cyrilzakka/clinical-trials huggingface dataset:
IRIS-BVS AMI Registry

The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug eluting stents) DES.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Acute myocardial infarction
* Intervention with Bioresorbable Vascular Scaffold
* Agreed with written informed consent form

Exclusion Criteria:

* Bypass graft surgery (CABG) recommended
* Lesion with previous bypass graft surgery (CABG)
* Severe calcification and/or severe tortuosity
* Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
* Life expectancy of 1year and under
* Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
* Cardiac shock
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age

Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.

Eligibility Criteria:
Inclusion Criteria:

* Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
* Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria:

* Subject whose parent or legal representative does not agree to participate in the study
* Subject who is considered inappropriate to participate in the study by the investigator
Respiratory Training in Patients With Leukemia

Forty male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group.

The following measures were taken before and after the study period : Maximum voluntary ventilation(MVV) , 2 min walk test, FACT-G questionnaire

Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo ( inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly assigned into two groups.Group A (30 patients) who received inspiratory muscles training for 4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and Quality of life questionnaire (FACT-G) were statistically analyzed and compared

Eligibility Criteria:
Inclusion Criteria:

* male patient with age ranges from 30-50 years
* All patients were leukemic receiving chemotherapy for at least one cycle as a treatment of malignant tumor
* All patients were hemodynamically stable
* All patients were ambulant

Exclusion Criteria:

* lung cancer
* History of any pulmonary disease.
* Metastasis of lungs, ribs, mediastinal structure
* Pulmonary pathology(e.g acute respiratory distress syndrome or exacerbation of chronic obstructive pulmonary disease)
* ruptured ear drum or any other condition of the ear
* High peak airway pressure (barotraumas)
* patients with marked elevated left ventricular end diastolic volume and pressure
* patients with worsening heart failure signs and symptoms
Efficacy of Novel Drug-combinations for Relief of Psoriasis

ENDURE is a prospective, observational study aimed to document clinical response and side effects associated with compounded psoriasis medications when prescribed as routine care. As a secondary initiative, this study will assess methotrexate systemic absorption and toxicity in patients prescribed a methotrexate-containing compounded formulation.

In this prospective, observational study, change in psoriasis plaque appearance, per the Psoriasis Area Severity Index (PASI) tool, will be evaluated after using a topical psoriasis cream containing at least 3 of the following: corticosteroid, methotrexate, vitamin D3 or synthetic analog, retinoid acid, or urea, or a topical shampoo or spray containing a corticosteroid and vitamin D3 or synthetic analog. The change in quality of life will be assessed during all visits using the Skindex-16 assessment tool. In patients receiving a methotrexate-containing formulation, a sub-study will be available as an option, where laboratory values (methotrexate levels, complete blood count, liver function tests, etc.) will be obtained to confirm that methotrexate absorption is negligible.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Diagnosis of psoriasis vulgaris
* Being initiated on a topical compounded medication for psoriasis from Medimix Specialty Pharmacy containing at least 3 of the following ingredients as part of standard of care: corticosteroid, methotrexate, retinoic acid, vitamin D3 or synthetic analog, urea, AND/OR a shampoo/spray containing a corticosteroid and vitamin D3 or synthetic analog for the first time.

Exclusion Criteria:

* Pregnancy \& nursing
* Active infectious disease
* Kidney abnormalities
* Blood deficiencies
* Alcohol consumption
* Immunodeficiency syndromes
* History of systemic psoriasis medications, including conventional DMARDs, oral retinoids, oral calcineurin inhibitors, TNF-inhibitors, and monoclonal antibodies within the past 120 days
* Current or planned use of concomitant psoriasis medications and/or phototherapy
* Any additional health conditions or concomitant use of other prescription/over-the-counter products that may confound the study results at the discretion of the study investigators
Yoga Nasal Irrigation in the Treatment of Chronic Tension Type Headache

To evaluate the effectiveness of Yoga Nasal Irrigation (Jalaneti) on patients with chronic tension-type headache reducing pain and disability.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria of chronic tension type headache as per International Classification of Headache Disorders, 3rd edition (beta version) (ICHD-3 beta criteria)
* Aged 18-60 years;
* Ability of understand and completing the headache dairy;
* Volunteering to the study
* Provide written informed consent.

