cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma

The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.

Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients must satisfy all the following criteria for entry into the protocol:

Primary CBCL including (according to WHO/EORTC classification 2005) :

* Primary cutaneous marginal zone B-cell lymphoma
* Primary cutaneous follicle center B-cell lymphoma
* Primary cutaneous diffuse large B-cell other than leg type

  * Histologically consistent with primary CBCL.
  * Relapse or active disease after radiotherapy or other adequate therapy if radiotherapy was contra-indicated (chemotherapy, surgical excision, interferonα, rituximab).
  * Performance status of 0, 1 on the Eastern Cooperative Oncology Group (ECOG) scale (See Appendix E).
  * Minimum Life Expectancy \> 3 months.
  * Adequate blood count: hemoglobin \>= 10.0 g/dL; White Blood Count (WBC) \>= 3.0 x 109/L; and platelet count \>= 75 x 109/L.
  * Adequate hepatic function: bilirubin =\< 1.5 times the upper limit of normal and serum transaminase (SGOT and SGPT)=\< 2.5 times the upper limit of normal.
  * Adequate renal function: creatinine =\< 1.5 times the upper limit of normal.
  * Written informed consent from patient.

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

* Primary cutaneous diffuse large B-cell lymphoma, leg type.
* Primary cutaneous intravascular large B-cell lymphoma.
* Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
* No histologic documentation of CBCL.
* History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
* Serious uncontrolled, concomitant medical disorders.
* Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab...(not limited listing)
* Major surgery in previous 4 weeks preceding the 1st injection.
* Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
* Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
* Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
* Patient previously included in this study.
* Non compliance with the study.
Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide

A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male;
2. Age 18-40 (including threshold);
3. Weight ≥ 50 kg, body mass index (BMI): 19.0\~26.0 kg/m2 (including critical value);
4. Volunteers (and their spouses) must not plan for childbearing or sperm donation within one month prior to signing the informed consent form and from the period of taking the research drug until three months after stopping it;
5. Be able to communicate well with the investigators and understand and comply with the requirements in this study.

Exclusion Criteria:

1. Those have allergic constitution, or those with a known history of allergies to study drug or their excipients
2. Physical examination, vital signs, blood-routine examination, blood biochemistry, infectious disease screening, coagulation function, urine-routine examination, chest x-ray, B ultrasound and other examination results are abnormal and judged by the research doctor as clinically significant.
3. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive, syphilis antibody positive;
4. Previous history of urinary tract infection or genital infection;
5. Previous history of hypoglycemia and other important diseases;
6. Those who have used other experimental drugs or medical devices within 3 months before screening;
7. Those who seek medical within 3 months prior to screening, which are judged by the research doctor to be unfit for participants;Those who have undergone any surgery within 6 months prior to screening;
8. Those who donate blood or other reasons of bleeding cause the total loss of blood more than 400mL or receive blood transfusions within 3 months before screening;
9. Have used any drugs in two weeks prior to taking the study drug;
10. Can not comply with the unified dietary arrangement;
11. Alcohol abuse, or those who smoke more 5 cigarettes per day in the 6 months prior to screening;
12. Positive alcohol breath test,or positive drug screening;
13. From 3 days before taking the study drug, subjects have xanthine-rich beverages or food, or grapefruit and other fruits or juices that may affect metabolism;
14. Subjects who are judged by researchers to be unsuitable for participating in this test.
Phase I Study of PDR001 in Patients With Advanced Malignancies.

The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
* ECOG Performance Status ≤ 2

Exclusion Criteria:

* Active autoimmune disease
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Prior PD-1- or PD-L1-directed therapy

Other protocol defined inclusion/exclusion may apply.
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery

Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to have significantly decreased venous thromboembolism risk (VTE), which is desirable. However, 30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who are over-anticoagulated are significantly more likely to have ADEs including bleeding requiring return to the operating room, need for blood transfusion, or death. The optimal way to dose enoxaparin to minimize ADEs remains unknown. This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

Eligibility Criteria:
Inclusion Criteria:

* receiving plastic and reconstructive surgery under general anesthesis
* Expected post-operative stay of 2 days or more

Exclusion Criteria:

* Contraindication to use of enoxaparin
* intracranial bleeding/stroke
* Hematoma or bleeding disorder
* Heparin-induced thrmbocytopenia positive
* Creatinine clearance less than or equal to 30 mL/min
* Serum creatinine greater than 1.6 mg/dL
* epidural anesthesia
* patients placed on non-enoxaparin chemoprophylaxis regimens
* gross weight exceeding 150kg
BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients

The objectives of this study is to establish the natural history of BK virus viremia and other possible opportunistic viral pathogens in renal transplants recipients.

This is a Natural History study in renal or renal-pancreas transplant recipients. In an effort to capture patients early in the course of an evolving BK virus infection and avoid patients who have already developed evidence of BKV-induced nephropathy (BKVN), this protocol will emphasize the initiation of screening in the early post-transplant period. Patients who have undergone renal or renal/pancreas transplantation within 4 weeks, but not more than 90 day previously, will be asked to participate and then consented to be enrolled in a Natural History-Surveillance period for up to approximately 24 months. Participants enrolled in this study will provide valuable natural history data regarding BKV viremia, and potentially other viral pathogen, in the post-renal transplant period. Participants will provide blood samples to undergo measurement for plasma BKV DNA by PCR approximately every 6 weeks, to be resulted in real time at the UAB Diagnostic Virology Laboratory at UAB.

Eligibility Criteria:
Inclusion Criteria:

Renal or renal-pancreas transplant patients who are within 4 weeks and not more than 90 days post-transplant with or without qualifying BKV viremia Age greater than or equal to 18 years; Provides written informed consent.

Exclusion Criteria:

Evidence of proven or suspected BKVN by clinical or pathologic diagnostic criteria Loss of renal graft function Initiation of chronic dialysis
Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes

The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180 healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes per week. Women will be randomized to one of three arms: 4.5 grams/day (dry weight of extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 40 to 60.
* Currently receiving medical care from a health care provider.
* Self-report 5 hot flashes per day or 35 hot flashes per week.
* Postmenopausal as defined by 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 30mlU/ml or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or hysterectomy with FSH levels \> 30 mlU/ml.
* Agree not to start new herbal or dietary supplements and not to change the dose of any currently used herbal or dietary supplements for the duration of the trial.
* Successful completion of a Hot Flash Diary, a Daily Study Medication Diary and a Bleeding Diary, tolerates placebo, and 80% compliant at run-in.
* Must have had a mammogram within the last 9 months.
* Have access to a phone.
* Provide informed consent.

Exclusion Criteria:

* Inability to sign an informed consent or fill out questionnaires.
* History of breast, uterine or ovarian cancer or melanoma.
* Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
* Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
* Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
* Unexplained abnormal uterine bleeding within six months of enrollment.
* Pregnancy or lactating.
* Clinical evidence of active ischemic cardiovascular disease or a history of cardiovascular disease.
* History of deep vein thrombosis or pulmonary embolism requiring anticoagulation.
* Active liver or gallbladder disease.
* Use of medications, herbal or dietary supplements known to possibly be effective for the treatment of hot flashes within three months of enrollment for oral or transdermal drugs, or within 6 months of enrollment for implanted or injected drugs.
* Use of raloxifene or tamoxifen within three months of enrollment.
* Use of another investigational agent within 3 months of enrollment.
* History of multiple or severe food or medicine allergies.
* Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial, including severe illness, plans to move, substance abuse, significant problems, or dementia.
Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation

Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) parameters predictive of tumor response and local control

The identification of robust prognostic and predictive markers could allow the individualization of pulmonary stereotactic radiotherapy treatments and the selection of patients at high risk of relapse, who could then benefit from a dose escalation in order to increase the chances of local control .

