cyrilzakka/clinical-trials huggingface dataset:
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis for at least 6 months before the first administration of study drug
* Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (\>=) 12 at Screening and at Baseline
* Have an Investigator's Global Assessment (IGA) \>=3 at Screening and at Baseline
* Have an involved body surface area (BSA) \>= 10 percent (%) at Screening and at Baseline
* Be a candidate for phototherapy or systemic treatment for psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has unstable cardiovascular disease, defined as a recent clinical deterioration (example \[eg\], unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
* Currently has a malignancy or has a history of malignancy within 5 years before Screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration)
* Has previously received guselkumab or ustekinumab
Honest Open Proud for Adolescents With Mental Illness

The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest Open Proud' among adolescents with mental illness.

Both due to fear of public stigma and due to self-stigma or shame, people with mental illness may decide to keep their condition a secret or even to withdraw from other people altogether in order to minimise the risk of being labelled. Secrecy can help on the short term to protect individuals from public stigma, but often it has negative long-term consequences such as social isolation, distress and unemployment. Disclosure, on the other hand, carries the risk to be discriminated by others, but can reduce the burden of secrecy, lead to support by others and reduce public stigma. In this study investigators aim to evaluate whether a group program run both by people with mental illness (peers) and professionals helps to reduce self-stigma and makes it easier for adolescents to handle the necessary choices related to secrecy versus disclosure.

Eligibility Criteria:
Inclusion Criteria:

* At least one self-reported current axis I or axis II disorder according to DSM-5 (American Psychiatric Association, 2013), which is not restricted to only substance-related disorder(s)
* Age 13 to 18
* Ability to provide written informed consent
* Fluid in German (needed for self-report measures)
* At least a moderate level of self-reported disclosure-related distress/difficulty (score 4 or higher on the screening item 'In general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?', rated from 1, not at all, to 7, very much)

Exclusion Criteria:

* Self-reported diagnosis of only a substance- or alcohol-related disorder, without non-substance related current psychiatric comorbidity. We will exclude people who only have a substance-/alcohol-related disorder because the disclosure of these disorders is not the topic of the HOP intervention
* Intellectual disability
* Organic disorders
Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal

There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). There has been considerable discussion among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. The investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND
* Have at least one chest tube.

Exclusion Criteria:

* Less than 19 years old,
* With interstitial lung disease, OR
* Any patient intubated.
Intensive Outpatient Treatment for Suicidal Veterans

This investigation is a feasibility study conducted in a VA outpatient treatment setting. The study is designed to test the feasibility of implementing a novel way of working with suicidal patients, the Collaborative Assessment and Management of Suicidality (CAMS). The primary purpose of the proposed project is to determine if it is possible to train clinicians working in the Mental Health Clinic at the Denver VA Medical Center (VAMC) to utilize this therapeutic framework. This project is extremely timely in relation to expectations of future increased clinical demands among potentially high-risk Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans who may become suicidal in the years to come.


Eligibility Criteria:
Inclusion Criteria:

1. Suicidality endorsed during the regular Mental Health intake interview or at the time of admission.
2. Over the age of 18 years.
3. New or returning patients to the VA MHC.
4. Living within the larger Denver metropolitan region during the duration of the treatment.
5. Willing to travel to the ECHCS Denver VAMC at times other than scheduled therapy appointments to complete follow-up assessment measures.

Exclusion Criteria:

1. Psychosis that would interfere with an individual's ability to provide informed consent.
2. Imminent suicidality with the need for immediate psychiatric hospitalization, as defined above in the Background section, at the time of MH intake.
3. Current involuntary status for psychiatric hospitalization.
4. Inability to adequately respond to questions regarding the informed consent procedure. See Special Consent Issues section below.
Silymarin (Milk Thistle Extract) in Treating Patients With Acute Lymphoblastic Leukemia Who Are Receiving Chemotherapy

RATIONALE: Silymarin (milk thistle extract) is an herb that may be effective in treating liver disorders caused by cancer therapy.

PURPOSE: Randomized phase II trial to study the effectiveness of silymarin in treating patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the liver.

OBJECTIVES:

* Determine the effect of silymarin, in terms of liver function tests, in patients with acute lymphoblastic leukemia receiving hepatotoxic chemotherapy.
* Determine the effect of this drug on free and conjugated serum silibinin values in these patients.
* Determine the serum antioxidant capacity by Oxygen Radical Absorbance Capacity in patients treated with this drug.
* Determine the oxidative damage, as determined by 8-oxodeoxyguanosine adducts, in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral silymarin daily for 28 days.
* Arm II: Patients receive oral placebo as in arm I. Patients are followed at day 56.

