cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome.

OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy with high-dose cytarabine plus a single high dose of idarubicin in patients with previously untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or immunophenotypic markers in AML patients for use in the study of residual disease.

OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day. Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen. Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21) or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks, then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients are followed for survival.

PROJECTED ACCRUAL: 60 patients will be entered over 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: One of the following hematologic malignancies that is ineligible for higher priority protocols and confirmed at Memorial Hospital: Acute myelogenous leukemia Accelerated or blastic phase (greater than 10% blasts in marrow) chronic myelogenous leukemia Poor-risk myelodysplastic syndrome, defined as: Refractory anemia with excess blasts (RAEB) with at least 10% marrow blasts and cytopenia requiring therapy RAEB in transformation Chronic myelomonocytic leukemia No acute promyelocytic leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No cardiomyopathy No symptomatic congestive heart failure Other: No concurrent active malignancy No pregnant or nursing women

PRIOR CONCURRENT THERAPY: No prior therapy except biologic agent alone or hydroxyurea
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer

The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* At least 1 lesion with measurable disease

Exclusion Criteria:

* HER2-positive tumor and previously untreated with trastuzumab
* Suspected, known or progressive central nervous system metastases
* Other active malignancy requiring concurrent intervention
* Active, known or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply
Venovenous CO2 Removal (VVCO2R) in Patients With COPD and Acute Respiratory Failure

The purpose of this study to determine the safety and effectiveness of a mechanical device to remove carbon dioxide from the blood of patients with chronic obstructive pulmonary disease (COPD)when they are hospitalized in the intensive care unit for exacerbation of their condition.

This is a pilot study to examine the efficacy and safety of an extracorporeal circuit to remove carbon dioxide (CO2) from the blood in patients with an acute exacerbation of COPD resulting in acute or acute on chronic respiratory failure. The extracorporeal circuit consists of venovenous configuration through a percutaneously inserted 18 F double lumen catheter placed in a central vein. Centrifugal pump and heparin bonded circuit are used and patient is heparinized to maintain an activated clotting time (ACT) \> 180. Circuit blood flow and gas sweep speed will be adjusted to maximize CO2 removal and minimize ventilator settings and patient's work of breathing. Patients will remain on the extracorporeal circuit for a maximum of four days as tolerated. Plasma Hemoglobin will be monitored daily.

Eligibility Criteria:
Inclusion Criteria:

1. Acute respiratory failure on invasive mechanical ventilation or
2. Acute respiratory failure and an advanced directive foregoing invasive mechanical ventilation
3. Established diagnosis of COPD
4. Age group: 18 years or greater

Exclusion Criteria:

1. Significant vasopressor support
2. Systolic BP \< 100 torr systolic despite vasopressor support
3. Class III or Class IV congestive heart failure
4. Left ventricular ejection fraction \< 30% by previous echocardiogram
5. Recent (6 month) history of myocardial infarction
6. Coronary artery disease with unstable angina
7. Recent (6 month) history of venous embolism
8. Uncontrolled coagulopathy (international normalized ratio (INR) \> 5 or activated partial thromboplastin time (aPTT) \> 80s) despite corrective therapy
9. History of heparin-induced thrombocytopenia or other adverse event following the administration of heparin (heparin group only)
10. Pregnancy
11. Severe chronic liver disease
12. Severe anemia (Hgb \< 9 gm/dl)
13. Any contraindication to systemic anticoagulation with heparin, including recent central nervous system injury or hemorrhage, retinal hemorrhage or other recent hemorrhage from sites which cannot be controlled
14. Technically unable to access vessels (obesity, limb deformity, previous surgery at the site, infection, etc.)
15. Evidence of increased intracranial pressure or history of an intracranial hemorrhage within the past 3 months
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age
* Has advanced (unresectable Stage III) or metastatic (Stage IV) melanoma that is BRAF mutation positive (V600E)
* Is treatment naive for advanced (unresectable) or metastatic melanoma, with the exception of Interleukin 2 (IL-2) which is allowed.
* Has measurable disease according to RECIST 1.1 criteria.
* Women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment.
* Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
* Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
* Must have adequate organ function.
* Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Exclusion Criteria:

* Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
* Evidence of active central nervous system (CNS) disease.
* Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
* A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* History of Human Immunodeficiency Virus (HIV) infection.
* Certain cardiac abnormalities
Improving Health of Nurses With Burnout Through Positive Psychological Intervention

Burnout is usually regarded as a response to chronic professional stressors like high workload, unfavorable emotion and complex interpersonal relationships. A high prevalence of burnout was found in many countries, and large-scale studies also showed high levels of burnout in Chinese nurses. As a stress-related syndrome, burnout was found to have detrimental influences on both psychological and physical health of nurses. Psychological problems such as depression and insomnia are verified to be associated with burnout. Endocrine dysfunction such as abnormal cortisol secretion rhythm occurred in shift-work nurses. Thyroid dysfunction was increasing and a sample of nurses were diagnosed with thyroid nodules and thyroid hormonal disorder during annual physical examination. Therefore, it is important to take measures to alleviate nurses' burnout to improve health.

Positive psychological interventions are defined as treatment methods or intentional activities to enhance person's positive emotions, cognitions and behaviours. In these methods and activities, people are usually required to finish a systematic exercise. According to a recent meta-analysis, Positive psychological interventions showed effectiveness in enhancing participants' well-being and reducing depressive symptoms. Therefore, this study aims to explore whether positive psychological intervention could reduce burnout and improve health of nurses.


Eligibility Criteria:
Inclusion Criteria:

* officially employed licensed nurses; burnout score higher than 1.49; had a telephone on which WeChat could be installed.

Exclusion Criteria:

* pregnant; current endocrine disorder; taking hormone drugs such as contraceptives.
Comparing the Nautilus NeuroWaveTM to TCD or DSA for the Detection of Vasospasm

To determine the efficacy of using the Jan Medical NNW system as a diagnostic aid in detection of moderate and severe vasospasm for detection of vasospasm in patients with subarachnoid hemorrhage.

This study is a prospective, comparative, non-randomized study in subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm. The study will be conducted in one center.

The primary objective of Phase I of this non-significant risk study is proof of principle. During this phase the goal is to build a library of Jan Medical NNW system recordings from patients with moderate and severe vasospasms. A signature for detecting vasospasms will be developed using the signals from a vasospasm epoch to a patient's individual baseline recording and confirming the presence of vasospasm by comparison of Jan Medical NNW system data to TCD and, when available Digital Subtraction Angiography (DSA). The number of patients required for Phase I is estimated to be 20 patients with confirmed moderate or severe vasospasm with a minimum of 10 these patients having at least one severe vasospasm recording confirmed by TCD or DSA. Daily recordings are to be taken.

During Phase II the Jan Medical NNW system will independently utilize the signatures identified in Phase I to identify the presence or absence of moderate and severe vasospasm in a blinded recording. This recording will be compared to TCD or DSA, when DSA is available, for analysis of sensitivity and specificity. Up to 50 subjects will be enrolled in Phase II. When possible, multiple recordings will be obtained from each subject to include recordings with and without vasospasm.

Duration of each subject's enrollment in this study is limited to the period of time when Jan Medical NNW system recordings are performed. No additional tests or procedures will be performed during participation in this study and all other data collected (including TCD or DSA) will be based on available evaluations conducted as part of the patient's standard of care. Upon completing the last Jan Medical NNW system recording or when no further data collection is expected, the subject will be exited from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 years of age or older.
2. Subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm.
3. Signed informed consent from the patient or the patient's Legally Authorized Representative

Exclusion Criteria:

1. Unstable medical illness such that recordings might interfere with medical care.
2. Presence of head bandages or brain monitors that might physically interfere with the NNW recording device.
3. Current hemicraniectomy.
Vitamin D3 Supplementation in Dialysis Patients

Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis or peritoneal dialysis \> 3 months

Exclusion Criteria:

* Hypercalceamia
* Cancer
* Inability to give informed consent
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations
* Aged 18 to 75 years old, inclusive, at the time of informed consent
* Documented diagnosis of SLE according to the current ACR criteria
* Stable immunosuppressive treatment for SLE for a minimum of one year/six months
* Stable treatment with antimalarials for a minimum of 3 months
* stable (lasting for at least 6 months) low disease activity

Exclusion Criteria:

* Disease activity (non LLDAS) within 6 months prior to screening
* Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC).
* Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule
* Nursing mothers, pregnant women or women planning to become pregnant during the study.
Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer

The standard treatment of rectal adenocarcinoma is total mesorectal excision (TME). The technique involves a low anterior rectal or colo-anal resection, very often associated with a protective stoma or abdominal-perineal resection with permanent colostomy. Transanal endoscopic microsurgery (TEM) allows access to tumors up to 20 cm from the anal margin, with minimal postoperative morbidity and mortality. Recent studies of T1 rectal adenocarcinomas consider TEM to be the technique of choice. However the treatment of T2 rectal cancers remains controversial. Chemotherapy and radiotherapy (CT/RT) has achieved a concomitant reduction in local recurrence and an increase in survival.

Hypothesis: Patients with rectal adenocarcinoma less than 10 cm from the anal margin and up to 4 cm in size, staged after endorectal ultrasound and MRI as T2 or superficial T3 N0-M0-N0-M0, who underwent surgery after preoperative local chemoradiotherapy (TEM), achieve effective results in terms of local recurrence similar to radical surgery (TME).

OBJECTIVES:

Primary: To compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and TEM and in patients treated with conventional radical surgery (TME).

Secondary: To analyse the 3-year survival results in patients treated with CT/RT.

Methodology: Multicenter clinical trial in a calculated sample of 173 patients.


Eligibility Criteria:
Inclusion Criteria:

1. Rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the EUS.
2. Preoperative staging by EUS and pelvic MRI of T2 or T3 superficial, N0. In case of disparity, the higher staging is considered as the definitive diagnosis.
3. Tumours equal to or less than 4 cm of diameter maximum measured using colonoscopy, EUS or MRI. We use the highest score on both scores.
4. ASA score III or less.
5. Absence of distance metastasis as shown on abdominal CT.

Exclusion Criteria:

1. Preoperative staging by EUS or pelvic MRI of T1, deep T3, T4 or N1.
2. Presence of distance metastasis.
3. Synchrony with other colorectal adenocarcinomas.
4. Undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy.
5. Patients with intolerance of preoperative chemotherapy or radiotherapy.
6. Refusal to sign informed consent to enter the study.
Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy

Cerebral palsy (CP ) is one of the most prevalent motor disabilities in childhood, significantly impacting both children and their caregivers. This study explores the experiences, psychological well-being, and unmet needs of caregivers of children with CP. Using an explanatory sequential design (QUAN → QUAL), first it will be assessed burden, stress levels, and quality of life of caregivers through standardized questionnaires (PedsQL-FIM , ZBI , PSS-14 ).

Before the recruitment begins, the principal investigator will present the project to the pediatric service of the Arnau de Vilanova University Hospital of Lleida (HUAV). During medical consultations, the pediatric service will inform eligible participants about the study. If the caregiver agrees to participate, they will give consent for the pediatric service to share their contact details with the research team. The investigators will then contact the participant to explain the project in detail, schedule a first meeting to sign the Informed Consent, and complete the initial questionnaires. The Informed Consent will include the first author's contact information so that participants can address any questions or concerns about the study. Additionally, participants who sign the informed consent will be asked to provide their contact information for potential follow-up regarding the qualitative interview.

