cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke

The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.

The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. A tablet will be provided to participants who do not have access to complete the web based intervention. All participants will be asked to complete questionnaires at the beginning of therapy, the end of therapy, and one month post therapy.

Eligibility Criteria:
Inclusion Criteria:

Stroke Survivors

* One month to five years post ischemic or hemorrhagic event
* Minimal to moderate upper extremity deficits (ability to initiate wrist and finger extension)
* Mini-mental screening test score of greater than 24
* Presence of a care partner

Caregivers

* At least 18 years old
* Ability to read and write English
* Mini-mental screening test score of greater than 24

Exclusion Criteria:

Stroke Survivors

* Severe cognitive deficits

Caregivers

* Significant cognitive deficits
Trastuzumab Based Therapy in HER2 Positive AGC

Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.

A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Eligibility Criteria:
Inclusion Criteria:

1. pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;
2. received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;
3. with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;
4. Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;
5. left ventricular ejection fraction(LVEF) more than 50 percents;
6. sufficient bone marrow, liver and renal function.

Exclusion Criteria:

1. received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);
2. trastuzumab based adjuvant/neoadjuvant therapy;
3. treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);
4. patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.
5. trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.
Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients receiving intravenous Proton Pump Inhibitor (PPI）and is now recommended as the first hemostatic modality for these patients. In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle.

We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Eligibility Criteria:
Inclusion Criteria:

* patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb\<10, shock, or coffee grounds or blood in stomach)

Exclusion Criteria:

* age \>90y/o
* pregnant woman
* allergic to esomeprazole
* unwilling to enter this study
* bleeding tendency
* severe co-morbid illness, including cancer, hepatic failure, renal failure,
Resistance Exercise in Children With Post-operative Congenital Diaphragmatic Hernia

Congenital diaphragmatic hernia (CDH) is a life-threatening condition with long-term complications including respiratory tract infections, respiratory muscle weakness, and abnormal lung functions. This study, therefore, has been designed to ascertain the effect of chest resistance exercise and chest expansion exercise on respiratory muscle strength, lung function, and chest mobility in children with post-operative CDH.

With the advances in surgical and neonatal treatment, the survival rates in children with CDH have been improved in the last decades. The surviving children may suffer from long-term complications such as impairments in lung growth (lung hypoplasia), cardiovascular disorders, pulmonary hypertension, gastrointestinal problems, and recurrent occurrence of lower respiratory tract infection. One of the physical therapy techniques used to treat chest disorders via encouraging the normal alignment of respiratory muscles with respiratory rhythm is chest resistance exercise through applying resistance to the sternal and coastal areas .

Eligibility Criteria:
Inclusion Criteria:

* ages between 10 and 14 years.
* the BMI between 20 and 25 Kg/m2. the children were considered as high risky CDH as they developed respiratory distress in the first days of their life.
* CDH was corrected surgically immediately after birth.
* children are still in following upstate in pediatric and physical therapy departments.

Exclusion Criteria:

* physical disability.
* diaphragmatic eventration.
* unable to perform all tests or procedures.
* children with cardiac anomalies
Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies

Pediatric acute myeloid leukemias are disease with poor prognosis (overall survival of 60-75%) and high relapse rate of 35-45% require further understanding of the underlying biological mechanisms.

The main objective of this study is to establish a biological collection to evaluate the genomic profiling of leukemic cells from primary blasts at diagnosis and/or relapse to improve identification of the main genetic hits involved in resistance and could predict a high risk of relapse. Other objectives include the study of bone marrow mesenchymal stem cells and ex vivo drug testing.


Eligibility Criteria:
Inclusion Criteria:

* 0-25 years old
* Newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML) or
* Relapsed or refractory AML or
* Patients with genetic predisposition to develop AML or
* Patients without haematological malignancy nor AML genetic predisposition syndrome who undergo bone marrow aspirate as part of standard of care
* Signed informed consent of parents for patients aged less than 18 years old or signed informed consent of the patient for patients aged 18 and over.

Exclusion Criteria:

* Refuse to participate
* Chronic myeloid leukemia (CML)
* Lack of health insurance (French social security)
* Under protection (tutelle, curatelle or sauvegarde de justice)
* Pregnancy or breastfeeding
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older.
* Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
* Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
* Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
* ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.

Exclusion Criteria:

* Treatment with any of the following agents within 4 weeks prior to the baseline visit:
* Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
* Phototherapy and photochemotherapy (PUVA) for AD.
* Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
* Treatment with:
* An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
* Dupilumab within 3 months prior to baseline visit.
* Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
* Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
* Use of prescription moisturizers within 7 days of the baseline visit.
Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients

The purpose of this study is to determine whether bright light phototherapy can improve depressive symptoms in hospitalized patients with cystic fibrosis (CF) with subsequent effects on quality of life and illness recovery. It is hypothesized that phototherapy will improve depressive symptoms and decrease length of stay in depressed patients with CF who are hospitalized.

Adults and adolescent with CF who are admitted to the hospital for pulmonary exacerbations will be enrolled. Subjects will use a Sun Touch Plus light box that emits 10,000 lux at a minimum distance of 60-80 cm away upon first awakening. Light exposure will last for 30 minutes each day over one week. Nursing staff will ensure compliance and a light sensor attached to the light box will measure use as well. There will not be a placebo during this pilot trial due to recruitment concerns for the sample size required for a single center placebo controlled trial. All light boxes will be sterilized between patient use. Vitamin D levels will be recorded at enrollment from routine clinical measurement. Light boxes do NOT emit UV light and have a negative ionizer.

Depression Screening: Quick Inventory of Depressive Symptomatology self report and clinician administered survey (QIDS-SR and QIDS-C) will be administered at admission (day 0) and completion of light therapy (day 7) to look at changes in depressive symptoms. The QIDS assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) to diagnose a major depressive episode. The QIDS is sensitive to change, with medications, psychotherapy, or somatic treatments, making it useful for research purposes. The psychometric properties of both the QIDS has been established in various study samples. Cronbach's alpha was 0.85 (QIDS-C16) and 0.86 (QIDS-SR16) in a reliability study by Triveldi in 2004.

Quality of Life Scoring: The CF questionnaire revised (CFQ-R) will be administered simultaneously with the QIDS at days 0 \& 7 as a measure of health related quality of life (HRQOL). This is a well validated measure in the CF population for research studies (Riekert et al., 2007).

Eligibility Criteria:
Inclusion Criteria:

* Patients with CF greater than 12 years of age
* Pulmonary exacerbation

Exclusion Criteria:

* planned admission less than 24 hours
* suicidal ideation
* Bipolar depression
* known retinal disorder/photosensitivity
* light induced epilepsy or migraines
* age less than 12 years of age
Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors

Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.


Eligibility Criteria:
Inclusion Criteria:

* Smokers who have tried vaping multiple times.
* Generally good health.

Exclusion Criteria:

* If female, currently pregnant, trying to become pregnant or breastfeeding.
* Planning to quit smoking.
A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion compared with placebo in participants with mild to moderate Alzheimer's disease (AD).

Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each participant must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent - participant (or participant´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study
* Diagnosis of probable Alzheimer´s Disease (AD)
* Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening
* Neuroimaging (computed tomography \[CT\] or MRI) performed after symptom onset consistent with AD diagnosis
* Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability
* On stable doses of regulatory authority approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.
* If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening

Main Exclusion Criteria (Reasons why it might not be appropriate to participate):

* Any other forms of dementia
* Medical issues that might increase the risk of treatment with IGIV, 10%, such as:

  1. Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
  2. Evidence of current bleeding in the brain by MRI
  3. Serious problems with the liver or kidneys
  4. Allergies to blood products
* Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:

  1. Diabetes
  2. Recent treatment with chemotherapy or immune suppression
  3. The recent use of other investigational drugs, especially antibody therapy for AD
  4. Severe headaches or psychiatric problems
Topical Antibiotic Prophylaxis for Nasal Packing Post-ESBS

This is an interventional study that will examine the effect of prophylactic topical antibiotics on nasal packing colonization following endoscopic skull base surgery.

Following endoscopic skull base surgery (ESBS), nasal packing is used to control bleeding and to support reconstruction but can be a source for possibly infectious colonization. Antibiotic use and selection in ESBS varies largely and topical antibiotics are not routinely employed despite favorable qualities (i.e. direct delivery of high antibiotic concentrations with low adverse systemic effects). The effect of prophylactic topical antibiotics on nasal packing colonization is currently understudied. A larger study is needed to test the validity of the conclusion. Employing a larger sample size undergoing ESBS (which does not directly act on the nasal cavity), the investigators hope to amend the lack of literature evaluating the effect of prophylactic topical antibiotics on nasal packing post-ESBS. THe investigators hope to contribute to the determination of an ideal antibiotic regimen following ESBS, which may be especially beneficial for immunocompromised patients or patients at risk of post-surgery infections such as meningitis. Furthermore, the effect of ESBS on the nasal flora is largely understudied, with limited literature only reporting on the nasal flora following endoscopic sinus surgery (ESS). The investigators hope to also amend the lack of literature exploring the effects of ESBS on the nasal flora, especially long-term effects that may be examined in patients undergoing revision surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary or revision endoscopic skull base surgery
* Sellar or Intracranial pathology

Exclusion Criteria:

* Patients with sinonasal malignancy
* Prior radiation therapy
* Concurrent sinusitis and/or nasal polyposis
Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

The purpose of this project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve, injury incidence rate will decrease and on-field soccer performance will improve.


Eligibility Criteria:
Inclusion Criteria:

* Male and female athletes
* 18 years of age or older
* on the soccer roster who are eligible to play in the fall 2019 season at the participating institutions.

Exclusion Criteria:

* Current diagnosis of concussion (i.e. a non-medically cleared concussion)
* Current lower-extremity musculoskeletal injury,
* Seizure disorder with photo sensitivity
* Other medical diagnosis that will prevent participation in the intervention.
Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers

to evaluate tears between habitual contact lens wearers and non contact lens wearers

The objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a Schirmer Strip for tear collection.

Eligibility Criteria:
Inclusion Criteria:

* Have no allergic conjunctivitis.
* Not be using any topical ocular medications.

Exclusion Criteria:

* Considered by the Investigator to not be a suitable candidate for participation
Effect of a Social Media-based Health Education Program on Postnatal Care (PNC) Knowledge Among Pregnant Women Using Smartphones in Dhulikhel Hospital

Its an interventional study conducted to assess the effect of social media-based health education program on PNC knowledge among pregnant women attending Dhulikhel hospital, Nepal.

The study is a two-arm open-label randomized controlled trial conducted among literate pregnant visiting Dhulikhel hospital for ANC check-up. A computer-based program allocated 229 pregnant women owning smartphone with internet connectivity in a 1:1 ratio to either intervention (n=109) or usual care (n=120). The investigators assessed PNC knowledge in the participants by interviewing in-person or via phone; questionnaire was adopted from the previous study conducted to determine the knowledge of postnatal care among postpartum mothers in Asmara; that contained 20 knowledge questions with a maximum possible score of 61. The questionnaire was translated and pretested in Nepali, with the Cronbach alpa of 0.83. The intervention group received a 16 minutes video developed by using Health belief model via social media and the participants were reminded to view the video every week via telephone for a month. Control group received usual care. The primary outcome of the study was PNC knowledge score. The investigators utilized intent-to-treat analysis and measured the effect of the intervention on PNC knowledge score using linear regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* literate pregnant women
* owned a smartphone
* used social media (either What's App, Viber, or Facebook)
* had internet connectivity (WIFI or mobile data)

Exclusion Criteria:

• learning difficulties(dementia) or vision impairment
Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

Hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis). Blood, urine, and dialysate samples will be collected at the end of each study period to determine adequacy of treatment and to assess uremic solute levels. Participants will complete quality of life questionnaires and cognitive paper tests. Food records and medications may be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Stable dialysis patients able to provide consent

Exclusion Criteria:

* Use of antibiotics for last two months or expected antibiotic use
* Recent hospitalization or other event resulting in instability of food intake
* Residual kidney function \< 2.5 mL/min