Beyond the pulmonary RTS (Radiotherapy in stereotactic condition), this study will aim to generate one or more models of multi-scale response to hypofractionated irradiation from biomarkers (biological or images) extracted from preclinical or clinical literature data and to allow simulations of Various modified fractionation irradiation schemes, potentially leading to new regimens that reduce side effects and increase therapeutic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Performance Index WHO (World Health Organization) ≤ 2
* Bronchopulmonary carcinoma not in small cells proved histologically or cytologically (epidermoid, adenocarcinoma, or large cell carcinoma).
* Tumor classified T1 - T2 (Tumor=1-2) N0 (Node=0) M0 (Metastasis=0) and diameter ≤ 5 cm or Tumor classified T3 (≤5cm) N0M0 of the chest wall
* Tumor located more than 2 cm from the trachea and bronchus stem and more than 1.5 cm from the organs at risk
* Medically inoperable or refusing surgery
* Indication of stereotactic radiotherapy validated in multidisciplinary consultation meeting
* Formulation of consent

Exclusion Criteria:

* Age \<18 years.
* History of pulmonary irradiation
* Pulmonary surgery of the tumor
* Different histology of non-small cell carcinoma
* Patient with a T2 or T3\> 5 cm tumor or patients with a T3 tumor invading a structure other than the chest wall
* Patient with a tumor within 2 cm of the trachea and bronchus stem and within 1.5 cm of the organs at risk in the proximal area of the no fly zone (defined as a volume Located 2 cm in all directions of the proximal bronchial tree - Pulmonary metastases
* Declared pregnancy, breast-feeding
* Refusal to use effective contraception
* Against indication to the realization of the PET to the 18FDG (18-fluorodeoxyglucose)(uncontrolled diabetes)
* Refusal or inability to consent to participate in the study.
* Estimated life expectancy \<2 months in the absence of treatment
* Other invasive tumors diagnosed in the previous 2 years, with the exception of non-melanocytic cutaneous carcinomas.
Diagnostic Performance of Shear Wave Dispersive Imaging in Breast Lesions: Comparison With Shear Wave Elastography

Human soft tissue such as breast tissue has viscoelasticity property. However, most ultrasound has only been measured for elasticity and viscosity has been neglected. Shear wave elastography (SWE) is a ultrasound technique that quantifies tissue elasticity. Shear wave dispersion (SWD) imaging is a newly developed ultrasound technique that evaluates the dispersion slope of shear waves, which is related to the viscosity of biological tissues. The goal of this retrospective study was to compare diagnostic performance between SWE and SWD to distinguish benign from malignant breast masses and to investigate additional role of SWD. Using histological diagnosis of breast lesions as a standard reference, quantitative indices of SWE and SWD were evaluated to diagnose breast cancer, and the diagnostic performance of SWE and SWD was compared.

This retrospective study was approved by our institutional review board, which waved the requrement for informed consent. The investigators obtained quantitative parameters of SWE and SWD of solid breast lesions before biopsy. The investigators measured average tumor elasticity and tumor-to-fat elasticity ratio on SWE and average tumor dispersion and tumor-to-fat ratio and on SWD from each breast lesion. Diagnostic performance of SWE and SWD was compared using the area under the curve (AUC), sensitivity, specificity, and accuracy.

Eligibility Criteria:
Inclusion Criteria:

* patients with histological results

Exclusion Criteria:

* patients without histological results
Mechanisms for Alcohol Treatment Change [MATCH] Study

A 5-arm randomized trial to determine what components of a text message intervention are necessary to reduce hazardous drinking among young adults and mechanisms through which these changes occur.

Young adults ages 18-25 have high rates of hazardous alcohol use and alcohol-related consequences. The Emergency Department (ED) provides an important opportunity to identify young adult hazardous drinkers who could benefit from interventions. A Text Message (TM) intervention was shown to reduce alcohol consumption among young adult ED patients, showing durable effects over 9-months. The TM intervention uses behavior change techniques with the largest effect sizes in an alcohol intervention meta-analysis: "goal commitment" and "self-monitoring", along with real-time "feedback". However, the unique effect of these ingredients, and mechanisms (processes occurring within the individual) through which they operate to reduce drinking remain unclear, a critical gap addressed by this project. Young adult ED patients (ages 18-25) who screen positive for hazardous drinking will be recruited to participate in a randomized trial to determine how best to help individuals reduce hazardous drinking. All participants will be asked to complete web-based surveys at baseline, 12 and 24 weeks after enrollment, complete brief psychomotor tasks weekly for 14 weeks, and respond to text messages each Thursday and Sunday for the next 12 weeks. Those randomized to the TM interventions will additionally receive feedback on their text reports. The four TM intervention arms are: (1) Drinking Cognition Feedback (DCF), (2) Alcohol Risk Feedback (ARF), (3) Adaptive Goal Support (AGS) and (4) a combination of DCF, ARF, and AGS=COMBO). Study results have implications for designing efficient mobile interventions, and developing a dynamic theory of behavior change.

