cyrilzakka/clinical-trials huggingface dataset:
Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%

Clinical triple-blind randomized controlled trial to assess the use of two different mouthwashes to reduce the oral colonization by gramnegative bacteria in patients with chemotherapy

Clinical triple-blind randomized controlled trial.

With two arms to the study:

1. Mouth rinses with chlorhexidine-based solution at a concentration of 0.12%, using as a vehicle to 7% ethyl alcohol.
2. Mouthwashes with solution based only 7% ethyl alcohol.

GOAL. Assess whether there decrease in the rate of oral colonization by gram-negative bacteria in patients with chemotherapy by using chlorhexidine mouthwash.

SPECIFIC OBJECTIVES:

1. The rate of the oral colonization by gram-negative bacteria initiation of chemotherapy.
2. The rate of oral colonization by gram-negative bacteria after 10 days of initiation of chemotherapy.
3. Identify microbiologically gram-negative bacteria colonizing the oral cavity.

SECONDARY OBJECTIVES

1. The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18years, no upper age limit.
2. Acceptance of participation in the study.
3. Signature of informed consent.
4. Inpatient and remain hospitalized for at least 10 days.
5. The following haematological diagnosis:

   1. acute lymphoblastic leukemia.
   2. acute myelogenous leukemia.
   3. relapsed non-Hodgkin lymphoma.
6. Receiving Chemotherapy scheme as a treatment for the underlying disease

Exclusion Criteria:

1. Patients who choose not to participate in the study.
2. Patients in whom no possible mouthwashes.
3. Patients who willingly choose to withdraw from the study.
4. Patients who develop conditions in which the administration is not possible rinses.
5. Duration of hospital stay less than 10 days, regardless of cause.
Effectiveness of Rotavirus Immunization in Nicaragua

The purpose of the investigators study is to compare the rates of childhood diarrhea at the community level before and after the rotavirus vaccination program in León, Nicaragua. From preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following the vaccination program among children who received the vaccine, and a smaller reduction in diarrhea among children who did not receive the vaccine, due to the effects of "herd immunity". In addition, the investigators will collect stool samples from children who develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus immunization era.


Eligibility Criteria:
Inclusion Criteria:

* Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua

Exclusion Criteria:

* Parents do not consent to child's participation
Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants

This is a prospective, multicentric, randomized, open labeled superiority trial

This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment.

The primary outcome is the anticoagulant's half life. Plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).

A total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.


Eligibility Criteria:
Inclusion Criteria:

* Patients under direct oral anticoagulant treatment (Apixaban, Rivaroxaban or Dabigatran)
* Age ≥18 years;
* Clinical condition needing a surgery or invasive procedure ( lumbar puncture, biopsy...), needing anticoagulant treatment interruption and intervention to be postponed
* Signed informed consent

Exclusion Criteria:

* Urgent immediate surgery without any possibility to wait for 24 hours
* contraindication for receiving oral treatment
* Active uncontrolled bleeding or bleeding in critical organ
* Hemodynamic instability, shock
* Known anticoagulant concentration \< 50ng/mL
* drug intoxication
* Fructose intolerance, glucose and galactose malabsorption syndrome, sucrase-isomaltase deficit
* Treated epileptic disease
* Pregnant or breast feeding
* Patient under guardianship
* No insurance cover
* Patient unable to give his consent
* Participation to another therapeutic trial
Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis

Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC chloride.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects:

* no cardiovascular abnormalities
* not overweight BMI\>25
* 18-55 years of age

CF subjects:

* mild to moderate CF (FEV1\>40% predicted)
* clinically diagnosed with positive sweat test (sweat Cl-\>60mmol/L)
* 10-55 years of age
* clinically stable

Exclusion Criteria:

Healthy subjects will be excluded if:

* If unable to consent for him/herself (cognitive impairment)
* Have a history or evidence of cardiovascular and/or pulmonary abnormalities.
* Have an abnormal 12-lead EKG
* Have an abnormal pulmonary function test
* Have a history of asthma
* Have a history of renal disease or estimated creatinine clearance \< 55ml/min
* Women who are pregnant or planning to become pregnant during the study

CF subjects:

* If unable to consent for him/herself (cognitive impairment)
* Physically unable to perform exercise or breathing tests
* Have a history of renal disease or estimated creatinine clearance \< 55ml/min
* Women who are pregnant or planning to become pregnant during the study.
* Have an abnormal 12-lead EKG
* Cystic Fibrosis related diabetes is uncontrolled
* Forced Expiratory Volume after 1 second (FEV1) is less than 40% predicted
* Have a history of joint disease
* Have history of pulmonary exacerbation within the last two weeks
* Experienced pulmonary hemorrhage within 6 months resulting in greater than 50cc of blood in the sputum
* not currently enrolled in any other research study
Pathophysiology of Orthostatic Intolerance

The purpose of this study is to describe the mechanism of orthostatic intolerance, relying on cardiovascular physiological studies. The syndrome is of undetermined etiology, but the syndrome causes impairment of a number of young adults, females more than males, with symptoms of tachycardia, fatigue, lightheadedness, palpitations, blurred vision, chest discomfort, difficulty concentrating, and dizziness with the upright posture. It is believed that many different pathophysiological processes can give rise to this disorder.


Eligibility Criteria:
Inclusion Criteria:

* Orthostatic intolerance

Exclusion Criteria:

* Inability or unwillingness to give informed consent
Pilot Study of Familial Nonsyndromal Mondini Dysplasia

OBJECTIVES:

I. Determine the mode of inheritance of nonsyndromal Mondini inner ear dysplasia, an inner ear malformation causing deafness, vestibular dysfunction, and recurrent meningitis.

PROTOCOL OUTLINE:

The parents of 1 family with known Mondini dysplasia are screened for the disorder using temporal bone computerized tomography without contrast. This information is used to determine the mode of inheritance.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Parents of a study family with nonsyndromal Mondini dysplasia
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-75 years of age;
* histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.

Exclusion Criteria:

* previous chemotherapy
Impact of the Navilas ® Micropulse Laser Treatment for Macular Edema Within the CHU Brugmann Hospital Macular Edema

The Navilas® micropulse laser can be used to treat patients with macular edema and good visual acuity, which therefore do not fall within the indications for conventional treatments by intravitreal injections.

The CHU Brugmann Hospital is the only center to own this laser in Belgium.This study aims to evaluate the efficacy of this laser.


Eligibility Criteria:
Inclusion Criteria:

* Diffuse macular edema without focal edema source accessible by focal laser (e.g. capillary telangiectasia)
* Central retinal thickness ≤ 400microns.
* Patient does not meet the reimbursement criteria for intra-vitreous injections(IVI) of anti-VEGF (eg AV\> 5/10).
* IVI are contraindicated.
* Physician considers that it is preferable to space out the injections because of the side effects (eg. ocular disturbance during IVI, eye pain, sensation of a foreign body, spots in the visual field generating a visual gene etc.)
* Patient wishing to space the anti-VEGF IVI.

Exclusion Criteria:

* Macular edema of a different etiology than diabetic macular edema or venous thrombosis (e.g. cataract extraction, vitreomacular traction, epiretinal membrane etc.)
* Central retinal thickness \> 400 microns.
* The eye presents a focal edematous maculopathy accessible to conventional laser.
Comorbid Chronic Lung Disease on Heart Failure

Comorbid chronic lung disease (CLD) increases mortality in heart failure (HF) patients. Understanding the predictors and pathophysiology of HF can improve the efficacy of HF treatment. This study evaluated the cardiopulmonary exercise test (CPET) results to identify significant predictors on long-term outcomes in HF patients with CLD.

The CPET was administered in a cohort of 169 HF outpatients with exercise intolerance at a tertiary referral center between May 2007 and July 2010. A CLD was defined as abnormal spirometry accompanied by clinical symptoms and signs included in the Global Initiative for Chronic Obstructive Lung Disease criteria. The primary endpoint was defined as CV mortality or the first HF hospitalization. Totally 49 events occurred before the end of follow up in January 2018.

Eligibility Criteria:
Inclusion Criteria:

* outpatients ≥ 18 years of age, male or female.
* Patients with a diagnosis of heart failure with clinical symptoms and echocardiography evidence
* Patients received cardiopulmonary exercise test exams

Exclusion Criteria:

* Cannot tolerance exercise test due to muscular-skeletal disorder
* Cannot co-operate all functional studies
* Family reject to participate in this project
Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction

Purpose of the study is to compare clinically, radiographically and biochemically the effect of intra- articular injection of hypertonic dextrose with a stabilization appliance and the intra- articular injection of 2 ml of liquid phase concentrated growth factor with a stabilization appliance as a prolotherapy for temporomandibular joint anterior disc displacement without reduction.

Twenty four patients with anterior disc displacement without reduction will be selected from those attending the Prosthodontic Department, Faculty of Dentistry, Alexandria University and diagnosed clinically and by magnetic resonance imaging. Patients will be randomly assigned into 2 study groups each comprising 12 patients. Group I will receive an intra-articular injection of hypertonic dextrose in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance while group II will receive an intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with painful TMJ.
* Patients with limited mouth opening (MMO \<40mm).
* Patients with anterior disc displacement without reduction confirmed by MRI.
* Presence of full or nearly full complement of natural teeth.
* Patients with angle class I occlusion.
* Patients with RCP not greater than 2mm and with no open bite.

Exclusion Criteria:

* Patients who have anterior disc dislocation with reduction detected by MRI.
* Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
* Patients having uncontrolled systemic disease, hematologic or neurologic disorders or inflammatory diseases.
* Patients under anticoagulant drug therapy.
Paper vs. Internet

Research has shown that questionnaires completed on the internet have the potential to provide more complete and honest data with fewer errors in a more efficient manner than questionnaires completed using the paper and pencil format. Despite the numerous advantages of internet-administered questionnaires, it is important to make sure that the internet questionnaires will yield comparable results to the well-established paper and pencil versions. No one has studied internet administration of scoliosis specific questionnaires in adolescents with scoliosis. The investigators will test whether the internet administration of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The investigators predict that the internet-administered questionnaire will provide the same reliability as the paper-administered questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Aged 10-18
* Male or female
* Diagnosis of Adolescent or Juvenile Idiopathic Scoliosis
* Home access to computer and internet
* Capable or oral and written communication in English

Exclusion Criteria:

* Unable to communicate in English
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.

This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed MTAP loss in their tumor. The Phase 1 portion is a dose escalation study of oral TNG456 administered as a single agent and in combination with oral abemaciclib in solid tumor patients with confirmed MTAP loss. In the Phase 2 expansion part of the study, 6 arms defined by confirmed tumor types will enroll in parallel at the RP2D(s) of TNG456 and in combination. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Has a tumor with a confirmed MTAP loss
* Is ≥18 years of age at the time of signature of the main study ICF
* Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care therapy is not appropriate.
* Is able to swallow tablets
* Adequate Organ function/reserve per local labs
* Negative serum pregnancy test result at screening
* Has an ECOG performance status score of 0 to 1
* Has measurable disease based on RECIST v1.1 or a confirmed glioblastoma (IDH-wildtype) with radiographic evidence of disease progression or recurrence defined by RANO 2.0.
* Has an ECOG performance score of 0 to 1 or for GBM has a Karnofsky performance status score ≥70.

Exclusion Criteria:

* A female patient is who is pregnant or breastfeeding
* Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s)
* Has an active infection requiring systemic therapy
* Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor
* Patients in the expansion receiving the combination therapy that have received prior treatment with a CDK4/6 inhibitor
* Clinically relevant cardiovascular disease
* Has a prior or ongoing clinically significant illness may affect the safety of the patient, impair the assessment of study results or compliance with the protocol
Piloting GETCare: A Remote Goal-based Education and Skills Training Program for Caregivers Poststroke

The purpose of this study was to evaluate the GETCare program, a Goal-based Education and skills Training program for Caregivers poststroke.

The purpose of this study was to utilize a single-arm mixed method pilot trial to evaluate the5-week GETCare program with the following study aims: (1) explore feasibility and acceptability, (2) assess knowledge acquisition and goal attainment, and (3) test preliminary effects on key caregiver outcomes. This remote program included guided goal setting, individualized resource recommendations, and education modules.

Eligibility Criteria:
Inclusion Criteria:

* self-identification as a primary caregiver (direct care involvement) of someone who had a stroke (no restriction on stroke duration)
* ≥ 18 years old
* access to internet/telephone throughout the study
* able to speak, read, and understand English
* person with stroke expected to discharge within 1 month if still in the hospital

Exclusion Criteria:

* unable to read and follow basic instructions
* indicated the individual with stroke had no deficits poststroke
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis

To compared the efficacy and safety of rifampicin and rifabutin which included in the standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and drug drug interaction will be investigated in order to provide optimized treatment for HIV/AIDs with tuberculosis.

Two hundreds and thirty participants will be randomly assigned to receive an anti--tuberculosis treatment include rifampicin or rifabutin for two months of intensive therapy. Isoniazid and rifampicin (or rifabutin) will be continued to use for four months of consolidation therapy. A total of followed up period will be 12 months.

The antiretroviral therapy（ART） include:

Tenofovir disoproxil fumarate 300mg/d +Lamivudine 300mg/d+ Efavirenz 600mg/d; or Zidovudine 300mg bid +Lamivudine 300mg/d +Efavirenz 600mg/d.

ART will be started after 2 weeks of anti-tuberculosis.

The follow-up visits include 2th, 4th, 6th, 8th, 12th,16th, 20th, 24th, 32th, 36th, 40th, 44th and 48th week. sputum smear, sputum culture, chest X-ray, CD4 Lymphocyte counts,HIV viral load and adverse event will be tested and recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years old;
2. No limited to gender;
3. If anti-HIV-1 positive samples are detected by an initial test based on the ELISA method, they should be confirmed by western blot;
4. The patients who are diagnosed with pulmonary TB (mycobacterium tuberculosis of sputum smear or culture was positive) but had never be treated;
5. Sign informed consent form voluntarily, and guarantee to attend follow-up visits;
6. Do not have plan to remove from the current experimental site during the trial process;
7. The patients do not receive any antiretroviral treatment before;
8. The overall situation of the patient should not affect the assessment and completion of the trial.

Exclusion Criteria:

1. Patients with acute infection;
2. During the screening period，patients with combined opportunistic infections and instability (National HIV/AIDS treatment guidelines) except for tuberculosis, or combined malignancy;
3. During the screening period，hemachrome \< 6 g/dl, leukocyte \< 2000 /µl, neutrophils \< 1000 /µl, platelet count \< 75000 /µl, blood amylase is greater than two times the upper limit of normal, Scr is greater than1.5 times the upper limit of normal, AST/ALT/AKP is greater than two times the upper limit of normal, TBIL is greater than two times the upper limit of normal, serum CK is greater than two times the upper limit of normal;
4. Now suffering from acute or chronic pancreatitis;
5. Now suffering from peripheral neuritis;
6. Pregnant and lactating women;
7. Patients with severe mental and neurological diseases;
8. Drug users；
9. Patients with history of heavy drinking and cannot be terminated;
10. Serious gastrointestinal ulcers；
11. Atherosclerosis affects the arteries in the heart, brain or kidneys；
12. Non-Chinese nationality；
13. Now suffering from myopathy；
14. Patients with previously treated tuberculosis.
Biomarker Database Registry for Photodynamic Therapy

The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.

Patients who have been scheduled to receive PDT in our noninvasive cutaneous oncology clinics will be given written information prior to their visit, including a copy of the Informed Consent (IC) that describes the purpose of the study. If the patient indicates that he/she is interested, the physician or study nurse will review the IC with the patient on the day of PDT and answer all questions. After the patient signs the IC, the patient will have their blood drawn by a caregiver who has completed PTS Phlebotomy Training.

DNA samples will be stored in a locked minus 80 degree ultrafreezer, in Dr. Maytin's laboratory (room ND4-25A in the Lerner Research Institute). The samples will be maintained for up to 10 years.

Blood sample tubes and data sheets in the laboratory will be labeled with a code consisting of the first 5 digits of the patient's 8-digit MRN along with the date that the phlebotomy was performed (i.e. the date of the blood draw). This should ensure anonymity of the data while preventing mistakes when linking the laboratory results to the correct patient. Study personnel with password-protected access to the database registry will use the code to unequivocally identify the subject's file within the Oracle database and thereby enter the subject's laboratory results into the proper data field.

The Informed Consent document informs the subject that he/she can withdraw permission for use of their samples at any time, and explains how to do this by contacting the Principal Investigator (PI) in writing.

Information will not be disclosed to third party outside of Cleveland Clinic for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, at least 18 years of age
* Patient has nonhypertrophic actinic keratosis, at least 10 AK lesions present on the face, scalp, forearms, chest, or legs at the time of PDT treatment

Exclusion Criteria:

* taking doxycline, a photosensitizer
* using topical retinoids, since these can exacerbate the post-PDT erythema reaction
* pregnant