cyrilzakka/clinical-trials huggingface dataset:
Wedged Orthoses and Knee Osteoarthritis

The five-year goal of this project is to investigate the effect of in-shoe wedged orthoses on lower extremity function in patients with knee osteoarthritis. In general, our aims address the long-term effects of orthoses. The investigators hypothesize that subjects who use the lateral wedged in shoe orthosis will result in altered gait mechanics that reflect a reduction in the frontal plane knee joint moment compared to subjects who use a neutral in shoe orthosis.

Introduction: In shoe wedged orthoses have been shown to be an effective conservative approach in reducing pain in patients with osteoarthritis (OA). The mechanism responsible for this pain reduction is not well-understood. It is not known whether placing a medial or lateral wedge in the shoe results in alterations in lower extremity alignment, knee joint moments or some combination of the two. The longterm effects of this intervention on OA patients' functional status as well the progression of their OA has not been studied. Therefore, the purpose of this study is to examine the effect of in-shoe wedged orthoses in patients with knee OA on the frontal plane knee joint moment. Methods: 38 patients between the ages of 40-70 yrs with knee OA (grades I-IV) will be recruited from within the medical community. Subjects with a diagnosis of unilateral knee OA of greater than 3 months duration, as defined by the American College of Rheumatology Guidelines, will be included. 19 subjects will be assigned to a treatment group and 19 subjects will be assigned to a control group. The treatment group will receive custom molded orthotics with a lateral wedge. Both the treatment and control groups will be tested initially and then again 1 year later. The dependent variable is peak knee adduction moment. Statistics: A two-way ANOVA will be used to test the hypothesis. This design will include 2 levels of group (control and treatment) and two levels of trial (pretest and 1 yr posttest). Significance will be determined at a level of p\<.05.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed unilateral knee osteoarthritis by a qualified physician
* Recent (within 3 months of entrance into the study) radiographic confirmation of OA grade (I-IV) as evidenced by joint space narrowing and the presence of osteophytes
* A score of 50-90 mm on a 100 mm visual analogue pain scale for walking
* Ability to walk independently without the use of assistive devices

Exclusion Criteria:

* History of lower extremity joint surgery or other lower extremity injury that would hinder ambulation
* Severe foot deformity that would prevent the accommodation of the wedged orthotic device
* Other disease process such as neurologic, cardiac, or oncologic, that would hinder one's ability to ambulate
* Any condition, such as diabetes, that results in loss of sensation in the lower extremities
Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic colorectal cancer
* Presence of measurable metastases
* No previous treatment for metastatic cancer

Exclusion Criteria:

* No presence of Central Nervous System metastases
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
A Study to Evaluate the Effect of Funk It Cycle Bites on PMS

This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods (intervention cycles 1, 2, and 3). The study will involve 30 female participants with regular menstrual cycles who experience PMS.

Questionnaires will be used to monitor menstrual pain/cramps, energy levels, mood, and hormonal acne experienced before and during the menstrual cycle. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18-40
* Have a regular menstrual cycle (every 21-35 days).
* Suffer from mild to moderate menstrual pain.
* May experience mood swings and/or hormonal acne related to the menstrual cycle.
* Otherwise generally healthy.
* Willing to consume the test product with a ginger flavor.
* Willing to refrain from taking any other supplements or prescription medications that may target the menstrual cycle or premenstrual syndrome (PMS) symptoms throughout the study period.
* Willing and able to adhere to the study protocol, including taking supplements at the required times and completing questionnaires via the technology portal.
* Able to communicate in English.
* Participants must provide written informed consent (ICF).

Exclusion Criteria:

* Any unstable or uncontrolled medical or psychiatric illness.
* Any uncontrolled chronic disease or condition that would prevent full participation in the study protocol.
* A history of polycystic ovary syndrome (PCOS), endometriosis, premenstrual dysphoric disorder (PMDD), or undiagnosed vaginal bleeding.
* Are taking hormonal contraception or exogenous sex hormones (estrogen, testosterone, progesterone), or have taken hormonal contraception or exogenous hormones in the past 6 months.
* Are taking any prescription medication or supplements that target the menstrual cycle or PMS symptoms.
* Are pregnant, breastfeeding, trying to become pregnant, or have been pregnant in the past 12 months.
* Have any known severe allergic reactions, or any allergies of any severity to any of the test product's ingredients.
Improving Teamwork in an Academic, Tertiary Care Labor and Delivery Unit

The investigators wanted to determine if the establishment of interdisciplinary rounds has made meaningful changes in the perceptions of teamwork and communication.

The purpose of this study is to determine if the establishment of interdisciplinary daily rounding has improved teamwork in an academic, tertiary care labor and delivery unit.

