cyrilzakka/clinical-trials huggingface dataset:
Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)

This study is prospective, two-center, single-arm objective performance criteria. This trial will be conducted in 2 clinical trial sites with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing clinical evidence for the medical device registration.

Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors. The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months after treatment completion and long-term follow-up is 5 years after the end of the last radiotherapy session.

The clinical trial with short-term follow-up fulfills the requirements for National Medical Products Administration (NMPA) regulatory registration. All the end points claimed will be achieved in the short-term follow-up stage. The trial is defined as completion once short-term follow-up finished.

Long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Eligibility Criteria:
Inclusion Criteria (Major Criteria):

1. 18≤ age≤ 80 years;
2. First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
3. Eastern Cooperative Oncology Group (ECOG) physical condition is graded as 0 to 2;
4. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
5. The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form.

Exclusion Criteria (Major Criteria):

1. The subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy;
2. The subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment;
3. Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
4. Other situations that investigator determines not suitable for enrollment.
MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer

This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.

PRIMARY OBJECTIVE:

I. Evaluate late grade 2+ genitourinary (GU) toxicity.

SECONDARY OBJECTIVE:

I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life.

OUTLINE:

Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients may also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for a total of 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Age: above 18 years
* Participants must be histologically proven, adenocarcinoma prostate
* Localized to the prostate without positive pelvic lymph node involvement
* No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan
* High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) \> 20 ng/mL
* Ability to receive long term hormone therapy
* Karnofsky performance score (KPS) \> 70
* No prior history of therapeutic irradiation to pelvis
* Patient willing and reliable for follow-up and quality of life (QOL)
* English speaking/reading

Exclusion Criteria:

* Evidence of distant or pelvic metastasis at any time since presentation
* Life expectancy \< 2 years
* Previous radiation therapy (RT) to prostate or prostatectomy
* A previous trans-urethral resection of the prostate (TURP)
* Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT
* Patients with known obstructive symptoms with stricture
* Any contraindication to radiotherapy such as inflammatory bowel disease
Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria

OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia.

II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients.

III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.

PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days.

Patients are followed every 3 months for at least 2 years and annually thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria
* Not a candidate for allogeneic bone marrow transplantation
* Must meet one of the following criteria:

  * Severe aplastic anemia

    * Less than 25% bone marrow cellularity and depression in two of three blood counts (reticulocytes less than 40,000/mm3
    * platelet count less than 20,000/mm3 and granulocytes less than 500/mm3)
  * Life-threatening paroxysmal nocturnal hemoglobinuria

    * Absolute neutrophil count less than 500/mm3
    * platelet transfusion dependent
    * thrombotic disease
* No Fanconi anemia
* No abnormal cytogenetics

--Patient Characteristics--

* Renal: Creatinine no greater than 2.0 mg/dL
* Cardiovascular: Cardiac ejection fraction at least 45%
* Other: Not preterminal or moribund Not pregnant
SCT in Ph Positive Acute Lymphoblastic Leukemia

This study includes a registry-based, nationwide analysis to describe the clinical outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who underwent an allogeneic hematopoietic stem cell transplantation (HSCT) after a Tyrosine Kinase Inhibitors (TKI)-based treatment.

This was a retrospective nationwide analysis based on registry data collected by GITMO. Inclusion criteria were: 1) diagnosis of Ph+ ALL; age ≥18 years at transplant; 2) patients receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a GITMO center; 3) TKI-based treatment prior to HSCT; 4) patients with available pre-transplant MRD status, as well as complete clinical data and outcome. Data were extracted from the GITMO Registry (PROMISE Registry).

The endpoints of the study were: OS, progression-free survival (PFS), cumulative incidence of relapse (CIR), non-relapse mortality (NRM), cumulative incidence of extensive chronic graft versus host disease (cGVHD), rate of minimal residual disease (MRD) negativity and the rate of complete cytologic remission (CR) before and after transplant.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ph+ ALL; age ≥18 years at transplant.
* Patients receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a GITMO center.
* TKI-based treatment prior to HSCT.
* Patients with available pre-transplant MRD status, as well as complete clinical data and outcome.

Exclusion Criteria:

* All cases without one or more of inclusion criteria.
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia

To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine for prevention of post-stroke dementia by comparing with clinical conventional treatment methods.


Eligibility Criteria:
Inclusion Criteria:

1. Definite ischemic stroke or hemorrhagic stroke confirmed by head CT / MRI examination
2. Memory or cognitive and executive dysfunction. Cognitive dysfunction will be determined after the mini mental state evaluation (MMSE) score
3. Age limited to 40-85 years, irrespective of gender
4. Stable condition, clear consciousness, no aphasia, oral medication available
5. No major comorbidity, no major depression
6. Consent and signed patient informed consent

Exclusion Criteria:

1. Had serious medical conditions, such as heart, liver, kidney, or endocrine disease
2. Aphasia or hearing impairment
3. Participants in other clinical trials
4. Patients currently on medication to improve cognitive function
Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults

To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults.

A double-blinded prospective, randomized study undertaken at outpatient clinic of King Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and divided into three groups according to their initial 25OHD concentrations. Patients are randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD concentration are measure again at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Adult age ≥ 15 years
2. BMI 18 - 35 kg/m2
3. Serum 25(OH)D \< 30ng/ml

Exclusion Criteria:

1. Hypercalcemia, nephrolithiasis, or fractures
2. Hepatic disease
3. Kidney disease
4. Granulomatous disease
5. Currently supplemented with vitamin D
Modifying Diet to Improve Gut Microbiome

The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.


