cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis

This study is a Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis

Total 278 patients with mild to moderate plaque psoriasis were randomized into the study. Study medications were applied twice daily for 8 weeks of study duration.

Patient's condition was assessed using of Physician's Global Assessment (PGA) and PASI Scale.

Primary objective of this study is to assess the therapeutic equivalence of Calcipotriol/AKVANO, 50 μg/g cutaneous solution with Calcipotriol Ointment 50 micrograms/g, Sandoz based on PASI score.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients (Non-pregnant) of plaque psoriasis aged 18 to 65 years having either Fitzpatrick skin type I-III or IV-VI.\<br/\>
* Diagnosis of stable plaque psoriasis for 6 month by a dermatologist with lesions on arms, legs or trunk.
* Mild to moderate psoriasis on Physician's global assessment (PGA),
* Body Surface Area (BSA) involvement of 5-10% (both included) and PASI ≥ 5.
* Patients must be willing to provide written informed consent and willing to comply with study requirements

Exclusion Criteria:

* Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis
* Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
* Patient with any uncontrolled systemic disease
* Patient with positive serology tests like HIV, HCV \& HBsAg.
* Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
* Patient with spontaneously improving or rapidly deteriorating plaque psoriasis.
* Use of systemic agents within four weeks prior to screening.
* Use of biologic agents within four weeks prior to study entry.
* Use of topical drugs that might alter the course of psoriasis or has received ultraviolet B treatment within two weeks prior to study entry.
* Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
* Known sensitivity to any of the study treatments and/or study treatment's components.
* Need for surgery or hospitalization during the study
* Pregnant or nursing Female patient or planning a pregnancy
* Concurrent involvement in any other clinical study within 30 days prior to entering the study
PROOF: Pancreatitis-associated Risk Of Organ Failure

This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis.

This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis. Therefore, the investigators aim to determine whether etiology of acute pancreatitis, segregates with candidate genetic polymorphisms and their m-RNA expression, as well as whether functional polymorphisms in inflammation regulating genes predict a more severe outcome in acute pancreatits. The investigators anticipate that based on our results that we will provide a more accurate predictor of the clinical course of acute pancreatits and help direct more aggressive or cytokine specific treatment of patients at greater risk of a more severe form of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for Subjects (all three) Males and females of 16 years of age and older. Body weight at least 40kg

Diagnosis of acute pancreatitis by both: Abdominal pain or abdominal localizing signs AND Elevated amylase levels by at-least three times the upper limit of normal and/or elevated lipase levels by at-least three times the upper limit of normal (25, 26). Acute pancreatitis must be defined by 2 of the 3 following criteria:

* Serum amylase or lipase elevated greater than 3X upper limit of normal
* epigastric acute pancreatitis pain
* abdominal imaging studies demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis Willingness to participate in the study and sign the informed consent. (Children and subjects who are cognitively impaired for temporary reasons as mentioned in the section 4.7 of this protocol will require a representative to sign the informed consent).

Inclusion criteria for Controls (all three) Males and females of 18 years of age and older. a. Unrelated family member or a friend of the subject or a patient having blood drawn in general medicine outpatient clinic, without a history of pancreatitis, OR Willingness to participate in the study and sign the informed consent.

Additional Inclusion Criteria for subjects with a previous attack of acute pancreatitis:

age criteria as defined above.

- Previous severe attack of severe acute pancreatitis requiring a ICU stay of at least 48 hours or evidence of pancreatic necrosis on computerized tomography.

Willingness to participate and sign informed consent

Exclusion Criteria:

* Exclusion Criteria for Subjects:

Persons unwilling to sign the informed consent Disorientation secondary to irreversible organic brain damage. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.

Blood transfusion within one week of enrollment Chronic Pancreatitis History of pancreatic cancer History of cancer requiring chemotherapy or radiation within the past 1 year History of organ transplant Subject is a prisoner Pancreatitis due to multiple trauma or surgical complications

Exclusion criteria for Controls:

Persons unwilling to sign the informed consent
Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)

Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).

Since once-a-day dosing is actually a driver for human immunodeficiency virus (HIV)-infected patients to request a specific antiretroviral, the aim of this study is to assess both patient's perception of and adherence to Kaletra once-a-day, as well as with which factors they are related.

This is a multicenter, post-marketing, observational, cross-sectional (single visit) study in HIV-infected patients treated with a combination of antiretroviral treatment (ART) containing LPV/r 200/50 mg tablets dosed QD for at least 12 weeks to assess the participants' satisfaction and adherence level with LPV/r QD ART as measured by specific validated participant questionnaires.

