cyrilzakka/clinical-trials huggingface dataset:
Tislelizumab Combined Treatment in Refractory Extranodal NK/T-cell Lymphoma

Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.

About 20-30% of early-stage patients and 40-60% of late-stage NKTCL patients will experience disease relapse and refractory disease, and the median survival time of relapsed patients is about 6 months. PD-1 antibody is an effective drug for the treatment of patients with relapsed/refractory NKTCL, but the response rate and complete remission rate of monotherapy are low. How to improve the prognosis of patients is an important way to try combination therapy. In this study, we aim to explore the effectiveness and safety of a novel anti-PD-1 antibody, tislelizumab, in combination with different drugs (tislelizumab plus azacytidine and lenalidomide, or tislelizumab plus etoposide and pegaspargase) to treat refractory NK/T.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma.
2. With progressive disease after asparaginase-based combined chemotherapy
3. Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease.
4. PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion.
5. General ECOG score 0-3 points.
6. The laboratory examination within 1 week before enrollment meets the following conditions:

   Blood routine: Hb\>80g/L, PLT\>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Blood coagulation test: plasma fibrinogen ≥1.0g/L. Heart function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular block of degree I or more.
7. Signed informed consent form.
8. Voluntarily comply with research protocols, follow-up plans, laboratory and auxiliary examinations.

Exclusion Criteria:

1. Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded).
2. Severe infections require ICU treatment.
3. Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded.
4. There are serious complications such as fulminant DIC.
5. Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months.
6. Pregnant and lactating women.
7. Have a history of autoimmune diseases, have disease activity in the past 6 months, and are still receiving oral immunosuppressive therapy within the past three months, and the daily dose of oral prednisone is greater than 10 mg.
Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients with inadequate glycaemic control with diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Patients should be drug naïve ie, not received medical treatment for diabetes
* HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

Exclusion Criteria:

* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
* Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy (PROTECT-04)

This is a transversal monocentric study comparing two groups of women (group 1, patient group : patients who have been treated for a breast cancer with taxane-based chemotherapy ; group 2, control group : healthy volunteers). The aim of this study is to evaluate if a difference exists regarding the maximal isometric muscle strength between group 1 and 2.

All subjects will be evaluated a single time during two hours. For patients from group 1 the evaluation should take place within the two weeks that follow the end of adjuvant treatment. There is no specificity regarding evaluation of volunteers from group 2, their evaluation can take place at any time.

Eligibility Criteria:
Inclusion Criteria :

Group 1 - Patients :

* Give written inform consent
* Age ≥ 18 years
* Affiliate to social security system
* Ability to speak, understand and read French
* Breast cancer, Stage II or III, treated by taxane-based chemotherapy

Group 2 - Control group :

* Give written inform consent
* Age ≥ 18 years
* Affiliate to social security system
* Ability to speak, understand and read French

Exclusion Criteria:

Group 1 - Patients :

* \< 18 years old or patients ≥ 18 years old under guardianship, or supervision
* Psychiatric, musculoskeletal or neurologic disorders
* Patients presenting one of the following contraindications to transcranial magnetic stimulation :
* Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.)
* History of epilepsy
* Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic)
* Women that are pregnant
* Serious or recent heart disease

Group 2 -Control group :

* \< 18 years old or patients ≥ 18 years old under guardianship, or supervision
* Psychiatric, musculoskeletal or neurologic disorders
* Pacemaker implantation
* History of cancer
* All known chronic disease
* Subjects presenting one of the following contraindications to transcranial magnetic stimulation :
* Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.)
* History of epilepsy
* Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic)
* Women that are pregnant
* Serious or recent heart disease
Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency

To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.

This is a parallel-group, multicenter, randomized controlled trial of 48 pregnancies with protein S deficiency in China. Patients are randomized into three groups to receive enoxaparin combined with aspirin, aspirin alone and no intervention. The primary outcome measure is livebirth rate.