Eligibility Criteria:
Inclusion Criteria:

* female
* non-Hispanic, black or white
* age 19-65 years
* BMI \>= 30 kg/m\^2
* able to visit Bionutrition Unit daily

Exclusion Criteria:

* gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
* antibiotic or probiotic use in the previous 90 days
* tobacco use
* heavy alcohol consumption
* major medical conditions (e.g., renal disease, diabetes, cancer)
Use of FFR-CT in Stable Intermediate Chest Pain Patients With Severe Coronary Calcium Score

A prospective, blinded multicenter study for evaluation of chest pain patients with severe coronary calcium (Agatston score \> 399). The objective is to evaluate if an initial non-invasive strategy with coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) is as effective as invasive coronary angiography (ICA) including functional flow reserve (FFR) for the detection and exclusion of obstructive coronary artery disease (CAD). Study hypothesis: initial non-invasive anatomic and functional testing is non-inferior to an invasive anatomic and functional testing strategy.

Prospective, blinded multicenter study evaluating the diagnostic performance of coronary computed tomography angiography (CCTA) including functional flow reserve derived from CCTA (FFR-CT) for the detection and exclusion of significant obstructive coronary artery disease (CAD). The reference standard vil be invasive coronary angiography (ICA) including functional flow reserve (FFR). Patients referred for elective CCTA because of suspected stable CAD are considered. If the initial routine non-enhanced CT scan shows an Agatston score \> 399, the patient is eligible for study inclusion. Four sites in the region of Southern Denmark will participate (Odense University Hospital, Svendborg Hospital, Vejle Hospital and Esbjerg Hospital). A total of 278 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* An estimated likelihood for the presence of significant CAD between 15% and 85%
* Clinical stable patients with symptoms of suspected CAD referred for CTTA
* Initial routine non-enhanced CT scan shows an Agatston score \>399
* Written informed consent
* Accept to undergo elective invasive coronary angiography (ICA) within 90 days

Exclusion Criteria:

* Known prior myocardial infarction
* Prior percutaneous coronary intervention (PCI)
* Prior coronary artery bypass surgery (CABG)
* Pacemaker or internal defibrillator lead implantation
* Prosthetic heart valve
* Atrial fibrillation
* Renal Insufficiency (\<40 mL/min)
* Known anaphylactic reaction to iodinated contrast
* Pregnancy
Biofeedback for Adolescent Cannabis Use Disorder

The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number of days used cannabis in the past 30 days).


Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 13 and 19 years, with a parent or legal guardian available to complete parental assessments, if the participant is a minor
* meet Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V) criteria for cannabis use disorder by clinical interview;
* be medically healthy;
* be willing to participate in the study intervention and assessments;
* plan to live locally for at least 4 months;
* be able to read English well enough to complete study questionnaires;
* have self-reported cannabis use in the past 28 days;
* have a Perceived Stress Scale score \> 20.

Exclusion Criteria:

* current or past psychosis;
* bipolar I or II disorder;
* the need to take psychotropic medications at any time during the study;
* pregnancy;
* psychiatric or substance use disorder that cannot be managed with outpatient care (e.g. alcohol withdrawal, severe major depressive disorder, significant suicidal ideation); and
* medications known to affect HRV (e.g. albuterol, pseudoephedrine, beta adrenergic blockers).
Fat Reduction and Muscle Toning of Thighs

This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* Voluntarily signed an informed consent form
* BMI ≤ 35 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Metal implants
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Injured or otherwise impaired muscles
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy, postpartum period, nursing, and menstruation
* Intrauterine device (IUD)
* Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
* Basedow's disease
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.

A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.


Eligibility Criteria:
Subject Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma metastatic to the liver.
* The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
* A patient may have had prior chemotherapy or be previously untreated.
* ECOG PS \<2

Subject Exclusion Criteria:

* Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver.
* Patient may not have received prior treatment with hepatic artery infusion (HAI).
* Extrahepatic metastases
* Female patients who are pregnant or lactating
Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma

This is an individual patient, expanded access protocol using Selinexor and dexamethasone ("Sd") for the treatment of Relapsed, Refractory multiple myeloma in a 64 year old male, "19023-UMN-01" weighing 105.7 kg. 19023-UMN-01 has IgG kappa myeloma that has relapsed after numerous treatments.

Selinexor is an oral, first in class, slowly reversible, potent and Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks Exportin 1 (XPO1). It is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib)
* Aged 18 years and older
* Patient able to provide written, informed consent to participate in and follow the KEAP Treatment Plan

Exclusion Criteria:

* Known hypersensitivity to selinexor or any excipients.
* Patient receiving any other investigational agent.
* Any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.).
* Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
* Active graft versus host disease (after allogeneic stem cell transplantation).
* Active, unstable cardiovascular function:

  * Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics)
  * Congestive heart failure of New York Heart Association Class ≥ 3 or known leftventricular ejection fraction \< 40%, or
  * Myocardial infarction within 3 months prior to C1D1.
* Significant renal impairment with ongoing dialysis treatment
* Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment.
* Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.