cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection

This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children, less than (\<) 13 years of age, with confirmed influenza infection. Participants will be randomized to receive either the standard dose or triple dose of oseltamivir orally daily for a minimum of 5 days and up to 20 days. Infants \<1 year of age will be randomized to the standard dose arm only.


Eligibility Criteria:
Inclusion Criteria:

* Male or female children, \<13 years of age
* Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
* Immunocompromised
* Symptoms/signs suggestive of influenza like illness (ILI)
* Less than or equal to (\</=) 96 hours between onset of ILI and first dose of study drug

Exclusion Criteria:

* Clinical evidence of severe hepatic impairment
* Infants with post-menstrual age (PMA) \<36 weeks
* Clinical evidence of significant renal impairment
* Allergy to oseltamivir or excipients
* Hereditary fructose intolerance
* Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization
UPLC-MS/MS Monitoring of Emicizumab Therapy

Emicizumab is a monoclonal bispecific antibody with a terminal half-life of 28 days which is now licensed in the treatment of severe haemophilia A with or without inhibitors. Some heterogeneity in residual emicizumab concentrations have been reported according to age, body mass index or drug therapeutic regimen. Some cases of neutralizing antidrug antibodies have been also reported. Whether monitoring emicizumab plasma concentration could predict the residual bleeding risk under emicizumab is unknown. As conventional coagulation assays are not adapted for emicizumab monitoring, this study aims to assess the value of monitoring residual emicizumab plasma concentration by UPLC-MS/MS in bleeding risk prediction.


Eligibility Criteria:
Inclusion Criteria:

* Adult or child with Clinical diagnosis of severe hemophilia A (FVIII activity \< 1%) with or without inhibitor
* Clinical indication to emicizumab therapy

Exclusion Criteria:

* Refusal to give informed consent
* acquired hemophilia A
* other inherited or acquired bleeding disorder
* bodyweight \< 10 kgs
Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting

This prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8 months.


Eligibility Criteria:
Inclusion Criteria:

1. Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation:

   * As treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
   * As treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with chemotherapy
2. At least 4 treatment cycles with MabThera is planned
3. Patients \>/= 18 years at inclusion
4. Patients written informed consent
5. Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study

Exclusion Criteria:

1. Contraindications according to SPC for MabThera SC formulation:

   * Hypersensitivity for the active substance or murine antibodies, hyaluronidase or any other excipients
   * Active and severe infections
   * Patients with severe immunsuppression
2. Patient included in clinical trials with experimental pharmaceuticals
3. Pregnancy
Protein Blends (Soy, Whey and Casein) for Muscle Synthesis

Soy protein is a high quality, plant-based protein that is comparable to milk, meat and eggs. Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein (slow). This intermediate rate may allow soy protein to have an extended window of muscle protein synthesis that has not been monitored in previous studies. While most of the sports nutrition "recovery" products are dairy-based protein blends (high in branched-chain amino acids), soy protein offers additional benefits that can make an important contribution to these types of sports nutrition products. Soy protein contains approximately 300% more arginine and 30% more glutamine compared to whey protein and these two amino acids may bring additional benefits (immunity and hydration, respectively) to athletes. A "blend" of high-quality proteins (soy and dairy) may be the optimal sports nutrition product for athletes to consume following training.


Eligibility Criteria:
Inclusion:

1. Age 18-35 yrs
2. Stable body weight for at least 1 year

Exclusion criteria will be:

1. Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
2. Significant heart, liver, kidney, blood, or respiratory disease
3. Peripheral vascular disease
4. Diabetes mellitus or other untreated endocrine disease
5. Active cancer (all groups) and history of cancer (groups potentially randomizable to rapamycin)
6. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
7. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
8. Alcohol or drug abuse
9. Tobacco use (smoking or chewing)
10. Malnutrition (BMI \< 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)
11. Obesity (BMI \> 30 kg/m2)
12. Low hemoglobin levels (below normal values)
13. Food allergies
14. Taking dietary supplements such as green tea, etc.
15. Currently on a high-soy diet (consuming \>2 servings of soy per day)
Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device

A total of 40 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.


Eligibility Criteria:
Inclusion Criteria:

patients taking class I and class III antiarrhythmic drugs could not prevent atrial fibrillation, patients younger than 80 years old Cha2ds2-vasc score ≥2 and Has-bled score ≥3, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria:

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.
Comparative Efficacy of Escitalopram Monotherapy and Escitalopram in Adjuvant With Pizotifen in Depressive Disorder

To compare the efficacy of escitalopram monotherapy and combination with pizotifen in patients of major depressive disorder(MDD).The levels of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) at base level and during follow-up.

This is an open-label study assessing the comparative efficacy of escitalopram monotherapy and combination with pizotifen in patients of major depressive disorder efficacy of antidepressants in combination therapy. The plan is to enroll 84 patients with depression based on the Patient Health Questionnaire (PHQ-9) score of 9 and above is a valid and reliable Structured Clinical Interview. The investigators will collect data from the enrolled patient populations. The participants will be able to receive their results, on request, upon completion of the study. The investigators hypothesize that depressive symptoms can be improved by the addition of the above-mentioned drug with antidepressant medication.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients of Depressive Disorder (PHQ-9).6
* Males and female patients from age 14-70 years.
* The same drug brand will be used throughout the study period.

Exclusion Criteria:

* Schizophrenia, bipolar disease, active delirium, dementia.
* Pregnant and lactating females.
* History of renal and hepatic disease, myasthenia gravis, gastrointestinal (GI) disease, asthma, cardiovascular disease, and Diabetes Mellitus.
* Mentally handicapped or terminally ill patients.
* Age less than 14 years or above 70 years.
* Patients already taking multiple nutritional supplements.
* Patients taking medications known to interact with the drugs in this study.
Exercising With Computers in Later Life

This is a pilot study to assess whether balance training with the Nintendo® Wii is comparable to a physiotherapist-led falls group in terms of improvement in balance. The acceptability of the Nintendo® Wii will also be assessed.

The population is ageing and as a result medical staff and allied health professionals are likely to see an increase in the number of patients with falls. Community dwelling individuals over 65 fall at a rate of 30% per year. This risk increases with advancing age. Falls have significant consequences for both the individual and the population as a whole. Falls risk increases with age due to increased body sway, a reduction in reaction times, deterioration in the efficiency of the walking pattern and diminished balance.

People who fall should be referred for multidisciplinary falls assessment. Locally, patients are assessed by the multidisciplinary team and, if appropriate, attend falls group. This group consists of a 12 week exercise program to improve balance and muscle strength (patients attend the group up to 3 times weekly). Previously trials have shown variable compliance with exercise programs but locally compliance is felt to be good. Falls groups aim to reduce falls through the benefits of exercise; improvement in muscle strength,balance, general fitness and well being. It has been shown that exercise has statistically significant beneficial effects on balance.

Due to advances in technology, equipment has been produced to improve balance on both the medical and commercial market. There is a large variability in cost between this equipment with commercial prices being much lower. The Wii has been very successful in encouraging sedentary youths to partake in exercise (all be it in a limited form). WiiFit is a specifically designed "game" for the Wii to improve balance with an element of entertainment value.

This project is important due the large number of falls that occur in the community and the significant impact this has on an under resourced NHS. It is timely because the WiiFit has only just been introduced into the market. Through the use of a Wii, balance training may be more enjoyable and as a result elderly community dwellers may be more likely to participate in exercise programmes. The Wii is considerably cheaper than the medical alternatives and if an improvement can be shown in post-intervention balance assessments, then we have to consider whether the use of similar equipment should be instituted in falls groups.

Eligibility Criteria:
Inclusion Criteria:

* age 70 years or older
* living locally in the community (in either sheltered accommodation or own home
* fallen at least once in the preceding 12 months
* abbreviated mental test (AMT) of seven or over

Exclusion Criteria:

* wheelchair bound
* people living in a care home or long-term hospital care.
Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.


