cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis
* Negative skin tests to a panel of allergens and positive histamine test within last 2 years
* History of symptoms related to defined VMR triggers

Exclusion Criteria:

* Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications
* Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit
* Chronic use of drugs that can cause rhinitis
Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study

The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.

The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for GEHC's VolumeRAD advanced application. The results of this study are intended for use in the submission of FDA 510(k) claims in the United States.

Eligibility Criteria:
Inclusion Criteria for Control-arm Subjects:

Subjects who meet all of the following inclusion criteria may be enrolled in this study:

1. Are adults aged 18 years or older;
2. Are able and willing to comply with study procedures; and
3. Are able and willing to provide written informed consent to participate in this study.

Exclusion Criteria for Control-arm Subjects:

Subjects who meet any of the following exclusion criteria will be excluded from this study:

1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
2. Have had known prior trauma in either wrist.

Inclusion Criteria for Test-arm Subjects:

Subjects who meet all of the following inclusion criteria may be enrolled in this study:

1. Are adults aged 18 years or older;
2. Have a confirmed or suspected distal radius or scaphoid wrist fracture;
3. Have completed an X-ray imaging exam per standard of care;
4. Have a standard of care (SOC) CT or MRI exam ordered;
5. Are able and willing to complete DTS imaging exam (if not already completed);
6. Are able and willing to comply with study procedures; and
7. Are able and willing to provide written informed consent to participate in this study.

Exclusion Criteria for Test-arm Subjects:

Subjects who meet any of the following exclusion criteria will be excluded from this study:

1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
2. Have additional trauma within the image field of view that either impacts the visualization or changes the treatment of the scaphoid or distal radius fracture;
3. Have had prior reconstructive surgery or fixation in the wrist.
Detection of Colorectal Adenomas in Côte-d'Or

Previous studies have shown geographic disparities in the detection of colorectal adenomas in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological deprivation index (EDI). On the other hand, the extremely low detection rates for these lesions in everyday practice before the implementation of organized screening for colorectal cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce socio-geographic inequalities in access to care and prevention. Yet, participation in screening also varies depending on the socio-economic level. In this context, the Côte-d'Or Polyps Registry, the only body to have data for the pre-screening period (before 2003), will make it possible to determine whether the implementation of organized screening led to the elimination of socio-geographic disparities concerning the detection of adenomas.


Eligibility Criteria:
Inclusion Criteria:

* The study population will include all patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008

Exclusion Criteria:

* Absence of address
* history (or suspected history) of previously resected adenoma
* personal history of colorectal cancer or colorectal cancer discovered in the year following resection of the adenoma (because the cancer was probably not seen at the initial colonoscopy)
* familial polyposis or known HNPCC
* chronic inflammatory bowel disease
Adding Specialist Palliative Care to Transplantation Pilot Trial

Specialist palliative care has been shown to be beneficial for patients experiencing serious illness, but has not been studied for patients being evaluated for liver transplantation. The investigators hope in the future to design a multi-center trial of a specialist palliative care intervention to measure the effects of specialist palliative care for patients undergoing liver transplant evaluation. This project represents a pilot to gather needed information to design such a future study.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (age 18 years or greater) undergoing evaluation for liver transplantation at Vanderbilt University Medical Center

Exclusion Criteria:

1. Patient does not speak English fluently
2. Patient lacks a telephone
3. Patient is a prisoner
4. Patient is deaf
5. Patient currently receives specialist palliative care
6. Patient is not a resident of Tennessee
Insulin Versus Hyaluronic Acid in Management of Periodontal Defects

in this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically

n this study, insulin versus hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically after a follow up period

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with periodontitis

Exclusion Criteria:

* patients with systemic illness that contraindicate periodontal surgery
TOP-mums, for a Healthy Start

This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.


Eligibility Criteria:
Inclusion Criteria:

* Women with a pregnancy wish within 1 year;
* Aged 18-40 years;
* Overweight/obesity (BMI ≥ 25 kg/m2).

Exclusion Criteria:

* Haemodynamically significant heart disease;
* Restrictive lung disease;
* Congenital metabolic disease;
* Mentally retarded;
* Bariatric surgery;
* Diabetes type II, dependent on medicine.
Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)

A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate the effectiveness of one type of blood thinner as compared to another type of blood thinner.

Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated with diet and 4 months placebo followed by diet and approved drug) in patients who have experienced acute chest pain or heart attack.


Eligibility Criteria:
Inclusion Criteria:

* A-Phase: Chest pain at rest for 10 minutes, EKG changes or elevated cardiac blood work
* Z-Phase: elevated cholesterol , plus at least one risk factor ( \> 70 years old, diabetes, history of prior heart or blood vessel disease, chest pain with EKG changes, elevation of cardiac lab work or positive cardiac tests , at least 2 heart vessels blocked \[one \>= 75% and one \>= 50%\])

Exclusion Criteria:

* A-Phase: use of some specific cardiac drugs, high risk bleeding, prior blood clotting disorders
* Z-Phase: elevation in certain cardiac blood tests, no significant heart damage at catheterization, planned cardiac surgery or specific cardiac drugs that lower cholesterol levels, within 6 weeks of enrollment
Intraosseous Pressure Monitoring in Intensive Care Unit Patients

In emergency situations, access to the venous system is essential in order to administer fluids and medication and to monitor patients. When peripheral veins are difficult to access or the patient's condition requires certain medications, or monitoring, central venous catheters (CVC) are inserted. CVC placement introduces a much higher level of risk compared to peripheral catheters. The technique of intraosseous (IO) infusion has been used by healthcare professionals for several decades, but recently has gained wide popularity in the emergency care settings. This technique allows providers to secure a needle in the bony matrix at the ends of long bones (tibia and humerus) and infuse fluids and medications into the intramedullary space. The ability to monitor a patient's blood pressure through an intraosseous needle is unknown. The primary objective of this study is to describe the relationship (ratio) of intraosseous pressure (IOP) values to standard pressure values, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and central venous pressure (CVP).


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Admitted to the surgical intensive care units
* Current central pressure monitoring through a central line
* Patient currently intubated and sedated
* Informed consent obtained from family member
* English speaking patient

Exclusion Criteria:

* Known implanted devices in the humerus or tibia that prohibit placement of the intraosseous needle.
* Known osteoporosis, avascular necrosis, or other bone pathology affecting bone healing.
* Fracture or other significant injury to the tibia or humerus or surrounding musculature/tissue.
* Inability to landmark IO placement due to excessive tissue over placement location.
* Anticipated surgery within 12 hours of time of consent
* Current infection at the placement site.
* Previous, significant orthopedic procedure at the site
* Pregnant or has the potential for being pregnant
* Prisoner of the state
* Minor (\< 18 years old)
* Inability to obtain informed consent from family member
* Non-English speaking patient
Adjuvant Therapies for Patients With HCC and MVI

Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis.

Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
* Patients with microvascular invasion by histopathological examination of surgical samples
* Patients have Child-Pugh A or B liver function
* No previous neoadjuvant treatment
* No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
* No malignancy other than HCC for 5 years prior to the initial HCC treatment

Exclusion Criteria:

* History of cardiac disease
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease
* History of organ allograft
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
* Pregnant or breast-feeding patients
Consistencies in Responses to Sodium Bicarbonate?

Intervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. The investigators aim to determine the consistency of metabolic and exercise responses following repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active males will complete six cycling capacity tests at 110% of maximum power output (CCT110%) following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise outcome.


Eligibility Criteria:
Inclusion Criteria:

* recreationally active males

Exclusion Criteria:

* use of dietary supplements in the past 6 months
* the presence of any musculoskeletal disorder
* the use of anabolic steroids
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests

Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
* Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) grade III, IV V and VI
* Baseline oxygen saturation\<90% (room air)
* Body Mass Index (BMI) \>=35
Magnetic Mallet and Densah Bur for Crestal Sinus Left

Background: Implant placement in the posterior maxilla is problematic procedure, not only due to inferior properties of bone but also due to loss of vertical bone height, which happens after extraction of posterior teeth. When the required additional height is few millimeters, indirect transcrestal sinus lifting is recommended. Aim: The aim of this study is to evaluate Densah bur versus Magnetic mallet in transcrestal sinus lifting procedure in edentulous molar and premolar maxillary region.


Eligibility Criteria:
Inclusion Criteria:

* Patient seeking replacement of missing maxillary posterior teeth by dental implant procedure.
* Residual bone height is (5-7) mm measured from crestal bone to sinus floor.
* Both genders.
* Good general health;
* Good oral hygiene.

Exclusion Criteria:

* Uncontrolled Diabetes.
* Coagulation disorders.
* Immunological disorders.
* Previous radiation of the head and neck region.
* Presence of chronic systemic diseases;
* Presence of acute or chronic sinus problems;
* Alcohol or drug abuse;
* Heavy smokers.
Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway

The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation


Eligibility Criteria:
Inclusion Criteria:

* BMI \>30 kg/m2
* Mallampati class III or IV
* Requiring general anesthesia

Exclusion Criteria:

* Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma
* American Society of Anesthesiologists (ASA)physical status classification ≥IV
* Emergency surgery
* Induction requiring rapid sequence for intubation
* Patients requiring awake intubation
* Pregnant women
* Untreated ischemic heart disease
* Contraindication for mask ventilation
Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients

Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and vitamin C potentially have beneficial effects on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.

Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementation of glutamine in ICU patients has been under much debate. Another nutritional supplement, vitamin C, had a beneficial effect on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.

Methods. This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group. Plasma glutamine, interleukin-6 (IL-6), and clinical data were collected and analyzed with biostatistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages 20 and 85 years
* Not enrolled in other clinical trials in the previous 1 month and during the study period
* Surgical ICU patients cared by the 9 participating surgeons

Exclusion Criteria:

* Older than age 85 years
* Pregnant women
* With an abnormal liver function (receiving drugs or clinical therapies)
* Abnormal renal function (under hemodialysis)
* Multiple organ failure (more than 2 organs)
* Expected ICU stay of less than 72 hours
Esmolol in Cardiac Surgery

This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.


Eligibility Criteria:
Inclusion Criteria:

* end diastolic diameter \>60 mm and/or an ejection fraction \<50%
* written informed consent
* age \>18 years

Exclusion Criteria:

* previous unusual response to esmolol
* inclusion in other randomized studies
* esmolol administration in the previous 30 days
* emergency operation
Vonoprazan Hp Dual or Triple Eradication Regimes

To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years old, both gender is eligiable;
* Patients with definite Helicobacter Pylori infection (13C/14C urea breath test, rapid urease test and fecal Helicobacter Pylori antigen test positive) ;
* Voluntary to accept Helicobacter Pylori eradication treatment;
* Females of childbearing age are required to use medically acceptable contraceptive methods during the trial and within 30 days after the trial.

Exclusion Criteria:

* Patients with contraindications to the study drug or allergic to the study drug;
* Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
* Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (at least 2 weeks before the examination for Helicobacter Pylori infection);
* Pregnant and lactating women;
* Have received upper gastrointestinal surgery;
* Symptoms of dysphagia;
* Evidence of bleeding or iron deficiency anemia;
* have a history of malignant tumor;
* History of drug or alcohol abuse within the past 1 year;
* Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, and platelet aggregation inhibitors (except aspirin ≤100 mg/d);
* Persons with mental disorders;
* Received other clinical trials within the past 3 months;
* Refused to sign the informed consent.
PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy

This is a randomized and comparative prospective test, monocentric and controlled (mirror therapy versus bimanual rehabilitation exercises), in single-blind (investigator and occupational therapist " 1 " do not know the type of rehabilitation performed).


Eligibility Criteria:
Inclusion Criteria:

* Unilateral spastic cerebral palsy as defined by SCPE (Surveillance of Cerebral Palsy in Europe)
* Aged 7 to 17 years
* MACS (Manual Ability Classification System) 1 to 3
* Extension of the wrist more than 10°
* Free, informed and written consent of the parents
* Free, informed and written consent of the child
* affiliated, via his/her parents, to the Social Security regime

Exclusion Criteria:

* Other neuromuscular disorders known
* Cognitive impairment hampering the understanding of instructions
* Upper-limb pain (EVA score \>3)
* Restriction of passive range of motion
* Visual impairment not allowing the visualization of the upper limb in the mirror
* Upper-limb Botulinum toxin injection in upper limb 6 months prior to inclusion