cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes

The investigators are planning to do a cluster randomized trial to test the effect of different educational programs for staff according to nursing home patients FI (fecal incontinence). Since there are very few published trials of treatment of FI in older people, and no rigorously evaluated studies on interventions for FI in nursing homes, or rigorously evaluated continence education program for staff concerning continence care, a pilot study is necessary. The aim for the pilot study is to evaluate feasibility, acceptability and adherence according to the educational intervention, methods used and outcome measures. This is designed to be an external pilot study. External pilot studies are small scale versions of the main study which are not intended to be part of the main study. The pilot intervention period is 3 month.


Eligibility Criteria:
Inclusion Criteria:

* Nursing homes Wards with 24 hour long term care residency, similar nurse/patient ratio and General Practitioner consultancy, comparable patient groups according to frailty, comparable ward size according to number of patients and staff.
* Patients All patients on long term residency (1 month or more) are eligible for measurements.
* Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position above 50% are eligible according to participation in the educational meeting and to be recruited as a local opinion leader in intervention 2. All staff is invited to the educational outreach meetings throughout the intervention period.

Exclusion Criteria:

* Nursing homes with diverse staff and patient composition
* Patients on short term residency
* Registered nurses (RN) and authorized social educators (ASE) RN's and ASE's with position less than 50%
Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome

A multicentric randomized controlled trial has been designed to study the effects of a decompression prototype splint on symptoms, functional capacity and nerve conduction studies in patients with carpal tunnel syndrome.

A decompression prototype splint was designed to simulate an manual mobilization that is able to increase the CSA of the carpal tunnel and the median nerve in cadavers. These changes are important because they may relate to the decrease in CTS symptoms.

Patients with mild or moderate carpal tunnel syndrome will be selected for the trial. They will be randomized in 2 groups. One group will wear an standard splint for carpal tunnel syndrome and the other the decompression prototype splint.

Eligibility Criteria:
Inclusion Criteria:

* Be medically diagnosed with carpal tunnel syndrome after electrophysiological tests and present mild to moderate involvement. This test is performed according to the standards established by the "American Academy of Physical Medicine and Rehabilitation"
* Ability to understand and communicate their symptoms and to complete the questionnaires.

Exclusion Criteria:

* Previous surgery in the carpal tunnel in the same limb Other pathologies that may be associated with carpal tunnel syndrome: traumas, pathologies or disorders of the upper limb or cervical spine (cervical radiculopathy, cervical sprain, etc.) or prior cervical surgery
* Concurrent comorbidities that may be the cause and interfere with the treatment of the carpal tunnel syndrome: diabetes mellitus, hypothyroidism, rheumatoid arthritis, fibromyalgia, reflex sympathetic dysfunction, obesity, renal disease, alcoholism, significant vitamin deficiency and associated viral or bacterial processes
* Pregnancy
* Oral drugs, physiotherapy treatment , treatment with splints or infiltrations for carpal tunnel syndrome prior or during the study.
Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension

The aim of this study is to assess the influence of the severity of chronic periodontitis on hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to identify evolution of several biomarkers and correlate the clinical situation with oral microflora.


Eligibility Criteria:
Inclusion Criteria:

* -Men- \>40 years
* moderate and severe generalized chronic periodontitis
* Former diagnosis of hypertension
* \>12 teeth

Exclusion Criteria:

* \>70 years
* smokers (\>10 cig/day)
* body mass index\>30
* Need of antibioprophylaxis
* Medical treatment including anti-inflammatory drugs and/or antibiotics
* Refractory form of hypertension- aggressive periodontitis
Studying DNA in Samples From Younger Patients With Down Syndrome and Acute Myeloid Leukemia Treated on COG-AAML0431 Clinical Trial

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies DNA samples from patients with Down syndrome and acute myeloid leukemia treated on COG-AAML0431 clinical trial.

OBJECTIVES:

* To identify new genetic abnormalities associated with acute myeloid leukemia (AML) in patients with Down syndrome through whole-genome sequencing.

