cyrilzakka/clinical-trials huggingface dataset:
EMST and TMS for Treatment of Dysphagia in Parkinson's Disease

The purpose of the study is to examine the effectiveness of different methods for the treatment of dysphagia in Parkinson's disease (PD). More than 80% of patients suffering from PD develop dysphagia during the course of their disease leading to malnutrition, loss of life quality, weight loss and pneumonia, which is the leading cause of death in these patients. So far, only a few specific treatment approaches have been investigated in PD patients with swallowing disorders. The investigator want to compare a 4-week expiratory muscle strength training (EMST), transcranial magnetic stimulation (TMS), and combination of both with a sham therapy. Dysphagia severity before and after intervention is measured by flexible endoscopic evaluation of swallowing (FEES). For the evaluation of changes in cortical swallowing processing the investigators apply magnetoencephalography (MEG).


Eligibility Criteria:
Inclusion Criteria:

* Hoehn \& Yahr stages II-IV
* Parkinson-related dysphagia
* Oral nutrition
* Ambulant setting
* No change of medication for at least 4 weeks before study inclusion

Exclusion Criteria:

* Other causes for dysphagia
* Other neurological disease potentially causing dysphagia
* Dementia (MMSE\<25; Montreal cognitive assessment (MoCA)\<26)
* Severe depression (BDI\>19)
* Percutaneous endoscopic gastrostomy (PEG)
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.


Eligibility Criteria:
Key Inclusion Criteria

1. Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
2. Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol
3. Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol
4. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

1. Participation in a prior REGN5713-5714-5715 clinical trial
2. Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator
3. Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator
4. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve
5. Documentation of active SARS-CoV-2 infection, as defined in the protocol
6. A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
7. History of birch allergy immunotherapy as defined in the protocol
8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators

There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers.


Eligibility Criteria:
Inclusion Criteria:

* young, healthy, non-obese males and females;
* nonsmoker;
* no needle phobia;
* not taking medication and/or dietary supplements that may affect experimental variables.

Exclusion Criteria:

* neurological, cardiovascular, metabolic, and/or inflammatory diseases, or conditions that could be worsened by exposure to acute thermal stimuli and that could affect experimental variables;
* involvement in temperature manipulation program for ≥ 3 months;
* attendance at any excessive formal physical exercise or sports program.
Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections

Abstract:

It is intuitive that post discharge surgical complications are associated with increased patient dissatisfaction, and directly associated with an increase in medical expenditures. It is also easy to make the connection that many post hospital discharge surgical complications including surgical site infections could be influenced or exacerbated by patient co-morbidities. The authors of a recent study reported that female gender, obesity, diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive pulmonary disease, dyspnea, and neurologic disease were all of among significant predictors of surgical site infections after vascular reconstruction was performed. The main concern for optimal patient care especially in geographically isolated areas of West Virginia is to have early, expeditious, and prompt diagnosis of early surgical site infection with subsequent indicated interventions. This theme will lead to patient satisfaction, minimizing third party interventions and decrease the total cost associated with these complications. Nevertheless, it seems reasonable to believe that monitoring using telehealth technology and managing the general health care patients receive after a hospital vascular intervention will improve overall health and reduce post-operative complications.

Aims/Objectives:

1. The primary objective of the current project is to compare early and late outcomes for patients who receive post discharge health care monitoring (which includes using Telehealth electronic monitoring; THEM) to patients who receive standard of care (SOC) and routine discharge instructions and no monitoring.

Methods:

1. Randomize patients who are scheduled to have revascularization interventions with groin incisions to receive either telehealth electronic health care monitoring or normal standard of follow-up care.
2. Follow patients for 4 weeks, record any 30-day hospital readmissions or complications. In addition, have participants complete the follow-up survey questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with any planned vascular procedures with cut-down access to the groin and treated by one of the Charleston Area Medical Center -Vascular Surgeons in the Vascular Center (VCOE) will be consented and enrolled.

Exclusion Criteria:

1. do not plan to do follow-up visit at the VCOE;
2. history of dementia;
3. do not have home internet service with WIFI or live outside of the provided cell coverage area (cell coverage will be provided for patients without internet WIFI).
Comparing Nd:YAG Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy

No single type of laser or set of laser parameters is appropriate for all type of irides. Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as the gold standard for iridotomy. It, however, is less effective and causes some complication such as iris hemorrhage especially in patients with dark iris.

By using the double frequency YAG to make the initial bore and the Nd:YAG laser to complete the perforation, the technique should be able to effectively combine most of the advantages of both lasers whilst avoiding their disadvantages. It is possibly the ideal iridotomy technique to use in the Asian irides. The investigators aim to study the energy use for laser iridotomy comparing between the two techniques as well as objectively measure the variables associated with complications.

Eligibility Criteria:
Inclusion Criteria:

* Patient in need to have a laser iridotomy

  * primary angle closure glaucoma or
  * primary angle closure or
  * primary angle closure suspect (needed repeated pupil dilation) or
  * fellow eyes of acute angle closure crisis, and
* Age of at least 18 years, and
* Dark iris patients (only black and dark brown color)

Exclusion Criteria:

* Eye with acute angle closure crisis
* Active conjunctiva or corneal infection or inflammation
* Active anterior uveitis
* History of any prior laser treatment
* History intraocular surgery
* Eye with corneal scar
* Corneal haziness obscure iridotomy site
* Endothelial cell count less than 1000 cells/mm2 (pre-laser)
* Iris color other than black or dark brown
* Inability to sit at the slit lamp to have laser done
The Effect of Intra-Articular Injection of RegenoGel-OSP™(Self-Plasma) to Treat Pain Following Arthroscopic Surgery

This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be randomized and sequentially assigned to RegenoGel-OSP™ or placebo treatment on a 1:1 basis.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed and dated the informed consent form.
* Subject is a male or female over the age of 45.
* Patients scheduled for knee arthroscopic surgery due to degenerative or traumatic meniscal tear.

Exclusion Criteria:

* Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
* Subject is unable to stop chronic administration of pain medications (including paracetamol), from the day before each study visit through completion of the study visit.
* Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis,or any other inflammatory condition associated with arthritis.
* Subject has a superficial wound in the area of the intended study knee.
* Subject is scheduled for knee ligaments reconstructive surgery.
* Subject has fever signs or symptoms of systemic infection or infection of the intended study knee.
* Subject has known sensitivity to any of the treatment components, egg, rubber or latex.
* Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products.
* Subject has a clinically significant abnormal finding (e.g., laboratory result or ECG).
* Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease.
* Subject has ever had cellulitis of the lower extremities, a superficial or deep vein thrombosis, or a family history of a clotting disorders.
* Subject receives any investigational device or product within 30 days of Visit l.
* Subject is receiving an oral or injected anticoagulant.
* Subject ever abused drugs or alcohol (self-reported).
A Phase 1 Study of ESG206 in Adult Subjects With B-cell Lymphoid Malignancies

This is a phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK (pharmacokinetics), and preliminary efficacy and to establish the MTD (maximum tolerated dose), if any, and RP2D (recommended phaseII dose) of ESG206 in adult subjects with B lymphoid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent for the trial.
* Male or female and at least 18 years of age.
* Subjects must have a histologically confirmed (or documented), incurable B-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable.
* Measurable or evaluable Disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject must have adequate organ function.

Exclusion Criteria:

* Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing.
* Had major surgery within 4 weeks before first dosing.
* Had undergone an autologous stem cell transplant within 100 days before first dosing.
* Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
* Pregnant or breastfeeding women.
* Unwillingness or inability to follow the procedures outlined in the protocol.
Short-course High-dose Prednisone and Dexamethasone in Children With ITP

Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)


Eligibility Criteria:
Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:

1. Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
2. Age \> 28 days and ≤ 14 years old
3. Untreated PLT\<20×109/L, or PLT\<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
4. Have signed the informed consent

Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:

1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and thrombopoietic drugs (recombinant human thrombopoietin, eltrombopag, etc.)
2. Received glucocorticoid therapy within 6 months
3. Menstrual female children
4. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
5. Patients who have received radiotherapy and chemotherapy
6. There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.)
7. There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results
Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
* Age between 6 and 17 years, inclusive
* Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
* General good health as judged by the Principal Investigator
* Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / \[height (m)\]2
* Subject as well as parent/guardian able to sign informed assent or consent form

Exclusion Criteria:

* If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device
* Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
* Presence of clinically significant abnormality on centrally interpreted electrocardiogram readings
* History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis I or axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
* Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
* Presence of alcohol or drug abuse.
Tissue Repair in Stem Cell Transplant Recipients

Primary Objective:

1. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation.

Secondary Objective:

1. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.

It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available.

Before treatment starts, participants will have at least one (and up to three) biopsy(ies) of damaged tissue performed to find out about the severity of tissue damage. A biopsy is taken with a large needle. Women able to have children must have a negative blood pregnancy test.

Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week. This will be repeated every other week for a total of 4 weeks. Blood tests (about 2 teaspoons each) will be performed 3 times while at M. D. Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range. Participants will have at least one (and up to three) biopsy(ies) again performed about 8 weeks after the start of rhG-CSF treatment. An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it, and not for research purposes only.

Participants will be taken off study if severe side effects occur. The study will end after the last biopsy or biopsies are taken, about 3 months after the start of rhG-CSF treatment.

This is an investigational study. RhG-CSF is FDA approved and commercially available, though its use in this study is investigational. A maximum of 5 patients will be treated on this protocol. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
2. Patients should have engrafted with WBC concentration \>3000/ul. Patients should have acute GVHD overall \> grade 2 or chronic GVHD.
3. Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
4. Donors and patients must be of different gender.
5. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
6. The only acceptable consent form is the one attached at the end of this protocol.
7. Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.

Exclusion Criteria:

1. Patients who are allergic to rhG-CSF.
2. Patients who had any prior allogeneic stem cell transplantation using a sex mismatched donor other than the donor used for the previous stem cell allotransplantation.
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks

The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.


Eligibility Criteria:
Inclusion Criteria:

- History of at least 1 HAE attack per month or any history of laryngeal edema

In addition, this study was open to all subjects who:

* Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
* Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
* Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up
* Were excluded from LEVP2005-1 for any of the following reasons:

  * Pregnancy or lactation
  * Age less than 6 years
  * Narcotic addiction
  * Presence of anti-C1 inhibitor (C1INH) autoantibodies
* Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:

  * Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
  * Had a known HAE-causing C1INH mutation, or
  * Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator

Exclusion Criteria:

* History of allergic reaction to C1INH or other blood products
* Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals
* Received blood or a blood product in the past 60 days other than C1INH-nf