cyrilzakka/clinical-trials huggingface dataset:
Predictors of Steroid Response in Childhood Nephrotic Syndrome

Retrospective study of predictors of steroid response in childhood nephrotic syndrom

Nephrotic syndrome is the most common glomerular disease affecting children worldwide ,Nephrotic syndrome is the combination of nephrotic-range proteinuria with a low serum albumin level and edema. Nephrotic-range proteinuria is the loss of 3 grams or more per day of protein into the urine or, on a single spot urine collection, the presence of 2 g of protein per gram of urine creatinine. Minimal change disease (MCD) or minimal change glomerulonephritis and focal segmental glomerulosclerosis (FSGS) are the two major causes of nephrotic syndrome in children and young adults, Idiopathic, hereditary, and secondary forms are due to underlying increased protein leakiness across the glomerular capillary wall, as a result of immune and non-immune insults affecting the podocyte.

The incidence worldwide varies widely between 1.2 and 16.9 cases per 100,000 children with the highest incidence observed on the Indian subcontinent compared to 2-3 cases per 100,000 children in most other regions . Males appear to be more affected than females at a ratio of 2:1 at a younger age, but this predominance fails to persist in adolescence.

treatment of nephrotic syndrome:- Corticosteroids have been used to treat childhood nephrotic syndrome since 1950 when large doses of adrenocorticotrophic hormone (ACTH) and cortisone given for two to three weeks were found to induce diuresis with loss of oedema and proteinuria. The response to treatment with steroids has been shown to vary by ethnicity, likely due to environmental and genetic factors. Corticosteroid usage has reduced the mortality rate in childhood nephrotic syndrome to around 3%, with infection remaining the most important cause of death. Of children who present with their first episode of nephrotic syndrome, approximately 80% will achieve remission with corticosteroid Prednisolone is the mainstay treatment, whose response is often presumed to determine the long-term risk of disease progression and is a better prognostic indicator . Although patients with steroid-sensitive nephrotic syndrome generally have good outcomes, more than half will have a frequently relapsing course and steroid dependence. Up to 95% of patients with minimal change nephrotic syndrome (MCNS) attain complete remission after an 8-week course of high dose steroids there are some factors affecting response to treatment with the steroids such as age of onset (the older the age of onset the better the response) ,gender (the females respond more to treatment) and type of nephrotic syndrome( minimal change glomerulonephritis responds more than focal segmental glomerulosclerosis to steroids ).

Eligibility Criteria:
Inclusion Criteria:

* all children from 1 year to 18 years treated with steroid for nephrotic syndrom

Exclusion Criteria:

* children with other kideny disease Children less than 1 year old Children with secondary nephrotic syndrom
A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia

The purpose of this study is to determine whether EV06 Ophthalmic Solution is safe and effective in improving distance corrected near vision in people who have presbyopia.

Study subjects who were eligible for enrollment and had provided written informed consent were randomized in a 2:1 ratio to use of either EV06 Ophthalmic Solution or Placebo Ophthalmic Solution. For the first 7 days of study product administration (Period 1: Days 1-7), subjects applied 1 drop of their assigned study product to one eye twice per day. For the next 84 days (Period 2: Days 8 - 91), if there were no unanticipated and no significant adverse events observed in the treated eye, subjects applied 1 drop of their assigned study product to both eyes twice per day.

Eligibility Criteria:
Inclusion Criteria:

* 45 to 55 years of age
* Distance Corrected Near Visual Acuity worse than 20/40
* Best Corrected Distance Visual Acuity of 20/20 or better in each eye
* Willing and able to sign consent, following study instructions

Exclusion Criteria:

* Certain pupillary conditions
* Significant astigmatism, glaucoma, diabetes, cataracts, eye surgery, ocular trauma or accommodative issues
* contact lens wear within 3 days prior to and for duration of study
* use of prohibited medications
* participation in a clinical study within 30 days prior
An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of the Iliotibial Band

Participants will report for two research sessions. Prior to arrival, membership to a club sports team will be confirmed via email. The first session will require one hour, while the second will require 30 minutes. Maximum amount of time expected is one and a half hours, over two sessions in 48 hours. The 1st and 2nd sessions will be separated by 48 hours. Upon arrival for session 1, informed consent will be obtained along with the following demographic information: age, sex, height, weight, dominant leg, and sport. Next, the participant will complete the Musculoskeletal Questionnaire (MQ) in regard to the last 12 months. Participants will then be assessed for trigger points in their dominant side iliotibial band via palpation. Diagnostic criteria for trigger point will be modeled after Travell and Simons: taut band, pain upon palpation, referred pain, and a local twitch response. Up to four trigger points will be marked on the subject's skin with marker or pen. Pain pressure threshold will be obtained via algometer, using the terminology "Tell me the first moment you experience pain by verbalizing 'pain' ". Then, three pain pressure threshold readings will be taken per trigger point and then averaged by the researcher. Kinesiology tape will then be applied to the identified trigger points using the Fascial Technique. Pain pressure threshold will be obtained again with the same protocols 10 minutes after the tape is applied. The participant will be asked to wear the tape for 48 hours. Upon arrival for session 2, the application of the tape will be confirmed. With the participant's choice to continue in the study, a third and fourth measurement of pain pressure threshold will be obtained: one with the tape remaining on, and another 10 minutes after removal of the tape. Again, three pain pressure threshold readings will be taken per trigger point and then averaged by the researcher.


Eligibility Criteria:
Inclusion Criteria:

* member of club sports team

Exclusion Criteria:

* acute quadriceps strain in last six months
* knee surgery in last six months
* acute hamstring strain in last six months
* allergy to adhesive
* malignancies
* cellulitis
* skin infection
* diabetes
* fragile skin
Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension

To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in healthy subjects with mild hypertension.


Eligibility Criteria:
Inclusion criteria:

* Subject is healthy at the time of pre-examination
* Subject has a BMI of 25 - 35 kg/m²
* Subject is aged 25 - 50 years at the time of pre-examination
* Signed written informed consent
* Inactive (IPAQ score \<1)
* Waist to Hip ratio ≥0.90 cm for males, ≥0.85 cm for females
* High-normo/Mild hypertensive (SBP: 130-159 mmHg / DBP: 80-99 mmHg)

Exclusion criteria:

* Use of medication interfering with RAAS, such as ACE-inhibitors,
* Advanced cardio-vascular disease (CVD),
* Severe kidney disorders (CKD),
* Diabetes mellitus, both type 1 and II diabetes,
* Pregnant, lactating or wish to become pregnant,
* Hypersensitivity to any of the components of the test product,
* Restricted diet (vegetarian)
* Thyroid disease
* Heavy Smokers (light smokers allowed)
* Lack of suitability for participation in the trial, for any medical reason, as judged by the PI.
* Excessive alcohol consumption (\>21 units/week for males \& \>14 units/week for females)
Secondary Data Analysis of Patients at Risk for CKD to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics

This study is a national secondary data analysis to determine the prevalence of diagnosed and undiagnosed CKD in German primary care offices in a patient population at high risk for the development and progression of CKD. Furthermore, it addresses the question of how CKD screening, monitoring and treatment of these patients is conducted within the German primary care setting.

The study does not attempt to test any specific a priori hypothesis; it is descriptive only. Data on general patient characteristics, health insurance details, participation in disease management programs and/or family doctor-centred care, diagnoses, prescriptions, surgeries, and procedures, used billable services and laboratory test results are documented during daily routine by the physician. The data used in this setting are part of routine visits, dating back a maximum of 24 months from the date of first data transfer within the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at start of the patient´s observation period
2. Having at least one of the following diseases (based on the documented ICD-10 code):

   * Type 1 diabetes
   * Type 2 diabetes
   * Hypertension
   * Cardiovascular disease, including:

     1. Coronary and/or other atherosclerosis
     2. Myocardial infarction
     3. Heart failure
     4. Peripheral arterial disease
     5. Arrythmia
     6. Stroke
3. Having at least one year (52 weeks) of observation period

Exclusion Criteria: NA
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.


Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
* Requiring hormonal treatment
* Postmenopausal women defined as a woman who has stopped having menstrual periods
* Evidence of positive estrogen receptor hormone sensitivity
* Written informed consent to participate in the trial

Exclusion Criteria:

* Treatment with an investigational or non-approved drug within one month
* An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
* A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
* Treatment with more than one regimen of chemotherapy for advanced breast cancer
* Treatment with more than one regimen of hormonal treatment for advanced breast cancer
The Drug-drug Interaction of SP2086 and Metformin

This is an open single and self-control study,planning to recruit 24 cases of healthy male volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and Metformin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2,weight among of 50-100kg.
* willing to using contraception during the study and after the 6 months.

