cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics

In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. How obesity affects asthma is not fully understood. This research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways.

Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.

This research study includes optional genetic and bronchoscopy substudies.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 70 years of age
* If asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid
* Never smoked or limited smoking history

Exclusion Criteria:

* Current upper respiratory illness (other than asthma)
* Illegal drug use within past month
* Consumption of more than 6 alcoholic drinks per week
* Active, pronounced rhinitis or sinusitis
* Pregnancy
* Currently taking oral steroids or steroid injection over the past month
* Asthma exacerbation over the past month
* Certain medical illnesses
PDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. One treatment option involved a surgical fixation with plates or nails, screws and cables/wires along the side of your fractured bone. The second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint).

The primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. Secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. A health economic analysis will be conducted to assess the cost-effectiveness of both treatments.

A total of 148 patients (74/group) will be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* • 65 years and older

  * Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)
  * Fracture is acute (within 1 week from time of injury)
  * Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury
  * Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale
  * Patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up
  * Patient or substitute decision maker is able to provide written informed consent to participate in the study

Exclusion Criteria:

* • Active infection around the fracture (soft tissue or bone)

  * Open fracture
  * Bilateral femur fractures
  * Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries
  * Pathological fracture excluding osteoporosis
  * Ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components)
  * Periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (Lewis and Rorabeck Type III)
  * Ipsilateral primary partial knee or patellofemoral arthroplasty
  * Previous ORIF of the distal femur or proximal tibia or patella
  * Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair
  * Poly-trauma status (Injury Severity Score\>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation
  * Medical contraindication to surgery
Surgical or Non-surgical Treatment of Plantar Fasciitis

Plantar fasciitis (PF) is one of the most common causes of heel pain in 40-60 year old people. Approximately 10% of the population is affected by the disorder and the PF prevalence is 3.6-7.0%. The risk factors include decreased ankle dorsiflexion, overweight (BMI\> 27), pronated foot position, and prolonged work and activity-related weight bearing. The condition affects both active and less active people.

The typical symptoms are pain around the attachment of the foot's tendon mirror (fascia plantaris), especially the medial part. The pain is well defined and occurs during weight bearing activities or during the first steps after rest. The walking pattern is changed to relieve pain. Ultrasound scan is used to confirm the diagnosis (thickened tendon mirror\> 4 mm). The condition is described as inflammatory, but the relationship between the initial inflammatory condition and the chronic tendon mirror overload injury (fasciopathy) is unknown and marked by degenerative changes.

Although the majority of people improve within 1-2 years, the long-term prognosis is unknown. People with symptoms lasting \> 7 months have poor prognosis and should be offered other treatment. Non-surgical treatment is often first line of treatment followed by surgical treatment.

In this clinical trial investigators compare pain levels (FHSQ-DK) in people, who receive surgical treatment (radiofrequency microtenotomy, shoe inserts and patient education) and people who receive non-surgical treatment (strength training, shoe inserts and patient education) with a primary end-point at 6 months. The hypothesis is that surgical treatment is better than non-surgical treatment measured by FHSQ-DK (pain)

To be completed later

Eligibility Criteria:
Inclusion Criteria:

* VAS pain score \> 30 within last 7 days
* Plantar heel pain\> 7 months
* Palpation soreness fascia plantaris at heel
* Plantar heel pain during first steps (First-step sign)
* Read and understand Danish

Exclusion Criteria:

* Systemic diseases or neuropathy
* Diabetes
* Pregnant
* Previous heel surgery on same foot
* Cortisone injections within past 3 months
* Bilateral symptom onset within past 7 days
* Signs of tarsal tunnel
* Facia plantaris thickness of less than 4 mm
* Performed message / head recovery / stretching within the past month
* Any treatment for plantar pain within the past 3 months
* Other reasons
Determinants of Oral Anticoagulants' Activity

The primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants.