PROJECTED ACCRUAL: A total of 50 patients (25 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia (ALL)
* Currently receiving maintenance or continuation phase chemotherapy for ALL

  * Regimen comprising intrathecal and oral methotrexate; vincristine IV; oral prednisone or dexamethasone; and oral mercaptopurine
* Elevated liver function tests, evidenced by 1 of the following criteria:

  * Bilirubin greater than 1.5 times upper limit of normal (ULN)
  * AST greater than 2.5 times ULN
  * ALT greater than 2.5 times ULN

PATIENT CHARACTERISTICS:

Age

* 2 to 21

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* See Disease Characteristics

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* Not specified

Surgery

* Not specified
Outpatient Office Based Endovascular Procedures

The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite. Additionally, other studies could compare clinical outcomes between procedures performed in an office based angiosuite and other settings.

Endovascular surgery combined with the demands of patients and physicians for less invasive procedures, have make this type of surgery one of the most innovative fields in medicine. However the endovascular experience in an office-based angiosuite is different from that in a hospital suite, and has been viewed in the past by some physicians as unsafe because it lacks the safety net of immediate hospital resources. In 2005, medicine allowed endovascular procedures to be performed in the office setting. The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of peripheral arterial disease (PAD), chronic venous insufficiency, dialysis access and malfunctioning arteriovenous fistulas, varicose veins, vertebrobasilar insufficiency, and thoracic outlet syndrome.
* Procedures performed as an outpatient in an office based angiosuite.

Exclusion Criteria:

* Age ≤ 18 years
Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form by the patient or a legal representative according to local regulations'
* Man or women 18 years of age or older
* Body weight below 115 kg for male patients and 100 kg for female patients
* Proven or suspected infection
* Septic shock, i.e. vasodilatory hypotension requiring vasopressor support
* Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication

Exclusion Criteria:

* Present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina)
* Known or suspected endocarditis
* Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test
* Known or suspected cardiac failure
* Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C
* Pregnancy or breastfeeding
* Any cause of hypotension other than early septic shock
* Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion
* Proven or suspected acute mesenteric ischemia, as judged by the investigator
* Known episode of septic shock within 1 month prior to screening
* Death anticipated within 24 hours, or due to the underlying disease within 3 months
* Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker
* Brain injury within current hospitalisation
* Present hospitalisation with burn injury
* Symptomatic peripheral vascular disease including Raynaud's syndrome
* Previously included in this trial
* Intake of an Investigational Medicinal Product (IMP) within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
* Known participation in another interventional clinical trial
* Considered by the investigator to be unsuitable to participate in the trial for any other reason
Cigarette Smoking in Non-alcoholic Steatohepatitis

This non-randomized clinical trial was performed to clarify the effect of cigarette smoking reduction on liver function and some anthropocentric indices in smoker patients with non-alcoholic steatohepatitis.

After excluding other causes of high aminotransferase level, participants with persistent elevated serum aminotransferase levels and evidence of fatty liver in ultrasonography were presumed to have non-alcoholic steatohepatitis. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were assigned to lifestyle modification alone or lifestyle modification plus smoking reduction groups.

Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Eligibility Criteria:
Inclusion Criteria:

Smokers with persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion Criteria:

* alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
* heart disease (ischemic or congestive),
* hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
* renal disease (serum creatinine concentration of \> 1.5 mg/dl),
* any severe systemic co-morbidities, neoplasm,
* using any hepatotoxic medication during the past 3 months,
* pregnant or lactating women.
Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe Acute Respiratory Syndrome Corona Virus 2) positive and negative children and adults with the Resp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratory aerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established. Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive and negative participants (children and adults) will be conducted. In addition to the measurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratory inflammatory markers will be analyzed.

Corona virus disease 2019 (COVID-19) is a viral illness caused by SARS-CoV-2. Current research suggests that the SARS-CoV-2 infection is primarily spread through droplets and aerosols. As per current literature, the spread through asymptomatic carriers, as well as highly contagious carriers ('super spreader') play an important role in the infectiousness of the virus. It is currently unclear, if the contagiousness of children differs from adults.

In the proposed investigation, measurement of the particle size and concentration in respiratory aerosols will be conducted via the Resp-Aer-Meter (Palas GmbH). First step will be to establish the measurements with this new device. Thereafter, a comparison between PCR SARS-CoV-2 positive and negative participants, as well as between children and adults, will be conducted. In addition to the measurement of aerosols, the clinical symptoms suggestive of COVID-19, lung function (FEV1) and laboratory inflammatory markers, if available, will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 years or older
* SARS-CoV-2 PCR testing within the last 3 days
* Ability to capture extend and consequences of the study
* Written informed consent of patient and, if applicable, of caregiver

Exclusion Criteria:

* Age under 6 years
* Inability to participate in aerosol measurement
* Inability to participate in Spirometry
* Inability to capture extend and consequences of the study
* Only for arm 1 (PCR SARS-CoV-2 negative adults): chronic disease with immunosuppressive therapy
High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study

Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids, proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA. Ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function. There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The investigators will compare the mtDNA copy number and fatigue scale between moderate-severe fatigue patients and control group that had not malignant and chronic illness by a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Adults with above 18 years old and 6 month fatigue duration
2. Moderate to severe fatigue scale (Brief fatigue inventory-Korean version scale ≥ 4)
3. Normal limit values in the screening test (White blood cell count, Hemoglobin, Creatinine, SGOT/SGPT, Thyroid stimulating hormone, Urinalysis)
4. Normal limit values in glucose 6 phosphate dehydrogenase level
5. Agree the subjects explanation

Exclusion Criteria:

1. pregnancy and lactation
2. acute common cold, acute gastroenteritis, uncontrolled diabetes, uncontrolled hypertension, liver disease or renal disease
3. previous medical history, affectable by high-dose ascorbic acid (gout, renal calculi and glucose 6 phosphate dehydrogenase deficiency)
4. hypersensitivity from ascorbic acid
5. vitamin supplement intake until 2 days ago
6. drug interactions with ascorbic acid ( aspirin, Fe, phenytoin, estrogen, tetracycline, coumarin, corticosteroid)
7. Do not read a consent fom
Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans

Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality, amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. The objective of the study was to determine the efficacy of Carica Papaya peel extract (suckling) as an inhibitor of Streptococcus Mutans in students of the dental faculty of the National University of Caaguazú in 2018.

Specific objectives

* To determine the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on Streptococcus Mutans by age and sex grouping.
* To quantify the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on the growth of Streptococcus Mutans before, at 10 minutes and 8 days of use in the experimental group.
* Quantify the inhibition of 0.12% Chlorhexidine Gluconate on the growth of Streptococcus Mutans before, after 10 minutes and 8 days of use in the control group.
* Compare the count of Colony Forming Units (CFU) between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants that signed the informed consent

Exclusion Criteria:

* allergic to carica papaya
* ongoing medical or dental treatment that could interfere with the results.
Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression?

Our primary aim is to evaluate whether Vitamin D deficiency causes depressive symptoms in antepartum and postpartum depression and whether early correction of Vitamin D deficiency improves these symptoms.

Our secondary aims evaluate maternal and fetal outcomes including antepartum, intrapartum, and immediate postpartum complications. We are also evaluating the effectiveness of a common vitamin D treatment regimen used outside of pregnancy.

Our study recruitment will be at a single center in our pregnant private and clinic population. We will recruit eligible pregnant women 20 weeks 0 days or less. On study entry, patients will complete a demographic survey, vitamin D exposure survey, and an Edinburgh Postnatal Depression Score (EPDS) questionnaire. Baseline vitamin D levels will be obtained using a 25 OH D (vitamin D) assay.

Women found to be vitamin D deficient/insufficient will be approached for randomization to vitamin D3 (Cholecalciferol) 50,000 IU/week x 8 weeks + prenatal vitamin versus placebo + prenatal vitamin. A repeat 25 OH D sample plus a vitamin D exposure and EPDS questionnaires will be obtained between 24-28 weeks gestation upon completing treatment. All patients will then be kept on maintenance vitamin D until delivery (total vitamin D 800IU/day which includes prenatal vitamin). Delivery 25 OH D samples will be collected on all women. At delivery, these women will also complete vitamin D exposure and EPDS questionnaires. Maternal and fetal outcome data will be collected on all patients.

As for vitamin D sufficient patients, they will be followed with vitamin D exposure and EPDS questionnaires at 24-28 weeks and delivery. A 25 OH D sample will be obtained at delivery for these women. Maternal and fetal outcome data will be obtained.

For vitamin D deficient women declining randomization, they will be given vitamin D repletion based on their preference after counseling. We will continue to follow their questionnaires and outcomes similarly to the vitamin D sufficient group.

Eligibility Criteria:
Inclusion Criteria:

* Evaluation at Roosevelt Hospital (Receiving prenatal care with St Luke's Roosevelt Hospital center private physicians and clinic) by 20w0d gestation.
* Planned delivery at Roosevelt Hospital Labor \& Delivery
* English or Spanish speaking

Exclusion Criteria:

* Non-english or non-spanish speaking
* Currently on anti-depressants/mood stabilizing medications
* Medical comorbidities affecting vitamin D absorption or metabolism:Bone disease (osteoporosis, osteomalacia); Malabsorption disorders (cystic fibrosis, inflammatory bowel disease, roux-en-y bariatric surgery); Chronic kidney disease; Severe liver disease; Granuloma forming disorders (active tuberculosis, sarcoidosis);Parathyroid disease; Lymphoma; HIV on HAART medication; anti-seizure medications.