cyrilzakka/clinical-trials huggingface dataset:
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.

Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m\^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.

Eligibility Criteria:
Inclusion criteria:

* A histologically confirmed diagnosis of PTCL
* Participants must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
* Participants must have at least one site of disease measurable in two dimensions by computed tomography (CT).
* Age ≥ 18 years.
* Adequate bone marrow, liver, and renal functions.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Negative pregnancy test for women of childbearing potential.

Exclusion criteria:

* Relapse within 100 days of autologous or allogeneic bone marrow transplant.
* Prior histone deacetylase (HDAC) inhibitor therapy.
* Co-existing active infection or any medical condition likely to interfere with trial procedures.
* Severe cardiovascular disease.
* Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
* Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
* Symptomatic or untreated central nervous system (CNS) metastases.
* Pregnant or breast-feeding women.
* Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
Can Non-invasive Sampling Determine the Inflammatory Status of the Intra-uterine Environment?

Preterm birth (birth before 37 weeks gestation) is a large problem in the United States and is a major cause of neonatal morbidity and mortality and childhood neurological disability. Despite significant advances in the care of pregnant mothers, the incidence of preterm labor is on the rise. There is growing recognition that cytokines and inflammatory mediators present at amniotic fluid and placenta play a fundamental role in regulating labor.

Cytokines are chemicals in the fluid that tell the body's immune system what to do. These (and other biomarkers) can be measured with a small amount (a few drops) of amniotic fluid. The researchers have previously shown that people at risk for preterm labor have higher cytokine levels. However, understanding the in-utero environment currently requires invasive sampling, such as amniocentesis, to determine cytokine concentrations. This procedure has inherent risks, causes patient discomfort and anxiety, and thus does not avail itself to routine use or repeated sampling, especially in non-high risk patients. Therefore, the researchers are looking for non-invasive sampling that can predict the in-utero environment.

To date, no studies have simultaneously evaluated different maternal-fetal compartments to determine the relationship of these markers among the compartments. Therefore, the purpose of this pilot study is to determine the differential expression of inflammatory mediators in various maternal-fetal compartments; specifically, vaginal fluid, cervical secretions, placenta, cord blood (arterial and venous), amniotic fluid, maternal serum, maternal urine, and maternal saliva.

The researchers seek to obtain fluid samples from nine maternal-fetal compartments and determine the inflammatory mediator expression in each. The timing of collection, location, and proposed studies for each of the samples is outlined in Table 1. In this pilot study, we plan to enroll 20 patients undergoing cesarean delivery.

After consent, the samples will be collected and given a unique Study ID number. No protected health information will be collected. In addition, there will be no link between the Study ID and patient identifiers. Therefore, we are not seeking HIPAA authorization at the time of consent. While none of these samples would routinely be collected as part of the standard of care, the collection procedures meet the criteria for minimal risk.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing cesarean delivery
* Able to provide informed consent, including permission of storage of specimens
* No apparent major fetal abnormality

Exclusion Criteria:

* Major Fetal Malformation
* Rupture of membranes
Impact of Acquired FXIII Deficiency on Morbidity and Mortality

Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality

All patients admitted to a large tertiary hospital with FXIII levels below 70% during their hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity and mortality is registered.

Eligibility Criteria:
Inclusion Criteria:

* FXIII levels \< 70%

Exclusion Criteria:

* None
Efficacy and Safety of Linggui Yangyuan Paste in Patients With Male Infertility

Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. The diagnosis of male infertility has a negative effect on men's physical and psychological status, poses a threat to their social relationships, lowers self-esteem, and disrupts family harmony. At present, the treatment of ASZ and OA are all mostly empirical, including antioxidants, endocrine therapy, and anti-infection. However, there are still limitations due to inefficiencies. Linggui Yangyuan paste (LGYY), a traditional Chinese compound herbal past, had been used to treat ASZ and OA for several years at the Xiyuan Hospital of China Academy of Chinese Medical Sciences. The investigators designed this program to study the efficacy and safety of LGYY for the treatment of patients with male infertility (AZS and OA).


