cyrilzakka/clinical-trials huggingface dataset:
Corneal Endothelial Cell Density Changes, When Mapracorat Ophthalmic Suspension 3%, is Administered for 14 Days

The objective of this study is to evaluate the effect on corneal endothelial cell density (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered QID (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.


Eligibility Criteria:
Inclusion Criteria:

* Must have a Pinhole visual acuity (VA) equal to or better than 20/40 in both eyes.
* Must be in good ocular health

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug or its components.
* Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
* Any topical ophthalmic medication, including tear substitutes that cannot be discontinued during the study.
* Subjects who are monocular (fellow eye is absent or fellow eye's Pinhole VA is worse than 20/200).
* Subjects with a history of ocular surgery, or who anticipate ocular surgery in either eye within the study period.
* Presence of significant ocular or systemic disease that the Investigator determines could interfere with the study.
Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty

The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results.

The purpose of this study is to compare the anterolateral- to posterolateral approaches in patients suffering a displaced femoral neck fracture operated with an hip arthroplasty. Our hypothesis is that the anterolateral approach gives equal or better clinical function, health related quality of life and less complication and reoperations.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* Displaced femoral neck fracture

Exclusion Criteria:

* Pathologic fracture
* Not Swedish speaker
* Not living in Västernorrlands county
Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease

The purpose of this study is to prospectively collect data on doses of Erythropoietic Stimulating Agents (ESA) and Intravenous Iron, and the markers of erythropoietic activity and iron status. These data will be used to derive mathematical models which will subsequently guide dosing of both agents, such that a desired therapeutic outcome is achieved in every patient, while minimizing patient exposure to both agents.

Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek treatment (Wed/Thu) to measure:

Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor

Weekly ESA and Iron dose delivered will also be recorded.

From these data:

1. a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy,
2. a mathematical model will be established to correlate iron dose with iron markers.

Eligibility Criteria:
Inclusion Criteria:

* receiving or expected to receive ESA

Exclusion Criteria:

* life expectancy less than 12 months
* frequent (once or more per month w/in last 6 months) uncontrolled blood loss
* frequent (once or more per month w/in last 6 months) hospitalization
* frequent (once or more per month w/in last 6 months) access complications
Impact of a Memory Group for Older Adults Reporting Memory Difficulties

Aims:

To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive impairment, assisted by family members or friends. To equip persons with mild cognitive impairment with specific skills to prevent memory failures and improve the capacity of patients and families to cope with everyday memory difficulties.

Participants:

The sample will consist of 60 families who have a family member reporting memory loss and who have recently been assessed within the Cognitive Dementia and Memory Service (CDAMS). Participants will include patients and a family member / close friend. The potential patient participants must have received a diagnosis of mild cognitive impairment following a comprehensive clinical assessment. They must also be English speakers, live in the community, have no evidence of significant visual or auditory impairment, and have no history of diagnosed alcohol or drug abuse or major psychological disorder. Potential family / friend participants are expected to be spouses or adult children.

Brief Description:

Patients and their carers will be assigned to either a 'brief intervention group' or a 'no intervention group'. Over 5 1 1/2 -hour weekly sessions, the brief intervention group will be taught a memory skills program which emphasises practical strategies for dealing with everyday memory problems. Interactive group discussion and 'take home' exercises are also included. The no intervention group will serve as a control group, and will receive only their usual care from the the memory clinic. At the completion of the study, the brief intervention will be offered to those in the no intervention group.

All participants will complete questionnaires about knowledge of memory techniques, common memory and behaviour problems and emotional health at pre-intervention, post-intervention and after a 3-month follow-up.

Methods of Data Analysis:

Outcome evaluation will be monitored by neuropsychological assessments of memory performance, and subjective self-reports. A 2 x 3 multivariate analysis of variance (MANOVA) will be used to assess differences on the experimental measures between groups (brief intervention, no intervention) across repeated assessment phases (pre-intervention, post-intervention, 3-month follow-up).

