cyrilzakka/clinical-trials huggingface dataset:
Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.
* Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.
* Patient is willing to comply with follow up

Exclusion Criteria:

* Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.
* Patient had active infection
* Implants were implanted without bone cement
* Patients did not have sufficient bone stock to allow for insertion and fixation of components
* Patient did not have sufficient soft tissue integrity to allow for stability
* Patient had a neurological or muscular deformity that did not allow for control of the knee.
Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint.

II. To assess time to progression and 2-year overall survival after bortezomib therapy.

III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed classical Hodgkin's lymphoma

  * No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis
  * Core biopsies allowed if they contain adequate tissue for primary diagnosis
* The following subtypes are allowed:

  * Nodular sclerosis
  * Lymphocyte rich
  * Mixed cellularity
  * Lymphocyte depletion
  * Classical Hodgkin's lymphoma, not otherwise specified
* No nodular lymphocyte-predominant Hodgkin's lymphoma
* Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen
* Measurable disease by physical exam or imaging studies

  * Any tumor mass \> 1 cm is allowed
  * No non-measurable disease only, including the following:

    * Bone lesions
    * Ascites
    * Pleural or pericardial effusion
    * Lymphangitis cutis/pulmonis
    * Bone marrow
* No curative option available with high-dose therapy and stem cell transplantation
* Performance status - 0-2
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 2.5 times ULN
* Creatinine ≤ 2.5 mg/dL
* No sensory or motor peripheral neuropathy ≥ grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 3 months after study participation
* See Disease Characteristics
* Prior stem cell transplantation allowed
* See Disease Characteristics
* No concurrent chemotherapy
* No concurrent dexamethasone or other steroidal antiemetics

  * Concurrent steroids for adrenal failure allowed
* Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
* Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present
* No concurrent palliative radiotherapy
* Recovered from all prior treatment
* No prior bortezomib or other proteosome inhibitors
Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-8 years
* Signed Informed consent by parent or guardian
* Meet all inclusion criteria.

Exclusion Criteria:

* Children with a history of developmental delay or cognitive deficit
* Children unable to complete the GSE (including visual acuity testing)
Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD

The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state.

The longitude observational study will be performed to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). We will follow up the subjects at 3-, 6-, 9-, 12-, 18-, 24-, 30-, and 36-month-old. Clinical diagnosis will be made on 24-month-old or after, with the DSM-5 as the diagnostic criterion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were enrolled as high-risk if they had an older sibling with a clinical diagnosis of ASD confirmed on the Autism Diagnostic Observation Schedule, second edition (ADOS-2) or Autism Diagnostic Interview (ADI-R).
* Subjects were enrolled in the low-risk group if they had an older sibling without evidence of ASD and no family history of a first or second-degree relative with ASD.

Exclusion Criteria:

1. diagnosis or physical signs strongly suggestive of a genetic condition or syndrome (e.g., fragile X syndrome) reported to be associated with ASDs;
2. a significant medical or neurological condition affecting growth, development or cognition (e.g., CNS infection, seizure disorder, congenital heart disease);
3. sensory impairment such as vision or hearing loss;
4. low birth weight (\<2000 grams) or prematurity (\<37 weeks gestation);
5. possible perinatal brain injury from exposure to in-utero exogenous compounds reported to likely affect the brain adversely in at least some individuals (e.g., alcohol, selected prescription medications);
6. contraindication for MRI (e.g., metal implants);
7. a family history of intellectual disability, psychosis, schizophrenia or bipolar disorder in a first-degree relative.
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are randomized to isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.

Eligibility Criteria:
Inclusion Criteria:

* Patients with candidemia or with an invasive Candida infection
* Presence of fever, hypothermia or other appropriate local sign of infection
* Female patients must be non-lactating and at no risk of pregnancy

Exclusion Criteria:

* Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens
* Patients with candidemia who failed a previous antifungal therapy for the same infection
* Patients previously enrolled in a phase III study with isavuconazole
* Patients with a body weight \<40kg
Intraarticular Collagen in Patients With Gonarthrosis

The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following:

1. - Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.
2. - Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.
3. - Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.

Patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks.

INTRODUCTION: Osteoarthritis is a disorder characterized by progressive deterioration of cartilage in synovial joints, affecting more than 55% of the elderly population, causing significant physical disability, implying a great challenge in medical treatment.

MATERIAL AND METHODS: A sequential, simple randomized clinical trial was carried out in patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service in 3 months, through two study groups: GROUP Those who received intra-articular infiltration of Collagen PVP, GROUP B: patients who received conservative treatment through rehabilitation with a home program for one month. In both cases, ENA and the WOMAC scale were evaluated at the beginning of the study and at 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 40 years.
2. Both sexes.
3. Joint stiffness less than 30 minutes.
4. Crepitus in the knee joint.
5. Pain in one or both knees lasting more than three months.
6. Continuous pain Quantified in \>5 Analog Numerical Scale.
7. Patients entitled to the Mexican Social Security Institute.
8. Radiological criteria for gonarthrosis in phases II, III, IV.
9. Patients not candidates for surgical treatment.

Exclusion Criteria:

1. Rheumatoid arthritis, gout or chondrocalcinosis.
2. Treatment with glucosamine, chondroitin, diacerein, silver non-saponifiables or slow-acting drug in the last three months.

4. Anticoagulant treatment. 5. Paget's disease. 6. Treatment with viscosupplementation in the last six months. 7. Patients not entitled to the Mexican Social Security Institute.
Humanity Neurotech Device Clinical Trial in Adults with Long COVID Cognitive Dysfunction

The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English Speaking
* SARS CoV-2 infection as documented by laboratory nucleic acid amplification test or antibody test ≥ 6 months from screening or signed attestation of positive test result
* Experiencing PASC symptoms ≥ 6 months
* Objective cognitive impairment on neuropsychological measures (as defined by a z-score ≥1 standard deviation below the normative mean) in executive functioning
* Individuals of childbearing age agreeing to use a highly effective form of birth control

Exclusion Criteria:

* History of cognitive dysfunction present prior to SARS CoV-2 infection
* Febrile (\> 99 F) at the time of the enrollment visit
* Enrollment in another interventional clinical trial in the last 90 days or during the study period
* Recent SARS CoV-2 reinfection in the last 30 days or during the study period
* Recent SARS CoV-2 vaccination in the last 30 days or plans to be vaccinated during the 8 week study period
* Currently taking immunomodulatory medication on an ongoing basis (NSAIDs, corticosteroids, cytokine antagonists, IVIG)
* History of bipolar disorder, psychotic disorder, substance use disorder
* Change in anti-depressant or other psychoactive medication or dose in the last 90 days
* Cranially implanted devices or metal
* Any serious unstable medical or neurologic condition
* History of severe head injury (as defined by loss of consciousness for ≥30 minutes) or stroke in the past 12 months
* Pregnant or plan to become pregnant during the study as indicated by positive pregnancy test
* Serious immune/autoimmune diagnoses prior to SARS-CoV-2 infection
* ME/CFS diagnosis prior to first SARS-CoV-2 infection
* Existing diagnosis of Post-treatment Lyme Disease Syndrome
* Inability to achieve appropriate positioning of the study device on the head
Hepatic Impairment Study

This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.
Internet Delivered Cognitive Behavioural Therapy for Persons With Mild Traumatic Brain Injury

Background: Individuals with neurological conditions (stemming from brain injury or stroke) can experience high levels of emotional distress leading to decreased quality of life and increased health care costs. Though mental health problems are prevalent and disabling, they often go untreated for various reasons, such as access to specialized care, rural and remote location, lack of time, or concerns about stigma related to seeking care. Internet delivered cognitive behaviour therapy (ICBT) overcomes barriers to face-to-face therapy by often reaching a much wider group of patients who experience unequal access to health care. The internet based program is based on cognitive behaviour therapy, which is an evidenced-based treatment that helps patients identify and modify thoughts and behaviours that contribute to their mental health concerns. ICBT has been shown to be effective in improving psychosocial outcomes such as depression and anxiety, along with disability and quality of life among persons with chronic health conditions.

Rationale: Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions such as brain injury and stroke.

Objective: The aim of the current study is to pilot an ICBT program developed through a patient oriented approach to improve overall wellbeing among those with mild traumatic brain injury.

Methods: In this project, an ICBT program for those with mild traumatic brain injury developed through an patient oriented approach (Phase 1) will be piloted amongst a small group of participants (n=20) to examine acceptability, feasibility, and limited efficacy. At the end of the program, participants will be asked to complete a brief semi-structured interview examining barriers and facilitators to the ICBT program. Participant feedback from the interviews will be used to further improve the ICBT program to meet the needs of the population. The results from the study will be used to guide larger studies to evaluate effectiveness of the program in a community setting.

Anticipated Impact: Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those who have mild traumatic brain injury and mental health concerns.


Eligibility Criteria:
Inclusion Criteria:

1. adults ≥ 18 years
2. diagnosed with mild traumatic brain injury (a neurological condition)
3. resident of Canada
4. access to a computer and the internet
5. cognitive capacity to read and understand the content of the program.

