cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.

This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed invasive adenocarcinoma of the breast.
* Triple negative breast cancer: hormone receptor negative (ER \< 10% and PgR \< 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
* Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
* Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
* Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
* Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
* ECOG Performance Status: 0-1.
* Patients without severe heart, lung, liver and kidney disease.
* Adequate hematologic and end-organ function.
* No more than 6 weeks may elapse between definitive breast surgery and randomization.

Exclusion Criteria:

* Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
* Previous neoadjuvant chemotherapy with platinum or taxanes alone.
* Patients have received other adjuvant therapy.
* Comprehensive medical examinations have revealed distant metastases before randomization.
* Patients who are not suitable for anthracycline evaluated by investigators.
* Prior history of other malignancy (except carcinoma in situ).
Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)

In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.

Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.

Eligibility Criteria:
Inclusion Criteria:

* women with PCOS
* previous OHSS
* Infertility

Exclusion Criteria:

* more than 38 years old
* Body mass index pore than 30
* other systemic diseases
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.

In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.
* Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
* Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
* Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.

Exclusion Criteria:

* Current diagnosis of ulcerative colitis or indeterminate colitis.
* Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
* Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
* Currently know complications of CD (strictures, short bowel, etc).
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma

This phase 2 trial studies the efficacy and safety of Avatrombopag for the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy in patients with lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed lymphoma;
* Patients are scheduled to receive cytarabine-based chemotherapy including Ara-C at dose of 4g/m2.
* Eastern Cooperative Oncology Group (ECOG) of 0-1;
* Proper functioning of the major organs: 1) The absolute value of neutrophils (\>1.5×10\^9/L); platelet count (\> 100×10\^9/L); Hemoglobin (\> 90 g/L); 2) Serum total bilirubin \< 1.5 times ULN; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \< 3 times ULN;3) Serum creatinine \<1.5 times Upper Limit Normal (ULN) ; 4) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT)\< 1.5 times ULN
* Able to use oral drugs
* Patients volunteer to sign an informed consent
* Life expectancy \> 3 months;
* Contraceptives are used

Exclusion Criteria:

* Thrombocytopenia unrelated to chemotherapy during six months before screening, including but not limited to hypersplenism, infection and hemorrhage.
* In addtion to CIT caused by lymphoma and chemotherapy,patients also suffer from other blood diseases including ALL, AML, myeloid neoplasms, MDS, myeloproliferative disorders, MM;
* A thrombosis of a coronary artery or vein developed during three months before screening;
* Haemorrhage with severe clinical symptoms, such as gastrointestinal and cerebral hemorrhage;
* Platelet transfusion during two days before randomization;
* Allergic to avatrombopag;
* Participation in any other research about novel agents or devices;
* Pregnant or breastfeeding women;
* Researchers consider it unsuitable for patients to participate in this study.
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed stage III (unresectable) or stage IV melanoma
* Treatment naïve patients
* Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
* Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Ocular melanoma
* Subjects with active, known or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
* Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
Team Science (The Liver Health Study)

Liver damage from alcohol intake and weight-related behaviors is preventable and treatable only through lifestyle changes. This mixed-methods randomized controlled trial compares standard and enhanced approaches to screening, brief intervention, and referral to treatment/prevention (SBIRT/P) to identify and intervene for metabolism- and alcohol-associated liver disease (MetALD). Our multidisciplinary team aims to show that integrating results of noninvasive liver screening with Fibroscan®, a painless ultrasound that measures stiffness and fat in the liver, can optimize our brief intervention. The study population is adults age 21+ who speak Spanish or English from underresourced communities with alcohol- and weight-related risks for MetALD.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 21 years of age.
* Exceed alcohol intake screening guidelines for MetALD.
* Have a Body Mass Index (BMI) \>=25 kg/m2.
* Be able to speak and read English or Spanish to provide written informed consent and understand written and oral instructions in English or Spanish.

Exclusion Criteria:

* Pre-existing liver disease or hepatocellular carcinoma or prior liver transplant.
* Pre-existing medical conditions that, in the opinion of the investigative team, would interfere with research participation (e.g., loss of kidney function, uncontrolled infections, multiorgan failure, uncontrolled upper gastrointestinal bleeding, other active malignancies except skin cancer).
* Pre-existing mental health conditions that, in the opinion of the investigative team, would interfere with the ability to provide informed consent and understand written and oral instructions (e.g., hepatic encephalopathy, psychotic disorder diagnosis or symptoms).
* Current pregnancy.
* Be anyone who, based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification.
* Currently receiving formalized psychosocial treatment for an alcohol use or drug problem and/or newly taking medications for an alcohol use or drug problem.
* Currently receiving formalized behavioral weight management treatment and/or newly taking weight loss medications.
Tailored Therapeutic Model According to the Expression of Genes in Inflammatory Bowel Disease Patients

This study is a randomized controlled study conducted at five tertiary university hospitals. Patients who are 20-80 years old, diagnosed as having Inflammatory Bowel Disease(IBD) and who are planned to start thiopurines for the first time for the treatment of IBD are enrolled. Patients are assigned to the genotyping group or to the non-genotyping group. The patients who carry any heterozygotic variant among the three genes receive 50 mg azathioprine (AZA) or 25 mg of 6-mercaptopurine, while those who have any homozygotic variant are recommended to take other alternative drugs. The patients who do not carry any genetic variant or are assigned in non-genotyping group receive the standard dose of thiopurines based on the conventional approach.

Patients in the non-genotyping group receive the standard dose of thiopurines based on the conventional approach.


Eligibility Criteria:
Inclusion Criteria:

* 20-80 years old
* Patients who were diagnosed as having IBD based on clinical, endoscopic, radiographic, and histological assessments,
* Patients who were planned to start thiopurines for the first time for the treatment of IBD.

Exclusion Criteria:

* Patients who had previous use of thiopurine
* Those who had abnormal laboratory findings prior to screening, including white blood cell (WBC) count \< 3,000/μL, platelet (PLT) count \< 100/μL, or elevation of aminotransferase more than twice the upper normal limits
* Those who were diagnosed other infectious diseases at the time of screening or receiving antibiotics within the previous 7 days;
* Those who were pregnant or lactating.
The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.


Eligibility Criteria:
Inclusion Criteria:

* PNH;
* At least 18 years old
* Avoid conception; and
* Willing and able to give written informed consent

Exclusion Criteria:

* Active bacterial infection
* Participation in any other drug trial
* Pregnant breast feeding, or intending to conceive
* Not vaccinated against N meningitidis
Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors

The primary objective of this study is to determine the medical and neurodevelopmental outcomes of congenital diaphragmatic hernia (CDH) survivors at school-age (4-6 years) follow-up. It is generally assumed that older CDH survivors have normal daily function and are able to live normal lives, but this has not been adequately studied.

Congenital diaphragmatic hernia (CDH) is a relatively rare malformation, seen in approximately 1 in 3000-5000 live births. The overall survival for infants born with CDH ranges from 50-70% despite continuing advances in prenatal diagnosis and post-natal medical and surgical care. Infants with CDH remain one of the most complex groups of patients to care for - both in the intensive care nursery and after hospital discharge.

Several studies have shown that CDH survivors have predictable pulmonary, gastrointestinal, cardiac, and neurologic morbidities. In particular, CDH survivors are at an increased risk for growth and nutrition difficulties, including feeding problems, symptomatic gastroesophageal reflux, and failure to thrive. They are also more likely to suffer from chronic lung disease, bronchial hyperreactivity, and pulmonary hypertension. In addition, a significant number of CDH survivors show evidence of neurocognitive delay, hearing impairment, and behavioral disorders in follow-up studies.

Most outcome studies of CDH survivors have focused on the 18-36 month follow-up period. However, there is a paucity of literature on longer-term, school-age outcomes of these children. In order that we might better understand the impact of our current CDH management protocols, it is imperative to determine whether the cognitive delays and other morbidities noted in these patients at an early age are of a transient nature, or persist throughout childhood. It is also crucial to develop a predictive model to understand which patients with CDH will undoubtedly develop long-term neurodevelopmental impairment. Collecting and sharing knowledge with the broader community of Neonatal Intensive Care providers who manage infants with CDH will ultimately help guide therapeutic strategies in the intensive care nursery so that parents can make informed decisions about aggressiveness of care and we may optimize the outcomes of this unique patient population.

Eligibility Criteria:
Inclusion Criteria:

* Survivors of CDH who are at least 4 years old at the time of the study will be eligible for inclusion in the follow-up portion of the study.