As this is a non-interventional study, the decision to enroll a participant was separate from the decision to treat the subject with LPV/r. Prescription of LPV/r and duration of treatment were the responsibility of the treating physician.

In addition, the overall study population was compared to Cohort 2 (394 patients on LPV/r BID for ≥3 months to \<2 years) from KAPITAL2, a post-marketing observational, cross-sectional, single visit, multicenter, national study. For further details on this study, please see: Casado JL, Griffa L, Cabrero E, Burgos A, Norton M and the KAPITAL 2 Collaborative Group. A study of treatment satisfaction reported by patients on lopinavir/r anchored regimens and physicians who provide HIV care (KAPITAL 2). 9th International Congress on Drug Therapy in HIV Infection. 9th International Congress on Drug Therapy in HIV Infection. Glasgow, 2008.#P080.

Eligibility Criteria:
Inclusion criteria:

1. Men or women aged 18 years or older, HIV-infected.
2. Patients who were under LPV/r Highly Active Anti-Retroviral Therapy (HAART) for 3 to 24 months before study visit:

   Cohort 1: patients on LPV/r QD since they started the LPV/r regimen and who were naïve to protease inhibitor (PI) therapy.\* Cohort 2: patients who previously started on LPV/r BID (maximum of 24 months before study) and switched to LPV/r QD (at least 3 months before the study visit).\*
3. Patients who were able to complete questionnaires by themselves.
4. Patients who signed/dated informed consent to participate in the study.

   * NOTE: Patients who were taking LPV/r QD should have had no more than 3 protease inhibitor mutations by the time the treatment with this LPV/r dosing was initiated.

Exclusion criteria:

1. Patients who were on LPV/r monotherapy or bi-therapy or on BID dosing at time of study visit.
2. Patients who were using another LPV/r formulation different from 200/50 LPV/r mg tablets.
3. Patients who were participating in any other clinical trial or postmarketing observational study (PMOS).
4. Patients who were unable to read and/or write.
5. Patients who were under treatment interruption. Patients who have stopped LPV-therapy for more than 3 months in the 12 months preceding study visit.
A Virtual Reality Videogame for E-cigarette Prevention in Teens

The use of the Invite Only VR, with the aim to prevent the initiation of e-cigarette use in teens by increasing their knowledge, decreasing their intentions to use e-cigarettes, influencing their harm perceptions and attitudes associated with e-cigarettes, and increasing self-efficacy associated with refusing peers involving e-cigarettes.

Specific Aim #1: DEVELOPMENT: The researcher will update our current VR prototype into a polished videogame intervention using input from 4 focus groups of 5 adolescents each (n = 20), aged 12-17 and the extant literature. These focus groups will inform the development of the VR videogame intervention, Invite Only VR, for e-cigarette prevention among teens.

Specific Aim #2: EVALUATION: Conduct a pilot non-randomized cluster trial with 295 teens ages 11-14 comparing the Invite Only VR intervention vs. an attention/control non-health-related VR videogame, collecting assessment data at baseline, post-gameplay, three months and six months to determine:

1. the preliminary impact of the intervention on e-cigarette use behaviors, knowledge, nicotine addiction knowledge, perceived addictiveness of e-cigarettes, perceived likelihood of using e-cigarettes, perceptions of harm, self-efficacy to refuse, social approval of e-cigarettes, and e-cigarette social perceptions
2. the intervention's acceptability and feasibility by collecting quantitative and qualitative data on teens' satisfaction and gameplay experience of the intervention.
3. preliminary evidence of the impact of Invite Only VR on players' perception and experience of social pressure and social norm development

Eligibility Criteria:
Inclusion Criteria:

* Willing to wear a VR headset and play a video game for 45-60 minutes for 2-3 sessions and answer questions before and after playing the videogame.
* Be enrolled in Milford Middle School District

Exclusion Criteria:

* If subject does not fit the criteria above
Onsite Versus Referral Models of Primary Care for Substance Abusing Patients

Veterans presenting for treatment of substance use disorders (SUDs) often have multiple and serious comorbid medical conditions that affect functional health status and health care costs. Prior studies show higher rates of medical follow-up when onsite primary health care was provided to patients with SUDs within an addictions clinic (onsite care). However, no data are available on differences between onsite versus referral models of primary care delivery in terms of clinical outcomes and total health care costs.

