cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)

This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (\>=70 mg/m\^2).
* Subject has a Karnofsky performance score of \>=60.
* Subject has a predicted life expectancy of \>=3 months.
* Subject has adequate bone marrow, kidney, and liver function as evidenced by:

  * Absolute neutrophil count \>=1,500/mm3 and white blood cell count \>=3,000/mm3.
  * Platelet count \>=100,000/mm3.
  * Aspartate aminotransferase (AST) \<=2.5 x upper limit of normal (ULN) range.
  * Alanine aminotransferase (ALT) \<=2.5 x ULN.
  * Bilirubin \<=1.5 x ULN, except for subjects with Gilbert's syndrome.
  * Creatinine \<=1.5 x ULN.
* Subject is able to read, understand, and complete the questionnaires.

Exclusion Criteria:

* Any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
* Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.
* Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6.
* Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion.
* Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
* Subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.
A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic.
* In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate.
* Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Adequate organ function, including hematologic, hepatic, and renal.
* Estimated life expectancy of ≥12 weeks.

Exclusion Criteria:

* Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively.
* Have serious preexisting medical conditions.
* Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea.
* Have an active bacterial, fungal, and/or known viral infection.
* Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Male/female from 16 to 65 years
* Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
* History of partial onset seizures
* Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
* Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

* Seizure type IA non-motor as only seizure type
* Seizures occurring only in clusters
* Status epilepticus during the last 2 years before Visit 1
* History of cerebrovascular accident (CVA)
* Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Determination of SpO2 and PR Accuracy Specifications At Rest (71Ag_Vital-0031)

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest

This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study
Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints

The aim of this study is to assess the effect of a simple intervention (a combination of education and feedback) on Antinuclear Antibody (ANA) testing.

This aim was chosen because of the known overuse of many laboratory tests, of which ANA testing is one. As overuse of ANA tests can have negative consequences (both for patients and society), the investigators designed an intervention to see how this would influence Antinuclear Antibody testing by rheumatologists.


Eligibility Criteria:
Inclusion Criteria rheumatologists:

* rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre

Exclusion Criteria rheumatologists:

* rheumatologists not working the full study period (pre- and post-intervention) at a participating centre
* rheumatologists not giving their consent to participate

Inclusion Criteria patients - all patients with an ANA test requested by an included rheumatologist during the study period

Exclusion Criteria patients

- patients with an ANA test requested during a clinical admission
Avatrombopag Combined With IST as First-line Treatment for SAA

This single-center study aims to evaluate the early efficacy and safety of avatrombopag combined with immunosuppressive therapy (IST) in the first-line treatment of severe aplastic anemia (SAA).

This is a single center, single arm, phase II clinical study. Fifty-three patients will be enrolled.

Treatment protocol is as follows: 1) Anti-human thymocyte porcine immunoglobulin (P-ATG 20mg/kg/d) or rabbit anti human thymocyte globulin (R-ATG 3.0mg/kg/d) was administered intravenously for 5 days; 2) Cyclosporine (CSA) is given at 3-5 mg/kg.d in divided doses for at least 6 months. The trough concentration is maintained at 150-250 ng/ml. 3) Avatrombopag is given orally at 60 mg once a day for patients with body weight ≥ 50 kg, and 40 mg orally once a day for patients with body weight\<50 kg, for a total of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed severe aplastic anemia.
2. Men and women aged between 12 and 60.
3. Subjects must complete all screening assessments as outlined in the test protocol.
4. Able to swallow or administer orally.
5. Before the start of the research procedure, the patient or guardian should fully understand the research procedure and purpose and sign the informed consent form. If the patient's signature is not conducive to the treatment of the disease, the patient's immediate family should sign the informed consent form.

Exclusion Criteria:

1. Congenital bone marrow failure (eg. Fanconi anemia).
2. Accompanied by cytogenetic cloning changes (chromosomal karyotype and FISH detection found somatic cloning abnormalities; Simple -Y abnormality can be included in this study;) .
3. ATG or middle/high-dose cyclophosphamide was used in the past.
4. Previous treatment with cyclosporine or tacrolimus \> 6 months.
5. The total course of treatment with TPO receptor agonists (including thrombopoietin, eltrombopag,hetrombopag and avatrombopag) was more than 1 month.
6. Serious infectious diseases (tuberculosis without effective control, pulmonary aspergillosis, viral infections).
7. AIDS patients.
8. Pregnant or breastfeeding, fertile but unwilling to take effective contraceptive measures.
9. Patients with malignant tumors who are not suitable for ATG treatment.
10. A newly diagnosed history of cardio/cerebral vascular thrombosis within 12 months.
11. Those who are assessed as unsuitable for inclusion by the investigator.
A Study For Using Radiosurgery On Limited Metastases

The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. A second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.

In this research study high dose stereotactic body radiation therapy will be directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated. Blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. Two to four tablespoons of blood will be removed each time.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

KPS ≥ 70

Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria.

The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol

Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements.

Informed consent must be obtained.

Pregnancy test must be negative for women of child bearing potential.

Out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. The secondary aim (blood cytokines) is optional for out-of-state patients.

Exclusion Criteria:

Technical inability to achieve required dose based on safe dose constraints required for radiosurgery

Women who are pregnant or nursing..

Failure to meet inclusion requirements

Contraindications to radiation.

Patient should not be eligible for primary disease specific radiosurgical protocols
Bone MicroArchitecture in Acromegaly

The investigators will conduct a cross-sectional study of bone density, bone microarchitecture, vertebral fractures and trabecular bone score in 25 patients with acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least 1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to describe the bone architecture and associated biochemical indices of bone turnover and metabolism in patients with active acromegaly and how these are altered with treatment of the disease.

Growth hormone (GH) and Insulin-Like Growth Factor-1 (IGF-1) are important regulators of bone modeling and remodeling, fundamental to maintenance of normal skeletal integrity. In acromegaly, a disease characterized by longstanding exposure to excess GH and IGF-1, these hormones induce marked skeletal changes. Most dual energy X-ray absorptiometry (DXA) studies report that bone mineral density (BMD) is normal in acromegaly. Despite this, however, there is mounting evidence that bone health is adversely affected in patients with both active and successfully treated acromegaly.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with acromegaly
* On pegvisomant therapy with a normal IGF-1 level for at least 1 year

Exclusion Criteria:

* Malignancy (except cured basal, squamous cell skin carcinoma or other cured cancers free from recurrence \> 3 years)
* Pregnancy or lactation within last 12 months
* Untreated primary hyperparathyroidism, hyper- or hypothyroidism
* Cushing's syndrome
* Prolactin-secreting pituitary adenoma
* GH deficiency
* On current drug therapy for osteoporosis
* Diabetes mellitus
* Renal insufficiency
* Liver disease
* Current or past use of glucocorticoids (more than physiologic dose), anticonvulsants, anticoagulants, methotrexate, aromatase inhibitors
A Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction

The investigators describe a modified knotless Z-suture technique to stabilize the capsular bag to the sclera in eyes with moderate and severe ectopic lentis requiring cataract surgery using a standard CTR. This technology has the advantages of few complications, low technical difficulty, and no dependence on complex equipment.

A dislocated crystalline lens, also known as ectopia lentis, is the result of lax zonule fibers causing the lens to dislocate from its anatomical position, which can be caused by various factors such as inherited autosomal dominant disorders, trauma, or several systemic diseases. According to the ratio of the pupil area uncovered by the lens to the whole pupil area after mydriasis, the degree of subluxation of the crystalline lens can be divided into three grades: mild (0-25%), moderate (25-50%), and severe (more than 50%). Moderate or severe cases may manifest as progressive blurred vision, monodiplopia or even secondary angle-closure glaucoma, resulting in a poor prognosis, thereby emphasizing the urgency for effective therapeutic interventions. Preserving the posterior capsular diaphragm is the key to preventing glaucoma, optic capture, and retinal detachment.

Phacoemulsification and fixation of the capsular bag have been described with various methods and devices, such as intraoperative use of iris hooks orcapsular retractors, and permanent capsular support like Capsular tension rings (CTRs) firstly introduced in 1993 by Legler et al6. It is recommended to use a standard CTR when the zonular weakness is less than 120 degrees (\&amp;lt;4 clock hours). However, in instances of more extensive zonular weakness and progressive pathologies such as Marfan syndrome, Weill-Marchesani syndrome, pseudo exfoliation, high myopia and homocystinuria, intrascleral fixation of the capsular bag with a capsular tension segment (CTS), a modified CTR (m-CTR) or other devices such as the Assia Anchor is recommended6. However, m-CTR and a variety of new capsule assist devices are difficult to obtain in some countries. Therefore, how to make the most of the common auxiliary tools such as standard CTR in moderate and severe subluxation to retain the capsular bag requires ophthalmologists to continue exploring.

The investigators describe a novel technique of stabilizing a moderate or severe subluxated capsular bag which utilizes double-strand polypropylene sutures to suspend a standard capsular tension ring thereby enabling safe insertion of an intraocular lens (IOL) within the bag. The technique has been successfully demonstrated in 16 eyes of nine patients with congenital or traumatic lens subluxations ranging between 120 and 300 degrees.

Eligibility Criteria:
Inclusion Criteria:

- Patients with moderate to severe lens subluxation ranging from 120-300 degrees caused by different reasons.

Exclusion Criteria:

- Unable to cooperate in completing the lens subluxation surgery Lens subluxation accompanied by eyeball rupture injury Refuse surgery
Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Trial

This study is conducted to assess whether Omega-3 fatty acid improves neurobehavioral staus of children with Autism Spectrum Disorder and whether there is any correlation of this improvement with reference range of Omega-3 fatty acid.

Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder of children with lifelong impacts. WHO estimates the international prevalence of ASD in 2022 at 1 in 100 children. Till date, no pharmacological treatment has been proven effective for ASD. This proposed study is an effort to explore whether Omega-3 fatty acid supplementation produces improvement in neurobehavioral symptoms of ASD. This study will be a randomized, double-blind, placebo-controlled trial.A total of sixty four (64) ASD patients attended in the outpatient department of IPNA, BSMMU will be selected for the study according to inclusion and exclusion criteria. Diagnosis of ASD will be made by DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition). After completion of necessary formalities including informed consent of the patients, each participant will be assessed by translated and validated Bangla version of Aberrant Behaviour Checklist (ABC-parents rated). Omega-3 fatty acid ( Docosahexaenoic acid, DHA and Eicosapentaenoic acid, EPA) level in plasma will be measured in HPLC. 32 patients having DHA and EPA within reference value and 32 patients below the reference value will be selected. Then participants of each group will randomly be assigned into two groups: Intervention group and Control group. The intervention group patients will receive Omega-3 fatty acid 1 gm softgel once daily for 8 weeks at or below 25 kg and 1 gm softgel twice daily for 8 weeks above 25 kg making a total dose of 2gm/day. On the other hand, patients in control group will receive 1 placebo softgel of 1 gm once daily for 8 weeks at or below 25 kg and twice daily above 25 kg. After 8 weeks of therapy each participant will be assessed once again by Bangla version of ABC and plasma level of DHA and EPA will be measured.

Eligibility Criteria:
Inclusion Criteria:

Fulfills diagnosis of ASD by meeting DSM-5 diagnostic criteria. Written parental consent for participation. Age of children: 2-18 years. Sex: all.

-

Exclusion Criteria:

Those taking Omega-3 fatty acid or fish oil at present. Known allergy to fish or fish oil. Diagnosed with a psychotic disorder (e.g. Schizophrenia) or mood disorder, including depression or bipolar disorder.
Clinical Characteristics and Outcomes of 187 Critically Ill Patients With Coronavirus Disease 2019 (COVID-19)

This case series describes the clinical characteristics, treatment and outcomes of patients with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary hospital in Northeast Brazil.

This retrospective observational study will be carried out at Hospital São Domingos, state of Maranhao, Brasil. It is a tertiary hospital with 450 beds and six Intensive Care Units (ICU) with a total of 63 beds. With the admission of the first patients with Coronavirus Disease 2019 (COVID-19) as of March 20, we initially made available a 12 beds ICU exclusively for the treatment of patients with COVID-19. At the beginning of April, the number of beds was increased to 35 and, immediately afterwards, two semi-intensive units (16 and 21 beds) were created for patients in need of non-invasive respiratory support, with the 35 beds ICU 35 dedicated to receive only patients in need of high-level support (usually invasive mechanical ventilation) with or without other organ dysfunctions.

In the period from March 20 to June 15, 2020, 935 patients with confirmed diagnosis (RT-PCR) of COVID-19 were admitted to the hospital and 187 of them were treated in the ICU.

Data were obtained from the hospital's electronic medical record. Demographic and severity data included age, sex, Simplified Acute Physiology 3 (SAPS 3) and Sequential Organ Failure Assessment (SOFA) scores at admission, nutritional risk determined by Nutritional Risk Screening 2002 (NRS-2002) and commodities. Clinical and laboratory data on arrival at the ICU including Partial pressure of oxygen in arterial bood / Inspired fraction of oxygen (PaO2 / FIO2) complete blood count and PCR D-dimer, ferritin, fibrinogen and lactic acid dehydrogenasew (LDH). Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position, ECMO and vasoactive drugs. The main complications, acute kidney injury requiring hemodialysis, secondary infectious complications will be documented as well as the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the 35 beds ICU between March 20 and June 15, 2020 with laboratory confirmed diagnosis of COVID-19 (RT-PCR).

Exclusion Criteria:

* Patients admitted to the ICU in which the RT-PCR was negative, and patients that did not require high level life support (RRT, Prone position, ECMO, hemodymnamic monitoring and support).
Low Grade Inflammation in Type 1 Diabetes Children

The study propose to measure the inflammation level in type 1 diabetes children with the cytokine analysis compared to non diabetic children of the same sibling and to healthy children.

The increase of type 1 diabetes incidence, particularly in young children leads to conduce new diagnostic and therapeutic strategies, notably for associated chronic morbidity.Measurement of chronic inflammation, with modification of the balance between pro-inflammatory cytokines and anti-inflammatory cytokines, could lead to detect patients with high risk to diabetes chronic morbidity.

After parental consent, blood sampling will be carried out by micromethod for cytokine (500 µl) and CRPhs dosages and glycemia (100 µl) and glycated hemoglobin (1 µl). Urine will be collected (50 ml) in the morning for further researches.

Eligibility Criteria:
Inclusion Criteria:

Type 1 diabetes children group :

* Children aged 2 to 17 years
* Type 1 diabetes children

Controlled group :

* Children aged 2 to 17 years
* Brother or sister of type 1 diabetes children

Exclusion Criteria:

* Per os or inhaled corticoid in the previous month of inclusion
* Acute infectious disease in the previous week of inclusion
* Other chronic disease than diabetes type1