Eligibility Criteria:
Inclusion Criteria:

Participant presents with memory complaint Objective memory impairment on neuropsychological tests Normal general cognitive function Adequate activities of daily living Fails to reach criterion for clinical dementia according to NINCDS-ADRDA guidelines Living in the community Absence of significant visual or auditory impairment English speaker -

Exclusion Criteria:

-
Effect of Fresh Gas Flow on Emergence Time

The purpose of this study is to evaluate the effect of fresh gas flow on emergence time in patients undergoing transurethral resection of bladder tumor.

The purpose of this study is to evaluate the effect of fresh gas flow (5 L/min vs. 10 L/min) on emergence time in patients undergoing transurethral resection of bladder tumor.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled transurethral resection of bladder tumor under general anesthesia
* Patients aged between 20 and 79 years old
* American Society of Anesthesiologists physical status ≤2
* Patients who are voluntarily agreed to this clinical study

Exclusion Criteria:

* A long operation (2 hours or longer)
* Hearing disturbance
* Cognitive disorder
* Psychiatric substance abuse
* Patient's denial
Burnout Among Members of AAGL

This study seeks to determine the burnout rate among minimally invasive gynecologic surgeons (MIGS) as well as to evaluate other personal, professional, and psychosocial factors associated with this condition.

An anonymous electronic survey will be sent to the American Association of Gynecologic Laparoscopists (AAGL) members. The survey will contain items that will inquire about socioeconomic background, professional characteristic, and about physical and psychologic well-being.


Eligibility Criteria:
Inclusion Criteria:

* members of the AAGL

Exclusion Criteria:

* not a member of the AAGL
A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
* Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
* HbA1c 7.0% - 10.0%
* Body mass index (BMI) less than or equal to 40.0 kg/m\^2

Exclusion Criteria:

* Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
* Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Chronic disorder or disease which might jeopardise safety or compliance
* Malignant neoplasms
* Recurrent severe hypoglycaemia
Effects of a Single Dose of Amisulpride on Functional Brain Changes

This study is designed to investigate effects of a single dose of amisulpride on functional brain changes during reward- and motivation-related processing and at rest in healthy volunteers (HV) and in patients with Major Depressive Disorder (MDD).

Double blind, placebo-controlled, randomized, single dose, parallel-group design The study is designed to investigate effects of a single dose of amisulpride on functional brain changes during reward- and motivation-related processing and at rest. Measurement of functional brain changes will occur after a single dose of amisulpride or placebo in HV and patients with MDD. It is hypothesized that functional brain changes previously linked to reward- and motivation-related processing require dopaminergic signaling and are diminished in MDD compared to HV. In MDD, but not in HV, treatment with a single low dose (100 mg) amisulpride should increase brain activation associated with reward- and motivation-related processing. To test these hypotheses, we will implement a randomized, placebo-controlled, parallel- group design with 4 treatment arms (MDD/placebo, MDD/amisulpride, HV/placebo and HV/ amisulpride). All subjects will undergo MRI scanning sessions at Visit 3 and Visit 4. Treatment with amisulpride or matching placebo will occur 3.5 to 4 hours before the start of each scanning session. Time of treatment will be standardized across subjects.

At Visit 3 and Visit 4, blood samples will be taken 30 minutes pre-dose, and 1 hour, 3.5 to 4 hours, and 4.5 to 5 hours after oral drug administration to determine target plasma levels of amisulpride.

The study is composed of 4 outpatient visits: Screening, baseline and 2 scanning sessions.

Eligibility Criteria:
MDD Patients:

Inclusion:

* Male and female patients with MDD; aged 18 to 45 years
* Montgomery-Åsberg Depression Rating Scale (MADRS) score \> 7 and \<26 at screening.

Exclusion:

* Meeting diagnostic criteria for any major psychiatric disorder (other than MDD), as determined by DSM-5 at screening.
* Having received prescribed medication (including antidepressants (AD)) within 14 days or fluoxetine within 90 days prior to Visit 3 (apart from the contraceptive pill).
* Having received psychotherapy within 14 days prior to Visit 3.
* Positive severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) test.

Healthy Volunteers:

Inclusion:

* Healthy
* aged 18 to 45 years

Exclusion:

* Meeting diagnostic criteria for any major psychiatric disorder.
* A history of psychiatric or neurologic disorders.
* Having received prescribed medication within 14 days prior to Visit 3 (apart from the contraceptive pill).
* Positive SARS-CoV-2 test.
LEO 124249 Ointment in the Treatment of Alopecia Areata

This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.

The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO 124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial.
* Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline).
* Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit.
* Subject must accept to not cut hair in the treated scalp areas during the trial.

Exclusion Criteria:

* Females who are pregnant or are breast feeding.
* Current signs of spontaneous hair regrowth.
* Diffuse type alopecia areata.
* Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III)
* Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial.
* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
Intraabdominal Hypertension After Kidney Transplantation

Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury is the most frequent and described complication of IAH condition.

Patients undergoing kidney transplantation have several risk factors to develop IAH. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.

We aim to study IAH incidence, associated factors and impact on renal function recovery in post kidney transplantation period.

Intraabdominal hypertension (IAH) is a frequent and severe condition affecting 30 to 54% of intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IAH is defined by IVP elevation above 12mmHg. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury (AKI)is the most frequent and described complication of IAH condition. IAH related AKI traduces renal hypoperfusion and its severity seems to correlate with IVP levels.

Patients undergoing kidney transplantation have several risk factors to develop IAH : abdominal wall surgery, acidosis and hypervolemic resuscitation. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.

We aim to study IAH incidence in post kidney transplantation period. Thus, we want to identify associated factors with IAH development in this context. We also aim to correlate IVP early evolution with extra-cellular hydration status evolution. Finally, impact of IAH on renal function recovery will be investigated.

Presupposing that 50 kidney transplantations per year will take place in University Hospital of Reims (France), we attend to include about 100 patients in this study. With a prevalence of at least 30% of IAH prevalence (as reported in intensive care units cohorts), enrollment of 100 patients will permit to estimate IAH prevalence with a 9% precision (with a 95%IC).

Eligibility Criteria:
Inclusion Criteria:

* End stage chronic kidney disease ;
* Hospitalized in intensive care of nephrology unit in University Hospital of Reims (France) during study period ;
* Undergoing kidney transplantation ;
* Accepting to participate.

Exclusion Criteria:

* Minor ;
* Protected by the law.
Duration of Doxycycline Treatment in EM Patients

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.


Eligibility Criteria:
Inclusion Criteria:

* solitary erythema migrans

Exclusion Criteria:

* pregnancy or lactation
* immunocompromised
* serious adverse event to doxycycline
* taking antibiotic with antiborrelial activity within 10 days
* multiple erythema migrans or extracutaneous manifestations of lyme borreliosis
SKINI - Radicality of Skin-Sparing and Nipple-Sparing Mastectomy

Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.

In this prospective, multi-center trial patients undergoing mastectomy and fulfilling inclusion criteria receive additional biopsies from the remaining skin envelope in order to quantify the amount of residual breast tissue.

Since the investigators will assess, 142 breasts will be investigated. This means a maximum of n=142 patients will be included (corresponding to a minimum of n=71 patient).

On the specimen additional histological sections in radial direction will be performed.

The aim of the study is to evaluate the quality of Skin- Sparing and Nipple-Sparing Mastectomy. On each predefined location in the wound cavity the investigators will investigate where residual breast tissue (RBT) will be found or not. If no RBT can be detected at all predefined breast locations this breast will be classified as having no RBT (=RBT negative). If breast tissue can be detected the investigators have a RBT positive breast.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing uni- or bilateral Skin-Sparing or Nipple-Sparing mastectomy
* Female participants ≥ 18 years of age
* The subject was informed on the project and gave her written informed consent to use her data and samples for this project.

Exclusion Criteria:

- Not fulfilling inclusion criteria
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection

This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* 1. Inert lymphoma, including follicular lymphoma (FL), extranodal marginal zone B-cell lymphomas of the mucosa-associated lymphoid tissue (MALT), lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocyte B-cell lymphoma and chronic lymphoblastic leukemia (CLL).

  2. At least one measurable lesion with the longest diameter \> 1.5 cm and the short diameter \> 1.0 cm, or the peripheral blood B lymphocyte ≥ 5.0×109/L.

  3.Adequate laboratory indicators. 4. Has received one to three chemotherapy regimens (with or without rituximab) before enrollment.

  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

  6. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Patients who could not tolerate bendamustine treatment according to the investigators' judgment.

  2. Has received anti-tumor treatment (including major surgery) in the last 4 weeks.

  3. Transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3B follicular lymphoma.

  4. Has received corticosteroids regularly in the last 4 weeks. 5. Has a history of central nervous system disease or central nervous system disease.

  6. Has other tumors. 7. Has suffered from serious infection and other drugs or mental illness,which affects signing informed consent form and follow-up visit.

  8. Pregnant or breastfeeding women. 9. Has participated in other clinical trials within three months.
Effect of MRA on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia

Elevated aldosterone causes moderate to severe increase in blood pressure, and leads to various target organ damage including cardiovascular ones. Aldosterone has been considered one of the important risk factors for cardiovascular and cerebrovascular diseases. Currently, the use of mineralocorticoid receptor antagonists(MRA) has been proven to reduce blood pressure levels, but long-term prognostic data are lacking in hypertensive patients. Therefore, the purpose of this clinical trial is to assess the effect of MRA on cardiovascular disease in patients with Hypertension and Hyperaldosteronemia.

The trial will randomize about 7800 participants aged between 30 and 75 years with Hypertension and Hyperaldosteronemia(Plasma aldosterone concentration \>12 ng/dl). All participants were randomly assigned to two different intervention groups. One group was treated with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in addition to the original antihypertensive drugs. One group was given the original antihypertensive drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years old;
2. Blood pressure ≥140/90 mmHg, or have taken antihypertensive drugs;
3. Plasma aldosterone concentration\> 12ng/ dL;
4. Serum potassium \< 4.8mmol/L;
5. Signed the written informed consent.

Exclusion Criteria:

1. SBP/DBP≥190/120mmHg, DBP\<60 mmHg;
2. Known secondary cause of hypertension, including pheochromocytoma, primary aldosteronism (adrenal tumor \> 1cm), Cushing's syndrome, renal artery stenosis, renin tumor, connotation of aorta, etc.;
3. History of ischemic or hemorrhagic stroke within the last 3 months (not lacunar infarction and transient ischemic attack \[TIA\]).
4. History of Hospitalization for myocardial infarction or unstable angina, or coronary revascularization (PCI or CABG) within the last 3 months.
5. History of aortic dissection/dissection aneurysm rupture.
6. History of NYHA Grade III-IV heart failure or hospitalization Aggravated chronic heart failure upon admission within the last 3 months.
7. A history of persistent atrial fibrillation, atrial flutter, or other severe arrhythmias on admission (including sinus delay, diseased sinus, high atrioventricular block, frequent ventricular morning, etc.).
8. Severe liver disease or liver dysfunction: AST, ALT, or ALP \> 5ULN (5 times the upper limit of normal), or BIL \> 3ULN (3 times the upper limit of normal).
9. End-stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) \<30 mL/min, or serum creatine \>2.5 mg/dl \[\>221 umol/L\];
10. Patients with serious physical diseases such as malignant tumors and autoimmune diseases.
11. Severe cognitive or mental impairment.
12. Pregnant and lactating women.
13. Those who have contraindications or allergies to MRAs.
14. Patients with hypoadrenocortical function.
15. Participating in other clinical trials.