Eligibility Criteria:
Inclusion Criteria:

* total score of \>2 for women or \>3 for men on the AUDIT-C
* at least 1 binged drinking episode in the prior 30 days

Exclusion Criteria:

* no cell phone with text messaging
* have been diagnosed with an alcohol or substance use disorder
* pregnant or planning pregnancy
* taking medicine for a psychiatric disorder (including depression, anxiety)
* taking any medicine that could interact with alcohol
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur

The purpose of this study is to look at two different types of surgeries regularly used for treating cancer that has spread to and weakened the thigh bone (femur). Because it is not known which of these surgeries is best, the investigators will compare the results of the two procedures. They are looking to see if differences exist (after surgery) in function, quality of life, pain control, and possible complications.


Eligibility Criteria:
Inclusion Criteria:

* Surgeon's estimated survival ≥ 1 month
* Patients presenting for orthopaedic evaluation with a painful impending pathologic femur fracture or displaced pathologic femur fracture in the intertrochanteric, pertrochanteric, or subtrochanteric region of the proximal femur. The anatomic region of interest is defined by a line drawn from the base of the femoral neck to 5 cm below the base of the lesser trochanter or 2 diaphyseal shaft widths, whichever is greater.
* Patients with an impending fracture who have had bevacizumab are eligible provided there will be a 3-week window between their last infusion and surgery.
* Diagnosis of widespread visceral and/or osseous metastatic disease based on clinical and radiographic evidence. (Patients may continue on study if surgery shows a non-malignant process.)
* All cancer diagnoses, except lymphoma, will be eligible

Exclusion Criteria:

* Estimated survival \<1 month
* A large soft tissue mass or other disease involving an area outside of the defined pertrochanteric anatomic region described above. (Patients excluded based on intraoperative findings will be replaced on the study.)
* Prior surgical treatment of the area (i.e., revision cases). A biopsy does not constitute prior surgical treatment.
* Radiographic evidence of an intramedullary occlusion by blastic metastases that would necessitate an alternative method of treatment, such as a plate/screw construct.
* Diagnosis of lymphoma
* Age \< 18 years
* Patients with advanced hip arthritis on radiographic imaging
* Previous randomization for a contralateral procedure as part of this study
Balance Training vs. Balance Training w/ STARS

Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains and other residual impairments. CAI has been linked to many different causative factors including sensory and motor deficits that affect the global function of the sensorimotor system as well as the patient. Over the past 20 years, strong evidence has been generated to support balance training as an effective intervention strategy in the CAI population. Unfortunately, most investigations have focused solely on maximizing motor output through balance training, while ignoring the full spectrum of sensorimotor dysfunction associated with CAI. There may be advantageous sensory-targeted interventions that augment the effects of balance training and lead to greater enhancements of functional outcomes for CAI. However, this possibility has not been systematically explored. Sensory-targeted ankle rehabilitation strategies (STARS), such as joint mobilization and plantar massage have resulted in improved sensorimotor function in those with CAI. However, only a single STARS (i.e. stochastic resonance) has been investigated in combination with balance training. While the combined effects were greater than those of balance training alone, stochastic resonance requires relatively expensive equipment that is not commercially available. Thus, the purpose of this investigation is to test the hypothesis that combining low cost STARS (e.g. plantar massage and joint mobilizations) with balance training will result in greater sensorimotor and functional improvements in those with CAI than balance training alone.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 35.
* A history of at least one episode of "giving way" within the past 3 months.
* Answering 4 or more questions of "Yes" on the Ankle Instability Instrument (AII).
* Score of \<90% on the self-reported Foot and Ankle Ability Measure (FAAM).
* Score of \<80% on the FAAM Sport.

Exclusion Criteria:

* Failing to meet the inclusion criteria.
* Known balance and vision problems.
* Acute lower extremities and head injuries that occurred \<6 weeks ago.
* Chronic musculoskeletal conditions known to affect balance.
* A history of ankle surgeries to fix internal derangements.