cyrilzakka/clinical-trials huggingface dataset:
Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.

Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and microbiological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis.

Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and immunological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis. Patients will be randomized into 3 groups: Group 1 (n=15): periodontal debridement, Group 2 (n=15): periodontal debridement associated with antibiotic (Metronidazole 400 mg + Amoxicillin 500mg) and Group 3 (n=15): periodontal debridement associated with probiotic (Lactobacillus reuteri). Clinical (plaque index, gingival index, probing depth, gingival recession, relative clinical attachment level and periodontal inflamed surface area (PISA) index) and immunological data obtained before and after periodontal therapy (baseline, 30 and 90) will be consolidated and made available on average ± standard deviation and normality tested using the Shapiro-Wilk test. For statistical analysis, the software BioEstat 5.0 (Belém, PA, Brazil) will be used, with p-value \< 0,05.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between 35 and 50 years of age;
* Be diagnosed with generalized chronic periodontitis: present a loss of interproximal clinical insertion\> 3 mm in 2 nonadjacent teeth and loss of interproximal clinical insertion ≥5 mm, in 30% or more of the teeth present;
* Present at least 16 teeth;
* Present good systemic health;
* Agree to participate in the study and sign the informed consent form

Exclusion Criteria:

* Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, among others), which do not indicate the periodontal procedure;
* Have undergone periodontal treatment in the last twelve months;
* Have used antibiotics and/or anti-inflammatories for the past six months;
* Smoking patients;
* Pregnancy or Lactation;
* Chronic use of medications that may alter the response of periodontal tissues.
A Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances (VASCO)

The transient visual disturbances (TVD) are defined by a short abnormality of visual function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.

The difficulty is to recognize an ischemic mechanism which imposes emergency cares.

A clinical score could help the clinician to recognize the etiology of the TVD .


Eligibility Criteria:
Inclusion Criteria:

* Transient visual disturbances (i.e. less than 24 hours) during the last 8 days

Exclusion Criteria:

-
Investigation of Anatomical Correlates of Speech Discrimination

Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.


Eligibility Criteria:
Inclusion Criteria:

* Normal hearing to moderate sensorineural hearing loss
* Sufficient English proficiency to complete speech discrimination testing in English

Exclusion Criteria:

* Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz)
* Conductive hearing loss
* Neurodegenerative disease
Once-daily Fixed Combination of Three Antihypertensive Drugs

Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension

The aim of this randomized study is to compare a once-daily fixed combination pill with a free-drug combination of three antihypertensive agents in arterial hypertension

Eligibility Criteria:
Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

None
A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy

The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable Diabetes Mellitus 1 or 2
* Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks
* No clinically significant motor deficits
* Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea

Exclusion Criteria:

* Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin
* Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety
A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer

The main purpose of this observational study with Oxaliplatin onkovis is to determine the number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.

Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.

Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this end, data regarding co-medication and adverse events are also collected.


Eligibility Criteria:
Inclusion Criteria:

* Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician

Exclusion Criteria:

* According to the Oxaliplatin SmPC
Pre- vs Post-Pandemic Risk-adjusted Survival Rates in the US Hospitals

This study aims to perform a retrospective cohort study of administrative health data to understand how care delivery performance varies across US hospitals post-COVID-19 pandemic compared to the pre-pandemic performance. We also hope to identify which factors contribute to performance changes.


Eligibility Criteria:
The study cohort will include one random encounter per patient for all adult (age ≥18years) encounters. All inpatients with the Premier healthcare database (PINC-AI) and those patients who were admitted under observation status and expired in the hospital or those who presented acutely to the emergency department and died in the emergency department will be considered as inpatients for the purpose of this study as per prior precedence in including such patients.

All pediatric inpatients, skilled nursing facilities inpatients, long term acute care inpatients, rehabilitation facility inpatients, psychiatric inpatients, hospice inpatients, chemical dependency unit inpatients and deceased organ donor inpatients are excluded after applying encounter level exclusion criteria from this inpatient cohort. Application of this encounter level exclusion will also preferentially exclude any children hospitals, skilled nursing facilities, acute long term care facilities, psychiatry hospitals, inpatient hospices and chemical dependency units.
Propofol-butorphanol Anesthesia During Uterine Curettage

Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or para-cervical block,of which generally has significant incidence of respiratory depression which increases the demand on intraoperative monitoring, or has unavoidable insufficient blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with combined effects on mu and kappa opioid receptors leading to a role as analgesia and sedation. The investigators hypothesized that combined propofol with butorphanol during uterine curettage would produce optimal effectiveness of these two drugs by adding sedative and analgesic effects together. In addition, it would decrease the intraoperative consumption of propofol without increase the incidence of side effects. Furthermore, such combination would alleviate postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-II;
* Performing abortion operation (medical- or drug-induced);
* Requiring painless abortion;

Exclusion Criteria:

* \< 19yrs, and \>= 45yrs;
* History of central active drugs administration;
* Drug abuse;
* Hypertension;
* Diabetes;
* Any other chronic diseases;
* Allergy to the study drugs;
* Habit of over-volume alcohol drinking;
* Records of history of centrally active drug use and psychiatry;
* Any organic disorders.
Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial

A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy.

Two groups of each 24 patients. All patients are given general anesthesia. The patients are randomized to have a ultrasound guided bilateral transversus abdominis plane block with either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided with a PCA for self administration of morphine.

Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively as well as the total consumption of morphine after 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Assigned to elective abdominal hysterectomy
* Must be able to understand and speak danish
* Must be able to give verbal and written consent

Exclusion Criteria:

* Abuse of alcohol or medicin
* Daily treatment with opoids or glucocorticoids
* Allergy towards any kind of localanesthetic drug
* Intolerance toward morphine
* Psychiatric desease
* Age below 18
A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

Individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The costs of MRI will be covered by the study.

Eligibility Criteria:
Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)

1. For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
2. For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
3. The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.
4. The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
5. ECOG Performance Status of 0-1.
6. No known contraindications to MRI examination or gadolinium contrast.
7. Willing to undergo MRI and screening for metal implants or metal injury.
8. Estimated GFR \>29 mL/min
9. Ability to provide informed consent.
10. Willing to return to study site for all study assessments.

Registration-Exclusion Criteria:

1. Prior history of pancreatic cancer.
2. Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
3. Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
4. Hereditary pancreatitis.
5. eGFR \< 30 mL/min
6. Contraindication to MRI examination or gadolinium contrast.
7. Pregnant or nursing women.
8. Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.
A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.

RSV causes significant disease. There is a paucity of data from developing countries even though existing data clearly indicate that RSV accounts for a high proportion of acute respiratory illnesses (ARIs) in children.

This is a multi-center study in a cohort of infants at risk for RSV infection in Latin America who have received palivizumab in the usual manner in accordance with the terms of marketing authorization with regard to dose, population and indication. Enrolled participants were followed for one year after their first dose of palivizumab. Epidemiological and clinical data as well as information about compliance, hospitalizations and safety was collected.

Eligibility Criteria:
Inclusion Criteria:

* Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form.
* Parent or legal guardian of child provides written Informed Consent

Exclusion Criteria:

* Children excluded from receiving palivizumab as per local guidelines
Assessment of Circulating Tumor Cells and microRNAs in Patients With Metastatic Non-cutaneous Melanoma

the study aims to implement new approaches for the identification of circulating tumor cells and circulating microRNAs, which aim to silence the expression of genes and thus prevent the production of proteins in patients with advanced melanoma (uval, mucosal, of unknown origin). It also aims to verify whether their expression can be related to the prognosis of the disease and the response to treatments.

Here we propose a study to identify a technique for the isolation of circulating tumor cells (CTCs) from blood samples of patients with diagnosis of metastatic melanoma (uveal, mucosal, from primary unknown) to identify a potential role of CTCs and to study the role for circulating microRNAs (miRNAs) in the management of metastatic UM, MM and MUP.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UM, MM or MUP
* Diagnosis of metastatic disease
* Age ≥ 18 years, at the time of the tissue collection

Exclusion Criteria:

* Personal medical history of concomitant other cancer
Magnesium Sulfate Versus Placebo for Tocolysis in PPROM

Study compares the outcomes of women between 26 and 32 wks gestation with rupture of membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.