Exclusion Criteria:

* Not having tension-type headache during the pervious 3 months or having less than 8 episode of tension type headache in serious month.
* Taking any prophylactic headache medication or complementary and alternative medicine in last 3 month;
* Secondary Headaches
* In pregnancy, lactation, or planning to be pregnant in 6 months
* Having nose bleeding disorders or recurrent infections;
* Psychiatric diagnosis or medication history
Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines

The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines \[UFL\]): Horizontal Forehead Lines \[HFL\], Glabellar Frown Lines \[GFL\], and Lateral Canthal Lines \[LCL\]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension (OLEX) period.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients (male or female) 18 years of age or older.
* Horizontal forehead lines (HFL), glabellar frown lines (GFL), and symmetrical lateral canthal lines (LCL) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales (MAS).

Exclusion Criteria:

* Previous treatment with botulinum neurotoxin (BoNT) of any serotype in the face within the last 12 months before injection.
* Any facial cosmetic procedure within the last 12 months before baseline injection.
* Previous treatment with any biodegradable filler in the face within the last 12 months before injection.
* Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).
* Any medical condition that may put the subject at increased risk with exposure to NT201.
Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

The purpose of this study is to reveal if higher doses of vasopressors in septic shock patients correlates with cerebral vasoconstriction and lower cerebral oximetry.

The mortality with septic shock is high. Treatment includes antibiotics, intravenous fluid and drugs for circulatory support, especially the vasopressor norepinephrine. Fluids and drugs for circulatory support are to restore adequate organ perfusion. Inadequate oxygenation of the brain can give neurologic damage. Traditionally treatment is guided by surrogate markers like arterial and central venous pressure. Cerebral oximetry is a non-invasive method which measures cerebral saturation of oxygen, SCO2, and thereby expresses regional cerebral perfusion. By registering cerebral oxymetry on patients treated with vasopressors for septic shock we want to reveal if higher doses of vasopressor correlates with cerebral vasoconstriction and lower cerebral oximetry.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Septic shock patients in ICU department requiring vasopressor therapy

Exclusion Criteria:

* Damage to the frontal lobes corresponding to the area where SCO2 is monitored
* Patients in pharmacological studies
* Patients with known intracranial vascular anomalies or cerebral aneurysms
* Patients where vasoactive medication is started before cerebral oxymetry is established
* Patients with known neurological disease
* Patients with undergone cerebral insult, transient ischemic attack or carotid stenosis
* Patients who have been resuscitated after cardiac arrest in connection with this hospital stay
* Patients with a body temperature below 35 degrees Celsius when establishing monitoring
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance

This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.


Eligibility Criteria:
Key Inclusion Criteria:

* A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment
* For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides \<350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)
* For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG \<400 mg/dL

Key Exclusion Criteria:

* Acute significant cardiovascular disease
* Poorly controlled hypertension
Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma

This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).


Eligibility Criteria:
Inclusion Criteria (abbreviated):

1. Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
2. Schedule to undergo either partial or radical nephrectomy as part of treatment plan
3. Patient agrees to have a tumor biopsy
4. ECOG performance status of 0 or 1
5. Adequate organ and marrow function defined by study-specified laboratory tests
6. Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion
7. Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures

Exclusion Criteria (abbreviated):

1. Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
2. Need for urgent or emergent nephrectomy to relieve symptoms
3. Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
4. Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
5. Received live vaccine for infectious diseases within 28 days of starting study treatment
6. Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
7. Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
8. Current use of immunosuppressive agents
9. History of severe hypersensitivity reaction to other monoclonal antibodies
10. Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
11. Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
12. Active infection requiring therapy.
13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
14. Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
15. History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).
16. Pulse oximetry of \<92% on room air
17. Pregnant or breastfeeding women
Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse

Evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of pelvic organ prolapse


Eligibility Criteria:
Inclusion Criteria:

1. being 18 years old or older
2. needing an operation for symptomatic pelvic organ prolapse -

Exclusion Criteria:

1. past history of chemotherapy or radiotherapy
2. past history of pelvic organ prolapse surgery
3. if there is a contraindication of laparoscopy -
The Clareon PanOptix Trifocal IOL: Visual Outcomes and Patient Satisfaction

This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Panoptix or Panoptix Toric implant.

The PanOptix trifocal lens by Alcon was introduced in 2015 and is currently in use in over 70 countries. Its outcomes on the AcrySof platform are well documented and highly appealing to patients and clinicians.,, Clinicians no longer need to routinely target monovision or modified monovision to provide a range of vision. With the release of the Clareon material for this lens, questions remain about how the new lens material will influence patient satisfaction and uncorrected visual performance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
* Patients implanted with Clareon PanOptix or Clareon Panoptix Toric lenses bilaterally within 6 months of the survey administration.

Exclusion Criteria:

* Patients with visually significant comorbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
* Patients with previous refractive surgery within the past 6 months prior to cataract surgery
* Patients with \> grade 1 posterior capsule opacity at their last visit
Effects of Routine Feedback to Clinicians on Youth Mental Health Outcomes: A Randomized Cluster Design

The purpose of this clinical trial was to test the hypothesis that clients of clinicians who were scheduled to receive weekly feedback on their clients' progress would improve faster than clients of clinicians who were not scheduled to receive weekly feedback.

The primary approach to improving psychosocial treatment for youths has been to implement evidence-supported treatments (ESTs) in community services. However, this approach has not produced clear cut results of effectiveness. A recently developed alternative is to improve outcomes through routine measurement and feedback to clinicians and supervisors. The investigators used a cluster randomized experiment with 28 sites affiliated with a national behavioral health organization to assess whether clients of clinicians who were scheduled to receive weekly feedback on their clients' progress would improve faster than clients of clinicians who were not scheduled to receive weekly feedback.

Eligibility Criteria:
Inclusion Criteria:

* all youths 11-18 years old, entering treatment as usual, home-based services through the service provider. Youths' primary caregiver and clinician also participate.
Lorazepam Sedation for Critically Ill Children

This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to make sure that lorazepam, when given to children who are very sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well as a drug called midazolam. Midazolam is already approved by the FDA for this use, but lorazepam is not, even though both drugs are commonly used for sedation.

Lorazepam is used clinically for sedation of mechanically ventilated children, but has not been approved by the FDA for this indication in children. The purpose of this study, in response to the Written Request by FDA, is to determine the safety, efficacy, and dosage required for lorazepam compared with midazolam, which is approved by FDA for children for this indication.

Study participants must be children who are critically ill and receiving mechanical ventilation who require sedation. Participants will be randomized to lorazepam (intermittent bolus or continuous infusion) or midazolam (continuous infusion). Sedation will be monitored using the COMFORT score. Blood will be drawn to measure lorazepam/midazolam plasma concentrations, and to measure the plasma concentrations of excipients (benzyl alcohol and glycols) in patients receiving lorazepam.