OUTLINE: This is a multicenter study.

Extracted DNA and RNA from cryopreserved specimens are analyzed for genomic sequencing, gene mutation, and microarray analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Down syndrome children diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS)
* Clinical samples from patients enrolled on the Children's Oncology Group (COG) AAML0431 phase III clinical trial, and from the Children's Hospital of Michigan Cell Bank

  * Diagnostic blast samples and matched remission samples

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Preliminary Assessment of the Psycho-emotional State of Patients With TMD

TMD (temporomandibular disorders) is the name for a collective syndrome of disorders that includes abnormal function of the muscles of mastication, the temporomandibular joints and surrounding structures. It is one of the most significant causes of orofacial pain, along with dental pain. In TMD syndrome, the cause of pain is often due to overloading of the masticatory muscles rather than primary changes in the joints themselves.

Nowadays, doctors who treat patients with TMD have no doubt that one of the very important etiological factors of this condition is psycho-emotional disorders (excessive nervous excitability, anxiety, depression), which has been confirmed by numerous authors of studies on this subject \[4-11\].

The etiology of TMD is complex and multifactorial. Numerous factors may also contribute to the development of the disorder. An important factor affecting the state of masticatory function is an increase in stress levels (psycho-emotional tension). Structures such as the hypothalamus, reticular formation and limbic system have a decisive influence on the emotional state of each patient The activity of the limbic system, which governs the emotions of adults, and the additional connections of the gamma loops to the masticatory muscles, determine that increased emotional tension translates into a significant increase in the "contractile" activity of the masticatory muscles.

TMD and functional disorder of the masticatory muscles are the most common complaint of the patients, seeking treatment in dental office. The two main symptoms of TMD problems are pain and dysfunction. Myalgia -the most common cause is an increased level of muscle use. It is related to vasocontraction of relevant arteries and accumulation of metabolic waste product in the muscles. Activities such as daytime clenching of the teeth and bruxism, habits of chewing gum, biting lips, finger nails or cheeks are factors that cause significant strain on the masticatory muscles and temporomandibular joints.


Eligibility Criteria:
Inclusion Criteria:

(i) good general health, with no craniofacial trauma in the last 5 years and without severe mental conditions (ii) the presence of TMD symptoms (pain in the masticatory muscles, limitation of mouth opening range, clicking or popping in the temporomandibular joints. For control group there was absences of these symptoms.

(iii) consent of the patient to participate in the research project

The exclusion criteria for the study were:

-

Exclusion Criteria:

(i). willingness to resign out of the study.

-
Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss

In 50% of women with recurrent pregnancy loss (RPL) miscarriages are unexplained, therefore no therapeutic intervention is possible. In a pilot study, women with unexplained RPL showed less endometrial NK cells (eNK) compared to women with a previously uncomplicated pregnancy. It is known that eNK cells are important for embryo implantation during early pregnancy. Investigators presume that high sympathetic activity in these women is related to eNK cell number, function and phenotype and that exercise is an effective intervention to lower sympathetic activity and to influence the immune system, as especially peripheral NK cells have been assumed to be responsive to physical training. The investigators hypothesize that moderate exercise can lower the adrenergic tone of the sympathetic nervous system hereby influencing endometrial NK cells in women with RPL and eventually pregnancy outcome.


Eligibility Criteria:
Inclusion Criteria:

* RPL defined as 2 or more unexplained pregnancy losses from the time of conception until 24 weeks of gestation, known cause for the miscarriages are the presence of thyroid abnormalities, anti-phospholipid syndrome, uterine malformation, and abnormal parental karyotype according to international guideline.
* Couples should not be aiming to conceive during the time course of the exercise intervention.

Exclusion Criteria:

* Age above 40 years
* BMI above 40
* Current use of immunosuppressive or biological drugs
* Current use of hormone conceptive
* HIV positivity
* Current or recent (\<2 weeks) symptomatic genital infection such as chlamydia, gonorroa, or pelvic inflammatory disease
* Pre-existent diabetes mellitus, autoimmune disease or overt cardiovascular disease
* Vaccination (i.e Covid) within 1 month prior to or during sampling and intervention
* New pregnancy at time of measurements, breastfeeding
* Current or recent (\<2-3 months ago) pregnancy
* (Physical) inabilities to follow moderate aerobe cycling training
* Participants who are not capable of signing the informed consent
Polarity Management Training Program for First Line Nurse Manager

Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance.

Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance. This study aimed to examine the influence of polarity management training program on first-line nurse managers' creative behavior and motivation.

Eligibility Criteria:
Inclusion Criteria:

First-line nurse managers

* willing to participate in the study
* work in all inpatient care units of Alexandria University hospitals
* Sign a consent

Exclusion Criteria:

First-line nurse managers

* work in outpatient units
* Did not sign a consent
* Absent from training
The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders

Anxiety and mood disorders are among the most prevalent mental health problems in childhood. They have severe long-term morbidity, and associated academic and social impairment.

Building on the investigators' experience with outcome evaluation in clinically anxious or depressed children, they propose to evaluate within the school system a cognitive behavioral therapy (CBT) intervention for children in grades 3 to 6 with elevated symptoms of anxiety or depression on standardized questionnaires.

The participant's outcomes will be compared with those of similar children randomly assigned to an activity control group.

Hypothesis 1a): Children in the intervention condition will show greater symptom reduction relative to children in the control condition (primary outcome: anxiety symptoms).

Hypothesis 1b): Children in the intervention condition will show fewer symptoms during follow-up relative to children in the control condition.

Hypothesis 2: Children with anxious or depressive symptoms treated in the school setting using CBT have a lower risk of developing internalizing disorders within 1 year of treatment than children in a control condition.

Hypothesis 3: Self-esteem, anxiety and depression-related impairment, and academic functioning will improve more in intervention participants than in controls.

Hypothesis 4: School characteristics, child age, and attitudes of participating personnel are predictive of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Children with t-score elevations \> 60 on either the total score or at least 4 subscales of either instrument will be considered eligible for the study.

Exclusion Criteria:

* Children will be excluded if they already meet criteria for disorders on the Anxiety Disorders Interview Schedule (ADIS), are unable to complete the inventories due to intellectual impairment or weak English skills (limiting the benefits of cognitive behavioral therapy), or if they are already engaged in ongoing psychiatric or psychological treatment that could confound study intervention effects.
* Children with elevated 'externalizing' scores on the Child Behavior Checklist (CBCL) (t-score \> 60) will also be excluded, as they are often difficult to manage in CBT groups, and may obtain more benefit from other interventions.
Sublingual Immunotherapy in Children With Allergic Rhinitis

The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.

Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of allergic rhinitis
* Positive skin test to Dermatophagoides pteronyssinus total extract
* Positive serum levels of specific IgE to D. pteronyssinus extract

Exclusion Criteria:

* Previous allergen immunotherapy
* Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test
* Long term use of systemic corticosteroid.
* Airway infection 30 days prior to the selection.
* Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy.
* Users of cigarette smoke
* Presence of severe skin lesions
Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)

Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.


Eligibility Criteria:
Inclusion Criteria:

* adult patients who are referred for coronary CTA for suspected or known coronary artery disease

Exclusion Criteria:

* creatinine greater than 2.0
* allergy to contrast media
* patients under the age of 18
* women who are pregnant or breast feeding
* patients with cardiac arrhythmia will also be excluded
Protein Source on Plasma Amino Acid Concentrations In Older Adults

This study will determine the effect of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in older adults. Each participant will receive all four treatments.

