cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women with HR+/Her2- Breast Cancer

This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.

As the investigators understanding of how ER-positive breast cancer (a type of cancer in which the cells need the hormone estrogen to grow) improves, more treatment decisions are being tailored to an individual's unique genetic makeup. National medical guidelines now include the routine use of tumor profiling tests, like the Prosigna® assay, which look at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery.

Currently, the Prosigna® assay (also called PAM-50) is FDA approved as a tool that physicians can use to help make decisions about a patient's treatment after their breast surgery. In these cases, physicians run this test using tumor tissue from a patient's breast surgery. However, the Prosigna® assay is not approved for use preoperatively, or before surgery.

Previous studies showed that the Prosigna® assay was able to identify tumor types that were more likely to benefit from treatment before surgery (whether it's hormonal therapy or chemotherapy). In this study, the investigators will use tumor tissue from the participant's biopsy to run the Prosigna® assay. The test may give both the participant and the investigators more information about the best possible treatment option for the participant before surgery.

This study is being done to determine how Prosigna® assay results may affect the physician's choice of treatment before surgery and how well patients understand the test and its implications.

Eligibility Criteria:
Inclusion Criteria:

* Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer
* ER or PR ≥ 1% by immunohistochemistry (IHC)
* HER2-negative status, according to guidelines by ASCO CAP guidelines:

https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9751

* Tumor size ≥ 0.5cm (clinical or radiographic measurements)
* Any nodal status allowed
* Age \> 18 years old
* Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician

Exclusion Criteria:

* ER-negative and PR-negative invasive breast cancer (\< 1% by IHC)
* Known metastatic disease
Sleeve Gastrectomy with Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

sleeve gastrectomy with jejunoileal bypass (SGJIB) is a novel technique for the surgical treatment of obesity. The aim of the study is to compare this maneuver with single anastomosis sleeve jejunal bypass (SAS-JB)

200 patients will be randomly divided into to equal . Group 1 will be operated by sleeve gastrectomy with jejunoileal bypass with the anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction. and group 2 will be operated by single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.


Eligibility Criteria:
Key Inclusion Criteria:

* Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
* Compensated liver disease

Key Exclusion Criteria:

* Pregnant or lactating female or males with a pregnant partner.
* A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
* A history of moderate, severe or uncontrolled psychiatric disease.
* A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.
Patients With Diabetes Mellitus on Drug Treatment on the List or Already Undergoing Orthotopic Liver Transplantation

observational study through which we aim to collect information on metabolic compensation, the degree of satisfaction with hypoglycemic therapy, the onset of complications of diabetes or liver disease, evaluation of survival, in patients on the list for at least three months or already undergoing liver transplantation for at least three months


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* presence on the list for OLT for at least 3 months or have already been submitted to OLT for at least 3 months
* age ≥ 18 years
* signature of written informed consent to participate in the observational study, either by the participant or legal guardian

Exclusion Criteria:

- Pregnancy or breastfeeding
A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot

This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
* good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ECGs) and physical examinations
* ability to provide informed consent and/or consent from a legally acceptable representation
* body mass index (BMI) of 18 to 35 kg/m\^2

Exclusion Criteria:

* sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication
* history of drug or alcohol abuse within 6 months and/or positive urine drug screen
* participants who consume alcohol beverages routinely
* participants who consume alcohol beverages during the screening period
* use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 inducers within 14 days
* use of any prescription medication unless approved by Medical Monitor or Study Director
* history of current hepatitis or carrier of HBsAg (Hepatitis B surface antigen) and/or Hepatitis C Virus antibodies (anti-HCV)
* females who are pregnant or lactating
* participants who have participated in any clinical trial involving a psychotropic medication within one month prior to enrollment; participants who have participated in a previous IM Depot study within the last 1 year; patients who have previously enrolled and received study medication in an aripiprazole IM Depot clinical trial
* donation of blood or plasma to a blood bank or in a clinical study (except a screening visit)within 30 days prior to enrollment
* any major surgery within 30 days prior to enrollment
* blood transfusion within 30 days prior to enrollment
* evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations
* patient represents a significant risk of committing suicide based on history
* patients currently in an acute relapse
* patients with Axis I (DSM-IV) diagnosis of schizoaffective or bipolar disorder
* patients who are considered treatment-resistant to antipsychotic medication
* patients with a history of neuroleptic malignant syndrome
* any other sound medical reason as determined by the clinical investigator
Building Resilience Against ViolencE (BRAVE)

The study has both quantitative and qualitative components.

