cyrilzakka/clinical-trials huggingface dataset:
Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation (P02733/MK-4031-085)

This study aims to compare the role of peginterferon α-2b (50 μg/week) vs. control (no treatment) in the prevention of hepatocellular carcinoma, in adult patients with cirrhosis and initial signs of portal hypertension who did not respond to previous combined therapy with interferon alfa + ribavirin or peginterferon alfa + ribavirin or to interferon alfa monotherapy and with a high proliferation rate before entering the study. The duration of treatment will be 3 years, and the follow-up period will be 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic participants, both sexes, Child Pugh A, B, HCV-RNA positive, age \< 70 years
* Participants non-responders to IFN + Ribavirin or PegIFN + Ribavirin or IFN monotherapy
* Pre-therapy liver biopsy (\< 36 months) with PCNA-LI \> 2.0
* Fibrosis score 5-6 (Ishak)
* Initial portal hypertension, such as gastroesophageal varices or one of the following US sign:

  * Collateral circles
  * Spleen longitudinal diameter \> 12 cm
  * Portal vein diameter at hilus \> 12 mm
  * Portal flow \> 12 cm/sec
  * Participants must have the following minimum hematologic and biochemical criteria:
  * Hemoglobin \>= 11 g/dL
  * Granulocyte count \> 1,000/mm\^3
  * Platelets \> 70,000/mm\^3
  * Prothrombin activity \> 50%
  * Total bilirubin \<3 mg/dL
  * Albumin \>= 3.5 g/dL
  * Serum creatinine within normal limits
* Uric Acid within normal limits
* Thyroid Stimulating Hormone (TSH), within normal limits
* Antinuclear antibodies (ANA) \< 1:160
* Written informed consent
* Women of childbearing potential must have a negative pregnancy test
* Acceptance of patients of both sexes of proper contraceptive measures for the study period

Exclusion Criteria:

* Pregnant or breast-feeding women
* Co-infection with HIV and/or HBV
* Autoimmune hepatitis or history of autoimmune disease
* Alcoholic liver disease
* Metabolic disease
* HCC
* Participants with liver and kidney transplants
* Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy
* Chronic renal failure or creatinine clearance \< 50 mL/min
* Pre-existing thyroid disease unless it can be controlled with conventional treatment
* History or presence of psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt
* Epilepsy and/or compromised central nervous system (CNS) function
* Significant cardiovascular dysfunction within the previous 6 months before the study starts (eg, angina, congestive heart failure, recent myocardial infarction, moderate or severe hypertension, significant arrhythmia)
* Hemoglobinopathies
* Poorly controlled diabetes mellitus
* Chronic pulmonary disease (eg, chronic obstructive pulmonary disease)
* Clinical gout
* Hypersensitivity to interferons or any component of the drug
Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19

The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. The aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19.

The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. It has been examined that menstruation volume decreased or cycle lengthened in one-fifth of women who had COVID-19, and this condition was more intense in those who had severe COVID-19. Studies have shown that the possible effects of COVID-19 on the female genital system often remain theoretical hypotheses. In the literature, there was no study in which menstrual dysfunctions and secondary problems caused by the state of inactivity entering our lives during pandemic were discussed in a wide spectrum of women who had COVID-19. Therefore the aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 45,
* PCR test result positive confirmed having COVID-19 infection,
* Women had at least one period of Menstrual cycle after COVID-19
* Being an Internet connection,
* To be able to speak and write in Turkish.

Exclusion Criteria:

* To be in the premenaposual/postmenopausal period (to be in the transition period to menopause or in the period after menopause.)
* Having insufficient co-operation.
The Effects of Radiation in Reconstructed Breasts

The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.

Immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients. This change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction. Following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result. The effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.

Eligibility Criteria:
Inclusion Criteria:

* Female patients between 18 and 90 years of age.
* Patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction.
* Patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction.