Eligibility Criteria:
Inclusion Criteria:

* The participants must meet all following criteria at the time of randomization to be eligible for recruitment :

  1. Study participants met the diagnostic criteria for male infertility 1)inability to have a child after at least 1 year of marriage with regular sexual life and without using any preventive methods 2)normal fertile female partner
  2. Study participants met the diagnostic criteria for AZS or OA

For AZS:

1. sperm concentration ≥15 × 106/ mL
2. PR \<32%

For OA:

1. sperm concentration \<15 × 106/ mL
2. PR \<32% (3) Study participants met the TCM diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms

Exclusion Criteria:

* The trial exclusion criteria included any of the following:

  1. infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders
  2. with infertility caused by organic lesions of the reproductive system
  3. with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection
  4. with palpable varicocele
  5. with abnormal and clinical significance of sex hormone (FSH, LH, T)
  6. complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases
  7. with a history of allergy to any medicine or ingredients used in this study
  8. receive other relevant treatment for the disease 2 weeks before treatment
A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Fluimucil 600mg Granules in COPD Subjects

To evaluate the safety and efficacy of Taneasy 600mg granules and Fluimucil 600mg granules administered twice daily for 14 days in treatment of COPD Disease.

The study will enroll 40\~60 patients and complete 40 patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged older than 20\~75 years old.
* Able to sign informed consent prior to the study.
* The appearance of sputum and the difficulty of expectoration are both at level 2 or above.

Exclusion Criteria:

* Subjects with known hypersensitivity to Acetylcysteine preparations.
* Subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.)
* Pregnancy or breast-feeding woman.
* Female subjects or their sexual partners do not use contraception during the trial.
* Joining any drug clinical trial within 3 months prior to dosing.
* Investigator considered to be inappropriate for enrollment.
Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle

despite the large number of papers published on COH protocols comparing the efficiency of different exogenous gonadotropins, no confirmed protocol exists, and it is not quite clear which is superior to the others.

, the objective of the current study was to compare the efficacy of 2 different ovarian stimulation protocols, comprising hpFSH, HMG versus R-FSH on oocyte and embryo quality and IVF treatment outcome in patients undergoing IVF or intracytoplasmic sperm injection (ICSI)(4).

Eligibility Criteria:
Inclusion Criteria:

* 1-Aged 20-35 yr, male factor, 2-Tubal or unexplained infertility, 3-regular menstruation cycle between 21 and 35 days, 4-Normal function of uterus according to hysterosalpingography, hysteroscopy or transvaginal ultrasonography, 5-Normal ovaries according to transvaginal ultrasonography during past 6 months prior to study and compatible with normal adnexa and 6-Normal ovarian anatomy, and serum FSH level less than 8 IU/l All women showed no recognizable endometriosis according to symptoms and clinical examination in transvaginal ultrasonography or diagnostic laparoscopy. 7-7-All women have a history of unexplained infertility 8-Normal ovulatory function and normal semen analysis according to the World Health Organization criteria .

Exclusion Criteria:

* Patients with other ovulation disorders such as hypo and hypergonadotropic, hypogonadism, hyperprolactinemia.

  2-Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous history of systemic diseases such as endocrine and metabolic disorders.

  6- Previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders).

  7-Prior history of more than 3 unsucce
Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis

Sepsis is a disruption of homeostasis in the human body in response to bloodstream infection and is associated with a high risk of mortality.

Worldwide, sepsis is affecting approximately 30 million people and resulting in six million deaths.

Blood culture is a specific blood sample used to identifying microbial agent (bacterium or yeast) and determine the sensitivity of these microorganisms to antibiotics and antifungals.

Any delay in identifying the microorganism and/or determining the AST (antibiotic susceptibility testing) has a direct impact on the administration of appropriate antibiotic treatment and, consequently, on mortality of the patient. The faster the diagnosis, the faster the antibiotic treatment will be adapted, the higher the survival rate/probability of patients, and the lower the ecological impact.

In routine, clinical microbiology laboratories currently use 2 automatized techniques: MALDI-TOF MS® for microorganisms identification and VITEK2® method for AST determination.

Based on a proteomic approach, the IDBIORIV method is a rapid method (90 minutes) in comparison of current methods (24/48 hours) able to identifying a large panel of 113 pathogens and determine the antibiotic resistance profile of 49 species for 4 classes of antibiotics (Beta-lactams, Aminosides, Glycopeptides, Colistin).

The main objective of this study is to evaluate the performance of the IDBIORIV method in pathogen identification and antibiotic susceptibility testing in comparison with current methods of analysis of positive blood cultures used at the microbiology laboratory of the Hospices Civils de Lyon, in a real clinical situation, over a 2-year period.