Eligibility Criteria:
Inclusion Criteria:

* Males or females from full term birth (at least 38 weeks post conceptual age) through 18 years
* Patients must be intubated and mechanically ventilated in the PICU less than or equal to 24 hr
* Patients in whom the use of neuromuscular blocking agents would normally NOT be expected to be used.
* Patient's parent or guardian has signed a consent form prior to initiation of study procedures
* Patients with cardiac, renal, or hepatic dysfunction will be actively sought

Exclusion Criteria:

* Life expectancy \< 48 hr
* Expected duration of sedation \< 48 hr
* Patient with history of hypersensitivity to any component of lorazepam, midazolam, fentanyl, thiopental
* Females pregnant or breast feeding
* Patient requires sedatives or analgesics other than study drug
Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

The aims of this pilot study are to determine the metabolic demand and exercise intensity level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the same way as compared to healthy controls. We hypothesise that 1) the metabolic demand and exercise intensity of E-Fit exercise intervention is equivalent to moderate-to-vigorous level; and 2) AIS girls have different cardiovascular responses as compared to healthy controls

AIS girls and age- and gender-matched healthy controls will perform the E-Fit exercise intervention for two trials and gas exchange parameters including oxygen consumption (VO2) and carbon dioxide production (VCO2) will be taken continuously during the exercise. Comparison of VO2 and VCO2 between AIS and healthy controls when performing E-Fit exercise will be made.

Eligibility Criteria:
Inclusion Criteria:

* Cobb angle greater or equal to 15 degree
* Cleared for physical activity by doctor

Exclusion Criteria:

* Cobb angle greater or equal to 40 degree, or
* Scoliosis with any known etiology, scoliosis with skeletal dysplasia, know endocrine and connective tissue abnormalities, or
* Known heart condition or other diseases that could affect the safety of exercise, or
* Eating disorders or GI malabsorption disorders, or
* Currently taking medication that affects bone or muscle metabolism
Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens with or without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

HIVIS DNA and MVA-CMDR vaccines induce immune responses important for clearing infected cells: broad HIV-specific CD8+ cytotoxic T cells, potent antibodydependent cellular cytotoxicity (ADCC), and binding antibody (Ab) and neutralizing antibody (NAb). The study include early treated children because of their healthy immunity and small HIV reservoirs. Giving licensed vaccine, Cervarix®, against human papilloma virus (HPV) that contains toll-like receptor (TLR) 4 agonist with HIVIS DNA could increase DNA antigen loading on dendritic cells and promote adaptive immune responses to the HIV vaccine.

Eligibility Criteria:
Inclusion criteria:

1. HIV perinatally infected
2. Know their HIV+ status
3. Initiated ART prior to 6 months of age
4. Male and female ≥ 9 years old
5. In generally good health
6. Plasma viral load \< 200 copies/ml on ART at screening
7. CD4 count above 400 cells/mm3 at screening
8. Participants of childbearing potential who are sexually active must be willing to practice effective contraception during the study
9. Negative urine β-HCG (human chorionic gonadotropin) pregnancy test for any female of childbearing age (post-menarche)
10. Availability for follow-up for planned duration of the study
11. Passing a test of understanding is required for participants ≥ 18 years old or the parent(s)/legal representative of participants \< 18 years old before consent.
12. Written informed consent from participants ≥ 18 years old or parent(s)/legal representative of participants \< 18 years old. Assent by participants aged 9-17 years old will also be required.
13. Laboratory criteria within 8 weeks prior to enrollment

    * Hb \>11.0 g/dl
    * White blood cell count \>3000 cells/mm3
    * Platelets \>125,000/ mm3
    * ALT \<1.5 x upper limit of normal
    * Creatinine \<1.5 x upper limit of normal

Exclusion criteria:

1. Participants who experienced virological failure necessitating ART modifications
2. Participants who had ART interruption that lasted \>2 weeks
3. Prior or current pancreatitis or history of alcohol abuse.
4. Systemic cortisone treatment within the past 30 days
5. Participants coinfected with chronic hepatitis B (Hepatitis B surface antigen, HBsAg+) or hepatitis C (Hepatitis C antibody, HCV Ab+) at screening
6. Participants with signs of autoimmune diseases
7. Participants with history of myocarditis
8. Participants on any immune modulating or investigational drug
9. Pregnant or breastfeeding female