cyrilzakka/clinical-trials huggingface dataset:
Comparison of Lma-Protector With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration

The aim of this prospective, randomized, comparative, controlled clinical study is to compare laryngeal mask airway ProtectorTM with the endotracheal tube, regarding to the respiratory mechanical parameters during controlled mechanical ventilation and the prevalence of aspiration. Aspiration will be evaluated by detecting and quantifying pepsin (a marker of gastric aspiration) and α-amylase (a marker of salivary aspiration) in the bronchoalveolar lavage ( mini BAL) of patients ≥18 years old, ASA 1-2, undergoing selective low-risk surgery under general anesthesia in a lithotomy position.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years ASA1-2 who are to undergo planned urological surgery of low or intermediate severity, under general anesthesia in the lithotomy position.

Exclusion Criteria:

* patients \< 18 years old.
* Patients who are going to undergo an emergency/urgent operation/ trauma patients.
* Maternal population.
* Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
* Patients in whom LMA placement is contraindicated, such as patients at high risk for reflux and aspiration of gastric contents (eg, history of gastroesophageal reflux, hiatal hernia, pyloric stenosis, gastrointestinal obstruction, morbid obesity).
* Patients who meet at least one of the four RODS difficulty criteria.
* Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
* Patients who refuse to participate in the study.
Single Dose rATG for Renal Allograft Rejection

Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter.Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration including correlation to length of hospital stay and hospital costs.

Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter. This prolonged course is not consistent with the Medicare diagnosis-related group (DRG) for acute rejection which limits rejection admission to 3 days. The prolonged hospitalization results in increased medical costs and uniform financial loss to the hospital for patients admitted under this DRG. In addition there is a patient related toll of the prolonged hospitalization and a potential for additional hospital acquired complications. Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. The investigators hypothesize that single-dose rATG infusion will be as safe and efficacious as standard rATG administration when used for rejection treatment and would result in significant reduction in the length of hospital stay (LOS) and hospital costs for rejection treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18 years or older
2. Experiencing a biopsy-proven acute rejection episode which:

   * will require the use of rATG based on severity, or
   * is exhibiting resistance to corticosteroid treatment, defined as failure of the serum creatinine to decrease after at least 3 days of corticosteroid treatment (≥200 mg/day of methylprednisolone or equivalent)

Exclusion Criteria:

1. Patients with known severe allergy to antithymocyte globulin or rabbits
2. Rejection episode requiring the use of therapeutic plasma exchange immediately subsequent to rATG administration
3. Currently receiving any investigational drug or treatments
ERAP1,2 in Recalcitrant Warts

The exact mechanisms underlying the contribution of cellular immunity in the eradication of human papillomavirus (HPV) infections remain obscure. Individuals who have treatment-resistant warts frequently have immune deficiencies. Amino-peptidases (ERAP1, ERAP2) of endoplasmic reticulum are essential for production of antigenic epitopes that attach to the Major Histocompatibility Complex (MHC) class I and activate T-lymphocytes or natural killer (NK) cells. Aim: To assess ERAP1 and ERAP2 serum concentrations in patients with resistant warts.


Eligibility Criteria:
Inclusion Criteria:

• Patients who had a history of incomplete clearance or recurrence following two or more electrocautery sessions and four or more cryocautery treatments and intralesional bleomycin.

Exclusion Criteria:

* Patients with genital warts
* Patients on systemic steroids or other immunosuppressive treatments
* Immunocompromised individuals
* Patients suffering from chronic systemic diseases
* Pregnant women
Analysis of Deposition With Nebulizers Membrane

BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled 99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine distribution of deposition and mass balance between compartments.


Eligibility Criteria:
Inclusion Criteria:

* The study inclusion critera was healthy adults of both sexes, between 18 to 65 years, without history of lung disease or smoking, with forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) greater or equal to 80% of predicted values (Pereira et al., 1992), ability to follow and retain verbal commands while able and willing to provide signed consent to participate in this study.

Exclusion Criteria:

* Participants were excluded if they have been diagnosed with a lung disease, current smoker, unable to understand and follow the procedures and pregnant or unable to tolerate nebulization.
MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.

Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before colorectal surgery. However, several recent retrospective register studies have suggested that mechanical bowel preparation combined to oral antibiotics before colectomy reduces complications compared to no preparation at all. This trial compares these two strategies to find out whether complications can indeed be reduced by mechanically preparing the bowel with oral antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colon resection

Exclusion Criteria:

* Emergency surgery needed
* Bowel obstruction
* Colonoscopy scheduled to be undertaken peroperatively
* Other reason indicating mechanical preparation or contradicting it
* Allergy to used drugs (PEG, neomycin, metronidazole)
Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial

The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients 18 years to 80 years of age
* no general medical condition which represents a contraindication to implant treatment
* two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
* at least one tooth present adjacent to the edentulous space
* indication for implant treatment is given
* at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
* at least 4 mm of vertical bone height in the maxilla
* signed informed consent after being informed

Exclusion Criteria:

* smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
* poor oral hygiene after hygienic phase (Plaque Index over 30 %)
* active periodontal disease
* pregnancy or breastfeeding at date of inclusion
A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy

To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

Eligibility Criteria:
Inclusion Criteria:

* who undergo transrectal prostate biopsy

Exclusion Criteria:

* patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy

This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.

PRIMARY OBJECTIVES:

I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.

SECONDARY OBJECTIVES:

I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.

TERTIARY:

I. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Must have diagnosis of urothelial cancer
* Scheduled for extirpative surgery or biopsy of suspected metastatic lesion
* Women of reproductive potential must have a urine pregnancy test day of injection
* Men of reproductive potential must use condoms

Exclusion Criteria:

* Pregnancy or lactation
* Known allergic reactions to components of the study product(s)
* Treatment with another investigational drug or other intervention with 24 hours of injection
* Must not have had an injection of a radioisotope 24 hours prior to exam
The Impact of Social Proximity on Conversion to Generic Prescription Medications

The goal of this project is to understand the effects of receiving peer information on individuals' conversion rates from brand name prescription medication to generic prescription medication.

At companies where employees are predominantly union members, we will compare the efficacy of a peer information intervention using a testimonial from a union identified employee to an intervention using a testimonial with no union identification, as well as to a no-testimonial intervention.

The control arm will receive a letter signed by our partner company's Chief Medical Officer, explaining the health and monetary benefits of switching from brand name prescription medication to generic prescription medication. The testimonial treatment arm will receive the exact same letter, but the letter will feature an employee's testimonial along with the first name, last initial, city and state of the employee giving the testimonial. The testimonial and union arm will receive the same letter as the testimonial treatment arm but with the addition of the union affiliation of the employee giving the testimonial.

Eligibility Criteria:
Inclusion Criteria:

* Employee of a company that uses Express Scripts as its pharmacy benefits manager.
* Employee at a company with predominantly union employees.
* Currently taking a brand name medication with an exact generic equivalent.

Exclusion Criteria:

* Employees on any psychological prescription medication.
Four Dimensions in Schizophrenia

Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The primary objective is to asses evolution of subjective well-being and depressive symptoms in schizophrenic patients for six months after an acute episode treated in outpatient psychiatric units. The primary endpoint is: Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline. Secondary objectives include: To evaluate the relationship between subjective well-being and psychopathology, subjective clinical global impression, adverse events and compliance of treatment. Also to compare the clinical global impression of psychiatrist and patient. In addiction to know the clinical, social and demographic factors involve in the subjective well-being and patient clinical global impression.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written inform consent
* Diagnosed of Schizophrenia of Schizoaffective Disorder based on DSM-IV-TR
* With an acute episode or worsening of clinical status. Defined as change in clinical status that need a significant change in therapeutic plan.
* Able to understand and comply with requirements of the study

Exclusion Criteria:

* Mental retardation
* Unstable somatic disease, that is not receiving adequate treatment, based on investigator opinion.
* To have been recruited in a clinical trial in the last 4 weeks
* To have planned the inclusion in a clinical trial during the follow-up of this study
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
* Subjects will be treatment naïve
* Subjects must have documentation of the presence or absence of cirrhosis

Exclusion Criteria:

* History or other clinical evidence of significant or unstable cardiac disease
* Evidence of hepatic decompensation
* Diagnosed or suspected hepatocellular carcinoma
* Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
* History of organ transplant, with the exception of corneal transplants and skin grafts
Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation

Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. It is a complex procedure to perform so only a few hospitals are able to offer this treatment in the UK. A new technology allows the operator to guide their catheters (thin wires) in the patient by using a robotically steered sheath. This allows accurate and precise navigation that may improve the accuracy and integrity of ablation. We aim to prove whether this technology can make AF ablation easier and more effective.

Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.


Eligibility Criteria:
Inclusion Criteria:

* All patients with symptomatic AF planned for catheter ablation.

Exclusion Criteria:

* Age \< 18 years
* Previous ablation procedure
* Expected life expectancy \< 6 months
* Inability or unwillingness to sign consent
* Pregnancy
* Contraindications for the ablation procedure o Thrombus in the left atrium that fails to resolve with optimal oral anticoagulation therapy
Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth

The purpose of this randomized controlled clinical trial is to use Allium sativum oil as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil compared with Formocresol, when used as non-vital Pulpotomy medicaments.

It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Allium sativum oil). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).

Eligibility Criteria:
Inclusion Criteria:

1. Cooperation of patients and consent of parents.
2. Patients with ASA classification I and II (mild to moderate systemic disease).
3. Non-traumatic extensively carious hence restorable primary molars.
4. No history of antibiotic use for 2 weeks.
5. Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/redness/swelling, and/or slight mobility-grade I.

Exclusion Criteria:

1. History of allergy to anesthetics and latex.
2. Radiographic evidence of pulpal floor opening into the furcation area.
3. More than half of the roots resorbed.
Rouxbe Pilot for MS

The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with MS. The investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. This is an outpatient program designed for people with MS that would occur regardless of whether participant data is collected.

This pilot cooking course will run for approximately four weeks. The investigators intend start to the training course in mid-March 2015. Subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MS
* Willingness to comply with the diet and values set forth in the course
Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed.

Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan.

Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine (with or without aura).
* Less than 50 years of age at the time of migraine onset.
* History of 4 to 14 migraine days per month in the 3 months prior to screening.
* 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary.

Exclusion Criteria:

* Difficulty with distinguishing migraine headaches from tension-type or other headaches.
* Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia

On the basis that the clinical consequences of seemingly trivial levels of anemia are surprisingly severe, this study investigates if hemoglobin concentration accurately represents the underlying red cell mass in elderly patients with unresolved anemia.

For the study, the routine clinical measurement of hemoglobin will be compared to true red cell mass and plasma volume in elderly patients with anemia.

Eligibility Criteria:
INCLUSION CRITERIA:

* 65 and older
* Anemia (hemoglobin \< 13 g/dL in men or \< 12 g/dL in women)
* Outpatient at either the Stanford Health Care (SHC) Medical Center or VA Palo Alto Health Care System

EXCLUSION CRITERIA:

* Body mass index (BMI):

  * \< 18.5 kg/m2
  * \> 35 kg/m2
* Palpable splenomegaly
* Contraindication to RBC mass/plasma volume testing
* On any experimental pharmacologic agent in the prior 2 months