Eligibility Criteria:
Inclusion Criteria:

* Unexplained cytopenia for at least 6 months. Cytopenia is defined as the presence of ≥1 blood count indexes below the following thresholds:

  * Hgb \<10 g/dL
  * ANC \<1.8 × 109/L
  * Platelets \<100 × 109/L
* IDH2 gene mutation (R140 or R172), performed locally, at a frequency ≥ 2%.
* At least 18 years of age.
* ECOG performance status 0-2
* Adequate organ function as defined below:

  * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  * Serum total bilirubin \< 1.5 x IULN (un upper limit of bilirubin 5 mg/dL is acceptable if it can be attributed to Gilbert's syndrome or erythropoiesis)
  * Creatinine clearance \> 50 mL/min by Cockcroft-Gault glomerular filtration rate estimation or serum creatinine ≤ 2 x IULN
* The effects of enasidenib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 24 months after the last dose of enasidenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and for 4 months after the last dose of enasidenib.
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

* Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.

  * Evidence of disease progression from time of bone marrow biopsy to enrollment based on investigator review of symptoms and complete blood counts
* Active malignancy (defined as \> 1 cm disease on most recent CT scan in the past 6 months).
* Currently receiving therapy for solid tumor malignancy or received within the last 6 months.
* Currently receiving any other investigational agents.
* Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to enasidenib or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 72 hours of study entry.
* Positive direct Coombs test.
Holding, Stress, and Bonding During Therapeutic Hypothermia

Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period. This is a safety study that will assess whether or not there is an increase in adverse event frequency in infants that are held during hypothermia. Parents and NICU nurses will be given a questionnaire after holding is complete investigating their feelings on maternal-infant bonding and safety of the holding protocol.


Eligibility Criteria:
Inclusion Criteria:

* Infant must have a gestational age of greater than or equal to 35 weeks
* Infant must be undergoing treatment with therapeutic hypothermia
* Infant must be without seizures in the first 24 hours of treatment based on EEG
* Infant must be clinically stable on bubble CPAP, nasal cannula, or no respiratory support.
* Informed consent must be signed by the mother at Maine Medical Center

Exclusion Criteria:

* Infant is intubated
* Infant is being treated with inhaled nitric oxide
* Presence of Persistent Pulmonary Hypertension of the Newborn
* Presence of seizure on EEG
* Use of vasopressors or paralytic agents
* Presence of chest tubes, wound vacuums, or drains
* Neonatal abstinence syndrome
Effectiveness of Tai Chi Training on Metabolic Syndrome

Metabolic syndrome (MetS) is a serious public health problem in Hong Kong and worldwide. Older adults, the age group with the highest prevalence of MetS, may prefer specific exercise modalities that are suitable for their regular participation to manage MetS. This project aims to evaluate the effectiveness of Tai Chi, a very suitable exercise for older adults, to alleviate MetS in older population

PURPOSE/OBJECTIVE: Metabolic syndrome (MetS) is a serious public health problem in Hong Kong and worldwide. Older adults, the age by specific exercise modalities that are suitable for regular participation. This project aims to evaluate the effectiveness of Tai Chi to alleviate MetS in older population.

DESIGN \& METHODS: This study is a three-arm assesscer blinded randomized controlled trial. Older adults aged 50 years or above with abdominal obesity will be randomly assigned to passive control, active control and Tai Chi groups. Subjects assigned to Tai Chi and active control groups will receive a 12-week intervention of Tai Chi and generic fitness, respectively. No intervention will be given to the passive control group. Outcome measures including waist circumference, blood pressure, blood glucose, triglyceride and high density lipoprotein-cholesterol will be assessed at baseline, post-intervention and follow-up (6 months after the end of intervention) assessments in all groups.

HYPOTHESES: We hypothesize that: 1) improvements of waist circumference and other indicators of MetS are found in Tai Chi group but not in passive control group and 2) improvements of waist circumference and other indicators of MetS are more profound in Tai Chi group than active control group.

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Chinese
* Abdominal Obese: Meeting the defined criteria of International Diabetes Federation (IDF) and National Cholesterol Education Program (NCEP) for abdominal obesity using Asian-specific cut off (waist circumference ≥ 90 cm for male; ≥ 80 cm for female)

Exclusion Criteria:

* Regularly practice moderate-intensity exercise or tai chi (\>3 times a week of \>30-min/ session)
* Serious medical and somatic condition that prevent participation in generic fitness/Tai Chi exercise
* Serious chronic diseases known to affect mobility (eg. Neurological diseases, musculoskeletal disorder and autoimmune diseases)
* Under treatment for serious chronic diseases (eg. Cancer treatment)
VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years

This is a retrospective study to analyze the therapeutic results and clinical evolution all patients diagnosed with AML and aged ≥ 60años or not candidates for chemotherapy intensive, treated according to the different schemes available, including supportive care or palliative.

Approximately in 6 months, collect and review the retrospective data.

During this period, and in order to ensure an excellent quality of the collected data, perform constant monitoring and real-time data received in 2 phases:

1. Monitoring "in situ" in the focal point: once the information is received before shall enter in the database, will be reviewed each case report data (CRD) for screening for inconsistencies and issue unresolved issues (queries) to sender data center. After entering the information in the database is carry out and resolve those queries that have arisen after consultation Data tables in order to locate inconsistencies or unavailable fields.
2. Telephone Monitoring: data shall be verified through telephone consultations all centers to verify and update recruitment and monitoring patients . To ensure the completion, accuracy and data quality is monitored by telephone at least 30% of registered patients.

   * Final statistical analysis (approximately 8 months from baseline).
   * Publication of results.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥60 years, diagnosed of AML or not candidates to intensive chemotherapy

Exclusion Criteria:

* No exclusion criteria
S-1-induced Lacrimal Drainage Obstruction

S-1 is an effective drug in gastric cancer (GC) for palliative chemotherapy in Eastern and Western patients. Recently, S-1 has been also reported to be an effective adjuvant therapy for GC patients who received D2 surgery in Eastern Asian patients.

Recently, the development of lacrimal drainage obstruction (LDO) caused by S-1 has been reported from some case and small-sized studies. The incidence of developing LDO has been estimated to about 15\~20% of patients receiving S-1 therapy in some retrospective studies. However, there is no prospective report on the incidence of LDO in patients receiving S-1 chemotherapy. Moreover, the mechanism of developing S-1-induced LDO has not been systemically studied until now. Suggested mechanism of LDO involves direct secretion of S-1 into the tear.

Therefore, this study was initiated to prospectively investigate the incidence of LDO in GC patients receiving adjuvant S-1 chemotherapy. In addition, the correlation between the development of LDO and the concentration of S-1 (or its metabolites) in tear and plasma will be explored. These results will help clinicians identify patients who are at high risk of developing S-1-associated LDO.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received curative (R0) surgery for GC
* Patients receiving adjuvant S-1 chemotherapy
* Patients with adequate major organ functions for chemotherapy
* Patient who have taken S-1 at least 7 days (for blood and tear sampling)

Exclusion Criteria:

* Patients who are not candidate for adjuvant S-1 chemotherapy
* Patients with previous history of LDO
* Patients with other opthalmologic disease who are not appropriate to be included in this study (i.e., patients using eyedrop medication; patients with dry eye whose tears cannot be sampled)
Immersive Technology to Improve Physical Therapy Engagement

This is an experimental study to evaluate the efficacy of a Virtual Reality aid Physical Therapy (VRPT) in increasing the physical activity levels and quality of life of children.


Eligibility Criteria:
Inclusion Criteria:

* Between age 7-25
* has an active physical therapy consultation
* Anticipated inpatient stay for more than 2 days

Exclusion Criteria:

* Legal guardian not present to obtain consent
* child with a significant neurological condition, or major developmental disability
* child with active infection of the face or hand
* a history of severe motion sickness
* a history of seizures cause by flashing light
* Major surgery within the last 48 hours