cyrilzakka/clinical-trials huggingface dataset:
Do Throat Pack Used in Dental Treatments Under General Anesthesia of Patients Have an Effect on PONV and Sore Throat?

The aim of this study is to investigate the effect of throat packs on PONV in dental treatments under general anesthesia in special health care needs.

Throat packs are widely used to prevent aspiration of blood and other debris, especially in orofacial surgeries and dental treatments performed under general anesthesia. Aspiration of blood and other secretions into the stomach is one of the important causes of PONV. There is not much evidence that throat packs prevent nausea and vomiting after surgery. The most critical side effects of throat pack application are sore throat, difficulty swallowing, and being forgotten before extubation.

The incidence of cavities and other dental problems is higher in special health care needs due to reasons such as inadequate oral hygiene, malocclusion, high-carbohydrate diet, and lack of awareness about dental health. In this group of patients, dental treatments are primarily performed under general anesthesia. Since side effects are more difficult to identify by the patient, the procedures, technical applications and anaesthesia methods should be those with the least potential for side effects. Evidence is needed regarding the effect of throat packing on PONV. In this study, researchers planned to investigate the effects of using throat tampons during dental treatments under general anesthesia on PONV and sore throat in participants requiring special health care.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study with parental consent
* Being between the ages of 5-16
* Being grade 1 or 2 according to the ASA (American Society of Anesthesiologists) classification
* At least one primary or permanent and one restorative. Having undergone treatment (amalgam or composite restoration)

Exclusion Criteria:

* Having a tracheostomy
* Being evaluated as having difficult intubation
* Having an additional disease related to the oesophagus, stomach or intestines, having a percutaneous endoscopic gastrostomy,
* Having a history of PONV,
* Having morbid obesity,
* Having high airway pressure,
* Having a history of allergy to the drugs to be used,
* Needing an anaesthetic agent other than the anaesthesia method to be applied
* Having advanced mental retardation that prevents data collection
A Phase I Study of Fluzoparib in Patient With Advanced Solid Malignancies

Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this study will be to investigate the safety and tolerability of Fluzoparib Capsule when given orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 to 1.
* Life expectancy of more than 12 weeks.
* At least one measurable lesion exists.(RECIST 1.1).
* Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
* Subjects who have overall good overall general condition.
* Signed informed consent.

Exclusion Criteria:

* Subjects who received any previous treatment with a PARP inhibitor.
* Less than 4 weeks from the last clinical trial.
* Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hermone treatment and target therapy.
* Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
* Subjects with symptomatic uncontrolled brain metastases.
* Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
* Subjects with a known hypersensitivity to Fluzoparib or any of the excipients of the product.
* Ongoing infection (determined by investigator).
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
* Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
* Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS

The study's objective is to investigate the role of folic acid administration in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.

Folic acid is one of the B vitamins that when absorbed into its active form is converted to tetrahydrofolate. Folate is an essential cofactor for the biosynthesis of norepinephrine and serotonin. Studies have also noted that folate, with a mechanism like hormone replacement therapy (HRT), can improve hot flashes by interfering with monoamine neurotransmitters called norepinephrine and serotonin .The purpose of the current study is to investigate the role of folic acid administration in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Females older than 18 years
* Diagnosed with confirmed breast cancer and currently treated with an adjuvant endocrine
* Experiencing bothersome hot flashes at least 14 times/week
* Taking the treatment within 6 months to two years.

Exclusion Criteria:

* Known hypersensitivity to folic acid
* Patients who have been treated with selective serotonin reuptake inhibitors (SSRIs) within the past 30 days.
* Renal impairment is defined as a serum creatinine level greater than 2 mg/ld..
* Significant liver disease: Indicated by liver enzyme levels exceeding two times the upper limit of normal.
* Metastatic breast cancer
* Taking other medication for hot flashes
* Medications inducing hot flashes such as (Clomiphene, Opioids, Nifedipine, Prednisone)
Determinants and Outcomes of High Vs. Low Ultra-processed Feeding

The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are:

• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.

If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health.


Eligibility Criteria:
Inclusion Criteria:

* rural county resident
* not meeting physical activity guidelines for adults
* consuming a typical Western diet (rich in UPF)

Exclusion Criteria:

* chronic diseases
* tobacco, vape, or illicit drug use
* overly active
* already on a restrictive diet (e.g., keto, intermittent fasting)
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.

If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 20 days of the first eye surgery. Four postoperative follow-up visits are planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. Subject participation in this study is expected to last up to 7 months, including a total of 6 study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the study.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative cataract in the study eye(s)
* Planned implantation in at least one eye with:

  * Cohort 1: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling from November 2018 to July 2020
  * Cohort 2: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 2020.
* Able to comprehend and sign a statement of informed consent
* Willing and able to complete all required postoperative visits
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Eyes with clinically significant ocular, including adnexa, or intraocular infection or inflammation (at the screening visit prior to surgery or on the day of surgery)
* History of any intraocular inflammation within the past 12 months (ex: uveitis, choroiditis)
* Combined procedures introducing an additional medical device during cataract surgery (ex: cataract surgery with implant of glaucoma stent)
* Other protocol-specified exclusion criteria may apply.
Combining tDCS With VR-based Motor Training in Stroke

Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, our healthcare systems do not have enough resources to cover the current demand let alone its future increase. There is a need to deploy new approaches that advance the current rehabilitation methods and enhance their efficiency.

One of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (VR) applications, which combine training scenarios with dedicated interface devices. On the other hand, recent studies have shown the potential of transcranial direct current stimulation (tDCS) to restore motor function in hemiparetic stroke patients. It must be emphasized, however, that so far little work exists on the quantitative assessment of the clinical impact of VR based approaches in combination with tDCS protocols. We hypothesize that the combination of VR-based motor rehabilitation protocols with concurrent anodal tDCS can boost functional recovery, and may achieve superior effects when compared to 3 alternative treatments: 1) VR without tDCS, 2) occupational therapy with tDCS, and 3) occupational therapy without tDCS.

The findings derived from this study will contribute to establish a novel and superior neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hemiparesis secondary to first ever ischemic or hemorrhagic stroke (Medical Research Council score \> 2).
* Older than 18 years old.
* Sufficient cognitive capacity to understand and follow the experimental instructions (Mini-Mental State Evaluation \> 20).

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Epilepsia and metal implants. A diagnostic EEG will be performed by the Department of Clinical Neurophysiology of the hospital to detect epileptic paroxysmal in order to include or exclude patients in the study.
* Low Cognitive capabilities that prohibits the execution of the experiment Arteriovenous malformation
* Severe associated impairment such as spasticity, communication disabilities (sensorial, mixed or global aphasia or apraxia), major pain or other neuromuscular impairments or orthopaedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale \> 3)
* History of serious mental-health problems in acute or sub acute phase
* Refusal to sign the consent form
* Previous surgeries opening the skull.
* Active or recent substance abuse or dependence within the past year.
* Pregnancy, breastfeeding, unwillingness to practice birth control during participation in the study.
Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment

A Phase I/II Pilot Clinical Trial to Evaluate the Efficacy and Safety of Ebola Virus Disease (EVD) Convalescent Plasma (ECP) for treatment of EVD.

This pilot trial will treat subjects in the ECP Group with ECP derived from two donors. ECP will be provided as ECPSDU each comprising 90 - 110mL of plasma from two individual ABO-compatible donors. Two ECPSDU will be administered as immediately sequential infusions. Subjects may receive up to three doses of ECP not less than 48 hours apart. ECP will be provided as Plasma Frozen Within 24 Hours After Phlebotomy (PF24) as described in Section 6.1. Pre-treatment and frequent post-treatment blood specimens for assay of anti-EBOV antibody and EBOV viral load by RT-PCR will be obtained from subjects. The pharmacodynamic effect of ECP anti-EBOV, including neutralization titers, on viral load will be examined in the ECP Group. Changes of individual and treatment group clinical and laboratory parameters with time will be described. Between-group and within-group will examine interactions of clinical parameters, outcome, ECP total dose, EBOV viral load, and anti-EBOV (IgG ELISAs for Zaire GP residues 1-649 and irradiated Zaire virus, and anti-EBOV PRNT). The MEWS will be assessed as a prognostic tool in the Screened Control Group. Efficacy of ECP will be assessed primarily by comparison of survival to hospital discharge between the ECP Group and the Screened Control Group.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female 18 years of age or older
* Confirmed case of EVD (CDC case definitions 14 SEP 2014)
* Admission to the hospital no more than 48 hours prior to availability of investigational product
* Able and willing to provide informed consent or family member who is willing and able to provide informed consent if potential subject is unable to consent
* Venous access adequate for administration of plasma
* Females only: negative qualitative urine Beta-HCG test

Exclusion Criteria:

* Prior history of severe transfusion reaction
* Fluid overload or other condition that would contraindicate administration of plasma at the protocol- specified doses
* History of blood product transfusion within 30 days prior to enrollment
* Prior treatment with any other specific experimental anti-EVD product or expectation to receive another experimental anti-EVD product during the course of the study (does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with EVD)
* Unresponsive on AVPU (Alert, Voice Responsive, Pain Responsive, Unresponsive) testing
A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants

The purpose of this study is assess the: (a) incidence of severe uterine bleeding (SUB) following exposure to individual direct oral anticoagulant (DOACs) (rivaroxaban, apixaban, dabigatran) and warfarin, (b) individual DOACs (rivaroxaban, apixaban, dabigatran) association with risk of SUB compared with warfarin, and (c) individual DOACs (rivaroxaban, apixaban, dabigatran) associated with risk of SUB compared with other individual DOACs - among women with prior diagnoses for DOAC and warfarin indications (non-valvular atrial fibrillation \[NVAF\], venous thromboembolism \[VTE\], total hip replacement \[THR\] or total knee replacement \[TKR\]).


Eligibility Criteria:
Inclusion Criteria:

* Non-valvular atrial fibrillation (NVAF) diagnosis any time prior and no Venous thromboembolism (VTE) (Deep vein thrombosis \[DVT\] or Pulmonary embolism \[PE\]) in the past 183 days and no knee or hip replacement surgery in the past 35 days
* VTE (DVT or PE) in the past 183 days and no NVAF diagnosis any time prior and no knee or hip replacement surgery in the past 35 days
* Total hip replacement (THR) or Total knee replacement (TKR) in the past 35 days and no non-valvular atrial fibrillation any time prior and no venous thromboembolism (deep vein thrombosis of pulmonary embolism) in the past 183 days

Exclusion Criteria:

* Participants were excluded for edoxaban exposure, exposure to other exposures of interest (example: Direct oral anticoagulant \[DOACs\] for warfarin exposure cohort), hysterectomy, vaginal bleed, and medical, surgical, or transfusion management for vaginal bleeding any time prior to the index exposure
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP

The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.


Eligibility Criteria:
Inclusion Criteria:

1. Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age
2. Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded
3. Willing and able to sign informed consent prior to study initiation

Exclusion Criteria:

1. Subject has a baseline heart rate of \< 60 or \>100 beats/min
2. Subject has moderate to severe valvular disease
3. Subject suffers from atrial fibrillation or other tachyarrhythmias
4. Subject suffers from hemodynamic instability
5. Subject is candidate for primary PCI
Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol

Coronavirus Disease (COVID-19) recommendations are usually developed for healthcare professionals (for example Doctors, health organizations, etc.). It is important to make sure that these recommendations can be used and understood by everyone. This study aims to make COVID-19 recommendations more accessible and understandable for parents and caregivers, adults, and youth.

This is a two-arm superiority randomized controlled trial. The primary objective is to compare the understanding of key guideline information between the Plain Language Recommendation (PLR) (intervention) and the Standard Language Version (SLV- original recommendation as available in the published guideline) (comparison). Secondary outcomes include accessibility and usability of the information, satisfaction with the presentation, intended behavior to follow the information in the recommendation, and preference toward one of the two presentations. Recruitment will be global for the three populations (youth, parents, and adults), using three different online links. Data will be collected using a survey with 1:1 randomization to the intervention and subsequent demographic questions. Superiority will be declared if a minimal difference of 10% in understanding is achieved between the two groups (an average difference of 1 correct answer).

Eligibility Criteria:
Inclusion Criteria:

* For youth population: be between the ages of 15 to 24 years
* For parents population: be 18 years and above and making decisions with or for their children (parent, caregiver, the legal guardian of a child \< 18 years)
* For adults: be 21 years of age or older
* Need to be able to complete the survey in English

Exclusion Criteria:

* Individuals not fitting any of the above age categories or language requirement
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated

This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows:

Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)

The allocation will take place in two phases:

Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan

If losartan arm shows benefits we will proceed to the second phase:

Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.

Patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years.
2. Patients with HIV infection in antiretroviral treatment with EFV / FTC / TDF with undetectable viral load (VL \<37 copies) for at least 48 weeks.
3. Nadir CD4 +\> 250 cells/mm3.
4. Patients, properly informed, give their written consent to participate in the study.

Exclusion Criteria:

1. Criteria for patients with AIDS.
2. Patients with active opportunistic diseases.
3. Patients coinfected with HCV.
4. Patients without tonsillar tissue.
5. Treatment with other drugs receptor antagonists or angiotensin II converting enzyme inhibitors, angiotensin II.
6. Kidney failure.(Glomerular Filtration Rate (GFR \< 60 mL/mn)
7. Severe liver failure (PT\> 60% ).
8. Pregnant women
9. Known hypersensitivity or contraindication to any study drug.
10. determination of blood pressure (BP) \<100/60 mmHg
11. Hyponatremia with serum Na numbers \<132 Meq / l
12. History of chronic vomiting the last 6 months
13. History of chronic diarrhea the last 6 months
Using Of Chitosan in Alveolar Ridge Preservation

The goal of this clinical trial is to assess the efficacy of chitosan as a socket preservation material after tooth extraction in compare to the standard treatment. The study will include patients who exhibit hopeless tooth without any periodontal infection. Smokers, history of allergy, patients with major medical issue and pregnant women will be excluded from the study. The main question\[s\] to answer is : is there a significant difference in bone density and dimension between the test and control groups after tooth extraction or not.

Participants will be asked to do CBCT scan and take upper and lower impressions before extraction and after three month from extraction. Then, the patients will randomly assigned to one from these groups: There will be a total of three groups (10 patients for each), first group will be treated using mixed of chitosan and allograft, second group will be treated using allograft alone and the last group will be used as control. All patients will be treated in accordance with the 2013 Declaration of Helsinki.

To evaluate the tissue response, intraoral impressions and X-ray will be taking from each patient before extraction and three months after. Also, Cone-beam computed tomography (CBCT) will be taking to measure the bone growth at base line and three months after surgery is done. For measurement, each socket will be vertically divided into 3 equal areas: coronal, middle, and apical. Regenerated bone density will be assessed in each area, in both control and intervention groups.

Data then can be analyzed using SPSS ver. 11 (SPSS Inc., Chicago,USA). P-values less than 0.05 were considered as significant.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hopeless tooth.
* Healthy patient.
* Healthy gingiva without any periodontal disease.
* Patient is welling to come after three months.

Exclusion Criteria:

* Smokers.
* History of allergy.
* pregnant women.
* patient with systemic disease.