cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent

This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.

The perpose of this study to prove the significance of the hypothesis that there will be a significant improvement in motor development when remote tele-rehabilitation treatment is performed for extremely premature infants. The investigators plan to recruit subjects who meet the inclusion criteria and do not meet the exclusion criteria from among extremely premature infants born at Samsung Hospital, Seoul, Korea, whose gestational age is from 23 weeks to 28 weeks. The target number of n is 110, 55 per group. After randomization into an intervention group and a control group, the intervention group get the intervention starting at 0 months of correctional age and runs for 3 months. In both groups, motor outcomes are measured at the time of enrollment, at 3 months of correction age, 6 months of correction age and 12 months of correction age

Eligibility Criteria:
Inclusion Criteria:

* Extreme premature baby (gestationl age 23\~28 weeks)
* Corrected age under one month at the time of enroll of this study
* Children of those who voluntarily decided to participate after hearing detailed explanations about this study and gave their written consent.
* Children whose parents are Korean

Exclusion Criteria:

* Congenital anomalies in the central nervous system
* Hereditary diseases
* Chromosomal abnormalities (Down syndrome, etc.)
* Stage 3 or more intraventricular hemorrhage
* If surgery was performed for hydrocephalus
* Leukomalacia confirmed by ultrasound examination (not applicable to increase in white matter shading)
* Neonatal asphyxia
* Other central nervous system diseases
* If taking medications for convulsions or epilepsy
* Metabolic disease
* In the case of premature infants undergoing surgery for retinal disease
* Hearing loss
* In case of surgery due to complex congenital anomaly or planned operation (not excluded if surgery is not required)
* In case of oxygen dependence due to lung disease in premature infants
* Musculoskeletal disorders (hip dislocation, polyarthrosis, etc.)
* Neuromuscular disease, etc.
* Those whose family has social problems
* Those whose parents cannot participate in this study
* Those who have other serious complications that cannot proceed with the study
Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes

In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.

Trigonella foenum-graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of antidiabetic compounds, from its seeds, leaves and extracts in different systems of medicine in asia. Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems. Preliminary animal and human studies suggest possible hypoglycemic and anti-hyperlipidemic properties of fenugreek seed powder taken orally. In a randomized placebo controlled study conducted by Gupta et al showed that two month treatment with the hydro-alcoholic extract of fenugreek seeds improved glycemic control in 12 non-insulin dependent diabetes mellitus patients. In addition, there was improvement in insulin sensitivity and plasma lipid profile. Fenugreek extract was also well tolerated in diabetic patients.

In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Type-2 Diabetes of less than 10 years duration
* Patients with HbA1c \>7.0%
* Patients with fasting plasma glucose not exceeding 180 mg/dL
* Patients with Negative Urine sugar
* Patients who are on oral hypoglycaemic agents containing either Metformin or Sulfonylurea or both
* There should not be any change their in anti-diabetic treatment for at least one month

Exclusion Criteria:

* Patients with diabetes other than type-2 diabetes mellitus
* Patients with evidence of renal disease (S. Creatinine \> 1.5mg/dL)
* Patients with evidence of liver disease (AST/ALT \>3 times of normal
* Pregnant and lactating mothers and women intending pregnancy
* Patients who participated in any other clinical trial within the last 30 days
* Patients with history of any hemoglobinopathy
* History of intolerance or hypersensitivity to Fenugreek
Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma

This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children ≥ 6 years and \< 12 years with confirmed diagnosis of asthma for at least 1 year prior to study enrollment.
* Written informed consent by parent(s)/legal guardian(s) and depending upon their age and local requirements a consent or assent for the patient.
* Patients receiving daily treatment with a stable low dose Inhaled Corticosteroid (ICS) (with or without additional controller), or patients receiving daily treatment with a stable mid-dose ICS (monotherapy or together with LTRA) for at least 4 weeks prior to Screening, and able to tolerate fluticasone propionate 100 μg b.i.d. inhaler starting at Visit 1 (or soon after).
* Patients with a pre-bronchodilator FEV1 ≥ 50% and ≤ 90% of the predicted normal value for the patient at the start and end of Run-in (Visits 101 and 199).
* Patients who demonstrate an increase in FEV1 of 12% within 30 minutes after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Visit 101. All patients must perform a reversibility test at Visit 101.

Exclusion Criteria:

* Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any patient taking high-dose ICS.
* Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).
* Patients who have had an asthma attack/exacerbation requiring systemic steroids (SCS) or hospitalization or emergency room visit within 3 months prior to Visit 1 (Screening) or more than 3 separate exacerbations in the 12 months preceding Visit 1.
* Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Screening (Visit 1).
* Prior intubation for asthma.
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)

Even after the wide introduction of chemo/radiotherapy in the treatment algorithm, adequate surgery remains the cornerstone of gastric cancer treatment with curative intent. A proper D2 lymphadenectomy is associated with improved cancer specific survival as confirmed in Western countries by fifteen-year follow-up results of Dutch and Italian randomized trials.

