cyrilzakka/clinical-trials huggingface dataset:
Extracorporeal Therapy on Shoulder and Neck Pain

The purpose of this research was to investigate the clinical effects on the ESWT treatment of shoulder and neck pain.

Extracorporeal shock wave therapy (ESWT) has been used to treat various musculoskeletal disorders. The beneficial effects of the ESWT included pain alleviation and improvement in local blood circulation. However, few study exploring the effects of the ESWT for subjects with shoulder and neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific shoulder and neck pain
* Ages between 20yr to 45yr
* Shoulder and neck syndrome of upper trapezius and levator scapulae more than 3 months
* No using medicine such as anodyne and muscle relaxants.

Exclusion Criteria:

-
Vertical Ridge Augmentation With Autogenous Onlay Blocks Combined With Guided Bone Regeneration Versus Autogenous Bone Graft With Titanium Mesh in Posterior Mandible

Atrophic ridge augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. GBR was initially employed to treat simple defects, including dehiscence and fenestration defects. In addition, GBR has been utilized for horizontal and vertical ridge augmentations and has demonstrated reproducible outcomes, with high implant survival rates and low complication rates. The results of recent clinical and histologic studies of ridge augmentation with GBR indicated that autogenous bone graft may be a suitable material for staged localized ridge augmentation in both horizontal and vertical augmentations. The main advantages of autogenous grafts are their osteogenic, osteoinductive and osteoconductive capabilities. Because of these qualities, autogenous grafts are considered by many to be the gold standard for bone regeneration

The GBR Procedure requires to place a barrier between the bone graft and the surrounding soft tissues. This blocks the fast-duplicating connective and epithelial cells from colonizing the regenerating site.

Collagen membranes have been successfully used as a barrier membrane in clinical practice.

They have the advantage of being resorbable and pose less post-operative complications. On the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge.

Alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. They provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect.

However they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence.

Choice of the comparator:

Current studies have shown that using titanium mesh as a barrier to protect the bone graft during GBR can be considered successful in terms of vertical bone gain.

There might be variable in other findings which could be attributed to differences in the methodology, such as using other membranes over the titanium mesh (collagen or PTFE membranes).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with edentulous posterior mandible.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.
* Residual alveolar bone height more than 6 mm (7-9 mm) and less than 12 mm.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual ridge.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH

The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology.

On day 1 (Visit 1), the research subject will present to the Translational and Clinical Research Center (TCRC) after an overnight fast. We will obtain informed consent, check vital signs, take anthropometric measurements, and draw fasting blood work through an intravenous catheter. The subject will then be provided a standard mixed meal to be consumed within 30 minutes. Additional blood will be drawn at the time of meal completion (0 minutes), as well as 5, 15, 30, 60, 90, and 120 minutes following the meal. During study days 3-15, the subject will take 7 mg of oral semaglutide once daily. On day 16 (Visit 2), the research subject will return to the TCRC. During this visit, the subject will take the final (14th) dose of semaglutide, receive fasting blood work, and receive another mixed meal with subsequent blood draws at several time points over 120 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Males or non-pregnant females
2. Ages 18-50 (inclusive)
3. Able/willing to give consent
4. Span the metabolic range between normal glycemia and pre-diabetes (fasting glucose of 100-125 mg/dL based on chart review of existing laboratory data)

Exclusion Criteria:

1. Currently taking medications or intending to take medications for diabetes
2. Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
3. Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis
4. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
5. Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 per the Modification of Diet in Renal Disease equation
6. History of cirrhosis and/or aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal
7. Dietary restrictions preventing consumption of a MMTT
8. Women who are pregnant, nursing, or at risk of becoming pregnant
9. Participation in other interventional studies during the current study
A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns

The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices.

The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices. It is believed that this device will not only avoid many of the side effects when fluorescent tube lights are used, since it delivers safer, non-ultraviolet light; but may also be more effective than currently-used blankets or mattresses, which use blue halogen lamps or fluorescent tubes as light sources. The light is emitted under the baby. This study will discover if this device should be used in place of the currently-used devices.

Eligibility Criteria:
Inclusion Criteria:

* Male and female newborns greater of equal to 28 weeks GA
* Parental informed consent
* Enrollment at age greater than 6 hrs of age until neonatal discharge
* Phototherapy routine order

Exclusion Criteria:

* Infant requiring respiratory assistance (such as mechanical ventilation)
* Severe or life-threatening congenital anomalies
* Blood transfusion history
Allergy Testing of Patients Labeled as Penicillin Allergic

Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as "penicillin allergic" is associated with increased health care costs, adverse effects and antibiotic resistance. The investigators will recruit participants from primary care practices labeled as penicillin allergic and offer allergy testing. The aim of this study is to develop a community, outpatient program for evaluation of penicillin allergy.


Eligibility Criteria:
Inclusion Criteria:

1. Labeled as having penicillin or amoxicillin allergy
2. Family history of penicillin allergy

Exclusion Criteria:

1. History of beta-lactam associated toxic epidermal necrolysis/Stevens Johnson syndrome to penicillin or amoxicillin
2. History of Drug induced Eosinophilia with Systemic Symptoms (DRESS)
3. History of drug induced: autoimmune hepatitis/interstitial nephritis, or hemolytic anemia
4. Poorly controlled asthma or heart disease
5. Currently pregnant
6. Unable to discontinue certain medications that may interfere with testing including (antihistamines, steroids, beta-blockers, tricyclic antidepressants, omalizumab)
Happy Bob App: a Preliminary Evaluation of Its Use in Youth with Diabetes

The goal of this clinical trial is to evaluate the impact of peer support via the Happy Bob phone app in youth with Type 1 Diabetes.

The main questions it aims to answer are: What is the usability and acceptability of the app? What is the app's efficacy on measures such as treatment adherence and social support? And how are these effects impacted by remote patient monitoring by clinic staff?

Participants will use the Happy Bob app for 6 months and will complete a series of surveys at the start, middle, and end of their use of the app. Some participants will participate in 2 remote patient monitoring sessions when beginning their use of the app.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone

Exclusion Criteria:

Non-English Speaking
Fracture of Distal Radius and Ulna Healed With Shortening of One Bone. Clinical Significance at Skeletal Maturity

The fractures of distal forearm are the most common trauma in children. Sometimes one of the bones becomes shortened as a result of fracture fragments overlap. When some amount of shortening exists, concern regarding relationship of distal radio-ulnar joint (DRUJ) arises. The common opinion is expressed in one of the textbooks and is represented by one sentence, which usually one bone shortening is well tolerated, probably does not cause a problem, and does not have clinical significance. However, pathology of ulna plus or minus variants is well described and may cause ulno-carpal abutting syndrome or radiocarpal pain. This concern may lead to more aggressive approach in treatment of a fracture, with attempts to make an equal bone length. We did not find in the literature study that investigates this problem. We postulate that obvious shortening of one bone may cause an inequality of DRUJ and can be clinically significant.

We will evaluate the x-ray films of children that at the time of the injury were between the ages 1 day and 12 years. The selection of the x-ray films will be done based on the specific codes of the wrist x-rays (Ulna or Radius).

The evaluation will be merely to children that were treated in our hospital from 1996 to 2000.We are aiming to find cases when the fractures were healed with 1cm or more of shortening of one of the forearm's bones (Radius or Ulna).

We are going to compare these cases with another 20 patients with the same characteristics as the latter groups on the exception that their fractures were healed without shortening. The two groups will be matched by age, gender and the same diagnosis.

These patients will be summoned to the clinic when they are adult in respect to the skeletal maturity. The patients will be evaluated, including clinical examination of the hand wrists (left and right), motion rang, motor muscle function, description of abnormalities if there are and x-ray of both wrists.

Eligibility Criteria:
Inclusion Criteria:

* Children that had had Ulna or Radius X-rays
* Signing Informed consent.

Exclusion Criteria:

- Unwillingness to sign informed consent.
Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage

The purpose of this study is to learn about protecting the brain from dangerous low blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment.
* Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate.

Exclusion Criteria:

* Hunt Hess Scale \> 4
* Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort.
* Inability to obtain informed consent from the patient or a health care proxy.
* Ankle-brachial index \< 0.7
* Inability to start limb preconditioning within 4 days of bleeding.
* Inability to precondition a leg that is not-plegic (that is preserved anti- gravity strength) and has not been accessed for catheter angiography
* Age\<18 years
* Pregnant women
* Prisoners
CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent document;
* Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
* Near spectacle add of +0.50 or greater;
* Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
* Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
* Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses;
* Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
* Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

* Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP);
* Prior refractive surgery;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pathological dry eye that precludes contact lens wear;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Participation in any clinical study within 30 days of Visit 1;
* Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
* Other protocol-specific exclusion criteria may apply.
Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Men and women 18 - 80 years
3. Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease)
4. Symptomatic PAH (WHO- functional class II-IV) invasively diagnosed by right heart catheterisation

