cyrilzakka/clinical-trials huggingface dataset:
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.

Eligibility Criteria:
Inclusion Criteria:

* Dry Eye Disease diagnosis
* VAS eye dryness severity score ≥ 40.

Exclusion Criteria:

* Are unwilling to discontinue use of contact lenses
* Are unwilling to withhold use of artificial tears.
Thoraflex Hybrid and Relay Extension Post-Approval Study

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.

Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site.

Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.


Eligibility Criteria:
Inclusion Criteria:

Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study.

Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.

Exclusion Criteria:

* Patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates

Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Preterm
* Very low birth weight baby: birth weight 1-1.5 kg
* Both inside and outside delivered babies
* Gender: males and females
* Probable severe sepsis (septic score)

Exclusion Criteria:

* Extremely low birth weight babies: \< 1 kg
* Babies \>1.5 kg birth weight
* Babies born with congenital malformations
* Full term babies
* IUGR babies
* Child with no signs of sepsis
* HBsAg Positive
* HIV Positive
Effect of Consuming a Combination of Probiotic Strains on Postpartum Depression

The objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.

The mood disorders such as postpartum depression have a very high incidence. There is a relationship between a woman's microbiota and the risk of postpartum depression.

The possibility of influencing the microbiota through probiotic treatments opens a door to the prevention and/or treatment of postpartum depression.

Therefore, the objective of this trial is to evaluate the effect of consuming a combination of Lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant who is between 28-32 weeks of gestation.
* Normal development of pregnancy.
* Singleton pregnancy.
* Score ≥12 scale Postpartum depression questionnaire Edinburgh.
* Pregnant who has the firm intention of breastfeeding her child for at least the first month.
* Sign the Informed Consent.

Exclusion Criteria:

* Have any breast pathology that makes it difficult or impossible to breastfeed.
* Consume other probiotic supplements during the study.
* History of serious mental disorders other than affective disorders, whether or not currently under pharmacological treatment.
* Low expectation of adherence to the study protocol.
* Pharmacological treatment incompatible with the study.
* Non-compliance with the study protocol.
Phase 3 Study of ALK-001 in Geographic Atrophy

This is a double-masked, multicenter, randomized, placebo-controlled clinical trial, evaluating the efficacy and safety of ALK-001 in participants with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD).

Up to 200 participants will receive ALK-001 while up to 100 participants will receive a placebo.

There is no treatment available for Geographic Atrophy secondary to AMD. AMD is characterized by an age-related degeneration of the retina.

The root cause for this degeneration or why some people develop AMD while others do not, is unknown. Over 20 years ago, it was hypothesized that the dimerization of vitamin A may be a significant contributor to the etiology of AMD. The eye indeed uses vitamin A as a cofactor to sense light, and a striking chemical signature of the aging and degenerating retina is the accumulation of vitamin A dimers in the retinal pigment epithelium (RPE) and the underlying Bruch's membrane. In rodent models, high levels of vitamin A dimers correlate with poor retinal health, and a variety of mechanisms have been proposed by which vitamin A dimers may induce retinal toxicity. It has been argued that these mechanisms participate in the development and progression of AMD.

ALK-001, the study drug, is a modified form of vitamin A. When taken once a day as a capsule, it replaces natural vitamin A in the body with one that forms vitamin A dimers more slowly. This study will measure the extent to which treatment with ALK-001 slows the progression of Geographic Atrophy.

Eligibility Criteria:
Major Inclusion Criteria:

- At least one eye with geographic atrophy secondary to dry age-related macular degeneration (AMD)

Major Exclusion Criteria:

- Medical condition, which may interfere with the progression of GA, prevent performance of study procedures, compliance with protocol, or continuous participation in the study
System for Quantifying the Functional Strength of the Grip and Pinch Movements

This study developed a system to quantify the functional strength of young adults without motor impairment during grip and pinch movement. Making it possible to know the accuracy of the value of these strength, the range of motion performed and whether the grip force was maintained throughout the range of motion. In addition to checking the functionality, reliability and reproducibility of the system.

Quantifying grip and grip movement is essential as it allows for a basis in upper limb functionality. However, when there is access, it causes changes in the hands and changes the motor in relation to the force and range of motion, or generates changes in activities of daily living. Thus, a system with 5 devices, where each one the devices were prints in three-dimensional, and instrumented with force sensor for static-dynamic force analysis e potentiometer for analysis range of motion, during the execution of movements cylindrical grip, spherical grip, hook grip, pulp-pulp pinch, and pulp- side pinch in different activities of daily living. Elaborated a data storage interface through MATLAB® software that allows recording the data of each device. For the system functionality tests, 30 volunteers were selected for both sexes, young adults between 20 and 39 years old, students of the Physiotherapy and Graduate courses of the University of Mogi das Cruzes. The tests are divided into two sessions and are repeated after 7 days of the first test

Eligibility Criteria:
Inclusion Criteria:

* only right-handed individuals,
* male and female,
* have preserved cognitive functions,
* absence of neurological disorder
* who present minimum grip strength by the Jamar ® dynamometer, in the age group of 20-29 years men 45.08 ± 0.67 kg and women of 27.2 ± 0.46 kg, who present minimum grip strength by the dynamometer Jamar ®, aged 30 to 39 years old men 46.05 ± 0.47 kg and women 28.0 ± 0.39 kg, using the mean minus the standard deviation.

Exclusion Criteria:

* Injury to upper limbs such as amputation, recent surgery (6 months), fractures, bruising, pain and musculoskeletal disorders.
* Do not accept to participate in the survey.
Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke

Post-stroke cognitive impairment(PSCI) is one of the most important factors causing disabilities after stroke. Recent study found that gut microbiota plays a key role in neurological diseases. Two recent small sample studies reported gut dysbiosis in PSCI patients. In order to further verify the relationship between PSCI and gut microbiota and the predictive value of gut microbiota and serum markers for cognitive impairment and poor prognosis after ischemic stroke. The study intended to collect stool specimens of patients with acute ischemic stroke and assess their cognitive psychological state, and to establish a prospective multi-center follow-up cohort to explore the correlation between the dynamic changes of intestinal flora in patients with stroke and PSCI and poor prognosis of stroke.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for acute ischemic stroke;
* Aged between 18-75;
* Onset within 7 days;
* Sign informed consent and agree to provide relevant medical history data and biological specimens.

Exclusion Criteria:

* Patients diagnosed with TIA
* Severe disturbance of consciousness (NIHSS consciousness score \> 1)
* Previous severe mental disorders and dementia (AD8 score ≥ 2)
* History of cerebral hemorrhage or any stroke within 12 months;
* Serious systemic diseases including malignant tumors
* Patients with aphasia and unable to cooperate to complete the Montreal Cognitive Assessment (MoCA)
* ALT or AST greater than 2 times the upper limit of normal value or severe liver disease;
* GFR less than 30mL/min/1.72m2 or severe kidney disease
* Alcohol abused, drug use and chemical poisoning history (such as pesticide poisoning)
* Patients with previous history of gastrointestinal tract or confirmed during hospitalization
* Patients who could not collect stool samples within 4 days after admission.
GECo: Implementation and Effectiveness of COPD Case-Finding in Low and Middle Income Countries

This study will test how well short questionnaires, with and without a simple breathing test called 'peak flow', can identify people with COPD compared to the gold-standard diagnostic test called spirometry. We will test this in 10,500 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our case-finding intervention at scale.

The investigators will determine whether case-finding for COPD can be facilitated using 5-item questionnaires with and without a measurement of Peak-Flow. The investigators hypothesise that 5-item questionnaires will be a valid case-finding tool for COPD in LMIC and will be acceptable and feasible for use in these settings.

1. Clinical Aim: Determine the diagnostic accuracy of the case-finding questionnaires with and without PEF.
2. Implementation Aim: Assess the appropriateness, acceptability and feasibility of using questionnaires and PEF to identify COPD cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health.

The design of the intervention will be informed by formative work prior to commencement of the main study.

Study fieldworkers will enroll and screen a randomly-selected age- and sex-stratified population sample of adults aged ≥40 years; a total of 10,500 between the following three countries in the catchment areas of existing community census areas in Bhaktapur (Nepal), Lima (Peru), and Nakaseke (Uganda).

The investigators will report the sensitivity, specificity and positive predictive value of the case-finding questionnaire, with and without PEF, in relation to a gold standard COPD diagnosis made at spirometry (post-bronchodilator FEV1/VC ratio \<LLN, with a history of significant respiratory exposure to tobacco smoke or biomass). The investigators will construct ROC curves to visualise trade-offs in sensitivity and specificity across a range of questionnaire cut off values.

The investigators will also examine the feasibility of implementing a 5 item questionnaire +/- PEF intervention at scale.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged ≥40 years
* Full-time resident in the area (living in area \> 6 months)
* Able to perform adequate quality spirometry
* Capable of providing informed consent

Exclusion Criteria:

* Pregnancy (self-reported)
* Currently has active pulmonary TB or is taking medications for pulmonary TB
Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes

observation of females condition will getting pregnant by undergoing assisted reproductive technologies, the most important of which is the in vitro fertilization (IVF), where blood and follicular fluid samples are collected from them at the same stage of in vitro fertilization, and then monitor the IVF outcomes until pregnancy occurs or not, based on blood tests. The levels of interested markers in blood and follicular fluid samples of the study individuals are assayed in order to compare these levels with the egg criteria such as egg number and maturation rate and finally compare the results with occurrence or absence of pregnancy.

