cyrilzakka/clinical-trials huggingface dataset:
Can Shear Wave Elastography Predict the Success of ESWL: a Prospective Study

Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal stones treatment ? A prospective study

Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is recommended as the first choice in the treatment of small and medium sized renal stones and proximal ureteral stones.

This study is a trial to determine the predictive role of shear wave elastography in the success of ESWL management of kidney stones.

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years
* With single radiopaque renal stone
* Ranging in size from (1-1,5 cm) for ESWL.

Exclusion Criteria:

* Any urological abnormal anatomy
* Lower calyceal stone more than 1cm
* Impaired renal functions
* Uncorrected coagulopathy.
* Active UTI Pregnancy Single kidney Multiple stones
Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors

Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5% significance level. We anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.

The overall objective of this clinical trial is to investigate the effects of low and high doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal adiposity and dyslipidemia versus age and gender-matched controls.

Eligibility Criteria:
Inclusion Criteria:

* dyslipidemia
* abdominal adiposity (\>35 inches for women, \>40 inches for men)

Exclusion Criteria:

* on statin therapy
* taking hypoglycemic agents
A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

* Investigational Product: LIZTOX inj 100unit(HU-014)
* Title : A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
* Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D
* Objective : To evaluate the safety of LIZTOX inj in the treatment of Post Stroke Upper Limb Spasticity


Eligibility Criteria:
Inclusion Criteria:

* A subject who is diagnosed with Stroke at least six weeks prior to Screening.
* A subject who has Modified ashworth scale(MAS) score which Wrist Flexor is ≥ 2 and Flexor or Finger Flexor is ≥ 1.
* A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of the categories of hand hygiene, clothing, upper extremity, or pain for evaluation.

Exclusion Criteria:

* A subject who has medical history following. (Allergy, Chemodenervation(within 6 months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspiration pneumonia, etc.)
* A subject who has history of any diseases following. (neuromuscular junction disorder, NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, ALS, Skin disease, Dysphagia, etc.)
* From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
* Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
* A subject who tend to bleed or are taking anti-coagulant drugs.
* A sugject who is undergoing rehabilitation(physical therapy, occupational therapy, exercise therapy) or Splinting in the area where medication for clinical trials is scheduled to be administered.
* A sugject who has muscle atrophy, fixed joint/muscle contracture in the area where medication for clinical trials is scheduled to be administered.
* Any condition that, in the view of the investigator, would interfere with study participation.
Interest of LC-OCT for Diagnosing Inflammatory Dermatoses: ODIN (OCT Dermotoses INflammatoires)

Inflammatory dermatoses (eczematiform dermatoses, psoriasiform dermatoses, lichenoid dermatoses, toxic dermatoses, auto-immune and auto-inflammatory dermatoses, etc.) and their differential diagnoses (infectious or para-infectious dermatoses, deficiency dermatoses, etc.) are frequent reasons for dermatology consultations. These dermatoses are clinically heterogeneous eruptions for which a skin biopsy for histological examination may be routinely required to confirm the diagnosis.

LC-OCT (DeepLive Damae Medical machine) is a new non-invasive skin imaging technique (using non-ionizing infrared light), enabling observation of skin tissue to a depth of 500 µm with a resolution of 1 µm (= "cellular" resolution, the keratinocyte, the main skin cell, measuring between 5 and 10 µm).

This technique has already proved its worth in the diagnosis of skin cancers, and has the advantage of being non-invasive, painless and quicker than a biopsy. The investigators of the study want to study its value in the diagnosis of inflammatory dermatoses.

During the consultation dedicated to skin biopsy, a cutaneous LC-OCT examination is routinely performed, but only for exploratory purposes, allowing better targeting of the most modified area. The aim of the study is to describe and analyze the characteristics of cutaneous imaging (LC-OCT) in inflammatory dermatoses, comparing them with the histological appearance of biopsy specimens.

This is a preliminary study aimed at defining the value of LC-OCT in the diagnosis of inflammatory dermatoses, in the hope of replacing skin biopsy in the future.


Eligibility Criteria:
Inclusion Criteria:

* - Age greater than or equal to 18 years.
* Definitive histopathological diagnosis of inflammatory dermatosis, including classification by type (eczematiform, psoriasiform or lichenoid) and subtype (e.g. atopic dermatitis for eczematiform dermatosis, lupus for lichenoid dermatosis, etc.).
* Availability of good-quality LC-OCT images/videos, with at least one interpretable 3D block, a video scanning lesional and healthy skin in a manner deemed "sufficient", as judged collegially by the authors.

Exclusion Criteria:

* None
Duloxetine for Multiple Sclerosis Pain

This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg once daily (QD) compared with placebo on the reduction of pain severity in participants with central neuropathic pain due to Multiple Sclerosis.

Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Participants who screen successfully (Study Period I) will be randomized in a 1:1 fashion to duloxetine 60 mg QD or placebo. Starting with Study Period II, participants will be treated in a double-blind manner for 6 weeks. Participants who complete the 6-week, double-blind period will have the opportunity to participate in a 12-week, open-label, flexible-dose portion of the study (Study Period III). Study Period IV is a taper phase designed to reduce the occurrence of discontinuation adverse events. Participants may enter Study Period IV at any time after Visit 3.

Eligibility Criteria:
Inclusion Criteria:

* Have central neuropathic pain due to multiple sclerosis (MS) based on the disease diagnostic criteria
* Adult males or females
* Have a score of 4 or greater on the daily 24-hour average pain score
* Females must test negative for pregnancy at study entry
* Complete the daily diaries for at least 70% of the days of the study
* Participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study Disease Diagnostic Criteria:

  * Diagnosis of MS at least 1 year prior to study entry
  * No MS flares or change in disease treatment for the 3 months prior to study entry
  * Daily pain due to MS for a minimum of 3 months prior to study entry

Exclusion Criteria:

* Are currently in a clinical trial of MS disease-modifying therapy
* Have pain that cannot be clearly differentiated from causes other than MS
* Any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
* History of substance abuse or dependence
* Are pregnant or breast-feeding
Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.


Eligibility Criteria:
Inclusion Criteria:

1. Must be able to provide written informed consent.
2. All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
3. All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol.
4. Patients between 18-80 years of age

Exclusion Criteria:

1. Recipients of multi-organ transplant
2. Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
3. Recipients of kidneys from a deceased donor
4. Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
5. Women who are pregnant
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial.
A Long Term Follow-Up Study for Subjects Who Have Received Q-Cells

This study is an observational study designed to obtain information on the long-term safety, tolerability, and continued activity of Q-Cells®. The study will follow the participants who previously received Q-Cells® for 10 years.

The goal of this observational study is to learn about the long term effects of Q-Cells® in people with transverse myelitis.

The main objectives the study is to evaluate the safety of patients who have received Q-Cells®.

The secondary goal of the study is to get data about the long-term activity of Q-Cells® over a period of 10 years.

Patients will complete exams, lab tests, imaging, and questionnaires to monitor their safety.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have been administered Q-Cells® as part of Protocol QTM-101 or other treatment Protocol.
2. Subjects must have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations.

Exclusion Criteria:

1. The study is intended to follow all subjects who have received Q-Cells® without exception.
Constructive Self Assertiveness Via the Internet

Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.

In a randomized controlled trial three groups will be compared:

1. constructive self-assertiveness with guidance
2. constructive self-assertiveness without guidance
3. Waitlist control

Some people have problems with self-assertiveness. That can have negative impact on their lives. This study will test a constructive self-assertiveness intervention program delivered online. In addition, the relative effect of guidance during the intervention will be investigated.

In a randomized controlled trial three groups will be compared:

1. constructive self-assertiveness with guidance
2. constructive self-assertiveness without guidance
3. Waitlist control

The treatment (and wait) will be 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Human,
* At least 18 years old,
* Able to speak and read Swedish,
* Informed consent.

Exclusion Criteria:

* Severe depression (as defined by a PHQ9 score of 15 points or higher),
* If on medication the dosage has been stable for at least the past 3 months,
* No ongoing psychotherapy.
Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

The purpose of this study is to assess the dynamics of inflammatory parameters in presence or absence of infectious complications after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy is the treatment of choice in patients with primary or secondary peritoneal surface malignancies. However the survival benefit is achieved at the cost of increased morbidity and mortality due to an extensive surgery and intraoperative chemo-therapy. Among complications infectious complications are the most common. The early diagnosis of a potential fatal infection is therefore crucial to ensure a good outcome in patients.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients (more than 18 years) subjected to CRS and HIPEC due to peritoneal malignancy.
* Written informed consent by the participant after information about the research project

Exclusion Criteria:

* No primary or secondary peritoneal surface malignancy
* No CRS and HIPEC
* Pregnancy
* Younger than 18 years
Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in combination with metformin and glimepiride.

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
* HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
* BMI less than or equal to 40 kg/m2

Exclusion Criteria:

* Current smoking or smoking within the last 6 months
* Current acute or chronic pulmonary disease (except for asthma)
* Proliferative retinopathy requiring acute treatment
* Clinically significant disease history including kidney or liver disease
* Heart disease which limits physical activity or results in discomfort with physical activity
* Pregnancy
Prevention, Access to Rights, Catch-up Vaccination, Treatment of Conditions During Pregnancy and for Children

Insufficient screening and diagnostic delay play a significant role in sustaining the HIV epidemic by France.

Gender inequalities major factors reinforce social inequalities in order to of heterosexual men born abroad the most later diagnosed with HIV infection. Those gender differences are largely due to efficiency antenatal HIV screening, offered to women every pregnancy and widely accepted: a billed HIV serology in the context of pregnancy monitoring was found for 92% pregnant women benefiting from health insurance in 2015 the health of men is not taken into account in prenatal follow-up current French. The maternity hospital drains a population largely immigrant, often precarious The male prenatal consultation exists but it is not organized: it is possible to implement it, provided that the constraints exerted on men are taken into account.

the projet study the feasibility and the implementation processes place of prenatal consultation of future fathers

Insufficient screening and diagnostic delay play a significant role in sustaining the HIV epidemic by France. No significant decline is recorded in heterosexual, whether born in France or abroad. Gender inequalities major factors reinforce social inequalities in order to of heterosexual men born abroad the most later diagnosed with HIV infection. Those gender differences are largely due to efficiency antenatal HIV screening, offered to women every pregnancy and widely accepted: a billed HIV serology in the context of pregnancy monitoring was found for 92% pregnant women benefiting from health insurance in 2015. The arrival of a child could be an opportunity to screening for the future father as well. However, well that a consultation and a biological assessment intended for future fathers are provided for and fully reimbursed by the social security, the health of men is not taken into account in prenatal follow-up current French. The maternity hospital drains a population largely immigrant, often precarious. She puts in contact with the care of pregnant women who were sometimes distant, but not their companions: beyond the issue of reduction of the hidden HIV epidemic, increased needs for prevention and access to health appeared to us for the pilot phase of this project.

Eligibility Criteria:
Inclusion Criteria:

* For future fathers

  * are eligible for a prenatal consultation all adult men living in Ile de France whose companion is followed at the intercommunal hospital of Montreuil for a pregnancy Evolutionary.
  * having expressed no opposition to participation in the research

For future mothers

* all adult women newly enrolled in the maternity ward of the Montreuil intercommunal hospital centre for a progressive pregnancy declaring a partner involved in pregnancy and residing in Ile de France.
* having expressed no opposition to participation in the research

Exclusion Criteria:

* Persons who are unable to give their non-opposition due to a poor understanding of the French language
Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.

During the last 2 decades, the management of hyperglycemia in critically ill patients has become one of the most discussed topics in the intensive-care field. The initial data suggesting significant benefit from the normalization of blood glucose levels in critically ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some studies suggested that strict blood glucose control might benefit in non-diabetic patient and worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target based on glycated hemoglobin measured at ICU admission would improve outcome when compared to a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a randomized double blinded study in which Blood glucose control is piloted in both groups by a web-guided protocol that directly gives instruction to nurses (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers. Primary end point is 90 d outcome after randomization.


Eligibility Criteria:
Inclusion Criteria:

Patients are eligible for INCLUSION in the study if ALL the following criteria are met:

* Patient is 18 year old or older;
* At time of the patient's admission to the ICU the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission.

Exclusion Criteria:

* Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:

  * Patient or legal surrogate decision maker does not accept the participation to the study;
  * Imminent death (anticipated in less than 48 hours);
  * The treating clinicians are not committed to full supportive care (no resuscitation, no renal replacement therapy limits in dose of vasoactive support);
  * Patient is expected to be eating before the end of the day following admission;
  * Admission in ICU for hypoglycemic encephalopathy or patient at risk for hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or fulminant hepatic failure);
  * If a patient has previously been enrolled in the CONTROLING Study (patients cannot be enrolled in the CONTROLING Study more than once).
Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia

Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male aged 45 years old or older
2. Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination
3. Subjects with lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria:

1. Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years
2. Subjects who have acute urinary retention within 4 weeks before screening
3. Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening
4. Subjects who have hypersensitivity to investigational product or sulfa medications
5. Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,)
6. Subjects who have myasthenia gravis, narrow angle glaucoma or autonomic neuropathy
7. Subjects who have cataract or glaucoma scheduled to be operated in the study duration.
8. Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
9. Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.