cyrilzakka/clinical-trials huggingface dataset:
Assessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial

Assessment of bone quality and quantity for three dimensional bone augmentation for maxilla using titanium meshes loaded with bone marrow aspirate mixed with xenograft versus xenograft mixed with autografts only


Eligibility Criteria:
Inclusion Criteria:

* Patients are free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.

  * Edentulous anterior or posterior maxilla with deficient alveolar ridge that is less than 5 mm measured from the crest of the alveolar ridge to the nasal or maxillary sinus and less than 4mm in buccolingual width.
  * The minimum number of missing teeth in the alveolar ridge is two adjacent teeth.

Exclusion Criteria:

* Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.

  * Previous grafting procedures in the edentulous area.
Real-World Use of Novel Treatments in Patients With Spinal Muscular Atrophy (SMA): A Multi-Site Retrospective Chart Review of Pediatric SMA Patients Outside of the United States

This global, retrospective, non-interventional, medical chart review (MCR), descriptive study collected patient-level data in regions outside the US.

The study required a repeated data collection at follow-up dates from start of treatment with nusinersen, onasemnogene abeparvovec-xioi (OA), and/or risdiplam. At the start of data collection, the study team reached out to the health care providers (HCPs) involved in treating pediatric SMA patients for participating in this study. The physicians across the participating countries conducted a retrospective MCR of pediatric patients diagnosed with SMA who were treated with at least 1of the 3 novel disease-modifying treatments (DMTs): nusinersen, OA, and/or risdiplam.

All health care encounters data i.e., emergency and inpatient admissions, surgery, and outpatient consultations of recruited patients, including their treatment with nusinersen, OA, and/or risdiplam, were abstracted to understand the treatment patterns as per routine clinical practice for SMA management globally. The first date of initial administration of 1 of the 3 target drugs was used as the "index date." Based on this, the record abstraction was performed through a retrospective MCR during the pre-index period, at index date and in the post-index period.


Eligibility Criteria:
Inclusion criteria:

* Genetically confirmed diagnosis of SMA.
* Aged less than 5 years at index date.
* Initiated treatment with nusinersen or onasemnogene abeparvovec-xioi or risdiplam or any combination of them during the identification period.
* Availability of medical information in chart for at least 1 visit prior to initiation of treatment with the target treatment(s).

Exclusion criteria:

None
Treatment of Keratosis Pilaris With 810 nm Diode Laser

The investigators hope to establish whether or not the diode laser, a longer-wavelength laser, is effective in treating keratosis pilaris, and hopefully opening a door into the discussion and management of this skin condition. The primary outcome of interest is the difference in the overall blind rater severity scores of the treated versus the untreated sites. The secondary outcome of interest is the change in the patient's self-rated severity score of the treated site. To account for potential natural disease progression or regression, the investigators will also compare patient mean changes to the mean changes in severity scores of the untreated site.


Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18 to 65
* Subject has diagnosis of keratosis pilaris involving both arms
* Subject has Fitzpatrick Skin Type I - III
* Subject is in good health
* Subject has the willingness and ability to understand and provide informed consen

Exclusion Criteria:

* Under 18 or over 65 years of age
* Subjects with Fitzpatrick Skin Type greater than III
* Subjects who have received any laser therapy to the armsin the past year
* Subjects with concurrent diagnosis of another skin condition or malignancy
* Subjects with tan or sunburn over the upper arms in the past month
* Subjects with open, non-healing sores or infections at any skin site
* Subjects who are unable to understand the protocol or give informed consent
* Subjects who take oral photosensitizing medications or who apply topical photosensitizing medications to either arm
GCSF Adjunct Therapy for Biliary Atresia

The Investigators propose to test the hypothesis that GCSF therapy enhances the clinical outcome of Kasai operated Biliary Atresia (BA) patients. In this study, Investigators will conduct a dose determination for GCSF use in post Kasai subjects to support a future phase 2 efficacy study. The first 3 post Kasai BA subjects with liver biopsy-confirmed BA will be given 5 ug/kg/d of GCSF in 3 daily subcutaneous doses starting on post Kasai day 3. A second group of 3 subjects will be assigned to the 10 ug/Kg/d dose after the 5ug/kg/d dose has been proven to be safe. The levels of circulating hematopoietic stem cells and a 1-month safety profile will be analyzed.

