cyrilzakka/clinical-trials huggingface dataset:
Total Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty

There are concerns that total infrapatellar fat pad (IPFP) excision in total knee arthroplasty (TKA) results in patellar tendon shortening due to ischemic contracture. But, individual preference of the surgeon is still the main determinant between total or partial excision. The aim of this randomized controlled trial is to compare knee society score (KSS), knee extension and flexion peak torque in patients undergoing TKA with total IPFP excision or partial IPFP excision. The hypothesis of the study is that during TKA, total IPFP excision would lead to worse isokinetic performance and clinical outcome.

A total of 72 patients scheduled to undergo TKA for primary osteoarthritis of the knee by a single surgeon were randomly assigned to either the total or partial excision group. Patients were evaluated preoperatively and at postoperative 1 year, with Knee Society Score (KSS) and isokinetic measurements. Physiatrist doing isokinetic tests and patients were blinded to the study.


Eligibility Criteria:
Inclusion Criteria:

* Age between 55 and 80 years
* Scheduled to undergo unilateral TKA on for primary knee osteoarthritis

Exclusion Criteria:

* Inflammatory arthritis
* Post-traumatic osteoarthritis
* Previous knee surgery
* Neuromuscular diseases
* Bilateral TKA
* Insufficiency of collateral ligaments
A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab \[400, 1000, 1500, and 2000 milligrams (mg)\]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe RA for at least 6 months
* Positive serum rheumatoid factor (\>/= 20 international units per milliliter)
* Current treatment with RA on an outpatient basis
* Treatment failure with one disease modifying anti-rheumatic drug (DMARD) or biologic, but have not failed more than six of these agents including methotrexate
* Current treatment with methotrexate for at least 12 weeks, at a stable dose
* Use of highly effective contraception.

Exclusion Criteria:

* Rheumatic autoimmune disease or inflammatory joint disease, other than RA
* Concurrent treatment with any disease-modifying anti-rheumatic drug (DMARD) (other than methotrexate) or any anti-tumor necrosis factor (TNF) -alfa or other biologic therapy
* Treatment with any other investigational drug within 4 weeks of screening
* Previous treatment with cell-depleting therapies, IV gamma-globulin, intra-articular or parenteral corticosteroids, and receipt of live/attenuated vaccine prior to screening
* Previous treatment with rituximab or any other anti-cluster of differentiation 20 (CD20) agent
* History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies
* Known active bacterial, viral or fungal infections
* History of active tuberculosis and primary or secondary immunodeficiency
* History of concomitant diseases such as cardiovascular disease, nervous system, pulmonary disease, renal, hepatic, endocrine or gastrointestinal disorders
* Pregnancy or lactation.
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer

The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
* Metastatic disease
* Documented disease progression after prior gemcitabine based therapy
* KPS \>/= 70
* Adequate bone marrow function
* Adequate hepatic function
* Adequate renal function

Exclusion Criteria:

* Active CNS metastasis
* Clinically significant GI disorders
* Severe arterial thromboembolic events less than 6 months before inclusion
* NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
* Active infection or uncontrolled fever
* Pregnant or breast feeding patients
Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and vascular procedures and major orthopedic surgery (primarily complex spine surgeries).

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.

This multi-center, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using the ROTEM Delta.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥18 years
* Subject is scheduled for either 1) cardiac or vascular surgery utilizing cardiopulmonary bypass (CPB) or 2) orthopedic surgery including major deformity correction spine surgery
* Subject has a cardiac assist device and is hospitalized for any procedure
* Subject underwent cardiac, vascular or orthopedic surgery and presents with acute bleeding or suspected hypercoagulability in a post-surgical unit
* Subject is undergoing emergency cardiac, vascular or orthopedic surgery
* Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* Subject is unable to provide written informed consent
* Subject is younger than 18 years
* Subject is incarcerated at the time of the study
* Subject is pregnant
* Subject is currently enrolled in a study that might confound the result of the proposed study
* Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
EMDR for Depressed People With Multiple Sclerosis