Eligibility Criteria:
Inclusion Criteria:

* Adult or child patient
* Hospitalized in one of the departments registered with Hospices Civils de Lyon
* Showing signs of infection
* Confirmed by a 1st positive blood culture
* Patient or close relative (trustworthy person or family member) or holder of parental authority who has given his or her non-objection after receiving the information note

Exclusion Criteria:

* Patients under court protection
* Patients under guardianship or curatorship
Clinical and Sonographic Diaphragm Evaluation Post-plication

Objectives: We aim to clarify the role of diaphragm ultrasonography (DUS) in evaluating the outcome of surgical diaphragmatic plication (SDP) in adults with symptomatic unilateral diaphragmatic paralysis (UDP).


Eligibility Criteria:
Inclusion Criteria:

- Symptomatic unilateral diaphragmatic paralysis.

Exclusion Criteria:

* Children
* Morbid obesity
* Certain neuromuscular disorders
* Previous thoracic surgical intervention on the affected
* Recurrent eventration
Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.

This study has important implications in the field of pain management for surgical abortion. While NO is administered in some outpatient clinics for surgical abortion, its effect on pain has not been systematically studied in a randomized controlled trial in women undergoing first trimester surgical abortion under local/oral analgesia. Expanding pain management options for women undergoing abortion confers significant public health benefits.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older,
* elective pregnancy termination at gestational age of less than 11 weeks,
* speak English
* candidate for an in-clinic procedure.
* desire local anesthesia, ibuprofen, Vicodin and Ativan (the usual treatment in our clinic) for managing pain

Exclusion Criteria:

* no medical problems preventing the use of nitrous oxide
* no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, Vicodin or Ativan
* significant active upper respiratory infection
* chronic obstructive pulmonary disease (COPD)
* intoxication
* use of street drugs
Endothelial Function and Arterio-Venous Fistula Maturation

An arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. A primary aim of this study is to see if endothelial function (the biochemical events initiated by cells lining the arteries) is associated with successful maturation. Other aims include determining if pro-inflammatory markers in the blood or evidence of gene expression are associated with successful maturation.

Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent vascular access created surgically by connecting a vein with an artery and is the preferred mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of primary failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%. Traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have limited ability to allow surgeons to predict which AVFs will mature.

One possible explanation involves vascular remodeling, the structural changes which occur in a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and pressure. It initiates a complex biological response including cellular proliferation and migration, matrix degradation, and cellular apoptosis. This longitudinal, observational study hypothesizes that endothelial function is a critical modulator of AVF maturation. Specifically, that patients with inflammation will have impaired endothelial function and demonstrate less significant remodeling than others.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease classification Stage IV or V
* Adequate quality cephalic or basilic vein based on pre-operative assessment
* Able to provide written informed consent
* Able to travel to the SFVA Medical Center or UCSF Medical Center for follow-up examination

Exclusion Criteria:

* Age \>90 or \< 18 years
* Diagnosed hypercoaguble state
* Recent surgery or other major illness or infection within 6 weeks
* Use of immunosuppresive medication
* History or organ transplantation
* Pregnancy or plans to become pregnant
* Estimated life expectancy is less than 1 year
A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.

This study will investigate the safety, tolerability and potential health benefits of the dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third of subjects will receive the low dose Basis, one third will receive the higher dose Basis and one third will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 60 to 80 (inclusive) years of age
* Body Mass Index (BMI) must be 18 to 35 kg/ m2 (±1 kg/m2)
* •Be able to make scheduled office visits 4 times during the study
* Willing to follow the instructions and complete multiple study questionnaires and assessments
* Agrees to avoid taking Vitamin B3 (Niacin, Nicotinic acid or niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
* Healthy otherwise as determined by laboratory results and medical history
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* History of any significant chronic disease or any clinically active illness within 3 months of study entry, including any history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease. Clinical significance of disease will be assessed by the Qualified Investigator and eligibility determined.
* Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease
* Subjects with or who have recently experienced a traumatic injury, infections or undergone surgery
* Subjects with history of pellagra or niacin deficiency
* Taking lipid lowering drugs
* Use of natural health products containing Nicotinamide riboside within 14 days prior to randomization and during the course of the study
* History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission more than 5 years after diagnosis are acceptable
* Has participated in any clinical trial with an investigational medicinal product within the past three months prior to the first dose in the current study
* Unstable medical conditions
* Alcohol use \>2 standard alcoholic drinks per day
* History of alcoholism or drug abuse within 1 year prior to screening
* History of significant allergies
* Allergy or sensitivity to any of the investigational product ingredients
* Use of medicinal marijuana
* Clinically significant abnormal laboratory results at screening
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant