cyrilzakka/clinical-trials huggingface dataset:
tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study

The investigators will test the feasibility of using transcranial direct current stimulation (tDCS) and speech therapy to treat participants with motor speech disorders caused by Frontotemporal Lobar Degeneration Pathology including nonfluent variant Primary Progressive Aphasia, Progressive Supranuclear Palsy, Corticobasal Syndrome, or behavioral variant Frontotemporal Dementia.

The investigators will deliver transcranial direct current stimulation (tDCS) either in a clinic setting at the University of California San Francisco, or in patients' homes, via a consumer tDCS device and videoconferencing. Transcranial direct current stimulation (tDCS) is a neuromodulation technique that can enhance the benefits of speech therapy treatment. Participants will receive a dose of tDCS stimulation + speech therapy and a dose of sham tDCS + speech therapy in a randomized double blind crossover study performed either in the clinic or at home via videoconferencing. This study can be performed entirely remotely.


Eligibility Criteria:
Inclusion Criteria:

* Mini Mental Status Exam score \> 10
* diagnosis of nfvPPA via Gorno-Tempini 2011 criteria, or a diagnosis of FTLD syndrome including progressive supranuclear palsy, corticobasal syndrome or behavioral variant frontotemporal dementia PLUS a motor speech disorder (apraxia of speech and/or dysarthria)
* able to give consent
* right-handed
* native English speaker
* having a caregiver who is also able to sign and understand the caregiver's consent form.

Exclusion Criteria: History of:

* stroke
* TBI
* brain cancer
* seizures
* craniotomy, skull surgery or fracture
* metallic implant in head
* pacemaker or cardioverter-defibrillator
* pregnancy.
Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients

Educating patients on visual performance with presbyopic correcting intraocular lenses is crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic crystalline lens will provide eye care provides useful information to better educate patients on visual performance expectations after cataract surgery with a presbyopic correcting intraocular lens. Our objective will be to assess the subjective range of clear vision of a pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved presbyopic intraocular lenses will be discussed in the manuscript.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent on the IRB approved Informed Consent Form
2. 37-48 years of age
3. Phakic

Exclusion Criteria:

1. Previous cataract surgery
2. Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
3. Subjects that are unable to obtain 20/20 BCVA (i.e. amblyopia, etc.)
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia

This study included women who underwent voluntary second trimester termination of pregnancy. Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous epidural infusion for pain analgesia. In this randomized, double-blind study, the investigators assess the incidence of motor block (primary outcome), degree of satisfaction of the patients, total levobupivacaine and sufentanil consumption and adverse events (secondary outcomes) between the two study groups.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* pregnancy at second trimester
* willingness of voluntary interrupt the pregnancy
* comprehension of Italian Language
* baseline pain score ≥ 30 on a 100-mm visual analog pain scale (VAPS)

Exclusion Criteria:

* contraindication to epidural analgesia and to narcotics
* history of drug abuse or chronic use
* maternal disease (such as severe asthma, cardiac, liver or kidney disease)
* inability to comprehend or comply with the analgesia pain management procedures.
Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria:

* patients completing one of double blind phase II trials 1245.9 or 1245.10
* informed consent

Exclusion criteria:

* patients meeting withdrawal criteria of preceding trial
* significant hepatic impairment
* significant renal impairment with creatinine clearance \< 50 ml/min
* contraindication to Metformin for all patients treated with Metformin
* premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
* drug or alcohol abuse
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Documented diagnosis of scleroderma
* Willing and able to provide written informed consent

Exclusion Criteria:

* Use of experimental therapies within 28 days prior to Screening.
* Aspirin use \> 81 mg daily within 1 week prior to Screening.
* Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study
Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity

Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective measures.

Prospective observational study is conducted with expected sample size of 100 patients. Participants are classified into active and inactive disease status according to standard IBD severity assessment measures. Demographic data, disease activity, quality of life, sleep questionnaire (validated PSQI questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. Association between sleep quality and disease activity will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosed inflammatory bowel disease, followed up in Siriraj hospital, Mahidol University

Exclusion Criteria:

* Unstable medical conditions
* Known psychiatric disease
* Patients who could not withhold sedative drugs
* Pregnant patients
* Obese patients with body mass index (BMI) ≥ 35 kg/m2
* Refuse to sign a consent/ had cognitive impairment
Evaluation of an Oral Nutritional Supplement in Older Hospitalized Patients

Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 55 years of age.
2. Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
3. Anticipated length of hospital stay of at least 3 days.
4. Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
5. Able to consume foods and beverages orally.

Exclusion Criteria:

1. Unstable heart failure which requires ICU admission.
2. Severe respiratory disease requiring long-term, continuous oxygen therapy.
3. Diabetes.
4. Impaired renal function.
5. Impaired liver function.
6. Cancer.
7. Hospitalized for two or more days in past 4 weeks.
8. Requires intubation or tube feeding.
9. Expected to be transferred to an advanced care unit.
10. Body mass index of ≥ 40 kg/m2.
11. Active tuberculosis.
12. Ascites or severe edema.
13. Acute Hepatitis or HIV.
14. Disorder of gastrointestinal tract.
15. Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
16. Medication/dietary supplements/substances that could modulate metabolism or weight.
17. Partial or full artificial lower limb.
18. Allergy or intolerance to any of the ingredients in the study products.
19. Procedure using iodine-based contrast media within 7 days prior to hospitalization; or, anticipated to need procedure using iodine-based contrast media within 3 days after hospital admission.
Kinesiophobia in Chronic Neck Pain

In this study, the effect of kinesiophobia on pain, disability, and quality of life in individuals with chronic neck pain will be evaluated. Neck pain is a common musculoskeletal disorder that can become chronic in some individuals. Kinesiophobia may lead to a reduction in physical activity due to fear of movement and re-injury, thereby increasing pain and disability. In this cross-sectional study, 57 participants will be assessed using the Visual Analog Scale (VAS), Tampa Scale for Kinesiophobia (TSK), Neck Disability Index (NDI), and the SF-36 Quality of Life Scale. Participants will be selected from individuals aged 18-59 who have experienced neck pain for at least 3 months, and those with a history of neurological disorders, spinal surgery, or pain treatment in the last 3 months will be excluded. This research aims to determine the effects of kinesiophobia on chronic neck pain, thereby contributing to the development of more effective treatment strategies. Written informed consent will be obtained from all participants.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 59
* Patients of both genders experiencing neck pain for at least 3 months

Exclusion Criteria:

* Patients with neurological deficits
* Patients with any neurological disorder
* Patients with a history of spinal fractures, spinal tumors, or spinal infections
* Patients with a history of spinal surgery
* Patients with any congenital spinal anomaly
* Patients with vestibular disorders
* Patients taking antidepressant and antihypertensive medications
* Patients unwilling to participate in the study
* Patients who have received any pain treatment in the last 3 months
* Patients who have engaged in any strenuous physical activity within the 24 hours prior to the assessment
Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger

Aim:

The purpose of the study is to learn more about how a person recovers after treatment for mallet finger injury. The investigators want to identify the best outcome after mallet finger injury and how to improve treatment strategies.

Primary null hypothesis:

There are no statistically significant factors associated with extensor lag between 4 weeks and 4 months after immobilization is discontinued for a mallet finger among demographic, injury, and treatment factors.

Secondary null hypothesis:

There are no statistically significant factors associated with PROMIS upper extremity function between 4 weeks and 4 months after completion of immobilization for a mallet finger among demographic, psychological, injury, and treatment factors.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* English fluency and literacy
* Mallet finger fracture or non-fracture
* Mallet finger subluxation or non-subluxation

Exclusion Criteria:

* Pregnant Women
Effectiveness of an Eight Week Online Mediterranean Based Diet

This research is examining whether an 8-week online nutritional programming based on a Mediterranean diet can achieve meaningful increase intake of a Mediterranean based diet and improvements in measures of body weight and laboratory measures of oxidative stress, a risk marker for cardiovascular disease. This study will also examine whether weekly short support and communication from a medical assistant (MA) in a primary care setting in addition to the online program will result in better program adherence and have a positive impact on health.

Eligible participants will be identified by primary care providers or their staff at clinical outpatient site(s). Study is 3-arm randomized control trial where participants will be randomized to 1) Control group (CTL)-will not receive access to online program nor intervention for first 12 weeks; 2) GFFY-1-will receive access to online program without MA intervention 3) GFFY-2-will receive access to online program and MA intervention with weekly phone call. The core of the intervention is an 8-week Mediterranean diet and behavioral online program called "Go! Foods for You (GFFY)" which is offered on the Cleveland Clinic's 360.5.com website. The research will last for 24 weeks. Questionnaire data and biometric measurements will be collected at pre and post intervention (0-8 weeks) and at followup (12 and 24 weeks). Regardless of randomization, participants will be asked to provide their weight every week and an activity log at the end of each week of the program. A urine sample to measure F2-isoprostane will be collected at week 0 and 12 for GFFY-2 and CTL groups.

A preparatory phase requiring the involvement of MAs to provide weekly support to participants is necessary to test process and communication with MAs. Enrollment of 10-20 volunteers for the preparatory phase is desired. Data collected during this phase will not be part of study analysis. To test data collection process, we may ask a few participants to complete baseline questionnaire only.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 25 or greater.
* Age 18 to 70 years old.
* Patient of a participating Internal Medicine or Family Medicine primary care provider at a Cleveland Clinic Family Health Center.
* Registered on the Cleveland Clinic's electric medical records, My Chart.

Exclusion Criteria:

* Women who are pregnant or planning to be pregnant in the next 6 months.
* No easy internet and email access at place of residence.
* No access to a scale at place of residence for weekly weight measurement.
* Sudden unintentional weight loss or weight gain in the past 3 months due to medical illness
* Currently involved in a weight loss program
* unwilling to be in the wait-list control group where participant will not have access to the program for 3 months
* unwilling to log onto the internet on a regular basis for the duration of the study (3-4 months)
Continuous Saphenous Block Versus Continuous Femoral Block for Total Knee Arthroplasty

Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this study we compare two techniques for pain control after total knee arthroplasty in terms of preserving the motor function (the strength of the quadriceps muscles of the thigh) which will facilitate the rehabilitation and accelerate the hospital discharge. We will use ultrasound guided technique to block either the femoral nerve in the control group or the saphenous nerve in the experimental group. The primary outcome is the functional capacity and the impact of each block on the ability to walk by measuring the distance patients are able to walk in two minutes in post operative day one in the two groups. The secondary outcome is the morphine consumption in the two groups.


Eligibility Criteria:
Inclusion Criteria:

- Subject age over 18 years coming for total knee arthroplasty secondary to osteoarthritis

Exclusion Criteria:

* ASA 4-5
* Abnormal liver enzymes, hepatic failure, renal failure and cardiac failure if they become contraindication for the use of regional anesthesia
* Contraindications for spinal anesthesia
* Morbid obesity
* Organ transplant
* Neuropathic pain
* History of stroke or major neurological deficit
* Sensory and motor disorders in the operated limb
* Previous drug dependency
* Chronic use of opioids
* Allergy to local anesthetics
* Inability to comprehend pain assessment
Evaluation of RC28-E Injection in Diabetic Retinopathy

This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
* Aged 18 years to 80 years, male or female;
* Diabetes mellitus(type 1 or 2);
* Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
* BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
* If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye;

Exclusion Criteria:

* Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
* Evidence of retinal neovascularization on clinical examination or FA;
* Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
* Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
* History of vitreoretinal surgery in the study eye;
* Active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments in either eye ;
* Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0 visit;
* Previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day 0.
* Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
* Pregnant or lactating women, subjects who had family planning throughout the study period;
* Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theDay 0
* Those who considered unsuitable for enrollment by investigator.
Effects of Oxybutynin Topical Gel on Gastric Emptying

This study explores the effect of oxybutynin topical gel on gastric emptying


Eligibility Criteria:
Inclusion Criteria:

* Adult, healthy, post-menopausal females

Exclusion Criteria:

* Patients for whom OTG or acetaminophen is contraindicated.
* Abnormality of the GI tract.
* Taking drugs that affect gastric motility.
Effects of a Mobile App-Based Mindfulness Intervention in Persons with Spinal Cord Injury and Chronic Pain

The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic SCI of at least 6 months duration
* Chronic pain \[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\]
* Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys

Exclusion Criteria:

* Lack of daily internet access
* inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study
* Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations
* Use of any meditation more than once a week in the last 3 months
* Inability to provide or obtain an email address for registration to the AC intervention and/or communication with study staff
* inability to provide a phone number for communication with study staff
The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.


Eligibility Criteria:
Inclusion Criteria:

* Microspherophakia was diagnosed and lens diameter\<9mm;
* The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
* Lens dislocated into the anterior chamber;
* Lens dislocation caused elevated intraocular pressure (IOP);
* The lens contacted the corneal endothelium;
* Cataract;
* Corneal endothelial cell density\>1000/mm2;
* The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；
* There was possible improvement in postoperative visual acuity measured by retinometer.

Exclusion Criteria:

* The lens is centered and the position of the lens is stable;
* Glasses can correct the vision obviously;
* The reason for the elevated IOP was independent with the lens;
* A high possibility of corneal decompensation after surgery;
* Fundus function was poor and it is not expected to improve the vision after surgery;
* Combined with other ocular diseases which were not suitable for IOL implantation;
* Combined with a systemic disease that the patient cannot tolerate the surgery.
A Prospective Observational Case Series of a Four-ring-haptic Acrylic One-piece IOL

To describe biocompatibility, postoperative results and complications after implantation of the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.

In this prospective case series the Corneal Quatrix Evolutive IOL was implanted in 14 eyes of nine patients with senile cortico-nuclear cataract. A standardized surgical technique and post-operative regimen were applied. Six months postoperatively best corrected visual acuity (BCVA), refraction and complications (especially) posterior capsule opacification (PCO) were analysed.

Eligibility Criteria:
Inclusion Criteria:

Patients with senile cortico-nuclear cataracts without previous intraocular surgery

Exclusion Criteria:

* Dilated pupil size of \< 6 mm
* long-term anti-inflammatory treatment
* previous history of intraocular surgery
* previous history of corneal endothelial damage
* previous history of ocular trauma
* traumatic cataract
* history of uveitis
* diabetic retinopathy
* advanced macular degeneration