cyrilzakka/clinical-trials huggingface dataset:
Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery

Subjects who underwent a dental implant surgery were studied.Subjects randomly were aligned into three groups:In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days). The sign and symptom of infection were studied and the incidence of infection in each group was determined.

Subjects eligible for study inclusion had an edentulous area in the mandible or maxilla and underwent a dental implant surgery. Subjects were excluded from study enrollment if they had systemic diseases which affect bone metabolism, history of allergy to amoxicillin, refused study enrollment or failed to return for follow-up.

Subjects were randomly divided into three groups : In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) . An independent researcher made random allocation cards using computer-generated random. Then, allocated cases were placed in a sealed envelope. All subjects used 0.2% chlorhexidine mouthwash in the treatment period. All implants were placed with a two-stage protocol.

All subjects were followed up for 3 months to assess any infection signs and symptoms. Infection was diagnosed based on clinical findings such as pain, redness of the area, and discharge around the fixture.An independent dentist who was blind the study groups, evaluated all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Have an edentulous area in the mandible or maxilla
* underwent a dental implant surgery

Exclusion Criteria:

* systemic diseases which affect bone metabolism
* history of allergy to amoxicillin
* refused study enrollment
* failed to return for follow-up.
Sorafenib in Elderly mRCC

This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
* \>=65 years of age
* Patients who have signed the informed consent
* Patients with a life expectancy of ≥12 weeks
* No prior systemic treatment

Exclusion Criteria:

* The approved local product label must be followed for the exclusion criteria
Betaferon® Regulatory Post-Marketing Surveillance

To identify problems/questions about following items in the clinical practice using Betaferon

1. Unknown adverse event (especially serious adverse event)
2. Identification of adverse event occurred in the real practice
3. Factors that may affect the safety of drug
4. Factors that may affect the effectiveness of the drug


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon
* Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with local product information
Sleep Intervention for Kids and Parents: A Self-Management Pilot Study

Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance and a parent with sleep disturbance.


Eligibility Criteria:
Inclusion Criteria (child):

* Children 6-11 years
* Child diagnosis of asthma with prescription for daily medication
* Able to understand English (child)
* Sleep disturbance per CSHQ (child \>= 41) and/or \< 9 hours of sleep per night

Exclusion Criteria (child)

* Parent reported diagnosis of traumatic brain injury, developmental delay, autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), obstructive sleep apnea, cancer
* Positive sleep related breathing disorder screening (obstructive sleep apnea screening)

Inclusion Criteria (parent)

* 18 years or older
* Able to understand and read English
* Lives with child 50% of time or more
* Is child's legal guardian
* Has reliable access to internet
* \>/= 5 on Pittsburgh Sleep Quality Index or \<7 hours overnight reported sleep

Exclusion Criteria (parent)

* Diagnosed obstructive sleep apnea or sleep disordered breathing
* Is a nightshift worker
* Uses sleep medication
Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs

The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.

This study is a rollover study for patients who participated in A5058s: Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies. In A5058s, patients received a series of therapeutic vaccinations to elicit HIV-specific immune responses. This study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy (ART).

Upon study entry, patients will discontinue ART. During the first 6 weeks of the study, viral load will be monitored weekly and CD4+ T-cell counts will be monitored every other week. Viral load and CD4+ T-cell counts will be measured every other week from Week 6 through Week 24, then monthly until patients restart ART or until Week 48. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participation in A5058s and receipt of a minimum of 7 sets of injections on that study
* Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure
* No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry
* CD4+ T-cell count \> 300 cells/mm3 obtained within 30 days prior to study entry
* HIV-1 RNA \< 500 copies/ml obtained within 30 days prior to study entry
* Agreement to use approved methods of contraception

Exclusion Criteria:

* Pregnancy or breast-feeding
* Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery
* Symptomatic chronic infections other than HIV
* Malignancy that may require systemic therapy
* History of lymph node irradiation
* Use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed
* Hydroxyurea within 30 days prior to study entry
* Use of GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines within 30 days prior to study entry
* Active drug or alcohol use or dependence that would interfere with adherence to study requirements
* Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 13-55 years
* Concussion sustained within the last 12 days

Exclusion Criteria:

* Contraindications to OMT, such as skull fracture, cervical fracture, signs of intracranial bleeding, or stroke
* Neck surgery within the last 6 months
* Any conditions recognized by a physician as contraindicating or impeding protocol implementation
* Will not be under the care of a healthcare professional
* Any active (or pending) worker's compensation, disability, or personal injury claims related to their concussion injury
Lumbar Manipulation for Hip and Muscle Strength

The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free deep squat range of motion in order to answer several conceptual and practical research questions

This prospective, double-blind, randomized control trial clinical will use a multigroup pretest-posttest control design with 1 treatment arm and 1 control arm. Interpreted within the biopsychosocial model and the International Classification of Functioning, Disability and Health (ICF) framework, this research will measure the outcomes between patellofemoral pain syndrome (PFPS), the health condition, and contextual factors, particularly personal factors. It will address personal factors such as gender and age but will not address environmental factors. This research includes tests and measures of two of the three levels of human functioning, or domains, impairments to body functions and structures and activity limitations. Muscle strength testing is an impairment-level measure and pain-free deep squat range of morion (ROM) is an activity limitation-level measure.

Eligibility Criteria:
Inclusion Criteria:

* Referred to out-patient physical therapy for a knee condition and a chief complaint of anterior knee pain
* Anterior knee pain with squatting
* Agreed to be in the study and signed the informed consent document

Exclusion Criteria:

* Presence of any medical 'red flags' suggestive of pain that is not of musculoskeletal origin
* Osteoporosis or recent fracture of the hip or spinal joints
* Spinal or hip joint surgery or prosthesis
* Knee surgery on the affected knee within the last 6 months
* Spinal instability (Grade II spondylolithesis or greater), spondyloarthritides, or severe spinal misalignment
* Nervous system disease or disorder
* Pregnant
* Lumbar nerve root compression (any of the following signs present)
* Positive straight leg raise (SLR) test less than 45°
* Marked paresis involving a major muscle group of the lower extremity
* Diminished, and asymmetric (lower than uninvolved side), lower extremity
* muscle stretch reflex
* Diminished or absent sensation to pinprick in any lower extremity dermatome
Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients

The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.

SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.

Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye twice daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
2. Diagnosis with Sjogren's syndrome and have corneal erosion
3. Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test

Exclusion Criteria:

1. Ocular surface corneal disease, other than corneal erosion and dry eye disease (DED).
2. Lid margin disorder other than meibomian gland dysfunction (MGD)
3. Presence of any ocular condition
4. Any history of eyelid surgery or intraocular/ocular surgery
5. Cauterization of the punctum or punctal plug
6. Use of lid scrubs containing chemicals or baby shampoo, or eyelid makeup
7. Use of any of the contraindicated drugs medications
8. Any changes in the dosing of any chronically used systemic drug
9. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
10. Known history of alcohol and/or drug abuse within 12 months
11. Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
12. Participation in any drug or device clinical investigation within 30 days
Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids - a PET Study

The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neuronal processing assessed by fMRI as well as D2-receptor availability assessed by \[18F\] desmethoxyfallypride.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent given by the subject
* Healthy young man (age between 18 and 45) insightful to the study (WST\> 95)
* Right handedness
* At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse
* Negative drug-screening at the time of screening
* Body Mass Index between 18 and 30

Exclusion Criteria:

* Lack of accountability
* Participation in other interventional trials
* Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
* Any known psychiatric illness in the participant's history
* Known family history concerning psychiatric disorders
* Cannabis consumption within the last six months
* Consumption of any illegal drugs (except cannabis in history, see above)
* Intake of interfering medication, at the discretion of the investigator
* High intracranial pressure
* Any disorders in stereoscopic vision (measured by the TNO-Test, Lamerics, Utrecht) or hearing deficits
* Contraindications due to the Investigators Brochure Contraindication for Magnetic Resonance Imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like Phenprocoumon) or contradiction for the PET-CT method and the radiopharmaceutical
NGAL Predictive Value of Acute Kidney Failure After Cardiac Surgery in Patients With Preoperative Chronic Kidney Failure

Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL.

