cyrilzakka/clinical-trials huggingface dataset:
Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis

This study investigate the nasal irrigation with Traditional herbal medicine extract-saline isotonic solution in the treatment of chronic rhinitis and sinusitis. Half of participants will receive Traditional herbal medicine extract-saline isotonic solution nasal irrigation, while the other half will receive saline alone nasal irrigation.

In the program, the investigators plan to investigate a clinical triad to research the outcomes of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution for treatment of chronic rhinitis and sinusitis. The aims of this study are listed below:

Aim 1: evaluating the outcomes and quality of life of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution to treat enrolled patients with chronic rhinitis or sinusitis. The investigators use modern devices to evaluate the autonomic nerve, meridian energy and pulse. The questionnaires of quality of life and symptoms will be recorded. Nasal irrigation with saline alone will be conducted during the clinical triad to compare the effectiveness and quality of life with Traditional herbal medicine extract.

Aim 2: analyzing the changes of bacteria culture in nasal discharge collected during the clinical triad before and after nasal irrigation for investigating the microenvironment of Traditional herbal medicine extract-saline isotonic solution.

According to the research, the investigators will realize the improvement of using Traditional herbal medicine extract-saline isotonic solution for nasal irrigation to treat sino-nasal diseases, by investigating the changes of quality of life and microenvironment of nasal cavity. The nasopharyngoscopic examination, autonomic nerve, meridian energy and pulse were record to compare the effectiveness of Traditional herbal medicine extract-saline isotonic solution with nasal irrigation with saline alone.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic criteria for chronic rhinitis and sinusitis male and female volunteers.
2. Stop using oral and topical steroid and anti-histamine treatments \>2 weeks prior to enrollment.
3. \>20 years of age.

Exclusion Criteria:

1. Allergy to herbal medicine.
2. Presence of a sinus tumor.
3. Significant immune dysfunction.
4. Pregnancy and breast-feeding women.
5. Undergone nasal surgery \<1 week prior to enrollment.
Prevalence of Post-craniotomy Headache in Siriraj Hospital

Headache after major craniotomy may be a problem in taking care of the patients. The investigators want to identify the incidence of headache after major craniotomy and also the risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing major craniotomy

Exclusion Criteria:

* emergency surgery or traumatic patients
* may need postoperative ventilatory support more than 2 days
* cannot communicate
* psychiatric patients
* chronic use of benzodiazepine or drug abuse
* cannot follow the treatment
Clinical Value of Noninvasive Intracranial Pressure Measurement

The aim of the study is to evaluate accuracy and precision of non-invasive intracranial pressure measurement device (Vittamed 205) for selected patients compared with cerebrospinal fluid pressure measured during lumbar puncture

Non-invasive intracranial pressure (ICP) measurements with Vittamed 205 aICP meter will be compared to simultaneous cerebrospinal fluid (CSF) pressure measurements during lumbar puncture. Measures of pressure in mmHg will be compared. These measurements will be compared in chronic daily headache, normal pressure hydrocephalus and multiple sclerosis patients groups. For stroke patients noninvasive measurements will be compared with cerebral lesion in brain MRI/CT.

Eligibility Criteria:
Inclusion Criteria:

* Chronic daily headache with suspected idiopathic intracranial hypertension
* Diagnosed of suspected multiple sclerosis (MS)
* Intracranial hemorrhage/ stroke

Exclusion Criteria:

* Patient not able to understand information about the trial
* Uncooperative patient
* Intracranial hemorrhage volume \<20 or \>40ml
* Stroke area larger than 1/3 of the middle cerebral artery
Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.


Eligibility Criteria:
Inclusion criteria:

* Must be ≥ 18 years of age
* Confirmed and documented diagnosis of prostate cancer
* Confirmed and documented evidence of progression of disease (hormone refractory)
* Low testosterone levels
* Chemotherapy-naïve

Exclusion criteria:

* Recent radiation therapy (within 4 weeks)
* Known brain metastasis
* Peripheral neuropathy
* Active diarrhea
* Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
* Allergic reactions to patupilone or docetaxel or prednisone or similar compounds

Other protocol-defined inclusion/exclusion criteria may apply
A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica

The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.

Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast.

The study has been designed as an open trial which will be conducted in 4 Spanish sites.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must sign the informed consent form.
2. Patients must be between 18 and 60 years of age.
3. Patients with seasonal allergic rhinoconjunctivitis against Parietaria judaica during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013).
4. Patients who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.
5. Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.
6. Patients sensitized to Parietaria judaica with clinically relevant symptoms in which treatment with Parietaria judaica 100% vaccine is indicated.
7. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
8. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.

Exclusion Criteria:

1. Patients who received immunotherapy in the previous 5 years for Parietaria judaica or fo rany allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
2. Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1\< 70% even if the are pharmacologically controlled .
3. Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
4. Patients with a previous history of anaphylaxis
5. Patients with chronic urticaria,
6. Patients with moderate to severe atopic dermatitis
7. Patients who have participated in another clinical trial within 3 month prior to enrolment.
8. Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
9. Female patients who are pregnant or breast-feeding
10. Patient who does not attend the visits
11. Patient's lack of collaboration or refusal to participate.
High Intensity Light Therapy in Alzheimer's Disease

The purpose of this study is to determine whether bright light improves the sleep, mood, and behavior of persons with Alzheimer's disease and related dementias (AD) who live in long-term care settings and, if so, to determine the best timing for the light therapy. The light levels being used in the study have been shown to improve depression in persons with seasonal affective disorder (SAD) and to relieve sleep problems in persons with jet lag and other body rhythm disturbances. Because persons with AD often will not remain still in front of a fluorescent panel, this project has involved renovations in the study units that provide for even, regulated, high-intensity light in all public areas of the study settings.

See Brief Summary

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of dementia
* Residence on study units

Exclusion criteria:

* Bipolar disorder
* Severe retinal (eye) disease
Studying Gene Expression in Tissue Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue 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 study is looking at gene expression in tissue samples from patients with acute myeloid leukemia.

OBJECTIVES:

* Screen acute myeloid leukemia (AML) samples to correlate high relative expression levels of PLAGL2 and putative PLAGL2 target genes (implicated in microarray study) with potential pathogenic relevance with respect to AML development.

OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia, including inv(16)(p13;q22) abnormalities

  * No t(15;17)(q22;q12) or t(8;21)(q22;q22) abnormalities

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors

This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).

Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we conducted a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We focused on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapted an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We adapted NOURISH for caregivers of 5 - 13 year old PCS (6 months -4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary feasibility efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project enrolled caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments of both caregivers and PCS occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up. In comparison to EUC, we hypothesized that caregivers and PCS assigned to the NOURISH-T condition would show greater improvements in dietary intake, physical activity, and in anthropometric health indicators over time.

Eligibility Criteria:
Inclusion Criteria:

Caregivers

* Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors
* 18 years or older
* Fluent in English

Pediatric Cancer Survivors

* Diagnosis of cancer
* between 5-13 years of age at study entry
* off active cancer treatment for 6 months to 4 years,
* reside with a participating caregiver
* able to engage in PA tailored to current medical status
* NOT taking medications that affect body weight, e.g., steroids within 6 months of enrollment
* at or above the 85th BMI %ile.

Exclusion Criteria:

Caregivers

* are non-ambulatory
* do not reside with the PCS at least 50% of the time.

Pediatric cancer survivor

* relapse during the intervention
* taken a medication known to affect body weight such as oral steroids or antipsychotic medications within 6 months of enrollment
Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)

The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.

Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory response to ingested gluten in susceptible individuals.

These changes cause a loss of absorptive capacity which in turn leads to variable degrees of malabsorption. A person suffering from celiac may have symptoms ranging from mild iron deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten from the diet is followed by resolution of the mucosal changes and the symptoms.

Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally confirmed by serological testing and small bowel biopsy. Patients with suspected celiac disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect the characteristic histological changes.

Although the main role for endoscopy in GSE is to obtain tissue for histological examination, a variety of endoscopic changes have been described in these patients,such as nodularity of the mucosa and 'scalloping' or loss of the duodenal mucosal folds.

The Given® Diagnostic System can visually investigate the small bowel, producing high-quality images of the mucosa, which might be able to detect villous atrophy and thus could be used in the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and does not require sedation.

Capsule Endoscopy could become an important tool for the non-invasive assessment of small bowel mucosa in GSE.

Eligibility Criteria:
Inclusion Criteria:

* Patient age is 18 years or older
* Patient agrees to sign the Informed Consent Form
* Patient has positive celiac serology or negative celiac serology + IgA deficiency and suffers from one or more of the following symptoms and/or abdominal biochemical values:

  1. Chronic diarrhea
  2. Weight loss
  3. Abdominal cramps
  4. History of spontaneous abortion
  5. Iron deficiency anemia
  6. Osteoporosis
  7. Infertility
  8. Hypoalbuminaemia
  9. Low cholesterol
  10. Low prothrombin activity

Exclusion Criteria:

* Patient is known or is suspected to suffer from intestinal obstruction.
* Patient has a cardiac pacemaker or other electro-medical device.
* Patient suffers from severe swallowing disorder or Zenker's diverticulum
* Patient has any condition, which precludes compliance with study and/or device instructions.
* Female patient is pregnant
* Patient suffers from life threatening conditions
* Patient is currently participating in another clinical study.
Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD)

The purpose of this study is to investigate the impact of a pharmacist-led intervention to expand access to medications for opioid use disorder (MOUD) on racial/ethnic differences in opioid-related overdose among individuals diagnosed with opioid use disorder (OUD) currently incarcerated in a carceral setting. In this study, participants will be screened for opioid use, trained to administer Narcan nasal spray, receive motivational counseling and referral to treatment post-release from a carceral setting (a Re-Entry program) into the community.