   * Mean pulmonary artery pressure (mPAP) \> 25 mmHg
   * Pulmonary capillary wedge pressure (PCWP) \> 15 mmHg
   * Pulmonary vascular resistance (PVR) at baseline \>320 dyn.sec/cm5 patients under optimized medical treatment since at least 2 ½ months

Exclusion Criteria:

1. Other forms of PAH.
2. Pregnancy or lactation
3. Change in medication during the last 2 ½ months
4. Patients with signs of right heart decompensation
5. Severe impairment of walking
6. Unclear diagnosis
7. No invasive diagnosis of PH
8. Acute illness, infection, fever
9. Severe lung disease with FEV1 \<50% and TLC\< 70% below reference
Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study

To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with photon/proton therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Treated with photon/proton at Mayo Clinic Rochester in Radiation Oncology
2. Radiation therapy for curative intent

Exclusion Criteria:

None
Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer

The goal of this observational study is to learn about the diagnostic performance of a novel Neoantigen-Reactive CD8+ T cell (NART) technology detecting minimal residual disease (MRD) in postoperative surveillance of pancreatic cancer. The main question it aims to answer is: Is NART a sensitive and accurate detection for MRD? Participants are required to undergo periodic blood sampling and imaging examinations as the protocol specifies.


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* Assessd as resectable PDAC before surgical procedure
* Voluntary to donate tumor samples resected in curative surgery for PDAC
* Voluntary to participate in the radiological evaluation, tests of serum tumor markers, and the collection of MRD samples according to the study protocol
* ECOG state (PS) grades ≤ 2
* Voluntary to sign informed consent and adhering to the requirements and limitations outlined by lCD and this protocol
* Confimed as pancreatic ductal adenocarcinoma by pathology
* RO or R1 resection
* Clinically evalutated eligible for adjuvant therapy
* Tumor tissue samples meet the requirements of whole exome sequencing (WES)

Exclusion Criteria:

* Preoperative imaging examinations show distant metastasis
* Have received neoadjuvant therapy
* Have any other active malignancy within 5 years before enrollment, or have any other indolent cancers that did not interfere with the primary cancer assessment in the study without prior approval from the research committee
* With other physical or mental conditions that may increase the risk of study participation or (in the investigator's judgment) may make the subject ineligible for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities
* Have participated in other interventional or observational clinical studies
Pilot Sugar Reduction Intervention in Kiritimati Teenagers

Kiritimati is an isolated coral atoll in the Pacific Ocean, and is one of 32 islands that comprise the Republic of Kiribati. Obesity and type 2 diabetes rates are high in Kiribati, but the causes and rates of childhood obesity/diabetes are unknown. However, it has been hypothesized that high consumption of sugar-sweetened beverages on Kiritimati may be a contributing factor. The investigators therefore conducted a study in Kiritimati in September 2018 with the aim of 1) quantifying obesity and diabetes rates amongst children on Kiritimati and 2) testing the feasibility of a sugar-reduction intervention in Kiritimati schools. The investigators randomized the two high schools on the island to either the control group or the intervention group. The investigators measured height/weight, continuous blood glucose (using flash glucose monitoring), and diet (using 24-hour diet recalls). One week into the study, the intervention school received an intervention, which consisted of installation of a water filter at the school, the provision of water bottles to each student at the school, and a 30-minute educational presentation on the link between sugar consumption and type 2 diabetes. The investigators then measured how blood glucose and diet changed the week following the intervention, and compared this to the control school.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in one of the two high schools on Kiritimati

Exclusion Criteria:

* \> 18 years of age
Real-world Clinical Efficacy of Abatacept in the T3 Data Registry

The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, "Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n \~= 200)".

Two secondary hypotheses that will be tested are:

* Abatacept aids in achieving low disease activity or clinical remission in patients of the following Rheumatoid Arthritis (RA) sub-groups: RF+/CCP+, RF+/CCP- RF-/CCP+ RF-/CCP-; first time on a bio-tech drug; having previously failed a biological drug; having interstitial lung disease; identified as disabled; twenty-eight individual joints identified as {swollen, painful, tender, deformed or having decreased range of motion}; on or not on oral DMARD; age; or gender.
* A database with sufficient attributes exists from which a patient's efficacy on abatacept is accurately predictable.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis
* Have used Abatacept for 3 or more months

Exclusion Criteria:

* None
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
* Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
* At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Exclusion Criteria:

* Brain metastases
* Malignant pleural effusion that is recurrent
* Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment