cyrilzakka/clinical-trials huggingface dataset:
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.

Comparing efficacy and safety of Olverembatinib in combination with chemotherapy (investigational arm) vs. Imatinib in combination with chemotherapy (control arm).

Eligibility Criteria:
Inclusion Criteria:

1. Meet the WHO 2016 Ph chromosome or BCR/ABL1 positive Ph+ALL diagnostic and typing criteria for acute lymphoblastic leukemia. This is a newly diagnosed Ph+ALL.
2. Expected survival of at least 3 months.
3. ECOG ≤ 2.
4. Adequate organ function.
5. Use effective contraception during treatment and for at least three months after the last dose of the study drug, and male patients may not donate sperm.
6. Pregnancy test results of serum samples obtained within 7 days prior to the first dosing of a fertile female subject were negative.
7. Understand and voluntarily sign the informed consent approved by the Ethics Committee (EC) and voluntarily complete the study procedure and follow-up examination.

Exclusion Criteria:

1. A history of chronic myeloid leukemia and a diagnosis of acute leukemia with chronic myeloid leukemia.
2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly.
3. Previous or current clinical CNS diseases.
4. Autoimmune diseases that may involve the CNS.
5. Use therapeutic doses of anticoagulants and/or antiplatelet agents but allow low doses of anticoagulants to keep central venous lines open.
6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days prior to the first receipt of the investigational drug.
7. Uncontrolled Heart diseases.
8. Had any VTE in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism.
9. Use of prohibited drugs.
10. The presence of any disease or medical condition that is unstable or may affect its safety or compliance with the study.
11. Medications known to cause prolonged QT interval.
12. Active infections requiring systemic treatment.
13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer.
14. Contraindications to the use of glucocorticoids, and the researchers judge that they are not suitable to participate in this study.
15. Bleeding disorders unrelated to the tumor.
16. Plan to undergone major surgery.
17. Allergy to drug ingredients, excipients, or their analogues in the study.
18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study plan or within 3 months of the last dosing.
19. Other malignant tumors within 2 years.
20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study.
Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia

The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.

In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 60 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Eligibility Criteria:
Inclusion Criteria:

* Men \> 20 years
* Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC \>200 mg/dL and/or HDL-C \<40 mg/dL)
* Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

* Patients with Chronic obstructive pulmonary disease (COPD)
* Women
* Patients with severe liver, renal, cardiac or brain diseases.
* Unable to complete follow up.
* Subjects on any medication like diuretics.
* Allergic to any medication.
* With a history of alcohol and/or drug abuse.
International Lung Screen Trial (ILST)

People who may be at increased risk of lung cancer due to age and smoking history will be invited to participate in this international study to determine the best way of using computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show that CT screening (screening tests can find diseases early, when they're easier to treat) can reduce deaths from lung cancer and this study will help determine who is most likely benefit from screening.

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Eligibility Criteria:
* Inclusion Criteria:
* Women or men age from 55 to 80.
* Current or former smokers. A former smoker is defined as one who has stopped smoking for one or more years.
* An estimated 6-year lung cancer risk of ≥1.51% based on the PLCOm2012 risk prediction model or ≥ 30 pack-years smoking history (pack-year is defined as number of pack of cigarettes smoked per day multiply by the number of years smoked. If a participant stopped smoking for 6 months or more and then restarted smoking again, the time will be subtracted from the total duration of smoking in 0.5 year increments)
* ECOG performance status 0 or 1.
* Capable of providing, informed consent for screening procedures (low dose spiral CT)
* Exclusion Criteria
* Clinical symptoms suspicious for lung cancer e.g. hemoptysis, chest pain, weight loss
* Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, home oxygen therapy, bleeding disorder, that in the opinion of the investigator could jeopardize the subject's safety during participation in the study or unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities
* Have been previously diagnosed with lung cancer
* Have had other non-curatively treated cancer outside the lung.
* Pregnancy
* Pneumonia or bronchitis requiring antibiotic treatment within the last 12 weeks
* Unwilling to have a spiral chest CT
* Chest CT within 2 years
* Does not fit into CT scanner table due to gross obesity
* Cannot lie on CT scanning table on the back with arms over the head
* Received chemotherapy or cytotoxic drugs within the last 6 months
* Unwilling to sign a consent
Physical Therapy in Shoulder Impingement Syndrome

The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).

SIS is an important cause of pain and disability and affects activities of daily living. Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity function. In this prospective, randomized controlled, single-blind, interventional trial, a total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the study. Eligible participants are going to randomly assign to one of the three groups by an independent blinded researcher, using a computer-generated random numbers and allocation ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and the control group (CG, n = 20). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of subacromial impingement syndrome based on physical examinations
* Persistent pain in one shoulder for at least 2 months
* No passive shoulder range of motion limitations
* Failure of improvement in pain after analgesic medications

Exclusion Criteria:

* History of malignancy and systemic rheumatic diseases
* Evidence of systemic or local infection
* Presence of major trauma at the affected shoulder
* History of shoulder surgery
* Rotator cuff lesions in the form of either calcific tendinosis or full-thickness tear as confirmed on MRI scanning
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn \& Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Current presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* A history of non-response to an adequate course of l-dopa or a dopamine agonist,
* Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.
Impact of School Based Intervention on Psychosocial Factors Associated With Trauma Among Adolescents

The present study is designed to identifying the post-traumatic stress symptoms in children experiencing some traumatic event and to adapt and apply school based intervention (Support for students exposed to trauma SSET) to students who shows the symptoms of post-traumatic stress disorder.

Childhood trauma is a major mental health problem in recent era. Children who experienced sudden trauma have difficulty in learning, poor concentration in schools, and faced emotional and behavioral difficulties (Holt, Finkelhor, Kantor, 2007). Children who have been exposed to traumatic event are at a higher risk of developing psychopathology followed by trauma (Alisic et al.,2014). The present study is designed to identifying the post-traumatic stress symptoms in children experiencing some traumatic event and to adapt and apply school based intervention (Support for students exposed to trauma SSET) to students who shows the symptoms of post-traumatic stress disorder. This school based intervention (SSET) will provides a basis for how students can address overwhelming emotions, can deal with their daily life stressors and proactively learn to address unhelpful or maladaptive cognitions in positive way. This study will help to aware parents and teachers about mental health needs of children and adolescents.

Eligibility Criteria:
Inclusion Criteria of the study is:

* meets the cut off score on scale CATS (child and adolescent trauma screen).
* students availability for intervention phase
* age range 10-16 years

Exclusion Criteria:

* students above 16 years and below 10 years will not be included in the study.
* receiving any psychological/Mental health services or taking antidepressants
* Students whose primary problem is child abuse .
Recovery of Biographical Memories Associated With a Melody: a Functional Magnetic Resonance Imaging Study

This study aims to validate a functional MRI paradigm to determine the regions involved in the retrieve of music-linked memories


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women (aged 20 - 50)
* Signature of the study's informed consent form, accepting to not receive information with regards to any research results that are not clinically relevant.
* Persons that accept the study's procedure: magnetic resonance imaging.

Exclusion Criteria:

* Contraindication to MRI scanning or conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
* Persons with severe or profound hearing loss or deafness
SLV308 for Treatment of Patients With Early Parkinson's Disease

This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease,
* Early stage of disease, Modified Hoehn \& Yahr up to stage III,
* UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* Clinically significant abnormalities,
* Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
* Antipsychotic.
Phase II Study of Grass Pollen Allergy Vaccine BM32

The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.

The present study is designed to evaluate the efficacy and safety of a treatment with the recombinant vaccine BM32 during two consecutive grass pollen seasons. Efficacy evaluation will be performed on the basis of allergy symptoms and use of relief medication as well as based on immunological parameters. After patient assessment during a screening season, patients will be randomized to one of two doses of BM32 or placebo. Patients will receive three injections of BM32 pre-season and one post-season boost injection to maintain optimal allergen specific IgG responses. Outcome will be measured after both seasons individually.

Eligibility Criteria:
Inclusion Criteria:

* Positive history of grass pollen allergy
* Positive skin prick test reaction to grass pollen extract
* Grass pollen specific IgE and rPhl p 1/rPhl p 5 specific IgE (\>3 kUA/L)
* Moderate to severe symptoms of grass pollen allergy during pollen peak

Exclusion Criteria:

* Symptomatic perennial allergies
* Atopic dermatitis
* Pregnancy or breast feeding
* Women with childbearing potential not using medically accepted birth control
* Autoimmune diseases, immune defects, immune suppression
* Immune complex induced immunopathies
* Contra indications for adrenaline
* Severe general maladies, malignancies
* Patients on long-term systematic corticosteroids, immune suppressive drugs, tranquilizers or psychoactive drugs
* Contra indication for skin prick testing
* Bronchial asthma not controlled by low dose inhaled corticosteroids
* Chronic use of beta blockers
* Participation in another clinical trial within one month prior to study
* Participation in SIT trial in 2 years prio to study
* Patients who had a previous grass pollen SIT
* Risk of non-compliance with study procedures
* Use of prohibited medications

  * Depot corticosteroids - 12 weeks prior to enrolment
  * Oral corticosteroids - 8 weeks prior to enrolment
  * High dose inhaled corticosteroids - 4 weeks prior to enrolment
  * Use of H1 antihistamines 3 days prior to enrolment
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates

A research study that will evaluate if giving surfactant medication to premature babies weighing \< 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life.