Exclusion Criteria:

* Women who do not undergo immediate, bilateral breast reconstruction using a free flap.
* Women who do not require unilateral, adjuvant radiation therapy
* Women who are pregnant
* Women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3
Negative Valence Brain Targets and Predictors of Anxiety and Depression Treatment

Internalizing psychopathologies (IPs) involving depression and anxiety are among the most prevalent, costly and disabling illnesses. Treatments for IPs are available but the extent to which individual patients respond is quite heterogeneous. Little information exists, particularly in the biological domain, which helps to explain individual differences in treatment response. IPs share similar patterns of dysfunction within the Fronto-Limbic Affect Regulation and Emotional Salience (FLARES) brain circuit, and two commonly used, 'gold standard' treatments - selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapies (CBTs) - are equally effective for both anxiety and depressive disorders, and appear to change brain activity in the same areas within the FLARES circuit. The overarching goal of the project is delineate what are common versus specific FLARE brain targets for SSRI and CBT and identify specific aspects of FLARE dysfunction that might better predict response to both and to a specific modality of treatment. This experiment integrates emotion and its interaction with cognition across several stages of emotional experience, encompassing studies that probe sensitivity to acute and potential threat and automatic and volitional forms of affect regulation in relation to the FLARES brain network.

We will enroll 200 patients presenting to our Mood and Anxiety Disorders Program seeking treatment for disabling 'anxiety, worry, depressed mood' (IPs, including those characterized as Not Otherwise Specified) and randomize them to a 12-week course of SSRI or CBT. Dimensional, transdiagnostic negative valence systems (NVS) constructs, including FLARES function, will be measured before and after each treatment. Specifically, the project will examine 2 Specific Aims: 1) Where and how do SSRI and CBT treatments exert their effects on NVS constructs?; and 2) Which NVS construct can predict the likelihood of success from SSRI and CBT treatment? Such findings can be used to guide the right patients to the right treatments with the highest likelihood of success. They also elucidate a pathophysiologically-driven mechanistic model of where and how treatments work in the brain and thus hasten the development of new treatments that target the underlying pathophysiology across internalizing conditions.


Eligibility Criteria:
Inclusion Criteria:

* Generally medically and neurologically healthy
* Chief complaint(s) of "anxiety, worry, and/or depressed mood

Exclusion Criteria:

* Current or past manic/hypomanic episode or psychotic symptoms
* Suicidal ideation
* Presence of contraindications (e.g., history of SSRI adverse events) or prior history of SSRI resistance (no response to \> 2 SSRI trials with adequate duration and dose)
* Obsessive compulsive disorder (OCD)
* Current cognitive dysfunction (traumatic brain injury, mental retardation, dementia)
* Current alcohol and substance dependence
* Ongoing therapy/medication treatment of any kind outside of this study
Metacognitive Training Program With Depression

The participants of this study have been diagnosed with mild to moderate depression with no evidence of suicidal actions prior to recruitment. All recruited subjects receive standard therapy and participate in a metacognitive training program (D-MKT) independently of study participation. Diagnostic and therapeutical interventions are not part of this study. As part of this study, the change of cognitive and psychosocial achievement/behavior in patients with mild to moderate depression after taking part in the training program is being investigated. The training program seeks to enable group members to recognize and correct the often automatic and unconscious thought patterns that accompany depression, in part by viewing this depressive thought process at a distance (i.e., depersonalizing). In addition, dysfunctional assumptions about one's thought processes, as well as dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are targeted (Lena Jelinek \& Steffen Moritz, http://clinical-neuropsychology.de/metacognitive_training_for_depression.html). Within this study the cognitive and psychosocial behaviour changes are being investigated by neuropsychological assessment as well as questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the Metacognitive Training Program
* Subjects with an age over 55 years and a diagnosed mild to moderate depression without psychotic Symptoms (F32, F33)
* Subjects have to be able to understand verbal and written information regarding treatment and procedures of the study.
* Subjects have to be able to understand and perform verbal and written tasks (cognitive tests/questionnaires).
* No evidence of suicidal tendency

Exclusion Criteria:

* Taking of medication or drugs that could influence cognition
* Diseases that prevent the subject from giving consent to this study or affect the collaboration during the examination
* Major and/or unstable physical diseases
* Strongly impaired vision/eye diseases
* Psychotic or manic symptoms
* Benzodiazepine addiction/dependency
* Suicidal tendency
Peroxisomal Defects and Familial Risk for Bipolar Disorder

The purpose of this study is to screen for peroxisome defects in child and adolescent offspring of Bipolar Disorder I (BD-I) parents at different stages of risk for transitioning to mania and following the onset of mania.

Prediction 1: Youth with an elevated risk for developing BD-I and first-episode manic patients will exhibit graded deficits in measures of peroxisomal function compared with healthy controls.

Prediction 2: Indices of peroxisomal function will be correlated with Red Blood Cells Docosahexaenoic acid (DHA) composition.

Prediction 3: Graded deficits in measures of peroxisomal function will be inversely correlated with manic and depression symptom severity scores.

Overall Study Design: This study entails collecting fasting venous blood (20 ml) from, and administering the 'omega-3 questionnaire' to, subjects being recruited from ongoing National Institute of Mental Health (NIMH)-sponsored trials within the Department of Psychiatry, University of Cincinnati College of Medicine. Specifically, blood will be collected from 20 healthy controls (i.e., no personal or family history of any Axis I mood disorder according to the Diagnostic and Statistical Manual of Mental Disorders-IV \[DSM-IV\]) and 20 asymptomatic high-risk (i.e., have a biological parent with BD-I) adolescents (aged 10-18 years old) recruited for study MH077138 (UC-IRB #: 07-04-10-03, BITREC Project 3; PI: DelBello), 20 ultra-high risk (i.e., have a biological parent with BD-I and a Major Depressive Disorder (MDD) diagnosis) recruited for study MH083924 (UC-IRB #: 04-09-15-03, CO-Principal Investigators DelBello/McNamara), and 20 adolescents who are admitted for their first hospitalization and who have a diagnosis of BD-I recruited for study MH080973 (UC-IRB #: 08-10-30-01, Principal Investigator: DelBello). Blood will then be processed, and de-identified tubes sent to the Kennedy Krieger Institute, Peroxisomal Diseases Section, to determine the following measures of peroxisomal function: (1) plasma very long chain fatty acids (C24:0 \& C26:0) concentrations, (2) plasma bile acid C27 intermediate (dehydrocrepenynic acid {DHCA},tetrahydrocannabinolic acid {THCA})concentrations, (3) plasma pipecolic acid concentrations, and (4) Red Blood Cell (RBC) plasmalogen concentrations. Additionally, RBC fatty acid composition will be determined by gas chromatography, and platelet function and plasma inflammatory markers assayed using commercially available kits according to manufacturer's instructions.

Eligibility Criteria:
Subject characteristics: All subjects will be 10-18 year old males and females. Up to 80 patients will be enrolled in this study. Subjects will be screened according to previously approved individual study criteria (UC-IRB #: 07-04-10-03; 04-09-15-03; 08-10-30-01).

Inclusion Criteria:

* 10 -18 year old males \& females
* Based on currently enrolled study.

Exclusion Criteria:

* Based on currently enrolled study.
Leflunomide in Mild COVID-19 Patients

This study aims to examine the tolerability of high dose of leflunomide in patients with COVID-19 who are being managed in the outpatient setting.

This is a single are and single-center tolerability study of high dose leflunomide therapy in outpatient adult participants with mild COVID-19. In vitro studies have shown antiviral effects of leflunomide against SARS CoV-2, but the clinical outcomes in the disease have been variable. Our hypothesis is that targeting high risk patients earlier in the disease course and with a higher dose regimen are both required to see improvement in disease outcome measures in COVID-19. This study aims to prove the tolerability of high dose leflunomide in this setting.

Patients are selected based on identification of mild COVID-19 symptoms. Investigators will enroll twenty patients and perform a detailed Tele-helath interview to ensure they meet eligibility criteria and provide informed consent. 100 mg leflunomide daily for three days followed by 30 mg day will be prescribed. The subjects will be required to monitor their temperatures twice daily and a daily telephone call with an investigatory will review symptoms of disease and potential side effects of the drug. Subjects can discontinue the drug after five days if they no longer have fever, or take the drug for up to ten days if required for fever resolution.

Eligibility Criteria:
Inclusion Criteria:

* Being tested positive for SARS-Cov-2 in outpatient setting in drive-thru, ED, or ambulatory clinics at the University of Chicago within 72 hours of enrollment.
* Age \>18
* Mild COVID-19, defined as the presence of any symptom consistent with an upper respiratory tract infection, including dry cough, sore throat, nasal congestion, fatigue, myalgia, headaches

Exclusion Criteria:

* Participation in any other clinical trial of an experimental agent treatment for COVID-19
* Current hospitalization
* Known hypersensitivity to leflunomide
* Currently taking methotrexate
* Currently taking terliflunomide
* Known chronic kidney disease, stage 4-5, or receiving dialysis
* History of liver disease
* History of interstitial lung disease
* Pregnancy and lactation - pregnancy test required for females
* Inability to monitor body temperature (oral, axillary, tympanic or frontal) at least twice a day from study enrollment day (Day 1) to the end of the study (Day 14).
* Inability to provide informed consent to the study.
Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study)

SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition.

SuperCAP study will include 2 stages.

Stage 1 will involve the composition of a focus group previous to the effectiveness study development.

The work with this focus group will have several aims, among them, mainly, to participate in the design of the intervention program, and to provide feedback on the study follow-up.

Stage 2 will include the effectiveness study. This stage will comprise the initiation of the intervention program, study follow-up, and dissemination of the results in the end of the project.

Two study groups will participate: the Intervention Group and the Control Group.

The Intervention Group will be comprised by people with post-COVID condition who will follow the intervention program proposed.

The Control Group will be comprised by people with post-COVID condition who will not follow the program.

Both groups will fulfill the same study participation criteria.

The intervention will consist of the follow-up of a distance program via mobile/tablet. This program will integrate different games and exercises always with the objective of stimulating the cognitive functioning and the emotional status.

Eligibility Criteria:
Inclusion Criteria:

* Presenting Post-COVID Syndrome, defined as presenting 3 or more symptoms associated with post-COVID condition for at least 3 months.
* Age of 18-65 years old.
* Presence of self-reported cognitive complaints associated with post-COVID infection.
* Positive and favorable attitude on the use of electronic devices.
* Will to participate in a stimulation program for improvement of cognitive symptoms.
* Availability of cell phone and computer or tablet with the minimum technical features considered.

Exclusion Criteria:

* Inability to undergo the neuropsychological tests or complementary study assessments.
* Current participation in a trial or program for improvement of post-COVID symptoms.
* Any condition that in the opinion of the investigator would make study participation unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives, or otherwise could impair the subject's ability to complete the study.
Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Researchers are trying to understand why people with indigestion and diabetes mellitus have gastrointestinal symptoms and in particular to understand whether symptoms are related to increased sensitivity to nutrients in the small intestine. As part of this investigation, a medication called ondansetron will also be studied to determine its effects on gastrointestinal function and associated symptoms.

The primary objectives of this study are to evaluate the effects of ondansetron, on symptoms (i) during a gastric emptying study, (ii) during enteral lipid infusion and (iii) in daily life.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant, non-breastfeeding female volunteers;
* 18-75 years old;
* Able to provide written informed consent before participating in the study
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study; including the willingness and ability to consume the components of the test meals
* Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)
* Patients in the DM group will also require Type 1 or 2 DM of ≥ 3 years duration; in patients with type 2 DM, the dyspepsia symptoms should have begun or worsened after DM was diagnosed

Exclusion Criteria:

* Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are permissible)
* Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
* Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, and high doses of anticholinergic agents (eg, amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments.
* Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain
* Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies
* Positive tissue transglutaminase antibodies (TTG),
* Pregnant or breast-feeding females
* Known intolerance or allergy to eggs
* Poor peripheral venous access, if central venous access is not available
* Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study
* History of Long QT Syndrome or prolonged QT interval (i.e., corrected QT interval \> 480 ms)
* Current symptoms of a functional gastrointestinal disorder assessed by questionnaire
* Severe vomiting that would preclude tube placement or participation in the study
* Structural cause for symptoms by endoscopy within the past 12 months
* Patients with gastric pacemakers
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children


Eligibility Criteria:
Inclusion Criteria:

* children aged 12-35 months
* youngest eligible child in each household

Exclusion Criteria:

* severe or moderate acute malnutrition
* severe chronic illness
* children unable to drink 20 mL of dual sugar solution
* children in need of acute medical treatment for illness or injury at time of enrollment