cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcome Following Arthroscopic Knee Surgery

Purpose: There are no existing data available to guide clinicians in the appropriate rehabilitation progression of patients who have undergone knee arthroscopy. The investigator intends to fill this void by establishing normative recovery curves for patients undergoing knee arthroscopy.

Research Design: Prospective Observational Design Procedures: Patients 10-70 years old will be screened for "standard of care" clinical and functional outcomes to occur at standardized time-points (post-op weeks 1-4, 8, 12, 16, 20 and return to sport/activity) following arthroscopic knee surgery. Recovery curves will be plotted for all outcome variables of interest including; (1) International knee Disability Committee (IKDC) survey, (2) Tampa Kinesiophobia scale, (3) Tegner activity scale, (4) Marx activity scale, (5) Passive knee range of motion/heel-height difference, (6) Balance Error Scoring System (BESS), (7) Quad/Hamstring strength ratios, (8) Y-Balance, (9) Functional Movement Screening, (10) Vail-Sport Test, (11) Landing Error Scoring System (LESS), (12) Hop Testing, and the (13) Sports Metrics Test. Polynomial lines-of-best-fit and 95% confidence intervals will be plotted to provide objective recovery curves for clinical utilization and stratification of patient recovery.

Risks: There are no additional risks to "standard physical therapy practice" for post-surgical patients participating in this study. The investigator will not be using invasive procedures or testing modalities that emit radiation.

Benefits \& Clinical Relevance: This information may offer valuable information to clinicians treating patients following knee arthroscopy by providing objective data for each phase of post-operative recovery. Identifying key landmarks and functional milestones may allow the ability to identify patients who are not meeting clinical expectations and subsequently tailor rehabilitation programs to improve recovery trajectories.


Eligibility Criteria:
Inclusion Criteria:

* Ages 10-70; undergoing primary knee arthroscopy; \& participating in post-operative physical therapy management.

Exclusion Criteria:

* Patients will be excluded from the study if they elect to not have knee arthroscopy. Have other orthopedic or medical complications (fractures, deep vein thrombosis,) that would be a contraindication to standard post-operative physical therapy care.
Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice

In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.


Eligibility Criteria:
Inclusion Criteria:

* Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens \[required dimensions 12 x 7 millimeters (mm)\].
Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%

The purpose of this study is to evaluate the feasibility of rapid evaluation and administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the progression or improves recovery of patients who are randomly assigned to treatment versus standard of care.

Non-arteritic anterior ischemic optic neuropathy (NAION) currently has no widely accepted acute treatment to improve recovery or prevent progression in the first month. It causes monocular vision loss with potential second eye involvement in 15% at 5 years. This leads to significant disability. It is the most common acute optic neuropathy in patients over 55 years of age. The final mechanism of injury is believed to be ischemic. Increasing perfusion of the optic nerve may reduce damage and prevent progression. Reduction in intraocular pressure has been shown to increase optic disc perfusion in animal models. Timolol maleate is a widely used medication for Glaucoma that reduces intraocular pressure. Treatment with Timolol maleate may improve optic disc perfusion in NAION and reduce ischemic damage from this condition. This study aims to enroll and treat patients with Timolol maleate 0.5% within 48 hours of symptom onset to assess feasibility of the study design and potential benefit of rapid intraocular pressure reduction.

Eligibility Criteria:
Inclusion Criteria:

* Age \>40
* Sudden, painless monocular vision loss with edema of the optic disc
* Clinical diagnosis is Non-Arteritic Anterior Ischemic Optic Neuropathy
* Relative Afferent Pupil Defect (RAPD) at first study visit

Exclusion Criteria:

* Onset of vision loss \>48 hours from time of enrollment
* History of Asthma or COPD
* History of Heart Block or Sinus Bradycardia
* Allergy to any beta blocker
* History of Multiple Sclerosis or optic neuropathy
* Active Ocular Inflammation on examination
* Currently being treated for Cancer or systemic vasculitis
* History of Glaucoma or use of medications that lower IOP
* Symptomatic cataract, retinopathy, macular disease or amblyopia in the symptomatic eye
* IOP of \<10 at baseline
* Ocular surgery in past three months
* Women who are pregnant, breast-feeding or may become pregnant
* Inability to provide informed consent or follow up at three months
* Currently enrolled in any other study drug trial or previously enrolled in this study
Does Venous pCO2 Increase by 20 mmHg or More During Apnea Challenge Test?

