cyrilzakka/clinical-trials huggingface dataset:
Implementation of an Outpatient Parenteral Antimicrobial Therapy Program

To determine cost changes with an Outpatient Parenteral Antimicrobial Therapy Program (OPAT) treatment compared to standard therapy while maintaining safety and efficacy.

Patients will be evaluated during the period January 2023 to January 2024. Patients over 18 years admitted to the University Hospital Dr. José Eleuterio González with microbiological diagnosis of an infection that needs an intravenous antimicrobial treatment for more than three days, without other criteria to remain hospitalized.

Informed consent will be provided to the patient, which is a requirement to enter the study, on it we will explain in detail the processes and follow-ups that you will have during participation in the study, as well as the confidentiality of personal data and results.

After signing informed consent, patients will be randomized 1:1 to enter the OPAT group or the inpatient antimicrobial therapy group.

Subjects will be stratified according to the diagnosed infection and will be followed within the protocol up to 30 after the end of the antimicrobial treatment established by the physician.

Eligibility Criteria:
Inclusion Criteria:

* Infectious disease confirmed
* Need to be treated for 3 or more days
* Suitable catheter/venous access

Exclusion Criteria:

* Patients who have to be hospitalized for other cause
* Age \< 18 years
* Pregnancy
* Not appropriate catheter/venous access
* Patients who changed of hospital
* Patients who got any other medical insurance
* Patients absent for treatment
Apremilast for Atopic Dermatitis - A Pilot Study in Adults

The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.

To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Disease severity of Moderate, Severe, or Very Severe by Investigator Global Assessment.
* Disease severity must be greater than or equal to 6 on the Rajka-Langeland Severity Scoring system corresponding to moderate-severe disease.
* Baseline EASI score must be greater than or equal to 11. A previous validation study for the EASI scoring system revealed patients with moderate to very severe disease had mean EASI scores ranging from 11-30.
* Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. Specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
* Subjects must meet the washout requirements

Exclusion Criteria:

* History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification.
* At least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years.
* Clinically significant abnormality on the chest X-ray (CXR) at screening. Chest X-rays performed within 3 months prior to start of study drug are acceptable.
* Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
* Any clinically significant abnormality on 12-lead ECG (electrocardiogram) at screening.
* History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency \[CVID\]).
* Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening.
* History of Human Immunodeficiency Virus (HIV) infection.
* Antibodies to Hepatitis C at screening.
* History of squamous cell carcinoma of the skin and thin melanoma.
* Systemic corticosteroid-dependent asthma.
* Active infection of any type at the time of enrollment.
A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma

This prospective, open-label, single arm, non-interventional study will investigate the effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Participant who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab
* Participant who received only 1 cycle of bevacizumab maintenance treatment
* Meet summary of product characteristics guidelines

Exclusion Criteria:

* Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
* Pregnant or breast-feeding
Opening Wedge High Tibial Osteotomy

A prospective, randomised controlled trial where clinical and radiological outcome of high tibial opening wedge osteotomy with physiotherapy is compared to physiotherapy alone while treating symptomatic medial knee osteoarthrosis.

90 Symptomatic patients with mild to moderate medial knee osteoarthrosis are randomized to two groups:

Group 1 (HTO-group) receive an diagnostic arthroscopy with high tibial opening wedge osteotomy (Tomofix-plate). Postoperatively a supervised physiotherapeutic rehabilitation program is started.

Group 2 (FT-group) receive the same supervised physiotherapeutic rehabilitation program without the HTO or arthroscopy.

Primary outcome measure is composite score of Knee injury and Osteoarthritis Outcome Score (KOOS5).

Secondary outcome measures are pain (VAS), KOOS subscales, objective physical performance measurements, progression of osteoarthrosis (X-ray, MRI), change of mechanical axis, complications, treatment costs, rate of reoperation, revision to total knee arthroplasty (TKA), biological markers of arthrosis progression, 15D (quality of life assessment), QALY (Quality-Adjusted Life-Year), Work Productivity and Activity Impairment Questionnaire, Work Productivity and Activity Impairment Questionnaire, sum of governmental benefits received.

Outcomes will be measured at 24, 60 and 120 months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Pain: Subjective pain in the knee most of the month for at least one month during past 12 months.
* Knee range of motion (ROM) at least 5-120 degrees
* X-ray: medial joint space Altman \> 1. Lateral joint space Altman \< 2.
* Mechanical axis \> 3 degrees varus alignment.
* Medial proximal tibial angle (MPTA) \< 90 degrees
* age 25-55.
* Written consent, accepts both treatment arms.

