cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas

Identification of T cell inhibitory signals, including PD-1/PD-L1, has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. However, elimination of cancer by T cells is only one step in the Cancer-Immunity Cycle, which enable providing several therapeutic targets and tailoring of combinations of immune therapies. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This study is a first-in-man, Phase I, 3 + 3 dose escalation study of a combined regimen of Manganese and anti-PD-1 antibody with or without chemotherapies in subjects with unresectable/ metastatic solid tumors or lymphomas. This study is designed to assess the safety, tolerability, pharmacokinetic profile (PK profile), mode of delivery and Recommended Phase 2 Dose (RP2D) of this regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histologically proven unresectable/ metastatic solid tumors or lymphomas.
2. ≥ 18 years old.
3. Life expectancy of at least 6 months.
4. Eastern Cooperative Oncology Group performance status 0-2.
5. Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
6. Subjects must have received at least two frontline therapies, except for patients initially diagnosed with local advanced or metastatic pancreatic cancer or cholangiocarcinoma.
7. Subjects must be off prior therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Subjects with Anti-PD-1 antibody are eligible which must be resistance.
8. Adequate organ function.
9. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. T cell lymphomas or leukemia.
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

The purpose of this study was to assess the continued safety of topical use of SD-101 cream (6%) in participants with Epidermolysis Bullosa (EB).

Funding Source: FDA Office of Orphan Products Development

This was an open-label extension study to assess the continued safety of topically applied SD-101 dermal cream (6%) in participants with Simplex, Recessive Dystrophic, and Junctional non-Herlitz EB.

SD-101 dermal cream (6%) was applied topically, once a day to the entire body for the duration of the study. Participants who successfully completed the entire SD-003 study (NCT02014376) had the option to roll over into the SD-004 study (NCT02090283). The baseline visit occurred at the final visit date for the SD-003 study. The body surface area (BSA) coverage of blisters and lesions assessment made at the final SD-003 study visit were used as the baseline information at the baseline visit for the SD-004 study. Participants returned to the study site for the following 13 visits (36 months) to have BSA assessed. BSA was assessed at all subsequent scheduled study center visits. Scheduled study center visits occurred every 6 months after Month 36 (Month 42, 48, and so on). After completion of Month 36, the next participant visit (Month 39) was a phone call from the site to the participant. Telephone visits occurred every 6 months thereafter (Month 45, 51, and so on) and included assessment of adverse events and concomitant medications only. For female participants of childbearing potential, a urine pregnancy test was performed at Month 6 and every 6 months up to and including the final study visit.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed by the participant or participant's legal representative; if the participant is under the age of 18 but capable of providing assent, signed assent from the participant.
* Participant (or caretaker) must be willing to comply with all protocol requirements.
* Participant must have successfully completed the SD-003 study.

Exclusion Criteria:

* Participants who do not meet the inclusion criteria.
* Pregnancy or breastfeeding during the study. A urine pregnancy test will be performed at the final visit for SD-003 for female participants of childbearing potential.
* Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.

There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM.

Eligibility Criteria:
Inclusion Criteria:

* Ethnicity: all ethnic groups
* Gender: men and women
* Age

  1. Lower age limit: 40 years inclusive
  2. Upper age limit: NONE
* BMI

  1. Lower BMI limit: 25 inclusive
  2. Upper BMI limit: 40 inclusive
* Glucose Intolerance / Mild Diabetes defined as

  1. Fasting glucose ≥100 mg/dl OR
  2. 2-hr glucose after OGTT ≥140 mg/dl OR
  3. 5.8 ≤ Hemoglobin A1c ≤ 7

Major Exclusion Criteria:

* Diabetes requiring pharmacotherapy
* Smoking
* Hyperparathyroidism
* Hypercalcemia (Calcium \> 10.5 mg/dl)
* Kidney stone
* Pregnancy
BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study

This is an implementation type II hybrid study with randomisation in cluster, whose objective is to compare two strategies of implementation of the Brazilian cardioprotective diet guidelines in primary health care in two Brazilian cities. All health professionals from the health units (clusters) randomized to the intervention group will receive training on the subject. The health professionals from the health units randomized to the control group will follow the usual activities, receiving only the printed guidelines, as usually done. After 6 months, the prescription rate of the Brazilian cardioprotective diet will be evaluated, as well as the quality of the diet of patients in both groups.


Eligibility Criteria:
Clusters Inclusion criteria: All Public Primary Care Units from both cities will be included. However, the Health services that encourage health professionals to use the Cardioprotective Food manual before randomization will be excluded.

Participants (patients) Inclusion criteria:

* Individuals aged ≥20 years of either sex who have a previous medical diagnosis of at least one of the following conditions:
* Type 2 diabetes mellitus;
* Systemic arterial hypertension (Systolic blood pressure ≥140 mmHg or diastolic blood pressure greater than ≥90 mmHg or in drug treatment for hypertension);
* Isolated hypercholesterolemia: isolated increase in LDL-c (LDL-c ≥ 160 mg/dL).
* Isolated hypertriglyceridemia: isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL if the sample is obtained without fasting).
* Obesity or overweight (body mass index ≥25.0 kg/m2).

Exclusion Criteria:

* Prior cardiovascular event (acute myocardial infarction, stroke, peripheral arterial disease);
* Psychiatric or neurocognitive condition that prevents understanding of guidelines (defined by the clinical judgment of the investigators);
* Life expectancy less than 6 months (example: metastatic malignant neoplasm) to be defined by the investigator's judgment;
* Pregnancy or lactation;
* Liver failure with a previous history of encephalopathy or anasarca;
* Chronic renal failure;
* Organ transplantation;
* Gastroplasty for less than a year;
* Impossibility of oral feeding.
* No access to internet or mobile phone.
Genetic Risk Estimations for Influencing Decision Making in Women At High Risk of Breast Cancer, GENRE 2 Study

The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.

This is a minimal risk prospective multisite study with a single arm incorporating the PRS into a standard breast cancer risk reduction consultation, followed by annual surveys over 10 years to determine if and how the availability of the PRS influenced patient decisions regarding preventive medicine and medication compliance. Because women know beforehand that the PRS is pending, study participants will be advised that a final decision to take preventive medicine must be deferred until after the PRS results are made available. Nevertheless, a survey of understanding of risk and benefit and assessment of willingness to take preventive medicine will be done prior to receiving the PRS results and then another survey will be completed after receiving the PRS score.

Eligibility Criteria:
Inclusion Criteria:

* Women \>= 35 years old and =\< 75 years old with at least one of the following:

  * A National Cancer Institute (NCI)-BCRAT 5 year risk of \>= 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the United States (US) Preventative Services Task Force
  * IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of \>= 5%
  * History atypical ductal hyperplasia or atypical lobular hyperplasia with a BCRAT \>= 3% or IBIS \>= 5%
  * History of lobular carcinoma in situ with a BCRAT \>= 3% or IBIS \>= 5% OR
* Women \>= 18 years old or =\< 75 years old with a BRCA 1 or 2 mutation, CHEK 2, PALB 2, ATM, or other hereditary breast mutation carrier per investigator
* Willing and able to provide an email address to receive study surveys
* Able to participate in all aspects of the study
* Understand and sign the study informed consent

Exclusion Criteria:

* Women whose BCRAT falls below the threshold (\<3 % 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is \<8% for the 10 year risk
* Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole
* Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole
* Unable to give informed consent
* Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers
* At high risk due to prior radiation therapy to the chest
* Women who are pregnant or breastfeeding
* Prior risk reducing or prophylactic mastectomy
* Unwilling or unable to provide an email address for study surveys to be sent to
* Subject has a known history or any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALN-TTRSC04 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single ascending doses of ALN-TTRSC04.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.0 kg/m\^2 and ≤30 kg/m\^2 assessed at Screening.

Exclusion Criteria:

* Has an estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73m\^2 at screening.
* Has alanine aminotransferase (ALT), aspartate aminotransferase (AST) or direct bilirubin above the upper limit of normal (ULN).
Electro-massage in Subjects With Subacromial Pain Syndrome

Objectives: Establishing and validating an electrotherapy procedure with interferential current (IFC) application using electro-massage on patients who have undergone acromioplasty surgery. To evaluate the possible decrease in pain perception and improvement of functionality following surgical intervention.

Design: Randomized, single blind clinical trial. Subjects: 18-patients, aged 18 to 65, with a similar distribution of male and female participants Methods: 10-patients will be enrolled in the experimental group and 8 patients as the control group. Both groups of patients will undergo six physiotherapy sessions (three times a week). The experimental group will undergo a treatment consisting of electro-massage with constant voltage (CV) IFC bipolar application, 4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes will be used. Session length with electrotherapy will be approximately ten minutes.


Eligibility Criteria:
Inclusion Criteria:

* patients having undergone acromioplasty surgery in the three months prior to the first day of Physiotherapy treatment

Exclusion Criteria:

* Value equal to or less than 45 in Personal Psychological Apprehension Scale, showing any absolute contraindication for Physiotherapy or Electrotherapy treatment, fear or apprehension for Electrotherapy application, not signing informed consent, showing alterations in local level sensitivity (cervical-scapulohumeral complex), showing bone fracture associated with SCS, having been applied local infiltration with corticoids following surgery and having started Physiotherapy treatment before signing informed consent.
Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region

This study will investigate the ability of Lucerno Dynamics Lara sensor when placed on the palpable carotid artery (or femoral artery) to monitor blood flow following the injection of 18-FDG and to distinguish peak flow in tumor versus tissue uptake. Investigators will then assess if differences in tumor versus tissue correlates with tumor response.

Primary Objective: To determine if Lara sensors placed over the carotid and femoral arteries can measure the plasma activity of 18 F-fludeoxyglucose (18-FDG) at time of injection and determine if that peak activity in the artery can be distinguished from peak activity in malignant tissue to provide enough information to obtain the arterial input function.

Secondary Objective: To evaluate changes (baseline to post treatment) in tissue uptake at first pass (AUC and time to peak blood flow) and during the 60-minute period (metabolic activity) leading to the , positron emission tomography (PET) scan. This data is to be collected from the Lucerno Device placed over the carotid and femoral arteries monitoring 18 F-fludeoxyglucose (18-FDG) activity in blood and malignant tissue throughout the pre positron emission tomography (PET) scan period.

Eligibility Criteria:
Inclusion Criteria

* Squamous cell carcinoma of the nasopharynx, oral cavity, oropharynx or hypopharynx with palpable adenopathy in the neck. Biopsy proven within the last 90 days.
* Squamous cell carcinoma of the larynx regardless of lymph node status. Biopsy proven within the last 90 days.
* Age 18 or greater.
* Receiving definitive radiation therapy at Wake Forest University with or without concurrent systematic therapy.
* Participants must be able to provide study specific informed consent prior to study entry.
* Presence of metastatic disease is not an exclusion criteria provided subject will be receiving definitive doses of radiation to the local and regional disease.

Exclusion Criteria

* Cancers of the head and neck other than those stated above. This would include squamous cell carcinoma of unknown primary.
* No measurable disease in the head and neck (ie planned adjuvant radiation therapy for allowable cancers with high risk pathology following definitive surgery).
* Persons receiving less than curative doses of radiation.
* Age under 18
* Unable or unwilling to tolerate PET/CT scan
* Unable or unwilling to receive definitive treatment of their cancer at Wake Forest University
* Pregnant women
* Participants who present having already undergone a PET/CT will not be eligible for this study-because an important element of this trial is the assessment of 18-FDG uptake changes in response to treatment
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery

This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.

This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients undergoing a CABG, AVR, or CABG/AVR. Kidney injury biomarkers NGAL, Uromodulin, and Hepcidin-25 will be used to assess cardiac-induced kidney injury. Patients will be randomly enrolled in either standard care for fluid management or goal-directed fluid management with ACUMEN.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing cardiopulmonary bypass
* Procedure coronary artery bypass grafting, aortic valve replacement, or both

Exclusion Criteria:

* Patients \< 18 years old
* Emergent surgery
* Preoperative kidney disease (Cr \> 2.0 or on renal replacement therapy)
* Ejection fraction \< 40%
* Incomplete data in medical record
Ibuprofen Lozenge in Acute Sore Throat Pain

The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged at least 18 years old
* patient with an acute sore throat

Exclusion Criteria:

* Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
* Oro-pharyngeal paresthesia or mycosis
* Severely traumatised and/or very severe oromucosal inflammation
* Tonsillopharyngectomy
* Peritonsillar abscess
* Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients
* Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
* Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
* Any paracetamol intake within 6 hours before randomisation
* Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
* Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
* Heavy smokers (\>20 cigarettes/day)
4SCAR19U T Cells Targeting B Cell Malignancies

The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.

Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, the application itself is still limited by the high cost and long preparation time which often do not meet the urgent need of patients. In addition, some patients may suffer from long-term immunosuppression caused by tumor microenvironment or after radiotherapy and chemotherapy, resulting in exhaustion, aging and functional defects of the autologous T cells, which will eventually affect the quality of the CAR-T cells and affect the clinical efficacy.

The 4SCAR19U T cells are genetically engineered and manufactured in bulk amount that can be supplied off-the-shelf without being custom made from individual patients. The immediate availability of the CAR-T cells makes clinical treatment convenient and timely for rapid progressing disease or for the highly immune suppressed patients. This application can be time- and cost-effective. This novel approach may also overcome problems of functionally defective autologous T cells. The purpose of this clinical trial is to assess the feasibility, safety and efficacy of the 4SCAR19U T cell product in hematological malignancies. Another goal of the study is to learn more about the function of this novel product and its persistence in the patients

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 6 months.
2. Primary B cell surface expression of CD19.
3. The KPS score over 80 points, and survival time is more than 1 month.
4. Greater than Hgb 80 g/L.
5. No contraindications to blood cell collection.

Exclusion Criteria:

1. Accompanied with other active diseases, and difficult to assess response after treatment.
2. Bacterial, fungal, or viral infection, unable to control.
3. Living with HIV.
4. Active HBV or HCV infection.
5. Pregnant and nursing mothers.
6. under systemic steroid treatment within a week of the treatment.
7. Prior failed CAR-T treatment.
Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar

Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.


Eligibility Criteria:
Inclusion Criteria:

* older than 19 years
* depressed scar less than volume of 5 ml
* negative for urine beta-HCG for women of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* failure to meet inclusion criteria
* any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
* allergy to bovine-derived materials
* Diagnosis of cancer, AIDS, HBV or HCV.
* Patient has a lot of hairs or a tattoo on depressed site
* Insufficient adipose tissue for manufacturing of ANTG-adip
* Patient has depressed scar caused by a malignant tumor
* Patient whom investigator consider is not suitable in this study