Exclusion Criteria:

1. High risk of suicide
2. Serious cognitive impairment or dementia (\<21 on the Telephone Interview of Cognitive Status (TICS)
3. primary problems with psychosis, alcohol or drug problems, mania
4. Currently receiving active psychological treatment for anxiety or depression
5. Not present in Canada during treatment; 6) Concerns about online therapy
6. Physically unable to perform the tasks.
Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients

This is an open-label, non-randomized Phase I study of sorafenib 400 mg bid (2 x 200 mg tablets) in cancer patients. The primary objective of the study is to evaluate the effect of sorafenib on cardiovascular safety parameters. The secondary objectives are to evaluate the safety, pharmacokinetics, and anti-tumor activity of sorafenib in cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory solid cancer for which curative or palliative measures have failed or patients for whom standard treatment is considered ineffective or intolerable
* Histological or cytological documentation of cancer is required
* Patients with at least one evaluable lesion. Lesions must be evaluated by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI)
* Life expectancy of at least 12 weeks
* Left ventricular ejection fraction (LVEF) \>=45 % as assessed at the Baseline Multiple Gated Acquisition (MUGA) scan
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:

  * Hemoglobin \> 9.0 g/dL
  * Absolute neutrophil count (ANC) \> 1,500/mm3
  * Platelet count \>=100,000/dL
  * Total bilirubin \<=1.5 times the upper limit of normal
  * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \<=2.5 x upper limit of normal, except if there is metastatic disease to the liver, in which case \<=5 x upper limit of normal is acceptable
  * Prothrombin Time-International Normalized Ratio/Partial Thromboplastin Time (PT-INR/PTT) \< 1.5 x upper limit of normal. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. For patients on anticoagulation therapy, at least weekly evaluations will be performed until International Normalized Ratio (INR) is stable as defined by the local standard of care
* Serum creatinine \<=1.5 x upper limit of normal

Exclusion Criteria:

* Colorectal cancer whether refractory or not
* Supine systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 100 mmHg (mean of duplicate readings) at Screening with or without antihypertensives
* Symptomatic metastatic brain or meningeal tumors
* Pregnant or breast-feeding patients
Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors

Prospective controlled study randomized comparing bipolar enbloc versus thulium enbloc for bladder tumours

Bladder cancer is the ninth most prevalent cancer worldwide and the 2nd most common urologic cancer in the last two decades after cancer prostate .

Most bladder cancers attributed to exposure to environmental and occupational chemicals, the largest of which by far is tobacco smoke. Greater tobacco smoke and occupational exposure in men may help in the explanation of the 4-fold gender difference in bladder cancer incidence .

Approximately 75-85% of patients with bladder cancer present with disease confined to the mucosa or submucosa , which is referred to as nonmuscle invasive bladder cancer (NMIBC).

Transurethral resection of bladder tumor (TURBT) is still considered the gold standard treatment for primary nonmuscle invasive bladder cancer.

There are many drawbacks for conventional TURBT procedure such as such as the deficiency of the bladder detrusor muscle In the specimen

, the obturator jerk, thermal damage to surrounding tissues, and the technique of( incise and scatter). These drawbacks may lead to difficulty in performing an accurate pathological evaluation of fragment tissue and increase the risk of recurrence.

Laser therapy for bladder cancer was first reported in Germany in the 1970s and was approved to clinical use in the USA in 1984.

Modern laser technology has led to new alternatives to conventional transurethral resection of bladder tumor (TURBT) due to its efficacy and good control of bleeding. With the introduction of en-bloc resection of urinary bladder tumors, Laser come back into focus. The two most commonly used lasers at present are thulium and holmium Laser.

In 2018 PA Geavlete, declared that the enbloc bipolar resection of bladder tumors using mushroom loop provide the advantages of superior surgical safety, decreased perioperative morbidity and faster postoperative recovery, when compared to the standard monopolar TURBT but showed no superiority in oncological outcome.

Eligibility Criteria:
* Inclusion criteria:

  1. Patients with NMIBC
  2. Bladder tumors\<4 cm in CT.
  3. Resectable bladder tumors.
  4. Age \<80 years.
* Exclusion criteria :

  1. Bladder tumours \> 4cm .
  2. Metastatic bladder tumors.
  3. Patients with carcinoma in situ CIS .
  4. Patients with coagulopathies.
  5. Domal bladder tumors.
Observational Study of the Association Between Food Intake and Endometrial Polyps

There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps.

The incidence of endometrial polyps is closely related to daily diet and living habits. Due to the excessive use of food additives, the content of some common dietary hormones exceeds the standard, causing irreversible effects on female growth and development.

The daily diet structure is closely related to women's health, and the enrichment of estrogen in common drinks may cause adverse effects such as premature puberty in women, abnormal thyroid function, and changes in uterine structure. Therefore, the researchers conducted a retrospective analysis of patients with endometrial polyps and normal women to compare the associations and differences between daily diet and disease.

Eligibility Criteria:
Inclusion Criteria:

* Consistent with the international clinical diagnosis of endometrial polyps.Can complete content recall alone.

Exclusion Criteria:

* No other mental diseases. Not associated with other major diseases, including tumors, immune system diseases