Several studies have reported high rates of depression in people with MS. Depressive symptoms represent a serious threat to quality of life and well-being. Furthermore, findings from the literature suggest that mechanisms underneath depressive features and loss of physical functions in MS could be related. The current study aims at investigating the feasibility of a fairly new type of psychotherapy known as "eye movement desensitization and reprocessing" (EMDR) on depression in people with MS. The goal of this intervention is to reduce the long-lasting effects of distressing memories by developing more adaptive coping mechanisms, through bilateral sensory stimulation. Together with the study on clinical measures, brain mechanisms of change will be assessed with MRI. Fifteen depressed or mildly depressed people with MS will be recruited. Participants will be assessed for depression, and quality of life, before and after the intervention. Participants will also undergo an MRI for brain structural and functional assessments before and after the EMDR intervention. The main aim of the study is to verify that EMDR is a feasible psychotherapeutic approach for people with depression and MS and to collect preliminary data on the efficacy of this type of intervention in reducing the depressive symptoms and improving the quality of life. The study, however, will not be limited to the analysis of outcome differences. The use of MRI assessments, in fact, will allow to explore possible brain change modifications related to depression reduction and/or symptoms modifications.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing-remitting or progressive MS.
* Presence of depressive symptomatology, with HADS scores \> 8, confirmed by HDRS scores (clinical interview) \> 14.
* No change of pharmacological treatment in the 3 months before the enrolment.
* Ability to communicate and to understand tasks.
* No clinical relapses or use of steroid treatment during the 4 weeks before the enrolment.
* Provided informed consent for study participation.

Exclusion Criteria:

* Severe co-morbidity that would reduce life expectancy to less than one year (i.e. end-stage oncological diseases or severe cardiac dysfunction).
* Severe neuropsychological impairment evaluated with the MMSE.
* Psychosis or dissociative disorders.
* No current psychotherapy treatment
* Pregnancy.
Telerehabilitation Program in Persistent COVID-19

The syndrome characterized by the persistence of symptoms typical of COVID-19, beyond 4 weeks after discharge, is called long COVID. Long COVID affects a high percentage of patients who have suffered from COVID-19, regardless of its severity. The various symptoms present in that patients affect the functionality and physical, mental and psychological capacities of patients. Therefore, it is necessary to implement therapeutic programs, based on exercises and techniques of physiotherapy, to help affected people to resume their work, family, social and sports activities; prior to illness. Given the context in which these programs must be developed, telecare is positioned as the most recommended care method to carry out the rehabilitation of these patients. The general objective of this study is to evaluate the effectiveness of a cardiorespiratory tele-rehabilitation program in persistent COVID-19 patients. Study participants (n=60) will be randomly assigned to one of two intervention groups. Group 1 will combine breathing exercises with aerobic exercise: walk; and group 2 will perform functional exercises in addition to respiratory physiotherapy with. All participants will be evaluated at the beginning of the intervention, at the end of it.


Eligibility Criteria:
Inclusion Criteria:

* Who have been diagnosed with coronavirus infection (PCR + and / or Antigen Test +).
* Have had a mild form of COVID-19 (absence of symptoms or mild symptoms without signs of viral pneumonia or hypoxia).
* Have overcome such infection; and continue to experience persistent symptoms, including dyspnea, fatigue, and / or functional limitation.

Exclusion Criteria:

* Subjects suffering from other pulmonary or cardiac pathologies and / or diabetes, cancer.
* Individuals who required hospitalization, during the acute stage of infection;
* People who continue to obtain a positive PCR and / or positive Antigen Test;
* Those who have not been discharged by their doctor;
* Subjects who show serious symptoms and / or require medical supervision;
* Individuals with an inability to handle the internet and devices, such as mobile phones, computers or tablets; essential for telecare
Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)

The purpose of this study is to establish the feasibility of a program of remotely supervised transcranial direct current stimulation (RS-tDCS) paired with language skills practice for people living with the semantic or logopenic variants of primary progressive aphasia (PPA). There are currently no established standard-of-care treatments for PPA. This study will evaluate whether RS-tDCS combined with language skills practice is a feasible study design for individuals with PPA.


Eligibility Criteria:
Inclusion Criteria:

1. Primary progressive aphasia diagnosis (logopenic or semantic variant)
2. Peabody Picture Vocabulary Test (PPVT) score \< -1.0 SD, serving as a literacy proxy for premorbid cognitive ability and ensuring English language fluency sufficient for participation in the study procedures.
3. WAIS-IV Matrix Reasoning T score \< 20, serving as an index of current general cognitive functioning to exclude those with severe cognitive impairment
4. Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
5. Fluent in English language (due to outcomes validated in English versions only)

Exclusion Criteria:

1. Disorder other than PPA known to cause language dysfunction
2. Diagnosis of nonfluent/agrammatic subtype of primary progressive aphasia
3. History of traumatic brain injury
4. Uncontrolled seizure disorder and/or recent (\<5 years) history of seizure
5. Metal implants in the head or neck
6. Any skin disorder or skin sensitive area near stimulation locations
7. Pregnant or breastfeeding
Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T

Long-term follow-up of study subjects who received AGT103-T product in HIV study. The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants.

The primary objective of this study is to monitor study participant who receive the genetically modified gag specific CD4 T cells for the long term adverse event, evaluate sustained impact on immunity and the persistence of vector modified CD4 T cells.

Eligibility Criteria:
Inclusion Criteria:

1. Received the investigational product, AGT103-T, in the AGT-sponsored AGT-HC168 clinical trial
2. Provided written informed consent, signed and dated by the study participant in the long-term follow-up study

Exclusion Criteria:

1. Did not receive the investigational product, AGT103-T
Radiotherapy for Extracranial Oligometastatic Breast Cancer

More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. \>2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* ECOG performance status 0-2.
* Newly-diagnosed or metachronous extracranial oligometastatic diseases confirmed by pathology or imaging, with or without locoregional disease (biopsy of metastasis is preferred).
* Total number of locoregional and metastatic lesions of 1-5 , the maximum diameter of lesions ≤5 cm and at least one lesion could be evaluated by RECIST1.1.
* Have received or plan to receive systemic therapy.
* All lesions could be safely treated by radiotherapy.
* Life expectancy \> 6 months.
* Have adequate organ function.

Exclusion Criteria:

* Have metastases in the central nervous system.
* have indications for palliative radiotherapy to reduce symptoms, such as pain, bleeding, obstruction, and pending fractures caused by the tumor.
* Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases, .
* Malignant pleural effusion
* Unable to tolerate radiotherapy due to serious comorbidity
* Have received prior radiotherapy for target area
* Pregnant or lactating women
A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants

The objective of this study is to measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range of ≥ 18.5 to \< 38.0 kilogram-meter squared (kg/m\^2) at the Screening visit

Participants With Renal Impairment

* Participants that are not undergoing dialysis must have mild, moderate, or severe renal impairment based upon their Modification of Diet in Renal Disease (MDRD) creatinine clearance estimate (estimated glomerular filtration rate \[eGFR\]) calculated at the Screening visit:

  1. Mild renal impairment: 60 to 89 milliliters per minute (mL/min)/1.73 m\^2
  2. Moderate renal impairment: 30 to 59 mL/min/1.73 m\^2
  3. Severe renal impairment: No lower limit of eGFR, \<30 mL/min
* A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit.

Healthy Participants

* Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by MDRD, must be normal (ie, eGFR \> 90 mL/min/1.73 m\^2).
* Matched to each participant with moderate renal impairment with respect to sex, age (± 5 years), and BMI (± 10%).

Exclusion Criteria:

* Participants with life expectancy less than 3 months.
* History or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function.
* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Breast cancer within the past 10 years.
* Participant with poor venous access.
Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy

The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.

During ureteroscopic treatment for ureteral stones, lithotripsy, irrigation, and manipulation of the stone often pushes stone away into the kidney itself. This phenomenon is called retropulsion, which is defined as clinically significant retrograde migration of stone or stone fragments. Movement of stones retrograde into the renal pelvis could potentially add and complicate the surgery further. Often scopes need to be changed in order to reach the stone, and chasing these stones will add time to the surgery and require more valuable resources. Furthermore, sometimes a second operation will need to be done when these retropulsed fragments could not be all found and cleaned out.

A number of devices have been developed to prevent such migration including stone baskets and conical devices. These are wire-based devices which have the potential of injuring the ureter. Because of safety concerns and that there is limited data available on the effectiveness of these devices; these are not widely used by urologists. BackStop has recently been developed as another tool to prevent retropulsion. It is a water soluble gel that is injected proximal to the stone. This creates a physical barrier that prevents stone migration during ureteroscopic lithotripsy for ureteral calculus.

Eligibility Criteria:
Inclusion Criteria:

* patient with solitary ureteral stone ranging from 5mm to 15mm diameter
* able to tolerate general anesthesia
* clinical indication for treatment by ureteroscopic lithotripsy
* must be willing and able to participate in any follow-up visits
* provide informed consent
* have a CT scan demonstrating the stone

Exclusion Criteria:

* patients undergoing extracorporeal shock wave lithotripsy (ESWL) or any other extracorporeal or percutaneous lithotripsy procedure as primary procedure
* any co-morbidity or condition that would necessitate exclusion of patient (physician opinion)
* renal or ureteral anatomical abnormality
* multiple stones in the indicated ureter
* stones in the indicated kidney
* patient is immunocompromised
* multiple organ dysfunction syndrome
* has an absolute or relative solitary kidney mass
* \>= Stage 3 chronic kidney disease
* bilateral ureteral obstructing stones
* staghorn calculi
* impaction of several stone fragments (Steinstrasse)
* uncorrected coagulopathy/thrombocytopenia
* urethral and/or ureteral stricture
* reconstructive urinary surgery
Healthy Liver - Healthy Brain

People with liver disease report difficulties with attention and problem-solving skills. Diet plays an important role in the development of liver disease and/or pre-diabetes. The purpose of this study is to examine whether participation in a brief diet intervention (up to 3 weeks) can improve brain and liver health and function.

The importance of liver function for brain and cognitive health is undeniable. Specifically, adults with chronic liver diseases such as non-alcoholic fatty liver disease (NAFLD), a factor of metabolic syndrome (MetS), experience a range of symptoms including problems with attention, problem solving skills and executive function. Importantly, diet plays a role in the development of NAFLD. The investigators propose to be the first to demonstrate that Metabolic syndrome-related brain vulnerability, in the form of elevated free cerebral glutamate, is related to hepatic triglyceride level, through experimental manipulation of liver fat and multiorgan imaging. The investigators seek to improve liver health by altering diet content in a block randomized feeding trial. The investigators selected a low-carbohydrate (\<30 g/d) diet (LoCHO) to reduce liver fat and a low-calorie (LoCAL) diet as a control for weight loss. The investigators hypothesize that LoCHO diet will improve cognitive performance by improving liver health and thus, brain health. This work may provide a way to support brain function in MetS and delay cognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* at least 40 years of age
* English speakers
* show a minimum of 5% hepatic triglyceride level on liver imaging
* have not taken part in a weight loss/dietary intervention within 6 months
* not currently adhering to a low-carbohydrate diet (e.g., Atkins, Paleo)

Exclusion Criteria:

* younger than 40 years of age
* have a history of neurological disease (e.g. stroke, seizure disorder)
* psychiatric illness (e.g. schizophrenia, bipolar disorder)
* harmful alcohol use (AUDIT-C score \>5)
* morbid obesity (BMI\>40)
* MRI contraindications