cyrilzakka/clinical-trials huggingface dataset:
Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia

Introduction: Staphylococcus aureus bacteremia (SAB) plays an important role in long-course antibiotic therapy. Current international guidelines recommend fourteen days of intravenous antibiotic treatment for SAB in order to minimize risks of secondary deep infections and complications. However, patients with simple SAB are known to have a low risk of complications. Reducing treatment length in uncomplicated SAB would reduce the total consumption of antibiotics, adverse events and duration of hospital admission. SAB7 seeks to determine if seven days of antibiotic treatment in patients with uncomplicated SAB is non-inferior to fourteen days of treatment.

Method: The study is designed as a randomized, non-blinded, non-inferiority interventional study. Primary measure of outcome will be failure to treatment or recurrence of SAB twelve weeks after termination of antibiotic treatment. As a measure of secondary outcome the prevalence of severe adverse effects will be evaluated, in particular secondary infection with Clostridium difficile, mortality as well as public health related costs. Patients identified with uncomplicated SAB, are randomized 1:1 in two parallel arms to seven or fourteen days of antimicrobial treatment, respectively. Endpoints will be tested with a statistical non-inferiority margin of 10%.

Conclusion: SAB 7 will determine if seven days of antibiotic treatment in patients with uncomplicated SAB is sufficient and safe, potentially modifying current treatment recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Blood culture positive for Staphylococcus aureus
* Antibiotic treatment with antimicrobial activity to S. aureus administrated within 12 hours of the first positive blood culture
* Temperature \< 37,5 degrees celsius at randomization
* S. aureus negative follow-up blood culture obtained 48-96 hours after microbiological verified SAB.
* Patients written consent obtained

Exclusion Criteria:

* Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-96 hours of the first positive blood culture)
* Polymicrobial infection
* Antibiotic treatment whit no antimicrobial activity to S. aureus administrated more than 12 hours of the first positive blood culture
* Endocarditis or other intracardiac infection demonstrated with transthoracic or transesophageal echocardiography
* Previous history of endocarditis
* Pacemaker or other intracardiac implant
* Failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture.
* Prosthetics in joints and bones or vascular grafts
* Pneumonia or infection involving bone or joints
* Previously bone/join infection
* S. aureus infection within the last 90 days
* Pregnancy or breastfeeding
* Neutropenia (blood neutrophils \< 1,0 x 109/l)
* Untreated cancer
* Chemotherapy within 90 days.
Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma

The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants with age ≥18 years at the time of signing the informed consent.
2. Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.

   B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.
3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014.
4. ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1.
5. Life expectancy of ≥12 weeks as judged by the investigator.
6. Adequate organ function as determined by medical assessment.
7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
8. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.

Exclusion Criteria:

1. Prior treated with other QPCTL, CD47 or SIRPα inhibitors.
2. Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
3. Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.
4. Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.
5. Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.
6. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding alopecia).
7. Received antitumor steroid therapy within 7 days prior to the first study treatment administration.
8. A serious illness or medical condition(s)
The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines

This study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization program in July 2014.

The two-year study period started in February 2015.

The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients.

Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital.

Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.

Eligibility Criteria:
Inclusion Criteria:

* children aged \< 18 year
* hospitalized due to acute gastroenteritis

Exclusion Criteria:

* children aged \> 18 years
* gastroenteritis due to known non-infectious causes
Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

The bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole blood. It is designed to promote healing in the setting of intraarticular knee pathology. This study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the BEAR implant.


Eligibility Criteria:
Inclusion Criteria:

• History of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.

Exclusion Criteria:

* Patients who are undergoing meniscal repair for displaced bucket-handle meniscal tears
* Patients with a history of blood-borne diseases including HIV, hepatitis B virus, hepatitis C virus, human T-lymphotropic virus, and syphilis
Usefulness Of Flospan As A Premedication For Colonoscopy

Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind controlled trial

Cimetropium bromide is premedication of colonoscopy. However, it is contraindication for some diseases; benign prostatic hyperplasia(BPH) or other obstructive uropathy, intestinal obstruction, pyloric stenosis, glaucoma, myasthenia gravis, megacolon, paralytic ileus. In this cases, Flospan (phloroglucin) is effective alternative drug. So our research was to compare the effects of these two drugs.

Eligibility Criteria:
Inclusion Criteria:

* Recipient endoscopic diagnostic purposes.

Exclusion Criteria:

* If you currently pregnant, or of childbearing potential
* Previous abdominal surgery or bowel resection.
* If under 18 years of age
* If the last two days, the administration of anticholinergic
FT516 in Subjects With Advanced Hematologic Malignancies

This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.


Eligibility Criteria:
KEY INCLUSION CRITERIA:

Diagnosis of the following:

Regimen A (FT516 monotherapy):

* Primary Refractory AML
* Relapsed AML defined as not in CR after 1 or more re-induction attempts; if \>60 years of age, prior re-induction therapy is not required

Regimen B (FT516 + rituximab or obinutuzumab):

* Histologically documented B-cell lymphoma expected to express CD20 who have relapsed after or failed to respond to at least on prior treatment regimen and for whom there is no available therapy expected to improve survival.

All subjects:

* Provision of signed and dated informed consent form (ICF)
* Age ≥18 years old
* Stated willingness to comply with study procedures and duration
* Presence of measurable disease

KEY EXCLUSION CRITERIA:

All subjects:

* Females of reproductive potential who are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
* Evidence of insufficient organ function
* Receipt of therapy within 2 weeks prior to Cycle 1 Day 1 or within five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Cycle 1 Day 1
* Currently receiving or likely to require systemic immunosuppressive therapy
* Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Cycle 1 Day 1, or ongoing requirement for systemic graft-versus-host therapy
* Receipt of an allograft organ transplant
* Known active central nervous system (CNS) involvement by malignancy.
* Clinically significant cardiovascular disease
* Clinically significant infections including: Known HIV infection; Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* Live vaccine \<6 weeks prior to start of lympho-conditioning
* Known allergy to human albumin and DMSO

Additional Exclusion Criteria for FT516 monotherapy Regimen: Diagnosis of promyelocytic leukemia with t(15:17) translocation

Additional Exclusion Criteria for FT516 plus monoclonal antibody Regimens: Diagnosis of Waldenstrom macroglobulinemia
DISCOVER Workshop Programme for Care Experienced Young People

The NHS DISCOVER team has secured 2-year funding from the Maudsley Charity to tailor the workshop programme the investigators deliver in school Sixth Forms to meet the specific needs of Care Experienced young people. The investigators are planning to complete a pilot of this adapted workshop programme within Medway Children's Social Services to explore its feasibility, accessibility, acceptability and early-stage efficacy within this population of adolescents.

Investigators from the DISCOVER team will recruit young people aged 16-19yrs who are currently known to the Medway Care Leavers 16+ teams. The study will be conducted at Medway Local Authority sites, with the option of some stages being completed remotely via Microsoft Teams if needed in the context of the ongoing COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

Participants who are eligible to take part in this DISCOVER research project will be:

* Young people aged 16-19 years who have experience of being in Care and are currently under one of the Medway Children's Social Care, Care Leavers 16+ teams. This means that they are either currently a Looked After young person or a Care Leaver (i.e. they are no longer Looked After but they remain under the care of a Medway Care Leavers team).
* Able to work within a group setting over the course of a day workshop.
* Able to communicate and read in English.

Exclusion Criteria:

The investigators will not be able to recruit young people to the project if they are:

* Acutely psychotic or actively suicidal.
* Currently taking part in other research project(s).
* Under the influence of alcohol or any other substances during DISCOVER programme meetings - this is essential as a safety consideration for all participants and staff. Struggles with alcohol/substance use in themselves are not necessarily grounds for exclusion; the investigators will discuss with the allocated member of the young person's Care Leavers 16+ team on a case-by-case basis where relevant.
* Unable to communicate and read in English - as the investigators are at an early stage in developing this DISCOVER workshop programme for Care Experienced young people, these young people must be excluded at this time. However, the investigators are eager to review this criterion in future to enhance the accessibility of the intervention, once the initial feasibility and acceptability of the workshop programme has been established.
A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel

Patients with short bowel intestinal failure are recommended to aim for a diet high in energy and protein. Some patients have difficulties in achieving recommended intakes and additional nutrition may be provided by oral nutritional supplements. There is very little research completed on which is the best oral nutritional supplement for patients. The aim of the study is to see the effect different oral nutritional supplements have on your stoma or fistula output and levels of hydration.

After written consent is obtained, patients will be asked to fast from 12.00am on day one. At 08.00am patients will be asked to pass urine and to empty their stoma bag. After this they will be asked to drink 200ml of the ONS which they have been randomised to test on day one over a 30 minute period. Urine and intestinal output will be collected into two separate containers over the next 6 hours. During this time the patient will not be permitted to eat or drink other fluids. After 6 hours the patient will be able to eat and drink normally. The urine and intestinal output will be weighed and then an aliquot will be stored in a -20oC freezer before being sent for analysis. Day two is a washout day when the patient will be able to eat and drink normally. Day three will be the same as day one but the patient will have the other ONS that they did not have on day one. No changes will be made to the patient's usual anti diarrhoeal and/or anti motility agents or parenteral support during the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* Residual length of small bowel \<200cm determined either at operation or radiologically.
* Patients with a stoma or an established enterocutaneous fistula
* Normal hydration status (urinary sodium \>20mmol/L)

Exclusion Criteria:

* Dehydration (urinary sodium \<20mmol/L)
* Patients with short bowel and a jejunocolonic anastomosis
* Current sepsis of any cause
* Addition/amendment to anti-diarrhoeal or anti motility agents in the last 3 days
* Severe gastrointestinal obstruction or structural abnormality of the intestine
* Active Crohn's disease - assessed using two of the three parameters:

CReactive Protein \>10 Albumin \<30g/L Platelets \>400

* Participation in another intervention trial which may affect intestinal absorption
* Nil by mouth
* Unable or unwilling to provide consent
SIRT-1 Antagonism for Endometrial Receptivity

Progesterone resistance is mediated through epigenetic modification through SirT1 activation and is thought to contribute to infertility and progression of endometriosis. Endometriosis is a leading cause of unexplained IVF failure secondary to inflammatory changes that induce SirT1. The current study is designed to investigate a small molecule inhibitor of SirT1, in the clinical setting of In Vitro Fertilization and Embryo Transfer. The SAFER trial will compare EX-527 to placebo in a randomized, double-blind trial. Primary endpoints include Live Birth Rate (LBR) and secondary outcomes include pregnancy rate (PR), miscarriage rate (MR) and implantation failure rate.

The SAFER Trial will enroll women with unexplained failure after embryo transfer with euploid embryos. Subjects must have existing euploid embryos for transfer and test positive for SirT1 testing on endometrial biopsy. To qualify, they must be 18 to 40 years of age, have a normal uterine cavity, no serious systemic diseases (diabetes, lupus, cancer, etc) and be willing to be randomized to treatment with a SirT1 inhibitor, EX-527 or placebo. The medication will be provided and administered for 5 days prior to embryo transfer, after progesterone therapy is begun. The drug will be stopped 24 hr before embryo transfer. Standard protocols will be used including administration of progesterone, checking hCG 8 days after transfer, ultrasound monitoring of pregnancy and pregnancy outcomes recording, with Live Birth Rate (LBR) being the primary outcome of interest. We expect to enroll 30 women, with 15 subjects per arm. The goal of this study is to demonstrate efficacy for a specific inhibitor of SirT1 as a primary treatment of defects in endometrial receptivity due to endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Must test positive for SIRT1 on mid-luteal endometrial biopsy
* Prior failed embryo transfer with euploid embryos
* Have at least one euploid embryo for transfer

