cyrilzakka/clinical-trials huggingface dataset:
Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment

This is a retrospective data analysis of patients with high blood pressure (hypertension) who took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a minimum of 6 month to treat hypertension. These patients will be identified from a large medical claims database. This study tests the hypothesis (alternative, higher or lower) that average patient monthly health care administrative cost changes after switching from metoprolol to nebivolol.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old at initiation of metoprolol (or first date on metoprolol treatment between 2007 and 2011)
* Had one or more inpatient or outpatient claims with a primary or non-primary diagnosis of hypertension (ICD-9-CM 401.xx-405.xx)
* Received nebivolol treatment continuously (defined as supply gap \<30 days) for at least 6 months after initiation
* Received metoprolol treatment continuously for at least 6 months prior to switching to (initiation of) nebivolol (defined as metoprolol was discontinued whereas a prescription for nebivolol was filled)
* Had at least 12 months of continuous enrollment (as verified using enrollment file): 6 month prior to nebivolol initiation and 6 months following nebivolol initiation.
Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies

The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Present with type 2 diabetes mellitus
* Have been taking metformin and/or pioglitazone
* Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
* Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5
* Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter \[mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)\], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
* Not pregnant or breastfeeding

Exclusion Criteria:

* Have Type 1 Diabetes
* Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
* Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).
* Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
* Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
* Have cardiac disease with a functional status that is Class III or IV
* Have a history of renal or liver disease
* Have had a blood transfusion or have a blood disorder
Comparative Study Between Level I and Level II Temporomandibular Joint Arthroscopy in Wilkes Stage III Patients

Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Internal derangement of the temporomandibular joint (TMJ) is the most frequent disorder; with anterior disc displacement is the most common form. Wilkes has classified internal derangement into five stages; patients with stage III usually present with limited mouth opening, joint pain and deviation of jaw upon opening to the affected side. MRI is considered the gold standard for diagnosis. Treatment of TMJD include non-surgical and surgical methods. Non-surgical treatment includes instructions, pharmacotherapy, physiotherapy and occlusal splints; while surgical interventions include minimally invasive procedures (arthroscopy and arthrocentesis) and open joint surgery

Arthroscopy of TMJ was first introduced by Ohnishi in 1975. There are three different levels of TMJ arthroscopy. Level I, single puncture arthroscopy, it allows lysis of adhesions in the upper joint compartment and lavage of the joint space and the inflammatory products. Level II is done by double puncture and it enables to perform maneuvers such as lateral pterygoid myotomy and ablation of the retrodiscal tissue. Operative devices including arthroscopic instruments, Nd-YAG and Holmium laser, and the high-frequency wave system (Coblation) is very useful for tissue coagulation and cutting. Both levels enabled getting joint mobilization and significant pain reduction. Level III (arthroscopic discopexy), it needs customized special instruments.

Eligibility Criteria:
Inclusion Criteria:

* Wilkes stage III patients

Exclusion Criteria:

* previous TMJ surgery
Transoesophageal Echocardiography in Liver Transplantation

Severe hypotension during reperfusion in liver transplantation is a frequent adverse event. Rare data exist so far about pathophysiology of this phenomenon. The exact role of left ventricular function, which might be impaired causing hypotension, has not been elucidated during the period of reperfusion.

Goal of this study is to:

* perform transesophageal echocardiography in order to assess systolic and diastolic left ventricular function during reperfusion
* determine inflammatory mediators in the plasma which could cause left ventricular dysfunction


Eligibility Criteria:
Inclusion criteria:

* Patients on waiting list for liver transplantation.
* Age: 18-75 years.

Exclusion criteria:

* Strictures, tumours and diverticula of the oesophagus.
* History of oesophageal varices with recent bleeding.
* Oesophageal varices and prothrombin time less than 20% or platetlets les than 30000/ml.
* Instable cervical spine.
* Involvement in other studies.
Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer

This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.

PRIMARY OBJECTIVE:

I. Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer.

OULINE: This is a multicenter, pilot study.

Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0.

After completion of study treatment, patients are followed for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* No prior or concurrent hormonal therapy for breast cancer
* Histologically confirmed breast cancer, stage I-III disease, scheduled to undergo definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic treatment) for breast cancer
* ECOG 0-2 OR Karnofsky 60-100%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* PT ≤ 14 seconds
* Creatinine normal
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled intercurrent illness
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat
* At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin)
* Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed
* No concurrent birth control pills
* No prior radiotherapy to the ipsilateral breast
* No prior or concurrent radiotherapy for breast cancer
* No prior or concurrent novel therapy for breast cancer
* At least 14 days since prior valproic acid or another histone deacetylase inhibitor
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent therapy for this cancer
* WBC ≥ 3,000/mm\^3

Exclusion criteria:

* Patients must not be recieving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA.
* Patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating SAHA.
* Women who are pregnant.
Cardiac Safety Evaluation of P03277

The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.