Exclusion Criteria:

* Pain is caused by something else than medial knee osteoarthrosis
* deficient ROM (flexion contracture \> 10 degrees, flexion \< 110 degrees)
* significant ligament instability
* post traumatic OA
* clinically relevant neurological disease (e.g. Alzheimer´s disease)
* clinically relevant metabolical disease (e.g. Diabetes)
* alcohol/drug abuse
* infectious/inflammatory joint disease
* previous knee area osteotomy or lower limb arthroplasty
* smoking (\> 0 cigarette per day)
* obesity (BMI \> 33)
* pregnancy or hope of pregnancy in the following two years
Measuring Eating, Activity and Strength: Understanding the Response -Using Protein

The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (\>/= 60) who participate in a 6 month weight reduction intervention. Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from beef. Subject criteria will include obese (\>30 kg/m2) older adults (\>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score \>/= 4)


Eligibility Criteria:
Inclusion Criteria:

* Age 60+ yrs.
* BMI of \>30 kg/m2
* Body weight \<495 lbs.
* Normal blood chemistries
* Normal renal function
* Primary care physician acknowledgement
* Non-Vegetarian
* Mild to moderate movement impairment

Exclusion Criteria:

* Body weight \>495 pounds.
* Current smoker.
* Presence of unstable, acutely symptomatic, or life-limiting illness.
* Positive screen for dementia using Mini-Cog evaluation tool.
* Neurological conditions causing functional or cognitive impairments.
* History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation).
* Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months.
* Inability to walk independently.
* Bilateral hip replacements.
* Unable to give consent.
* Unable to complete written recording forms including journals of eating and exercise behaviors.
* Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications.
* Primary Care Physician advises against participation.
A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

This prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. All visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7
* Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
* Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
* Treated with glucocorticoids for RA when starting tocilizumab treatment

Exclusion Criteria:

* Treatment with any investigational agent within 4 weeks or 5 half-lives before tocilizumab
* Continuous or regular treatment with oral corticosteroids for any indication other than RA
Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)

The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's effect on the clinical signs and symptoms associated with Tinea Pedis


Eligibility Criteria:
Inclusion Criteria:

* Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination
* Must have a clinical symptom severity score of at least 20 on a possible 64 point scale
* Written informed consent must be obtained from the subject.
* Must ≥ 19 years of age
* Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.
* Must agree to take measures to avoid pregnancy during the 12 day (or 26 day if in cross over group) study period

Exclusion Criteria:

* Has a diagnosis of either psoriasis or eczema
* Has a visual diagnosis, by the investigator, of onychomycosis.
* Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1)
* Use of systemic corticosteroids in the preceding 7 days of screening visit (Day 1)
* Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (Gris-PEG®, Pedinol), butoconazole, terconazole, Potassium iodide)
* Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
* Has cardiovascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
* Is pregnant or is a nursing mother
* Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
* Is \< 19 years of age
* Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety
Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).


Eligibility Criteria:
Inclusion Criteria:

* Japanese subject
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI): 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Application of Health Education Path of Traditional Chinese Medicine Nursin

To explore the effect of traditional Chinese medicine (TCM) health education standard path on the treatment of patients with acute myeloid leukemia (AML). A total of 60 patients with acute myeloid leukemia in Shijiazhuang Ping An Hospital were selected and divided into control group (n=30) and observation group (n=30) according to the time of admission. Both groups received the same chemotherapy, the control group received routine nursing, and the observation group received TCM health education standard path intervention. The scores of Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Spitzer Quality of Life Index (QLI), awareness of TCM health education standard path content and nursing satisfaction were compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the hospital for the first time during the observation period
* patients who met the diagnostic criteria for AML
* patients with stable disease, clear consciousness, fluent speech, and normal communication
* patients who volunteered to participate in the research

Exclusion Criteria:

* patients who were repeatedly admitted to hospital during the investigation period
* patients with hospitalization time ≤3 days
* patients whose condition changed after admission and could not continue to cooperate with the investigation
* patients who asked to withdraw during the observation period.
Spanish-Language Smoking Cessation Trial

Results of a recently completed National Cancer Institute (NCI) funded trial of an intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24- month follow-up period, further supporting the utility of extended self-help for promoting and maintaining tobacco abstinence. Investigators have recognized that wide-scale implementation, and therefore public health impact, would be enhanced by the availability of a Spanish-language version to reach the largest and fastest growing ethnic minority population of smokers.

The goal of this study is to address this gap by testing a Spanish-language version of the validated self-help smoking cessation intervention. If demonstrated effective, the proposed intervention would represent an easily disseminable and low-cost intervention with significant public health impact for Hispanic/Latino smokers throughout the United States. The aims of this project are to test the efficacy of a Spanish-language version of a validated, extended self-help intervention for smoking cessation among Spanish-speaking smokers against usual care control. Participants (N = 1400) recruited nationally will be randomized to the two arms.


Eligibility Criteria:
Inclusion Criteria:

* Smoking ≥ 5 tobacco cigarettes/week over the past year
* Not currently enrolled in a face-to-face smoking cessation program
* Monolingual Spanish-speaking, or bilingual Spanish-English and prefer receiving educational health materials in Spanish
Childhood Passive Smoking: Cohort Study of Cardiac Risk

To determine the effects of long-term exposure to passive smoking on the cardiovascular and oxygen transport systems in pre-adolescent twins.

BACKGROUND:

The adverse health effects of actively inhaled cigarette smoke include impaired pulmonary function, increased coronary and cerebrovascular disease, chronic pulmonary disease, and cancer. Infants and young children of smoking parents are at increased risk for lower respiratory tract infections and small airways disease than are children of non-smoking parents. What is less clear is how the oxygen transport system of the growing child is affected by the long-term exposure to and passive inhalation of cigarette smoke and if this exposure represents a risk for the subsequent development of atherosclerotic heart disease.

DESIGN NARRATIVE:

A sample of 300 pre-adolescent twin pairs was recruited from an established population-based twin study. The three cohorts of twins and their parents were initially evaluated in a cross-sectional study and then followed longitudinally for up to three years. In the initial testing cycle the following data were collected: genotype; general health; anthropometric measures; resting and exercise noninvasive evaluation of hemodynamic parameters including blood pressure, heart rate, cardiac output, left ventricular mass, and oxygen consumption; hematocrit and blood levels of 2,3-DPG, cotinine, thiocyanate, and erythropoietin; spirometric and pulmonary flow data; lipid levels. There were three follow-up exams. The availability of repeated measures of oxygen delivery and its determinants in twins and their parents permitted both a unique analysis of genetic and environmental factors during the process of developmental change and measurements of the risks of accelerated atherosclerotic/ischemic heart disease and of the development of reactive airway disease.

The following hypotheses were tested: genetic factors accounted for a significant proportion of the variation in the hematologic and cardiovascular determinants of systemic oxygen delivery; adaptive responses of the oxygen delivery system differed in the same individual before and after puberty; passive smoking in children was an incremental risk factor for the development of accelerated atherosclerotic/ischemic cardiovascular disease; passive smoking in children was a contributing factor in the development of reactive airway disease.

Eligibility Criteria:
No eligibility criteria
Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin

Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years need of at least one single rooted tooth extraction.
* Non-restorable teeth.
* Systemically healthy patients.
* Good oral hygiene, Plaque index less than 15%.
* Non-smoker or Smoking ≤ 10 cigarettes/day.
* Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

* Any interim intervention that may have affected any of the outcomes of interest.
* Pregnant and lactation females.
* Smoking ˃ 10 cigarettes/day.
* Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
* Patients with poor oral hygiene.
* Any known allergies.
Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid \[leucovorin\], 5-fluorouracil \[5-FU\], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with KRAS wild-type status
* Progressive disease on or after first-line oxaliplatin-containing regimen for mCRC; participants must have received oxaliplatin-containing chemotherapy for greater than or equal to (\>/=) 3 months; no more than one prior chemotherapy regimen for metastatic disease is allowed
* Measurable disease per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic and end-organ function

Exclusion Criteria:

* Prior treatment with irinotecan
* Prior treatment with an investigational or approved human epidermal growth factor receptor (HER)-targeted agent
* Last anti-tumor therapy within 4 weeks prior to Cycle 1, Day 1
* Leptomeningeal disease as the only manifestation of the current malignancy
* Active infection requiring intravenous antibiotics
* Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
* Current severe, uncontrolled systemic disease
* Known human immunodeficiency virus (HIV) infection
* Untreated/active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
* Pregnant or lactating women
* Malignancies other than colorectal cancer within 5 years prior to randomization, except for adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix