cyrilzakka/clinical-trials huggingface dataset:
Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus

This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo.

Status asthmaticus is an acute exacerbation of asthma that often requires treatment in a pediatric intensive care unit (PICU). Standard therapies for status asthmaticus include corticosteroids and bronchodilators, typically albuterol. Ipratropium bromide is also a bronchodilator, but has a different mechanism of action than albuterol. The addition of Ipraropium to children in the Emergency Room with severe asthma exacerbations improves outcomes, so many PICU doctors treat patients with status asthmaticus with Ipratropium. However, two studies of children hospitalized in the general wards of the hospital (not the PICU) show that the addition of Ipratropium to standard care does not effect clinical outcomes. This study is a first step towards determining in Ipratropium is helpful in PICU patients (like it is in ER patients) or if it not helpful (like it is in general ward patients).

Eligibility Criteria:
Inclusion Criteria:

* Admission to the PICU
* Treatment with continuous albuterol via the Asthma Carepath
* Enrollment occurred within 4 hours of starting continuous albuterol in the PICU
* Treatment with systemic corticosteroids by the clinical team

Exclusion Criteria:

* First episode of wheezing that prompted treatment with bronchodilators by medical personnel
* Prior enrollment in this study
* Patients with chronic lung disease requiring routine home oxygen use
* Allergy to inhaled ipratropium or inhaled saline
* Positive pressure ventilation (via an endotracheal tube or a non-invasive mask \[e.g. CPAP (continuous positive airway pressure) or BiPAP\])
* Pregnancy
* Tracheostomy
* Age \< 2 years
* Age \> 17 years
* Patient with pulmonary hypertension requiring daily therapy
* Patient with cyanotic congenital heart disease
* Cystic fibrosis
Immune Response to Shingles Vaccination

The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).

Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.

Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older.
* History of chickenpox.

Exclusion Criteria

* Previous vaccination with Zostavax or with the chickenpox vaccine.
* History of ever having had shingles.
* Been in close contact with a person who had chickenpox or shingles in the past 5 years.
* VZV seronegative
* Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
* HIV seropositive.
* Hepatitis C infection or active Hepatitis B infection.
* History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion.
* Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
* Has long-term use of oral or parenteral steroids (\>7 days), or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
* Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination
* Donated blood in the past 8 weeks or planning to donate blood during the study
* Weighs less than 110 lbs
* Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Additional exclusions for optional skin biopsy:

1. Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
2. History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
3. History of keloid formation or excessive scarring
4. History of frequent cellulitis or boils (\>3 episodes in past 2 years) requiring antibiotic therapy.
5. Allergy to lidocaine, silver nitrate, or mupirocin.
Protocol of Multi-domain Attention Training

This study sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training .

This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Multi-domain Attention Training, MAT), or active control group (Passive information activities, PIA). Training sessions of the MAT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as MAT group. The investigators constructed a rigorous MAT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in attention function of older adults with mild cognitive impairment after using the MAT program.

Eligibility Criteria:
Inclusion Criteria:

* Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
* Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
* Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher
* No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family

Exclusion Criteria:

* The clinical diagnosis of dementia was based on the DSM-IV-TR
* Active in another cognitive or memory-related training in the past year
* Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
* A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
* Severe losses in vision, hearing, or communicative ability
Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population

Osteoarthritis (OA) is a persistent joint disorder, which normally affects the weight bearing joints especially knee joint. Lateral wedge insole is one such approach suggested by professionals to manage the knee osteoarthritis.Effectiveness of lateral wedge insoles (LWI) group (n=20), and conventional physical therapy (CPT) group (n=20) with home exercises as baseline treatment were assessed on Urdu version of Knee Injury and Osteoarthritis Outcome Score scale (KOOS).

A total of n=104 patients were recruited through the non-probability convenience sampling technique and were thus evaluated for the inclusion criteria. Of which, n=40 participants fulfilled the inclusion criteria. Participants were randomly divided through the sealed envelope method in two groups; lateral wedge insoles with home exercises group (n=20), and traditional physiotherapy with home exercises group (n=20). The data was collected through a general demographic questionnaire and Knee injury and Osteoarthritis Outcome Score (KOOS) in Urdu to determine the severity of pain, stiffness, functional activities, recreational activities and Quality of life to promote functional independence in osteoarthritic patients.\[20\] The level of significance was set at p\<0.05. Statistical Package for the Social Sciences (SPSS) ver. 23 was used for data analysis.As the assumption of the parametric test was met, mixed ANOVA was used for the interaction effect of between-subject factor (group) and within-subject factor (time). With-in group analysis and one way ANOVA was used for between-group comparisons to determine the effect size (ɳp2).

Eligibility Criteria:
Inclusion Criteria:

* Patients with the age criteria of 40-70 years, and who had a history of knee OA were included in the study.

Exclusion Criteria:

* Patients had knee OA due to trauma or any pathology, multiple fractures, or had a medical condition due to which rehabilitation wasn't possible, and not willing to participate in the clinical trials were excluded from the study.
Sweeping the Membranes, Cervical Length and Duration of Labor

Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery.

Cervical length will be measured in both groups. The membranes will be swept in pregnancies beyond 38 weeks by digital examination in the study group. The control group will only be examined for Bishop score. Two days later cervical length will be Measured once more.

Eligibility Criteria:
Inclusion Criteria:

* The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.

Exclusion Criteria:

* Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.
Intervention for Stroke Survivors and Their Spousal Caregivers

This is an interdisciplinary, intervention study with stroke survivors and their spousal caregivers after discharge from a rehabilitation unit. It will determine whether couples receiving home visits from nurses and therapists over a 6 month period demonstrate better function and less psychological distress than couples who receive information by mail. All couples are visited every 3 months by a nurse who assesses their physical and psychosocial functioning.

This 5-year randomized intervention study uses an advanced practice nurse, with the assistance of an interdisciplinary rehabilitation team, to provide education, support, skill training, counseling, and social and community linkages to stroke survivors and their spouses for 6 months post-hospital discharge. The intervention will be delivered using previously tested protocol guidelines. Stroke survivors and their spousal caregivers will be assessed to determine whether or not the intervention is successful in (1) improving function, quality of life and perceived health and decreasing depression in the stroke survivor; (2) decreasing unplanned clinic and emergency room visits, reducing rehospitalizations and admissions to nursing homes; (3) decreasing depression, burden, stress and improving the health of spousal caregivers and (4) decreasing cytokine imbalances related to the chronic stress of caregiving among spouses. Assessments will be made at baseline and at 3, 6, 9, and 12 months post-discharge on the stroke survivor and on the spousal caregiver by a nurse who is masked to the group assignment. To determine the effect of the intervention on cytokine imbalance, the researchers will: (1) generate cytokines from cell cultures (mitogen-induced and antigen specific T-cell lines) and (2) analyze culture supernatants and plasma samples for their immunoregulatory cytokine content. The laboratory technician and immunologist will be masked to the intervention group. All covariates (i.e., sociodemographic characteristics, severity of the stroke, dyadic relationships, family functioning, co-morbid health conditions, etc.) will be evaluated to determine which are significantly related to the outcomes and only those will be included in the model. Hierarchical Linear Models (HLM) will be used to model change over time for individual participants using a polynomial form. Depending on the nature of the change function, individual parameter estimates of the intercept, slope, and if necessary, curvature will be compared across groups.

Eligibility Criteria:
Inclusion Criteria:

Patient experienced a stroke within the last year Age 50 or older Going home with a spouse or committed partner Needs daily assistance Live within 50 miles fo the TMC Can be reached by telephone Able to understand English -

Exclusion Criteria:

Admitted from or being discharged to a nursing home Disability requiring total assistance Lethargic, obtunded or comatose Other significant CNS disease (ie, severe Parkinson's) Severe psychopathology Globally aphasic Other major illness that would interfere with rehabilitation (ie, advanced cancer) -
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects

Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR (Pelubiprofen 45 mg) in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy males aged 20\~40 years
* BMI valued over 19 kg/m2, below 27 kg/m2
* Subjects whose blood pressure ; systolic BP over 90mmHg below 140mmHg, diastolic BP over 60mmHg below 90mmHg, stable station pulse over 45 bpm below 100 bpm
* Subjects who agree with double protective contraception or able to certificate already sterilization operation 1 day before administration of Investigational new drugs within 14 days after completion
* Subjects who voluntarily agreed with written consent

Exclusion Criteria:

* Subjects with clinically significant disease or past medical history in hepatic, renal, GI tract, respiratory, musculoskeletal, endocrine, neuropsychiatry, blood tumor and cardiovascular system
* Subjects with GI tract disease (eg. Crohn's disease, peptic ulcer etc.) or surgery (except appendectomy and herniotomy) influence on administration Investigational new drugs
* Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID anti-inflammatory agents and antibiotics) including Pelubiprofen and Food
Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

Aims of this research are to detect if an improvement in sleep pattern in patients suffering from obstructive sleep apnea (OSA), produces a reduction in pain and dysfunction in the orofacial area by examining variation in temporo-mandibular disorder (TMD) signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.

41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.

Since a bidirectional relationship has been suggested for poor sleep and pain and considering that patients suffering from obstructive sleep apnea (OSA) have been reported to present a higher prevalence of temporo-mandibular disorder (TMD) signs and symptoms compared to healthy controls; aims of this research are to detect if an improvement in sleep pattern in patients suffering from OSA, produces a reduction in pain and dysfunction in the orofacial area by examining variation in TMD signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.

41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment

Exclusion Criteria:

* patients presenting some kind of cognitive impairment, due to difficulties in undergoing TMD examination
* patients presenting dental problems
* patients assuming medications that would alter pain perception
* patients not signing the informed consent
Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic

This is a retrospective, descriptive study that involves de-identified data consisting of weight changes, pertinent vital signs and laboratory values influenced by body weight, and healthcare utilization of patients prescribed lorcaserin at The Center for Weight Management at the Scripps Clinic in San Diego, CA.

All patients who initiated treatment with Lorcaserin during the review period will undergo chart review. The primary endpoint will be weight change in patients on Lorcaserin and average duration of Lorcaserin treatment over time (up to 1 year). Secondary endpoints will include changes in vital signs, liver function, glucose, and lipids. In addition, time on treatment, reasons for discontinuation of medication, and changes in healthcare utilization (to include inpatient and outpatient utilization) will be examined. This is a retrospective, one-arm observational study that will include chart reviews of 157 patients who have been treated in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Received at least one prescription for Lorcaserin treatment
* At least 18 years of age or with guardian/parent able to consent for a minor

Exclusion Criteria:

- Patient under the age of 18 at time of index date
Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different regimens of low-dose radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with follicular or marginal zone non-Hodgkin's lymphoma.

OBJECTIVES:

Primary

* Compare the local progression-free interval in patients with follicular non-Hodgkin's lymphoma (NHL) treated with 2 different regimens of low-dose radiotherapy.

Secondary

* Compare acute toxicity at 4 weeks in patients treated with these regimens.
* Compare late toxicity in patients treated with these regimens.
* Compare tumor response at 12 weeks in patients treated with these regimens.
* Compare overall survival in patients treated with these regimens.
* Assess the health economics of these regimens in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to one of two treatment arms.

* Arm I 4Gy: Patients undergo low-dose radiotherapy once daily on days 1 and 2.
* Arm II 24Gy: Patients undergo low-dose radiotherapy once daily on days 1-5, 8-12, 15, and 16.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed follicular or mmarginal zone non-Hodgkin's lymphoma (NHL)

  * Any stage
* Radiotherapy is indicated for curative treatment of stage IA or IIA disease OR palliation due to tumor bulk or anatomical position

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months

PRIOR CONCURRENT THERAPY:

* More than 4 weeks since prior chemotherapy
10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals

This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.


Eligibility Criteria:
Inclusion Criteria:

* Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).
* A minimum of 18 months on antipsychotic treatment.
* Meeting clinical remission criteria for at least the 12 months prior to inclusion.
* Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
* Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.

Exclusion Criteria:

* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.
* Meeting DSM-IV criteria for mental retardation.
* Having a history of neurological disease or head injury.
A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later.

A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540D) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540D in healthy adults and if people tolerate it.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of abnormal Pap smears, HPV- related external genital lesions (eg, condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer
* Has a history of cancer (malignancy)
* Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol