cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.


Eligibility Criteria:
Inclusion criteria:

1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1\<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC \<70% at Visit 1
2. Male or female patients, 40 years of age or older
3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years:

Exclusion criteria:

1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN
2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
3. Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute)
4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
5. Patients who have undergone thoracotomy with pulmonary resection
6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
7. Patients who regularly use daytime oxygen therapy for more than one hour per day.
8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
9. Pregnant or nursing women
10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
Management of Ovarian Masses in Pediatric Patients: an Italian Survey

Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian masses' management (from diagnosis to treatment) in patients aged 1-18.

Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries.

PURPOSE AND OBJECTIVES OF THE CLINICAL TRIAL The aim of the present study is to propose a survey among Italian Pediatric Surgeons (inside the Società Italiana di Chirurgia Pediatrica-SICP) to evaluate the current management of ovarian masses in patients aged 1 -18, in terms of preoperative work up and surgical modalities.

EXPERIMENTAL DESIGN

PRIMARY OBJECTIVE:

To evaluate the current management of ovarian masses in patients aged between 1 and 18.

EXPERIMENTAL PLAN:

Observational study, survey.

SETTING:

This is an online survey designed using REDCap forms feature. Data will be collected in a period of 6 months. The informed consent forms for participation, use of personal data and the link for the questionnaire will be sent by e-mail to all Italian Pediatric Surgeons belonging to the SICP. The surgeons who accept to participate, will return both signed consent forms and a copy of their Identity Card.

The survey is divided into seven sections.

* Section 1: demographic data.
* Section 2: data on surgical background of the institution and the pediatric surgeons.
* Section 3: management of pediatric patients in emergency.
* Section 4: management of pediatric patients who had planned surgery.
* Section 5: additional management data.
* Section 6: knowledge of the IOTA group and terminology.
* Section 7: availability to participate in a multi-center retrospective study.

Questions asked for responses using yes/no, multiple-choice, or short freeform written answers. More than one response could be given for many questions, it is specified.

(The detailed description is reported in the attachment 1).

Eligibility Criteria:
Inclusion Criteria:

Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst.

Signed informed consent for participation in the study and for the use of personal data.

Exclusion Criteria No answer and/or non-completion of the questionnaire within 1 month after sending our e-mail.
Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients

The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM with micro- or macroangiopathy.
* HbA1c 6-9 % (Mono-S method).
* Need for, or already on-going aspirin treatment.
* Age 50-75 years
* Antecubital forearm veins allowing technically good sampling for platelet studies

Exclusion Criteria:

* Diet controlled DM.
* Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
* Acute or chronic kidney disease (P-cystatin C within the reference interval)
* Acute or chronic liver disease (ALAT ≤2 times the upper reference value).
* A history of gastric or duodenal ulcer disease.
* Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
* Thrombocytopenia (platelet count \<150 x 109/L)
* Anticipated need for alteration of concomitant drug therapy during the course of the study.
* Enrollment in another clinical study.
* Contraindication(s) to aspirin treatment.
Influence of Sit Muscle Strength Training and Game on Elderly

Objective: The study aims to understand the physical function, body composition, mental state, behavior, depression, and life quality change of the elderly in a long-term care before and after the intervention. Four interventional activities are sitting strength training, games, sitting strength training with games, and health education.

Expected results: (1) The program will facilitate arrange activities that are beneficial to the body and mind, activate bodily functions, and promote the quality of life of the elderly in Taiwan. (2) The program can compare the effectiveness of different trainings for the elderly and provide a reference for future implementation planning. (3) Evidence of the empirical study of this program can provide future comparisons with other domestic and foreign studies.

Eligibility Criteria:
1.Inclusion Criteria:

1. Elderly persons between the age of 60 and 100 who take long-term care of the relevant units do not have limited sports
2. stable condition with sufficient physical strength: at least one hour sitting in the wheelchair or bed edge.
3. Subjects in the past month tended to live in static state (less than 150 minutes of exercise time per week).

2.Exclusion Criteria:

1. Serious illness / unstable status (judged by medical staff), such as serious cardiopulmonary diseases, severe malignant tumor (assessment from medical personnel), severe malnutrition (mini nutrition assessment scale 0-7 points).
2. Unstable weight over the past six months (\> ± 4 kg).
Patient Preference Study

In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Diagnosis of glaucoma or ocular hypertension;
* On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
* IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
* Pregnant, nursing, or not using highly effective birth control methods;
* Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
* History of bronchial asthma or severe chronic obstructive pulmonary disease;
* Other protocol-defined exclusion criteria may apply.
Bilateral Prefrontal Modulation in Alcoholism

In this study, eligible alcoholic inpatients recruited from a specialized clinic for addiction treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of alcohol was examined before (baseline), during and after the end of the tDCS treatment.

Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change craving in alcoholism and this would be a long-lasting effect.

Before (baseline) and after tDCS or sham-tDCS treatment, subjects were clinically examined regarding craving (obsessive compulsive drinking scale) and they were followed-up for relapses at least 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients between the age of 18 and 60 years;
* met criteria for alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), as determined by clinical evaluation;
* in stable clinical condition with no need for inpatient care;
* able to read, write, and speak Portuguese; and
* no severe withdrawal signs or symptoms at baseline.

Exclusion Criteria:

* a condition of intoxication or withdrawal due to a substance other alcohol;
* unstable mental or medical disorder or substance abuse or addiction other than alcohol dependence, except nicotine and/or caffeine;
* a diagnosis of epilepsy, convulsions, or delirium tremens during abstinence from alcohol;
* a previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol;
* any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants;
* suspected pregnancy for female participants;
* any contraindication for magnetic resonance procedures such as electronic implants, metal implants, claustrophobia, or permanent make-up or tattoo received within the previous 3 months;
* the presence of vascular, traumatic, inflammatory, or tumor injuries detectable by CT examination.
Online Treatment of Trichotillomania

Online study for patients with trichotillomania. 4 main hypothesis.

1. Alexithymia and Trichotillomania correlated and regression analyses find association between them
2. we will be able to find patient who have never been treated before. Those will suffer to the same amount as previously treated patients
3. Decoupling will be more helpful than progressive muscle relaxation
4. different constructs of emotion regulation will show different trait and state characteristics in patients with trichotillomania

Randomized controlled trial with about 100 participants.

Eligibility Criteria:
Inclusion Criteria:

* suffering from trichotillomania 18 to 65 years old

Exclusion Criteria:

* current drug or alcohol addiction current psychosis
Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments

To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments

Bilateral retinal detachment is a rare but sight-threatening disease, that can cause blindness and poor quality of life.

It has been proved that patients who suffer from RD in one eye have a considerably increased risk to subsequently develop an RD in the fellow eye.

It can be expected that patients who experienced a RD in one eye, tend to present sooner when experiencing a RD in the fellow eye, and thus have a greater visual and/or anatomical prognosis.

In this study, we aim to describe characteristics of bilateral RD and compare the initial and subsequent eye in terms of clinical preoperative features, surgical management, and anatomical and visual results.

Eligibility Criteria:
Inclusion Criteria:

* All patients that underwent retinal detachment repair surgery for bilateral sequential retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center (via pars plana vitrectomy or scleral buckling) and with a minimum of 6 month of post-operative follow-up after the last surgery.

Exclusion Criteria:

* Patients that underwent surgery at another facility
* Patients with a history of previous vitrectomy or
* Patients with a history of trauma from a penetrating injury or ruptured globe, retinal neovascular condition, hereditary vitreo-retinopathy
Comparative Efficacy of Ovule vs Tablet

The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
* Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
* Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
* Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
* Negative saline smear for Trichomonas vaginalis

Exclusion Criteria:

* Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
* Subjects presenting a protozoan infection as confirmed by microscopic investigation.
* Pregnant, breast feeding or lactating subjects.
* Subjects with suspected bacterial vaginal infection.
* Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
* Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1.
* Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.
* Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).
* Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).
* Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).
* Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.
* Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.
* Subjects who received another investigational drug within 30 days before visit 1.
* Unwillingness to refrain from sexual activity during 3 days thereafter.
* Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.
A Neonatal Bimodal MR-CT Head Template

This is a retrospective study based on the images contained in the database of the University Hospital of Amiens. There is no further examination. Electroencephalography (EEG) and Near-Infrared Spectroscopy (NIRS). These sources are widely used to specify the source of certain evoked potentials or to better define the sources of epileptic graphoelements, especially in the pre-surgical assessment of refractory epilepsies.

It is therefore important that these regions are more widely available in the constitution of the world, and that they are suitable for use in the design of new technologies. Although MRI is the gold standard for soft tissue segmentation, it is not suitable for bone extraction; especially in the newborn or the bone is very thin. On the other hand, CTscan is an excellent method for extracting bone. The contrast between bone and soft tissue is excellent. In this case, with the CTscan, the fontanelles are identified as discontinuities between the images of the temporal scales.

Magnetic resonance imaging (MRI) and brain scan (CT Scan) are the two main modalities of structural brain imaging that are widely used in routine practice. The extraction of bone from MRI and CTscan images is an important step in the segmentation of the different tissues of the subjects' heads. It is indeed necessary to know precisely the electrical characteristics (conductivities) and optical (absorption, diffraction) of tissues (skin, bone, LCS, gray matter and white matter), or by electric currents or by photons. One of the major problems is the one that is not very poorly visualized in MRIs in CTscan, the bone is well individualized and that inversely the various brain structures are difficult to extract. This justifies the fact of performing a coregistration of images obtained in MRI and CTscan.

The skull of the newborn is an inhomogeneous structure. The fontanelles are invisible in MRI and identifiable in CTscan.

Electroencephalography (EEG) and Near-Infrared Spectroscopy (NIRS). These sources are widely used to specify the source of certain evoked potentials or to better define the sources of epileptic graphoelements, especially in the pre-surgical assessment of refractory epilepsies.

It is therefore important that these regions are more widely available in the constitution of the world, and that they are suitable for use in the design of new technologies.

Although MRI is the gold standard for soft tissue segmentation, it is not suitable for bone extraction; especially in the newborn or the bone is very thin. On the other hand, CTscan is an excellent method for extracting bone. The contrast between bone and soft tissue is excellent. In this case, with the CTscan, the fontanelles are identified as discontinuities between the images of the temporal scales.

Eligibility Criteria:
Inclusion Criteria:

* children aged between 0 and 2 months new born at term
* with no structural abnormalities

Exclusion Criteria:

* infants \> 2 months
Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant

The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose \< 1,26 g/l without the need of hypoglycemic treatment.


Eligibility Criteria:
Inclusion Criteria:

* - Patients who have received a first liver transplantation and who are 18 to 70 year old
* Patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months
* Patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation

Exclusion Criteria

* Re-transplantation or multi-organ transplantation,
* Diabetes before the transplantation,
* Type I diabetes mellitus.

Other protocol-defined inclusion / exclusion criteria may apply
Suction Based Characterization of Healthy and Diseased Skin

The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements. The negative pressure needed to gain a certain tissue elevation, tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. Mesurments will be done with the new developed Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.

Patients with systemic sclerosis (SSc) show a thickening of the skin due to massive deposition of collagen and temporary edema in the dermis. The clinical palpation method is currently the only diagnosis method. For an objective detection a non-invasive skin elasticity measurement can be performed. The widely used approach is based on local tissue suction. This study aims at an identification and quantification of mechanical and structural properties of human skin. The results will then be compared in age- and gender matched control groups. For evaluation of the skin elasticity measurement the results will be compared to the clinical parametar validated, modified Rodnan skin score (mRSS).

The mechanical properties of healthy and diseased skin will be assessed by suction based measurements. The negative pressure is needed to gain a certain tissue elevation. Tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. (The different parameters depend on

Eligibility Criteria:
Inclusion Criteria:

-Signed Informed Consent

Healthy volunteers:

- Age ≥18 years old

SSc-Patients:

* Age ≥18 years old
* Diagnosis of systemic sclerosis according to the ACR/EULAR 2013 criteria
* Skin thickening diagnosed by clinical expert

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrolment into the current study,
* Participants, who are unable to hold still
* Impaired skin at the regions of measurements