cyrilzakka/clinical-trials huggingface dataset:
Cingal Study for Knee Osteoarthritis

The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.

This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
* Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.

Exclusion Criteria:

* Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
* Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).
A Comparison of the First Attempt Success Rate of Cannulation Between the Accuvein Apparatus and Standard Technique

Background: The AccuVein AV300 device helps in venepuncture and intravenous (IV) cannulation. It uses infrared light that can be absorbed by the blood hemoglobin so that veins location is clearly viewed on the skin's surface.

Objectives: To assess the effectiveness of the AV300 device over the standard technique in increasing the ﬁrst-time success rate (SR) for pediatric patients who needed IV cannulation.

Methods: This was a prospective cross study of patients aged 0-18 years scheduled for surgery or examination under anesthesia but without having an existing IV access and after providing consent form. Patients were randomized into two groups; cannulation with AV300 or standard insertion performed by experienced pediatric anesthesiologists and residents under training.

Patients who fulfilled the inclusion criteria and provided informed consent were assigned to one of two groups using a randomization program that assigned research participants into group A (AccuVein AV300 assisted intravenous catheter insertion) or group B (standard technique of insertion of the intravenous cannula). After pre-anesthetic evaluation, the research participant was brought to the operating room and standard monitoring were applied (EKG, SpO2, BP) if tolerated. Anesthesia was induced via face mask with sevoflurane in 100% O2. The anesthesiologist and resident decided on a site believed to be the best for cannulation and on the size of the venous cannula as 22g or 24g. When the supervising anesthesiologist deemed it appropriate, the venous cannulation was attempted, according to the randomization groups, either with the AccuVein device (group A) or blindly (group B). A rating of the vein attempted as either difficult or easy was established by the attending anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients less than 18 years of age, American Society of Anesthesiologist Physical Status (ASA) status I, II or III, undergoing elective surgery or examination under anesthesia, which did not have existing intravenous access.

Exclusion Criteria:

* Existing intravenous access, malformations or infections at the potential site of insertion, need for emergency surgery, and inability or unwillingness of parent or legal guardian to give written informed consent.
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.

This study is a prospective, single-arm, multicenter, post-market safety evaluation of subjects indicated for embolization of brain AVMs with the study device. The study device was developed to potentially minimize the side effects of catheter retainment and increased procedural risk associated with alternative methods necessary for removing entrapped catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.

Eligibility Criteria:
Inclusion Criteria:

* The Subject or Subject's legally authorized representative has signed and dated an informed consent form.
* The Subject has a confirmed diagnosis of a brain AVM.
* The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
* The Subject has a life expectancy of at least 1 year.
* The Subject agrees to and is capable of completing all study-required procedures.

Exclusion Criteria:

* Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease.
* The Subject has a bleeding disorder.
* The Subject is not a candidate for the use of vasodilators.
Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma

Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the response rate in patients with recurrent or metastatic soft tissue sarcomas treated with dolastatin 10.

II. Determine the toxicity of this regimen in this patient population.

OUTLINE: This is an open label, multicenter study. Patients are stratified according to center, prior therapy, histologic subtype, stage of disease at diagnosis, and current status of disease (recurrent vs metastatic).

Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven recurrent or metastatic soft tissue sarcoma
* No rhabdomyosarcoma, Ewing's sarcoma, chondrosarcoma, osteogenic sarcoma, mesothelioma, or Kaposi's sarcoma Bidimensionally measurable disease other than previously irradiated disease site(s) even if there has been progression within the radiation field
* Pulmonary nodule(s) at least 1 x 1 cm No brain metastases

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: ECOG 0 or 1
* Absolute neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present)
* Creatinine no greater than 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
* No uncontrolled infection
* No history of prior malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy in complete remission

PRIOR CONCURRENT THERAPY:

* No more than 1 prior chemotherapy regimen in the adjuvant setting
* No prior chemotherapy for metastatic disease
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
* At least 4 weeks since prior radiotherapy
* Recovered from prior surgery
A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement

Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. This randomized clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist administered physical activity intervention for people after TKR.

Methods/Design: One hundred and twenty-five individuals, over the age of 45, who seek outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control and intervention group. The intervention group will receive a weekly physical activity intervention during PT, which includes a FitbitTM monitor, individualized step goals, and face-to-face feedback provided by the physical therapist. Efficacy of the intervention will be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge from PT. The association of self-efficacy for exercise and kinesiophobia with physical activity will also be measured at the same time points. Fidelity and safety of the intervention will be assessed during outpatient PT.

Discussion: This study is designed to fill a critical clinical need to increase physical activity after TKR. The primary objective of the study is to evaluate the efficacy of a physical therapist administered physical activity intervention for people after TKR. The secondary objectives are to evaluate the fidelity and safety of a physical therapist administered physical activity intervention for people after TKR and to investigate changes in self-reported and performance-based physical function after a physical therapist administered physical activity intervention for people after TKR. The tertiary objective is to explore the association of psychosocial factors with physical activity 6 and 12 months after discharge from a physical therapist administered physical activity intervention for people after TKR. The findings will be used to support a large multi-site clinical trial to test the effectiveness, implementation, and cost of this intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 45
2. Seeking outpatient physical therapy for a unilateral TKR

Exclusion Criteria:

1. Not interested in increasing physical activity
2. Any other medical conditions that limit your physical activity
3. Have had or are planning on having another leg surgery within 6 months that is unrelated to your TKR surgery
4. Previously enrolled in a physical activity intervention study at this clinic
Vision Screening Study for College Students at Nankai University

The prevalence of myopia among high school students in China is as high as 80%-90%. For college students with longer years of education, the majority of myopia and the factors influencing the prevalence of high myopia should be better understood for timely prevention and treatment. This study aims to investigate the prevalence of myopia and education-related influencing factors among college students at Nankai University.


Eligibility Criteria:
Inclusion Criteria:

* All 1st year students

Exclusion Criteria:

* No eye diseases such as cataracts, glaucoma,keratoconus, etc.
* No psychiatric disorders
* Astigmatism ≤ -6.00D
Investigation of Brain Nitrogen in Partial Ornithine Transcarbamylase Deficiency (OTCD) Using 1 H MRS, DTI, and fMRI

The purpose of this study is to use various types of MRI and cognitive testing to evaluate changes in the brain and cognitive function that occur in subjects with ornithine transcarbamylase deficiency (OTCD) relative to healthy individuals

The overall goal of this project is to characterize metabolic, structural and cognitive changes in OTCD using 1H MRS, DTI, volumetric averaging and fMRI with cognitive testing of executive function measures to validate biomarkers for the effect of HA and its treatment on the brain.

The investigators will measure gln and mI in blood and brain (using 1H MRS) in affected participants, and mI in brain in controls, fractional anisotropy as a measure of white matter microstructural damage (by DTI) and brain activation pathways alterations with tasks probing working memory (fMRI). As a secondary outcome measure, the investigators will correlate the findings from neuroimaging with cognitive functioning. This protocol is based on the previous 5104 protocol, now includes children to evaluate the age and stage of disease on these indices in a cohort that is undergoing important developmental events against an age matched typically developing cohort.

Eligibility Criteria:
Inclusion Criteria:

Subject inclusion criteria:

1. Patients with OTCD;
2. Age range: 7-60 years
3. Able to undergo neuroimaging safely (i.e. without presence of ferromagnetic devices)
4. Subject has a documented full scale IQ \> 70

Control participant inclusion criteria:

1. Healthy males and females without metabolic disease aged 7-60 years
2. Subject has a documented full scale IQ \> 70

Exclusion Criteria:

Subject exclusion criteria:

1. Mental retardation (i.e., Full Scale IQ\< 70)
2. Age range \<7 or \>60 years
3. Presence of ferromagnetic device(s) that preclude safe imaging
4. Pregnant female

Control exclusion criteria:

1. Subjects with a documented history of an intellectual deficit (i.e., Full Scale IQ\< 70)
2. Age range \<7 or \>60 years
3. Presence of ferromagnetic device(s) that preclude safe imaging
4. Pregnant female
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients

The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death.

