cyrilzakka/clinical-trials huggingface dataset:
Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis

There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* undergoing unilateral TKR for the treatment of osteoarthritis
* between the age of 18 and 85 years of age
* able to read, speak and understand English, have a telephone
* are able to provide consent

Exclusion Criteria:

* enrolled in another study, are
* undergoing revision surgery or bilateral surgery, and are
* over the age of 85 years. Patients will also be excluded if they
* have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* Must be ≥ 18 years at the time of signing informed consent.
* Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
* Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
* Must have documented disease progression during or after their last anti-myeloma therapy.
* All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

Exclusion Criteria:

* Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m\^2 dose twice weekly dosing schedule.
* Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
* Non-secretory multiple myeloma.
* Subjects with severe renal impairment requiring dialysis.
* Previous therapy with pomalidomide.
Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat

The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled.

BACKGROUND: Situation of Non-communicable disease groups. It was the number one health problem in the world. The situation in Thailand from 2017-2022 found an increase in the number of new diagnoses and death cases from stroke patients. For the situation in Trat Province, it was found that the situation of sickness rates tend to be stable. As for the death rate per 100,000 people from stroke, there was a continuous upward trend. Therefore, a research project was organized to study the factors of control disease (hypertension or non-insulin-dependent diabetes mellitus type 2) on the severity of stroke and survival rates within 1 year to be used as information for further patient care.

OBJECTIVES: To study factors that influence the severity of stroke and correlate with survival rates within 1 year in Trat Province.

METHODS: This is a retrospective analytic cohort study. Data was collected using a Case Record Form (CRF) to record information on a total of 291 cases of hypertension and non-insulin-dependent diabetes mellitus type 2 patients who entered the stroke treatment system at Trat Hospital in the year 2022. Data were analyzed by Chi-square statistics to test the relationship of NCD control with the severity of stroke and using Kaplan-Meier Curve test hypotheses for comparing survival rates using Log-rank test statistics.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have chronic hypertension or type 2 diabetes with a history of illness of at least 1 year before the stroke.
* Patients had a new stroke for the first time in his life, including an ischemic stroke. hemorrhagic stroke and hemorrhage in the brain
* The patient was confirmed by CT scan
* Thai nationality.

Exclusion Criteria:

* Patients diagnosed with cerebrovascular disease who have a previous history of ischemic or hemorrhagic stroke.
* Patients diagnosed with transient ischemic attack
* Patients who have a history of chronic disease that are at high risk of having a stroke, such as being a pregnant patient, still taking birth control pills.
* There are certain genetic diseases, such as antiphospholipid syndrome
* Patients had previous history of brain aneurysm, extracranial arterial dissection, atrial fibrillation, drug addict use, etc.
AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation

A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase.

The study aims to investigate the effect of a multidisciplinary multimodal intervention in allo-HSCT survivors on survivorship-specific health-related quality of life and late effects.

Method:

This study is designed as a one-site, two-arm prospective randomized controlled trial proceeding an internal pilot phase.

Population/recruitment:

Recruitment, inclusion, and exclusion criteria as described in the eligibility section. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.

Intervention:

a stepped-care multi-modal intervention

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age\> 18 years) treated with myeloablative or non-myeloablative HSCT in outpatient follow-up without recurrent disease are eligible for inclusion.

Exclusion Criteria:

* Patients with recurrence or subsequent malignancy requiring cancer treatment or lack of access to email and the Internet will be excluded.
CO-OPerative Training for Stroke Rehabilitation

Cognitive impairments occur frequently after stroke, and are associated with significant long-term activities of daily living (ADL) disability and poor quality of life. This research study will undertake an innovative approach addressing cognitive impairments, by examining a new patient-centered functionally-relevant rehabilitation intervention that teaches individuals with cognitive impairments to manage their deficits to reduce ADL disability.