In clinical practice, the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy; nonetheless, the number of retrieved nodes does not necessarily correlate with residual nodes, which intuitively could represent a more reliable marker of surgical adequacy. The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes.

The goal of this multicentric observational prospective study is to test the reliability of a new score (PhotoNodes Score) created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer. The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopic/robotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection.

Ideally, this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy
* Patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
* Total or Subtotal Gastrectomy
* Laparoscopic or Robotic approach

Exclusion Criteria:

* Age less than 18 year old
* Esophago-gastric junction cancer Siewert type I, II or III
* Metastatic disease
* Lymphadenectomy less than D2
* Open surgery
* Conversion to open surgery
* Palliative gastrectomy
* R1 or R2 resection
* Multivisceral resection except for cholecystectomy
* Surgical procedures other than subtotal or total gastrectomy
* A single node station rated as unevaluable by more than one reviewer
Application of Intravitreal Conbercept Injection as a Primary Treatment for Exudative Circumscribed Choroidal Haemangioma

The aim of this study was to investigate the safety and effectiveness of application of intravitreal conbercept injection as the primary treatment for exudative circumscribed choroidal haemangioma.

This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection as the primary treatment for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

Eligibility Criteria:
Inclusion Criteria:

* 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.

Exclusion Criteria:

* patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.
Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

The goal of this (monocentric, randomised, placebo-controlled single-blinded; phase 2) clinical trial is to test the hypothesis that DNase 1 administration leads to a reduction in systemic immune response measured in patients after acute ischaemic stroke compared to control treatment.

Participants will receive intravenous DNase 1 (500 µg/kg) or placebo (NaCl 0.9%) twice within 24±6 hours after symptom onset (last seen well). Blood samples will be taken at baseline, day 1 and 3. Personal visits will occur on baseline, day 1, 3 and discharge date. A telephone interview will be conducted on day 30±3.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected acute ischemic stroke with symptom onset (last-seen-well) until Investigational drug application of less than 12 hours.
* Consent to participate in the study.
* Age ≥ 18 years.
* NIHSS ≥10 at admission.

Exclusion Criteria:

* Presence of any of the following conditions: Sinus or cerebral venous thrombosis, intracerebral haemorrhage, subarachnoid haemorrhage on qualified imaging (cCT with CT-A or MRI with MR-A). However, petechial haemorrhagic transformations of the index infarct and cerebral microhaemorrhages may be included.
* Active malignant tumour disease in the last 6 months.
* Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g. HIV).
* Acute fulminant infectious disease in the last 7 days (fever \> 38.5°C or suspected by the Investigator).
* Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives with positive urine or serum beta-human choriogonadotropin test.
* Ischemic stroke or myocardial infarction in the previous 30 days.
* Surgery in the previous 30 days, except minor dermatological or gynaecological surgery without anaesthesia and wound healing disorders and patients with thrombectomy.
* Estimated or known weight \> 100 kg.
* Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells.
* Thrombocytopenia, leukocyte count \<1500/μl.
* Known participation in another clinical trial investigating a drug and/or medical product in the last 7 days before study inclusion.
* Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis.
Effect of 25-OH-vitamin D3 on the Liver Transplant Recipients

The low vitamin D3 levels and malnutrition before liver transplantation showed an increase in the length of stay in ICU and hospital. Although several factors may influence the clinical outcomes of patients with liver transplantation, low vitamin D3 levels showed an independent risk factor. It is necessary to prospectively analyze the effect of vitamin D supplements on clinical outcomes in liver transplant recipients.

Purpose: Vitamin D deficiency is common in patients of chronic liver disease and has been associated with infection and mortality. The aim of this study is to determine whether preoperative vitamin D levels affect clinical outcomes after liver transplantation.

Methods : This was a single-center retrospective study. Between June and November 2017, a total of 219 patients underwent liver transplantation. The primary outcome was the relationship between serum 25-OH-vitamin D3 level before liver transplantation and length of stay in the intensive care unit (ICU). Secondary outcomes included the duration of normalization of inflammatory marker, such as white blood cell count (WBC) \& C-reactive protein (CRP) after liver transplantation, new infection rates, rejection rates, the length of hospital stay and mortality among vitamin D level.

Eligibility Criteria:
Inclusion Criteria:

* The patients who admitted to intensive care unit (ICU) after liver transplantation were studied

Exclusion Criteria:

* Patients who didn't have preoperative vitamin D level
Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits

Bladder cancer is the second most prevalent urological malignancy worldwide, with a high incidence and poor patient prognosis. Achieving early diagnosis and intervention for bladder cancer is one of the most important ways to improve clinical management and patient prognosis. Tumor exosomes can be released into biological fluids at an early stage of a tumor, and many studies have shown that exosomal RNA can be used as a reliable biomarker to diagnose tumors in a non-invasive way. Based on the clinical needs for early diagnosis of bladder cancer, we aim to screen several early diagnostic markers with potential predictive value, establish an early diagnostic model for bladder cancer, and validate the validity and reliability of this diagnostic model through a large-scale clinical cohort to complement the diagnosis of early-stage cancers and to improve the rate of early diagnosis of cancer.

In response to the clinical demand for accurate early diagnosis of bladder cancer, this project aims to gradually conduct in-depth research on precise early diagnosis of bladder cancer. This includes establishing key techniques for efficient and convenient enrichment of exosomes, identifying potential exosome biomarkers for bladder cancer based on bladder cancer transcriptome sequencing data, and conducting large-scale clinical cohort studies.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years with defined gender;
2. Preoperative patients are preliminarily evaluated as bladder tumors by cystoscopy, FISH, cytology, or imaging.

Exclusion Criteria:

1. Aged \<18 years;
2. Post-operative or after anti-tumor treatment such as chemotherapy or immunotherapy
3. History of other malignant tumors
4. Specimens with hemolytic conditions;
5. Patients with incomplete, undocumented, and uncooperative data.
Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery

Something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. Each of the cranial nerves is wrapped in a sheath of dura mater. As they exit the cranial vault they are described by Gray's Anatomy as having a "dural cuff".


Eligibility Criteria:
Inclusion Criteria:

* The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs.

Exclusion Criteria:

* Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality.
National Cohort of Children Born to HIV-positive Mothers

The purpose of this study is to provide a surveillance system to monitor changes in the rate of mother to child HIV transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

The goal of the CO11 national cohort is to provide with CO1 a wider surveillance system to monitor changes in the rate of mother to child transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

The CO11 EPF enrolle HIV infected women who delivery in maternity generally smaller than CO1 maternity (15 sites in Paris area, 35 in mainland France and 4 in the DOM).

Maternal clinical, biological and therapeutic data before and during pregnancy were collected at delivery, with simplified questionnaires.

The children are examined clinically and biologically at birth, 6, 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women \>= 18 years
* infected with HIV1 and/or HIV2

Exclusion Criteria:

* guardianship or judicial or administrative detention
Combined Treatment of RFA and Sorafenib on Recurrent HCC

RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.


Eligibility Criteria:
Inclusion Criteria:

* recurrent HCC after curative resection
* without gender restriction
* age between 18 to 75 years
* The liver function showed no worse than Child-Pugh B
* tumor nodes were less than 5cm and no more than 3 nodules

Exclusion Criteria:

* Pregnancy patients
* With extrahepatic tumor or lymphnode metastasis
* Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
Diagnosis Test for Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is an asymptomatic disease. Diagnosis is based on a oral glucose tolerance test (OGTT) requiring pregnant women to absorb 75g of glucose while fasting since midnight and to stay sober for another two hours. These OGTTs are poorly tolerated by pregnant women. As many OGTT are false positive according to self-monitoring blood glucose (SMBG), the investigators need now to determine the percentage of OGTT results that are false negative.

The comparison of the two tests (OGTT and SMBG) in the same patient with normal results of OGTT will determine the exact percentage of false negative OGTT results.

The opinion of women will also be taken into account. In the everyday clinic, many report that they prefer SMBG to OGTT because they do not have to be fasting, to drink non palatable drink and to attend a 2-hour visit in their schedule. However, no opinion study has yet been performed, the investigators will investigate formally what women think using a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* positive GDM screening test (glycemia post-50g of glucose ≥ 7.2 mmol/L),
* between 24 and 28 weeks of gestation from the last menstruation,
* single pregnancy,
* able to read and understand French.

Exclusion Criteria:

* known type 1 or type 2 diabetes,
* disease or treatment interfering with the metabolism of glucose,
* deficiency may hinder the understanding of the study.
Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above.
2. Adult subjects only - Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partners use of a highly effective form of birth control for 3 months.
3. Diagnosed as having Eczema.
4. Willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study.
5. Willing to not introduce any new fragrances (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, laundry detergents, etc.) for the duration of the study.
6. Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing.
7. Willing to not enter/use hot tub or whirlpool bath for the duration of the study.
8. Willing to avoid the beach during the course of the study, and willing to document any activities at or in a swimming pool in the daily diary.

Exclusion Criteria:

1. Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
2. Adults Females who are pregnant (self-reported) or breastfeeding.
3. Participation in any clinical study within 30 days of Visit 1.
4. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids.
5. Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids.
6. Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
7. Subjects who are currently on phototherapy.