cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Results of Closed Kinetic Chain Exercises in Patellofemoral Pain Syndrome

Non-selective closed kinetic chain exercises and or selective closed kinetic chain exercises has been shown to increase Vastus medialis obliquus muscle power in patellofemoral pain syndrome. However, the superiority of the exercises to each other has not been shown.

This study aimed to evaluating the effects of different exercises on the stiffness of the Vastus medialis obliquus and vastus lateralis muscles, pain management, functional scores, and thigh circumferences.

This randomized-controlled clinical trial included 40 patients (20 male and 20 female) who were admitted to hospital and who were clinically diagnosed with single-sided patellofemoral pain syndrome (PFPS) and 40 healthy controls (20 male and 20 female). Each group were randomized into subgroups according to diseased side of the PFPS group (40 knees), healthy side of the PFPS group (40 knees) and both side of the healthy control group (80 knees). Randomization was applied with random-number generator (Research Randomizer. Version 4.0). Only one of the authors was aware of randomization. Examiner and patient were blind to the relevant group. Non-selective closed kinetic chain and selective closed kinetic chain exercises were applied for 6 weeks in all groups. Thigh circumference measurement was performed 5-10 cm above the upper pole of the patella. In addition, evaluation was made with visual analog score (VAS) and Lysholm Knee Score (LKS) score. Vastus medialis obliquus (VMO) and vastus lateralis (VL) muscles of the participants were measured with Shear Wave Elastography 1 day before the therapy and 6 weeks after therapy. Written informed consent was taken from each patient.This study is in line with the Declaration of Helsinki. Approval was obtained by the Local Ethics Committee (17/07/2016-258642).

Eligibility Criteria:
Inclusion Criteria:

* Having peripatellar/retropatellar pain while sitting,going up and down the stairs
* Walking for a long time, crouching down, running, and kneeling down
* Having a VAS score of ≥3 during the evaluation and not developing these symptoms on a traumatic basis

Exclusion Criteria:

* Tendinitis
* Osgood-Schlatter Syndrome
* Traumatic hip or knee injuries
* Osteoarthritis
* Plica syndrome
* Sinding-Larsen-Johansson syndrome
* Ligamentous instability
* Spinal pain
* Chondral lesion
* Patellar tendon pathology
* Distraction apophysitis of knee circumference
MK0767 and Sulfonylurea Combination Study (0767-027)

This study will assess MK0767's ability vs. placebo to control blood glucose in patients with type 2 diabetes and to gauge whether fasting blood glucose is lowered, blood fats are improved, and insulin levels are impacted.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes with inadequate glycemic control
* On Sulfonylurea monotherapy
* Male or non-pregnant Females
* Age 21 to 78 years, inclusive
* On a stable dose of sulfonylurea for at least 2 weeks prior to Visit 2/Week-6

Exclusion Criteria:

* History of Type 1 diabetes
* Patient is currently on insulin (monotherapy or in combination with oral agent), Rosiglitazone or pioglitazone or other PPAR-y agonists, Metformin agents
* Patients with history of or intolerance of PPAR-y agonists
PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers

The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators hypothesize that the children participating in the intervention will have significantly lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity.


Eligibility Criteria:
Inclusion Criteria:

* child is 2 - 3 years at the time of enrollment
* child is \>85th percentile for BMI
* ability of the parents to speak and read in English at the 4th grade level
* provide primarily in-home care for the children at the time of enrollment
* child is Medicaid eligible

Exclusion Criteria:

* acute secondary complications of obesity for child (e.g., severe respiratory insufficiency)
* child with endocrine abnormalities
* child with severe obesity (\>99.5th BMI percentile)
* children who have participated in an obesity treatment program within the past year
* parent with significant sensory impairments (e.g. deaf, blind)
* parent with BMI \>40.0
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration


Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
* Have provided written consent

Exclusion Criteria:

* Monocular subject or Best Corrected Visual Acuity (BCVA) score of \<20 ETDRS letters or 20/400 in fellow eye at Screening
* Have evidence of a scar, fibrosis, or atrophy of \>50% of the total lesion in the study eye.
Periodontal and Cardiovascular Diseases Project

The purpose of this study is to investigate whether basic periodontal therapy aim to reduce subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, has an impact on the vascular function of patients suffering from established cardiovascular disease.

Design: randomized clinical trial, parallel design, double blinded.

Sample: 120 patients from the Cardiology Department of Hospital Severo Ochoa (Leganés, Madrid) suffering from established cardiovascular disease and generalized moderate/severe periodontitis. Sixty patients will be randomized to test group (scaling and root planing + systemic antimicrobials), and the other 60 subjects will be included in the control group, consisting on delayed periodontal treatment (supragingival prophylaxis + placebo).

Study visits:

Visit 1: screening Visit 2: baseline data collection (medical history, clinical variables, gingival crevicular fluid (GCF) samples, vascular function) Visit 3: panoramic x-ray, blood samples, randomization and first treatment session.

Visit 4: second treatment session. Visit 5: 24 hours inflammatory biomarkers assessment. Visit 6: 7 days inflammatory biomarkers assessment. Visit 7: 1 month follow up (clinical variables) Visit 8: 3 months follow up (clinical variables, vascular function) and supportive periodontal therapy.

Visit 9: 6 months follow up (clinical variables, GCF samples, inflammatory biomarkers, vascular function) and supportive periodontal therapy.

Eligibility Criteria:
Inclusion Criteria:

* (1) patients with established cardiovascular disease (unstable angina or stroke in the previous 3 to 12 months, and left ventricular ejection fraction ≥50%);
* (2) diagnosis of moderate to severe generalized periodontitis (PD\>5mm and marginal bone loss \>30% on at least 50% of the teeth, according to Tonetti et al. 2007);
* (3) presence of at least 3 teeth per quadrant.

Exclusion Criteria:

* (1) periodontal treatment in the previous year;
* (2) antibiotic intake in the previous 3 months;
* (3) smokers of ≥10 cigarettes per day;
* (4) pregnancy or breast feeding;
* (5) diabetes mellitus types I or II, with glycosylated hemoglobin values \>7;
* (6) necrotizing periodontal diseases;
* (7) HIV infection;
* (8) chronic intake of NSAID
The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter

Compare the effect of periradial injection of papaverine versus nitroglycerine on radial artery diamter before cannulation of it in cardiac surgery.

we want in this study to facilitate radial artery canulation and decrease the number of attemps of puncture which may lead to disappearance of the pulse.

The aim of this study is to compare the effect of adding papaverine to local anesthetic xylocaine versus adding nitroglycerine to it on the diameter and palpability of radial artery and if perioperative spasm will decrease significantly with one of these methods.

Eligibility Criteria:
Inclusion Criteria:

- Patients who will be included in the study are those scheduled for elective cardiac surgery who are hemodynamically stable.

Exclusion Criteria:

* Any patient with negative modified Allen test, atrioventricular block, glaucoma, altered liver function, unstable hemodynamics, emergency surgeries, and peripheral vascular disease.
Severity Postoperative Pain Prediction

A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery.

The purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery.

Study Design: A total of 400 evaluable patients will be studied using the various surgical populations listed. For statistical purposes, the following will be the surgical population by procedure. Two hundred healthy ASA I-II women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. Normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. The patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. At 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. Information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. The subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy ASA physical status class 1 or 2
* Aged 18 years or above
* Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections

Exclusion Criteria:

* ASA \>3
* \< 36 weeks for Cesarean Section
* \< 18 years of age
Preventing Smoking Relapse After Total Joint Replacement Surgery

Hospitalization for elective knee or hip replacement surgery presents an outstanding opportunity to motivate people to quit smoking, because it provides an opportunity to encourage patients to remain smoke-free as they proactively quit to optimize their surgery outcomes. This study will conduct a comparative effectiveness trial of patients who quit smoking pre-operatively, comparing the current standard of care with a novel comprehensive relapse prevention intervention guided by Marlatt's Relapse Prevention Model.

The specific aims of this study are to evaluate the effectiveness and cost-effectiveness of the relapse prevention intervention and will: 1) compare the effectiveness of standard post-operative cessation treatment with a comprehensive relapse prevention intervention on smoking cessation outcomes; 2) conduct a comparative economic analysis to assess the value of the relapse prevention intervention for patients and the healthcare system; and 3) explore the impact of the interventions on surgical complications and readmissions.

Eligibility Criteria:
Inclusion Criteria:

Patient Participants

* Received preoperative smoking cessation counseling through Orthopedic Surgery Quit Smoking Program
* Undergoing elective knee or hip arthroplasty surgery
* Have not smoked any cigarettes in the week prior to admission and carbon monoxide 4 ppm46,47
* Have a cell phone (for text messaging)
* Provide informed consent in English

Caregiver participants:

* Age ≥ 18 years
* Be a caregiver of the patient participant
* Provide informed consent in English

Exclusion Criteria:

* Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.
Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Normal eyes with no use of ocular medications.
* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
* Visual acuity with study lenses 20/25 or better.
* Cylinder less than or equal to 0.75 D.
* Currently wearing daily disposable lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality.
* Any active anterior segment ocular disease that would contraindicate contact lens wear.
* Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of refractive surgery or irregular cornea.
* Eye injury within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any clinical trial.
* Other protocol-defined exclusion criteria may apply.
Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

In hypotensive septic patients with controlled source, an hemodynamic management protocol including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction) Score by at least 3 points compared to the use of physiologic saline and norepinephrine.

The appropriate design for this trial would be factorial. For the time being, will consider de intervention as a whole unit for this pilot study. In the future an appropriately sized factorial multicentric study shall be necessary.

Other goals of the pilot study:

1. HS restores preload parameters adequately
2. HS associated with terlipressin normalizes blood pressure in septic shock
3. HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L
4. There is an inverse relationship between plasma sodium and procalcitonin levels
5. HS increases plasma levels of vasopressin (AVP)
6. HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)


Eligibility Criteria:
Inclusion Criteria:

* Criteria of SIRS: at least 2 of 4:

  * Temperature \> 38 °c or \< 36 ° C
  * More than 90 bpm heart rate
  * Respiratory rate more than 20rpm or PaCO2 less than 32 mm Hg or patient in mechanical ventilation
  * Less than 4000/ mm³ or more than 12000/mm³, or more than 10% leukocyte bands (immature)
* Septic source known demonstrated (or at least of high probability) and controlled (if it is controllable)
* Hematocrit 25% or higher and/or hemoglobin 8 g/dL or higher. If necessary, transfuse RBCs to meet this criteria
* MAP less than 70 mm Hg. Note there is no requirement for adequate preload evidence

Exclusion Criteria:

* Hypernatremia at base-line of 155 mEq/L or greater Hyponatremia at base-line less than 130mEq / L
* Prior endocrine disease affecting to the adrenal-pituitary axis.
* Intracranial Hypertension, brain tumor, seizures, head trauma
* Coronary Artery Disease active over the past year; or evidence of "myocardium at risk" by exercise stress test, pharmacological or positive gammagraphy last year without intervention
* Pregnancy
* Liver disease Child C, End-Stage-Renal-Disease
* Under the age of 18
* Patients with order "do not resuscitate" or with minimal chances to survive
Automated Intracytoplasmic Sperm Injection (ICSIA)

The purpose of this research study is to evaluate Overture's automated Intracytoplasmic Sperm Injection (ICSIA) System. ICSIA is an investigational medical device that automates injection of sperm into eggs. This study will evaluate survival and fertilization rates of oocytes handled via ICSIA and compare to survival and fertilization rates of oocytes which are manually injected with sperm.

Today Intracytoplasmic Sperm Injection (ICSI) is performed manually; a highly skilled technician manually injects a single sperm cell into an oocyte using a set of microinjectors. Success of ICSI is contingent on operator skills and has a direct impact on the number of fertilized oocytes available and cumulative pregnancy rates. Automation of the ICSI technique may help improve consistency and efficiency of the process, as well as improve reproducibility across operators. Overture has developed the ICSI system to automate these critical processes, named ICSIA.

ICSIA is composed of the same devices and consumables used for manual ICSI, but these devices have been integrated using a software interface with artificial intelligence to identify oocytes and allow for proper puncture of the oocyte and injection of the sperm without human intervention. The information from this study will be used by the study Sponsor, Overture Life, Inc, to help future development of the System and for submission of data to the United States Food and Drug Administration (FDA).

During the study, patients will undergo a conventional IVF cycle, or donor IVF cycle. After the oocyte retrieval or thawing of donor oocytes, the oocytes will be placed into equal groups: test and control. Test group oocytes will undergo ICSI via ICSIA (the investigational device), and control group oocytes will undergo manual ICSI as is routinely performed. The oocytes will be immediately evaluated for survival and fertilization rates and remain separate for the duration of the study. ICSIA has been extensively tested in hamster and mice oocytes, and fertilization/survival rates after ICSIA have been between 89%-96%.

After ICSI, conventional IVF processes will be followed and fertilized oocytes cultured up to blastocyst stage. Blastocysts will be biopsied for preimplantation genetic testing for aneuploidy (PGT-A) which assesses the embryo's chromosomes. All biopsied blastocysts will be frozen, and frozen embryo transfers (FET) scheduled after genetic results have been received. Embryo freezing and thaw will be performed manually. Selection of the embryo for transfer (whether test or control) will be at random.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women undergoing IVF treatment with ICSI

Exclusion Criteria:

* Severe male factor infertility
Efficacy and Safety of Liuwei Dihuang Pill Versus Placebo in Presbycusis With Shen (Kidney)-Yin Deficiency

The objective of this study is to examine the effects and safety of Liuwei Dihuang pill and placebo in presbycusis with Shen (kidney)-yin deficiency.

There are no approved pharmacologic therapies for age-related hearing loss (ARHL), also known as presbycusis. Based on the syndrome differentiation in Chinese medicine (CM) theory, the pathogenesis of presbycusis is related to the Shen (kidney)-yin deficiency. Liuwei Dihuang Pill (LDP) is effective and commonly prescribed for the treatment of Shen-yin deficiency.

The main purpose of this study is to try to demonstrate an improvement in phonetically balanced maximum (PBmax) after 1 years of treatment with the LDP versus the placebo. Subjects will undergo a safety follow-up after the treatment period. Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).The amount of drug in the blood will also be measured.

It is expected that around 120 people (at least 60 in each arm) with presbycusis with Shen (kidney)-yin deficiency may take part in the study. The study participants will be recruited at around 6 sites in the Shanghai, China.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have a current diagnosis of presbyacusis with symmetrical hearing loss, defined as 15-dB or less difference in pure tone average between ears at 0.5, 1, 2 and 4kHz. The average hearing threshold loss level is mild or moderate (20 ≤ average hearing threshold \< 50 dBHL).
2. Adult aged 65-75 years inclusive.
3. Maximum speech recognition rate in quiet environment is equal to or over 60% with ability to communicate well.
4. Subjects have no cognitive impairment with CDR score =0.
5. Subjects must have a current diagnosis of Shen (Kidney)-Yin Deficiency.
6. Subjects have read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.

Exclusion Criteria:

1. Subjects with sudden hearing loss or pure tone hearing fluctuation within the three months.
2. Subjects with a history of serious mental illness.
3. Subjects with severe cardiac insufficiency, malignant tumor or other serious systemic diseases.
4. Subjects with conductive deafness, congenital deafness, hereditary deafness, inner ear immune and autoimmune inner ear diseases, auditory neuropathy, toxic deafness and noise deafness.
5. Subjects with organic ear diseases, abnormal ear structure and symptomatic cerebral infarction.
6. Subjects with dementia, neurosyphilis, hypothyroidism and depression.
7. Subjects has previously participated in other clinical trial within the three months.
8. Subjects with using hearing aids or devices.
9. Other situations where the researcher thinks it is inappropriate to participate in this research.