cyrilzakka/clinical-trials huggingface dataset:
Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer

Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Cancer of the thyroid confirmed by a biopsy sample. Specific types of thyroid cancer included in this study are anaplastic, differentiated (papillary, follicular, or Hürthle cell), and medullary thyroid cancers.
* For patients with differentiated (papillary, follicular, or Hürthle cell) thyroid cancer, no more than 1 prior chemotherapy treatment is allowed.
* Measurable disease is required (at least one lesion at least 2 cm in length by conventional computed tomography (CT) techniques or at least 1 cm by spiral CT scan).
* Any prior chemotherapy or radiation therapy must be stopped at least 4 weeks before the first dose of study treatment. Prior radioiodine (I131) therapy must be stopped at least 3 (or 6) months before first dose of study treatment (depending on responsiveness to this therapy).
* Recovery from any toxic effects of prior chemotherapy, radiation therapy and surgery.
* Patients with reproductive potential must use a medically acceptable contraceptive method. Women of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

* History of retinopathy.
* Serious ongoing medical or psychiatric disorder (as determined by the clinical investigator).
* External beam radiation therapy to \>30% of the bone marrow at any time prior to study entry.
* Prior treatment with irofulven or capecitabine, or protracted infusion of 5-fluorouracil (5-FU) (infusion duration greater than or equal to 5 days) or other fluoropyrimidines.
* Therapeutic doses of coumarin derivatives (warfarin) 14 days prior to receiving the first dose of study treatment or during the study period.

Please note: There are additional criteria that must be met in order to be eligible for this study.
Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery

The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B).

The secondary aims are the evaluation of the following parameters:

* Effect of PTNS on manometric parameters
* Effect of PTNS on quality of life
* Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation
* Safety of PTNS

The study is a prospective randomized clinical trial that compares two treatments in patients with LARS:

Arm A: PTNS + conservative treatment (based on predominant symptom) Arm B: only conservative treatment

The study is divided into two phases:

1. PRETREATMENT PHASE

   The patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer, will be submitted during the first visit of the study to :
   * Collection of personal data
   * Collection of medical records
   * Collection of data relating to the intervention of anterior resection of the rectum
   * Verification of the criteria for inclusion / exclusion
   * Collection of informed consent
   * Administration of the questionnaires European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Cancer 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Colorectal 38 (EORTC QLQ-CR38), Faecal incontinence severity index (FISI); Fecal incontinence quality of life questionnaire (FIQL), Obstructed defaecation syndrome (ODS) score questionnaire and Constipation-related quality of life questionnaire (CRQoL)
   * Endoanal ultrasound
   * Anorectal manometry
2. PHASE OF TREATMENT During the treatment phase, data related to the treatment and any treatment related-complications will be recorded on a special form Bowel function and quality of life will be assessed using the same questionnaires at the end of treatment. Even anorectal manometry will be repeated at the end of treatment.

It is expected to enroll approximately 12 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;
* Age\> 18 years;
* Obtaining informed consent.

Exclusion Criteria:

* Patients carrying ostomy;
* Patients with clinical or radiological evidence of local or distant tumor recurrence;
* Patients suffering from neurological disorders;
* Patients with Inflammatory Bowel Disease (IBD);
* Patients who have a pacemaker or defibrillator;
* Patients taking antiplatelet agents or anticoagulants;
* Patients unable to follow the procedures of the Protocol or to provide informed consent.
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder

The purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.

The purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder. Incomplete treatment response can be common in these disorders. While there are medications that are effective at treating positive symptoms, some other symptoms of the disorders are often left only partially treated (cognitive impairment and negative symptoms). This study will begin to address if the medication isradipine might help to treat some of the cognitive problems associated with schizophrenia and schizoaffective disorder. Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. It is currently approved by the FDA for hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* DSM-IV schizophrenia or schizoaffective disorder diagnosis
* Residual phase of illness criteria met at screen and baseline as defined by item scores of equal to or less than 4 on each of the Brief Psychiatric Rating Scale (BPRS) hallucinatory behavior, unusual thought content, conceptual disorganization items
* Hamilton Rating Scale for Depression (HRSD) equal to or less than 12
* Baseline Clinician Administered Scale for Mania (CARS-M) score of less than 5
* Simpson Angus Scale (SAS) total score equal to or less than 6
* Treatment with at least one but no more than two stably-dosed second-generation antipsychotic medication (other than clozapine) for equal to or greater than 2 months and no changes planned over the 4-week study period

Exclusion Criteria:

* History of CNS trauma, neurological disorder, ADHD, mental retardation, learning disability, or other non-schizophrenic cause of cognitive impairment
* DSM-IV diagnosis of substance abuse/dependence within 3 months
* Pregnant women or women of childbearing age who are not using a medically accepted means of contraception
* Women who are breastfeeding
* Active, unstable medical problem that may interfere with cognition
* Current treatment for hypertension
* Uncontrolled hypertension
* Any drug known to interact with isradipine
* History of GI strictures
* History of heart disease
* Abnormal lab or ECG at screen
* Significant suicidal ideation at baseline (HRSD item 3\>2)
* ECT treatment within 12 months
Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System

In order to validate that the VIPUN, Gastric Monitoring System (GMS) is a gastric motility monitoring system, we intend to show that the VIPUN GMS can assess motility through pressure measurement similar to high-resolution manometry (HRM).