Exclusion Criteria:

* Spanish-speaking only children and families.
Quantitative And Qualitative Eus Elastography

Endoscopic ultrasonography is considered the most accurate methods for the diagnosis and staging of chronic inflammatory and neoplastic pancreatic diseases. Differential diagnosis of solid pancreatic masses, however, remains a challenge and endoscopic ultrasound-guided fine needle aspiration is necessary. Recently, Endoscopic ultrasound elastography has been introduced as an alternative method to evaluate tissue stiffness of solid pancreatic masses, being an index of tissue elasticity, which may be related to histopathology features (hard tissue = blue = neoplastic and soft tissue = red-yellow-green = non-neoplastic). However, recently publications show different results using elastography. Moreover, a lack of data in Endoscopic ultrasound-elastography exist regarding the compression rate of the probe and the diameter of the region of interest under analysis in previously studies that by physics could affect the tissue elasticity.

Based on the hypothesis that elastography could be affected by compression rate of the probe and the diameter of the region of interest analyzed the present study aimed to evaluate the quantitative (strain ratio) and qualitative endoscopic ultrasound-elastography results determined by the compression rate of the probe (measured by the curve of compression in the second generation of elastography) and the diameter of the region of interest in normal pancreatic tissue.

prospective study performed in patients undergoing for upper-endoscopic ultrasound from October 31-to end of November 2013. Endoscopic ultrasound-elastography was performed using linear Pentax-EUS and "Hitachi-Avius". The quantitative-strain ratio and qualitative endoscopic ultrasound-elastography was measured in the body of the pancreas taking in consideration the curve of the compression rate of the probe high: +0.4, middle: 0, low: -0.4 in the largest and smaller region of interest diameters. Analysis for qualitative elastography was obtained by the predominant color of the pancreatic area studied. Pictures where recorded and quantitative strain ratio data were calculated comparing endoscopic ultrasound-elastography of pancreatic tissue with soft tissue (normal mucosal layer: red). Finally, a comparative analysis was performed between the results with the mean normal value for quantitative strain ratio previously published for normal pancreatic tissue, and between the different compression rates of the probe.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopic Ultrasound for evaluate submucosal tumors

Exclusion Criteria:

* age\<18 or \> 55; pregnancy
* history of: pancreatic disease
* choledocolithiasis
* symptoms of maldigestion
* alcohol abuse
* increased serum levels of pancreatic enzymes
* smokers
* Endoscopic Ultrasound with signs of chronic pancreatitis (Rosemont classification)
Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee

This study plans to learn more about ways to treat a joint problem in the knee called Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to determine whether the injections lead to improvements in pain, performance of activities of daily living, improvements is sports activities and overall function and symptoms reduction. The investigators will compare PRP treatment to conservative therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 10 - 17 inclusive with open physis confirmed by MRI
2. Documented symptomatic stable juvenile osteochondritis dissecans of the knee based on MRI without changes of osteoarthritis and no prior history of knee surgery.
3. The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
4. Patients with Di Paola stage 1 or 2 lesions

Exclusion Criteria:

1. Patients with polyarticular disease.
2. Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin \<9g/dL). Only those patients with a positive history of blood disorders will have a Complete Blood Count (CBC) performed a week prior to inclusion in the study.
3. Patients who had intra-articular treatment with steroids within 3 months
4. Patients who are pregnant or nursing at the time of consent.
5. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
6. Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish)
7. Patients who had previous knee surgery
8. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
9. Chronic use of NSAID (defined as taking non-steroidal anti-inflammatory drug) regularly every week for the last 6 months), steroids or chemotherapy drugs
10. Treatment with NSAIDs within 15 days prior to randomization in this study
11. Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects.
12. Patients with a prolongation of bleeding time, e.g. those receiving anticoagulant drug therapy
13. Patients with a contraindication to MRI including: patients with cardiac pacemaker or non-approved intracranial vascular clip, and those with orthopedic hardware as the resulting artifact can complicate interpretation
14. Patients with acute or chronic renal failure
15. Patients with a previous anaphylactic reaction to gadolinium enhanced MRI.
16. Patients with Di Paola stage 3 or 4 lesions
Intraoperative Electrical Impedance Tomography in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy.

The primary objective of our study will be verify a possible improvement in arterial oxygenation in the obese patient undergoing robotic-assisted radical prostatectomy if the ventilation will be guided by electrical impedance tomography rather than peripheral saturation alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laparoscopic radical prostatectomy
* BMI ≥ 30 kg/m2

Exclusion Criteria:

* surgery duration \< 2 hours
* history of lung diseases