Pulmonary surfactant is required for normal lung function. Data from a previous study suggest that as many as 75% of chronically ventilated extremely low birthweight premature infants have at least one episode of surfactant dysfunction beyond the first week of life, as measured in vitro, associated with a low surfactant protein B content. Furthermore, episodes of surfactant dysfunction are significantly associated with clinically significant respiratory decompensations. We hypothesize that booster doses of surfactant given during the second and third week of life to extremely low birth weight premature infants requiring persistent intubation and mechanical ventilation will improve their respiratory status during the first 28 days of life. We propose to enroll premature infants \< 1250 gm birthweight, between days 7 and 10 of life who are intubated, and mechanically ventilated. Infants requiring persistent intubation and mechanical ventilation for respiratory support at 7-10 days of life will receive a total of 3 doses of Infasurf surfactant, 3 days apart, at the standard dose of 3 ml/kg. Primary outcome is the change in area under the respiratory severity score curve between days 7 and 28 of life. Total sample size is 88 infants, study duration is 36 months, and recruitment of study patients will occur at The Hospital of the University of Pennsylvania, in Philadelphia PA, Women and Children's Hospital in Buffalo, St. Louis Children's Hospital in St. Louis MO, Mercy Children's Hospital in Kansas City, Oakland Children's and Alta Bates Medical Center in Berkeley, CA and Long Island Jewish Medical Center, NY.

Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to1250 gm birthweight
* Day 7-10 of life
* Intubated and mechanically ventilated at day 7-10 of life

Exclusion Criteria:

* Infants intubated solely for apnea
* Serious congenital malformations
* Life expectancy \< 7 days from enrollment
* Pulmonary hemorrhage at time of enrollment
* Active air leak syndrome at time of enrollment
* Bilateral grade IV intracranial hemorrhage
* Postnatal systemic steroid therapy for lung disease

Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.
First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer

Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who suffer from locally advanced or metastatic pancreatic cancer
* Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
* ECOG performance status 0 to 1
* Signed written informed consent.
* White blood cell count (WBC) \>= 3x10\^9/L with neutrophils \>= 1.5 x 10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 5.6 mmol/L (9 g/dL).
* Total bilirubin \< 2 x upper limit of normal.
* AST and ALT \< 2.5 x upper limit of normal, or \< 5 x upper limit of normal in case of liver metastases.
* Serum creatinine \< 1.5 x upper limit of normal
* Normal ECG without QT prolongation

Exclusion Criteria:

* Resectable pancreatic cancer
* Previous chemotherapy (for adjuvant or metastatic disease)
* Any investigational drug within the 30 days before inclusion.
* Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
* Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
* Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
* Clinically symptomatic brain or meningeal metastasis. (known or suspected)
* Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
* History of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (CHF) \> NYHA Class II; cerebrovascular accident or transient ischemic attack; pulmonary embolism
* Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of up to 3 anti-hypertensive drugs
* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
* Previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \[Ta, Tis and T1\].
* History of organ allograft
* Patients requiring long-term cortisone therapy
* Patients requiring oral anticoagulation treatment (such as marcoumar)
A Study of Family Caregivers' Needs, Burden of Care and Quality of Life Over the Course of a Cancer Illness

This research will determine (a) the unmet needs of family caregivers of adult cancer patients and (b) determine the impact on stress, care burden and quality of life.

A cross-sectional questionnaire methodology will be used to answer the research questions. 510 family caregivers at different stages of patients' cancer journey will be recruited. The study duration is expected to take two years. Research findings will address the knowledge gap of caregivers' needs and stress, burden and quality of life and support plans to help caregivers.

The literature suggests that caregivers have unique psychological, emotional and lifestyle needs but there is a paucity of such information of caregivers in Singapore. As this study is exploratory, no a priori hylothesis has been made. The theoretical framework guiding this research is Fulfillment Theory in which the existence and perception of needs and need fulfillment are hypothesized to be antecedents to the experience of satisfaction about care.

A cross-sectional questionnaire methodology will be used to answer the research questions. Caregivers in this study are defined as: a family member who lends physical, emotional or other support to someone at any time during the cancer journey. A power calculation was not done, instead the sample size of 510 was based on what may be practically achievable and feasible for the duration of the short-term quantitative study. Descriptive statistics will be used to characterize the distribution of socio-demographic characteristics and caregiver-related information. Regression analysis will be used to evaluate difference in overall and domain specific needs across selected characteristics. Problems identified by caregivers will be dichotomized as present or absent and chi-square tests will be used to evaluate associations with selected characteristics.

Eligibility Criteria:
Inclusion Criteria:

an adult providing care for a familyt member with cancer aged between 21 and 90 years and willing to participate in the study

Exclusion Criteria:

caregiving adults who are not family members and not willing to particfipate in the study
Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.


Eligibility Criteria:
Inclusion Criteria:

* Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study

Exclusion Criteria:

* Children with history of chronic urticaria
* Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
* Children with known hypersensitivity to cetirizine/zyrtec
* Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
* Children who have received Ondansetron within 24hrs prior to randomization
* Children who are on Tricyclic antidepressants
* Children who are unwilling or unable to swallow the capsule.
* Children with chronic liver or kidney disease