cyrilzakka/clinical-trials huggingface dataset:
Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD

The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.


Eligibility Criteria:
Inclusion Criteria:

* ( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopoietic stem cell transplantation.

( 2 ) older than or equal to 18 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. The informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent will be signed by the legal guardian or the patient 's immediate family.

Exclusion Criteria:

* • (1) diagnosed as VOD/SOS.

  * (2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment;
  * (3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 xthe upper limit of normal (ULN) or serum total bilirubin \> 2.5 x ULN.
  * (4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.
  * (5) has both moderate hepatic insufficiency AND moderate renal insufficiency;
  * (6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments;
  * (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).
  * (8) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring;
  * (9) unable or unwilling to sign the consent form;
  * (10) patients with other special conditions assessed as unqualified by the investigator
Study of T-PRED(TM) Compared to Pred Forte(R)

Study of T-PRED(TM) compared to Pred Forte(R)


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age

Exclusion Criteria:

* No active or adverse disease
Bioequivalence Study for Terbinafine 250 mg

The objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent.

Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product Lamisil® 250 mg (Novartis). One tablet was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 30 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria: Males 18-50 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent. -

Exclusion Criteria:

Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.

Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation =\>450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.

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Physiological Abnormalities Associated with Down Syndrome

The overall goal of this study is to evaluate biomarkers of oxidative stress, mitochondrial function, and DNA methylation (epigenetics) in order to determine the extent to which these biomarkers are related to cognitive, behavioral and adaptive function in Down Syndrome. The inter-relationship between measurable biomarkers and functional/cognitive abilities will move beyond genetics to provide unprecedented new knowledge and a broader understanding of the underlying pathophysiology and abnormal gene expression induced by trisomy 21.

The Investigators preliminary evidence indicates that people with DS have metabolic biomarkers associated with oxidative stress (GSH/GSSG) and reduced methylation capacity (SAM/SAH) as well as abnormal DNA methylation (epigenetics). The investigative team hypothesize that these abnormal metabolic processes contribute to abnormalities in behavior and development associated with trisomy 21; this connection has never been investigated. Confirming and expanding on the preliminary data would provide new understanding of the biological and functional etiology of the behavioral and developmental delays associated with Trisomy 21. Further, establishing the underlying relationship between metabolic abnormalities and behavioral/cognitive function over the age spectrum can provide strong support for the design of future treatments of individuals with DS aimed at improving their behavior and development. In addition, these biomarkers may also prove to be predictive biomarkers for the risk of developing ASD like behaviors or Alzheimer's disease in this population. Finally, examining the modulating role of diet in the severity of biological abnormalities will provide new information for lifestyle guidance to improve biomarkers and potentially minimize the medical co-morbidities associated with trisomy 21.

Eligibility Criteria:
Inclusion Criteria:

1. Participant or guardian ability to consent/assent and willing to comply with protocol requirements

Exclusion Criteria:

1. Trisomy translocation or mosaics.
2. Untreated hypothyroidism
3. Known history of liver disease, renal disease, Hepatitis B or C or HIV
4. Recent infection with fever or requiring hospitalization within past 30 days.
5. Any medical condition, use of medications, nutrient or herbal supplements that would interfere with the study results as determined by the PI
6. Chemotherapy
7. Recent surgery (within 2 months)
8. Untreated Epilepsy
9. Any chronic medical/behavioral condition and/or treatments that may interfere with study related outcomes, as determined by PI
10. Dementia
11. History of a significant adverse reaction to a prior blood draw
12. Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation.
Walking Aids in the Management of Hip Osteoarthritis

The purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis.

Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Non-pharmacological treatments for hip OA include education, exercise, appliances (walking sticks or insoles), and weight reduction if obese or overweight. Canes are often recommended to reduce adverse forces across joints although there is currently no research evidence regarding the efficacy of walking sticks for hip OA. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with hip OA. This study will evaluate the effects of walking aids in hip OA by examining gait biomechanics, quality of life, pain, and opinions regarding using a cane.

Comparisons: Compare gait biomechanics in people with symptomatic unilateral hip OA while walking with and without a cane at baseline and after 4 weeks of cane use. Compare gait biomechanics in people with symptomatic unilateral hip OA with and without a cane to those of healthy, age-matched controls. Compare pain and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use. Determine the association between changes in gait biomechanics, pain, and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use.

Eligibility Criteria:
Inclusion Criteria:

1. hip OA (grades II-IV) of the Kellgren/Lawrence classification
2. with pain in one hip for most days of the prior month
3. Ability to walk 30 feet without postural sway
4. Ability to stand unaided
5. Ability to understand verbal instructions
6. Ability to give informed consent

Exclusion Criteria:

1. History of hip or knee trauma or surgery including arthroscopic surgery in the past six months
2. Severe obesity (\> 300 pounds)
3. Neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision
4. Injury or amputation to the lower extremity joints
5. History of other types of arthritis or fibromyalgia
6. Pain from spine, knee, ankle, or foot disease that would interfere with assessment of the hip
7. Poor health that would impair compliance or assessment such as shortness of breath with exertion, chest pain
8. Foot deformities such as hallux rigidus, valgus deformity of the midfoot, previous ankle arthrodesis
9. Greater trochanteric pain syndrome
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan

The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.

The objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with Familial Hypercholesterolemia (Heterozygous or Homozygous) and Hypercholesterolemia in Japan

Eligibility Criteria:
Inclusion Criteria:

* Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia (Heterozygous or Homozygous and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to HMGCoA reductase inhibitor (statin) for hypercholesterolemia).

Exclusion Criteria:

* No exclusion criteria are applied.
Effect of Biofeedback on Postoperative Pain

This study is a multi-center, randomized, controlled, double-blinded, and parallel design study. A total of 106 patients were decided to be recruited considering a 10% dropout rate. Patients are randomizes to perform or not respiratory exercises using biofeedback device(ResCalm). The randomization numbers are generated using a computer-generated randomization code and are sealed in the opaque envelope until they are handed over to anesthesiologist in charge of patient management. Record patient preoperative t anxiety, postoperative pain, and pain medication use. Patient aged 19-64 yr, ASA class 1 or 2, and are scheduled for elective laparoscopic cholecystectomy are included. Patients who were unable to perform self breathing at regular intervals were excluded.

1. Assignment of experimental groups

   Group A: Respiratory exercise using respiratory biofeedback device(ResCalm) is applied 2-3 times / day for 3 minutes until discharge from hospital and once in the recovery room before surgery.

   Group B: General surgery schedule without control exercise.

   All patients measure STAI(state trait anxiety inventory) at the operating room entrance on the day of surgery.
2. anesthesia methods Intravenous anesthesia is performed using the target injection concentration control method. As an anesthetic, propofol / remifentanil / rocuronium is used. The artificial ventilation method is a pressure-controlled ventilation method, which maintains an appropriate pressure and performs anesthesia.
3. postoperative care After anesthesia, the patient wakes up and transfers to the recovery room to encourage self-breathing exercise. After entering the recovery room, the patient's vital signs (average blood pressure, heart rate, oxygen saturation) and analgesic use are checked immediately before leaving.

The investigators check for the presence of pulmonary complications, visual analog scale (VAS), analgesic use, and hospital patient satisfaction for 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged between 19 and 64 years of age with ASA class I, II who underwent regular laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria:

* Seniors 65 years of age or older or minors under 19 years of age
* ASA (American Society of Anesthesiologists) class ≥ III
* Difficulties in proper cooperation with diseases such as Alzheimer dementia, cognitive disorders, and psychopathy
* Patients with respiratory diseases such as Asthma, Pnuemonia
* Patients with incomplete airway due to pulmonary resection, airway surgery, mouth or nose surgery
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit.

Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit.

The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

Cervarix or Control \[Al(OH)3\] has been administered in the primary study NCT00294047.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the subject prior to enrolment.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A subject previously enrolled in the study NCT00294047 and who fulfils either of the following criteria:

  * displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding NCT00294047 study visit
  * was pregnant so that no cervical sample could be collected at her concluding NCT00294047 study visit

Exclusion Criteria:

* A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
* A subject who at the NCT00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her NCT00294047 exit colposcopy.
* A subject for whom the cervical cytology results from the concluding NCT00294047 study visit were unavailable for reasons other than pregnancy.
Oxytocin Receptor Expression in Pregnancy

This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor.

In this descriptive study, we will obtain myometrial tissue samples by core needle biopsy under ultrasound guidance in anesthetized women immediately following surgical abortion and from controls, all of whom are undergoing a separate planned obstetric/gynecologic surgery. Tissue studies will be performed on these biopsy samples to examine oxytocin receptor expression and function.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18-50
* Gestational age 14-26 weeks; or 6-13 weeks, 37-42 weeks, or non-pregnant (controls)
* Undergoing another planned surgical procedure with anesthesia (suction D\&C, D\&E, gravid hysterectomy, cesarean section, or laparoscopic tubal ligation)
* Able to give informed consent in English or Spanish

Exclusion Criteria:

To optimize biopsy safety, we will exclude patients with anticipated difficult cases, that have additional risks of hemorrhage, or those with features that limit ultrasound visualization.

Increased risk of hemorrhage:

* Anemia (Hgb \< 9)
* Anticoagulation, bleeding disorder, or coagulopathy
* Multiple gestation
* Infection or sepsis

For ultrasound-guided procedures:

* Obese, BMI ≥ 40
* History of ≥2 cesarean sections
* Large fibroids or uterine anomalies obstructing view
* Other poor visualization
* Thin myometrium \< 1cm
User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

30 Veterans who are full-time wheelchair users will use personalized modular cushions for two weeks each. Personalized cushions will be created using a cushion fitting process the investigators have already developed and tested. Microenvironmental conditions will be monitored during use. A cost analysis will ensure the customized modular cushion applies value-driven principles. User satisfaction will be measured along with the effects on daily function, skin status and seated tissue health.

