cyrilzakka/clinical-trials huggingface dataset:
Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes

The primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes while maintaining disease control in males with hemophilia A or B.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a medically documented diagnosis of hemophilia A or B that is being treated prophylactically with a factor replacement product not designed to have a prolonged half-life and satisfy a therapeutic indication for rFVIIIFc/rFIXFc per the approved local label
* Have at least 50 prior exposure days (EDs) to any combination of factor replacement products
* Have documented pre-study data available that confirm fulfillment of the eligibility criteria
* Have no measurable inhibitor activity in a sample obtained within 4 weeks prior to the Baseline visit, and absence of clinical signs or symptoms of decreased response to the current factor replacement product

Key Exclusion Criteria:

* Have a diagnosis of any bleeding disorder other than hemophilia A or hemophilia B or an additional coagulation disorder(s) in addition to hemophilia A or hemophilia B
* Have a prior history of anaphylaxis associated with any factor VIII (FVIII)/ factor IX (FIX) or intravenous immunoglobin administration
* Had an inhibitor within 5 years before the Baseline visit. Note: A family history of inhibitors will not exclude the patient.
* Past or current treatment with any factor replacement product with a prolonged half-life, including an Fc product, for the treatment of hemophilia

NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.
Phase Locked TRanscranial Electrical EXcitation

Transcranial current stimulation (tCS) has been extensively studied due to its potential of selectively stimulate brain regions in a non-invasive way. However, classic stimulation paradigms are often applied in an open loop configuration, without considering the effects on the underlying brain activity.

Recent studies suggest that when alternating current are used, it would be beneficial to phase lock the stimulation to the target brain wave of interest to achieve selective temporal stimulation, allowing for better control over the stimulation effects.

This study aims at demonstrating a novel setup that allows for precise stimulation targeted in space and time. To achieve that, a combination of tCS and (EEG phased locked) closed-loop modality are used to obtain the required selectivity.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age between 18 and 64

Exclusion Criteria:

* Wounded or particular sensitive skin at areas of investigation. For example, skinrash, discoloration, scars, or open wounds
* Allergies to adhesive or dry electrodes or silver chloride
* Pregnant or lactating
* Any of the following symptoms (fever, tiredness, dry cough, aches and pains, nasal congestion, runny nose, sore throat, diarrhoea)
* Known neurological disorders
* Previous epileptic episodes
* Active implants such as pacemakers or brain stimulators
* Intracranial metal implants
Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends

The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.


Eligibility Criteria:
Inclusion Criteria:

* Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
* Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.

Exclusion Criteria:

* Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant has been treated with antibiotics 3 days prior to enrollment.
* Infant has received probiotics-containing products 3 days prior to enrollment.
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).

Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18).
* Have a viral load of at least 2,000 copies/ml within 21 days of study entry.
* Have a CD4 count of at least 100 cells/mm3 within 21 days of study entry.
* Agree to use a barrier method of birth control (such as condoms) during the study.
* Are available for follow-up for at least 56 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant or breast-feeding.
* Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 30 days and within 14 days of study entry.
* Have a new opportunistic (HIV-related) infection or condition requiring treatment.
* Have acute (early) HIV infection.
* Have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30 days prior to study entry.
* Abuse alcohol or drugs.
* Have active hepatitis within 30 days prior to study entry.
* Have a history of peripheral neuropathy (a condition affecting the nervous system).
* Cannot take medications by mouth.
* Are allergic to certain antiviral drugs.
* Need to take certain medications that should not be taken with EFV.
* Have certain other conditions or prior treatments that might affect the study.
Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients

Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. The population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* mean ambulatory blood pressure 125-146 mmHg and/or 80-89 mmHg
* high cardiovascular risk profile (one or more of the following: CAD, PAD, carotid stenosis, diabetes)
* informed consent

Exclusion Criteria:

* habituary intake of dark chocolate or cocoa products
* mean ambulatory blood pressure 147 mmHg or greater and/or 90 mmHg or greater
* pregnancy
* uncontrolled diabetes
* severe comorbidity
* change in blood pressure medication within last 6 weeks
* participation in another trial
Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees

This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent to participate in the study.
2. Subject is older than 18 years.
3. 3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.
4. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
5. If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.

Exclusion Criteria:

1. Pregnancy or trying to become pregnant in the next 2 months.
2. History of alcohol or drug abuse within the past 6 months as self-reported.
3. Presence of the following contraindication to transcranial direct current stimulation Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted head electronic medical devices (e.g., cochlear implants)
4. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
6. Uncontrolled Epilepsy
7. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).\*
8. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
9. History of neurosurgery, as self-reported.
Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant

Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may help to control leukemia. The purpose of this study is to find the highest dose of sorafenib for maintenance therapy that can be safely used in participants with AML who have undergone allogeneic stem cell transplant.

Subjects will taken sorafenib orally either once or twice daily. Subjects will come to the Bone Marrow Transplant Clinic 3 times (on Day 8, 15, and 30) during the first month of treatment. After the first month, they will be seen every month for 3 months and then at 9 at 6 and 9 months. Subjects will have a physical exam and be asked questions regarding general health and specific questions about any problems they might be having and any medications they are taking.

Subjects will have standard blood tests every month for 12 months to check liver and kidney function and complete blood count.

Subjects will have research blood tests on Days 8, 15 and 30 during the first month of treatment.

Subjects will have a bone marrow biopsy after 3 months and 12 months of treatment.

Subjects will receive treatment for up to 12 months and be followed for 1 year after completing the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with AML with the FLT3-ITD mutation who have undergone allogeneic HSCT
* Peripheral blood chimerism studies showing \>/= 70% of all cells are of donor origin
* Adequate hematologic and hepatic function
* ECOG performance status 0-2
* Able to swallow whole pills

Exclusion Criteria:

* Evidence of relapsed/recurrent/residual disease as assessed by bone marrow aspirate and biopsy performed between days 30-60 after HSCT
* Active acute graft vs host disease requiring an equivalent dose of \> 0.5 mg/kg/day of prednisone or equivalent or those patients which necessitated the addition of another agent for the treatment of GVHD beyond corticosteroids
* Ongoing uncontrolled infection
* Cardiac disease: congestive heart failure \> class II NYHA, unstable angina or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Uncontrolled hypertension
* Known HIV infection or chronic hepatitis B or C
* Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
* Pulmonary hemorrhage/bleeding event \> CTCAE v 4.0 Grade 2 within 4 weeks of starting study drug
* Any other hemorrhage/bleeding event \> CTCAE v. 4.0 Grade 3 within 4 weeks of starting study drug
* Serious non-healing wound, non-healing ulcer, or bone fracture
* Evidence or history of bleeding diathesis or coagulopathy
* Major surgery or significant traumatic injury within 4 weeks of starting study drug
* Use of St. John's Wort or rifampin (rifampicin)
* Known or suspected allergy to sorafenib
* Pregnant or breast-feeding
* Receiving any other investigational agents
Incretin Effect in Patients With Psoriasis and Controls

To investigate the incretin effect and postprandial incretin responses in plasma in patients with psoriasis


Eligibility Criteria:
Inclusion Criteria:

no diabetes BMI \< 27 kg/m\^2 normal Glucose tolerance test at screening normal fasting plasma glucose no islet auto antibodies no hormonel contraception informed consent psoriasis vulgaris (PASI\>8) (case not controls)

Exclusion Criteria:

other chronic inflammtory skin disease other chronic inflammatory disease pregnancy psychiatric illness
Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

The purpose of this study is to compare the difference of incidence of postoperative delirium between patients received general anesthesia guided by Bispectral index (BIS) and patients received general anesthesia using standard technique.

General anesthesia is one of precipitating factor of postoperative delirium which Its mechanism is still unknown. General anesthesia can affect on pattern of electroencephalograph. Previous studies showed that patients received BIS guided anesthesia could wake up faster, earlier extubation and stay in recovery room shorter compared to standard general anesthesia. Optimized level of anesthesia by BIS could reduce cognitive dysfunction in elderly patients and reduce biological marker of brain injury. Therefore, the investigators hypothesized that adjustment of general anesthesia by BIS guided could protect central nervous system and reduce incidence of postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* Patients age equal or more than 65 years.
* Patients undergoing general anesthesia.
* Patients undergoing scheduled, non-cardiac surgery

Exclusion Criteria:

* Patients undergoing neurosurgery.
* Patients cannot understand Thai language.
* Patients who have severe visual or hearing impairment.
Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery

Prospective, randomized, and controlled trial to compare the postoperative pain management of paravertebral nerve block with liposomal bupivacaine to ropivacaine in patients undergoing elective thoracoscopic surgery.

The objective of this study is to validate the analgesic efficacy of liposomal bupivacaine (LB) compared with ropivacaine when injected for paravertebral nerve block (PVB) for video-assisted thoracoscopic surgery (VATS).

We hypothesize that LB will be superior to ropivacaine in terms of postoperative pain control following VATS. The primary outcome of this study will be NRS pain scores for resting pain and NRS pain scores for cough pain 24 hours following surgery. Secondary outcomes will include pain scores over the first 120 hours following surgery, opioid consumption, opioid-related adverse events, block-related adverse events, time of first getting out of bed, catheter indwelling time, postoperative hospitalization time, patient satisfaction, and chronic pain at 1, 3, and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-64 years old
2. Elective unilateral thoracoscopic surgery
3. Hospital stay ≥3 days
4. Able to cooperate in completing interviews and scale assessments
5. American Society of Anesthesiologists (ASA) classification I-III
6. Signed informed consent form

Exclusion Criteria:

1. History of thoracic surgery within the past 6 months
2. Pre-existing history of chronic pain or acute pain in the surgical area
3. Allergy to local anesthetics
4. Contraindications to thoracic paravertebral nerve block
5. Mental disorders, intellectual disabilities, epilepsy, or other neurological conditions
6. Severe heart or lung diseases
7. History of opioid drug abuse or substance abuse
8. Postoperative intubation
9. Recent participation in other clinical studies
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency

The purpose of this study is to verify the efficacy and safety of the radiofrequency stimulation compared to the sham stimulation in reducing lower extremity edema in adult women with idiopathic edema.

In this study, based on the characteristics of radiofrequency, it was hypothesized that radiofrequency could have an effect on the reduction of lower extremity edema and prevention of fatigue. The occurrence of edema is interpreted as a problem that blood circulation is not smooth due to increased inflow of body fluid, and therefore the degree of edema is also used as an indicator of blood circulation.

Therefore, in this study, based on the principle that radiofrequency promotes phosphorylation and blood circulation, the purpose of this study is to investigate whether radiofrequency treatment is effective in reducing edema of the lower extremities and changing body heat in the lower extremities compared to the gastric stimulation device through exploratory research.

Eligibility Criteria:
Inclusion Criteria:

1. Women between the ages of 19 and 72
2. Those who are not likely to menstruate during the trial treatment period (3 days) (females within 8 to 18 days after the onset of menstruation)
3. Those who meet the diagnostic criteria for idiopathic edema (McKendry criteria score of 15 or higher)
4. Those who show a weight change of 1.4 kg or more between morning and night measurements
5. Those who have a difference of 1cm or more from the ankle or 2cm or more from the calf when measuring the circumference in the morning and evening
6. Those who voluntarily agree to participate in this clinical trial and sign the consent form

Exclusion Criteria:

1. In the case of using a heart rate control device such as a metallic substance in the human body
2. During menstruation or if there is a possibility of pregnancy
3. If you have heart disease
4. If you have liver or kidney disease
5. If there is bleeding or internal bleeding from wounds or surgery
6. For hypertensive patients
7. For epilepsy patients
8. If you are taking weight loss or health-related drugs/health functional foods
9. In the case where it is judged by the principal investigator that participation in this study is not appropriate
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison with Guardix-SP Plus After Spine Surgery

This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.

To evaluate preventing adhesion, the study group is compared with MegaShield®-SP or Guardix-SP Plus after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 weeks to conduct examinations and assess Questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 to 70 years.
* Patient diagnosed with single-level lumbar disc herniation and scheduled to perform Lumbar discectomy, or patients diagnosed with single-level spinal stenosis and scheduled to perform laminectomy.
* Patients who voluntarily decide to participate in the study and voluntarily agree in writing to the informed consent form.

Exclusion Criteria:

* Patients diagnosed with multi-level lumbar disc herniation or lumbar disectomy ,far lateral lumbar disc herniation(FLLDH).
* Patient diagnosed with spinal cord disease
* Patient who needs spinal fusion
* Patient who has previous experience in spinal surgery
* Patient diagnosed with a serious liver or kidney disease
* Patients with lymph fluid or blood clotting disorder or taking antithrombotic or antiplatelet agents
* Patients with uncontrolled diabetes that may affect surgery or postoperative progress according to the investigator's judgment,
* Patients with immunocompromised or autoimmune diseases such as rheumatoid arthritis or systemic erythematosus lupus, and severe systemic immune disease
* Patients with infectious diseases or healing disorders that can interfere with the normal healing process after surgery
* Patients who received steroid epidural injections within 2 weeks from the date of screening or who took oral steroids within 24 hours
* Patients who participated in other clinical trials within 30 days from the date of screening
* Patients who are unable to take MRI scans
* Pregnant or lactating women
* Patients who are not eligible for clinical trials according to the investigator's judgement
* Patients with a history of hypersensitivity to the main and other components of the investigational device
* Patients who are scheduled to receive myelogram or lumbar puncture within 24 hours from the application of the investigational device
Family Functioning and Child Behavior When a Sibling is Critically Ill

The goal of this study is to determine if there is a correlation between an efficacious family environment and sibling behavior in families with children who are critically ill.

Families of critically ill children can face many emotional challenges during the course of a child's illness. While some research has looked at the impact on parents, there has been little focused on siblings. We want to better understand how social support may have a protective effect on siblings' quality of life. The goal of this study is to determine if there is a correlation between an efficacious family environment and sibling behavior in families with children who are critically ill. Our hypothesis is that a cohesive, emotionally rich and open family environment provides social support so that siblings can explore and express the difficult emotions that accompany illness, and is therefore a protective factor for a sibling's behavior.

Eligibility Criteria:
Inclusion Criteria:

* adult (age 18 and older) who has decision making authority for CHOP patient who has been referred to the Pediatric Advanced Care Team (PACT) for palliative care services, and with a child(ren) age 6-11 years who is a sibling of the patient
* any race/ethnicity

Exclusion Criteria:

* Non-English speaking
Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients

TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

Secondary Objectives :

1. To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system
2. To assess the improvement in diabetes care provided by the use of the PDA-FIT system
3. Satisfaction of patients and physicians towards the PDA-FIT system

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)
* age \> 18 y.o.
* intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
* chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion

Exclusion Criteria:

* patient with unstable associated evolutive pathology
* patient who need a more frequent diabetic follow up (than in the protocol)
* patient with a education teaching within the 3 months before inclusion
* patient with a hemoglobinopathy
* patient with toxicomania, alcoholism or psychological troubles
* type 2 diabetes patients
* patient who don't need strict metabolic objectives
* pregnant or parturient women
* person with no freedom (prisoner)