cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL

The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch \& wait" policy.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed indolent lymphoma including:

  * follicular grade 1 or 2
  * small lymphocytic
  * marginal zone (nodal)
  * marginal zone (splenic)
  * mucosa associated lymphoid tissue (MALT)
* no evidence of transformation
* Stage III or IV disease
* No prior therapy
* involvement by less than 25% of bone marrow on assessment of trephine biopsy
* absolute lymphocyte count ≤ x 109/L
* platelets ≥ 150 x 109/L
* hemoglobin ≥ 100g/L
* absolute neutrophil count ≥ 1.5 x 109/L
* at least one bidimensionally measurable lesion at least 2cm by CT scanning

Exclusion Criteria:

* any other anticancer treatment for NHL
* prior radiation therapy
* prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
* no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix
* presence of central nervous system lymphoma
* patients known to be HIV positive
* patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment
* patients with abnormal liver function: total bilirubin \> 1.5X ULN or ALT \> 2.5X ULN
* patients with abnormal renal function: serum creatinine \> 2.5X ULN
* known hypersensitivity to murine antibodies or proteins
* immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)
Effects of Dexmedetomidine on OI, RI and Inflammatory Factors in Patients Undergoing Palatopalatyngoplasty.

The purpose of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.

Obstructive sleep apnea syndrome is common among people, especially among obese people, Which is characterized by periodic or complete upper airway obstruction and hypoxia during sleep. Intermittent hypoxia contributes to the lung damage by increased oxidative stress, inflammation. Some researchers suggested that dexmedetomidine can inhibit inflammatory reaction and lessen the damage of respiratory function. The aim of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing palatopalatyngoplasty
* ASA physical status II-III
* Aged 18-65 years
* BMI 18.5-30kg/m2

Exclusion Criteria:

* Bradycardia
* Atrioventricular block
* Allergic to the drugs
* Complicating pulmonary disease(including pulmonary infection,COPD, asthma and so on)
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease

Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting


Eligibility Criteria:
Inclusion criteria:

* Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need relief of various symptoms associated with Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (LAMA).
* Patients who are prescribed Tio+Olo FDC 5µg/5µg for the first time

Exclusion criteria:

* Patients who have been registered once in this study (i.e., re-entry of patients is not allowed).
* Patients who are participating in a registry or clinical trial.
* Patients who have a contraindication to Tio+Olo FDC 5µg/5µg defined in the package insert for Tio+Olo FDC 5µg/5µg.
Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke

This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute stroke. The study is designed to look at both infection rate and overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility Criteria:
Inclusion Criteria:

* Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with a score of at least 6 on the National Institute of Health Stroke Scale (NIHSS), and patient age of at least 18 years.
* Have no pneumonia according to modified criteria of the U.S. Centers for Disease Control and Prevention (CDC)
* Consistent with the Constipation of Phlegm-Heat Accumulation type by Traditional Chinese Medicine (TCM) standard
* Patients or their representatives voluntarily take part in this study and signed the informed consent

Exclusion Criteria:

* Cerebral hemorrhage, subarachnoid hemorrhage
* Transient ischemic attack(TIA)
* Proven cerebral embolism caused by tumor, Brain Trauma, cerebral parasitic disease, dysbolismus, fibrillation atrial resulted from rheumatic heart disease, coronary heart disease, and other heart diseases
* Clinical signs of infection on admission
* Pregnant or breast-feeding
* Allergic to rhubarb
* Preceding or ongoing antibiotic therapy within the last 24 h
* Participation in another interventional trial
* Immunosuppressant treatment within the last 30 days
* Combining severe clinical conditions such as liver, kidney, Hematopoietic System, endocrine system or psychological diseases
Efficacy and Safety of IQP-VV-102 in Weight Management

Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years
* 25 kg/m2 ≤ BMI ≤ 35 kg/m2
* Written informed consent

Exclusion Criteria:

* Known sensitivity to sources of the active ingredients and excipients
* Pregnancy or nursing
* Inability to comply with study requirements, e.g. due to language difficulties
* Participation in another study during the last 30 days of the screening visit
A Pilot Study of Evidence-based Guided Self-help for the Treatment of Binge Eating

The purpose of the present pilot study is to evaluate the feasibility, acceptability and likely effectiveness of an evidence-based guided self-help intervention for binge eating and related disordered over-eating in those unable to access clinician provided treatments. If feasible, acceptable and likely to be effective, such interventions could be made available more widely as an early intervention to those in need. Such interventions have the potential to improve quality of life by removing or ameliorating symptoms that impair psychological and social functioning. Eligible participants will receive the guided self-help intervention - an evidence-based self help program in the form of a self-help book plus telephone support and encouragement to follow the program provided by specially trained help-line volunteers. Support completing the self-help program will be provided over a period of 4 months and participants will be followed up for a year after completion of the intervention. Participants will be asked to complete brief online assessments before starting the program, at the end of 4 months when they complete the program and at 6 month and 12 month follow up.


