liver, cardiac and pulmonary organ function
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX120 infusion.

Key Exclusion Criteria:

1. Prior allogeneic stem cell transplant (SCT).
2. Less than 60 days from autologous SCT at time of screening and with unresolved serious complications.
3. Prior treatment with any gene therapy or genetically modified cell therapy, including CAR T cells or natural killer cells, or BCMA-directed therapy.
4. Evidence of direct central nervous system (CNS) involvement by multiple myeloma.
5. History or presence of clinically relevant CNS pathology such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement.
6. Unstable angina, clinically significant arrhythmia, or myocardial infarction within 6 months of enrollment.
7. Active HIV, hepatitis B virus or hepatitis C virus infection.
8. Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
9. Use of systemic anti-tumor therapy or investigational agent within 14 days prior to enrollment.
10. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
11. Women who are pregnant or breastfeeding.
Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery

The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery

This randomized, controlled, double-blind study will be conducted on ASA physical status II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In the ultrasonography group, lumbar spinal ultrasonography will be performed before administration of spinal anesthesia. In the palpation group, conventional palpation of the anatomical landmarks will be performed.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status II-III parturients
* Full term singleton pregnancy
* Body mass index ≥ 35 Kg/m2

Exclusion Criteria:

* Age \< 19 years
* Women presenting in labor
* Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection)
* Significant spinal deformities or previous spinal surgery
* Preeclampsia
A Study of LY2922083 in Healthy Participants and Participants With Diabetes

The aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study consists of two parts. Part A will study healthy participants in up to 3 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

For all participants :

* Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
* Have a screening body mass index (BMI) of at least 18.0 kilograms per square meter (kg/m\^2)
* Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

For participants with T2DM:

* Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
* Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening

Exclusion Criteria:

For all participants :

* Are currently participating in another clinical study or completed one in the last 30 days
* Are allergic to LY2922083 or other related drugs
* Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
* Have electrocardiogram (ECG) readings that are not suitable for the study
* Have a history of hepatitis or jaundice
* Are infected with hepatitis B
* Are infected with hepatitis C
* Are infected with human immunodeficiency virus (HIV)
* Have donated more than 450 milliliters (mL) of blood in the last 3 months or have donated any blood in the last month
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
* Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic

For participants with T2DM :

* Have had heart disease or stroke within 6 months before entering the study
* Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
* Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
* Have used insulin to control diabetes in the last 1 year
* Show symptoms of high blood sugar (for example, frequent urination, always feeling thirsty, or unexpected weight loss)
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy

A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy

Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned for ureteroscopy \\ retrograde intra renal surgery (RIRS) for stone treatment

Exclusion Criteria:

* known ureteral stricture
* severe immune deficiency
* patients after urinary diversion surgery
* patients with single \\ ectopic\\ implanted kidney
* double collecting system
* severe thrombocytopenia
* patients taking anticoagulant drugs that cannot be stooped before the operation
Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation

We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers


Eligibility Criteria:
Inclusion Criteria:

* - Recipients 18 years or older.
* Deceased donor whole graft liver transplant recipients undergoing liver transplant starting 07/01/2020 and onwards at VUMC.
* ABO-matched recipient and donor.
* Donor Hb level \>/= 8 g/dL
* Recipients with negative ABO antibody screen

Exclusion Criteria:

* - Pediatric recipient.
* HBS Antigen+ donors
* HCV NAT+ donors
* Donors of A2 blood type
* Donors on oral anticoagulants (except for aspirin) over the past 3 days before organ procurement
Effect of Deep Breathing on Balance in Patients With Chronic Mechanical Low Back Pain

The primary purpose of this study is to investigate the effects of deep breathing pattern on dynamic balance in patients with chronic mechanical low back pain versus healthy controls. Secondary to compare between dynamic balance control during deep versus regular breathing patterns in patients with chronic mechanical low back pain and healthy controls. Further, to detect whether pain intensity differs during balance testing applying either deep or regular breathing in patients with chronic mechanical low back pain.

Diaphragm has been reported as a contributor in postural control and respiration. However, the integrated function of postural control and respiration is a complex process, especially evident during activities that increase demands on one or both functions . Previous research reports noticed that breathing pattern is altered in cases of chronic mechanical low back pain during tasks that challenges the trunk muscles function, and trunk stability . Dynamic balance control is one of the functional tasks that burdens the trunk muscles, and requires high degree of integration. Dynamic balance is disturbed in cases of chronic mechanical low back pain, and reports indicate that balance deficits extends after the painful episodes in those who have history of low back pain In patients with chronic mechanical low back pain regular respiratory movements results in greater disturbances to balance than healthy subjects .

Accordingly, in this study will attempt to emphasize the role of the deep breathing pattern during dynamic balance testing in chronic mechanical low back pain patients and matched healthy control subjects. As it is suggested that activity of the diaphragm will be focused upon through introducing deep breathing during dynamic balance testing; it is expected to enhance dynamic balance through its dual integrating its dual function of postural control and respiration.

Eligibility Criteria:
Inclusion Criteria:

* Participants in both groups should fulfill the criteria set for age and BMI ranges.
* Patients in study group should complain of pain in the lower back for a period of more than 3 months.
* Referred from an orthopedist .
* Participants in control group should haven't complained of back pain

Exclusion Criteria:

* Patients complain of radiculopathy .
* Patients complain of any other musculoskeletal disorder other than chronic mechanical low back pain .
* Any previous or current complains of pain involving other regions of the spine.
* Have history of respiratory dysfunction due to current or previous respiratory condition.
* suffer from any condition that affect balance control, including neurological, vestibular, visual or somatosensory deficits.
* use drugs that might compromise their balance control