cyrilzakka/clinical-trials huggingface dataset:
Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus

Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore, an alternative medication with the same efficacy, but without the side-effects is sought after.

Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its efficacy in treating discoid lupus erythematosus has not been studied extensively yet. However studies performed till now show promising results. Long-term topical use of this medication has not shown any serious side-effects in other skin diseases.

In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an alternative medication in treating discoid lupus erythematosus.


Eligibility Criteria:
Inclusion Criteria:

* Patients harboring discoid lupus erythematosus lesions on their face or neck

Exclusion Criteria:

* Patients with discoid lupus erythematosus in the setting of systemic lupus erythematosus
* Patients having a more disseminated disease
OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction

The purpose of the OPTIMISER Registry is to prospectively and retrospectively collect baseline, clinical and procedural data in patients who present with AMI and are treated with PCI as well as prospectively collect the clinical outcome data. Outcomes will be compared in different clinical subgroups. The impact of PCI in AMI in general as well as cardiovascular outcomes after AMI will be assessed.

* To assess procedural success and clinical outcomes among persons with AMI, who undergo PCI and/ or CABG for AMI (STEMI or NSTEMI)

  1. Periprocedural outcomes/ complications, which will be analyzed, represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging)
  2. Short and long-term clinical outcomes of interest including: new AMI, unstable angina (UA), stent-/scaffold thrombosis, target lesion failure, target vessel revascularization, ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death.
* To describe procedural and clinical performance of various balloon, stent and scaffold devices implanted in patients presenting with AMI during the afore mentioned period
* To study the impact of different devices and strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI
* To describe early and late angiographic and OCT-findings among coronary artery disease in patients with AMI treated with various metallic stent and scaffold devices
* To assess possible predictors for coronary stent implantation or device failure
* To evaluate the impact of different antithrombotic regimens on patient clinical outcomes
* To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices.
* To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.

Eligibility Criteria:
Inclusion Criteria:

* Subject \>18 years of age
* Individuals who are newly diagnosed with AMI or have been diagnosed with AMI (STEMI or NSTEMI) within the last 5 years (since 2016).
* Subjects must be willing to sign a patient informed consent (PIC) OR a patient ́s relative/ proxy are willing to provide PIC or patients have signed the General Consent (GK).

Exclusion Criteria:

* Patient unwilling or unable to provide informed consent
* Patients with no ACS/AMI (e.g. Takotsubo cardiomyopathy, acute heart failure not related to AMI)
Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.

This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.

The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.

Eligibility Criteria:
Inclusion Criteria:

* Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg

Exclusion Criteria:

-
Remote Electronic Patient Monitoring in Gastrointestinal Cancer

The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.

Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.

The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosed with gastrointestinal cancer
* Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
* Planning to receive outpatient care at the MGH Cancer Center
* Ability to read and respond to questions in English

Exclusion Criteria:

* Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
* Enrolled in hospice
* Planning to be discharged to any location other than their home
Efficacy and Tolerability of MLC601 in Patients With Mild to Moderate Alzheimer Disease Who Were Unable to Tolerate or Failed to Benefit From Treatment With Rivastigmine

Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer disease (AD) offer limited and often transient symptomatic benefits to patients but do not mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with Rivastigmine.

An 18-month open-label pilot study would be conducted at three university referral centres in Tehran, Iran. All patients are at least 50 years old, met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and failed treatment with the cholinesterase inhibitor Rivastigmine for any reason. A baseline medical history will be taken and physical examination will be performed for all participants, and any comorbidities and concomitant therapies would be noted. Patients with controlled concomitant diseases, such as hypertension and diabetes, will be allowed to enter the study. Mini-Mental State Examination (MMSE)10 and Alzheimer disease assessment scale-cognitive sub scale11 (ADAS-cog) will be used to measure treatment efficacy. MLC601 will be prescribed as one capsule three times daily without an escalation dose. Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. The MMSE and ADAS-cog will be recorded at each efficacy follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* at least 50 years old
* met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
* failed treatment with the cholinesterase inhibitor Rivastigmine for any reason

Exclusion Criteria:

* uncontrolled diabetes mellitus
* hypertension
* unstable cardiac disease
* severe obstructive pulmonary disease
* renal or hepatic failure
* and/or other life threatening conditions
A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones

Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union (NU) fractures are hampered by lack of validated quantitative assessment tools for bone fracture healing during normal and delayed healing processes. In actual practice, sequential X-rays usually follow a pre-determined time interval in patients with fractures.They constitute the best available state of the art used by surgeons to assess the fracture healing course.

In an attempt to improve between raters reliability of radiographic assessment of healing, studies have explored a novel radiographic assessment for tibial shaft fractures, the Radiographic Union Scale for Tibial Fractures (RUST). The RUST assesses the presence of bridging callus and a fracture line on each of four cortices (seen on anterior-posterior and lateral views). This callus based scoring system has been since extended to other bones than the tibia in a retrospective case series. It has been renamed modified radiological union score (mRUS) and has shown potential value in bone healing measurement.

Based on an initial retrospective study in nail-treated fractures, the first objective of the present investigation is to prospectively validate mRUS as a tool to identify patients at increased risk of DU and NU within the first 75-110 days after fracture occurrence. This prospective validation will be performed on a retrospective cohort of patients having sustained long bone fractures, including both upper and lower extremities. A further objective of the present investigation is to apply the scoring system to tomographic imaging in case of nail/plate treated fractures, deriving a tomographic union score (TUS) and first assess its potential value in bone healing for fractures treated by nails/plates.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patient (\>18 and \< 80 years old)
* Patient with nail(s) (for mRUS validation study and TUS exploratory study) or plate(s) (for TUS exploratory study) treated long bone fractures, corresponding to the following OA/OTA classification: 11-A, 12-A, -B and -C, 13-A, 21-A, 22-A, -B and -C, , 31-A3, 32-A, -B and -C, 33-A 41-A2 and A3, 42-A, -B and -C and 43-A
* Patient for whom outcome of fracture is known
* For the mRUS validation study, patient with one follow up X-ray imaging performed 75-110 days after fracture occurrence
* For the TUS exploratory study, patient with one follow up CT-scan imaging performed 75-110 days after the fracture occurrence

Exclusion Criteria:

* Bone infection diagnosed between time of the fracture occurrence and the X-Ray or CT-scan imaging performed 75-110 days after the fracture occurrence
* Previous fracture and previous surgery on the fractured bone
* Bone tumour or history of bone tumour
* Bone metastasis
* Known evidence for ongoing metabolic bone disease (e.g. chronic renal failure, hyper or hypoparathyroidism, rickets, Paget's disease of bone, inherited or congenital bone abnormalities)
* Patient with current traumatic brain injury
Clinical Performance of Two Different Bevel Preparations in Class IV Lesions Using Nanofilled Composite

The purpose of the study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations.

The main reason for failure in anterior composite restorations is restoration fracture and aesthetic appearance. Restorations in anterior teeth are subjected to high-impact stresses produced through an incisal angle in class IV restorations, require high fracture resistance. It is the biomechanics of restorations that determine their functionality, retention, and functional longevity. Stair-step chamfer preparation is a modification of chamfer preparation that follows the vertical and horizontal anatomical contours, hence, achieves high degree of aesthetics along with exposure of enamel for bonding. According to current literature, no studies have analyzed the clinical performance of different bevel design using direct nano-filled composite resin restorations in Class IV lesions.

Therefore, the aim of this study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations.

Study will be conducted at Post Graduate Institute of Dental Sciences, Rohtak in Department of Conservative Dentistry \& Endodontics. Time Frame of the study will be 12 months. Patients ≥ 18 years of age with Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries will be enrolled in the study.

After complete carious removal, tooth will be prepared in class IV lesions according to 2mm bevel or 2mm stair-step chamfer preparation group, selective enamel etching and bonding of the tooth using universal adhesive will be done. The cavity will be restored using nanofilled composite by layering technique. The restorations will be undergoing the standard finishing and polishing procedures.

Follow up of patients will be carried out at 3 months for clinical evaluation, 6 and 12 months for both radiographic and clinical evaluation. Restorations will be assessed clinically according to FDI criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age at the time of treatment.
* Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries.
* Patients with complete and normal occlusion and teeth with proximal contacts.
* Patients not having periodontal or pulpal diseases.
* Positive response to the cold test and electric pulp test.

Exclusion Criteria:

* Patients with immunocompromised status or debilitating systemic diseases.
* Patients with uncontrolled parafunctional habits.
* Class IV lesion with involvement of pulp.ix
* Class IV lesions with no involvement of dentin.
* Patients presenting extremely poor oral hygiene.
* Patient with high caries index
Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients

Postoperative residual curarization in the post anaesthesia unit has been associated to complications involving respiratory function and impaired laryngeal and pharyngeal muscles' function. Speed of reversal of neuromuscular blockade after administration of sugammadex versus neostigmine has been studied, but up to date no data are available concerning continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in morbidly obese patients undergoing weight loss surgery. The investigators' aim in this prospective, double-blinded study was to compare train of four ( TOF ) values, the presence or absence of clinical criteria of postoperative residual curarization , the dose requirements and the side effects of sugammadex and neostigmine for the reversal of rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open surgery for morbid obesity.

Morbidly obese patients \[ body mass index (BMI) \> 40 kg/m2 \] planned to undergo open or laparoscopic surgery for weight loss will be managed with standardized general anesthesia (intravenous Propofol combined with remifentanil and muscle relaxation induced by rocuronium).

By the end of the surgery, Group A and group E patients will receive sugammadex 2 mg/kg corrected body weight \[corrected body weight(CBW)=ideal body weight(IBW) + 40%(real body weight(RBW)-ideal body weight)\] when T2 arises in adductor pollicis. Group C and group G will receive neostigmine 50μg/kg corrected body weight when T2 arises in adductor pollicis. Group B and group F patients will receive sugammadex 2 mg/kg ideal body weight when T2 arises in adductor pollicis. Group D and group H patients will receive 50μg/kg neostigmine ideal body weight.

Investigators will proceed in continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii during induction of anaesthesia, surgery, recovery and in the post anaesthesia care unit, recording TOF values. Total consumption of neuromuscular blocking agent, doses of reversal agents and clinical criteria of post operation residual curarization will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>40kg
* Age \< 60
* Patients written consent to participate in the study

Exclusion Criteria:

* Cardiovascular disease (NYHA\>2)
* Patients refusal to participate in the study
* Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
* coexisting neuromuscular disease
* history of allergic reaction to neuromuscular blocking agents
* history of difficult intubation
* creatinine levels \> 159lmol/l
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma

This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion Criteria: - Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation - Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty o previous laser or incisional intraocular surgery that might interfere with the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in the study eye - Active or history of chronic uveitis in the study eye - Unable to discontinue contact lens wear in the study eye during the study
The Metabolic Response to Reduced Branched-chain Amino Acids in Humans

Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from proteins found in food, especially meat, diary products, and legumes. Data from rodent studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs without reducing calorie intake will lead to similar metabolic benefits in humans. Here the investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement beverages for two months.

This study, which will be completed over three months, involves replacing two meals a day with meal replacement beverages for two months, with a one month follow-up visit. These beverages will be made up by subjects using either a complete protein powder or BCAD2, a BCAA-free medical food. Participants will complete food diaries at baseline and at one month intervals during the study, and compliance will be assessed via food diaries, weekly telephone contact, and measuring returned food powder.

Eligibility Criteria:
Inclusion Criteria:

1. Male between the age of 35 - 65
2. BMI between 28 - 35 (mildly obese/overweight)
3. Fasting glucose level of 101 - 125 mg/dL
4. Able and willing to give written informed consent
5. Stable weight (within 5 lbs. for at least 3 months)
6. Not taking (or willing to cease taking) over the counter vitamin/mineral supplements
7. Not planning to begin an exercise or diet program

Exclusion Criteria:

1. Female
2. Outside required age range of 35 - 65
3. BMI not within range of 28 - 35
4. Fasting glucose not within range of 101 - 125 mg/dL
5. Use of prescription medications for diabetes or weight-loss
6. Use of and unwillingness to discontinue over the counter supplements (e.g. cinnamon, chromium, protein powders) or weight loss beverage or meal plans (e.g. SlimFast or Jenny Craig).
7. Low baseline albumin or pre-albumin levels (below normal reference range)
8. Significant anemia (Hemoglobin \< 11 g/dL)
9. Known bleeding disorder or platelet dysfunction
10. Already eating a low protein diet (less than 14% total caloric intake from protein), as calculated from food diaries provided by subjects
11. Participating in intensive exercise training program (high to moderate intensity exercise greater than 210 minutes per week) or planning to start new exercise program during study period.
12. Significant co-morbidities (including kidney disease, liver disease, GI disease, cardiovascular disease, respiratory disease, malnutrition, substance abuse, psychiatric disease, or a diagnosed eating disorder).
13. Planned smoking cessation or attempt at smoking cessation during study period
14. Inability to tolerate meal replacement beverages due to palatability
15. Recent weight loss (\> 5 lbs within 3 months).
16. Bariatric surgery, gastric banding or liposuction
17. Current or past (within 1 year) use of illicit drugs
18. Claustrophobia