The 2015-2020 Dietary Guidelines for Americans (DGA) recommends how much protein-rich foods should be consumed as part of Healthy Eating Patterns. The predominant protein sources include lean meats, poultry, and eggs, along with nuts, seeds, and soy products (dairy is a separate category). Ounce-equivalent (oz-eq) is used as a standard unit of measure among these protein sources. One whole egg (1 oz-eq) is equal to 0.5 oz of nuts (1 oz-eq), 0.25 c (1 oz-eq) of beans, and 1 oz of lean meat (1 oz-eq). Importantly, protein quantity and quality of the foods are not considered. Consequently, consuming an oz-eq of protein foods from different sources may have different effects on an individuals' digestion, absorption, and use of the amino acids contained in proteins to build new proteins in their body (an anabolic response to feeding). Also importantly, while the current Recommended Dietary Allowance for protein (0.8 g total protein/kg/d) does not take into account the sources of protein consumed, these sources have varied essential amino acid patterns. The purpose of this study is to expand on a recent study assessing the effect of consuming ounce-equivalents of eggs versus pork, nuts, and beans on essential amino acid (EAA) substrate availability for protein anabolism in younger adults to include a cohort of older adults. Findings from this current research will allow direct comparisons of postprandial EAA substrate availability between different protein-rich food sources in a cohort of older adults (primary outcome). Subsequently, investigating postprandial responses of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in older adults will also allow for a comparison between the younger (from a study started prior to this one and still currently ongoing investigating the effect of the same ounce-equivalents of fresh pork versus nuts, beans, and eggs on postprandial plasma essential amino acid availability in adults) and older adult cohorts response to consuming different protein-rich foods (secondary outcome). This research will serve as an important resource for future DGA Committees to assess whether 'protein-ounce-equivalents' of varied protein-rich foods provide equivalent EAA substrate to promote postprandial protein synthesis in older adults, in support of dietary protein intake recommendations for younger and older adults.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 55-75
* BMI 20-35 kg∙m-2
* Weight stable (± 4.5 kg) 3 months pre-study
* Not acutely ill
* Not diabetic
* Not pregnant or lactating
* Not currently (or within 3 months pre-study) following a vigorous exercise regimen
* Non-smoking
* Willing to consume study foods and travel to testing facilities.

Exclusion Criteria:

-
Clinical Study of YQ1 Plus Cisplatin-based Chemotherapy in Advanced NSCLC EGFR Wild Type

This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV.

This randomized pilot phase II trial studies the effect of YQ1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with EGFR/ALK wild type non-small cell lung cancer, stage IIIB-IV. Chinese herbal medicine was known to be beneficial adjuvant or alternative medicine for cancer treatment. However, the mechanism was unknown. This study wants to investigate the effect and mechanism of YQ1, which was proved to improve the antitumor immunity, to inhibit cancer progression, and to prolong overall survival of lung adenocarcinoma in a series of preclinical studies.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is advanced/metastatic (stage IIIB/IV), EGFR/ALK wild type.
* Subjects who plan to receive cisplatin-based chemotherapy.
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* ECOG performance status \>= 3
* WBC =\< 4,000 cells/μl, ANC =\< 1,500/mcL, Platelets =\< 100,000/mcL , Hemoglobin =\< 9 g/dL,
* Total bilirubin \>= 1.5 x upper limit of normal (ULN), AST \>= 1.5x ULN, ALT \>= 2.5 x ULN, Creatinine \>= 1.5x ULN
* Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure.
* Chronic or current Inflammatory Bowel Disease, post-surgery of intestine, Lynch syndrome, FAP, Peutz-Jegher.
* History of allergic reactions cisplatin
* Pregnant women are excluded; breastfeeding should be discontinued prior to study entry.
* Received any other clinical trail at the same time.
* Current dementia or other cognitive disorders.
Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who have not responded to previous treatment. The primary efficacy objective is to estimate efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks after completion of all study therapy (Sustained Viral Response 24 \[SVR24\]).


Eligibility Criteria:
Inclusion criteria:

* Japanese participant diagnosed with compensated CHC GT 1
* Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
* Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (partial responder or null responder)
* No evidence of cirrhosis

Exclusion criteria:

* Co-infection with human immunodeficiency virus (HIV)
* Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
* Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
* Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant