cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers

This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This study is to be conducted at two clinical centers and in conformity with Good Clinical Practice (GCP).


Eligibility Criteria:
Inclusion Criteria:

* Each subject must be willing and able to provide written informed consent for the study
* Healthy volunteer subjects of both genders, aged 18-64 years old, and any race/ethnicity
* Subjects with normal blood pressure (between ranges of 120-140/60-80 mmHg) at screening and baseline
* Subjects with a body mass index (BMI) 18-30 kg/m2
* Men or woman of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during screening, while receiving the investigational drug, and for 60 days after stopping the investigational drug
* Female subjects of childbearing potential must have a negative urine pregnancy test at screening
* Subjects with physiological examination and laboratory values within normal limits (CBC/differential, blood chemistry, iron, Total Iron Binding Capacity (TIBC), urinalysis, ECG and vital signs)
* Subjects with the ability to comprehend and complete the telephone visits, screening, and site visits
* Subjects must be able to adhere to dose and visit schedules
* Subjects who agree to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial.

Exclusion Criteria:

* Subjects with any allergic reaction or sensitivity to glutamate acid, polyethylene glycol, or any component of the test article product
* Subjects who consume \> five alcoholic beverages per week
* Subjects who are pregnant or lactating
* Subjects who have blood (or urine) levels outside the normal range for any hepatic, renal, hematologic, lipid or coagulation parameters measured.
* Subjects on Hormone Replacement Therapy within the past three months
* Subjects in any other clinical trial or experimental treatment in the past three months
* Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, hypertension, hypotension or systolic blood pressure below 80 mmHg, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.
Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL

Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Reduced-dose Chemotherapy in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

This is a prospective, single-arm, phase II and open-label study. A total of 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is MRD-negative CR rate. The induction therapy is a combination of Blinatumomab(Blina), Vindesine(VDS), Cyclophosphamide(CTX) and Dexamethasone(DXM). The second cycle would be the combination of Blina and Venetoclax(VEN). As for consolidation therapy, we suggest the bone marrow transplantation. The purpose of this study is to explore the safety and efficacy of the treatment regimen in the treatment of newly diagnosed young Ph-negative B-ALL patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Before enrollment, patients must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and be negative for Philadelphia chromosome. The diagnostic criteria refer to the 2022 WHO classification; 2. Age≥15 years， ≤59 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time ≥ 2 months; 5. No organ dysfunction that would restrict the use of this protocol during the screening period; 6. Understand the study and sign the informed consent form. 7. Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.

Exclusion Criteria:

* 1. Patients with known central nervous system (CNS) involvement of ALL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.); 3. Cardiac ultrasound LVEF \< 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Unable to understand or comply with the study protocol.
Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

The clinical trial aims to evaluate the clinical and radiographic success of Zinc oxide- propolis versus Zinc oxide -Eugenol as obturating material in pulpectomy of non-vital primary teeth.

Pulpectomy is considered the most convenient way to treat the non-vital primary teeth as it preserves the affected tooth to maintain the length and integrity of the dental arch until exfoliation4. Zinc oxide-eugenol cement (ZOE) has been used as a root canal filling material for primary teeth and has long been the material of choice of pediatric dentists worldwide, although it fails to meet the ideal requirements of root canal filling material for primary teeth due to limited antimicrobial action, and a slower rate of resorption than the roots of the primary teeth. Concerns about these drawbacks of ZOE directed to search for alternative obturating materials for primary teeth.

Propolis, a natural resinous substance, is collected by honey bees with potent antimicrobial and anti-inflammatory properties. The main chemical constituents present in propolis are flavonoids, phenolics, and other aromatic compounds. Considering these beneficial effects of propolis, a zinc oxide-propolis mixture is suggested to increase the survival rate and improve the treatment prognosis of non-vital primary teeth.

Eligibility Criteria:
Inclusion Criteria:

* Children 4-6 years
* Non-vital primary molars
* Teeth with radiographic evidence of minimum bone loss.

Exclusion Criteria:

* Primary molars with less than two-thirds of the remaining root length
* Molars demonstrating extensive external or internal resorption,
* Teeth exhibiting greater than Grade I mobility
* Non-restorable with stainless steel
* Children whose parents or caregivers did not give consent for the study
Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA)

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies


Eligibility Criteria:
Inclusion Criteria:

* Males and females \> 18 years of age
* Active PsA with \> 3 tender and \> 3 swollen joints despite standard therapy
* Unsatisfactory response or intolerance to at least one prior or ongoing DMARD (study enrollment must be in accordance with current national guidelines for treatment of PsA with TNF inhibitors)
* A negative serum pregnancy test (serum HCG) for women of childbearing potential prior to the start of treatment.
* Use of a reliable method of contraception by all female patients of childbearing potential
* Able and willing to self-administer sc injections or have a suitable person to administer sc injections
* Able and willing to give written informed consent and comply with the protocol

Exclusion Criteria:

* Prior treatment with any investigational agent within 30 days or five half lives of the product, whichever is longer
* Treatment within last 2 months with infliximab or within last 3 weeks with etanercept
* Treatment within last 4 weeks with a combination of MTX and leflunomide
* Treatment within last 4 weeks with a combination of cyclosporine with any other DMARD-Subject has received UVA phototherapy (including PUVA within 2 weeks prior to screening)
* History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia
* History of or current active acute inflammatory joint disease of origin other than PsA
* Comorbidities (uncontrolled diabetes, unstable ischemic heart disease, CHF, active IBD, stroke within 3 months, chronic leg ulcer and other condition which would put subject at risk by participation in the protocol
* Positive serology for hepatitis B or C
* History of positive HIV status
* Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment
* Females who are pregnant or breast-feeding
* History of clinically significant drug or alcohol abuse in the last year
* Previous diagnosis or signs of central nervous system demyelinating diseases
* History of tuberculosis, histoplasmosis or listeriosis
* Subjects with latent TB or having other risk factors for activation of latent TB who have not initiated a TB prophylaxis prior to the first adalimumab treatment .
Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion

Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects at the age between ≥18 and ≤80 years old;
2. De novo native lesion, Median type 010/001 bifurcation lesion;
3. The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
4. Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.

Exclusion Criteria:

1. The diameter stenosis of adjacent branch vessel ostium ≥50%;
2. Acute ST-segment elevation myocardial infarction;
3. Stents implanted within 10 mm proximal or distal to the target lesion;
4. Aneurysm within 10 mm proximal or distal to the target lesion;
5. There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
6. Previous coronary artery bypass grafting;
7. Evidence for extensive thrombus within target vessel;
8. Evidence of heart failure by at least one of the following: a. Most recent LVEF ≤35%, or b. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or c. Killip class ≥2 (post STEMI patients);
9. Subjects with a life expectancy of ≤1 year;
10. Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months;
11. Subjects with severe renal failure (eGFR\<30ml/minute), failure to comply with angiography conditions;
12. Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
13. Subjects who are intolerance or allergic to heparin, contrast agent;
14. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
15. Subjects who are not applicable to be enrolled by investigators due to other reasons.
Residual Curarization and Its Incidence at Tracheal Extubation in China

This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.

This is a prospective, multi-site, anesthesiologist and PACU nurse TOF-Watch SX® blinded observational study of surgical patients undergoing elective laparoscopic or open abdominal procedures requiring general anesthesia and non-depolarizing neuromuscular blockade. There are two temporal aspects to the data collection: a prospective data collection in the OR and PACU; and a retrospective chart review one week after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18;
* American Society of Anesthesiologists(ASA) class 1-3;
* Scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours;
* Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade;
* Planned for extubation to occur in the OR;
* Signed informed consent.

Exclusion Criteria:

* Redo surgery on the same hospital admission;
* Pre-established need or expected to require post-operative mechanical ventilation;
* Conditions, surgical procedures, or participant positioning that may interfere with TOF-Watch SX® operation, calibration, or accuracy;
* Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method);
* Pregnancy;
* Participation in any other clinical trial;
* Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.
Neuropathic Pain in Survivors of Breast Cancer

The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in breast cancer survivors and 2) to develop preliminary statistical risk models for predicting the risk for NP incorporating disease-related variables (e.g., stage of disease, location of tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race).

Researchers will also gather data to answer the following secondary aims:

1. To assess the impact of NP on quality of life.
2. To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.

You have already been contacted by phone about participating in this study. You have received study documents (this consent and the study questionnaires) because you said over the phone that you would like to participate in this study.

In this study you will be asked to complete questionnaires that will ask about any pain you may be experiencing and about the quality of your life. These questionnaires will also ask for demographic information (such as age, race, and sex) and about your health. It should take about 1 hour to complete all of the questionnaires. In addition to the questionnaires, you will also be asked questions about any medications you may currently be taking for pain. All of the information you include on the questionnaires will be kept confidential. There are no right or wrong answers to the questions. A postage-paid return envelope has been provided for you to return this consent and the questionnaires.

Researchers are interested in how pain is related to certain treatments and medical conditions. As part of this study, researchers will review your medical records to see what type of cancer treatment you received and whether you had any pain related to the treatment. They will also see if you had any non-cancer health conditions that may have affected pain and quality of life.

This survey is for research purposes only. Your healthcare provider will not be informed of your responses to this survey. If you are experiencing severe pain and/or other symptoms, please contact your healthcare provider. The study staff has also included a list of community resources that you may contact for different types of services.

Your participation in this study will be over once you mail back the consent and questionnaires.

This is an investigational study. Up to 635 individuals will be asked to take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002) for taxanes during 1994-2001
* Alive and with current contact information
* Age ≥ 18 years. (This restriction is based on inclusion criteria for the clinical trials from which subjects will be recruited. All patients will be at least 18 years or older for this study.)

Exclusion Criteria:

1) None
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain in Dentistry Students

This study is designed to compare the short term effects of two different thoracic spine thrust manipulation techniques on neck range of motion, pain, and self-reported disability in a sample of dental students experiencing neck pain.

The hypothesis of the study is that there will be a difference between the two thoracic spine thrust manipulation techniques for short term effects on neck range of motion, pain, and self-reported disability in a sample of dental students experiencing neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Current student at the Arizona School of Dentistry and Oral Health (ASDOH) at A. T. Still University
* Primary complaint of neck pain with or without symptoms that spread down into one arm
* Overall rating of neck pain intensity is at least 3/10; the overall rating is the overall average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst pain possible".
* Neck Disability Index (NDI) score \> 10 points (measure of self-reported disability with a 0 to 50 point scale where higher scores indicate higher levels of disability.
* Proficient in speaking and reading English to complete outcome questionnaires

Exclusion Criteria:

* Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
* Neck pain that spreads down into both arms
* Low back pain or thoracic origin of pain
* Nerve root involvement; defined as the presence of two or more neurological findings (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
* Diagnosis of cervical spine stenosis (narrowing of the central canal that contains the spinal cord)
* History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
* Pending legal action related to current episode of neck pain
* Contraindications to thoracic spine thrust manipulation

  1. serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
  2. hyperreflexia
  3. unsteadiness during gait
  4. Nystagmus
  5. Loss of visual acuity
  6. Impaired sensation of the face
  7. Altered taste
  8. The presence of pathological reflexes
  9. pregnancy or considering pregnancy
Tecfidera and the Gut Microbiota

The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
* Female subjects of childbearing potential who are not surgically sterile must practice effective contraception according to the summary of product characteristics (SPC) during their participation in the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Key Exclusion Criteria:

* Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
* Antibiotic treatment in the last month prior to study entry.
* Scheduled alteration of diet, including the use of probiotics.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Prothrombin Time Predicts Steroid Response in Severe Alcoholic Hepatitis.

Alcoholic hepatitis (AH) is the most severe form of acute alcohol-related liver disease. Maddrey's discriminant function (mDF) \>32 defines the severe form of AH, which is associated with a high mortality. Corticosteroid therapy (CS) represents the main medical treatment that may reduce short-term mortality. Lille score at day 7 assesses the therapeutic response to steroid therapy. At present, no parameters able to predict the response to steroid therapy have been highlighted. The mDF depends mainly on prothrombin time (PT). Aim of the present study was to evaluate if the PT value could predict the response to CS in severe AH (sAH).


Eligibility Criteria:
Inclusion Criteria:

- clinical diagnosis of first episode of severe alcoholic hepatitis with Maddrey's function score of 32 or higher, and the absence of contraindication to CS therapy (non-controlled infections/sepsis, hepatic encephalopathy, recent acute gastrointestinal bleeding, severe kidney dysfunction). The diagnosis of AH was based on the criteria of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Alcoholic Hepatitis Consortia (Crabb DW, 2016). In particular, were enrolled in the study patients with: heavy alcohol use for \>6 months, with an average consumption of more than 3 drinks (∼40 g) per day for women and 4 drinks (∼50-60 g) per day for men and with \<30 days of abstinence before the onset of jaundice; AST/ALT ratio \> 1.5 with an AST level \> 45 IU/L (1.5 times upper limit of normal) and \< 400 IU/L; serum bilirubin \>3 mg/dL.

Exclusion Criteria:

* acute or chronic viral hepatitis,
* nonalcoholic steatohepatitis,
* cocaine use,
* drug-induced liver injury,
* fulminant Wilsons disease,
* hepatocellular carcinoma,
* portal vein thrombosis,
* biliary obstruction,
* severe autoimmune liver disease,
* neoplasms,
* severe comorbidities.