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or metformin
Anastomotic Leak Testing in Gastrectomy

Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.

Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group. patients underwent total gastrectomy for gastric cancer, with esophagojejunostomy reconstruction.

Eligibility Criteria:
Inclusion Criteria:

1. resectable gastric carcinoma according to the eighth edition of the TNM (clinical stages I-III).
2. Eastern Cooperative Oncology Group performance status of 0 or 1.
3. American Society of Anesthesiologists class of I-III.

Exclusion Criteria:

1. Patients had distant metastasis.
2. presence of obvious contraindications to surgery (e.g., liver and/or kidney function abnormalities).
3. any participation in another clinical trial within the past 6 months.
4. Previous chemotherapy or radiation therapy for any other malignancies.
5. past history of gastric resection, gastric cancer-related complications, other malignancy diagnosed within the previous 5 years,
Movement for Depression - An RCT Assessing the Effects of Physical Activity Promotion for People With MDD

Randomized clinical trial that aims to increase physical activity levels in people with depression and to evaluate if the increase on PA levels has impact on clinical and biological measures.

The contacts will be made by face-to-face interviews and telephone calls

Eligibility Criteria:
Inclusion Criteria:

* age: 18 - 65 years;
* diagnosis of Major Depressive Disorder (DSM-IV), assessed by a trained psychiatrist;
* score 7 or more in the HAM-D;
* do not present clinical comorbidities that limit or contra-indicate the practice of physical activity;
* be starting depression treatment at the Programa de transtorno do humor (PROTHUM) ;
* have acess to a computer and have a facebook account;
* be able to read and sign the consent term.

Exclusion Criteria:

* present other psychiatric diagnosis such as bipolar disorder, schizophrenia or use of alcohol or other drugs;
* be not liberated to the practice of physical exercises by the assistant psychiatrist.
Balloon Vaginoplasty for Treatment of Vaginal-aplasia

Vaginal aplasia is a congenital anomaly characterized by congenital absence of the vagina with an incidence approximately 1:4,500-6,000. It carries an emotional, sexual, and social embarrassing effect on those women, The primary aim of treatment is creation of a neo vagina for restoration of the ability for vaginal intercourse. There are several techniques for neo vaginal construction with variable satisfaction rates. Most of these procedures are either invasive and technically demanding or require long duration in a very motivated patient

Numerous surgical and nonsurgical procedures with varying degrees of success have been described for correction of the vaginal aplasia, but none have proved to be universally accepted.

Balloon vaginoplasty was first introduced in 2003 by El Saman et al for construction of a naturally lined neo vagina through a laparoscopic.

Technique hosts the triad of a perfect management modality; namely: simplicity, safety and success. The technique acts via mechanical expansion of the vaginal epithelium and underlying tissues at the pre-existing vaginal dimple Being a relatively new modality of management, it went through many refinements to make it much easier and feasible. The cornerstone of refinement always ran around the access to the peritoneal cavity. The latest of which was the fractionated intra umbilical micro ports which have the merits of totally hidden scar at the bottom the umbilicus consequently the best cosmetic outcomes. However, during its insertion process a troublesome partially unmonitored insertion was inevitably observed

Eligibility Criteria:
Inclusion Criteria:

* Married Females with vaginal aplasia scheduled for balloon vaginoplasty.

Exclusion Criteria:

* Females who refused to consent for participation in the study.
* Unstable marital relationship.
EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)

A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after angiogram and/or endovascular procedure. Study will be conducted in order to establish the level of comfort and confidence that this device provides for both patients and physician in terms of hemodynamic and usage outcomes.

The learning experience of new medical device technologies is a well-defined event but varies widely by device and user. Several factors influence rate of learning, including the device, the patient population the training technique, clear communication, and the rate of usage. Previous publication have reported on the learning curve of vascular closure technologies including; AngioSeal, Perclose \& StarClose. These reports established the curve to be close to 50 experiences in order to provide predictable results.

Many prior studies have studied the safety and efficacy of vascular closure devices. However, it is substantial to also study device success when in the hands of one specific operator. This study will examine 100 consecutive subjects which the FISH vascular closure device will be used on, and examine outcomes in the following way:

Primary Endpoint:

o Safety: Severe adverse events rate (SAE) (Device related only) (transfusion/vessel occlusion)

Secondary Endpoints:

* Safety: minor adverse event rate (MAE) (Hematoma)
* Success rate (Time to Hemostasis (TTH) \< 10min)
* Time to Hemostasis (TTH) mm:ss - measured from sheath pull to absence of arterial bleeding.
* Time to Ambulation (TTA) hh:mm - measured form sheath pull to walking 20 feet.
* Patient comfort - subjective measure (see scale below) measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)
* Physician Confidence and Comfort (C\&C)(measured every 10 patients)

Eligibility Criteria:
Inclusion Criteria:

* All patients on which a FISH device will be used for vascular closure, deemed appropriate by the Principal Investigator.

Exclusion Criteria:

* Patients on which a FISH device will not be used for vascular closure and another method will be used - deemed appropriate by the Principal Investigator (i.e. manual compressions, PerClose, AngioSeal, etc.).
The Effect of Social Media Use on Eating Behaviours

This project aims to explore how social media use, in particular food photography, influences eating behaviours. It will be approached through three methods - a correlational experience sampling method, an experimental experience sampling method, and an experimental laboratory method. This registration describes the experimental experience sampling method.

This project aims to explore how social media use, in particular food photography, influences eating behaviours.

The research question will be approached using a combination of methods. The first is the experience sampling method, where data is gathered from participants as they are going about their day-to-day lives. This method comprises two sub-sections - a correlational study, and an experimental study. This registration describes the experimental experience sampling method.

The study will experimentally control participants' engagement in the act of food photography, and measure their eating behaviours. Participants will be recruited via online platforms and participate in the study for one week. At the beginning of the week, they will be required to fill in some online questionnaires (e.g. demographic information). For the rest of the week, they will be prompted at specific time points in the day via smartphone to engage in food photography/ non-food photography/ no phone use, and then answer some questions about their eating behaviours.

The expected outcome of the project is to collectively evaluate the data from the various methods to conclude how social media use, and in particular the act of food photography, influences the various aspects of eating behaviours.

Eligibility Criteria:
Exclusion Criteria:

* Symptoms / history of any medical or psychiatric conditions
* Allergies to food products
* History of eating disorders
* Excessive exercise (≥ 5 times a week of self-reported exercise)
* Currently on a special diet or deliberating restricting caloric intake
* Currently on a weight loss program
Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease

This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 years and 18 years (age limits inclusive)
* Diagnosis of Trypanosoma cruzi (T. cruzi) infection by conventional serology based on positive ELISA and at least 1 other positive conventional serology test (recombinant ELISA or IIF)
* Written informed consent by parent/legal representative and informed assent from patients if \>7 years old when applicable (as requirements may vary by country and by site)
* Females of childbearing potential (ie, female patients who have experienced menarche) and male patients must agree to use highly effective contraception if sexually active from the time of signing of the informed consent/assent form until ≥5 days after the last dose of study treatment

Exclusion Criteria:

* Pregnant or intending to become pregnant during treatment and within 5 days after the last dose of study treatment
* Patient presenting any other acute or chronic health conditions, which in the opinion of the Principal Investigator (PI), may interfere with the pharmacokinetic (PK), efficacy, and/or safety evaluation of the study treatment
* Signs and/or symptoms of acute Chagas Disease
* Known history of hypersensitivity or serious adverse reactions to nitroimidazoles
* History of Chagas Disease treatment with Benznidazole (BZN) or nifurtimox
* Immunocompromised (clinical history compatible with human immunodeficiency virus (HIV) infection, primary immunodeficiency, or prolonged treatment with corticosteroids or other immunosuppressive drugs)
* Abnormal laboratory test values (as per protocol-specified ranges) at Screening for the following parameters: total white blood cell (WBC) count, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and creatinine
* Abnormal ECG (as per protocol-specified ranges) and/or any Chagas disease associated findings
* Any condition that prevents the patient from taking oral medication
* Patient is known to or suspected of not being able to comply with the study protocol and the use of the investigational medicinal product (IMP)
* Evidence or history of alcohol or drug abuse (within the last 12 months)
* Any planned procedure that may interfere with highly effective contraception during treatment and within 5 days after the last dose of study treatment
* Employee of the Investigator or trial centre, or family member of the employees or the Investigator
* Any condition that, in the opinion of the Investigator, may jeopardise the trial conduct according to the protocol