cyrilzakka/clinical-trials huggingface dataset:
AMEVIVE® Pregnancy Registry

This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defects.

The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development and will be managed by INC Research. The Registry will be monitored by an independent Advisory Committee of external experts in relevant specialties of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).

Prospective reports will be collected from pregnant subjects, health care provider (HCP), or Astellas Product Safety Management staff. Data from the pregnant subjects will be collected at 4 to 5 months of pregnancy by telephone interviews with the Registry. The Registry will also contact the subject at 2 months and 12 months after the estimated delivery date (EDD) for post-natal \& pediatric follow-up. The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry, forms mailed/faxed to the Registry, electronic forms/queries sent to the Registry, or a combination of these methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric Follow-Up at 2 months and 12 months of age. If a birth defect is reported, targeted follow-up will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Have been exposed to AMEVIVE® within 8 weeks prior to conception or at any time during pregnancy
* Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively)
* Provide verbal consent to participate in the Registry, and
* Verbally provide the contact information for herself, her healthcare provider (HCP), and the infant's HCP (if applicable)

Exclusion Criteria:

* None
Dry Eye Symptom Mitigation by Oral Intake of Probiotics

This study investigates whether the oral intake of a probiotics capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 1 probiotics capsule per day for 35 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, tear osmolarity and serum biochemical test. After the 35 days are completed, the participants will be assessed again for the same parameters.

This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to control group or treatment group, and asked to orally intake 1 capsule of either placebo or probiotics per day. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear osmolarity, ocular surface impression cytology, ocular surface disease index (OSDI) and serum biochemical tests for quantification of hyaluronic acid, sialic acid, glutathione contents.The assessments are conducted at day1 for baseline and after the 35-day oral intake. The parameters are used to compare and evaluate whether the probiotics can relieve dry eye symptoms.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 65 years
* with Schirmer's test results less than 10 mm or Ocular Surface Disease Index more than 25

Exclusion Criteria:

* evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.
* diabetes
* hypertension
* or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study

The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the optimal and feasible level of frequency of structured contact needed in a clinical setting for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity recommendations long-term.

The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three groups of study participants. Study participants will be randomized into three exercise group. Group 1 will participate in instructor-led exercise training sessions 1 time per week, for 24 weeks (approximately 6 months). Group 2 will participate in instructor-led exercise training sessions 3 times per week, for 24 weeks (approximately 6 months). Group 3 will not attend any instructor-led exercise training sessions. All groups will be encouraged to see their usual providers for routine healthcare, and continue their usual medication regimen.

Eligibility Criteria:
Inclusion Criteria:

* Recent hemoglobin A1c result between 6.5 and 13.0%
* Diagnosed with Type 2 Diabetes Mellitus
* Able and willing to enroll and meet the requirements of the study

Exclusion Criteria:

* Inability to speak, read or understand English
* Long-term current use or dependency on insulin
* Systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg
* Resting heart rate \> 120 bpm
* History of or present heart or cardiovascular conditions
* History of or present respiratory disease
* History of or present spinal cord injury
* History of stroke or Transient Ischemic Attack (TIA)
* History of cancer diagnosis in the past 5 years or present cancer diagnosis
* Medical, psychiatric, behavioral limitations that may interfere with study participation
* Participating in other clinical trials that may interfere with study procedures and outcomes
* Currently pregnant or plans to become pregnant within three years
Early Recovery After Gastric Cancer Surgery

Study preparation

* To progress this prospective study, the investigators analyzed the retrospective data of 426 patients who had been managed with conventional critical pathway after gastric cancer surgery during last 1 year.
* Through this retrospective analysis, we decided the inclusion criteria which showed significantly the lower complication rate and shorter hospital stay.

Method for Prospective study

* Patients who enroll in this prospective study are administered and are supplied a liquid diet one day before surgery without bowel preparation.
* After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.

Enrollment of patients

* Before the patients are enrolled in this study, they give us informed consents.
* A liquid diet is supplied beginning from the morning of the day prior to operation to the midnight.

Operation and postoperative management

* All procedures are approached by laparoscopic surgery, and partial gastrectomy with lymph node dissection are performed.
* The patients who are considered to be difficult to progress early oral feeding in surgical field are excluded from the study.
* Nasogastric tube is not applied to patients.
* Postoperative pain is managed by non-opioid pain killer.
* The patients are started on sips of water on the first postoperative day.
* If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them.
* We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.