The main objectives of this study are:

1. To increase understanding of racial/ethnic differences in the prevalence of OUD.
2. To test if a pharmacist-led intervention is more effective than a substance use counselor (lay person) in increasing knowledge and confidence among different racial/ethnic groups related to administering Narcan nasal spray in an opioid overdose situation.
3. To test if a pharmacist-delivered an evidence-based intervention, q brief intervention and referral to treatment (BIRT) versus standard medication counseling (SMC) is more effective in increasing access to MOUD.

Eligibility Criteria:
Inclusion Criteria

Narcan Training:

* a Re-Entry program participant 7-14 days from release from carceral setting
* provide collateral contact information for ≥2 persons (to ensure consistent contact/follow up)
* have a reliable landline or mobile phone to be contacted by pharmacist
* plan to remain in the Little Rock area for at least 6 months
* able to read and write English
* able to provide informed consent
* possesses manual dexterity; physical ability to roll a person onto her/his/their back and side
* have no allergy to naloxone hydrochloride (active ingredient in Narcan nasal spray)-
* identified on the RODS screener as positive for OUD.

BIRT/SMC:

* a Re-Entry program participant 7-14 days from release from the carceral setting
* provide contact information for ≥2 persons (to ensure consistent contact/follow -up)
* have a reliable landline or mobile phone to be contacted by pharmacist
* plan to remain in the Little Rock area for at least 6 months
* able to read and write English; able to provide informed consent
* identified with OUD.

Exclusion Criteria:

Narcan training:

* not a RE-entry program participant
* identified substance use disorders other than OUD

BIRT/SMC:

* not a RE-entry program participant
* identified substance use disorders other than OUD
Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.

The purpose of our study is to assess lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success

Assessment of lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success in critically ill patients .

Eligibility Criteria:
Inclusion Criteria:

* Patients more than18 years old.
* All patients intubated and requiring mechanical ventilation for 48 hours or more at respiratory intensive care unit (RICU)
* Patients fullfiled the criteria of readiness to wean according to European Respiratory Society guidelines (ERS)

Exclusion Criteria

* Patients with neuromuscular disease or diaphragmatic paralysis.
* Patients with tracheostomy.
* Patients who undergone surgical operations especially abdominal and thoracic operation.
* Patients with diseases that may affect the diaphragm (including pneumothorax, pneumomediastinum, patients with inserted intercostal tube (ICT), third trimester of pregnancy).
The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Pediatric Patients

Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.


Eligibility Criteria:
Inclusion Criteria:

* children (0-9 years of age)
* children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic

Exclusion Criteria:

* patients with an abnormal airway
* patients with reactive airway disease
* patients with gastroesophageal reflux disease
* patients with chronic respiratory disease
* patients who has a history of an upper respiratory tract infection in the preceding 6-week period
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Indonesia

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Asia. Further perceptions and practices of physicians and subjects about diabetes management in Asia will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients registered in the particular centre for more than 12 months.
* Patients should have visited the centre at least once in the last 3-6 months before the initial study visit.
* Patients willing to sign informed consent form.

Exclusion Criteria:

* Repetition of any patient as patients should not be included twice for any reason.
* Unwilling to participate or unable to comply with protocol requirements.
Gabapentin Premedication for ACL Reconstruction: RCT

This double blind randomized control trial will enroll 100 participants ages 12-18 years, undergoing ACL repair. Participants receive gabapentin or placebo preoperatively. Outcome measurements of self-reported pain score using scale of 1 to 10 with 10 being the worse obtained from the EMR and participants interviews with a phone nurse for five days postoperatively to determine severity of pain as well as use of opioids.

Anterior Cruciate Ligament (ACL) injury and surgical repair occurs in 200,000 active adolescent and young adult patients each year. ACL repair is associated with significant postoperative pain. Current methodologies for pain include regional nerve blocks, opioid or non-steroidal analgesia. Few studies have evaluated use of neuro-inhibitors such as gabapentin to limit pain response.

The purpose of this study then is to examine the use of gabapentin in reducing postoperative pain in adolescent ACL patients. The investigators hypothesize one 15mg/kg (up to 600mg) dose of gabapentin preoperatively would reduce: 1) self-reported postoperative pain and, 2) opioid use compared to patients who do not receive preoperative gabapentin.

This double blind randomized control trial will enroll 100 participants ages 12-18 years, undergoing ACL repair. Participants receive gabapentin or placebo preoperatively. Outcome measurements of self-reported pain score using scale of 1 to 10 with 10 being the worse obtained from the EMR and participant interviews with a phone nurse for five days postoperatively to determine severity of pain as well as use of opioids.

Outcome measurements will give a more comprehensive description of the postoperative experience and test gabapentin's opioid sparing effect. Due to paucity of literature on pain relief in this population, this pilot study will inform a larger multi-site study.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification 1 or 2
* Scheduled for elective ACL surgery in pediatric outpatient setting

Exclusion Criteria:

* BMI greater than 40
* ASA classification greater than 2
* Recurrent ACL reconstruction
* Allograft ACL reconstruction
* History of renal insufficiency
* History of chronic pain
* Allergy to Gabapentin