Failures in teamwork and communication are among the leading cases of sentinel and adverse obstetric events. Multidisciplinary approaches and communication could improve patients outcomes. In 2003, leaders from the department of obstetrics, anesthesia and nursing decided to institute interdisciplinary rounds as a method of improving team communication. Obstetricians, Anesthesiologists, Nurses, Perinatologists, Administrative Assistants, Consultants, and Neonatologists participate in the rounds. The investigators wanted to determine if the establishment of interdisciplinary rounds has made meaningful changes in the perceptions of teamwork and communication.

The purpose of this study is to determine if the establishment of interdisciplinary daily rounding has improved teamwork in an academic, tertiary care labor and delivery unit.

Eligibility Criteria:
Inclusion Criteria:

* Working at L\&D at Brigham and Women's and participating in daily rounds

Exclusion Criteria:

* subject's refusal to participate
Quantification of Nerve Stiffness in Neuropathies

This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.

The following nerve will be studied bilaterally, in a randomised order: Median, ulnar, Radial, Sciatic and Tibial.

Participants will be asked to remain relaxed during elastography measurements.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 65
* Having social insurance status
* Having given informed consent
* Diagnostic of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), CMT1a or Anti-MAG (peak immunoglobulin M (IGm)\>15,000 BTU)

Exclusion Criteria:

For controls:

* Person staying in a health or social facility
* Person unable to understand the protocol and to respect the modalities
* Person deprived of liberty
* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
* Participation in another biomedical research in progress
* Diabetes, history of neuromuscular disease

For CIDP:

* Person staying in a health or social facility
* Person unable to understand the protocol and to respect the modalities
* Person deprived of liberty
* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
* Participation in another biomedical research in progress
* MRC score \< 3

For Charcot-Marie-Tooth type 1 (CMT1) and anti-MAG:

* Person staying in a health or social facility
* Person unable to understand the protocol and to respect the modalities
* Person deprived of liberty
* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
* Participation in another biomedical research in progress
Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI

The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.

This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. All patients will be followed throughout the duration of the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is, male or female, \> 18 years of age; 2. The patient presents with coronary syndrome, unstable angina or non ST segment elevated myocardial infarction (NSTEMI) defined as at least one of the following criteria:

* Elevated creatine kinase MB or Troponin I or T (above ULN)
* ECG changes indicative of ischemia 3. The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease; 4. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.

  1. ST elevated myocardial infarction within the preceding 48 hours;
  2. Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg);
  3. Patients presenting on or received bivalirudin, GP IIb/IIIa inhibitors or low-molecular weight heparin within the preceding 24 hours;
  4. Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.
  5. Patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (GI bleed etc.);
  6. Known diagnosis of acute bacterial endocarditis;
  7. Patients with cardiogenic shock or required intra-aortic balloon pump (IABP)
  8. If patient is on warfarin (Coumadin) therapy;
  9. Patients who had a major or minor stroke (CVA or TIA) or major surgery within the past 6 months;
  10. Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L),) status post renal transplant, patients on chronic dialysis or creatinine clearance ≤ 30 ml/min;
  11. A platelet count of less than 100,000 cells/mm3;
  12. Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, or contrast that cannot be medically managed;
  13. Prior angioplasty within the previous 30 days;
  14. Contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin;
  15. Pregnant or lactating women;
  16. Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study;
  17. Currently participating in an investigational drug or another device study.
Application of Circulating Exosomes in Early Diagnosis and Prognosis Evaluation After Intracerebral Hemorrhage

The purpose of this study is to observe the relationship between the changes of circulating exosomes and the development and outcome of the disease in patients with intracerebral hemorrhage, and to search for early serum markers and potential intervention targets for disease monitoring in patients with intracerebral hemorrhage


Eligibility Criteria:
Inclusion Criteria:

1. No systematic treatment was given before admission;
2. The patients were diagnosed with cerebral hemorrhage, and had imaging evidence;
3. The age was more than 18 years old;
4. The patient or family member agrees to sign the informed consent.

Exclusion Criteria:

1. Hematoma is caused by secondary factors (intracranial tumor, arteriovenous malformation or aneurysm);
2. Bleeding into the ventricle;
3. Multiple cerebral hemorrhage;
4. The patient did not receive treatment in our hospital;
5. Severe disability, dementia, or organ dysfunction before onset
6. Coagulopathy or long-term use of anticoagulants
7. Hematoma affects brain stem
8. Subjects refused to participate
Metabolic Cost of Bodyweight Training

In this study, the investigators will be able to estimate the metabolic cost of several foundational bodyweight training exercises.

Bodyweight training has become a popular cardiovascular training choice in fitness centers and athletic performance enhancement facilities. Despite widespread use and growing popularity, little is known about the metabolic demands of such a training method. Therefore, the purpose of this study was to quantify the cardiovascular and metabolic cost from various foundational bodyweight exercises in order to contribute to a better planning of exercise programs in the real world.

Ten healthy young adults were assigned to execute seven bodyweight exercises (acute bout) for 30 and 45 seconds. Anthropometric, metabolic, and performance measurements were conducted at baseline. The metabolic cost was estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 35 years
* Physically active individuals
* Free of chronic diseases
* Free of musculoskeletal injuries
* Nonsmokers

Exclusion Criteria:

* Musculoskeletal injuries
* Chronic diseases
* Use of alcohol, caffeine and any type of ergogenic supplements or medication before (≤6 months) and throughout the study.
Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:

* unknown adverse drug reactions, especially clinically significant adverse reactions
* incidence and conditions of occurrence of adverse reactions in the clinical setting
* factors that may affect the safety and effectiveness of Humira.

This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice.

When investigators prescribed Humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. At the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. Even if Humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of Humira, and filled out a case report form for the participant at the end of the 24-week period.

Some participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.

Eligibility Criteria:
Inclusion Criteria:

All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be

* those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or
* patients with intractable eruptions of joint signs/symptoms.

Exclusion Criteria:

Contraindications according to the Package Insert include patients who have any of the following:

* serious infections
* tuberculosis
* a history of hypersensitivity to any ingredient of Humira
* demyelinating disease or a history of demyelinating disease
* congestive cardiac failure.
Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center

Aim of this project is to understand clinical features, clinical outcomes and efficacy and safety profiles of different therapies by analyzing a cohort of COVID-19 patients hospitalized and treated in a tertiary-level institution, University hospital Dubrava. Patients' clinical and laboratory characteristics, drug exposure and outcomes are obtained by analysis of written and electronical medical records.

University Hospital Dubrava has been completely repurposed during the COVID-19 pandemic to become high volume COVID-19 tertiary institution. Establishment of hospital registry project is necessary to properly understand disease characteristic, related outcomes and real-life treatment patterns. Registry provides a fundamental framework for future upgrading with emerging or retrogradely obtained specific data that will substantially facilitate understanding of COVID-19 in the context of other specific diseases, therapies and procedures. Large comprehensive database will provide sufficient statistical power to allow for investigation of large number of subgroups and existence of interactions between different variables. Assessment of large number of clinically important outcomes (mortality, occurrence of venous and arterial thromboses, major bleeding, bacteriemia, incidence of mechanical ventilation and intensive care unit admission) is necessary to put any investigated parameter in the proper efficacy and safety context.

Eligibility Criteria:
Inclusion Criteria:

* all hospitalized patients positive for COVID-19

Exclusion Criteria:

* none
Study Evaluating CCI-779 in Relapsing Multiple Sclerosis

To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with relapsing-remitting MS or secondary progressive MS with relapses.
* Successful completion of study 3066A2-205-WW with no major protocol violations.

Exclusion Criteria:

* Pregnancy or lactation.
* Clinically important abnormalities on the physical examination, vital signs, or electrocardiogram (ECG) performed at the last visit of study 3066A2-205-WW (day 252).
* Any adverse events or findings observed in study 3066A2-205-WW that in the opinion of the investigators would preclude the subject's entry into the extension study.

Please refer to section 16.2 'Discontinuation and Withdrawal of Subjects' regarding withdrawal of patients who have any clinical abnormalities in hematology or laboratory test results obtained at the last visit of the double-blind active phase of study 3066A2-205-WW.
Blood Biomarker in Early Parkinson's Disease

Currently, there are no cures or disease modifying therapies for Parkinson's disease (PD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for PD. Several detection parameters will be assessed through enrollment of Parkinson's patients and age matched healthy volunteers over 50 years of age to learn more about the analytical process and biological variability.


Eligibility Criteria:
Inclusion

Age matched to PD patient Parkinson's Disease Patients:

* 50 years and older
* PD patient who is seen at the Duke Movement Disorders Center
* Early PD diagnosis (Hoehn and Yahr scale ≤ 3)
* Non-smoking
* No cancer treatment in the last 5 years
* Able to read and speak English

Healthy Control Participants:

* 50 years and older
* Non-smoking
* No cancer treatment in the last 5 years
* Able to read and speak English

Exclusion Criteria:

Parkinson's Disease Patients:

* Known additional neurological disease
* Clinical trial intervention within the last 6 months

Healthy Control Participants:

* Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)
* Clinical trial intervention within the last 6 months
OPTIMIZATION of ADVANCED MR SEQUENCES

This monocentric methodological study aims at optimizing advanced MR sequences for image quality (reduced artefacts, signal to noise ratio, acquisition time, stability of quantitative measurements) on a new MR unit dedicated to research in clinical and cognitive neuroscience.

Primary goal : Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences.

Secondary goals

1. Perform acquisitions to validate the feasibility of research MR protocols (pilot subjects)
2. reproducibility studies

Eligibility Criteria:
Inclusion Criteria:

* 18 ans
* Covered by social security
* For women in age of procreation, under efficient contraception
* Written consent

Exclusion Criteria:

* Any MR contraindication
* Claustrophobia
* Pregnancy
* Under judiciary protection