cyrilzakka/clinical-trials huggingface dataset:
Chest Wall Repair of Rib Fractures After Trauma

This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.

Hypothesis:

Rib fracture repair utilizing open reduction and internal fixation with commercially available rib plating systems improves outcomes (i.e., infectious complications), decreases hospital stay and mortality.

Study Design:

This is a prospective, observational study of 50 patients who, due to their injury pattern, are operative candidates for open reduction and internal fixation with commercial available rib plating systems for one of the following indications:

1. Flail chest with/without failure to wean from the ventilator
2. Significantly displaced rib fractures with/without lung impalement
3. Symptomatic multiple rib fractures - Failure of pain control

Outcome measures to be evaluated include:

1. Hospital Mortality
2. Ventilator free days
3. Need for tracheotomy
4. Infectious Complications (pneumonia, bacteremia, UTI, empyema)
5. Hospital \& ICU Days
6. Disposition following discharge

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least \>18 years of age
* Subjects must have one of the following clinical indications:
* \>3 rib flail segments with paradoxical chest wall movement
* Non-repair of defect may result in pulmonary hernia
* Minimal associated injuries
* Severely displaced fractures are significantly impeding lung expansion.
* Failure of narcotics or epidural pain catheter to control pain

Exclusion Criteria:

* Significant pulmonary contusion
* Significant brain injury (AIS 4 and/or ICP monitoring)
* Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization
* Subjects not expected to survive the 90-day follow-up period
* Known pregnancy
* Prisoners
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

The purpose of this study is to meet a PMA condition of approval of the BHR System. The study will evaluate the long term safety and effectiveness of the BHR system in patients with non-inflammatory and inflammatory arthritis.

This is a post-approval, prospective, non-randomized, longitudinal, unmasked, multi-center, clinical trial designed to evaluate the longer-term safety and effectiveness of the BHR system. The data collected will permit clinical evaluation for the device performance in improving hip pain, function and range of motion through ten years. The study will permit radiographic evaluation of proper component fixation and alignment maintenance through 10 years post-operative. The incidence of revision is an especially important measure in this study. Data collected will allow analysis of the implant survivorship.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age and skeletally mature
* Patients requiring primary hip resurfacing due to:
* Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH
* Inflammatory arthritis such as rheumatoid arthritis
* Subject or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form
* Subject is available for clinical follow-up through at least ten years
* Subject meets none of the exclusion criteria

Exclusion Criteria:

* Subjects with infection or sepsis
* Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery
* Female subjects of child-bearing age
* Subjects with bone stock inadequate to support the device
* Subjects with known moderate to severe renal insufficiency
* Subjects with known or suspected metal sensitivity (e.g. jewelry)
* Subjects who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids
* Subjects with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study
* Subjects who are severely overweight
Junior / Senior Concordance in Ultrasound Assessment of Crohn's Disease

Observational study

Crohn's disease is a chronic inflammatory disease of the intestine (IBD), evolving with varying periods of remissions and relapses, characterized by segmental inflammation of the digestive tract, which can be complicated by stenosis, fistulas or even digestive cancers.

The emergence of effective therapeutic strategies has led to the adoption of more ambitious therapeutic objectives that have no longer the improvement of symptoms but a complete cicatrization of the intestinal mucosa as an objective.

The disadvantage of the latter is the need for its evaluation by ilo-colonoscopy, "gold-standard", invasive, not without risks (perforation, anesthesia, hemorrhage), requiring colonic preparation and hospitalization.

In this context, the use of non-invasive markers performed in routine practice (hemogram, VS, CRP, fibrinogen, fecal calprotectin, abdominal ultrasound), predictive of this endoscopic mucosal healing, is a necessity to improve the tolerance of follow-up and allow better adherence by the patient of the therapeutic project. A decrease in health costs could also be associated with the use of these markers.

Abdominal ultrasound is an accessible, inexpensive, non-invasive and non-irradiating imaging medium. It is very useful and has proved its effectiveness in monitoring Crohn's disease to evaluate the activity of the disease in order to predict mucosal healing and to detect complications (stenosis, fistula, abscess) (1, 2, 3). However, especially for the study of the small intestine this act is known to be very dependent on the operator and the conditions of examination (echogenicity of the patient). In addition, few objective criteria have been described in the literature for the study of Crohn's disease (2, 3).

A recent study under submission has developed an ultrasound score of Crohn's disease activity, which through the study of each segment (distal ileum, right colon / transverse / left, sigmoid) using 14 criteria , allowed to rule on the activity of the disease and thus to predict mucosal healing. In this study, which concerned 48 patients, ultrasound scans were performed by radiologists experienced in abdominal pathology. This score was very easy to use and powerful to study the disease activity of each segment with 2 parameters in particular: parietal thickness and changes in fat.

It therefore seems necessary to confirm the simplicity of this ultrasound score in a validation cohort to: in particular to study the inter-observer reproducibility so as to be able to extend the use of this score to non-specialist radiologists.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed for Crohn's disease;
* Crohn's disease diagnosed in accordance with the criteria of the European Crohn's and Colitis Organization (ECCO);
* Benefiting from an abdominal ultrasound as part of their usual follow-up;
* Not having expressed his opposition to participate in the study.

Exclusion Criteria:

* Persons of legal age subject to legal protection (protection of justice, guardianship, tutorship), persons deprived of their liberty.
The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction

This study looks at the effects of weight loss in people who have heart failure with preserved ejection fraction (HFpEF) and are overweight or obese.

The main questions it aims to answer are whether weight loss in this group of people improves:

1. The heart's shape, how well it pumps blood and how well it uses fuels
2. The person's quality of life and how much they can exercise

Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits.

Each study visit will involve measurements including:

* Symptom and quality of life questionnaires
* Body measurements such as height and weight
* Blood tests
* Ultrasound scans of the heart (echocardiogram)
* Magnetic Resonance Imaging (MRI) scans of the heart
* Exercise components during the scans
* 6 minute walk test

Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care.

The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.

An interim analysis is planned at 60 recruits to review the recruitment target.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure with preserved ejection fraction (HFpEF)
* Left ventricular ejection fraction (LVEF) =/\> 50%
* Body Mass Index (BMI) approximately =/\> 27.5 kg/m\^2

Exclusion Criteria:

* Contraindications to magnetic resonance imaging
* NYHA class IV
* Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
* Pregnancy, planned pregnancy or lactating
* Any other conditions which may potentially compromise the safety or scientific validity of the study
Exercise Training Study of Patients With Claudicatio Intermittens

The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking.

Patients with intermittent claudication will by a web-based program be randomized to either "five plus training" or walking at least 30 minutes three times per week. During the "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect.

The patients are followed by absolute walking distance on a treadmill, quality of life questionnaire, and Ankle-brachial index.

Eligibility Criteria:
Inclusion Criteria:

1. Pain in the calves after 300 m, or less measured on a treadmill
2. Stable symptoms last 6 months or more
3. The pain must be gone within 5 minutes after the patients stop walking
4. Ankle-Brachial index at 0.7 or lower at rest
5. Using statins and antiplatelet drugs since at least 3 months
6. age\> 18 years
7. Signed consent

Exclusion Criteria:

1. pain in the hips or elsewhere outside the calves while walking
2. Remaining pain more than 5 minutes after stopped walking.
3. Impossible to compress the arteries while measruing ABI or ABI lower than 0.4
4. Use of statins and antiplatelet drugs less than 3 months
5. symptoms less than 6 months
6. Diabetes measured with HbA1c being over 48 mmol/mol (6%)
7. Revascularisation the last 6 months
8. Pain in the calves after longer than 300 m measured on a treadmill
9. Reduced mobility in the ankles
10. Reduced physical ability to perform a test on a treadmill.
11. Age less than 18 years
12. General conditions that impairs the ability to take part in a training study including Obesity, KOLS, heart disease, arthrosis, inflammatory joint diseases .
13. No Signed consent
Prediction of Liver-related Outcomes After HCV Cure

Objectives: To develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals (DAA)-based therapy.

Methods:

Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients who fullfilled the following inclusion criteria are included in this study: 1) Have received a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of treatment.

Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a common protocol every six months. At every visit, clinical and laboratory examination focusing on the early detection of liver complications are carried out. LS is assessed by vibration-controlled transient elastography, according to a standardized procedure, every 12 months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein determination are conducted for hepatocellular carcinoma screening, every six months.

Variables and data analysis: The primary outcome variable of the study will be the emergence of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver transplant. Predictive models will be develop with clinical, analytical, and genetic variables independently associated with the primary variable in a Cox regression for competitive risks applied to a developmental subpopulation. The performance of the model will be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive values will be calculated, both in the developmental population and in a validation population.


Eligibility Criteria:
Inclusion Criteria:

* Had achieved SVR 12 weeks after DAA-based regimen, either with or without Peg-interferon
* Showed liver stiffness (LS) value ≥9.5 kPa prior to treatment
* Had LS measurement available at SVR time-point

Exclusion Criteria:

* Individuals seropositive for HBsAg
* Individuals who refuse to participate
* Individuals under 18 years old
Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-small cell lung cancer.

OBJECTIVES: I. Evaluate the response rate of previously treated patients with recurrent non-small cell lung cancer after treatment with irinotecan and docetaxel. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Reconfirmation of NSCLC required only if complete response for greater than 1 year Measurable or evaluable disease Tumor shrinkage or stability for at least 4 weeks on initial chemotherapy CNS metastases allowed, if symptoms controlled for greater than 8 weeks after surgery or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infection At least 5 years since any other prior malignancy except curatively treated basal or squamous cell skin cancer, carcinoma in situ, or other cancers No grade 2 or worse peripheral neuropathy No uncontrolled diabetes mellitus No other serious underlying disease Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose cisplatin as a radiosensitizer No prior irinotecan or docetaxel At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other anticonvulsants
Drug Treatment for Alcoholics With Bipolar Disorder

The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.

The aim of this study is to test the mood stabilizer, anticonvulsant, sodium valproate in individuals with alcohol dependence and bipolar disorder, in a double-blind, placebo-controlled, and randomized trial of 6 months duration. All subjects are treated with treatment as usual, which include lithium carbonate and individual dual recovery counseling and are randomized to either sodium valproate or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Meets the criteria for alcohol dependence with comorbid bipolar disorder.
* Agreement to participate in outpatient treatment.
* Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo.
* Stable living situation.
* Ability to provide informed consent.

Exclusion Criteria:

* Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, unipolar major depression, mental retardation, or signs of impaired cognitive functioning.
* Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination.
* Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.
* Persistent elevation of liver function enzymes indicating active liver disease.
* Pregnancy or not using an acceptable contraceptive method.
* Inability to read or understand study forms; agree to informed consent.
* Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder.
* The presence of either/or cocaine dependence, opioid dependence, and intravenous drug use.
Continuous Glucose Monitoring and Diabetes

The study is a longitudinal single-arm prospective study design. Adult patients who are African American or Hispanic with type 2 diabetes mellitus will be recruited to participate in this study. The goal of the study is to determine if the use of a continuous glucose monitoring system will improve diabetes management in persons from health disparity background.

The subjects will be closely monitored for the first 3 months as they utilize the continuous glucose monitor and engage in diabetes education classes. They will then be followed for an additional 3 months to determine if they are able to maintain the same glucose control as experienced for the initial 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with type 2 diabetes mellitus ≥18 years
* African-American or Hispanic
* with A1c ≥8% to ≤12%

Exclusion Criteria:

* Patients with type 1 diabetes,
* pregnant,
* End-Stage Renal Disease,
* recent use of any CGM within the last 12 months,
* on steroid therapy and history of adhesive allergy.
Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors

This is a multi-center, open-label, phase I study to assess the effects of dovitinib (TKI258) on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and midazolam in patients with advanced solid tumors, excluding breast cancer. The aim of this study is to evaluate the potential effect of dovitinib (TKI258) on the metabolism of the probe drugs caffeine, diclofenac, omeprazole and midazolam, which are metabolized by CYP1A2, CYP2C9, CYP2C19 and CYP3A4 respectively (Cytochrome P450 isoenzyme), comparing the single-dose pharmacokinetics (AUCtlast, AUCinf and Cmax parameters) of each of the individual probe drug co-administered with and without multiple dose of dovitinib (TKI258) 500 mg under a 5 days on / 2 days off dose schedule. The study foresees two treatment phases: DDI (drug-drug interaction) followed by post-DDI. During the DDI phase patients receive treatment with the probe drug cocktail and dovitinib (TKI258). During the post-DDI phase patients may continue to receive treatment with dovitinib (TKI258) until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer which has progressed despite standard therapy or for which no standard therapy exists
* ECOG performance status 0 or 1 and anticipated life expectancy ≥ 3 months
* Patient must meet protocol-specific laboratory values

Exclusion Criteria:

* Patients with brain metastases
* Patients who have received or who are expected to receive any prohibited medications and therapies
* Patients who have received CYP1A2 inducer, CYP2C9/2C19 inducer or CYP3A4 inducer medications within 30 days prior to start study treatment or are expected to receive during the first 14 days after starting the study treatment
* Patients with a known hypersensitivity to benzodiazepines
* Patients who have not recovered from previous anti-cancer therapies
* Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TKI258
* Patients who have concurrent severe and/or uncontrolled concomitant medical conditions that could compromise participation in the study
* Female patients who are pregnant or breast-feeding
* Fertile males or women not willing to use highly effective methods of contraception
* Other protocol-defined inclusion/exclusion criteria will apply
Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure

The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Major orthopedic surgery

Exclusion Criteria:

* Heparin exposure
* Infection