cyrilzakka/clinical-trials huggingface dataset:
Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer

Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB). It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over 30min weekly). The primary purpose is to evaluate objective response rate, complications, progression-free survival, overall survival. The second purpose is to evaluate quality of life and cost.


Eligibility Criteria:
Inclusion Criteria:

1. Inoperable stage IIIA/IIIB NSCLC proved by pathology or cytology
2. Age 18 to 75, ECOG ≤ 2, lose weight \<10% during 6 months
3. No serious diseases of important organs
4. Chest CT in recently 4 weeks
5. No other tumor disease except stage I cervical cancer or cutaneous basal cell carcinoma
6. Sign consent
7. Measurable lesion

Exclusion Criteria:

1. Pretreatment radiotherapy or chemotherapy
2. Pregnant or lactation woman
3. Serious diseases (include uncontrolled diabetes and infection) of important organs
4. Psychopath
5. Join in other clinical trial
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)

The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.

The drug being tested in this study is called soticlestat. Soticlestat is being tested to treat people with Dup 15q or CDD. This study will assess the effects of TAK-935 on seizure frequency, safety.

The study will enroll approximately 30 participants. Participants will be enrolled into 2 groups based on their diagnosis as: Dup 15q or CDD.

All participants will be asked to take soticlestat tablets twice daily with or without food.

The study comprises of 2 periods: Screening/Baseline Period and Treatment Period (Dose Optimization and Maintenance). The overall time to participate in this study is approximately 30 weeks, including 4 to 6 weeks Screening/Baseline Period, 20 weeks Treatment Period, 2 weeks Taper, and 2 weeks safety follow up period. Participants completing this study will have an option to enroll in the open-label extension (OLE) study, under a separate protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.
2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.

Exclusion Criteria:

1. Two or more episodes of convulsive status epilepticus per 3 months requiring hospitalization and intubation.
2. Currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month.
The Role of a Motion Sensor With Accompanying Web Application on Step Counts, Energy Balance, and Metabolic Markers in Nurses

The purpose of this prospective randomized controlled trial is to explore the role of a motion sensor with accompany web application on step counts, energy balance, and metabolic markers in nurses. Additionally, eating behaviours, behavioural regulation in exercise, and mood states that may impact these parameters will also be examined.


Eligibility Criteria:
Inclusion Criteria:

* 1. Participant must be a registered nurse with the University of Ottawa Heart Institute;

  2. Participant must be 18 years of age or older;

  3. Participant must be able to walk unassisted;

  4. Participant is able and willing to provide informed consent.

Exclusion Criteria:

1. Participant is pregnant, lactating or planning to become pregnant during the study period;
2. Participant is unable to read and understand English;
3. Medical contraindications to exercise;
4. Already using a motion sensor device to track physical activity. -
Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training

The purpose of this study is to evaluate the effectiveness of a neuromuscular training program in decreasing sport and recreational injuries and improving healthy outcomes in junior high school students (grades 7 to 9). The neuromuscular training program is implemented as a 15-minute warm-up at the beginning of the students' physical education classes over a three-month period. This study is a randomized controlled trial design, involving twelve schools over a three-year period. Upon enrolment into the study, schools are randomly assigned to the intervention (neuromuscular training) group, or the control group. The control group includes a standard-of practice warm-up consisting of aerobic components and static stretching.

A study athletic therapist visits the schools each week to assess and record information on any injuries sustained by study participants. Baseline health and physical fitness is measured at baseline, and again at 3-month follow-up in study participants to assess changes over the course of the program.


Eligibility Criteria:
Inclusion Criteria:

SCHOOLS

* junior high schools with a minimum of two physical education classes per week, per class
* physical education classes that are taught or co-taught by a physical education specialist

SUBJECTS

* students aged 11-15 who are fully participating in physical education curriculum at baseline
* students who return completed assent and parental consent forms

Exclusion Criteria:

SCHOOLS

* schools that are culturally distinct
* schools that have students that are of single sex
* schools that cater to students with special needs
* schools with incomplete grades

SUBJECTS

* history of musculoskeletal disorders or medical condition that prevents participation in regular physical education curriculum
* history of musculoskeletal injury within 6 weeks prior to study commencement that restricts full participation in physical education
* at least 80% of participation in physical education classes over the course of the study
Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

This study compares the effect of infusion of two types of modern hydroxyethyl starch on the renal function and acid-base in patients undergoing urologic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age group above 18 years,
* ASA І and ІІ,
* Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement

Exclusion Criteria:

* A known allergy to HES,
* Renal insufﬁciency (serum creatinine of \>2.5 mg/dL),
* Signiﬁcant hepatic disease (liver function tests more than three times the upper limit of normal),
* Coagulation disorders (INR \> 1.5).
Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda

Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound.

This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.

See above.

Eligibility Criteria:
Inclusion Criteria:

* age 1 to 10 years
* HIV-infected, meeting Ugandan criteria for antiretroviral therapy
* living within 30 km of Mbarara, Uganda

Exclusion Criteria:

* lack of mobile-phone reception
Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain

Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and oxygen is used in the emergency medical care of the trauma, burns, during transport of patient with pain. None randomized study has validated the use of premixed nitrous oxide and oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with out-of-hospital severe acute pain

The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower) 15 minutes after randomisation. Secondary endpoints are treatment safety and adverse events, time to analgesia and duration of analgesia. This study will expect 108 patients assigned in two parallel groups, defined by a randomization scheme. Four sites will participate to the research. Eligible patients with a numeric rating scale (NRS) score higher than 6/10 are randomly allocated to receive either MEOPA, or medical air. Neither the investigator nor the nurse knows the treatment. Pain score will be measured at baseline and every 5 minutes until pain relief will be obtained. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, and oxygen saturation by pulse oximetry (SpO2) and adverse events collection.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years old and over
* Severe acute pain (NRS score greater than 6)

Exclusion Criteria:

* Contraindication of premixed 50% nitrous oxide and oxygen
RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia

Men with infertility and normal hormone levels have few options for fertility treatment. Previous research suggests that men with infertility may have low levels of the active form of Vitamin A, called retinoic acid, in their testes. In a pilot study of 20 men with low numbers of sperm (\<10 million motile sperm), roughly half the men showed improvement in sperm production. Thus, we want to see if retinoic acid administration to men with azoospermia (no sperm present) can initiate sperm production.

Twenty men with infertility, aged 21 - 60, due to azoospermia (no apparent sperm in the ejaculate on two separate occasions) will be enrolled in a single-arm pilot trial of daily oral therapy of 20 mg twice daily of 13-cis retinoic acid for 32 weeks. The impact of treatment on the appearance of sperm in the ejaculate will be determined by monthly semen analyses.

Note: The outcome measure of serum and seminal plasma 13-cis-retinoic acid concentrations was entered in error and not intended to be reported for this study. Information on these levels is available in our earlier study of 13-cis-retinoic acid in men with sub-fertility. Amory et al. Andrology 2017 5:1115-1123.

Eligibility Criteria:
Inclusion Criteria: Infertile men with azoospermia on at least two semen analyses separated by at least one week, and no pregnancy with partner with normal cycles and normal hysterosalpingogram despite \>1 year of unprotected intercourse.

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Exclusion Criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin injections); use of anabolic steroids,illicit drugs, or consumption of more than 4 alcoholic beverages daily; current therapy with retinoic acid (eg Accutane) or vitamin A- of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication containing tetracycline; personal history of serious psychiatric disorders, score of greater than 15 on the PHQ9 (mood) questionnaire; elevated serum serum triglycerides or other abnormal serum chemistry values; history of inflammatory bowel disease or bone disease; not living within catchment area; participation in another clinical trial

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Validation of Laser Doppler Flowmetry to Identify Allergic Rhinitis Patients With Pharmacogenetic Alterations in Histamine Metabolism

The hypothesis to be proven is that histamine iontophoresis with measurement of microvascular blood flow by laser Doppler flowmetry can be used as a reliable marker to characterize the normal microvascular cutaneous response to histamine.

The specific aim of this study is to validate iontophoresis (with measurement of microvascular blood flow by laser Doppler flowmetry) in a pediatric cohort as a surrogate marker capable of reliably characterizing the normal physiologic response of the cutaneous microvasculature to histamine. In future studies laser Doppler flowmetry ultimately will be used to assess whether microvascular blood flow determined by a previously validated laser Doppler technique can be used as a reliable surrogate endpoint capable of functionally discriminating the effects of polymorphisms in the genes which are quantitatively important for histamine metabolism. The hypothesis to be proven is that histamine iontophoresis with measurement of microvascular blood flow by laser Doppler flowmetry can be used as a reliable marker to characterize the normal microvascular cutaneous response to histamine.

Eligibility Criteria:
Inclusion Criteria:

-Established diagnosis of allergic rhinitis and/or allergic conjunctivitis, and/or allergic asthma either clinically (by presence of rhinitis and/or conjunctivitis with or without associated wheezing) and/or with a positive RAST/skin test to the following allergens: trees, grass, weeds, molds, cat, dog, dust mites and/or cockroach)

Exclusion Criteria:

* Previous history or laboratory evidence of McCune Albright syndrome, immunodeficiency, mastocytosis, receipt of immunomodulatory treatment, chronic conditions associated with abnormalities of the integument, hepatic or renal compromise, neoplastic disease, movement or neurologic disorders and uncontrolled ADHD
* Active atopic dermatitis at the site of the skin prick test or site where histamine iontophoresis will be performed, i.e. active atopic dermatitis on anterior forearms
* History of anaphylaxis or anaphylactic like episode
* Evidence of pregnancy (by urinary hCG) or lactation
* Use of drugs (within a specified time period) of agents capable of altering the response to histamine provocation (e.g., antihistamines, systemic corticosteroids, tricyclic antidepressants)
* Presence of any condition that, in the opinion of the investigator, would produce difficulty with adherence to study procedures.
Application of 3D Printing Guide Plate in Percutaneous Disc Decompression

Application of 3D printing guide plate in percutaneous disc decompression

This study applies 3D-printed customized guide plate in assisting the accurate puncture in percutaneous disc decompression, in patients with low back pain, lumbosacral radicular pain, disogenic pain, lumbar disc herniation, disc degeneration, etc. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.

This study involved diseases such as lumbar disc herniation (LDH), disc degeneration, etc. Percutaneous disc decompression surgeries are effective treatments for these disease. Needle Puncture is the key technology in percutaneous disc decompression surgeries.

In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem could be well solved by applying the 3D printing guide plate.

The key processes for the 3D printing guide plate procedure: the model of the spine or bone is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT or evoked pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Pain lasting ≥12 weeks;
3. The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications;
4. Pain intensity≥4 out of 10 on the numerical rating scale (NRS);
5. Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features;
6. Agree with percutaneous disc decompression.

Exclusion Criteria:

1. Patient refusal to participate in the study;
2. Pregnant or nursing;
3. Allergies to local anesthetics, contrast dyes or steroids;
4. Significant anatomic deformity (either congenital or acquired) making it difficult to access the target as evidenced by computed tomography/magnetic resonance imaging;
5. Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment;
6. Systemic infection;
7. Injection site infection;
8. Unstable medical or psychiatric condition;
9. Unable to tolerate the surgeries.
Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who provide signed and dated written informed consent
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Subjects who have no known hypersensitivity to any component of Neulasta or MSB11455, and laboratory test results within predefined ranges
* Other protocol defined exclusion criteria could apply.
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females

The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects.


Eligibility Criteria:
INCLUSION CRITERIA

1. Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg.
3. Healthy as determined by the investigator on the basis of screening evaluation.

EXCLUSION CRITERIA

1. Any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
3. Use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs (OPTIMA)

This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.

The study objectives will be accomplished in a prospective, multicenter observational, longitudinal cohort study that includes 100-150 Pediatric Heart Transplant (PHT) patients from the United States. Patients will be screened for eligibility and enrolled \~1 month after PHT. Study participation will last 24 months.

All patients will follow the center's standard of care surveillance schedule after transplant. Blood samples will be collected for miR evaluation at:

1. specified time intervals after transplant and
2. when a clinical event of interest occurs, including rejection, infection, or major change in immunosuppression.

Research samples will be collected and used to evaluate microRNA expression as well as other biomarkers related to heart transplantation and immunosuppression medications. Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)/donor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB), echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing.

This work will form the basis for a non-invasive, genomic blood test that can be used to monitor patients after heart transplant to mitigate complications of over-immunosuppression, such as infection, without increasing the risks of under-immunosuppression, such as rejection.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 18 years at enrollment
* Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
* Planned follow-up at the transplant center for a minimum of one-year.
* Caregiver able and willing to comply with the study visit schedule, study procedures, and study requirements.

Exclusion Criteria:

* Recipient of a multi-organ transplant
* History of prior solid organ transplant before the index heart transplant
* Ongoing mechanical circulatory support or hemodynamic instability
* Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
* History of rejection prior to enrollment
* Inability to collect specified blood volume at enrollment +/- 1 week
Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study)

CORONA is a retrospective, observational, one center study to investigate the clinical evolution (in terms of survival and thromboembolic complications) of patients on chronic treatment with anticoagulants or antiplatelet agents who are admitted to the hospital for COVID-19 compared with patients who do not receive anticoagulants or antiplatelet agents.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted for COVID-19 at the Hospital de la Santa Creu i Sant Pau,
* Positive COVID-19 polymerase chain reaction test
* Length of stay more than 24 hours

Exclusion Criteria:

* No objective diagnose for COVID-19
* Outpatient
* Lenght of stay less than 24hours