It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1 infection (ELISA and Western Blot tests positive)
* CD4+ T lymphocytes below or equal 200/mm³ or previous AIDS-defining-illness at diagnosis
* Patient naïve from any antiretroviral
* In women, use of a contraceptive method, and lack of actual pregnancy
* Patients with a coverage from social health
* After informed consent

Exclusion Criteria:

* Current pregnancy, lack of contraceptive method, breast-feeding
* Current active tuberculosis (either suspected, diagnosed)
* Ongoing malignancies except cutaneous Kaposi's sarcoma. Patients with a previous cancer considered as cured for at least 6 months could be included in the study
* Current or previous severe cardiac failure, chronic respiratory disease, renal or liver insufficiency; any life-threatening organ failure
* Cognitive impairment, psychiatric disorders, severe depressive affects, unadapted behavior
* Use of cytostatic drugs, immunosuppressive agents, steroids
* PMN (polymorphonuclear neutrophil) below 750/mm³, platelets below 50,000/mm³, haemoglobin below 10 g/dL; ASAT (aspartate aminotransferase), ALAT (alanine aminotransferase) or bilirubin over 2.5 ULN; lipase over 2 ULN (Upper limit of normal), serum creatinine over 1.5 ULN; proteinuria over 1g/L; INR (International Normalized Ratio) abnormal
* Current or previous, during the 3 last months, use of immunomodulatory agents (G-CSF (granulocyte colony stimulating factor), IL-2 (Interleukin-2), GM-CSF (Granulocyte Macrophage colony stimulating factor), interferons, pentoxifylline)
* Hypersensitivity to peanut and /or soy products
Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects

The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy subjects men or women aged 18-50

Exclusion Criteria:

* Any significant clinically important disease
* Family history of long QT syndrome and/or sudden cardiac death
* Allergy to moxifloxacin or the quinolone class of antibiotics
Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy

The purpose of this study is to establish nomograms of penile length and width throughout the weeks of pregnancy.

Identifying pathology of male genitalia is important. It can be an isolated pathology, or connected to disorders in other organs, as part of genetic syndromes or endocrine disorders. Micropenis is a disorder, which is important to diagnose in the womb. Micropenis is defined as a penis which is measured 2.5 standard deviation below average. It is also thinner by diameter. This finding can also be the first expression of a lethal hormonal deficiency, hence the reason for early detection by ultrasound during pregnancy.

Past prenatal diagnosis ultrasound studies, measured the penis from the scrotum to the tip of the penis. Another study evaluated formalin fixated fetuses after pregnancy terminations, in which the penis was measured from the abdominal wall to the tip of the penis. To date there are no nomograms for penile length, via ultrasound measurement from abdominal wall or for penile width. The investigators assume that measuring the penis from the abdominal wall is more accurate and standard than from the end of the scrotum, which is a less definitive reference point.

The investigators aim to establish nomograms of penile length throughout the weeks of pregnancy. Exceptional penile width can also point out a problem with male genitalia. Therefore the investigators wish, as well to establish nomograms of penile width.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Proper pregnancy dating
* Normal fetal anatomical scan
* Gestational age 14 to 37 weeks
* Women aged 18 to 50

Exclusion Criteria:

* Multiple pregnancy
* Gestational age under 14 or above 37 weeks
* Fetus Small or Large for gestational age
* Abnormal anatomical scan or women who didn't perform such scan
* Minors
Fibrinogen in Liver Transplant Subjects

The study is a prospective, multi-centered, unblinded, randomized controlled pilot study. The primary objective is to compare functional hemostatic capacity of Investigational Cryoprecipitate Intercept Fibrinogen Complex (IFC) to Standard Cryoprecipitate Antihemophilic Factor (AHF) for liver transplant patients with bleeding and hypofibrinogenemia to determine impact of earlier access to a concentrated source of fibrinogen in a goal-directed manner.