(N/A)

Eligibility Criteria:
Inclusion Criteria:

* Renal clearance less than 60 mL/min
* Able to give written consent
* Elective valve surgery
* Elective CABG surgery

Exclusion Criteria:

* Less than 18 years old
* Iodine injection within 3 days before surgery
* Iodine injection within 24 first postoperative hours
* preoperative infection
* evolutive cancer disease
* Refusal
* Pregnancy
* Unable to give written consent
Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

Levetiracetam is a relatively novel anti-epileptic drug (AED), which has proven to be effective and well tolerated in many glioma patients with otherwise pharmacoresistant epilepsy. Moreover, levetiracetam has neither enzyme-inducing nor enzyme-inhibiting properties, which makes the drug particularly attractive for brain tumour patients, as they frequently receive chemotherapy and/or corticosteroids. Therefore, levetiracetam is the anti-epileptic drug of choice post-operatively in glioma patients suffering from epilepsy. Unfortunately, even with levetiracetam, a proportion of glioma patients is not free of seizures. It is unclear, however, which glioma patients benefit from levetiracetam treatment. It is suggested that the expression of protein SV2A is correlated with clinical response to levetiracetam. The determination of SV2A expression in brain (tumour) tissue might be used as a predictive tool for response to levetiracetam.

Objective of this study: Correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* suffering from partial seizures, with or without secondary generalisation
* must have undergone surgery for their newly diagnosed or recurrent glioma not more than 42 days previously
* treated with levetiracetam
* histologically proven astrocytoma grade II or III, oligodendroglioma grade II or III, oligoastrocytoma grade II or III, or glioblastoma multiforme according to the World Health Organisation (WHO) classification of tumours affecting the central nervous system
* written informed consent

Exclusion Criteria:

* Women who are pregnant or lactating
* Patients who do not have a basic proficiency of the Dutch language,or are unable to communicate adequately will also be excluded.
Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy

The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands.

Participants will have head and neck cancer that was treated with radiation therapy, and in this study will:

* Undergo a collection of bone marrow using a needle;
* Donate saliva;
* Undergo a salivary gland ultrasound; and,
* Complete questionnaires that ask about dry mouth

Participants can expect to be in this study for up to 30 months.


Eligibility Criteria:
Inclusion Criteria:

* History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED)
* Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation)
* ≥ 18 years of age, ≤ 90 years of age.
* Patients ≥ 2 years from completion of radiation therapy for HNC
* Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
* Willing and able to give informed consent
* Radiographically confirmed submandibular gland(s)

Exclusion Criteria:

* Salivary gland disease (i.e., sialolithiasis)
Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke

Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.


Eligibility Criteria:
Inclusion Criteria:

1. Hemiparesis of the upper extremity
2. Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry
3. Age 18 years or older
4. Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.

Exclusion Criteria:

1. Inability to understand and/or follow instructions
2. Pain in shoulder or arm
3. Other neurological or musculoskeletal target organ disorder
4. Inability to give informed consent personally
5. Previous or current contracture of the upper extremity
Cooled RF Lesion MRI Characteristics

This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).

This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.

The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.

MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years
2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
3. Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.
4. Willing and able to receive an MRI

Exclusion Criteria:

1. Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
2. Unable to receive an MRI (i.e. iron-based metal implant).
3. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.
4. Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
5. Subject currently implanted with a pacemaker or defibrillator
6. In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment
7. Subject unwillingness or unable to comply with protocol requirements