Cognitive impairments are characterized by problems sustaining attention in distracting conditions, shifting attention between different task demands, and using working memory to consistently execute intended actions, and as a result limit the ability to execute routine ADLs. Presently there are no interventions that have demonstrated robust effectiveness in reducing disability among individuals with cognitive impairments after stroke. Recent findings suggest that individuals with cognitive impairments may experience ADL disability in part because they have difficulty engaging in, and benefiting from rehabilitation programs as they are currently delivered. In other words, individuals with cognitive impairment, due to the nature of their impairments, have difficulty learning and applying adaptive strategies as they are currently provided during traditional rehabilitation training. Therefore, interventions that train individuals with cognitive impairments a new way to learn and apply adaptive strategies may help them benefit from rehabilitation programs and reduce long-term disability. Cognitive Orientation to daily Occupation Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Therefore, CO-OP teaches individuals to "take charge" of their rehabilitation, and develop adaptive behaviors to "work around" cognitive impairments to meet their goals. The proposed project examines whether CO-OP facilitates reductions in ADL disability and improvements in rehabilitation engagement among individuals with cognitive impairments after acute stroke.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of acute stroke
* admission to acute inpatient rehabilitation
* impairment in cognitive functions (Quick Executive Interview ≥ 3)

Exclusion Criteria:

* dementia diagnosis (as indicated in the medical record)
* severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3)
* current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders)
* drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
* anticipated length of stay less than 5 days
Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.

OBJECTIVES:

Primary

* Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy.

Secondary

* Determine the clinical benefit in patients treated with this regimen.
* Determine the tolerability of this regimen in these patients.
* Determine local relapse-free survival of patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed esophageal cancer

  * Metastatic disease
* At least 1 unidimensionally measurable metastatic lesion

  * At least 10 mm by spiral scanner OR 20 mm by sequential scanner
  * Outside the field of prior radiotherapy
* No known symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 to 75

Performance status

* ECOG 0-2

Life expectancy

* At least 3 months

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3

Hepatic

* Bilirubin ≤ 1.5 times normal
* Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present)
* SGOT and SGPT ≤ 3 times normal

Renal

* Creatinine ≤ 1.5 mg/dL

Cardiovascular

* No myocardial infarction within the past 6 months
* No uncontrolled angina

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
* No other illness or medical condition that would preclude study participation
* No psychological, social, familial, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 6 months since prior fluorouracil and/or cisplatin
* No other prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* More than 6 weeks since prior radiotherapy

Surgery

* More than 4 weeks since prior surgery

Other

* No concurrent participation in another clinical study
An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD

This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.

Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.

Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participation in and successful completion of a prior Transcend-sponsored clinical trial with TSND-201.
* Agree to not participate in any other interventional clinical trials for the duration of this study.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
* Change or development of any physical or psychological finding that would make participant unsuitable for study.
Isthmocele After Two Different Sutures in Cesarean Section

Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT.

A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another.

The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with singleton gestations
* Between ≥37 and ≤42 gestational age
* \>18 \<45 years
* Undergoing primary or secondary elective or urgent cesarean delivery

Exclusion Criteria:

* Multiple gestations
* Preterm cesarean
* 2 or more prior cesarean deliveries
* Uterine malformations
* Prior myomectomy
* Placenta accreta/previa
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant

This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients.


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

Inclusion Criteria:

* Participants must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
* Participants chronically infected with hepatitis C virus (HCV) Genotype 1, 2, 3, 4, 5, or 6 with HCV RNA viral load of ≥10,000 IU/mL at screening
* Participants may be treatment-naïve or treatment-experienced
* Cirrhotic participants must have cirrhosis confirmed by biopsy, Fibroscan or fibrotest and Aspartate aminotransferase platelet ratio index (APRI) criteria as outlined in the protocol
* Post-transplant participants must be at least 3 months post-transplant with no evidence of moderate or severe rejection

Exclusion Criteria:

* History of multi-organ transplant, with the exception of dual transplantation of the liver/kidney, is prohibited
* Current or known history of cancer (with the following exceptions: In situ carcinoma of the cervix, adequately treated basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma within Milan criteria for transplantation) within 5 years prior to screening
* Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV (such as, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, or toxin exposures)
* History of HIV infection or chronic hepatitis B virus (HBV) as documented by HBV serologies (e.g., HBsAg-seropositive). Participants with resolved HBV infection may participate (e.g., HBcAb-seropositive with concurrent HBsAg-seronegative)
* Active hospitalization for decompensated liver disease
Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect

The purpose of this study is to determine whether galvanic vestibular stimulation is effective in the treatment of spatial neglect after right brain-damage.