The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.

Each subjects will be administered with 4 products (P03277 at the 2 different doses, placebo and moxifloxacin) in a 4\*4 cross over sequence balanced for first order carry over effect. Twelve subjects will be assigned to each sequence (6 males and 6 females). The volunteers will be enrolled sequentially by cohort of 8 subjects.

ECG measurements will be compared with ECG parameters collected after administration of placebo (Nacl 0.9%). The test sensitivity will be assessed using a positive control (moxifloxacin 400 mg per os) known to induce delays in QT intervals.

Eligibility Criteria:
Inclusion Criteria:

* Subject assessed as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
* Subject with a Body Mass Index (BMI) \> 19 kg/m² and \< 28 kg/m² and a weight at least of 40 kg for female and 50 kg for male and at maximum of 100 kg

Exclusion Criteria:

-
Psychotherapy for Patients With Psoriasis: Effects in Quality of Life

The aim of this study is to determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical treatment, without psychotherapy.

Further investigations studies are needed to determine the efficacy of psychological interventions for people with psoriasis. The aim of this study is to determine the benefits of individual psychotherapy on quality of life for people with psoriasis receiving medical treatment versus a control group (awaiting group) treated with medical treatment, without psychotherapy.

This is an experimental randomized trial with control group. Quality of life, symptoms:

pruritus, scaling and pain, distress and the illness will be measured before and after the intervention using psychological and quality of life questionnaires, and dermatological evaluations for 120 subjects.

The investigators expect that the experimental group scores at the end of the psychotherapy program will be less than 4 points in Visual Analog Scale (VAS) for pruritus, scaling and pain. The Dermatology Quality of Life Index (DQLI) expected to be less than 4 points from the initial score, and the patients are expected to present less than 7 points in Hospital Anxiety and Depression Scale (HADS). The experimental group scores will be less than the control group for quality of life, symptoms and distress.

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years old at the time of selection.
* Subjects diagnosed with moderated or severe psoriasis.
* Subjects with a ≥ 10 punctuation in DLQI questionnaire.
* Subjects that are in dermatological treatment.
* Patients should be able to understand and communicate with the investigator.

Exclusion Criteria:

* Subjects suffering from a serious concomitant illness.
* Subjects with a mental illness.
* Subjects who are performing psychiatric treatment.
* Subjects who are performing psychotherapy sessions both individual and group.
* Patients who have alcohol dependence or drug abuse.
* Subjects that present legal incapacity or limited legal capacity.
* Subjects presenting illiteracy or language barriers.
Methotrexate for Central Serous Chorioretinopathy Treatment Trial

Central serous chorioretinopathy (CSC) is a disease of unknown origin however multiple reports have indicated correlation of appearance of CSC with exposure to exogenous or elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids is upregulated in many inflammatory conditions, control of the inflammation may be beneficial in reducing this level thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely used to control different types of inflammation. The investigators are going to try an escalating doses of MTX to treat CSC under full medical supervision.

Central serous chorioretinopathy (CSC) is a disease of unknown origin usually affecting the center of the macula in adults of working age. Though previously the condition was considered stress-related, multiple recent reports have indicated correlation of appearance of CSC with exposure to exogenous or elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids is upregulated in many inflammatory conditions, control of the inflammation may downregulate the endogenous steroids thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely used to control different types of inflammation. Few short retrospective series of beneficial effect of MTX on CSC were reported recently. The investigators are going to try an escalating doses of MTX to treat CSC under full medical supervision in a prospective manner.

Eligibility Criteria:
Inclusion Criteria:

* Central Serous Chorioretinopathy

Exclusion Criteria:

* Pregnancy
* Liver disease
* Kidney disease
* Steroid use
Safety in Seconds 2.0: An App to Increase Car Seat Use

This project will utilize the first web-based program to provide tailored injury prevention education. The existing Safety in Seconds program was adapted into a smartphone platform. Parents are recruited from and engage in the program in the clinical setting (PED or PTS). Parents download the app onto their smartphone which is used to ask the questions, collect a parent's responses, assess the parents' safety needs and give tailored directions for proper car sear use. The control group parents will also engage with the smartphone app and receive immediate feedback. However, they will receive tailored educational messages about smoke alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have educational features (e.g., tips for keeping children content in their CSSs, links to helpful websites). The investigators will use emerging technology such as push notification and email to remind parents to visit the portal and have their child's car seat reassessed.

The investigators plan to conduct a cost benefit analysis of the program's expected financial benefit from the perspective of a third party payer of medical claims and an in-depth examination of program adoption and implementation using qualitative data collected from key informant interviews, direct observations of the clinic environments, and document review.


Eligibility Criteria:
Inclusion Criteria:

* Visiting the Pediatric Emergency Department (PED) at Johns Hopkins Hospital or Arkansas Children's Hospital
* Parent or guardian of child 4-7 years
* English speaking
* Have and Android or iPhone smartphone
* Drive with the child in a car at least once per week in a car that the parent owns, borrows or gets a ride round-trip
* Resident of Baltimore City, MD or Little Rock, AR and surrounding area.

Exclusion Criteria:

* PED has flagged case as suspected abuse
* Another household member is enrolled in the study
* In Arkansas, less than 18 years without parent present at the PED
Treatment of Menstrual Cycle Alterations in Adolescents

the aim of the present study is intended to evaluate how treatment with Myo-Inositol and Dioscorea Villosa can help improve menstrual cycle irregularities in adolescents, both with and without PCOS.

The present study aims to evaluate the possible beneficial effect of a treatment with Inofolic HP combined with Inofolic phD on the improvement if menstrual cycle alteration in adolescent patients with or without PCOS.

The molecules chosen for the study are the following: myo-Inositol, α-lactalbumin, Dioscorea Villosa, and Vitamin D, are already commercialized as dietary supplements, commonly administered at same dosage provided in the present study, also for prolonged treatments, with no side effects associated.

Eligibility Criteria:
Inclusion Criteria:

* adolescent women aged 14-19 years old, with at least 3 years passed after menarche, and oligomenorrhea or amenorrhea

Exclusion Criteria:

* Primary amenorrhea.
* Hyperandrogenism due to other factors (i.e. adrenal hyperplasia or Cushing syndrome).
* Hyperprolactinemia or overt hypothyroidism (TSH ≥4).
* Other hormonal alterations.
* Ongoing hormonal therapies, including OCPs, six months before enrollment.
* Ongoing pharmacological therapies.
* Ongoing use of myo-Inositol supplement or other source of myo-Inositol, or Dioscorea villosa, six months before enrollment.
Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy

The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.

Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. The pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. The pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution.

To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored individually according to subject complaints and may be selected from categories including Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants).

The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the treatment of diabetic neuropathy as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diabetic neuropathy
* must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment
* must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed

Exclusion Criteria:

* uncontrolled pain that has persisted for \> 12 months.
Antibodies and Liver Retransplantation

Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due to the absence of an easily discernible clinical association between adverse recipient outcome and DSA. Re-transplantation provides a test environment where the presence of preformed DSA or other antibodies is prevalent and events (graft loss) more common so that the effect of these antibodies on outcome should be apparent. This is an observational study of routine clinical care to determine these effects on our own patients. The goal is to perfect donor-recipient matching to attain the best outcome. In addition, we may develop hypotheses and potential treatments that would be tested in further clinical trials

Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due to the absence of an easily discernible clinical association between adverse recipient outcome and DSA. Re-transplantation provides a test environment where the presence of preformed DSA or other antibodies is prevalent and events (graft loss) more common so that the effect of these antibodies on outcome should be apparent. This is an observational study of routine clinical care to determine these effects on our own patients.

In phase 1, we will examine the effect of antibodies specifically directed against the second donor in liver retransplantation. Other factors known to effect the outcome will be checked to allow for risk adjustment.

In phase 2, we will examine the role played by specific auto-antibodies such as angiotensin II receptor type 1 antibodies and endothelin-1 type A receptor antibodies on the outcome of liver retransplantation.

The goal of these observational study is to perfect donor-recipient matching to attain the best outcome. In addition, we may develop hypotheses and potential treatments that would be tested in further clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of a second liver transplantation performed at LHSC

Exclusion Criteria:

* Recipients of ABO incompatible second liver transplantation
* Recipients of multiple organs
Malaria in Strasbourg University Hospital

The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively


Eligibility Criteria:
Inclusion Criteria:- Patient over 18 years

* Patients from birth to 18 years
* Patient submitted to guardianship
* Patient submitted to trusteeship
* Diagnosis patients with malaria from 01/01/2017 to 01/01/2018
* Patient or legal representative agree to use medical data for this research

Exclusion Criteria:

* Lack of confirmation malaria diagnosis
* Impossibility to inform patients
* Patient who does not wish to participate in the study
* Patient submitted to justice safeguarding