Exclusion Criteria:

* systemic illness affecting kidneys or liver; chronic headache or severe migraine
* Endometritis, hydrosalpinges, and known adenomyosis
* Uterine septum, uterine fibroids, endometrial polyps
To Evaluate the Safety and Efficacy of TQB2618 Injection Combined With Penpulimab in the Treatment of Patients With Relapsed and Refractory Lymphoma

This is a two-phase, open-label Phase Ib clinical trial to evaluate the safety and efficacy of TQB2618 injection combined with Penpulimab in patients with relapsed and refractory lymphoma


Eligibility Criteria:
Inclusion Criteria:

* 1 Subjects with pathologically proven with relapsed or refractory lymphoma and with disease progression during or after the last treatment or no objective response confirmed after adequate treatment.
* 2 Cohort 1: Subjects with Classical Hodgkin lymphoma (cHL) who had previously received at least twice systemic therapy and are resistant to PD-1 or PD-L1.
* 3 Cohort 2: Subjects with B lymphocyte non-Hodgkin lymphoma (B-NHL) who had previously received at least twice systemic therapy containing anti-CD20-targeted therapy.
* 4 Cohort 3：Subjects with T lymphocyte non-Hodgkin lymphoma (T-NHL) who had previously received at least one systemic therapy.
* 5 Subjects with measurable lesions as defined by Lugano2014.
* 6 Aged 18-75 years ; Eastern Cooperative Oncology Group (ECOG) score:0 \~ 1; Expected survival ≥3 months.
* 7 Laboratory indicators meet the requirements.
* 8 Subjects voluntarily joined the study and signed the informed consent form.
* 9 Non-pregnant or non-breastfeeding women; Negative pregnancy subjects.

Exclusion Criteria:

* 1 Subjects who have developed or is currently suffering from other malignancies within 3 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ.
* 2 Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.
* 3 Subjects with significant surgery or significant traumatic injury within 28 days before first injection (excluding needle biopsy or endoscopic biopsy).
* 4 Subjects with long-term unhealed wounds or fractures.
* 5 Subjects with the high risk of bleeding or bleeding history or subjects with bleeding event (≥Common Terminology Criteria for Adverse Events Grade 3) within 4 weeks before first injection.
* 6 Subjects with arterial/venous thrombosis within 6 months.
* 7 Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.
* 8 Subjects with any severe and/or uncontrolled disease.
* 9 subjects with lymphoma originating from Central Nervous System, high-grade B-cell lymphoma or hemophagocytic syndrome during screening period.
* 10 Subjects with violating Central Nervous System (CNS) .
* 11 Subjects with allogeneic hematopoietic stem cell transplantation.
* 12 Subjects with autologous hematopoietic stem cell transplantation or Chimeric Antigen Receptor T-Cell Immunotherapy(CAR-T) within 3 months before first injection.
* 13 Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)

This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* B-ALL in relapse
* refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale
* adequate hepatic and renal functions (AST or ALT \<= 5 times the upper limit of normal creatinine \< 2 times the upper limit of normal)
* \> 20% blasts in bone marrow,
* \> 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping

Exclusion Criteria:

* Previous treatment by trastuzumab
* FEVG \< 50%
Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients

To determine the correlation between the region of abdominal tenderness determined by the examining physician and the location of acute pathology diagnosed on abdominal CT. We hypothesize that the acute pathology diagnosed by CT will lie within the region marked on the abdominal wall by the examining physician prior to CT.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled.

Exclusion Criteria:

* Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study.
* Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded.
* Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness.