cyrilzakka/clinical-trials huggingface dataset:
Visual Performance of Patients Implanted with a Multifocal IOL

The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D
* No visual acuity limiting pathologies other than cataract;
* Corneal Astigmatism of \<1.0 D;
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures;
* Written informed consent for participation in the study and data protection.

Exclusion Criteria:

* Corneal Astigmatism of ≥1.0 D;
* Difficulty for cooperation (distance from their home, general health conditions);
* History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.);
* Visual field loss which has an impact on visual acuity;
* Use of systemic or ocular medication that might affect vision;
* Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
* Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions);
* Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome);
* Cataract grades of 4, 5 or 6 on the LOCSIII scale ;
* Surgeries with incision size of ≥2.75mm ;
* Immediate Sequential Bilateral Cataract Surgery ;
* Concurrent participation in another device investigation;
* Usage of contact lenses during participation.
The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome

Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.

The aim of this study is to asses the influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.

Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets of Langerhans in the pancreas. Symptoms of diabetes present when the mass of insulin-producing cells reaches a point where insulin concentration does not suffice to maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of diabetes and initiation of insulin therapy. This phenomenon is called a remission.

The aim of this study is to asses influence of occurrence and duration of remission on development of chronic complications of diabetes and patients outcome.

Clinical remission was defined as time in which all of the following criteria were met: HbA1c below 6.5 % , dose of exogenous insulin below 0.3 U / kg body weight and serum C-peptide concentration above 0.5 ng / ml. Patients were divided into those who were in remission at any time during follow-up (remitters) and non-remitters.

At follow-up occurrence of chronic microvascular complications of diabetes (retinopathy, diabetic kidney disease and neuropathy) was evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997 criteria.
2. Age 18-35 years
3. Education with regard to intensive functional insulin therapy at the time of diagnosis
4. Patient consent to participation in the study

Exclusion Criteria:

1. Acute inflammation (serum C-reactive protein concentration (hsCRP) \>10mg/L, leukocytosis \>15x109/L, erythrocyte sedimentation rate (OB) \>30 mm/h)
2. Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated 2-fold over the upper limit of normal range
3. History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)
4. Other autoimmunological diseases other than diabetes
5. Not confirming type 1 diabetes after obtaining results of autoantibodies
Mantram Repetition to Manage PTSD in Veterans

With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat veterans is increasing. Creation, implementation, and testing of new and innovative interventions are needed to provide additional options for enhancing the mental health of those with PTSD. Surveys indicate that veterans are interested in complementary approaches to health care. The purpose of this study is to determine the efficacy of the Mantram Repetition Program (MRP) delivered as a brief, 6-week, complementary and portable intervention. It includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual associations, to manage PTSD symptoms and improve quality of life military veterans with trauma.

The Mantram Repetition Program (MRP) is an innovative, portable meditation-based group intervention. In this study, the MRP was delivered in addition to usual care (defined as case management and medication) in a 6-week (90 minutes/week) group setting. The MRP was compared to usual care only.

This 4-year study employed a mixed-methods, prospective, randomized controlled trial with qualitative phone interviews at 3 months post-intervention to explore ways that the intervention was used. Outpatient Veterans (N=146) with military-related PTSD were recruited from a single VA site and randomly assigned to the experimental arm (n=71) which consisted of usual care and the mantram program versus usual care only control group (n=76).

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of PTSD, military related
* Score of greater or equal to 45 on the Clinician Administered PTSD Scale
* Read and write English
* Score of \> 50 on PTSD Checklist
* Has a telephone with answering machine or voice mail to receive study messages
* Has a Case Manager assigned for usual care
* Willingness to track medications, relaxation techniques and number of case manager visit

Exclusion Criteria:

* Cognitive impairment including active psychosis, untreated bipolar disorder, dementia or personality disorder that interferes with group participation
* Presence of active, serious suicidal ideation
Epidemiology of Lupus Nephritis in Nephrology Unit in Assiut University Hospital

study epidemiology of lupus nephritis patients admitted to nephrology unit inward or in outpatient clinic in Assiut Nephrology Unit

this study are:

To describe socio-demographic characteristics of lupus nephritis patients in Nephrology Unit of Assiut University hospital ( Old and New cases).

To determine the associated risk factors in the study population

To describe the clinical, laboratory characteristics, treatment modalities of lupus nephritis patients in Nephrology Unit of Assiut University hospital ( Old and New cases)

To Identify outcomes of treatment of these cases within 2 years according to different classes

To evaluate the effectiveness of (type of interventions mentioned) among those patients.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to nephrology unit or visiting the outpatient nephrology clinic,previously or newly diagnosed with lupus nephritis.

Exclusion Criteria:

* incomplete Criteria for diagnosis of systemic lupus or presence of associated renal disease.
Evaluation of the Influence of Output on Skin Covered by Adhesives

This study investigates the impact real output has on peristomal skin covered by an adhesive


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation
Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.

Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.

Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. Human Leukocytes Antigen-G (HLA-G) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.

In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.

Eligibility Criteria:
Inclusion Criteria:

* pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy.
* 18 to 45 years of age will be included.

Exclusion Criteria:

* Patients with chronic hypertension
* children (age \< 17 years)
* Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors
* patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.
Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women

This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs \[loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)\], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.

The activities proposed will be performed in the context of health centres receiving pregnant women for antenatal care visit. Finger-prick blood (300 µL) will be collected and used to test for malaria with the HS-RDT, as well as with conventional good quality RDTs, microscopy and local NAATs (LAMP and nPCR). Dried blood spots will also be collected for qRT-PCR testing. Patient information (demographics, obstetric history, malaria prevention measures, etc.) as well as laboratory results will be recorded and entered into a dedicated database.

Eligibility Criteria:
Inclusion Criteria:

* Women with confirmed pregnancy and registered to the antenatal care programme in the local health centre
* Resident for at least 1 year in the study site
* Age ≥ 15
* Accepting to participate with willingness to give informed consent (pregnant adolescents younger than 18 y/o (age \< 18) will be considered only if they are accompanied by parent or carer if it is requested by local Institutional Review Boards)
* Willingness to provide finger-prick blood sample at enrolment

Exclusion Criteria:

* Past history of malaria and/or antimalarial drugs in the last three months
* Positive for malaria by microscopy and conventional RDT testing in any previous study screening visit
* Presence of severe malaria as defined by WHO guidelines at the moment of recruitment
* Presence of symptoms and signs of other severe disease and central nervous system infections, as defined by WHO guidelines.
A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants

The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months CGA.

Feeding Intolerance and other GI issues are a major concern in a NICU hospitalized population. Successful colonization with probiotic bacteria is thought to impact the incidence of GI related issues. This study will study the impact of prebiotics on the colonization of a population of VLBW infants in the NICU setting.

Eligibility Criteria:
Inclusion Criteria:

* infants with a birth weight \< 1500g
* admission to NICU at The Nebraska Medical Center

Exclusion Criteria:

* infants who have congenital anomalies
* have a diagnosis of a congenital metabolic disease
* are made a ward of the State or
* are born to a mother \< 19 years of age
A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

LIPO-102 is under evaluation for treatment of abdominal adiposity


Eligibility Criteria:
Inclusion Criteria:

* 18 - 50 years old inclusive
* Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS
* BMI \< 25kg/m sq
* Stable diet and exercise and body weight

Exclusion Criteria:

* Prior treatment of abdominal subcutaneous adipose tissue
* Females within 12 months postpardum
* Known hypersensitivity to the drugs or components
The Relationships Between the Noradrenergic, Opioid and Pain System

The role of alpha2 receptor agonist on pain perception and modulation will be examined. In addition whether this is mediated through the opioid system will be examined. Pain perception and modulation will be examined before and after administration of Clonidine or placebo together with Naloxone or saline.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18-40
* No chronic disease

Exclusion Criteria:

* Subjects who suffer from chronic pain / pain syndrome
* use of anti-depressant or anti-psychotic drugs
* suffering from cardiovascular disease
* breast feeding
Influence of Preschool Children's Fundamental Movement Skills, Physical Activity, and Physical Fitness on Executive Function: A Prospective Observation Study

Background: Early childhood is the most critical and rapid period of complete and healthy physical and cognitive development in human life. Executive function appears in early childhood and develops rapidly through complex coaction between environment and developmental processes. The preschool period is also characterized by a rapid growth in fundamental movement skills, physical activity and physical fitness. The scientific research on the relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschoolers remains to be explored.

Objective: The purpose of this study was to examine the cross-sectional relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschool children while controlling for potential confounding variables, examine the prospective influence (independent and interactive role) of preschooler's fundamental movement skills, physical activity and physical fitness on executive function, observe the preschoolers' fundamental movement skills, physical activity, physical fitness and executive function changes with age, and investigate gender and age differences in preschoolers' fundamental movement skills, physical activity, physical fitness and executive function.

Method: The proposed study consists of two phases, phase 1 is a cross-sectional study. Five hundred and five children aged 3-5 years will be recruited. The Test of Gross Motor Development Third Edition (TGMD-3) was used to assess children's fundamental movement skills. Preschool children's physical activity was monitored by accelerometer ActiGraph GT3X-BT. Physical fitness was tested using handgrip, 4\*10m shuttle run, 20m shuttle run, 30s sit-ups, sit and reach, and balance beam. Executive function was tested by computer-based tasks including animal stroop, safari training and stop signal task. Phase 2 is a 12-month follow-up study. In the phase 2, all children enrolled in the baseline study will be followed up, the measurements and contents of the follow-up are the same as the baseline instrument.


Eligibility Criteria:
Inclusion Criteria:

* aged 3-5 years
* normally developing children with corresponding cognitive ability to participate in the data collection
* without heart, lung, liver, kidney and other important organ diseases or any neurological disorders (e.g., intellectual disability or autism spectrum disorder) that prevent children from performing normal PA.

Exclusion Criteria:

* children with cognitive disability
* with heart, lung, liver, kidney and other important organ diseases or any neurological disorders (e.g., intellectual disability or autism spectrum disorder) that prevent children from performing normal PA.
Health Economic Evaluation of Primovist-enhanced Liver MRI

Patients with a history of colorectal cancer and known or suspected liver metastases who are scheduled for contrast-enhanced tomographic imaging will be included in this study. After randomization to either Primovist-enhanced MRI, extracellular contrast media (ECCM)-enhanced MRI or contrast-enhanced (CE)-CT outcomes and resource needs of the diagnostic work-up and treatment will be evaluated for each of the three imaging modalities. Main objectives of the study are to assess the proportion of patients for whom further imaging is required to come to a therapy decision and to evaluate the proportion of patients with intraoperatively modified surgical plans after Primovist-enhanced MRI as compared to ECCM-enhanced MRI and CE-CT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging

Exclusion Criteria:

* Patients (men or women) under 18 years of age
* Patients who have received any contrast material within 24 hours before injection of study drug, or who are scheduled to receive any contrast material within 24 hours after injection
* Patients not eligible to contrast media (CM) injection according to product labeling
* Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test at baseline visit(s)
* Patients scheduled for liver-specific MRI other than Primovist-enhanced MRI, i.e. Multihance-, Teslascan- or SPIO-enhanced MRI
* Patients who are clinically unstable and whose clinical course is unpredictable (e.g. due to previous surgery, acute myocardial infarction)
* Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs
* Patients with a contraindication for MRI or CT.
* Patients with severe renal impairment (eGFR \< 30ml/min/1.73m2) or patients on dialysis
Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers

To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.

Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* 30 - 70 years (extremes included)
* Medical history without any study relevant pathological findings
* Written and signed informed consent

Exclusion Criteria:

* Clinically study relevant acute or chronic disorders, that can be detected by clinical investigation or medical history
* Clinical, study-relevant pathological findings of clinical oar laboratory investigations
* Clinically relevant pathological EEG findings (e.g. artefact-free parts in Screening-EEG \<30% in one recording
* Clinically relevant allergies
* positive alcohol testing on Screening, Day A, B, or C, or anamnestic
* positive drug screening test on Screening, Day A, B, or C, or anamnestic
* Intake of study relevant medication 14 days prior to active Day A, or during active study duration, based on the volunteer´s information
* Regular intake of drug with primary central nervous effects (e.g. psychoactive drugs or central acting antihypertensive drugs)
* Known hypersensitivity / allergy against herbal extracts (i.e. dry extracts of Passionflower herb, St. John´s Wort herb, Valerian root) or lactose or an other excipient of the investigational medication
* Lapp-lactase deficiency (anamnestic)
* Hypersensitivity of the skin (anamnestic)
* BMI (Body-Mass-Index) \<18 or\>30
* Abuse of caffeine, teeine, or tobacco
* Smoking in the investigational site on Day A, B, or C
* Participation in an other clinical study within 60 days prior to Screening
* Positive Pregnancy Test (on Screening, Day A, B, or C) or Lactation
* Bad compliance
* Revocation of informed consent