cyrilzakka/clinical-trials huggingface dataset:
A Study to Quantify Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

Pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. The investigators will conduct a single-arm prospective study to quantify the reduction in tumour vasculature post-radiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Age ≥21 years of age
* Proven metastatic disease, excluding haematological and germ cell neoplasms
* Life expectancy \>3 months, Eastern Cooperative Oncology group (ECOG) 0-2

Exclusion Criteria:

* The patient must not have an allergy to gadolinium contrast that will limit the ability to image the tumour by MRI safely even with the use of premedication
* eGFR \< 30 mL/min or if patient is suffering from acute renal insufficiency
* Prior radiotherapy to the specified region
* Recent surgery to affected spinal levels, or patients requiring immediate surgical intervention
* Spinal instability score (SINS) \>12
* Symptomatic cord compression (Bilksy grade 2 or 3), or worsening neurological deficits
* Body weight of more than 120kg
* Pregnancy
Irreversible Electroporation(IRE) For Unresectable Lymph Node Metastases(Close to Nerve)

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Lymph Node Metastases.

By enrolling patients with unresectable Lymph Node Metastases adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Lymph Node Metastases.

Eligibility Criteria:
Inclusion Criteria:

* Lymph Node Metastases diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Developing a Pain Identification and Communication Toolkit

The proposed research will develop, refine, and pilot test the Pain Identification and Communication Toolkit (PICT), an intervention to help family caregivers of community-dwelling persons with dementia identify pain symptoms and communicate those symptoms to health care providers. Informed by self-efficacy theory, PICT will include: a) training in administering an observational assessment tool to identify pain in persons with dementia, b) coaching in effective communication about the person with dementia's pain symptoms, c) future planning for steps to take when pain is detected, and d) updating caregivers' skills through routine practice with the pain assessment tool. All components will be vetted and iteratively field-tested with a sample of racially and ethnically diverse caregivers of community-dwelling persons with dementia and health care providers. A two-group pilot randomized trial will examine the acceptability, feasibility, and preliminary impact of PICT on caregivers' initiation of pain-related communication with health care providers.


Eligibility Criteria:
For all phases:

Inclusion Criteria:

* Family caregiver
* Age 21 or older
* English speaking
* Cognitively intact
* Provides at least 8 hours of care per week to a person with dementia and pain
* Has provided care for at least 6 months

Exclusion Criteria:

* Paid caregiver
* Age 20 or younger
* Non-English speaking
* Cognitively impaired
* Does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis
* Has not provided care for at least 6 months
* Currently enrolled in hospice
* The patient to whom the caregiver provides assistance is in enrolled in hospice
* Care recipient does not have dementia diagnosis or pain diagnosis

For field test and interview phases:

Healthcare professionals:

* Currently providing clinical services to persons with dementia and/or chronic pain
* Has provided these clinical services for at least 1 year
The Changes of Urine Growth Factors Level

The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment.

The prevalence of benign prostate hyperplasia, like medical illness such as hypertension, diabetes mellitus and stroke, increase by age. Benign prostate hyperplasia will cause bothersome lower urinary tract symptoms in the middle and aged male. Previous studies have showed that overactive bladder syndrome (urge, frequency, nocturia or urinary incontinence) has been considered as an important factor to predict successful treatment.

Urine nerve growth factor level, brain-derived neurotrophic factor and endothelium vascular growth factor have been proved as a simple and noninvasive biomarker for diagnosing overactive bladder. As a result, investigator will investigate the changes of these growth factors level in patients with benign prostate hyperplasia before and after three and six-months medical treatment. In addition, investigator can understand whether overactive bladder will have effects on successful medical treatment in patients with benign prostate hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* men with age 50\~80 years old
* IPSS\>12
* maximal flowrate 5\~15ml/sec
* prostate size\>20ml
* urine amount\>150ml
* patient/family can sigh the inform concent

Exclusion Criteria:

* prostate cancer or suspected prostate cancer(PSA\>4ng/ml)
* history of prostate surgery
* free of active urinary tract infection in past 6 months
* patient with any other serious disease considered by investigator not in the condition to enter trials
Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia

This study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.

In this single-center, open-label, single-arm, prospective clinical trial, a total of 20 recurrent or refractory CD19+ B cell acute lymphoblastic leukemia patients will be enrolled.After recruiting eligible patients,autologous peripheral blood mononuclear cells(PBMCs) will be purified from whole blood.The CD3+ T cells were subsequently selected and re-stimulated by anti-CD3 and anti-CD28 monoclonal antibodies.T cells will be transduced with lentiviral vector for the generation of the CD19 CART cell and administered by i.v. injection.The purpose of current study is to determine the safety and clinical efficacy of CD19 CAR T cells therapy in patients with recurrent or refractory CD19+ ALL.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL)
* Patients who have failed at least one line of a standard treatment without effective treatment measures at present
* CD19 expression on the surface of B-ALL cells must be detected
* KPS\>80
* Life expectancy \>3 months
* Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF≥50%),adequate pulmonary function as indicated by room air oxygen saturation of \> 90%, and adequate renal function (Cr≤2.5 times of the normal range)
* The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)≤ 3 times of the normal range, and the total bilirubin (TBIL)≤2.0mg/dl(34.2umol/L)
* Hemoglobin(Hgb)≥80g/L
* Without contraindication of apheresis and cell isolation
* Patients and their families volunteer to participate in the research with signed written informed consent

Exclusion Criteria:

.Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease.

* Evidence of uncontrolled current serious active infection
* HIV/HBV/HCV infection
* Pregnancy and nursing females
* Systemic glucocorticoid therapy within one week
A Phase II Study of CCX282-B in Patients With Celiac Disease

The purpose of this study is to determine whether CCX282-B is effective in mitigating the effects of gluten ingestion in patients with celiac disease

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, between 18 and 75 years of age
* Established diagnosis of celiac disease
* Subject has been following a strict gluten-free diet for at least 24 months

Key Exclusion Criteria:

* History of any infection requiring intravenous antibiotics, a serious local infection, systemic infection, or gastrointestinal infection within 12 weeks of randomization
* Use of any immunosuppressants, TNF inhibitors, or natalizumab during the 12 weeks prior to study randomization
* Use of steroids during the 4 weeks prior to study randomization
* Receipt of an experimental treatment for any disease within 4 weeks prior to randomization
* Known IgE-mediated atopy or allergy or anaphylactic reactions to gluten
* The subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment
A Drug Interaction Study With Albiglutide and Warfarin

This open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

This Phase I open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.

Eligibility Criteria:
Inclusion Criteria:

* male healthy volunteers in good health
* no clinically significant diseases or clinically significant abnormal laboratory values
* body mass index (BMI) is \>/=18 kg and ≤30 kg/m2
* nonsmoker

Exclusion Criteria:

* positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* any clinically relevant abnormality
* history of any anaphylactic reaction to any drug
* history of significant cardiovascular or pulmonary dysfunction
* history of excessive bleeding
* current or chronic history of liver disease
* history of alcohol or substance abuse
* history of thyroid disease or dysfunction
* history of gastrointestinal surgery or disease
* history of pancreatitis
* previously received any GLP-1 mimetic compound (e.g., exenatide)
Testing Miglustat Administration in Subjects With Spastic Paraplegia 11

Hereditary spastic paraparesis type 11 (SPG11) is caused by mutations in the SPG11 gene that produces spatacsin, a protein involved in lysosomal function. Studies performed in skin cells (fibroblasts) from SPG11 patients, mice and zebrafish models of the disease showed that the material accumulated in the lysosomes is made of glycosphingolipids (GSL).

Miglustat is a drug that inhibits an enzyme called glucosylceramide synthetase (GCS) which is used for the production of GSL. Miglustat, therefore, helps to delay the production of GSL. This study aims to collect preliminary data on the safety of miglustat on the SPG11 disease and to assess biomarkers.

We will analyze the safety of Miglustat

Eligibility Criteria:
Inclusion Criteria:

* Written signed informed consent;
* Confirmed diagnosis of SPG11;
* Age \> 13 years;
* SPRS score ≥ 10 or ≤35;
* Use of effective contraceptive methods and the performance of pregnancy tests (only fertile subjects).

Exclusion Criteria:

* Diagnosis of other concomitant neurodegenerative diseases;
* Outcomes of severe pre- or peri-natal suffering;
* Age ≤ 13 years;
* SPRS score ≥ 35 or ≤10;
* Hypersensitivity or intolerance to miglustat;
* Participation in other pharmacological studies within 30 days of the first Study visit (T0);
* The inability to take the drug;
* Any additional medical conditions;
* Subjects with severe renal impairment;
* Refusal to use effective contraceptive methods and the performance of pregnancy tests (only fertile subjects).
Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module

The purpose of this study is to innovatively design and develop computerized dual-task balance training modules and home modules, and conduct proactive clinical verification to focus on the effectiveness of balance control and gait stabilization strategies. It is expected that in addition to the development of the training module, a proactive study will be conducted at the same time. During the period from the fourth quarter of the first year to the second year, there will be 25 patients in the experimental group and 25 patients in the control group. A total of 50 patients will undergo preliminary efficacy analysis.

After mild traumatic brain injury (mTBI), patients often complain of dizziness, balance disturbances, and gait instability. On average, dizziness accounts for about 23 to 81%, and dizziness symptoms persist from 1.2% 6 months after the injury. Between 32.5% in 5 years. In the past, in the process of neuron regeneration and repair after mild traumatic brain injury, it was found that vestibular function and biomarkers may be related to balance restoration and treatment. It is necessary to conduct further research to explain its potential mechanism and clinical significance. In addition, balance training after mTBI can accelerate dizziness recovery, balance control and gait stability, but the effect lasts for a limited time. The development of a dual-task balance training module can extend the recovery time, this project needs to be discussed in depth. This project mainly explores the influence of balance control and gait strategies after mTBI, linking vestibular function and biomarkers; innovative design and development of computerized dual-task balance training and home modules; combined with computerized dual-task balance training modules can accelerate the recovery of dizziness, balance control and gait stability after injury.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-80 years old.
* Patients with mild traumatic brain injury: According to the American Congress of Rehabilitation Medicine, the loss of consciousness is less than 30 minutes, the coma index is 13-15, and the post-traumatic amnesia is less than 24 hours.
* Healthy patients: healthy subjects without any neurological, psychiatric, or severe musculoskeletal medical history.
* Regardless of gender.

Exclusion Criteria:

* Mild traumatic brain injury: moderate to severe brain injury, epilepsy, history of cardiovascular disease, lack of intelligence, neurodegenerative diseases, history of head trauma, systemic diseases, left-handedness, and use of psychotropic drugs.
* Healthy subjects: any neurological, psychiatric, severe musculoskeletal medical history.
Black Adult Resilience Study

Alcohol and cannabis are the most misused psychoactive substances in the United States, and their misuse among African American young adults has the potential to be especially problematic. The proposed research examines how daily and racial stressors (e.g., racism and discrimination) may lead to alcohol and cannabis use among African American young adults, and what individual and community coping and resources mitigate this causal effect. This research is designed to identify possible targets for culturally responsive prevention and treatment efforts to help prevent and reduce alcohol and cannabis use among African American young adults.


Eligibility Criteria:
Inclusion Criteria:

* Identify as Black, African American, or Afro-Caribbean
* Proficient in English
* Alcohol and/or cannabis use at least 4 times in past month
* Endorse having used alcohol and/or cannabis to cope

Exclusion Criteria:

* Having participated in similar studies by the research team
* Obtain cut-off scores on measures indicating possible alcohol and/or cannabis use disorder
* In or seeking treatment for alcohol and/or cannabis use disorder
Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

To test the safety and efficacy of titrated oral misoprostol compared to vaginal dinoprostone for labor induction.

* There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common indication. It is well recognized that with an unripe cervix, induction may be difficult and often unsuccessful. The use of an agent to ripen the cervix prior to induction is acceptable in the modern practice.
* Misoprostol, a prostaglandin E1 analogue, is the most interesting alternative to Dinoprostone because of its effectiveness, low cost, and temperature stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise.
* Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction.

Eligibility Criteria:
Inclusion Criteria:

* Single vertex presentation.
* Gestational age \> 37 weeks calculated from last menstrual period or U/S scanning.
* Bishop score \<8 .
* Not in labor.
* Reassuring fetal heart rate (CTG for 20 min on the day of induction).
* Valid indication for Induction of labor.

Exclusion Criteria:

* Gestational age \<37 weeks.
* Patients with rupture of membranes.
* Previous uterine scar.
* Fetal malpresentation.
* Multiple pregnancy.
* Significant antepartum hemorrhage
* Uncontrolled DM.
* Severe Pre-eclampsia or Eclampsia
* If there are contraindications to receive the drugs, e.g. allergy, history of severe asthma,.....etc.
Hyperimmune Plasma for Critical Patients With COVID-19

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.

Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.

Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 yrs
* positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
* Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
* Polymerase chain reaction (PCR) increased by 3.5 with respect to baseline or \>1.8 mg/dl
* need for mechanical ventilation or continuous positive airway pressure (CPAP)
* signed informed consent unless unfeasible for the critical condition

Exclusion Criteria:

* Moderate to severe ARDS lasting more than 10 days
* proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
* consent denied
Family Intervention for Suicidal Youth: Emergency Care

This project evaluates a brief intervention in the emergency department (ED) for adolescents presenting with suicide attempts. The intervention aims to capitalize on the opportunity offered by the ED visit to deliver an effective intervention, improve adherence to follow-up care, decrease the risk of repeat suicide attempts, and improve clinical and functioning outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 10-18 years
* Suicidal patient presenting to Emergency Department

Exclusion Criteria:

* Acute psychosis/symptoms that impede consent/assessment
* No parent/guardian to consent (youth \<18)
* Youth not English-speaking
* Parents/guardians not English or Spanish-speaking.
Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome

This is the randomized trial to explore the effect of behavioral modification program (Tai Chi vs. self management) on adults with metabolic syndrome. The outcome variables include health behavior, metabolic syndrome indicators, quality of life.

1. venue: the individuals with diagnosis of metabolic syndrome are recruiting from university hospital outpatient clinic or primary clinic.
2. inclusion criteria: diagnosed of metabolic syndrome, agree to participate either programs, no history of participating regular exercise program past 6 months.
3. intervention: The behavioral modification program consisting of Tai Chi exercise (twice a week for 12 weeks) and self-management program (6 sessions every two weeks) is provided to the participants who randomly assigned to either group. Short form Yang style Tai Chi (16 movements) were led by trained Tai Chi practitioners, and self-management program were provided by nurse educators.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of metabolic syndrome
* adults who agree to participate either behavioral modification programs for 12 weeks
* be able to understand the questionnaire and follow the exercise or education program

Exclusion Criteria:

* who attend regular exercise program past 6 months