cyrilzakka/clinical-trials huggingface dataset:
An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops

A prospective, longitudinal, cross-sectional, observational Study with a 8-week Follow-up to evaluate the renewal of corneal nerves structure and function in patients with Neurotrophic Keratopathy treated with recombinant human Nerve Growth Factor (rhNGF) eyedrops.

This Study shows that topical treatment with Recombinant Nerve Growth Factor (rhNGF) improved corneal sensitivity and increased sub-basal nerves density, promoting corneal healing of persistent epithelial defects and corneal ulcers in patients with stage 2 and 3 NK

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented moderate or severe neurotrophic keratopathy based on a recent new classification of NK, refractory to conventional non surgical treatments. The diagnosis was made on medical and ophthalmological history, slit lamp examination, aesthesiometry, in vivo confocal microscopy.
* Decreased corneal sensitivity on the area of corneal defect and on superior, inferior, nasal and temporal quadrants (≤ 4 cm using the Cochet-Bonnet aesthesiometer)
* Patients who satisfy all Informed Consent requirements. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed
* Patients with ability to understand and perform the treatment.

Exclusion Criteria:

* active infective keratitis or inflammation not related to NK in the affected eye.
* presence of corneal dystrophies.
* presence of glaucoma.
* Any other ocular disease requiring topical ocular treatment during the course of the study treatment period.
* History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrolment. (An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the stage 2 or 3 NK).
* patients with known hypersensitivity to one of the components of the study or procedural medications (e.g. anaesthetic drops, fluorescein).
* Females currently pregnant
A Study of [14C]-LY3866288 in Healthy Participants

The main purpose of this study is to evaluate how much of the study drug (LY3866288), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study will also evaluate the safety and tolerability of LY3866288.The study is conducted in two parts. The study is expected to last approximately 68 days.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy determined by medical history, physical examination, 12-lead ECGs, vital signs measurements, and clinical laboratory evaluations at screening and/or check-in by the investigator
* Have Body mass index between 18.0 and 32.0 kg/m\^2 (kilograms per meter squared)
* Male participants who are infertile via bilateral orchiectomy or vasectomy
* Female participants (non-childbearing potential only for Part A) who follow standard contraceptive methods

Exclusion Criteria:

* Female participants who are lactating or pregnant
* Have history of alcohol and/or drug abuse within 2 years prior to screening
* Have history or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Have history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects

This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects.

The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects including assessment of immunogenicity.

32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤45 years old;
2. The body mass index (BMI) should be 19 or greater and \< 28kg/m2, the male weigh ≥50.0kg and \<90.0kg, and the female weigh ≥45.0kg and \<90.0kg;
3. Serum LDL-C concentration≥2.0mmol/L and \< 4.1mmol/L;
4. Fasting triglycerides \< 2.3 mmol/L;
5. The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.
6. Signed informed consent.

Exclusion Criteria:

1. Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;
2. A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
3. Serum creatinine exceeded the upper limit of normal value (ULN) during screening;
4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2 x ULN, or total bilirubin more than 1.5 x ULN during screening;
5. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
6. Subjects with previous malignant tumor diseases;
7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening. etc
Osmolality of Oral Supplements and Ileostomy Output

This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intestinal aquaporin expression in eight compensated patients with an ileostomy and not on home parenteral Nutrition or fluid support.

Patients with an ileostomy may experience fluid and electrolyte imbalances sedondary to an unregulated intestinal loss of water and electrolytes. The osmolality of oral supplements may affect these losses. In a double-blinded, active comparator, cross-over intervention study, the investigators test the effects of substituting 800 ml of the usual fluid intake with an intake of either an isoosmolar (300 mOsm/kg) or hyperosmolar (700 mOsm/kg) supplement during 48 hours, following baseline data collection before both intervention periods. Outcome measures were stoma output volume, 24-hour urine and urinary sodium excretion, and intestinal aquaporin 3 and 8 expressions.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or more
* ilestomy established 6 weeks or more prior to inclusion
* able to drink at least 100 ml fluid per 24 hours
* i known inflammatory bowel disease, clinical remission judged by physician's global assessment (PGA)
* less than 5 kg self-reported weight change during the past 3 months

Exclusion Criteria:

* self-reported intolerance to dairy products, including lactose
* known renal insufficiency, defined by an eGFR less than 30 ml/min
* known diabetes mellitus, defined by an HbA1C \> 48 mmol/mol (6.5%)
* current enteral tube feeding or parenteral fluid or Nutrition support more than twice weekly
Maternal Voice and Quantitative EEG (qEEG)

A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.

This will be a randomized placebo-controlled clinical trial. Infants consented to participate will be randomized into the intervention arm or non-intervention arm by sealed unmarked envelope.

All consented participants will have an initial EEG of 60-90 minutes duration, performed at 32 5/7 - 32 6/7 weeks (and after 72 hours of life).

Starting at 33 0/7 weeks corrected gestational age (regardless of birth gestation), eligible subjects will proceed with randomized intervention or placebo for a 2-week (14 day) intervention period.

All infants will receive a 2nd EEG of 30-60 minutes duration, performed between 35 0/7 - 35 6/7 weeks corrected gestational age, following completion of either the intervention or non-intervention arm (with the goal of the 2nd EEG occurring within 48 hours of infants having completed the intervention vs. non-intervention arm).

EEG technician and all persons reviewing, pruning and analyzing data from the qEEG will be blinded to whether the infant was in the intervention or the non-intervention arm.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at 28 0/7 - 32 3/7 weeks gestation (to allow for infants born at 32 3/7 weeks to have initial EEG performed after 72 hours of life and prior to initiating intervention or non-intervention arm at 33 0/7 weeks gestation)
* Mother available to provide voice recording, and have ability to converse and read in English (as the scripted content for the intervention will be provided in English)

Exclusion Criteria:

* Infant with Critical Congenital Cardiac Disease
* Infant with Chromosomal anomaly or Inborn Error of Metabolism
* Infant with known Neurologic disorder/abnormality - including hypoxic-ischemic encephalopathy (HIE), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), seizure activity, anatomic abnormality
* Infant receiving antiepileptic or sedation medications prior to EEG
* Initial EEG abnormal with epileptiform activity or not consistent with corrected gestational age
* Mother not available to provide voice recording in English
* Unable to obtain consent from mother due to maternal health issues following delivery (such as mother requiring intubation or sedation following delivery
* Mothers who are prisoners (as the study team would like to have continuing communication during the study period as needed)
* Mothers who are \<18 years of age will not be approached for consent
* Any mother that is not able to consent due to having a legal representative will not be approached for consent
* Any infant that is planned to be placed for adoption, is in foster care or is a ward of the state
Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Nutritional Status

Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.

Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included. Macro-micronutrient intake analysis, biochemical blood parameters, and anthropometric measures were performed before and 1, 3 and 6 months after LSG.

Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. Nutritional deficiencies are identified as the possible complications of bariatric surgery. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.

Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included in this study. Preoperative and postoperative (1, 3 and 6th months) protein-energy and other nutrient consumptions, eating habits, food consumption diversity were evaluated with food frequency questionnaire, 3-days food diary record, three-factor eating scale and healthy eating index. Also in the pre- and postoperative period; anthropometric (weight, height, waist, hip, fat free mass) values measured and biochemical blood parameters were collected.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research,
* To have sleeve gastrectomy surgery,
* To be over 18 and under 65 years old
* Not having a perception disorder and communication problems

Exclusion Criteria:

* Ages \<18 or \>65 years old
* Having a pacemaker (implantation) or any prosthesis (inconvenient for segmental body analysis)
Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy

Cardiovascular \& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.

Cardiovascular \& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women. Also,comparing echocardiographic parameters in hypertensive pregnant women being treated with either alfa methyl dopa or labetolol.

Eligibility Criteria:
Inclusion Criteria:

* hypertension during pregnancy: Chronic or pregnancy induced

Exclusion Criteria:

* Inability to sign informed consent
The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Section

Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.

The perfusion index is the ratio of pulsatile blood flow to non-pulsatile in peripheral tissues and can be measured non-invasively using a pulse oximeter .Perfusion index measurement is considered a non-invasive rapid indicator of microcirculation variation and can help to detect circulation disturbance.It also can assess peripheral perfusion dynamics resulting from changes in peripheral vascular tone. Perfusion index changes according to posture with its highest value in Trendelenburg position and lowest value during 45-degree sitting position. However, to the best of our knowledge, no studies have studied the effect of posture on perfusion index in a full-term pregnancy, and its ability to predict hypotension following spinal anesthesia for elective cesarean delivery.

A previous study had found a correlation between baseline perfusion index and the incidence of post-spinal hypotension in the cesarean section, however, they haven't studied the effect of postural change on PI and its predictability of post-spinal induced hypotension(,Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-2 Age \> 18 years uncomplicated singleton pregnancy at full-term Elective scheduled caesarian section under spinal anesthesia

Exclusion Criteria:

* pre-existing hypertension gestational hypertension or preeclampsia Diabetes mellitus, or autonomic neuropathy Patients with peripheral vascular diseases known fetal abnormality. Emergency caesarian section. Placenta previa or placenta accrete. absolute contraindications or failure to perform spinal anesthesia.Study
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis and history of moderate persistent allergic asthma
* body weight \>/= 20kg and \</= 150kg
* Total serum IgE \>/= 30 and \</= 700IU/mL
* on a stable asthma treatment including corticosteroids for the preceding 4 weeks
* non smoker for at least 1 year prior to visit 1

Exclusion Criteria:

* patients with severe asthma
* history of immunotherapy to any allergen within the past 3 years
* history of anaphylactic allergic reaction
* upper respiratory tract infection
Safety Study of Anti-Asthma Agent BMEC-1217B

BMEC-1217B is an abbreviated version of an old Chinese formulation. The ratio of each component was adopted by the sponsor following the observation that BMEC-1217B prepared from this ratio resulted in best pharmacological profile and in vitro bioactivities.

BMEC-1217B was studied for the pharmacological activity on the release of cysteinyl leukotrienes, IL-4 and TNF-alpha in vitro and the airway hyperreactivity. The result indicated that BMEC-1217B can inhibit the synthesis of several key pro-inflammatory mediators involved in the pathophysiology of allergic asthma and can also improve lung function in a mouse model of allergic asthma.

The purpose of this study is to evaluate the safety and tolerability of increasing dose of BMEC-1217B when administered orally in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Nonsmoking healthy adults between 20 and 40 years old.
2. Determined to be in good health based on medical history, clinical laboratory test values within normal range. Body weight within 20% of the ideal body weight \[(height - 80) x 0.7\].
3. No recent history of drug or alcohol abuse within one year prior to study enrollment
4. Signed informed consent form.

Exclusion Criteria:

1. Has any condition that interferes with the ability of the subject to comply with the requirements of the study.
2. Has known allergy to the study drug.
3. Has an acute illness or surgery within 28 days prior to study enrollment
4. Has participated in other investigational trials within 28 days prior to study enrollment.
5. Has taken prescription medication and/or over-the-counter medication\*4 and/or botanical medications within 28 days prior to study enrollment.
6. Has alcohol and caffeine consumption within 24 hours prior to the administration of study drug.
7. Has evidence of significant renal, cardiovascular, hepatic, hematopoetic, neurological, pulmonary or gastrointestinal pathology, or any other medical reason or disease that might interfere with the study objectives, as determined by the investigator.
8. Has donation or receive of more than 450 mL of blood within 28 days prior to the study enrollment.
9. Female subjects of child bearing potential who are pregnant, nursing, do not agree to practice effective birth control during the time period from 14 days before administration of study drug to 28 days after administration of study drug, or with irregular or abnormal menstruation.
10. Clinically significant deviation from normal physical examination findings that, in the principal investigator's judgment, may interfere with the study evaluation or affect subject safety.
11. Test positive for HIV, HBV or HCV
12. Test results indicate liver function failure
13. Has been diagnosed with Diabetes Mellitus
Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects

The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Healthy male and female subjects aged between 18 and 55 years (inclusive) at screening
* Negative serum pregnancy tests at screening and negative urine pregnancy test at Day -1 for women and agreement to use 2 reliable methods of contraception for at least 3 months after last study drug administration
* Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening
* Systolic blood pressure 100-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 minutes in the supine position at screening and on Day -1
* Healthy on the basis of physical examination, cardiovascular, ophthalmological, neurological assessments and laboratory tests

Exclusion Criteria:

* Known hypersensitivity to ACT-709478 or drugs of the same class, or any of their excipients
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments
* QT interval corrected with Fridericia's formula (QTcF) \> 450 ms (using the ECG machine HR correction method) at screening and on Day -1
* Treatment with another investigational treatment within 2 months or 5 t1/2 (whichever is the longest) prior to screening or participation in more than four investigational treatment studies within 1 year prior to screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
The Effect of New-style Vaginal Repair Mesh in the Treatment of Female Stress Urinary Incontinence

The study is to explore the effectiveness of a new-style anterior vaginal wall mesh in the treatment of female stress urinary incontinence(SUI). Meshes were made by Gynemech TM PS, (Johnson \& Johnson Shanghai Medical Equipment Co. China Food and Drug Administration (CFDA) registration No. 3460365, size 10 × 15cm). Meshes were cut to appropriate size. The incontinence questionnaire summary table (ICIQ-SF), pad test, urodynamic and other diagnostic tests were used for preoperative assessment and the evaluation of postoperative surgical outcome and complication. The results were compared with the one-year cure rates of Burch and trans vaginal taping (TVT) surgeries. The analysis indicated that the surgery using the new-style anterior vaginal mesh, as a minimally invasive procedure, not only achieved its expectation with similar cure rate to Burch, TVT/ trans vaginal taping obturator (TVT-O) surgeries, but also has lower economic cost and complication rate than the TVT /TVT-O approach. The evaluation of long-term treatment effect needs further follow-up of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva). Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.

Exclusion Criteria:

* Atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
* Vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
* Combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
* Other type of cancers that require urgent care.