Fibrinogen is an important factor for hemostasis and when it is deficient or dysfunctional replacing it will improve hemostasis and reduce bleeding. Observational data indicates the use of cryoprecipitate as a source of fibrinogen may reduce bleeding and improve outcomes in patients with severe bleeding. Liver transplant patients often become hypofibrinogenemic and may benefit from early goal directed use of cryoprecipitate or IFC. IFC can be more readily available since it can be stored at room temperature compared to cryoprecipitate which requires thawing. As a result, IFC can be immediately available when indicated compared to the delay in administration of cryoprecipitate due to the need for it to be thawed. This trial will compare clinical outcomes for subjects randomized to either cryoprecipitate or IFC in bleeding liver transplant patients with reduced fibrinogen function.

There is no data comparing outcomes for subjects receiving IFC or cryoprecipitate in any patient population.

The rationale for this trial is to compare IFC to cryoprecipitate (cryo) to assist with the design of a future definitice multicenter trial. Potential advantages of IFC are that since it is stored at room temperature it can be made immediatwlt available whereas with cryo the delay in treatment can be 30 to 40 min due to the need to thaw it from a frozen state. The reduced time to treatment of bleeding may improve outcomes with the use of IFC compared to cryo. In vitro data indicates similar hemostatic function between IFC and Cryo. IFC is pathogen reduced cryoprecipitate. The pathogen reduction methods are licensed for IFC and there has been no safety concerns regarding its use at the centers that are currently using it as their standard product (unpublished).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Scheduled to undergo cadaveric liver transplant
* Meets at least one of the following criteria:
* Baseline fibrinogen \<200 mg/dL
* Alcoholic cirrhosis
* Nonalcoholic Steatohepatitis (NASH)
* HCV infection

Exclusion Criteria:

* Living related donor transplant
* DCD liver recipient
* Known prothrombotic disorder
* Patient objection to blood transfusion
* Known severe allergic reaction to plasma-based products
* IgA deficiency with known hypersensitivity reaction to plasma
* Hepatocellular/cholangio carcinoma
* Primary biliary fibrosis
Evaluation of Effects of CBD Products on Anxiety Among U.S. Women

The investigators will conduct a retrospective cohort analysis of a consumer trial conducted by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD) products. Participants were randomized to one of 9 groups: 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery, concentration of Tetrahydrocannabinol (THC), and dosage of CBD. Participants were asked to use the product once daily for 60 day and to complete health questionnaires at baseline, 30 days and 60 days.

Between October 1-7, 2020, women from across the US were recruited by Rae Wellness to participate in a 60-day in-home use test (IHUT) of various Cannabidiol (CBD) products. The inclusion criteria were: women; between the ages of 24-44; reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido). Individuals were excluded if they were pregnant or breastfeeding. 1,350 women were randomly selected to participate in the study. The participants were randomized to one of 9 groups in the IHUT (150 in each group): 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery (oil or capsule), concentration of Tetrahydrocannabinol (THC; less than 0.3% THC or 0% THC), and dosage of CBD (15, 20, 25 and 30 mg). Participants were asked to use the product once daily every day for 60 consecutive days, and to complete a health questionnaire online on 3 occasions: before initiating the product (baseline), 30 days after initiating the product, and 60 days after initiating the product. Those in the control group were also asked to complete the health questionnaire at each time point but did not receive nor consume any CBD product. The health questionnaire assessed anxiety, physical health, digestive health, sleep patterns, general wellness and sexual satisfaction using questions drawn from validated health indices.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified female
* Ages of 24 to 44 years
* Reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido).

Exclusion Criteria:

-Pregnant or breastfeeding