In BA, neonatal fibrous obliteration of the biliary tract obstructs biliary drainage and promotes biliary fibrosis. BA is the leading cause of pediatric chronic end-stage liver disease and pediatric liver transplantation. Relief of cholestasis by the Kasai portoenterostomy is only partly successful with continued progression of fibrosis to hepatic insufficiency and, for long term survival, with eventual need for liver transplantation in the majority of the patients. In animal models of liver injury, GCSF enhances hematopoietic stem cell HSC mobilization and engraftment in the liver with associated improved liver repair response and attenuated hepatic necrosis and fibrosis. Randomized controlled trials of GCSF intervention for chronic liver failure in adult patients with acute hepatic decompensation showed improved short-term survival and hepatic indices such the model for end-stage liver disease (MELD) scores.

The Investigators propose that post Kasai GCSF therapy attenuates biliary fibrosis and progression to cirrhosis. The objectives are meant to demonstrate that Kasai-GCSF sequential therapy improves biliary drainage, and delays the progression of hepatic insufficiency. Toward this goal, Investigators will first evaluate in post Kasai subjects the maximum tolerated dose of GCSF in mobilizing circulating CD34+ hematopoietic stem cells, with the limiting dose based on GCSF-related severe adverse effects. A one-month safety of GCSF will be tested with the 2 standard doses of 5 ug/kg/d and 10 ug/kg/d.

Eligibility Criteria:
Inclusion Criteria:

1. Completed the preliminary work up for cholestasis with suspected or inconclusive diagnosis of BA
2. Gestational Age \> 36wks
3. Weight \> 2 Kg
4. Age \>-2 weeks-\<180 days at diagnosis
5. Serum Direct Bilirubin \> 2 mg/dL GGT \> 100 U/L
6. Kasai operated patients for Type 3 or 4 anatomy of BA
7. Cholangiogram/porta hepatis findings diagnostic of BA
8. Liver biopsy supporting BA diagnosis

Exclusion Criteria:

1. Having access to liver transplantation for immediate Kasai failure
2. Prior Kasai patients
3. Major cardiac, renal, CNS malformations with poor prognosis
4. Intracranial hemorrhage
5. History of recent TPN use within the last 2 weeks of surgery
6. GI tract obstruction
7. Laparoscopic Kasai repair
FES-Rowing: Preventing the Secondary Conditions of Paralysis Through Vigorous Exercise

Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. Despite the success of the FES-rowing Program at Spaulding, FES-rowing systems have not yet evolved beyond research prototypes, and ours is the only program in the US where FES-rowing is available. A new design is critically needed to enable people with paralysis to participate in FES rowing in their own homes, which we believe will maximize both the health and commercial impacts of FES-rowing.

The purpose of this observational study is to gain insights into user needs, and market perception of physical activity and FES-rowing to further develop a new, home-based FES-rowing system that meets the needs of people with paralysis. We will enroll a total of 20 subjects, male and female, 18 years and older with lower-limb paralysis who use a wheelchair as their primary means of mobility. Ten subjects will be current FES-rowing participants (especially those doing FES-rowing at home) and 10 subjects will be non-participants. To determine user needs we will survey prospective customers to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing.

Questionnaires:

Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI): measures barriers to physical activity across the intrapersonal and interpersonal domains.

Physical Activity and Disability Survey (PADS): measures physical activity for people with chronic neurological conditions.

Demographic and Mobility Questionnaire: Important information to inform on user and design needs and potential market for at home FES-row system.

Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)-(FES-row participants only): measures satisfaction with current FES-row system used in the ExPD Program.

Eligibility Criteria:
* male and female,
* 18 years of age and older
* lower-limb paralysis who use a wheelchair as their primary means of mobility.

Exclusion Criteria:

* Under 18 years of age
* no lower-limb paralysis
* People who do not use a wheelchair as their primary means of mobility
Blind and Ultrasound Guided Injection in Morton Neuroma

The aim of this work trial is to compare the effectiveness of blind and ultrasound guided injection for Morton neuroma in order to determine which is more appropriate as the initial procedure in conservative treatment

This is a evaluator-blinded randomized trial. The final sample size has been calculated to be 100 patients. 50 of group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. 50 of group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance.

The inclusion criteria are clinical suspicion of Morton neuroma confirmed in ultrasound scan. Included patients are assessed clinically by VAS score, the Manchester Foot Pain and Disability Schedule (MFPDS), and a generic quality-of-life instrument, the EQ-5D.

Injection includes 1 cc of 2% mepivacaine and 40 mg of triamcinolone in each web space with Morton Neuroma. According evolution until 4 injections were allowed the first 2 months of follow-up, Follow up was performed by phone calls and/or scheduled consultations at 15 days, 1 month, 45 days, 2 months, 3 months, 6 months and 1 year.

Statistical analysis was performed by unpaired Student's t test

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of Morton neuroma confirmed in ultrasound scan
* Symptoms present more than six months
* The thickness of the nerve must be at least 2 mm in short axis and at least 5 mm in the longitudinal axis.

Exclusion Criteria:

* Contraindication for the use of corticosteroids or local anesthetics
* Presence of inflammatory arthropathy or neuropathy
* Skin lesions in the area
* diabetes mellitus
* Infiltration or previous surgery in the area
* Refusal to participate in the study
3TC or No 3TC for HIV With 3TC Resistance

The purpose of this study is to compare the effects of continuing or discontinuing 3TC treatment in the presence of HIV virus with 3TC resistance for persons who are on a regimen including least three other anti-HIV drugs. The overall aim is to determine whether continuing 3TC is of benefit in HIV-positive persons who have already shown resistance to this drug.


Eligibility Criteria:
Inclusion Criteria:

* Be HIV positive
* Be at least 18 years old.
* Currently receiving 3TC for HIV infection in conjunction with at least three other antiretroviral drugs. Must have started this regimen at least three months prior to starting this study.
* A plasma viral load of less than 50 copies/mL on at least two occasions (measured at least 28 days apart immediately prior to screening).
* Evidence of resistance to 3TC

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Hepatitis B surface antigen (HbsAg) positive at time of screening or with the previous year.
Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough

This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old.
* Fulfilling the American College of Rheumatology criteria for SSc.
* For ILD subgroup (n=6):

  * An upright chest-roentgenogram (chest x-ray) is abnormal and compatible with an interstitial lung disease.
  * HRCT of the chest confirms the presence of bilateral reticular, ground glass, and/or honeycomb abnormalities that is otherwise unexplained by an alternative process
  * The HRCT fibrosis score must be ≥ 7.
  * The total lung capacity (TLC, measured by body plethysmography) and/or the diffusing capacity of the lung for carbon monoxide (DLCO) is below the predicted normal.
  * The forced vital capacity (FVC) is reduced below the predicted normal.
  * The patient is symptomatic (i.e. dyspnea and/or a chronic cough) for more than 8 weeks that is otherwise unexplained by an alternative mechanism.
* For No ILD subgroup (n=6):

  * No radiographic evidence of ILD on plain chest x-ray.
  * The HRCT fibrosis score, when performed) must be \< 7
  * The TLC and FVC are within their predicted normal.
  * The DLCO is within the predicted normal, except when reduced in isolation by pulmonary hypertension.

Exclusion Criteria:

* Active smoking within the 6 months.
* Pneumonia or bronchitis in past 4 weeks.
* Active acute illness such as uncontrolled heart failure, infection, or asthma.
* Use of more than 3 liters per minute (LPM) of oxygen by nasal cannula at rest.
* Coordinator, investigator, or clinician concerns on the patient's compliance, safety, or in ability to complete study requirements.
* Morbid condition not expected to live more than 1 year.
* Alternative cause or diagnosis for the patient's ILD besides SSc.
* Pregnancy.
* Obstructive lung disease with an FEV1 (forced expiratory volume in 1 second) to FVC ratio less than 0.7, nor radiographic evidence of emphysema on CT.
* Planned therapeutic procedures involving the esophagus (e.g. dilation, surgery) prior to completion of study tests
Future Patient - Telerehabilitation of Patients With Heart Failure II

The aim of the study is to test and evaluate the use of video consultations and an algorithm for weight gain and loss in the Future Patient Telerehabilitation program for HF patients in an RCT.

Next steps The Future Patient study - telerehabilitation of HF patients II

Based on the preliminary results from FP I (being published fall 2020) and a review of literature, the investigators would like to improve our telerehabilitation program and technologies in order to prepare for implementation of the FTP and technologies.

* The HF patients in FP I expressed that the KCCQ was too long when having to complete the questionnaire every other week. Therefore, the investigators would like to test a shorter questionnaire HeartQoL (ESC) as a patient-reported outcome tool every month.
* Video consultations instead of physical meetings with doctors and nurses at the hospital. Currently, there is a lack of evidence regarding the use of video to decrease physical visits at the hospitals instead of video consultations.
* Test of algorithms for detecting an increase in weight on two days following clinical cardiac guidelines (Ponikowski et al 2016).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with HF NYHA Class II-IV, who have a current hospitalization for acute decompensated HF or a visit to the HF outpatient clinic within the past two weeks
* Patients with an EF of 40% or less
* Adults (18 years or older); no upper age limit
* Patients living in Viborg and Skive Municipality
* Patients living at home and capable of caring for themselves
* Have basic computer skills or a relative who have basic computer skills

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Present and previous neurologic, musculoskeletal or cognitive disability or active psychiatric history (as noted in the medical record) other than depression or anxiety related to cardiac or other chronic illness
* Lack of ability to cooperate
* Does not speak/read/understand Danish
Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®

The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.

Evaluate the long term safety and effectiveness of the X-Stop interspinous process decompression system In the patients who received the X-Stop under the IDE. These patients consist of two cohorts to be evaluated: patients who had moderately impaired physical function prior to X-Stop implantation (as determined by a baseline score \>2.0 in the physical function (PF) domain of the Zurich claudication questionnaire), and patients who had mildly impaired physical function prior to X-Stop surgery(as determined by a baseline score \<=2.0 in the PF domain of the Zurich claudication questionnaire (ZCQ), through the fifth postoperative year. Clinical examination will be performed at each office visit to confirm the absence of neurological complications. X-ray films (AP/lateral views) taken during the fifth postoperative year will, be analyzed to confirm A) maintenance of distraction and B) the absence of radiological evidence of device-related complications. Secondary endpoints will include mean scores from the SF-36, and incidence rates of adverse events, device failures, and secondary surgeries.

Eligibility Criteria:
Inclusion Criteria:

A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:

1. Completed participation in the Pivotal Trial, CAP, or COS and has the X STOP implant(s) intact at the time of LTOS enrollment; OR is an active CAP/COS participant, has the X STOP implant(s) intact, and has not completed a 24-month follow-up visit in his/her CAP/COS study.
2. Is willing and able to provide Informed Consent
3. Is willing and able to return to the clinic for a clinical evaluation or complete study questionnaires without a clinic visit.

Exclusion Criteria:

A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:

1. Participated in the Pivotal Trial as part of the X STOP group, but the device has been removed.
2. Participated in the CAP or COS programs, but the device has been removed.
Travoprost 0.004%/Timolol 0.5% Versus Latanoprost 0.005%/Timolol in Chinese Patients With Open-Angle Glaucoma or Ocular Hypertension

Eligible patients will be randomized in a 1.1 ratio to receive Travoprost 0.004%/timolol 0.5% once daily or Latanoprost 0.005%/Timolol 0.5% once a day for 8 Weeks. The study treatments will be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8.

Safety parameters measured at 4 study visits: ocular signs, visual acuity, dilated fundus, cardiovascular parameters (blood pressure and pulse), and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma or ocular hypertension who are not sufficiently responsive to topical beta-blockers or prostaglandin analogues.
* Patients must meet the following IOP criteria in at least one eye. For each qualifying eye, the mean IOP should be ≥21 mmHg at 9 AM and 11 AM time points at the eligibility visit
* The mean IOP in either eye at the eligibility visit must not be greater than 35 mmHg at any time point.

Exclusion Criteria:

* Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension.
* Patients with iridocorneal angle Shaffer grade \< 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy
* Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
* Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of ≤ 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
* Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
* History of ocular trauma within the past 6 months.
* Intraocular surgery within the past 3 months.
* Ocular laser surgery within the past 3 months.
* Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
* Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients' history and/or examination.
* History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment.
* Any abnormality preventing reliable applanation tonometry.