Eligibility Criteria:
Inclusion Criteria:

* spatial neglect after unilateral ischemic infarction or unilateral haemorrhage

Exclusion Criteria:

* Chronic epilepsy
* Metallic implants (including pacemakers)
* Brain tumors
* Scalp inflammation
* Degenerative disease
Intelligibility Assessment for Parkinson's Disease

The investigators aim at testing the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.

Close to 90% of people with Parkinson's disease develop voice problems during the course of the disease. These problems lead to reduced intelligibility, which entails a subsequent reduction in social participation and overall quality of life. The current study will focus on developing and pilot-testing an app to measure the intelligibility of people with PD and of healthy controls. In order to test the app's efficacy, speakers will read a set of 50 sentences that will be embedded in noise for measurement purposes. A group of listeners will also transcribe the spoken sentences to correlate their performance to that of the app. The ultimate purpose of this investigation is to improve self-monitoring and self-sufficiency in people with PD. The study is expected to last 12 months.

Eligibility Criteria:
Speakers with PD:

Inclusion Criteria:

* Have a medical diagnosis of Parkinson's disease
* Have experienced changes in your voice (e.g., your voice has "lost its strength") and your voice is a current concern
* Have not received individual speech therapy for the past 2 years (group therapy is ok)
* Have a stable medication schedule
* Have not received DBS (Deep Brain Stimulation)
* Are a native speaker of American English

Exclusion Criteria:

* If criteria above are not met

Healthy controls:

Inclusion Criteria:

* Be a native speaker of American English
* Have no history of neurological impairment
* Have no history of speech or language problems

Exclusion Criteria:

* If criteria above are not met

Listeners:

Inclusion Criteria:

* Be a native speaker of American English
* Be between 18-55 years old
* Have no history of speech-language-hearing problems
* Pass a free hearing screening
* Have received the Covid19 vaccine

Exclusion Criteria:

* If criteria above are not met
Internet Auditory Rehabilitation: Follow-up to Adult Hearing Screening

The purpose of this study is to see if a newly developed program called "I Manage my hearing loss" (iManage) will increase the number of individuals who visit an audiologist after failing a hearing screening. The iManage program will educate individuals about hearing loss, demonstrate that hearing problems are important, demonstrate that support from family and friends is important and help participants identify the benefits and concerns related to seeking help for hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Subject must fail a hearing screening (any threshold \>34 decibels hearing level at 2000 or 3000 Hertz in either ear) or show equivalent or greater degree of hearing loss on most recent audiogram.
* Free of obvious outer or middle ear disease (as measured by otoscopy)
* Between the ages of 45 and 85
* Pass a health literacy screening
* Pass a thinking skills screening

Exclusion Criteria:

* Experience seeing an audiologist for a hearing evaluation or management
* Experience using a hearing aid
NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study

This single-center proof of concept study aims to assess the efficacy of a blood pressure strategy targeting person- and time-specific cerebral blood flow compared with standard-of-care using neuron-specific enolase as a quantitative biomarker of brain injury. Our central hypothesis is that an individualized blood pressure strategy targeting cerebral perfusion, compared with standard-of-care, will reduce the extent of brain injury as indicated by changes in levels of neuron-specific enolase from baseline at 72 hours. To test this hypothesis, the investigators will randomly assign 90 patients to an individualized blood pressure management strategy targeting cerebral blood flow, where optimal blood pressure will be serially calculated by the ICM+ brain monitoring software (Cambridge, UK) using inputs from transcranial Doppler ultrasound and near-infrared spectroscopy (intervention), versus achieving a standard level of systemic blood pressure (standard-of-care). This is done in a 2:1 allocation (60 to intervention, 30 to standard-of-care), in the first 72 hours after return of spontaneous circulation (ROSC).


Eligibility Criteria:
Inclusion Criteria:

1. At least 21 years of age
2. Comatose defined as not being able to obey verbal commands and no verbal response to pain after sustained ROSC.

Exclusion Criteria:

1. ≥ 80 years old at time of enrolment
2. Pregnant patients
3. Limitations of care or life support therapy withdrawn within 24 hours of admission