cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction and Bone Changes for OT Cap and OT Vertical Attachment

The purpose of this study aimed to answer a clinical question whether In a patient with bilateral distal extension area, would the metal framework partial denture with OT vertical attachment versus partial denture with OT CAP attachment result in better patient satisfaction?


Eligibility Criteria:
Inclusion Criteria:

* patients age ranged between 35-45years old.
* All patients have Kennedy class I partially edentulous mandibular arch in which the last remaining teeth were the second premolars bilaterally.
* The abutment teeth had an apparently good periodontal condition with no signs of mobility or inflammation with firm and healthy mucosa.
* Edentulous ridge covered by health firm mucoperiosteum, without abnormal bony irregularity or severe lingual undercuts.
* Patients with normal relationship of maxilla and mandible (Angle class I ridge classification) and sufficient inter-arch space (6mm) the size of the attachment
* The opposing dentition is intact arch with no noticeable over eruption or tilting or restored with acceptable fixed restoration.
* All patients are free from neurological, muscular disorders and tempro-mandibular joint disorders.
* Only patients who can be easily motivated to achieve and maintain good oral

Exclusion Criteria:

* Patient with limited skills
* Un co-operative patients.
* patient with bad oral hygiene
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine

This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into groups according to their number of migraine days during the baseline period.

All patients completing the Baseline period and fulfilling baseline eligibility criteria were invited to participate to the Double-blind, double-dummy Treatment Epoch (DBTE, 24 weeks) .

Eligible patients were randomized to one of two treatment arms. DBTE started with a titration phase for topiramate of a maximum of 6 weeks to determine the maximal tolerated dose and aimed to reach the recommended treatment dose of 100 mg according to the German SmPC. After the titration phase, maintenance phase started (18 weeks). Topiramate dose had to be maintained until the end of the DBTE. Erenumab dose at beginning of the DBTE was determined patient individually by the investigator based on the guidance provided in the SmPC and was either 70 mg or 140 mg. Dose escalation from 70 mg to 140 mg in case of insufficient response was considered at anytime during the DBTE.

Dose reduction of topiramate and erenumab was not allowed during DBTE (Week 0 to Week 24). After Week 24 or if the patient discontinued study drug, a one week double-blind taper off phase followed to ensure proper down titration for topiramate. At the end of the DBTE (24 weeks) the final assessment occurred to address the objectives.

A Follow-Up Visit 4 weeks after last study visit (or 8 weeks after last IMP injection for discontinued patients) was required as part of routine safety monitoring. The primary analysis was triggered when all patients had completed their respective last visit of the DBTE.

The End of study occurred when the last patient completed last visit (LPLV).

Eligibility Criteria:
Key Inclusion Criteria:

1. Documented history of migraine in the 12 months prior to screen
2. at least 4 days per month of migraine symptoms
3. \>=80% diary compliance during the Baseline period
4. Patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments

Key Exclusion Criteria:

1. Older than 50 years of age at migraine onset
2. Pregnant or nursing
3. History of cluster or hemiplegic headache
4. History or evidence of major psychiatric disorder
5. Score of 19 or higher on Beck Depression Inventory (BDI)
Application of the Triple Stimulation Technique to Patients With CNS Disorders Including Stroke

TST (Triple stimulation technique) helps to better quantify the proportion of motor units activated by transcranial magnetic stimulation. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise with this technique than with the slowing of the central conduction time (CCT).

The investigators propose to use this technique in CNS pathologies where this disorder is significant and essential, like multiple sclerosis and stroke.


Eligibility Criteria:
Inclusion Criteria:

* stroke patients with hemiparesia

Exclusion Criteria:

* pace maker
* epilepsia
* metallic neurosurgical implants
A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging

Growing evidence shows that altered blood flow plays a major role in many vision-threatening diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Optical coherence tomography, an established imaging technique use for eye exam in clinical ophthalmology, provides high-resolution cross sectional images of the retina and has increased our ability to understand many eye diseases.

Optical Coherence Tomography is a non-invasive technique use a broadband light source to illuminate the area of study with light in the near infrared spectrum, then obtains static images of tissue structure from interference signals of the back-reflected light.

Optical Coherence Tomography a non-contact, non-invasive means of documenting both tissue structure and blood flow changes in ocular disease and can provide high resolution cross-sectional images of tissue structure, direct visualization of blood flow in blood vessels of the eye.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and older with normal eye, or has been diagnosed with eye disease.

Exclusion Criteria:

* Less than 18 years of age.
Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy

Breast cancer patients who received docetaxel chemotherapy were randomly divided into two groups; experimental group: the patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day; control group: observation. Primary endpoint: total incidence of fluid retention. Secondary endpoints: severity and duration of fluid retention, change in quality of life score.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥18 years
* Diagnosed with breast cancer
* ECOG 0-2
* Received chemotherapy with docetaxel

Exclusion Criteria:

* Existed peripheral edema, ascites and pleural or pericardial effusion
* Serum creatinine exceeds 1.5 times of the upper normal limit
* Total serum bilirubin exceeds 1.25 times of the upper normal limit, or ASAT exceeds 2 times of the upper normal limit
Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

In the present study the investigators aim to determine the efficacy of an immunomodulating topical medication, compared with a topical lubricant, on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.

Dry eye disease (DED) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. DED prevalence is estimated around 15 -35% of the population over 50 years old. There is a wide variety of topic medications for the treatment of DED, though few aim the re-establishment of tear osmolarity equilibrium and reduction of damages to the ocular surface. The treatment of DED can include a medical treatment, such as tear substitution, tear preservation, production stimulation, anti-inflammatory; it can also include surgical treatment, as tarsorrhaphy and salivary gland transplant. Considering tear substitutes and anti-inflammatory topical treatments, the purpose of our study is to determine efficacy of an immunomodulating topical medication containing 0.05% cyclosporine A (CsA), compared to a topical lubricant (vitamin A, Refresh Endura®), on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative DED.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed for mild to moderate Aqueous Deficient DED (ADDED), defined as Schirmer 1 \< 10mm;
* Patients diagnosed for mild to moderate Evaporative DED (EDED), defined as normal Schirmer 1 and BUT \< 5 seconds;
* Patients submitted to refractive surgery,
* Patients capable of understanding instructions, signing the term of consent and available to attend all exam visits.

Exclusion Criteria:

* patients with punctual occlusion,
* active ocular infection or inflammatory disease,
* history of herpetic keratitis,
* contact lens use during trial period,
* patients with glaucoma,
* any eyelid globe malposition abnormality.
Second-line Treatment of Primary Autoimmune Hemolytic Anemia

the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This study compares cyclosporin versus rituximab in steroid-refractory anemia.

Auto-immune hemolytic anemia (AIHA) is a heterogeneous syndrome in adults. This disease is associated with significant morbidity-mortality. First-line treatment with prolonged corticosteroid is well identified but there is not enough data about cyclosporine treatment in case of resistance or dependence on steroids.

the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This drug is cheap, licensed in immunologic diseases, and does not expose to major infections. So, we compare cyclosporin versus rituximab in steroid-refractory anemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years old from any sex with a diagnosis of primary warm autoimmune hemolytic anemia (AIHA) based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test who have disease progression or failure after treatment with steroid therapy, or who are intolerant to treatment, or who refuse standard treatment.
* No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.

Exclusion Criteria:

* any contraindications to the drugs of the study.
* any identified secondary cause of the AIHA.
* pregnant or lactating women.
Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children

The goal of this research study is to compare two enhancements to well-child visits at Geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. Compared to the standard well-child visit, enhancements will offer advantages to obesity prevention, parent involvement in counseling, lifestyle behaviors, and food resource management.


Eligibility Criteria:
Inclusion Criteria:

* Age (20-months to 59-months, 29-days old)
* BMI-for-age and -sex \>50th percentile based on WHO growth standards
* Parent commitment to participate in 18-month study
* Plans to attend scheduled WCV and recommended follow-up WCV in 12 months
* No plans to move or change health systems in 2 years
* Parent age \> 18 years
* Parent is English-speaking
* Household is considered lower-income (i.e., eligible for or receiving Special Supplemental Nutrition Program for Women, Infants and Children \[WIC\], Supplemental Nutrition Assistance Program \[SNAP\], Temporary Assistance for Needy Families \[TANF\], Medicaid, or Children's Health Insurance Program \[CHIP\]) or screens positive for food insecurity.

Exclusion Criteria:

* Another child in family is participating
* Pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays such as autism)
* Parents with self-reported major depression will be excluded.
Study of a Primary Care Hypoglycemia Prevention Program

This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.


Eligibility Criteria:
Inclusion criteria for patients:

* Age 18 years or older
* Diabetes mellitus by electronic health record review
* Treatment with any of the following medication classes: insulin, sulfonylureas, meglitinides
* Community dwelling (not residing in long-term care or a skilled nursing facility)
* Receiving primary care from a participating primary care provider at Johns Hopkins Internal Medicine at Green Spring Station
* The patient's primary care provider approves their participation

Exclusion criteria for patients:

* Significant cognitive impairment or dementia
* Receiving hospice or end of life care
* Any other serious illness or condition not compatible with participation as determined by the investigators
* Planning to leave area prior to end of study
* Investigator discretion

Exclusion Criteria for continuous glucose monitoring (not required for study participation):

* History of allergic skin reaction to adhesive
* Implantable pacemaker

Inclusion criteria for primary care providers:

* Practicing at Johns Hopkins Internal Medicine Green Spring Station

Exclusion criteria for primary care providers:

* Planning to leave their position prior to end of study
* Not serving as primary care provider for any included patient

Inclusion criteria for clinic staff:

* Participating in check-in at Johns Hopkins Internal Medicine Green Spring Station

Exclusion criteria for clinic staff

* Planning to leave their position prior to end of study
Watermelon and Beetroot Products on Endothelial Function

Cardiovascular disease is the main cause of death worldwide. Endothelial dysfunction is the first step to development of cardiovascular diseases. Endothelial dysfunction occurs due to reduction in nitric oxide, a molecule that plays an important role on vascular health. Due to important role of nitric oxide in endothelial function, several studies have evaluated the effect of its precursors, such as L-citrulline and nitrate on endothelial function parameters. The present study will evaluate the effect of L-citrulline and nitrate derived by watermelon and beetroot products, respectively, on endothelial function of young and older participants. Furthermore, we will evaluate the plasmatic amino acids, nitrate, glucose and insulin in response to ingestion of these products.


Eligibility Criteria:
Inclusion Criteria for healthy young participants:

* Age between 18-35 years;
* Triglycerides ≤ 150 mg/dL
* HDL-cholesterol ≥ 50 mg/dL for women and ≥ 40 mg/dL for men;
* Waist circumference ≤ 102 cm for men and ≤ 88 cm for women).

Inclusion Criteria for older people with cardiovascular risk:

* Age ≥ 60 years;
* Elevated triglycerides ≥150 mg/dL;
* Reduced HDL-cholesterol ≤ 50 mg/dL for women and ≤ 40 mg/dL for men;
* Elevated waist circumference ≥102 cm for men and ≥ 88 cm for women).

Exclusion Criteria:

* Elevated fasting glucose (≥100 mg/dL);
* Smoking;
* Beetroot or watermelon allergy;
* Unwillingness to avoid beetroot or watermelon products during the entire study;
* Other chronic diseases (diabetes, liver disease, etc.) or acutely ill
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study

The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.

A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study.

Eligibility Criteria:
Inclusion Criteria:

* Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
* Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
* YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
* Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive

Exclusion Criteria:

* Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
* Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium
Post Market Clinical Follow-Up of Plasmafit® Cup

Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18 years
* Indication for cementless total hip arthroplasty
* Patient consent for study participation
* Physical and mental willingness to participate at clinical and radiological follow-up

Exclusion Criteria:

* Patient not available for follow-up
* Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV
* Tumor
* Alcohol or drug abuse
* Permanent cortisone therapy
* Clinically relevant infection
* Pregnancy or planned pregnancy
* Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip
* Acute fracture at the concerned hip
* Patients needing a cemented hip arthroplasty
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars

This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.


Eligibility Criteria:
Inclusion Criteria:

* Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision.
* Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.
* Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.
* Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea.
* Subjects must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

* Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.
* Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.
* No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.
* Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active.
* Ocular surgery planned during the study treatment period.
* Presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.

Note: Other inclusion/exclusion criteria apply.
A Randomized Controlled Trial to Evaluate the Effect of White Noises and Parental Voices As Protectors Against Noise Damage in a Neonatal Intensive Care Unit

The goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit.

The main question it aims to answer is:

• Could the combined use of white noises and maternal and/or paternal voices reduce the negative outcomes of continuous exposure to hospital noises on newborns hospitalized in a Neonatal Intensive Care Unit?

Participants in the intervention group will listen to a recorded track composed of white noises and voices of their parents who read a story or sing a lullaby from the day of enrollment until the day of discharge, for 4 hours per day.

Researchers will compare the intervention group with the control group (who will receive the usual care provided without any intervention on the noise level) to see if babies enrolled in the intervention group show fewer events of tachycardia, tachypnea, desaturation, apnoea, and language or hearing impairment.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the NICU with gestational age at birth ≥ 31 weeks (as this is the age at which sound perception is ≥ 40 dB and there is predictable clinical stability to allow intervention delivery without excessive interruptions)
* Patients admitted to the NICU who reach gestational age ≥ 31 weeks
* Patients monitored with the following types of monitors: Masimo rainbow SET™ (Masimo); Infinity® Delta (Draeger); Infinity® Acute Care System (Draeger); Efficia CM (Philips).

Exclusion Criteria:

* Patients with gestational age at birth \< 31 weeks
* Patients affected by meningitis or severe cerebral insults, congenital brain anomalies, congenital syndromes with suspected or known brain dysfunction
* Patients diagnosed with hypoxic-ischemic encephalopathy
* Patients with significant airway abnormalities resulting in altered breathing during sleep
* Patients with terminal illnesses
* Patients with congenital anomalies of the face, ears, skull, or brain
* Patients with non-bacterial congenital infections
* Patients with congenital hearing deficits
* Patients whose parents or legal guardians refuse to participate in the study
* Patients already enrolled in other clinical studies.