Background:

Veterans presenting for treatment of substance use disorders (SUDs) often have multiple and serious comorbid medical conditions that affect functional health status and health care costs. Prior studies show higher rates of medical follow-up when onsite primary health care was provided to patients with SUDs within an addictions clinic (onsite care). However, no data are available on differences between onsite versus referral models of primary care delivery in terms of clinical outcomes and total health care costs.

Objectives:

The objectives of this study are to compare patients with SUDs who receive onsite primary care in a VA outpatient addictions clinic to those referred for primary care to the general internal medicine clinic on: 1) medical outcomes and quality of life; 2) SUD treatment outcomes; and 3) overall health care costs. This information will assist in identifying practice guidelines for providing preventive services and treatment for acute and chronic medical conditions to individuals in SUD treatment.

Methods:

This study is a randomized clinical trial with two treatment conditions: 1) onsite primary care in the Addictions Treatment Center (ATC; experimental); or 2) referral primary care in the General Internal Medicine Clinic (GIMC; control). Subjects are assessed at baseline and at 3, 6, and 12-month time points. The sample includes 720 veterans, newly presenting or returning to SUD treatment, who exhibited a chronic medical condition at screening, did not have a primary care provider; and did not present with a serious medical condition requiring ongoing care in three or more organ systems. Medical status outcome measures include scores on the SF-36, and total emergency room visits and medical or surgical inpatient admissions. Substance abuse outcomes are measured by treatment retention, changes in Addiction Severity Index (ASI) scores, and self-reported alcohol use. Lastly, overall VA health care costs per subject per the 12-month period following randomization are compared across groups. The main analysis involves intent-to-treat analysis of group (onsite vs. referral) by time (3, 6, 12-month) using random effects regression models.

Status:

Complete. All subjects completed study interventions as of 3/31/2004. Currently data analysis is ongoing.

Eligibility Criteria:
Inclusion Criteria:

Enrolling in addictions treatment, has no primary care provider currently and has some ongoing medical concern that would benefit from primary care.

Exclusion Criteria:
Selenium in the Treatment of Arsenic Toxicity and Cancers

Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of \[(GS)2AsSe\]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients.

Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Bangladesh in an arsenic-affected region (Chandpur)
* Age between 12 and 55
* Exposure to arsenic in home drinking water greater than 50 ug/L.
* Arsenical melanosis on the torso confirmed by epiluminescence microscopy

Exclusion Criteria:

* Recent history or plans to consume selenium-containing supplements
* Anticipated change in home drinking water supply during study period
Feasibility of a Hybrid Delivery of Home-based Cluster Set Resistance Training in Lung Cancer

Symptom burden remains a critical concern for individuals with non-small cell lung cancer (NSCLC) following the completion of treatment. Of those, symptom clusters such as dyspnea (shortness of breath) and fatigue, contribute to physical decline, reductions in quality of life, and a higher risk of comorbidities and mortality. It has been proposed that dyspnea is a primary limiter of exercise capacity in individuals with lung cancer, resulting in exercise avoidance and an accelerated physical decline. As such, specifically designing resistance exercise programs with cluster sets, to mitigate feelings of dyspnea and fatigue may result in improved exercise tolerance, resulting in the maintenance of physical function and quality of life.

The purpose of this project is to investigate the feasibility and preliminary efficacy of a hybrid-delivery of home-based cluster-set resistance exercise in individuals with NSCLC. Methods: Individuals with NSCLC (n=15), within 12-months of completion of treatment will be recruited to participate in this single arm feasibility trial. Participants will complete 8-weeks of home-based resistance training (RT) designed to target dyspnea and fatigue. The hybrid-delivery of the program will include supervised sessions in the participants home, and virtual supervision via video conferencing. The primary outcome of feasibility will be measured via recruitment rates, retention, acceptability and intervention fidelity. Exploratory outcomes (dyspnea, fatigue, quality of life, physical function and body composition) will be assessed pre- and post- intervention.