The objective of the quantitative study is:

To evaluate the effectiveness of Learning Through Play (LTP) Plus culturally adapted Trauma Focused Cognitive Behavior Therapy (TF-CBT) for post-traumatic stress symptoms in parents.

The objective of the qualitative study is:

To find out facilitators and barriers from the perspective of the participants and other stakeholders (e.g., clinicians, GPs, people delivering the LTP plus TF CBT intervention etc)

Despite the high prevalence of post-traumatic stress disorder in Pakistan, research on psychosocial intervention is limited. We propose to investigate the acceptability, feasibility and effectiveness of manual assisted Learning Through Play (LTP) Plus culturally adapted Trauma Focused Cognitive Behavior Therapy (TF-CBT) among parents experiencing Post Traumatic Stress Disorder (PTSD). LTP Plus is proposed as a low cost intervention to improve parents' mental and physical health, and promote healthy child development. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. This will be integrated with Trauma Focused CBT.

Purpose of this RCT is to determine the effectiveness of LTP plus TF- CBT intervention. The study will be conducted in two cities of Pakistan, Karachi and Peshawar.Participants will be screened using Impact of Event Scale-Revised (IES-R) and eligibility checklist. Those scoring 24 or above will be eligible for more in depth assessment. Assessments will be done at baseline and after completion of intervention. Outcome assessments will be done by independent Research Assistants blind to group allocations.

Eligibility Criteria:
Inclusion Criteria:

Participants will be included in the study if they are:

Parents over the age of 16 years who are living with their children age 3-6 years. They meet the criteria for Post-Traumatic Stress Disorder (PTSD) and are able to give informed consent

Exclusion Criteria:

Participants will be excluded from the study if they have:

Any diagnosed physical or learning disability which prevents them from attending the LTP+ group intervention, or suffering from psychosis or those who are actively suicidal. This will be assessed by the research team at screening stage. Any disabilities or diagnosed mental illness. Any parent who is on current use of anti-depressant medication. And a prior self-reported mental illness, including depression.
Hyaluronic Acid for Hypofractionated Prostate Radiotherapy

The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.


Eligibility Criteria:
Inclusion Criteria:

* age superior or equal to 18 years and inferior to 80 years.
* patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
* prostate cancer histologically proven.
* life expectancy superior to 10 years.
* Karnofsky performance status ≥ 60% (performance status ECOG 0-2).
* the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from April 26th 2006).
* the signed consent form.

Exclusion Criteria:

* age inferior to 18 years and ≥ 80 years;
* history of rectal surgery;
* patient who can't cooperate during the treatment;
* history of pelvic irradiation;
* history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
* other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas;
* patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect);
* patients receiving anticoagulant treatment or PLAVIX;
* other undergoing study that may interfere with the present study;
* patient under legal protection measure.
Stool Testing for Pancreatic Cancer

The purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in early stages through the molecular analysis of stool samples. Investigators hypothesize that analysis of stool samples using digital melt curve (DMC) analysis, can be used as a sensitive and specific method to detect the common genetic abnormalities present in pancreatic cancers and pre-cancerous lesions of the pancreas.

Pancreatic ductal adenocarcinoma (PDC) remains the fourth leading cause of cancer-related death in the United States. This is largely due to the fact that most patients present with advanced, unresectable disease, highlighting the critical need for a screening test for this disease. Stool testing is an approach that has not been explored for use in PDC screening. With the advent of stool-based DNA tests, it may be possible to target genetic abnormalities that have been recently characterized in PDC tumorigenesis.

Aim: The aim of this study is to determine if deoxyribonucleic acid (DNA) alterations present in pancreatic cancer and precancerous intrapapillary mucinous neoplasms (IPMN) can be reliably recovered in matched stool.

Methods: This is a case-control prospective study to determine the utility of a stool-based digital melt curve (DMC) assay in PDC screening. A total of 30 patients (18 with pancreatic cancer, 12 with IPMN) who will be undergoing pancreatic resection will be enrolled. Pancreatic neoplastic tissue will be isolated from their surgical specimens and the genes most commonly mutated in PDC will be sequenced from extracted DNA. In addition, hypermethylation at common promoter sites will be assessed by methylation-specific PCR. The genetic and epigenetic alterations isolated in pancreatic tissue will be utilized as the targets for stool DMC assay. Blinded technicians will process stool specimens from control patients as well as a matched control. The primary outcomes of this study will be the sensitivity and specificity of the stool DMC assay in detecting genetic mutations present in tumor or IPMN lesions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older.
* Tissue-confirmed or radiological evidence of either pancreatic adenocarcinoma or intrapapillary mucinous neoplasm(IPMN).
* Scheduled for surgical resection of the adenocarcinoma or IPMN.
* Able to give informed consent

Exclusion Criteria:

* History of colorectal, gastric cancer, esophageal, or head-and-neck cancer.
* Endoscopic procedure conducted less than 1 week prior to enrollment.
* Unwillingness or inability to sign informed consent.
Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

To define a rational pharmacological management of pain for the subjects under opioid maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate the efficiency of the current practices on pain management as well as their potentially noxious consequences, in particular on the long term opioid maintenance therapy.

The objective of the study is to compare the efficiency of the opioid maintenance therapy according to the arisen of an acute painful phenomenon requiring an analgesic management for these patients. At first, this work will allow to determine the results on acute pain of the current practices for these patients. The comparison of the long term consequences on opioid maintenance therapy between the patients that presented an acute painful phenomenon and the control patients should help to improve acute pain management for these patients while limiting the risk of relapse in the abused consumption of psychoactive substances.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or more.
* Patients under opioid maintenance therapy (buprenorphine or methadone)
* Patients treated by the same drug (buprenorphine or methadone) since at least 3 months

Exclusion Criteria:

* Refusal of the patient to take part in the study
* Absence of possible follow-up
Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma

The primary objective of this study is to evaluate the efficacy of tislelizumab in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Progression-free Survival (PFS) as assessed by investigator


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and

1. Has failed to achieve a response or progressed after autologous hematopoietic stem cell transplant (ASCT). or
2. Has received at least two prior lines of systemic chemotherapies for cHL and is not an ASCT candidate.

   2. Must have measurable disease 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

   4. Must have adequate organ functions. 5. Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of study drug, and all treatment-related adverse events are stable and have either returned to baseline or Grade 0/1

   Key Exclusion Criteria:
   1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known central nervous system (CNS) lymphoma.
   2. Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study drug.
   3. Prior therapies targeting PD-1 or PD-L1.
   4. Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
   5. Participant with active autoimmune disease or history of autoimmune disease with high risk of recurrence.
   6. Serious acute or chronic infection requiring systemic therapy.
   7. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

   NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia

A randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia. Patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of VR assisted therapy plus treatment as usual (TAU). A control group will be exposed to a neutral VR environment plus TAU. The hypothesis is that patients who are treated with active VR assisted therapy will have less negative symptoms as rated by the PANSS-N scale, compared to the control group.

The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente. Patients sign an informed consent form, from which they may withdraw at any point during the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia made by the treating psychiatrist and corroborated by a team's psychiatrist under CIE-10 criteria.
* Age between 18 to 65 years-old.
* Outpatient setting,
* Clinical stability defined as no psychiatric hospitalizations in the last 6 months and not currently on queue for psychiatric hospitalization.
* No concomitant active substance abuse disorder, excluding nicotine.
* Subjects are capable of providing informed consent.

Exclusion Criteria:

* Previous diagnosis of learning disability according either to ICD- 10 or clinical history
* Verbal expression difficulties, determined by language or medical causes.
* Deafness and/or blindness.
* Other physical handicaps to use VR devices.
* Predominant positive symptoms, defined as PANNS-C \> 0.
* Catatonic symptoms.
* Previous epilepsy diagnosis.
* Neurodegenerative disease.
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures

This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be at least 18 years old
* Subjects will have 2 or more identified rib fractures
* Subjects will be willing to provide informed consent for procedure
* Subjects will be identified as appropriate for initiation of continuous nerve block therapy for treatment of rib fracture associated pain.

Exclusion Criteria:

* Documented allergy to study medication
* Epidural catheter use
* Prisoners
* Refusal of CINB therapy
The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors

The purpose of this study is to determine the effect of mifepristone on the expression of three cervical EP3 receptor isoforms (EP3-2, EP3-3 and EP3-6) in pregnant women ≤63 days gestational age.


Eligibility Criteria:
Inclusion Criteria:

* good general health
* ≥18 years old
* seeking termination of a viable intrauterine pregnancy of ≤63 days, without any evidence of a threatened or spontaneous abortion

Exclusion Criteria:

* medical problems
* confirmed or suspected ectopic pregnancy
* having taken medications in the seven days prior to enrollment that would affect PG synthesis or metabolism of mifepristone