Evaluation of patients

- The patients are followed up to 30 days after discharge from hospital, and we check whether they are tolerable without any compliant and are readmitted.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with gastric adenocarcinoma
* 65 years old and blew
* Patients are expected to be undergone distal subtotal gastrectomy
* No complication by gastric cancer
* No synchronous metastatic lesions
* Laparoscopic or robotic surgery
* Informed consent

Exclusion Criteria:

* Previous gastrectomy history
* Combined surgery due to synchronous malignancy
* Patients with major organ dysfunction
A Study to Evaluate Ketamine for the Treatment of Rett Syndrome

This 2 cohort, sequential, ascending dose study will assess the safety, tolerability and efficacy of oral ketamine dosed in a single 5-day BID regimen in addition to placebo, in a 4-week cross-over design in patients with Rett Syndrome. Approximately 12 patients per cohort are anticipated to participate for approximately 8-10 weeks at approximately 7 US study centers.

This study is designed to assess oral ketamine for the treatment of Rett Syndrome and consists of up to 4 ascending dose cohorts, each assessing 1 dose level of ketamine vs placebo. Patients will receive in either order, a 5-day BID regimen of both placebo and the cohort-specified dose level of oral ketamine. Patients may only participate in 1 cohort. Safety and tolerability will be assessed via patient disposition, vital signs, physical examination, adverse events and concomitant medication use. Efficacy will be assessed via physician and caregiver questionnaires and assessments, and continuous, wearable, at-home biosensor data collection. An independent safety committee will review safety data from each cohort to determine if the subsequent ascending dose cohort is warranted. A total of 12 patients per cohort is anticipated at approximately 7 sites. The screening period will last between 2 and 4 weeks, the cross-over treatment period will last 4 weeks, and the safety follow-up period will last 2 weeks. Total patient participation is approximately 8-10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female Rett Syndrome patients diagnosed with Rett Syndrome with a confirmed MECP2 mutation
* between the ages of 6 and 12, inclusive, who have not achieved menarche
* ability to take oral medications
* are generally healthy.

Exclusion Criteria:

* Patients not on stable medication regimens/other types of behavioral, educational, or dietary interventions for at least 4 weeks,
* are taking medications that may interact with ketamine,
* have a condition where increased blood pressure, spinal fluid pressure, or ocular pressure may put the patient at increased risk.
Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

Eligibility Criteria:
Inclusion Criteria:

* Atrioventricular Nodal Reentrant Tachycardia
* Atrioventricular Reentrant Tachycardia

Exclusion Criteria:

* Atrial Tachycardia
* Organic supraventricular tachycardia
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).


Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin II and III;
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunossupression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History of photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study
An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure

The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hysteroscopy

Exclusion Criteria:

* Pregnancy
The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease

The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.

In this double-blind, randomized and placebo-controlled trial, twenty participants experiencing dry eyes symptoms were recruited, and randomly assigned to consume 4 g/day of either ZSO or soy bean oil (SBO) as placebo for 10 weeks. All participants completed the study. Follow-ups of dry eye symptoms and objective signs, inflammatory and oxidative stress markers, and blood lipid analysis were performed.

Eligibility Criteria:
Inclusion criteria:

* men and women
* 20 to 70 years with dry eye disease
* low tear break-up time (TBUT) (\<10 seconds) or low Schirmer score (with application of local anesthetic) (\<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening.
* blood level of triglyceride higher than 150 mg/dL or HDL-cholesterol less than 40 and 50 mg/dL for men and women, respectively.

Exclusion Criteria:

* under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin)
* hypolipidemic medication within 3 months of study entry
* history of chronic disease
* any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study
* allergic or hypersensitive to any of the ingredients in the test products.
* women who were pregnant or breast feeding
* a history of alcoholism or drug abuse or medical or psychological conditions
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain

The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours.

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.During the past 3 months: Grade I-III sprain of the same ankle.During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis

The purposes of this study are to determine if the performance of a dialyzer depends on how tightly the hollow fiber membranes are packed in the housing of the dialyzer (the membrane packing density) and if that dependence is a function of the dialysate flow rate. The study will examine how efficiently three different sized molecules pass through a dialyzer membrane at different dialysate flow rates in dialyzers with different membrane packing densities. Transfer of urea, phosphorus and beta-2-microglobulin from blood to dialysate will be measured during clinical hemodialysis using four different dialyzers, each used at three different dialysate flow rates. The data derived from these measurements may provide insight into the importance of membrane packing density as a design parameter for hemodialyzers and if changing the membrane packing density might provide equivalent performance at a lower dialysate flow rate.


Eligibility Criteria:
Inclusion Criteria:

* Stable hemodialysis patients dialyzing through a native fistula or Gore-Tex graft. The access must be capable of delivering a stable blood flow of 400 ml/min.
* Age older than 18 years.
* Fluid removal requirement less than 3 liters per treatment.

Exclusion Criteria:

* Noncompliance with dialysis regimen.
* Hematocrit less than 28%.
* Active infection
Early Warning Study of Serum Thioredoixn Reductase Activity in Excised Non-small Cell Lung Cancers (EWSOTRILC)

In pre-clinical study, we found that serum thioredoxin reductase activity harbours huge difference after any kind of treatments, so we hypothesis that serum activity of thioredoxin reductase may be a warning markers in excised non-small lung cancers, serum activity of this enzyme may elevated before CT scan

This is a cooperative research project in Thoracic Surgery Department and Medical Oncology department of Affiliated Cancer Hospital of xiangya School of Medicine Central South University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The primary objective is to measure the thioredoxin reductase activity in blood in staged(Ⅰ\~ⅢA) non-small lung cancers, to study the warning relapse ability of thioredoxin reductase in blood. The secondary objective is to compare the warning relapse activity of blood thioredoxin reductase activity with carcinoembryonic antigen (CEA) in subjects who received surgery. Blood will be collected in subjects before surgery, 5 days after surgery, and every 3 months after surgery till 2 years, then every 6 months till 3 years, or collect blood till tumor relapse for the subjects at stage ⅠA and low risk ⅠB. Blood will be collected before surgery, 5 days after surgery, before adjuvant chemotherapy, after 2 circles of all adjuvant chemotherapy, then every 3 months after adjuvant chemotherapy till 2 years, and every 6 months till 3 years, or collect blood till tumor relapse for the subjects of high risk ⅠB\~ⅢA, evaluation CT results every time collect blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven staged(Ⅰ\~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass, fast pathology proved non-small cell lung cancer
* Receive surgery in Thoracic Oncology department Affiliated Cancer Hospital of xiangya School of Medicine Central South University without contraindication of surgery
* Tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
* Signed informed consent to provide blood and tissue for study

Exclusion Criteria:

* Patients received antitumor treatment before
* Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy
* Pregnant or breast feeding women
Price Changes and Nutrient Profiling Among Adult Grocery Shoppers

The purpose of the research is to examine the association between price changes, nutrient profiling, and grocery food purchases among household grocery shoppers.

Participants will be asked to select a week's worth of groceries for their household from a virtual online grocery store. Shoppers will be randomly assigned to one of four conditions (control, nutrient profiling, price change, nutrient profiling and price change).

Eligibility Criteria:
Inclusion Criteria:

* primary household grocery shopper
* at least 19 years old
* one or more child (2-18yrs) living full time in the household

Exclusion Criteria:

* not the primary household grocery shopper
* no dietary, medical, or psychopathology conditions that could interfere with the study
* under the age 19
* no children (2-18yrs) living full time in the household
Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle

This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the drug. A basal line control and After the application control will be made, and the investigators will evaluate the drug effects, based on clinical aspects, photographic registers and through electromyography exam (EMG).

Considering the results of our investigation, the investigators may propose a pattern of application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have indication for aesthetic treatment of the frontal dynamic wrinkles, in maximal contraction of the frontal muscle.
* Availability and understanding of the patient, for complete all the steps throughout the duration of the study.
* Medical history and physical examination compatible with the study.
* Informed consent signed.

Exclusion Criteria:

* Subjects with previous forehead face lifting or blepharoplasty surgery.
* Previous use of Botulinum toxin in the last 6 months.
* Forehead or eyelid asymmetry.
* Subjects with infections on site of injection or inflammatory skin diseases.
* Subjects with hypersensitivity to any component of the formulation, including albumin.
* Subjects with neuropathic or neuromuscular diseases.
* Subjects using aminoglycosides, penicillamine antibiotics, quinine and Ca2+ channel blockers.
* Subjects with pregnancy and lactation, or that planning become pregnant during the time of the study.
* Subjects with dimorphism or others psychological disorders.
A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in February 2018.

The purpose of this study is to make a monitoring of adverse reactions in 100 thousand children aged 14 years and below to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

In order to observe the clinical characteristics and adverse reactions of patients aged 14 and below using Reduning injection in hospital,registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of anaphylaxis. Calculating the incidence of adverse drug reactions is one of the main aims for this study. 100000 cases need to be registered at least. The aim population is who using Reduning injection from February 2018 to December 2018.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 14 and below using Reduning injection from February 2018 to December 2018.

Exclusion Criteria:

None