cyrilzakka/clinical-trials huggingface dataset:
Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.

Occlusive training in people with fibromyalgia

Intervention study in people with fibromyalgia with the implementation of a lower body occlusive tool in aerobic exercise. The study aims to descriptively test the impact on quality of life and functional autonomy of occlusive training in a controlled and individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.

Eligibility Criteria:
Inclusion Criteria:

A patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (American Rheumatology Association). Wolfe et al., (2010).

* o 1) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Score (SS Score) ≥ 5 or WPI 3-6 and SS ≥ 9.
* Symptoms have been present, at a similar level, during the last three months.
* The patient has no other pathology that could explain the pain.
* Recent negative COVID-19 test.

Exclusion Criteria:

* Other associated pathologies that may hinder the development of the research.
* Mobility limitations.
* Injuries that add to those of the disease itself and hinder mobility.
* No medical evaluation of the diagnosis of the disease.
* Negative results in the inclusion tests.
* Cardiac pathologies.
* Blood pressure higher than 130-90 mmHg.
* No COVID-19 test.
Navigator 1.5 Accuracy Study

The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.


Eligibility Criteria:
Inclusion Criteria:

* History consistent with Type 1 diabetes for at least 2 years prior to enrollment;
* For at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections;
* At least 18 years of age;
* Available and capable of following the protocol instructions provided by the healthcare professional;
* Signed and dated Informed Consent form.

Exclusion Criteria:

* Pregnancy;
* Type 2, gestational, or secondary diabetes;
* Known allergy to medical grade adhesives or skin disinfectant;
* Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
* Blood donation within 6 weeks prior to beginning study activities;
* Within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness;
* Active myocardial ischemia;
* Previous history of stroke;
* Any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety;
* Current participation in another clinical trial.
DESIGNING A PROGRAMMING LANGUAGE FOR PATIENT-ORIENTED PRESCRIPTIONS (POP-PL)

The purpose of this study is to create a human-readable and executable computer language to implement medical prescriptions and to evaluate and refine this language, with the goal of improving safety and efficacy of patient care

Preventable errors in healthcare are a leading cause of patient injury and death. Despite extensive effort and the expenditure of billions of dollars, computerization has failed to solve this problem. Research has shown that software design and debugging of a paper prescription markedly decreases the rate of injury and death associated with use of opioids in hospitalized patients. To further the application of insights from software engineering to the practice of medicine, the PIs will design and build a Patient-Oriented Prescription Programming Language (POP-PL) and evaluate if this new platform can be used to improve medical management of patients. The design of POP-PL will be based on building an understanding of the process of medical treatment of patients. This project is a collaboration between computer scientists and clinicians at Northwestern Medicine. The collaborating clinicians are co-investigators on this research project and also are providing healthcare to the patients that are being observed. The computer scientists and other research staff have undergone human subjects research training and are co-investigators on this research project as well. The clinician-investigators will oversee research project staff during all observations of patients, clinical encounters between healthcare providers and patients, and interactions between healthcare providers and healthcare information systems. Researchers involved in this study will observe interactions between health care providers and patients and will collate these observations with data from electronic data sources. Since this research is based mainly upon observation and chart review and will not involve any interventions or changes to patient care, the risk to study participants is minimal, involving inadvertent disclosure of healthcare information. This risk will be mitigated by anonymizing collected data.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen at Northwestern Memorial Hospital, Northwestern Medicine Clinics, Lurie Children's Clinics, and Lurie Children's Hospital between the ages of 0-79.

Exclusion Criteria:

* Patients without data within the NMEDW medical record database or LCH CDW or BIS medical record database.
Hypobaric Flight Simulation in COPD Patients

Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients.

Background and aim:

Commercial aircrafts have their altitude compensation adjusted to 2500 meter above sea level which corresponds to a pressure difference of about 270 hPa. This causes a reduction of the partial pressure of oxygen during the flight. Patients with lung disease are especially challenged by large walking distances within airports and during their journey. The objective of our study is to evaluate the impact of a simulated flight under hyperbaric conditions on walking endurance in healthy individuals as well as in COPD Patients with and without hypercapnia.

Method:

Healthy individuals as well as COPD patients were assessed pre-flight with the following measurements:

1. Arterial blood gas analysis
2. Lung function test
3. Lung diffusion test
4. Hemoglobin level
5. Six minute walking distance

During the flight measurements included (measured every 30 minutes until landing):

1. Heartrate
2. Oxygen saturation
3. Borg scale

Post flight measurements included:

1. Arterial blood gas analysis
2. Six minute walking distance

Intended analysis:

* Description of endurance response as a function of COPD disease severity.
* Description of endurance response in normocapnic and hypercapnic COPD patients.
* Detection of pre-flight predictors that determine flight tolerability and hypoxic response.

Eligibility Criteria:
Inclusion Criteria:

* No lung disease
* COPD without hypercapnea
* COPD with hypercapnea

Exclusion Criteria:

* Claustrophobia
* Renal insufficiency
* Heart failure (ejection fraction \< 45 %)
Opioid Use After Laparoscopic Salpingectomy

The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids.

The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a fallopian tube (unilateral and/or bilateral)
* Age 18 years old and above
* Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
* Benign indications for salpingectomy/tubal sterilization
* Agreeing to participate

Exclusion Criteria:

* Chronic pain syndromes patients including fibromyalgia
* Patients currently on long-term (i.e. for more than three months) opioid use
* Conversion to laparotomy
* Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
* Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
* Salpingectomy performed for treatment of ectopic pregnancy
* Patients with a history of gastritis and/or GI bleeding
Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy

The purpose of this study was to determine the effect of extracorporeal Shock wave therapy (ESWT) on functional activity and pain in patients with Achilles tendinopathy

Fifty patients of both sexes with Achilles tendinopathy aged 18-40 years, were assigned randomly into two equal groups. The study group received ESWT in addition to a conservative physical therapy program for four weeks, while the control group received a conservative physical therapy program only. Pain and functional mobility were assessed before and after treatment through a visual analog scale (VAS) and Victorian Institute of sports assessment - Achilles questionnaire (VISA-A), respectively

Eligibility Criteria:
Inclusion criteria

* Clinical history of Achilles tendon pain for at least six months
* A minimum of three months conservative treatment administered without benefit for at least four weeks before ESWT.

Exclusion Criteria:

* Patients underwent physical therapy in the four weeks prior enrollment to study.
* Patients had taken non-steroidal anti-inflammatory medication during the previous week
* Patients had received peritendinous injections of a local anesthetic or corticosteroid within last 4 weeks
* Patients had bilateral Achilles tendinopathy
* Patients with other conditions that could significantly contribute to posterior ankle pain (osteoarthritis, radiculopathy, systemic neurologic conditions)
* Patients having previous injury or surgical treatments of the ankle.
Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.

In order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population.


Eligibility Criteria:
Inclusion Criteria:

-HIV infected patients under injectable ART

Exclusion Criteria:

-Active HBV infection
Study Evaluating Impact of the Use of a Computer-based Tool on the Clinical Management of RA Patients

The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria:

* Patients, male or female, over 18 years old.
* Patients diagnosed with RA according to investigator criteria
* Patients with a disease evolution \>= 1 year
* Patients with \> = 5 affected joints

Exclusion Criteria:

Exclusion Criteria:

* Patients with other muscle skeletal, rheumatic and/or degenerative diseases different from RA.
* Patients who are taking part or have taken part in a clinical trial or in a study with drugs within the last 12 months. Any condition that, in the investigator's judgment would interfere with the subject's ability to comply with protocol requirements or give informed consent.
A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers

In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP)
* Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Abnormal vital signs, after 10 minutes supine rest
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound

Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are used for membership (between the aponeurosis of the abdominal flap and underlying muscles) for closing the donor area, where there is reduced incidence of complications.

This study evaluated seroma formation at the donor site of the TRAM patients who underwent breast reconstruction. Forty-eight breast reconstructions were performed using the bipedicled TRAM flap. The patients were randomly allocated into three groups of 16 participants each: DN group, use of suction drains but no quilting sutures between the remaining abdominal flap and musculoaponeurotic layer of the anterior abdominal wall; QS+DN group, use of quilting sutures and suction drains; and QS group, use of quilting sutures but no suction drains. In order to determine seroma formation, ultrasound examinations were performed on postoperative days 7 and 14 in 5 regions of the abdominal wall: epigastric, umbilical, hypogastric, right iliac, and left iliac regions.

Eligibility Criteria:
Inclusion Criteria:

* were age between 20 and 65 years
* body mass index (BMI) ≤ 30 kg/m2
* non-smokers.

Exclusion criteria:

* no skin excess in the infraumbilical region
* previous abdominoplasty
* uncontrolled systemic disease
* such as diabetes mellitus and arterial hypertension
* collagen diseases
* psychiatric disorders
* large weight loss
* and/or postoperative abdominal scars that could hinder flap vascularization.
Effects of a Walking Program on Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients

Overall Objective: To evaluate the efficacy of an interventional walking program on the quality of life and functional status of patients with Lumbar Spinal Stenosis, post-surgery, using subjective (VAS, ODI, RMDQ, SF-36), and objective measures (triaxial accelerometry, step count, weight).

Design and Methods: Two groups of subjects will be examined; patients diagnosed with lumbar spinal stenosis (LSS) that progress to surgical management, with one group of subjects staring on the walking program at 2 months postop, and the other group starting on the walking program at 3 months postop.

Subjects who agree to participate will be assessed (assessments listed below) after the diagnosis preoperatively and 2 months postoperatively. One half of the group will start the walking program at the 2 months postop visit and be assessed again at the end of the walking program, the other half will be assessed again at 3 months postop and start the walking program at that time and be assessed again at 4 months postop. All subjects will be contacted by phone during their walking program to allow for questions from the subjects and to offer support and encouragement. Subjects will be given instructions and a daily diary to track steps taken each day (appendix A).

Subjects will be recruited from the referrals to the practices of the Orthopedic and Neurosurgery Spine Surgeons at the Health Sciences Centre in Winnipeg. This encompasses the majority of new and currently managed cases in the Manitoba and Northwestern Ontario.

Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited into the study. All LSS patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis. Exclusion criteria will be any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program. Subjects participating will be required to speak English.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be between the ages of 18 and 90.
* Male and female subjects will be recruited into the study.
* All LSS patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis.

Exclusion Criteria:

* Any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program.
* Subjects participating will be required to speak English.
Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients

The purpose of this study is to determine whether micronized trans-resveratrol improves clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Eligibility Criteria:
Inclusion Criteria:

* PCO - Androgen Excess Society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone \>70ng/dl) and/or oligomenorrhea (\<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40

Exclusion Criteria:

* Use of oral contraceptives and/or other steroid hormones 3 months prior to the study
The Angel® Catheter Pivotal Clinical Trial

The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).


Eligibility Criteria:
Inclusion Criteria:

1. Subject or legally authorized representative is willing and able to provide written informed consent,
2. Subject is 18 years or older,
3. Subject is expected to remain in a critical care setting for at least 72 hours,

   AND at least one of the following inclusion criteria (4,5, and/or 6)
4. Subject has recognized contraindications to standard pharmacological thromboprophylaxis including:

   * Active bleeding or at high risk for bleeding OR
   * Hypersensitivity to pharmacological thromboprophylaxis OR
   * History of severe heparin induced thrombocytopenia OR
   * Severe thrombocytopenia
5. Subject has a confirmed acute proximal lower extremities DVT or a confirmed acute PE with recognized contraindication to anticoagulation
6. Subject requires a temporary interruption (\>24 hours) of pharmacological thromboprophylaxis for a surgical or medical procedure

Exclusion Criteria:

1. Subject is pregnant
2. Subject is in treatment with an investigational drug or device within 30 days prior to enrollment
3. Subject has a pre-existing IVC filter in place
4. BMI = \> 45
5. Subject has functioning pelvic renal allograft on the only side available for device insertion
6. Subject has undergone a surgical procedure involving the femoral vein or pelvic veins through which the device must be inserted
7. Anatomic inability to place the Angel® Catheter
8. Subject has known hypersensitivity to any of the components of the Angel® Catheter, specifically Nitinol (nickel and/or titanium)
Preterm Delivery After Septum Resection

Uterine septum is the most common congenital uterine malformation. It accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%.

The presence of a uterine septum is associated with subfertility and a high incidence of obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature rupture of the membranes (PROM), 6-fold increase in preterm delivery, malpresentation at delivery, caesarean section, and increased perinatal morbidity and mortality.

Some studies have found that surgical resection of the uterine septum improves pregnancy outcomes and significantly reduces the risk of preterm delivery. Therefore, the risk for a short-term adverse outcome and long-term sequelae due to preterm delivery such as intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus, retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired mental development in women with uterine septum could be lowered by performing a relatively simple and safe hysteroscopic septum resection (HSR).

However, there are two major concerns regarding HSR: cervical incompetence due to excessive dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in subsequent pregnancy or delivery.

Considering these elements, the aim of this study will be to evaluate the rate of preterm delivery in singleton pregnancy comparing primary infertile women who underwent HSR and who did not undergo the same procedure, with our without in vitro fertilization.


Eligibility Criteria:
Inclusion Criteria:

* Female primary infertility
* Singleton pregnancies

Exclusion Criteria:

* Female secondary infertility
* Multiple pregnancies