One required examination for declaration of death by neurological criteria is the apnea challenge test. The apnea challenge test evaluates the medulla brainstem respiratory center response to a rise in CO2. The current guideline requires arterial sampling of CO2 and therefore either arterial puncture or arterial catheter placement for the examination. Arterial catheter is an invasive monitoring device and is not without complications. Recent studies have demonstrated that there is a direct correlation between peripheral venous and arterial blood gas measures and that peripheral venous CO2 measures may be used as alternatives to arterial CO2 measure.The purpose of this study is to evaluate brainstem response during the apnea challenge test to a rise in venous CO2 and correlate it with the rise in arterial measured CO2. The objective of this study is to demonstrate a similar rise between the venous and arterial CO2 during the apnea challenge test and eliminate the necessity of arterial blood sampling for the sole purpose of apnea challenge test in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 37 weeks gestation up to any adult age
2. Patients admitted to Pediatric Intensive Care unit (PICU), Neonatal Intensive Care Unit (NICU), Medical Intensive Care Unit (MICU) and Cardiothoracic Intensive Care Unit (CTICU)
3. Patients with irreversible brain injury where the attending physician will be performing death by neurological criteria examination as per hospital policy
4. Presence of arterial catheter or arterial blood sampling during apnea challenge test
5. Presence of central venous catheter or easily drawing peripheral intravenous catheter

Exclusion Criteria:

1. Age less or equal to 37 weeks gestation
2. Inability to perform apnea challenge test as determined by primary physician
3. Family request for Donation after Cardiac Death (DCD) or withdrawal of Life Sustaining Therapy
4. Bicarbonate infusion within 30 minutes of apnea challenge test
Comparison of Dermis Vs. Auricular Cartilage Grafts for the Surgical Correction of Lower Eyelid Retraction

This study aimed to compare the effectiveness of two autologous grafts-dermis and auricular cartilage-in the surgical correction of the lower eyelid retraction. Our primary focus was assessing changes in lower eyelid position using lower eyelid Margin to corneal Reflex Distance measurements, a.k.a Margin reflex distance 2 (MRD2).

This prospective, randomized interventional study includes patients with stable LER. Patients are randomly assigned to undergo surgical correction using either auricular cartilage or dermis grafts, with the vertical dimension configured to be twice the scleral show height. MRD2 measurements were taken pre-operatively and at several post-operative intervals, with complications and outcomes recorded.

Eligibility Criteria:
Inclusion Criteria:

* eyelid retraction, scleral show

Exclusion Criteria:

* incomplete follow-up (less than 6 months), pregnancy and other abnormal ocular conditions or symptoms that preclude the patient's admission to the study, according to the clinical judgment of the investigator.
Early Versus Conventional Loading for Fully Guided Immediate Implant Placement

Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.

The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.

Eligibility Criteria:
Inclusion Criteria:

* Patients age range from 20-60 years.
* Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture.
* Primary implant stability is above 30 Ncm.

Exclusion Criteria:

* History or presence of severe uncontrolled systemic disease.
* Heavy smokers (\>10 cigarettes per day) or alcohol/drug abusers.
* Poor oral hygiene.
* Acute periapical infection.
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC.

Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:

* Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide)
* Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)


Eligibility Criteria:
Inclusion Criteria:

Voluntary participation in clinical studies.

Male or female aged ≥ 18 years at the time of signing the ICF.

Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).

No prior systemic therapy for ES-SCLC.

At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.

Major organs are functioning well.

Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.

An ECOG PS score of 0 or 1.

An expected survival ≥ 12 weeks.

Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.

Participant must keep contraception.

Exclusion Criteria:

Histologically or cytologically confirmed mixed SCLC.

Known history of severe allergy to any monoclonal antibody.

Known hypersensitivity to carboplatin or etoposide.

Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.

Pregnant or breastfeeding females.

Patients with a known history of psychotropic drug abuse or drug addiction.

Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement

Total knee replacement (TKR) is considered the most effective and safe method of radical treatment of late stages of knee osteoarthritis. A well-known problem of TKR is a severe postoperative pain syndrome, which is observed in more than 50% of patients.

Femoral nerve block (FNB) is the "gold standard" for continuous postoperative analgesia after total knee replacement, as it is effective in reducing the frequency of use of opioid analgetics and reduce the duration of hospitalization. At the same time, the negative effect of this method is the motor blockade of the quadriceps femoris muscle which leads to functional impairment and is associated with an increased risk of falling.

Adductor canal block (ACB) provides adequate analgesia comparable to femoral nerve block. Moreover, ACB doesn't affect the motor function of the quadriceps femoris muscle.

The possibility of enhanced recovery after total knee replacement is the reason to compare single-shot adductor canal block and continuous femoral nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Planned primary total knee replacement
* Planned neuraxial anesthesia
* Written informed consent

Exclusion Criteria:

* Urgent surgery
* Planned revision total knee replacement
* Known allergic reaction to anesthetics
* Confirmed localized infection at the puncture sites
* Confirmed localized tumor at the puncture sites
* Peripheral neuropathy of the lower extremities
* Parkinson's disease
* Previously enrolled in this trial
Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more cancer cells.

PRIMARY OBJECTIVES:

I. To assess the rate of achieving a "good complete response (CR)" after treating patients with newly diagnosed acute myeloid leukemia (AML) with idarubicin, cytarabine and pravastatin (pravastatin sodium) (IAP).

II. To determine the toxicity (death within 28 days of starting therapy = treatment related mortality or "TRM") with IAP in newly-diagnosed AML.

SECONDARY OBJECTIVES:

I. To determine rates of complete remission (CR), remission with incomplete blood count recovery (CRi), partial remission (PR), relapse-free survival and overall survival.

II. To identify biomarkers (ie. changes in serum cholesterol) associated with clinical responses.

OUTLINE:

Patients receive pravastatin sodium orally (PO) once daily (QD) on days 1-8, idarubicin intravenously (IV) over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World Health Organization (WHO) 2008 criteria, including patients with \>= 20% blasts in the bone marrow or peripheral blood (except acute promyelocytic leukemia), or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with \>= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2 by WHO 2008 classification
* Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score of =\< 9.2
* Bilirubin \< 2.0 mg/ml
* Any creatinine value is acceptable
* Any performance status is eligible
* Life expectancy otherwise \> 1 year
* Patients are not excluded based on cardiac history
* Females of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
* Patients must use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Safety FollowUp Study Of Cardiovascular Events In Subjects Who Participated In Selected Torcetrapib/Atorvastatin Studies

An observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials. No hypotheses will be tested.

Study A5091075, an observational study in subjects who had previously been treated with torcetrapib, was terminated on 20 Dec 2007. The study was terminated following reviews of final safety information from prior torcetrapib studies and the low participation rates observed during the recruitment period for study A5091075 . On the basis of this new information the Sponsor determined that it was unlikely that this study would result in new and scientifically valid information.

Eligibility Criteria:
Inclusion Criteria:

* Have signed informed consent prior to the initiation of any study-specific activities.
* Have participated in selected torcetrapib/atorvastatin Phase 1, 2, and 3 clinical trials and were treated with randomized study medication.