Analysis plan. Descriptive statistics (percentages and means (with standard deviations)) will be used to report on feasibility outcomes (recruitment, retention, fidelity etc.). Unless explicitly stated, means and standard deviations will be reported for assessments of exploratory outcomes at baseline and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Completed definitive treatment for localized NSCLC (stages I-III)
* Has access to stable internet access for Zoom participation
* Willing to complete an 8-week, home-based intervention program that includes face-to-face and Zoom interaction.
* Willing to consider behavior change at this time.
* Able to speak and read English.
* Capable of informed consent
* Has obtained medical clearance from medical practitioner or medical team

Exclusion Criteria:

* Individuals with a known diagnosis of advanced lung cancer (stage IV; due to potential added burden) or diagnosis of small-cell lung cancer,
* Anyone for whom physical activity is not recommended.
* aren't comfortable having study staff visit their homes for exercise sessions
* have any neuromuscular, cardiovascular, or psychological condition precluding safe exercise;
* have participated in structured RE ≥2 times/week for the past 6 months;
* are unable to read/understand English.
TrEatment Targets in Rheumatoid Arthritis: TETRA-study

There is currently no cure for rheumatoid arthritis (RA), but many treatment options are available. The central aim of RA treatment is lowering disease activity. The proactive treatment strategy called treat to target (T2T) includes measuring disease activity, setting a target and adjusting treatment accordingly until the goal is reached. T2T has proven to be superior to usual care, but there is much debate regarding the most optimal treatment measure and target. The Disease Activity Score with 28-joint counts and c-reactive protein (DAS28CRP) low-disease activity (LDA) target and the more stringent Simplified Disease Activity Index (SDAI) remission target are the best validated targets. Especially the DAS28CRP is the most commonly used in research and practice, whereas the SDAI remission target is most recommended. The European Alliance of Associations for Rheumatology (EULAR) recommends to strive for remission, whereas the American College of Rheumatology (ACR) recommends to strive for LDA. In patients with new and established RA, the (cost)effectiveness of aiming for remission compared to LDA when starting and tapering antirheumatic drugs has not been directly compared. This study therefore aims to directly compare two T2T strategies, aiming at DAS28CRP-LDA and SDAI remission, in patients with established RA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA (according to the 2010 or 1987 ACR/ EULAR classification criteria and/or clinical diagnosis)
* (Starting) use of a DMARD
* Aged 16 years or older
* At most low disease activity, operationalised as DAS28-CRP \<3.5 (DAS28 CRP 2.9 cut off for low disease activity with measurement error 0.6) or SDAI \<19 (SDAI 11 cut off for low disease activity with measurement error of 8). A state of low disease activity is required at inclusion, as for RA patients in moderate or high disease activity there is no equipoise on the best course of action (treatment needs to be escalated).
* Fluency of Dutch or English, both written and verbally; able to fill in questionnaires
* Provided informed consent

Exclusion Criteria:

* Clinical deep remission, operationalised as SDAI \<3.3 or DAS28-CRP \<2.4, and an taper attempt in the past 2 years that was discontinued due to occurrence of flare.
* Fewer than 3 DMARD treatment options left for this patient (severe difficult-to-treat or refractory RA)
* Current severe comorbidity or other serious life-shortening conditions hampering trial participation
* Inability to comply with the study protocol or to provide informed consent with regard to intervention control and measuring outcomes
Use of Puzzle Method in Psychiatric Nursing Teaching

Objective: It is thought that the puzzle technique and teaching method will be useful in teaching psychiatric nursing in order to facilitate the learning of psychiatric symptoms and findings and to increase awareness in mental state examination. For this reason, the research was planned to examine the effectiveness of the puzzle technique in learning psychiatric symptoms and findings in psychiatric nursing students.

Design: This study was planned in a randomized controlled experimental design.

Method

Place and Time The research is planned to be carried out between November and January 2022 at a foundation university.

Population and Sample of the Research The population of the research will be 108 students enrolled in the nursing program of a foundation university and taking the "Psychiatric Nursing" course in the fall semester of the 2022-2023 academic year.

In the study, it is aimed to reach the entire universe, not selecting the sample. The students in the universe, who accepted to participate in the study and completed the pre-test, will be assigned to the intervention and control groups by randomization with the help of a generator on the www.random.org website by being numbered according to their order in the student list.

Hypothesis: Students who use puzzle method in teaching psychiatric nursing have higher knowledge levels than students who do not.


Eligibility Criteria:
Inclusion Criteria:

* Registered in the nursing department of the university where the research will be conducted,
* Taking a psychiatric nursing course in the fall semester of the 2022-2023 academic year,
* Taking the Psychiatric Nursing course for the first time,
* Does not have a communication problem at a level that prevents the conversation,
* Students who volunteer to participate in the research will be included in the research.

Exclusion Criteria:

* Not registered in the nursing department of the university where the research will be conducted,
* Not taking a psychiatric nursing course in the fall semester of the 2022-2023 academic year,
* Taking the Psychiatric Nursing course for the second time,
* Having a communication problem at a level that prevents the conversation,
* Students who do not volunteer to participate in the research will not be included in the research.