Eligibility Criteria:
Inclusion Criteria:

* Participant contacted National Eating Disorder Association (NEDA) with binge eating problems or disordered overeating
* Completed NEDA screen and study screen
* Age 18 and over
* Able to speak, understand and read English
* Consenting to guided self-help and completing study assessments

Exclusion Criteria:

* Currently receiving treatment for an eating disorder
* Self-reported weight body mass index (BMI) \<20
* Reported self-induced vomiting, laxative or diuretic use (purging)
* Reports suicidal ideation
* Breast feeding or pregnant
* Receiving treatment for co-existing psychiatric condition (e.g., bipolar disorder, psychotic illness, drug or alcohol dependence
The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects, ages 18-70, inclusive.
2. Availability for the six-week duration of the clinical research study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Antibiotic use any time during the one month prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Dental prophylaxis during the past two weeks prior to baseline examinations.
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome.
11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Pregnant or lactating subjects.
Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes

Type 2 diabetes is a major public health concern. It is widely established that type 2 diabetes in linked to activated innate immunity and increased levels of C-reactive protein and interleukin-6 (IL-6) in plasma. Studies in humans and in liver cells has shown that IL-6 downregulates important drug metabolizing enzymes in the liver (cytochrome P450 (CYP) enzymes). More than half of the most prescribed drugs are eliminated by biotransformation of these enzymes.

The investigators have previously shown that initiating glucose-lowering treatment (e.g. metformin, sulphonylureas and insulin) leads to decreased therapeutic efficacy of the blood-thinning vitamin-K antagonist warfarin. Due to the non-specific effect of glucose lowering drugs, the investigators hypothesize that this is caused by the glucose-lowering effect rather than drug-drug interactions caused by the individual drugs.

Based on the proposal that reversal of increased plasma glucose affects drug metabolism, the investigators will perform a clinical pharmacokinetic trial. The purpose of the study is to elucidate whether initiation of glucose-lowering treatment causes altered drug metabolism among patients with type 2 diabetes. The study will include newly diagnosed and untreated type 2 diabetes patients who will ingest a 6-drug cocktail consisting of probes for specific CYP enzymes. Plasma and urine will be drawn over 6 hours to determine concentrations of the drugs and their metabolites. Patients will then initiate metformin treatment and to assess both short- and long-term impact of glucose-lowering, the same 6-drug cocktail will be ingested, and concentrations measured, after three weeks and three months. To help understand the mechanism and the putative involvement of inflammation, markers of inflammation such as cytokines, transcription factors, etc. will also be assesses.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, not treated metformin.
* Hemoglobin 1Ac (HbA1c): ≥48 mmol/mol
* Age: 18-75 years
* Body Mass Index (BMI) ≤ 40 kg/m2
* Estimated Glomerular Filtration Rate (eGFR) \> 60 mL/min
* Alanine Aminotransferase (ALAT), bilirubin and hemoglobin within reference range or clinically insignificant differ from this.

Exclusion Criteria:

* Acute or chronic infection or inflammation
* Active cancer
* Glutamic acid decarboxylase (GAD)-antibodies
* Known hypersensitivity to one or several of the drugs
* Intake of medications which can influence the safety of the patient or the results of the study
* Alcohol consumption above the limits recommended by the Danish Health Authorities (Men 14 units/week, women 7 units/week)
* Participation in other trials with interventions.
* Women: Positive pregnancy test at inclusion or on one of the test-days.
Population Research of Sublingual Microcirculation Data of Healthy Volunteers

This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam, The Netherlands). Five video sequences (20 s) was obtained from different sublingual sites, and digitally stored the images with code numbers that did not reflect volunteers' information for later offline analysis by automated analysis software (AVA 3.0; Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands).


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged from 20 to 79 years old
* BMI ranged from 18.5 to 27 kg/m2

Exclusion Criteria:

* Systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 95 mm Hg, or systolic blood pressure \< 90 mm Hg at enrollment
* Body temperature \> 37.5 ℃ or \< 35.5 ℃ at enrollment
* had been diagnose with any one of the following diseases
* hypertension
* diabetes mellitus
* peripheral arterial occlusive disease
* coronary arterial disease
* liver cirrhosis
* chronic kidney disease
* stroke
* anemia
* asthma
* chronic bronchitis
* any metabolic diseases
* any hematologic disease
* uncured cancer
* chronic uncontrolled infection
* other disease may limit daily activities
* non-native speakers
Risk Factors For Postoperative Respiratory Complications After Anesthesia

This project was aimed to identify the risk factors associated with the occurrence of respiratory complications in post anesthesia care unit. The primary outcome was the composite measure of occurrence of complications in PACU. The components were apnea or hypopnea, laryngospasm, bronchospasm and prolonged oxygen requirement.

This is a retrospective project. Data will be used from Quality Improvement database for publication purpose. Data was collected from a prospectively collected database that was done as a Quality Improvement Project. The study sites included post anesthesia care units (PACU) of the main and ambulatory campuses of our hospital. The data was collected from surgical and radiology PACU's. Data was collected each quarter for 2 weeks in the surgical PACU, and for 1 month in Radiology PACU, from Sep 2007 through Mar 2012. Trained perioperative nurses and Certified Registered Nurse Anesthesiologist did data collection. This ensured a sample representative of at least 10% of patients anesthetized for surgical and radiological procedures. The independent variables (risk factors) collected included age, American Society of Anesthesiology (ASA) physical status, obesity, preexisting airway or lung disease, preexisting neuromuscular disease or hypotonia, morbid obesity, intraoperative bronchospasm and intraoperative laryngospasm. The primary outcome variables collected were Apnea or hypopnea, Laryngospasm, Bronchospasm, and prolonged Oxygen requirement. Apnea or hypopnea was defined by the need for bag mask ventilation, Laryngospasm by the requirement of a positive pressure ventilation of \> 20 cmH2O or administration of succinylcholine, Bronchospasm by use of albuterol, and Oxygen requirement by continued oxygen administration to maintain SpO2\>92% for 2 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1) All patients who receive an anesthetic in participating institutions who are under 18 years of age and where an anesthetic record is generated will be included in the overall statistics for each center -

Exclusion Criteria:

1) Patients older than 18 years of age.-
Regulation of Human Intestinal Bile Acid Transport in Health and Disease

This study investigates distribution and regulation of bile acid transport in the human intestine.


Eligibility Criteria:
Veterans, healthy, scheduled for screening colonoscopy
Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial

To determine in patients requiring venoarterial (V-A) ECMO, whether the use of a conservative as compared with liberal oxygen strategy, results in a greater number of ICU-free days at day 28.

Extracorporeal membrane oxygenation (ECMO) can be a lifesaving procedure for the sickest patients in the Intensive Care Unit (ICU) who are at risk of death from severe cardiac and respiratory failure. ECMO is a device which pumps blood out of the body and returns it back after adding oxygen and removing carbon dioxide. While potentially life-saving, ECMO is associated with high use of critical care resources and increased risk of adverse outcomes in survivors.

The BLENDER Trial is a multicentre trial in ECMO patients to determine whether a conservative oxygen strategy during ECMO reduces ICU length of stay and improves patient outcomes compared to a liberal oxygen strategy. Both strategies are currently standard practice worldwide, however, there is no consensus to which strategy is better for our patients. This trial aims to utilise an existing intensive care registry and will recruit 300 patients with life threatening acute cardiac or respiratory failure. If the BLENDER Trial confirms that one oxygen management strategy is more effective than the other, its findings may improve the lives of critically ill Australians and inform clinical practice worldwide.

Eligibility Criteria:
Inclusion Criteria:

• Patients ≥18 years who are commenced on V-A ECMO for severe cardiac, or following refractory cardiac arrest.

Exclusion Criteria:

* Greater than 6 hours have elapsed from the time of initiation of ECMO to randomisation
* Patients who are suspected or confirmed to be pregnant
* Where an indication exists for a specific oxygen target as part of clinical care (e.g. carbon monoxide poisoning)
* Patients who are already enrolled in another oxygen titration study (unless agreed by study committees)
* Patients not willing to receive blood products (e.g. Jehovah's Witness)
* Where the treating physician deems the study is not in the patient's best interest
Effects of Vestibular Rehabilitation in the Treatment of Dizziness and Balance Disturbances After Concussion

The goal of this clinical trial is to study the effects of including vestibular rehabilitation in the treatment of dizziness and balance disturbances in athletes after concussion. The main questions it aims to answer are:

* Does inclusion of vestibular rehabilitation treatment have an effect on symptom resolution in those with concussion?
* Does inclusion of vestibular rehabilitation treatment have an effect on the rate of recovery and return to play after concussion? Researchers will compare vestibular rehabilitation treatment inclusion in concussion treatment to a traditional concussion treatment approach to see if the rate of symptom resolution and return to play are affected by including vestibular rehabilitation for participants who have experienced a concussion within one week of presenting for the study.

Participants will:

* Be randomly assigned to either receive vestibular rehabilitation included in their concussion treatment or have traditional concussion treatment without vestibular rehabilitation.
* Complete treatment sessions two times per week for up to four weeks
* Complete the corresponding home program for the treatment group
* Complete baseline symptom testing and repeat the symptom testing at study completion for data comparison. Testing includes: Sport Concussion Assessment Tool (SCAT5) including 1) the athlete's background 2) symptom evaluation 3) cognitive screening 4) neurological screening and 5) delayed recall, a Dynamic Gait Index (DGI) including 1) gait on level surface 2) change in gait speed 3) gait with horizontal head turns 4) gait with vertical head turns 5) gait and pivot turn 6) step over obstacle 7) step around obstacle 8) stairs, and a vestibular evaluation including 1) patient history 2) visual assessment 3) vertebral artery clearance 4) cervical spine clearance 5) inner ear assessment 6) brief balance assessment.

Nothing further to include that is not entered or uploaded elsewhere in the record

Eligibility Criteria:
Inclusion Criteria:

* Athlete from a small regional university
* Experiences a concussion
* Identified by their certified athletic trainer to have dizziness or balance dysfunctions
* Referred for initial contact testing and treatment

Exclusion Criteria:

* Acute spinal cord injury with neurological deficits
* Epidural and subdural hematoma with known manifestations
* Acute cervical spine injury