In the first meeting, participants who meet the inclusion criteria and have signed the informed consent will be directed to a study homepage hosted on the university's website. This website will provide a link to REDCap (Research Electronic Data Capture), a secure platform specifically designed for collecting research data (PedsQL-FIM, ZBI, PSS-14).

Participants' sociodemographic data will include descriptive information such as age, sex, household income, among others

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Being a caregiver of a child with Cerebral Palsy
* Spanish/Catalan speaking
* Willing to talk about their experiences and be audio/video-recorded.
* Accept and sign the informed consent form
Ultrasound-guide Corrected Glenohumeral Internal Rotation Deficit

Background:

Glenohumeral internal rotation deficit (GIRD) is believed to be one of the risk factors contributing to shoulder injuries. In addition, athletes with GIRD of greater than 20° appear to be at a greater risk for the shoulder injuries and surgery. Recently, GIRD can be divided in anatomical GIRD and pathological GIRD (pGIRD). The dominant arm of the athletes with pGIRD have not only humeral retrotorsion (HR) but also stiffer posterior capsule. The soft-tissue effect is believed to be the key point in pathological cascade of throwers. Therefore, the previous studies use gross GIRD as a risk factor may be modified by ultrasound-guide corrected GIRD.

Objective:

There are 4 objectives for the present study: (1) to investigate the Receiver operating characteristic (ROC) curves of the gross GIRD; (2) to investigate the ROC curves of the ultrasound-guide corrected GIRD; (3) to compare the area under curve (AUC) of the two methods; (4) to compare the gross GIRD and the ultrasound-guide corrected GIRD in baseball players.

Design:

Baseball players who have played baseball for at least 1 year and still active in training or competition will be recruited in this study. Participant characteristics will be collected by the main assessor, including age, gender, height, weight, dominant arm, practice time, years of playing baseball. Performance/function will be assessed via a Kerlan-Jobe Orthopaedic Clinic shoulder and elbow (KJOC) self-report questionnaire. The shoulder rotation ROM, ultrasound examination including ultrasound-corrected GIRD and posterior capsular thickness and posterior shoulder tightness will also be measured. we will follow subjects for a season. Once the injury occurs, deterioration or at the end of the season, we will collect the data again.

Main outcome measures:

The shoulder rotation ROM, ultrasound examination and posterior shoulder tightness are main outcomes of the study.


Eligibility Criteria:
Inclusion criteria:

1. Age range from 12 to 40 years old.
2. Playing baseball for at least 1 year.
3. Still active in training or competition.
4. The frequency of training or game should be at least 3 times per week, 3 hours per time.

Exclusion criteria:

1. Subjects with shoulder pain onset due to trauma.
2. A history of shoulder fractures or dislocation.
3. Cervical radiculopathy.
4. Degenerative joint disease of the shoulder.
5. Surgical interventions on the shoulder.
6. Inflammatory arthropathy.
Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia

Research has shown that cognitive-behavioral therapy (CBT) is an effective treatment for gambling disorder. Several studies had also been done to evaluate the effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in addiction management, particularly in alleviating craving. A randomised controlled trial (RCT) of 30 subjects would be conducted to evaluate the effectiveness of transmodalistic therapy with a combination of rTMS and CBT for online gambling disorder.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with pathological gambling (SOGS score ≥ 5)
* Subjects aged 18-59 years old
* Subjects who understand Bahasa Indonesia
* Subjects who agree to participate and receive treatment

Exclusion Criteria:

* Subjects with history of psychotic disorder, personality disorder, or sleep disorder according to ICD-11
* Subjects with history of neurostimulation
* Subjects with history of medical implant
* Subjects with history of severe neurological disorder, which causes seizure or loss of consciousness
* Subjects with intellectual disability
* Subjects with endocrinological disorders
* Subjects with contraindication during prior MR or other related procedures
* Subjects who are currently or expecting pregnancy
* Subjects with history of substance use in the last 6 months