Exclusion Criteria:

* There are no exclusion criteria.
Genotyping Influences Outcome of Coronary Artery Stenting

This study evaluated epidemiology and clinical outcome of clopidogrel related various genotyping in Korean patients who had undergone percutaneous coronary intervention as a all comer registry form.

This study evaluates the relationship between clopidogrel related various genotyping, epidemiology and clinical outcome of patient who had undergone percutaneous coronary intervention. Clopidogrel resistance was measured with VerifyNow, which is a device that can monitor platelet inhibition of clopidogrel. Genes which are known to be related with clopidogrel resistance were evaluated; (1-3) CYP 2C19 \*2, \*3, \*17, (4) PON1 Q192R, (5) ABCB1 3435C-\>T, (6) P2Y12, (7) CYP 2C9 \*3.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Older than 20 years
* All percutaneous coronary intervention patients within 1 month

Exclusion Criteria:

* Pregnancy
* Life expectancy below 1 year
* Known aspirin or clopidogrel allergy
Auxiliary Device to Alleviate Soldiers' Backload

Combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability.

The Auxiliary Device- "Minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried by the soldier. As a result, it may improve the soldier's physiological abilities and performance through enduring missions with heavy loads, and may lead to better protection on the soldier from overuse injuries.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any of the following: chronic background diseases, cardiovascular, lung or respiratory, heat stroke history, headaches,psychiatric background, musculoskeletal problems, and without drugs use.
* Lack of any acute disease during 2 weeks prior the study.
* Subjects will give their written consent for participating the study after being informed by the study's physician about the study's aims, importance and the possible risks.

Exclusion Criteria:

* Rectal temperature above 39 Celsius degrees.
* HR above maximal HR ( calculated as 220-age)
* The subject's will to stop the test.
* The researcher's/doctor's judgment.
Travoprost Five Day Posology Study

The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.


Eligibility Criteria:
Inclusion Criteria:

1. either sex and any race/ethnicity, ≥18 years old
2. diagnosed with open-angle glaucoma, and/or ocular hypertension
3. meets the following IOP entry criteria:

   * Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
   * Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
4. satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

1. females of childbearing potential not meeting protocol conditions
2. angle grade less than Grade 2 in either eye
3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
4. severe central visual field loss in either eye
5. any abnormality preventing reliable applanation tonometry in either eye
6. hypersensitivity to prostaglandin analogues or to any component of the study medication
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia

To determine the efficacy and safety of Botulax® in treatment of cervical dystonia


Eligibility Criteria:
Inclusion Criteria:

1. Male or female of aged over 19 years
2. Subjects diagnosed with primary cervical dystonia

Exclusion Criteria:

1. Subjects who have administered botulinum toxin within 16 weeks at the time of baseline
2. Pregnant or nursing
3. Females or males who do not agree on proper contraceptive measure
Maternal Health Diabetes Prevention Study

The aim of this project is to use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to collect pilot data on the implementation of a Diabetes Prevention Program-like intervention in the Women, Infants, and Children (WIC) program.

In this study, investigators will pilot a 2-month Diabetes Prevention Program-like program (delivered by WIC staff) to 20 women with recent gestational diabetes (6 weeks to 12 months postpartum) who receive WIC services.

The goal of this pilot is to evaluate the feasibility, acceptability, appropriateness, fidelity of implementing this intervention in the setting of WIC clinics and feasibility of conducting a larger-scale study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* 6 weeks to 12 months postpartum
* Medical record documented diagnosis of GDM during most recent pregnancy
* Access to a device that can access the internet
* English speaking

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next two months
* Planning to move out of the area in the next two months
* Self-report of diagnosed diabetes
* Use of glucose-lowering medications
* Plasma glucose \>200 mg/dL and classic symptoms of hyperglycemia (thirst, polyuria, weight loss, blurry vision) or HbA1c \>6.5% (based on screening visit blood draw)
* Unable or unwilling to provide informed consent