In addition, the study aims to contribute to the design and development of a position confirmation functionality integrated in the VIPUN Gastric Monitoring System by establishing volume-pressure relations in the stomach and esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Aged between and including 18 and 65 years
* In good health on the basis of medical history and anamnesis by the Principal Investigator (or delegate)
* Agrees to refrain from drug, non-allowed medication, herbal supplement and dietary supplement intake on the day of the study visit
* Agrees to an overnight fast in advance of the study visit

Exclusion Criteria:

* Current or chronic gastrointestinal symptoms
* Use of any medication that might affect gastric function or visceral sensitivity in the opinion of the PI
* (Suspected) current use of illicit drugs
* Psychiatric or neurological illness
* Any history of gastrointestinal surgery that could influence normal gastric function in the opinion of the PI, including, but not limited to gastrectomy, esophagectomy, duodenotomy, pancreatectomy, bariatric surgery (bypass surgery, gastric banding...), placement of neuromodulator
* Simultaneous participation in other clinical studies
* Suspected or confirmed basal skull fracture, mid face trauma or maxillofacial trauma
* Nasopharyngeal surgery in the last 30 days
* History of severe coagulation abnormalities
* Therapeutic or prophylactic anticoagulation
* Gastrointestinal bleeding
* Ischemic bowel
* Peritonitis
* Deviated nasal septum impeding catheter placement
* Inability to pass a feeding tube through the nares (e.g. in case of anatomical features, nasal congestion or blockage)
* Recent (\< 30 days) caustic ingestion (due to risk of esophageal rupture)
* Recent (\< 30 days) esophageal varices (active, untreated or recently banded/cauterized)
* History of esophageal strictures
* History of gastric varices
* History of gastric obstruction
* History of gastrectomy, esophagectomy, duodeno-pancreatectomy, bypass surgery, gastric banding, bariatric balloon, or short bowel syndrome
* History of gastrostomy
* Allergy to components of the VIPUN Catheter
* Pregnancy or breastfeeding
* Allergy to components of the enteral nutrition
* Allergy to the available lubricants
* Allergy to the available local anesthetic
* Recent infection with SARS-CoV-2 (in the last 2 weeks prior to study visit).
Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.

II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.

OUTLINE:

Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* DNA samples available from patients meeting the following criteria:

  * Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
  * Patients with pre-B ALL, including responders vs non-responders in selected genotypes \[hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)\] and responders and non-responders regardless of genotype
  * Pediatric patients with AML registered on POG-9421
  * Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML
  * Pediatric patients with relapsed ALL enrolled on COG-AALL01P2
  * Pediatric patients enrolled on COG-9900 and other CCG or POG trials
Multi-omics Analysis of Chronic Kidney Disease

Chronic kidney disease (CKD) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.


Eligibility Criteria:
Inclusion Criteria:

Age-matched and gender-matched HC with normal renal and liver function and not taking any medications were enrolled

Exclusion Criteria:

1. Age\<18 years.
2. Individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy.
3. Individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.
A Prognostic Model for Drug-induced Liver Injury in China

A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers.

A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .

Research Objectives:

1. To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data.
2. To establish and verify prognostic model(s) of DILI in China.
3. To explore novel serum biomarkers for the prognosis of DILI.

Eligibility Criteria:
Inclusion Criteria:

1. RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
3. Onset to enrollment ≤3 months.

Exclusion Criteria:

1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
3. Hypoxic ischemic hepatitis and congestive liver disease.
4. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years.
5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
7. Parasitic infection.
8. Sepsis.
9. Previous liver transplantation or bone marrow transplantation.
10. Pregnancy or lactation.
11. Genetic and metabolic liver diseases.
Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)

The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate acne papulopustulosa according to Burton Scale Stage 3 to 4
* At least 5 inflammatory and 5 non-inflammatory lesions in the face
* Age \>= 14 years

Exclusion Criteria:

* pregnant and nursing women
* Antiandrogen therapy
* therapy with antibiotics within the last 4 weeks
* therapy with retinoids within the last 6 months
* natural or artificial UV-therapy within the last 4 weeks
* severe acne papulopustulosa according to Burton Scale 5 or 6
* Severe systemic condition
* Secondary acne
Cortical Function Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome

The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). The main questions it aims to answer are:

* The alteration of cortical activation during swallowing in patients with LMS compared with healthy subjects.
* The alteration of cortical functional connectivity during swallowing in patients with LMS compared with healthy subjects.

fNIRS will be used to detect cortical activation and functional connectivity during swallowing tasks in LMS patients and healthy subjects, and to compare the differences between patients and healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* The first ischemic stroke was confirmed by head MRI as LMS;
* 18-80 years old, right-handed;
* Dysphagia was confirmed by video fluoroscopic swallow study(VFSS);
* Conscious enough to cooperate with fNIRS testing;
* No previous neurological or mental illness.

Exclusion Criteria:

* Other central nervous system diseases (Parkinson's disease, Alzheimer's disease, intracranial tumors, etc.);
* Other diseases causing dysphagia (tumors of the esophagus, larynx, nasopharynx, etc.);
* Serious physical diseases (cancer, fracture, etc.);
* Other mental disorders (mania, schizophrenia, etc.);
* Unconscious, unable to cooperate with the examination
Informational Meetings for Planning and Coordinating Treatment

This prospective cluster-randomized trial examines the efficacy of a novel communication intervention delivered by trained physician and nurse dyads to parents of children with cancer within the clinicians' practice, to foster alignment of the goals of treatment. The investigators hypothesize that goal alignment will improve quality of life outcomes, in particular for those patients who reach end of life. Findings from the proposed research will provide essential information to promote communication practice standards that can be rapidly translated into practice to improve outcomes for children, particularly those who reach end of life, and parents.

The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.

Eligibility Criteria:
Inclusion Criteria:

* Child 1 month to \< 18 years
* Child newly diagnosed, i.e., within 16 weeks (112 days) from time of diagnosis of cancer not including the day of diagnosis, OR
* Child with relapsed cancer, defined as within 16 weeks (112 days) of first-time relapse/evidence of progression of disease as noted by scan or biopsy after previous diagnosis of cancer.
* Child provide assent if age ≥ 7 years
* Poor prognosis, i.e., approximate \< 25 % estimated overall survival or at the discretion of the attending AND/OR:
* Falls into one of the following diagnosis categories, including but not limited to:

  * Atypical teratoid rhabdoid tumor
  * Glioblastoma multiforme
  * Diffuse intrinsic brainstem glioma
  * Embryonal tumors with multilayered rosettes
  * Other high-grade glioma
  * Gliomatosis cerebri
  * Metastatic osteosarcoma
  * Metastatic Ewing sarcoma
  * Metastatic rhabdomyosarcoma
  * Metastatic desmoplastic small round cell tumor (DSRCT)
  * Other metastatic sarcoma/carcinoma-at discretion of attending
  * Metastatic unknown primary- or rare pathology- at discretion of attending
* Parent(s) legal decision-maker(s) for child
* Parent(s) ≥18 years of age
* Parent (s) Informed of child's cancer diagnosis
* Parent(s) Able to read, speak and understand English
* Must be willing to be audio recorded during all study sessions.

Exclusion Criteria:

* The parent has neurological/cognitive impairments likely to interfere with study participation;
* The child ≥ 7 years of age does not provide assent
* Parent refuses to be audio recorded during sessions.
Verisee Software for Diabetic Retinopathy Screening

The investigators aim to improve the diagnostic accuracy and the clinical referral rate for diabetic retinopathy by using a deep learning-based software.

Diabetic retinopathy (DR) is the leading cause of blindness among working-age patients with type 2 diabetes. According to previous studies, early screening and timely treatment can reduce the risk of worsening DR and blindness. International guidelines recommend that screening for DR be performed at least once every year for patients with type 2 diabetes. The investigators will implement a validated deep learning-based software, VeriSee®, in clinics, and evaluate the benefits on diagnostic accuracy and the clinical referral rate for diabetic retinopathy after implementation of this software.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patients with diabetes
* Cooperation to fundal scopic examination

Exclusion Criteria:

* Diabetic duration \< 5 years in patients with type 1 diabetes
* Pregnancy
Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2

It is planned to include patients over 18 years of age of both sexes, admitted to the Intensive Care Unit of Clinical Hospital Centre Split for respiratory insufficiency caused by severe acute respiratory syndrome coronavirus 2 in need of invasive mechanical ventilation.

The patients will be divided into four groups. Group 1 will receive N-acetylcysteine inhalation, Group 2 will receive inhalation with a 5% sodium chloride solution, and Group 3 will receive inhalation of 8.4% sodium bicarbonate, group 4 is a control group and will not routinely receive inhaled mucolytics preventively.

All inhalations will be given twice a day 12 hours apart. The first inhalation will be included within 12 hours of the patient being enrolled in the Intensive Care Unit. Patients will be randomized according to the type of inhalation they will receive, randomization will be done by all researchers through the random.org website, and the inhalation will be given by a nurse according to the agreed protocol.

RESEARCH GOALS

The aim of this study is to determine whether there is a difference in the frequency and duration of ventilator-associated pneumonia (VAP) and whether there is a difference in the number of days spent on mechanical ventilation and in mortality in these four groups of patients.

Hypothesis

Coronavirus disease 2019 patients on invasive mechanical ventilation and preventive sodium bicarbonate inhalation will have a lower incidence of ventilator-associated pneumonia and fewer days spent on invasive mechanical ventilation than patients inhaled with N-acetylcysteine, 5% saline, or patients without preventive inhalation.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with coronavirus pneumonia who need invasive mechanical ventilation.

Exclusion Criteria:

* Patients with polytrauma,
* pregnant women,
* severe hemodynamic instability,
* patients with pulmonary edema,
* less than 3 days spent in the ICU,
* patients who have microbiologically proven bacterial infection on arrival.