cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Male or female between 18 and 70 years, inclusive, at time of Screening.
* Chronic HCV-infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
* Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
* A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.
Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe.

A variety of surgical procedures have been developed for the treatment of MTP joint osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe. Patients will be evaluated for pain and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years postoperatively or until allograft failure. Stability of the allograft will be evaluated by the surgeon at these time points per radiographic imaging.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic of stage 3 osteoarthritis of the great toe
* symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator

Exclusion Criteria:

* diabetes mellitus
* kidney insufficiency
* oa in the adjacent joints
* malignancy with in the past 10 yrs
* minors (\< 18 yrs of age)
* pregnant women and fetus
* mentally disabled or cognitively impaired individuals
The Short-term Effects of Instrument-Based Mobilization Compared With Manual Mobilization for Low Back Pain: A Randomized ClinicalTrial

Objectives: To investigate the effectiveness of instrument-based mobilization compared with manual mobilization in patients with non-specific low back pain (NLBP), in terms of spinal muscle activation, decrease in pain, and improvement in range of motion (ROM).

Design: Randomized clinical trial, double blind. Participants and interventions: A total of 66 participants with localized NLBP will be divided into 2 groups matched for sex, age, and body mass index. The intervention group will receive central postero-anterior mobilization with a force of 150 N through physiotherapy instrument mobilization at the level of pain in the lumbar spine. The control group will receive central postero-anterior grade III mobilization through the pisiform grip method at the level of pain in the lumbar spine.

Main outcome measures: Measurements will be taken before the intervention, after the 1st session, after the 6th session, and at 4 weeks follow-up. Rehabilitative ultrasound imaging will be done to identify lumbar multifidus (LM) activation through the measurement of muscle thickness at the level of L5-L4 vertebrae, during rest and lower-extremity movement. Each participant will self-rate the pain intensity in the lumbar spine according to the Numeric Pain Rating Scale (NPRS). The pressure-pain threshold (PPT) will be measured using an algometer. Lumbar ROM will be measured using a dual inclinometer method in flexion and extension.

The results will be compared between the intervention and control groups through mixed analysis of variance for LM thickness, lumbar ROM, PPT, and NPRS.


Eligibility Criteria:
Inclusion Criteria:

* age 20-59 years (commonly affected age range), BMI 18.5-30 kg/m2 (normal to overweight), localized NLBP, pain duration \<12 months, and pain score ≥3/10 on the NPRS.

Exclusion Criteria:

* history of spinal surgery, significant previous back trauma, spinal or lower-extremity deformities, LBP associated with peripheral neurological symptoms (paraesthesia, anaesthesia, signs of nerve root compression), neurological diseases, systemic diseases (diabetes mellitus, rheumatoid arthritis), and any contraindication to manual therapy (spinal instability, healing fracture, dislocations, pregnancy in women).
Spring Loaded Tri-Compartment Unloader Knee Brace Study

This study will examine clinical outcomes related to pain and function in patients with anterior knee pain (i.e. focal patella and/or trochlea cartilage defect(s), patellofemoral arthritis) before and after standard of care, non-surgical management with and without the addition of a Tri-Compartment Unloader (TCU) knee brace during activities of daily living. Randomly selected participants will wear a TCU brace for several weeks during physical therapy and activities of daily living that is designed to reduce compressive forces in all three compartments of the knee during weight-bearing flexion. Our hypothesis is that TCU bracing will improve clinical outcomes relatednto pain and function.

Patients in this study have been identified as good candidates by their physicians. As the study procedures closely follow the standard of care procedures in place, study participation presents little additional risk above and beyond the standard of care procedures. The study was designed to present the least risk possible consistent with sound research design.

Participants in this study will undergo standard of care X-rays that will help in eligibility determination. Participants will be randomized to either group, and will have a 50% chance of receiving the brace. Outcomes will be measured at baseline (before any intervention), 6 weeks after commencing rehabilitation at Stanford, and 3 months after commencing rehabilitation at Stanford.

These outcome measures are collected using PatientiQ which is is being used at the clinic as part of standard of care. Spring Loaded Tech is providing the TCU braces for the patients in this study at no cost.

Eligibility Criteria:
Inclusion Criteria:

1. Anterior knee pain that worsens when the knee is flexed and bearing weight
2. Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
3. Kellgren and Lawrence grade 0-3 of PF joint
4. Able to wear the TCU knee brace for a minimum of 3 hours per day
5. Over 18 years old, can understand written English
6. Coronal knee alignment within 7 degrees of neutral
7. Must be able to fit within an off-the-shelf knee brace size provided by Company
8. Must complete physical therapy through Stanford

Exclusion Criteria:

1. Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year
2. Use of another brace designed to unload the knee or manage knee pain during the study
3. Varus/Valgus joint alignment \> 7 degrees
4. Inability to be fit properly in an off-the-shelf brace provided by the Company
5. BMI \>40
6. Bilateral knee symptoms
Strategy to Adapt Botulinum Toxin Doses in Dystonia

The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended.

We we ll study the increase of the dose injected over the time, the side effects...

The hypothesis is that we inject smaller doses than we could regarding the recommandations


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old followed for dystonia and treated with botulinum toxin

Exclusion Criteria:

* first dose of botulinum toxin not available
Binocular Vision Alternations and fMRI Activation After ICL Implantation for High Myopia

Implantable collamer lens (ICL) is one of the most effective operation for high myopia. Due to refractive correction changed, and prism effect of the spectacle removed, in the early stage after ICL implantation, binocular function might be dysfunction, leading to asthenopia, blurred vision, double vision and so on. This study will recruit the high myopia subjects that scheduled for ICL implantation, purpose to investigate the binocular vision alternations and brain activation that impacted by ICL implantation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* Spherical equivalent over -6.00DS, astigmatism within -2.00DC, anisometropia within -2.00DS
* BCVA ≥ 0.8
* Plan to accept implantable collamer lens surgery
* Near point of convergence within 10cm
* Positive fusion vergence over 20pd

Exclusion Criteria:

* Stabismus
* Previous ocular surgery or trauma
* History of vision therapy
* Monovision and nystagmus
* Mental disease or craniocerebral trauma
Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery

To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.

Primary Objectives The primary protocol objectives are to establish the safety of CDE-SSRS alone in participants with MESCC. Specifically, we aim to maintain an RM risk no greater than 1%. RM will be defined as non-functional paresis per the McCormick score (i.e., Grade D).

Secondary Objectives Secondary objectives include pain control as measured by the Brief Pain Inventory, quality of life as measured by the EQ-5D, symptom burden as measured by the MDASI-SP, overall survival, toxicity, ambulatory rate and cost-effectiveness. LC will be defined radiographically with serial MRI scans by the study radiologist per SPINO criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Greater than or equal to 18 years old
2. Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
3. Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
4. All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to select the minimal dose to the organ at risk which will achieve a GTV Dmin of 14 Gy at the treating physician's discretion.
5. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
6. All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy
7. All participants must have a vertebral level site of interest from C1 to S2
8. Signed informed consent
9. Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
10. Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
11. ECOG ≤ 2

Exclusion Criteria:

1. Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
2. Prior history of radiation at the spinal site of interest
3. Inability to lie supine comfortably for ≥ 60 minutes
4. Progressive neurological deficits due to compression
5. Inability of obtain an MRI
6. Inability or refusal to undergo an MR simulation
7. No eligible for single fraction SSRS for any reason
8. Participants who are pregnant
Xylitol Disk Use in Adults With Dry Mouth

The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth.

Xylitol,an FDA approved sugar substitute, has been shown to reduce tooth decay. Patients who experience dry mouth may be more susceptible to dental decay because they lack the protection provided by an adequate flow of saliva. These patients are likely to have high levels of the decay causing bacteria, mutans streptococci.

The purpose of this research is to test the ability of a novel xylitol delivery vehicle to reduce mutans streptococci in patients with dry mouth over a two week period. The delivery vehicle is a slowly dissolving xylitol disk (lozenge) that adheres to soft tissues inside the mouth. Participants will place disks on both sides of the mouth three times a day.

Eligibility Criteria:
Inclusion Criteria:

* Adults 21 years old or older
* Daily use of at least 2 prescription medications known to cause dry mouth
* Current report of dry mouth

Exclusion Criteria:

* Antibiotic use in the last month
* Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month
* Change in medication or dose within the last month
* Use of mouthwash within the last week
* Use of lozenges or chewing gum with 500 mg or more of xylitol on a habitual basis
* History of gastrointestinal disease
Prospective Cohort Study of Patients with Early Alzheimer's Disease Treated with Lecanemab

As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targets the core pathology of AD-abnormal amyloid-beta (Aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. The optimal dosage and safety-efficacy profile of lecanemab for treating early AD have been observed in phase 2 and phase 3 clinical trials. However, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (ARIA), such as microhemorrhages or hemosiderin deposits (ARIA-H), and ARIA-E. This study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early AD patients (stages 3-4), and monitor the risk factors for adverse event occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;
* Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;
* Completion of APOE gene testing.
* Willingness to use Lecanemab.

Exclusion Criteria:

* Unable to tolerate MRI scans;
* MRI showing hemorrhagic manifestations, including \>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations;
* Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding;
* With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.
Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus

The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus patients with inadequate glycemic control.

There are several kinds of oral antidiabetic drugs (OADs) that are used in the treatment of patients with type 2 DM. Among them, sulfonylurea and metformin are well-established first-line OADs. However, as the beta cell dysfunction progresses over time, patients fail to achieve good glycemic control with OADs alone and need further treatment intensification, usually involving the introduction of insulin either alone or in combination with OADs. Now, an OAD combined with bedtime insulin is one of the recommended treatment options for patients with type 2 DM and OAD failure. But, it still remains unclear which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

so, this study we will be able to verify which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 years old with type 2 DM
* Patients with inadequate glycemic control despite continuous use of tolerable or maximal doses of one or more OADs for 3months or more.
* 7%\<HbA1c\<11 % at screening
* 21 kg/m2 ≤ BMI ≤ 30 kg/m2
* Patents who need insulin add-on therapy based on investigator's discretion
* Patients who would give the informed consent
* Patients who can perform SMBG and record the data on the patient's diary

Exclusion Criteria:

* History of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
* Pregnant or lactating females
* History of drug or alcohol abuse
* Patients with known hypersensitivity to glimepiride, metformin HCL or insulin
* Night-shift workers
* Patients who are under insulin therapy at screening
* Treatment with any investigational products in the last 3 months before screening
* Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision
* Patients with serum creatinine level \> 1.5 mg/dl in male and \> 1.4 mg/dl in female
* Patients with ALT or AST \> 3x ULN
Cancer Stem Cells in Multiple Myeloma

In multiple myeloma "cancer stem" cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response.

The investigators' hypothesis is that, multiple myeloma plasma cells derivate from principal cells that is called "cancer or progenitor stem cell". In multiple myeloma to define immunophenotyping features of these "cancer stem cells" with flow cytometry and to show their prognostic value and check for any relationship between cancer stem cell quantification and chemotherapy response are main aims of this study.

Eligibility Criteria:
Inclusion Criteria:

* New Diagnosed or Relapsed Multiple Myeloma
* Routine Bone Marrow Aspiration will be done

Exclusion Criteria:

* Bone Marrow Aspiration is not Needed
Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months

Exclusion Criteria:

* Surgical treatment for PD
* Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
* Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply
Compression Headphone Study

The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli will be randomized.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18-99 years) with ≥3 months hearing aid experience
* binaural, symmetric, sensorineural N3 to N4 hearing loss
* able to use Android interface and receive a video call on phone/computer
* fluent in English

Exclusion Criteria:

* children/teenagers
* normal hearing or hearing loss exceeding N4 by 10dB
* cannot wear over-ear headphones
PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

This randomized phase III trial studies how well biologic mesh works in preventing parastomal hernia in patients with bladder cancer who are undergoing radical cystectomy, or removal of the bladder, and ileal conduit diversion. An ileal conduit is a tube created from your small intestine that will be used as a tube for urine to flow out of your body. Parastomal hernia is a type of hernia that can occur in the stomach area where the ileal conduit is placed. Biologic mesh may help prevent parastomal hernia following surgery and ileal conduit diversion.

PRIMARY OBJECTIVES:

I. To estimate the rate of developing parastomal hernia detected either clinically or radiologically in patients with radical cystectomy and ileal conduit, with or without mesh.

SECONDARY OBJECTIVES:

I. To estimate the rate of developing symptomatic parastomal hernia requiring surgical intervention in patients with radical cystectomy and ileal conduit with or without mesh.

II. To estimate the time from cystectomy with an ileal conduit to diagnosis of clinical parastomal hernia development in patients with radical cystectomy and ileal conduit with or without mesh.

III. To estimate the time from cystectomy with an ileal conduit to diagnosis of radiological parastomal hernia development in patients with radical cystectomy and ileal conduit with or without mesh.

IV. To estimate the rate of stomal prolapse and time to its development in patients with radical cystectomy and ileal conduit with or without mesh.

V. To evaluate mesh-related complications in mesh group.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit.

ARM II: Patients undergo standard of care radical cystectomy and placement of the ileal conduit.

After completion of study, patients are followed up every 2-4 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Bladder cancer, undergoing radical cystectomy and ileal conduit diversion
* Ability to understand and the willingness to sign a written informed consent
* Follow-up either here at University of Southern California (USC) or centers that are available to transfer the requested clinical and radiological data

Exclusion Criteria:

* Previous scar or mesh at the level of ileal conduit
* Survival less than 12 months after surgery (either predicted survival before surgery or actual survival after surgery \< 12 months)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cadaveric component, i.e. Flex HD