The majority of studies of the effectiveness of tocolysis with PPROM were in the 1980s prior to the commmon usage of antenatal steroids and prophylactic maternal antibiotics. In most studies, tocolysis was not attempted prior to the onset of labor in this group of women. The ACOG Practice Bulletin of June 1998 concedes that the recommendation of tocolysis to permit administration of steroids and maternal antibiotics is based primarily upon consensus, not consistent scientific evidence.

The purpose of this study, which will randomize 128 subjects to tocolysis or no tocolysis, is to prospectively assess whether short term (48 hr) tocolysis affords benefit to women and babies between 26 and 32 weeks gestation with PPROM.

Subjects will be enrolled at 1-2 high risk hospitals in Chattanooga and Knoxville. All English and Spanish speaking women 18-45 years with PPROM and cervical dilation \<4 will be eligible. Women with suspected intrauterine infection, positive fetal lung maturity, or \> 6 hours tocolysis at time of admission will be excluded.

Both groups of women will receive continuous fetal monitoring, antibiotics, and antenatal steroids (if not previously administered). Both groups will be evaluated every 2-4 hours for fetal and maternal well being. Both groups will receive IVF at 125cc/hr, and the treatment group will be loaded with 4 grams of magnesium sulfate and receive maintainence dose of 2 grams/hr x 48 hrs.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* preterm premature rupture of membranes
* 26 - 32.6 weeks gestation
* cervical dilation \</= 4 cm

Exclusion Criteria:

* suspected intrauterine or intraamniotic infection
* \> 6 hours of tocolysis prior to admission
* positive fetal lung maturity
Nateglinide: a Double Blind Add-on Study With Pioglitazone for Type 2 Diabetic Patients

The purpose of this study is to investigate the superiority of nateglinide over placebo for inadequately controlled type 2 diabetic patients with pioglitazone treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus under the treatment with pioglitazone

Exclusion Criteria:

* Patients who cannot follow the diet therapy and/or exercise therapy
* Type 1 diabetes mellitus
Early Genomic Testing for Inherited Bleeding Disorders

The investigators aim to test the introduction of genomic testing early in the diagnostic pathway for inherited bleeding disorders in patients who have not received a diagnosis after first-line testing.

The goal of this clinical trial is to test the introduction of genomic testing early in the diagnostic pathway for patients referred to Hematology for a suspected inherited bleeding disorder. The main questions it aims to answer are:

1. Does adding early genomic testing increase the number of patients who are diagnosed?
2. Does adding early genomic testing decrease the overall time to diagnosis?
3. Is it cost-effective to include early genomic testing in the diagnostic pathway?

The investigators will compare with a control group of participants who are receiving standard care (no early genomic testing).

Participants will randomized to a standardized diagnostic testing plus early genomic testing group or to the standardized diagnostic testing group only (with the possibility of being offered genomic testing after 1 year in the study).

With the current standardized diagnostic testing process up to 50% of people referred with significant bleeding symptoms will be classified as bleeding disorder of unknown cause (BDUC), defined as those with a positive bleeding score but in whom all current diagnostic test results are repeatedly normal. Incorporating genomic testing early in the diagnostic pathway could significantly improve diagnostic yield, reduce diagnostic delay, alleviate patient anxiety, and allow for more prompt symptom recognition and targeted treatment.

Eligibility Criteria:
Inclusion Criteria:

* New patient referred for abnormal bleeding.
* Hemostasis expert clinician determined abnormal bleeding history AND family history of bleeding
* OR no family history of bleeding but hemostasis expert clinician determined severe bleeding history.

Exclusion Criteria:

* Prior diagnosis of an inherited bleeding disorder.
* Acquired cause of bleeding (i.e., medication known to cause bleeding, significant renal or hepatic disease)
PEA: the Ability of Nurses to Recognize It (PEA: ANTRI)

The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals should be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowledge of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk university and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized.

The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals should be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowledge of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk university and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized.

Eligibility Criteria:
Inclusion Criteria:

* Nurse or paramedic
* Participant of simulation course organised by Department of Simulation medicine, Faculty of medicine, Masaryk university

Exclusion Criteria:

* No experience wiht monitoring patients by vital signs monitor