A repeated measures clinical study design will be carried out with 30 Veterans. 'Pre-baseline' seated interface pressures will be assessed with study participants sitting on their own cushions and pelvic region skin checks carried out by the study Research Nurse. All participants will then receive customized modular cushions. Participants will be randomly assigned to Group A or Group B using a modified randomization scheme. Group A participants will first use a gel ball fitted cushion for 2 weeks during all daily living activities while seated in their wheelchair followed by use of a SquishINS fitted cushion for 2 weeks. Group B will first use the SquishINS fitted cushion then a gel ball fitted cushion. Seated interface pressure distribution will be obtained at the beginning and end of each test period. A dual temperature and humidity sensor placed in the cushion will enable continuous monitoring of microenvironmental status during use. The study Research Nurse will repeat the pelvic region skin check and participants will complete a questionnaire based on the QUEST 2.0 user satisfaction instrument. All responses will be documented as part of the QS/DC program.

Eligibility Criteria:
Inclusion Criteria:

* Veterans with mobility impairments requiring full time use of a power or manual wheelchair who are served through the LSCDVAMC Wheeled Mobility Clinic.

Exclusion Criteria:

* Pregnancy
* Inability to remain seated in the wheelchair for more than 4 hours/day
mHealth Intervention to Prevent Type 2 Diabetes Mellitus (Phase II Study)

The aim of this study is to develop and evaluate a low intensity, multifaceted, digital health intervention to prevent T2DM based on: i) the use of a system comprising mobile health (mHealth) technology integrated with electronic health records to send tailored text messages (SMSs) promoting lifestyle changes in people at risk of T2DM, and, ii) the provision of online education to primary healthcare workers about prediabetes management.

The PREDIABETEXT project will involve five WorkPackages (WP). In WP1-4 we will develop and pilot-test the different components of the intervention (WP1 will develop the brief text messages targeted to patients; WP2 will adapt our existing technology system to deliver the messages; WP3 will develop an educational intervention targeted to Primary Healthcare workers, and; WP4 will pilot-test and optimise both interventions). In WP5 we will conduct a phase II, six-month, three-arm, cluster randomised, clinical trial with 42 primary care workers and 420 patients at risk of T2DM (HbA1c from 6% to 6.4% or fasting plasma glucose 110-125mg/dl, or both) registered in Primary Care centres from Mallorca. Patients will be allocated to a control (usual care) group, intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare workers). The primary outcome will be HbA1c. Secondary outcomes will include additional clinical outcomes, and physiological, behavioural and psychological outcomes.

Eligibility Criteria:
ELIGIBILITY CRITERIA FOR PRIMARY HEALTHCARE WORKERS:

We will include physicians and nurses from primary care centres in Mallorca. We will exclude those anticipating moving to a different centre during the study period.

ELIGIBILITY CRITERIA FOR PATIENTS:

Inclusion Criteria:

* Registered in the Public Health Service of the Balearic Islands
* At risk of T2DM (HbA1c from 6% to 6.4% within the last 3 months or two consecutive values of fasting plasma glucose 110-125mg/dl within the last 12 months, or both)
* With access to a mobile device able to receive text messages.

Exclusion Criteria:

* People not able to read messages in Spanish
* Patients with severe mental conditions.
* Patients on an antidiabetic medication regime
* Pregnancy: currently or during the previous 12 months
* People planning to change healthcare centre during the intervention period
Safety and Efficacy of the Ultimaster Stent

Durable polymer was considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. Ultimaster stent (Ultimaster, Terumo Corporation, Tokyo, Japan) are thin strut, silorimus-eluting, biodegradable copolymer to completely degrade over 3-4 months.

Drug-eluting stents (DES) significantly improved outcome compared wiht bare-metal stents because of slow-elution of the antiproliferative drug mixed with a polymer coated on the stent surface. However, the polymers used in the first-generation DES were considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. One strategy to mitigate this problem is a biodegradable polymer, which dissolves over time and leaves only the metalic struts behind. Ultimaster stent are silorimus-eluting, biodegradable poly DL-lactide-co-caprolactone copolymer (PDLLA+PCL) to completely degrade over 3-4 months and is also made of 80μm thin strut. The aim of the current study is to investigate the efficacy and safety outcomes in patients treated with ultimaster stents in real-world.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19 or older
2. Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction, ST-elevation myocardial infarction)
3. No restrictions on the number of blood vessels, number of lesions, and length of lesions
4. Those who voluntarily gave written consent to participate in this clinical study

Exclusion Criteria:

1. Life expectancy within 1 year
2. Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor
3. If other researchers judge that it is inappropriate to participate in this study