Eligibility Criteria:
Inclusion Criteria:

1. Plasma activity levels of PS when not pregnant are below the lower limits of the adult reference values (generally about 60-70% for PS) without the use of warfarin. Or, free protein S antigen levels in the second and third trimesters are less than 30% and less than 24%, respectively
2. Pregnant women who delivered from Aug 1st, 2024 to Oct 15th, 2027
3. One or more family members exhibiting the same symptoms as the patient
4. Past history of early onset thrombosis (age 50 or below)
5. Repeated recurrence of thrombosis
6. Thromboses in unusual sites
7. New onset of thrombosis during current pregnancy or after delivery
8. Patients with diagnosis confirmed by gene analysis Inclusion criteria 1 and 2 must always be met regardless of items of 3-8.
9. Written informed consent

Exclusion Criteria:

1. Thrombophilia other than Protein S deficiency
2. Antiphospholipid syndrome, systemic lupus erythematosus, platelet abnormalities, vascular disorders, blood flow obstruction, paroxysmal nocturnal hemoglobinuria, malignant tumor and other conditions that tend to cause thrombosis
3. Allergy/hypersensitivity to enoxaparin or aspirin
4. Heparin-associated thrombocytopenia or thrombocytopenia (platelet count\<75 × 10\^9/L)
5. Organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm
6. uncontrolled hypertension or Severe hypertension (Systolic Blood Pressure \>200mmhg and/or Diastolic Blood Pressure \>120mmHg)
7. Severe hepatic failure (INR \>1.8)
8. Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine creatine clearance (\<30ml/min)
9. Abnormal uterine cavity on hysterosalpingogram/hysteroscopy
The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis

The object of the study is to evaluate the effect of Pugongying (Herba Taraxaci) Granules to reduce the application of antibiotics for women with acute mastitis.

Acute mastitis affects the health and quality of life of the infants and mothers during the lactation. Increasing studies indicate that bacterial infections and/or dysbacteriosis are essential to the mechanisms of the disease. Thus, antibiotics is widely used in clinical practice, especially cephalosporin in China. However, mistaking antibiotic will affect the physical function, even mothers' breastfeeding. The previous clinical trial that the investigators had conducted in the Third affiliated hospital of Beijing University of Chinese Medicine, has demonstrated that Chinese herbal medicine can act better than Cefdinir in the fever-relief time and breast pain scores. Some studies the investigators searched in the databases have showed that Pugongying (Herba Taraxaci) has a broad spectrum of antimicrobial activity, and it can regulate dysbacteriosis. At the same time, Pugongying (Herba Taraxaci) can also promote the secretion of milk and maintain the patency of milk well. The main ingredient of Pugongying (Herba Taraxaci) Granules is Pugongying herbs (Herba Taraxaci). Pugongying (Herba Taraxaci) Granules is approved by China Food and Drug Administration (CFDA) to treat acute mastitis. Although Pugongying (Herba Taraxaci) Granules is widely used in clinical practice, there is no trial to test the efficacy of Pugongying (Herba Taraxaci) for women with acute mastitis. Therefore, the investigators set three groups with Pugongying (Herba Taraxaci) Granules alone, Cefdinir alone and combination of Pugongying (Herba Taraxaci) Granules and Cefdinir.

Eligibility Criteria:
Inclusion Criteria:

1. Women in lactation who have strong willing to breastfeeding;
2. The course of acute mastitis should be within 3 days, and the ultrasound examination indicates there is no abscess cavity formed;
3. The body temperature is higher than 37.2°C but lower than 41°C;
4. The VAS scores of participants≥4;
5. Patients with acute mastitis have not received other medical therapies;
6. Those who have signed informed consent.

Exclusion Criteria:

1. Participants who suffered nipple ulceration, painful fissuring or developmental defects fail to breastfeed;
2. Participants with other breast diseases are not appropriate to breastfeed;
3. Participants with severe cognitive or metabolic diseases will affect breastfeeding;
4. Participants who have been allergic to penicillin and cephalosporin.
Day Zero Urinary Catheter Removal in Gen Thoracic Surgery Patients

Current standard of practice in study institution dictates day of surgery urinary catheter removal in general thoracic surgery patients receiving thoracic epidural analgesia. The investigators hypothesize that this practice results in low recatheterization rates secondary to urinary retention and low urinary tract infection rates.

Study Design A prospective study design will be utilized as data will be collected in a prospective manner and standard of care/current practice will be unaltered in the patient population.

Sampling will include all patients that meet the eligibility criteria from March 01, 2011 until August 01, 2011 with a goal of forty-five patients.

Data Collection Protocol

1. The patient will be interviewed and given information regarding participation in the study by Principal Investigator and/or research team prior to surgery. Informed Consent Forms will be collected by Principal Investigator and/or research team. Principal Investigator and/or research team will collect all data on Data Collection Sheet.
2. Thoracic epidural will be placed by the anesthesiologist in pre-op per standard protocol.

   * Location of epidural will be documented by Principal Investigator and/or research team on Data Collection Sheet. (See Appendix 1)
3. Prior to surgery, if indicated, an indwelling urinary bladder catheter will be placed per pre-operative protocol.
4. Post-operative documentation of time, type and settings for epidural infusion will be documented on Data Collection Sheet.
5. Post-op eligible patients admitted to cardiothoracic step-down unit will be placed on the following protocol:

   * Thoracic Epidural will be managed by the anesthesia group.

     * Any change in prescription or dosing will be documented on the Data Collection Sheet.
   * If urinary catheter present, will be discontinued at midnight day of surgery, Day Zero; the time of discontinuation will be noted on the Data Collection Sheet.

     * If micturition occurs, amount and time will be documented on Data Collection Sheet.
     * If no spontaneous void by 0800 post-operative day (POD) 1, bladder scanning will be initiated.
     * If ≥ 400 cc per bladder scanner, the thoracic surgeon, surgeon's nurse or the Principal Investigator will not notified.
   * Any ordered interventions, the response and re- evaluation will be noted on Data Collection Sheet.

     * Urinary retention will be defined as \> 400 cc and recatheterization (either intermittent or indwelling) will occur.
6. Data will only be collected during current surgery hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* All general thoracic surgery patients with a thoracic epidural catheter.

Exclusion Criteria:

* Men \> 65 years old
* History of urologic procedure
* Known benign prostatic hyperplasia
* Admission to intensive care units
* History of urinary retention
* Foreign speaking patient
* Pregnant women and those less than 18 years old
Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract.

PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.

OBJECTIVES:

* Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids.
* Minimize the serious side effects associated with systemic steroid use in these patients.

OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year.

PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract

  * Failed standard therapy with or has a contraindication to systemic immunosuppressive agents
* No clinically significant intestinal infection (confirmed by stool culture)
* No persistent vomiting of all oral intake
* Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol

PATIENT CHARACTERISTICS:

Age

* 4 to 70

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to swallow medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* Not specified

Surgery

* Not specified
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu

Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28

Eligibility Criteria:
Inclusion Criteria:

Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent

-

Exclusion Criteria:

No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
* Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.
* Life expectancy \> 12 weeks.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Laboratory values outside the Protocol-defined ranges.
* Clinically significant cardiac disease.
* History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.
* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
* Known additional malignancy that is progressing or requires active treatment.
* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
* Prior receipt of an anti-PD-L1 therapy.
* Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* A 28-day washout for systemic antibiotics is required.
* Probiotic usage while on study and during screening is prohibited.
* Active infection requiring systemic therapy.
* Known history of Human Immunodeficiency Virus (HIV)
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

This study is designated to:

1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer.
2. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
3. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and Age ≤ 75
* Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%
* Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment
* Full understand the informed consent form, and signed it voluntarily

Exclusion Criteria:

* Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception
* Be allergic to any component of the drug or showed allergic constitution
* Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI
* Have malignancy in the ulcer pathology test, or have a history of malignant tumor
* Unable to clean the wounds due to the formation of tract between the ulcer and other condition
* Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency virus (HIV), or treponema pallidum
* Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the normal value, or Cr\>200 μmol/L
* Have a history of apoplexy, unstable angina pectoris, myocardial infarct
* Have a psychiatric history, drug abuse or alcohol abuse history
* Had participated in any other clinical trials in the past 3 months
* Any other circumstances judged by the researchers disqualify the patient to participate in the trial
An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries

This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.


Eligibility Criteria:
Inclusion Criteria:

* After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

* Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months. Women of childbearing potential who are not using adequate contraceptive methods