The secondary objective is to determine the clinical, biological or genetic determinants of hemorrhagic or thrombotic complications during a one year follow-up.

Results will lead to a better prediction of both drug response and risk of complications.

Direct oral anticoagulants are changing clinical practices but a better knowledge of factors that may predict both drug response and risk of complications is need.

Anticoagulant activity is influenced by different factors. Because the biological activity is not easy to measure everywhere, it is important to clearly determine factors that are involved.

A cohort of 550 patients that receive either an anti-IIa or an anti-Xa will be recruited.

The primary objective is to determine clinical, biological and genetic determinants of anticoagulant activity.

This objective will be assessed through a multivariate logistic regression (separately for anti-IIa and anti-Xa) with anticoagulant activity as dependent variable.

Variables that will be included in the statistical model are those known or measured at the entry in the cohort such as :

* Clinical factors : age, sex, weight, dosage and time of the last dose
* Biological factors : serum creatinine level, plasma concentration of the drug
* Genetic polymorphisms :

Factor II and CES1 for anti-IIa drugs Factor X, CYP3, CYP3A4, CYP3A5 and ABCG2 for anti-Xa drugs.

By using the same statistical approach and the same variables, predictive factors of either hemorrhagic or thrombotic events will also be evaluated on the whole cohort. The occurence of hemorrhagic and thrombotic complications will then be assessed through a phone call every 3 months during a one-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient receiving direct oral anticoagulant
* Complete blood count and measure of hemostasis planned
* Patient able to give consent
* Patient with health insurance

Exclusion Criteria:

* Patient not able to consent
* Patient under 18 years old
* Patient refusal
* Patient without health insurance
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.

The present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female aged 18-55 years.
* BMI between 19 - 30 kg/m2

Exclusion criteria:

* Liver function tests above the upper limit
* Excessive alcohol consumption history
* History of Cigarette smoking
* Positive HIV, Hep B or C test
* Positive pregnancy test
* History of heparin sensitivity
* History of glucose intolerance
Azithromycin in Bronchiolitis Obliterans Syndrome

Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.

* Prospective, interventional, randomized, double-blind, placebo-controlled trial.
* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
* 1:1 inclusion ratio (placebo:azithromycin).
* Randomisation at discharge after informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Stable LTx recipients at discharge after transplantation.
* Signed informed consent
* Adult (age at least 18 years old at moment of transplantation)
* Able to take oral medication

Exclusion Criteria:

* Prolonged and/or complicated ICU-course after transplantation.
* Early (\<30 days post-transplant) post-operative death
* Major suture problems (airway stenosis or stent)
* Retransplantation (lung)
* Previous transplantation (solid organ)
* Multi-organ transplantation (lung+ other solid organ)
Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer

Interventional, randomised, prospective, monocentric study

Interventional, randomised, prospective, monocentric study

Primary objective :

Demonstrate the interest of the homeopathic Protocol to reduce the onset or aggravation of joint pain as a result of the taking of AI compared to conventional care

Secondary objective :

Compare between the two treatment groups:

* Evolution of joint pain
* Evolution of joint stiffness-rate of onset of pain and joint stiffness-delay in onset or aggravation of pain-evolution of the number of painful locations-evolution of the impact of pain on the quality of the sleep-consumption of permitted concomitant treatments (analgesics)
* Evolution of symptoms of hormonal deprivation-adherence to AI treatment
* Tolerance to AI
* Change seen by patients
* Stop rate and switch of AI-rate of recurrence of breast cancer

Describe in patients receiving homeopathic treatment:

* Adherence to homeopathic treatment
* Tolerance to homeopathic treatment
* Group A: Group of patients receiving conventional treatment (drug analgesic class 1) for joint pain + homeopathic treatment
* Group B: Group of patients receiving conventional treatment (drug analgesic class 1) for joint pain

Schedule :

* Inclusions start at: 01/09/2018
* End date of inclusions: 01/09/2021
* End date of follow-up: 23/03/2022
* Study report: 23/03/2023

Eligibility Criteria:
Inclusion Criteria:

* menopausal patient
* achieved histologically confirmed non-metastatic breast cancer with positive hormonal receptors
* starting an adjuvant anti-hormonal treatment with an AI
* patient benefiting from a social protection scheme
* patient mastering the French language -signature of free and informed consent -

Exclusion Criteria:

* patient whose treatment with chemotherapy or radiotherapy is ongoing or anticipated during the theoretical period of the study or patient who has completed her chemotherapy treatment within a period of less than 4 weeks prior to the inclusion visit
* patient with proven inflammatory rheumatism already diagnosed with rheumatoid arthritis, lupus, psoriatic rheumatism, ankylosing spondylitis -concomitant treatment with other complementary medicines (excepted Vitamin D), unless the treatment has been stable for at least 1 month.
* current treatment with narcotic drugs or corticosteroids
* patient with overexpressing breast cancer HER2
Effects of Projected Peripheral Defocus on Ocular Biometrics

Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery will stimulate physiological changes similar to those in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Spherical equivalent +2.00 to -4.00 diopters
* Refractive cylinder ≤ 0.75 diopters
* Visual acuity 20/20 -3 or better

Exclusion Criteria:

* Pregnant or lactating
* Active ocular infection
* History of dry eye, strabismus, or amblyopia
* Previous or planned ocular surgery
* Use of medication known to affect vision or accommodation
Application of OE in Diagnosis of EGC

The main purpose of this study is to evaluate application value of OE mode 2 in the diagnosis of early gastric cancer The Secondary purpose is to evaluate application value of OE mode 1 in differentiating the diagnosis of neoplastic lesions of the gastric mucosa.

Gastric cancer is the most prevalent cancer in China，while the detection rate of early gastric cancer is lower than 10%. An effective screening method to improve the detection rate is urgently needed. Optical Enhancement (OE) mode is an endoscopic mode that uses the principle of grating for electronic staining, which provides a clear picture of the submucosal and superficial mucosal vascular structures. The OE1 mode provides enhanced images of the gastric Gland tube and blood vessels, as well as magnification. The OE2 mode is used to identify small chromatic aberrations and to visualize superficial structures in the gastric mucosa. So we designed this randomized controlled trial to discuss effectiveness of OE in the diagnosis of early gastric cancer and we hope to find an effective method to improve the detection rate of early gastric cancer in China.

Eligibility Criteria:
Inclusion Criteria:

Meet item 1or 2 + any items of 3-7

1. Male ≥ 40 years old, female ≥ 50 years old.
2. More than one year since the last gastroscopy.
3. Patients from the areas with high incidence of stomach cancer (Shandong Province, Liaoning Province, Fujian Province, Gansu Province, Qinghai Province, Ningxia Province, Jilin Province, Jiangsu Province, Shanghai).
4. Patients with pre-cancerous gastric diseases such as chronic atrophic gastritis, gastric ulcer, gastric polyp, hypertrophic gastritis, pernicious anemia, etc. in the past.
5. First-degree relatives of patients with a family history of gastric cancer.
6. Other high-risk life factors for gastric cancer (high salt, pickled diet, smoking, heavy alcohol consumption, etc.)
7. Positive serum gastric function tests (GastroPanel) include: H. pylori (H.P) antibody （+）, Fasting pepsinogen I and II ratio (PG I/PGII) \<3.89, gastrin 17 (G-17) \>1.50 pmol/L.

Exclusion Criteria:

1. Patients who have undergone invasive treatment such as surgical resection, PEG, chemotherapy etc. of either stomach or oesophagus. (except for EMR and ESD).
2. Patients with a confirmed diagnosis of progressive cancer above T2 degreed according to the TMN classification of cancer。
3. Patients on anticoagulants that cannot be biopsied.
4. Patients who have undergone gastrectomy.
5. Patients who have taken PPIs or H2 receptor antagonist within two weeks.
6. Patients with history of malignant neoplasm; high suspicion of neoplasm; severe cardiac, pulmonary, hepatic or renal insufficiency; severe mental illness and pregnant women.
7. Patients who did not signed the consent form.
Predicting ICU Mortality in ARDS Patients

The investigators are planning to perform a secondary analysis of an academic dataset of 1,303 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) included in several published cohorts (NCT00736892, NCT02288949, NCT02836444, NCT03145974), aimed to characterize the best early model to predict duration of mechanical ventilation and mortality in the intensive care unit (ICU) after ARDS diagnosis using machine learning approaches.

The acute respiratory distress syndrome (ARDS) is a severe form of acute hypoxemic respiratory failure in Critical Care Units worldwide. Most ARDS patients requiere mechanical ventilation (MV). Few studies have investigated the prediction of MV duration and mortality of ARDS.

For model description, the investigators will extract data from the first two ICU days after diagnosis of moderate-to-severe ARDS from patients included in the de-identified database, which includes 1,303 mechanically ventilated patients enrolled in several observational cohorts in Spain, coordinated by the principal investigator (JV), and funded by the Instituto de Salud Carlos III (ISCIII). The investigators will follow the TRIPOD guidelines and machine learning tecniques will be implemented (Random Forest, XGBoost, Logistic regression analysis, and/or neural networks) for development of the prediction model, and the accuracy will be compared to those of existing scoring systems for assessing ICU severity (APACHE II, SOFA) and the PaO2/FiO2 ratio. For external validation, the investigators will use 303 patients enrolled in a contemporary observational study (NCT03145974). The investigators will evaluate the accuracy of prediction models by calculating the respective confusion matrices and several statistics such as sensitivity, specificity, positive predictive value, and negative predictive value for mortality and duration of MV. Investigators will select the best probabilistic model with a minimum number of clinical variables.

Eligibility Criteria:
Inclusion Criteria:

* Berlin criteria for moderate to severe ARDS

Exclusion Criteria:

* Postoperative patients ventilated \<24h; brain death patients.
Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population

This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income.

The Medically Intensive Nutritional Therapy (MINT) program at Massachusetts General Hospital (MGH) Weight Center is a low-calorie nutrition plan that may offer a solution for those who have difficulty implementing a low-calorie dietary plan on their own. This study examines the effects of MINT on weight loss and blood sugar control specifically in a low-income population and explores potential reasons for discontinuing the program.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Body mass index (BMI) greater than or equal to 27 kg/m\^2
* HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months
* Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022

Exclusion Criteria:

* Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment
* HbA1c greater than or equal to 10 percent
* Plans to pursue bariatric surgery over the 6 months post-study enrollment
* Weight loss of greater than 5 kg within the previous 3 months
* Current active eating disorder, with the exception of binge eating disorder
* Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention
* Active illicit substance abuse
* Pregnant, breastfeeding, or considering pregnancy within the next 6 months
* Current participation in another clinical research trial deemed by investigator to conflict with current study
Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods

The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.

The purpose of this study is to determine the minimum application site rest period that ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result in increased absorption of drug in normal healthy subjects.

Eligibility Criteria:
Inclusion Criteria Include:

* Males and females 18 to 45 years of age, inclusive.
* Weight of 60 to 100 kilograms (kg) \[132-220 pounds (lb)\] and within 15% of optimum for height and body frame.
* In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
* Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
* Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
* Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study

Exclusion Criteria Include:

* A history of hypersensitivity to opioid or psychotropic drugs.
* A history of recurrent seizures or syncope.
* Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
* Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count \[ANC\] \<1000/mm3 or thrombocytopenia (platelet \<150,000/mm3).
* Positive results of urine drug screen or urine cotinine (consistent with active smoking).
* A history of substance or alcohol abuse within the past 5 years.
* Females who are nursing.
* Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.

Other protocol-specific exclusion/inclusion criteria may apply.