Vitamin D, vitamin E, zinc and glutathione peroxidase will be measured in blood and follicular fluid samples of study subjects for women undergoing in vitro fertilization after monitoring their health for two to three months before beginning the first stage of in vitro fertilization. Once start the ovulation induction protocol, which is the first stage of in vitro fertilization, we will monitor all the results from the number of eggs and follicles, their diameter, the thickness of the endometrium, the number of mature eggs, the egg maturation rate and fertilization rate to the occurrence of biochemical pregnancy or not later, based on the blood Human chorionic gonadotropin (hCG) levels two weeks after the embryos transfer to the uterus. The patient is monitored until clinical pregnancy is complete or not. On the other hand, we will later compare the levels of studied parameters with the aforementioned egg quality criteria and with the clinical pregnancy rate of the study group in order to understand the relationship between these studied parameters and the occurrence of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Cases of Healthy women (in terms of reproductive function).
* Aged between 20-40 years and were close in terms of education, nutrition, and social status.
* Explicit male factor such as Oligospermia, Azoospermia, Asthenozoospermia, or TESA (Testicular Sperm Aspiration), ensuring that there is no fertility-interfering female factor.
* Undergoing long Gonadotropin-releasing hormone (GnRH) agonist down-regulation protocol.

Exclusion Criteria:

* Cases classified by the specialist clinician as a female factor such as PCOs (Polycystic Ovary Syndrome), Uterine Fibroids, Uterine Infections, Uterine Adhesions, and Endometriosis.
* Compound cases.
* Sex selection cases.
* Undergoing short GnRH agonist or antagonist protocol.
* Women aged under 20 or above 40.
* Women who took nutritional supplements, for at least two to three months before the egg retrieval procedure.
* Smokers.
* Cases with the following medical conditions: Tumors, Diabetes, Multiple sclerosis, Autoimmune Diseases, Liver or Kidney Disorders, Cushing's Syndrome, and women who take chronic medications
Promoting Stretching Exercise to Reduce Cardiovascular Health Risk in Late Pregnant Women With Obesity

The purpose of this trial is to determine whether a stretching intervention is superior to a usual care control condition (moderate/vigorous activity 30 minutes daily, 5 days per week) for pregnant women from 27 to 37 gestational weeks.

Although being sedentary can lead to excess risk for maternal and child mortality and morbidity, most pregnant women reduce their physical activity and only 8% meet the recommendations in the 3rd trimester.

In a prior randomized control trial, it was found that fewer women who stretched developed preeclampsia than did women who walked (3/60 "stretchers" vs. 10/64 "walkers", p=.05).

In this study, participants will either receive a stretching intervention

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at less than 24 weeks gestation
* Singleton pregnancy
* BMI ≥ 30 kg/m\^2 at their first prenatal care visit
* English or Spanish speaking

Exclusion Criteria:

* Women who expect or are scheduled to deliver prior to 37 weeks gestation
* Women who expect to move from the area during their participation in the study
* Women who are unable to exercise for 30 or more minutes 3 times per week
PK of Levofloxacin in MDR-TB Patients

The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various factors contributing to the development of drug resistance, low drug exposure is well recognized. To overcome this, either new drugs have to be developed or the dose of currently used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired drug resistance to these drugs could complicate and narrow down the available options, and further exacerbate to pre-XDR and XDR-TB.

Objective:

The main objective of this prospective clinical study is to understand the pharmacokinetics of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body weight and correlate drug exposure, with treatment outcomes.

Study design:

A prospective pharmacokinetic study

Study population: 20 MDR-TB patients

Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on the body weight, under MDR-TB treatment regimen of Nepal.

Main study parameters/end points:

The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated in plasma and in oral fluid


Eligibility Criteria:
Inclusion Criteria:

* Patient with TB, with Mycobacterium tuberculosis by culture/ Gene Xpert
* Patient is 18 years or older with newly diagnosed or previously treated MDR-TB
* Patient with sputum smear positive for acid-fast bacilli or sputum smear negative but Gene Xpert (MTB/RIF) positive, and resistant to both isoniazid and rifampicin
* Patients with MDR-TB receiving levofloxacin as a part of MDR-TB regimen

Exclusion Criteria:

* Patient with neurologic or severe extra-pulmonary manifestations of tuberculosis
* Pregnant women or breast feeding mothers with MDR-TB
* Patients with diminished renal functions or on medications for the treatment of renal disorders
* Body weight \<35 kg
* Patients treated with aluminium- and magnesium containing antacids and ferrous sulphates, cimetidine and probenecid, theophylline, warfarin, zidovudine, digoxin or cyclosporine.
Hepatocyte Matrix Implant Study

This clinical investigation of the hepatocyte matrix implant is an evaluation blinded non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic investigation. Randomization is not possible due to ethical and practical reasons. Pending approval of the ethical committee the study will also be conducted in Indonesia.

This new treatment procedure has already been successfully used on the basis of compassionate use in Germany. The hepatocyte matrix implant is a new patented procedure consisting of bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving polymers is applied as a carrier substance and is cultivated with human autologous cells using a special technique. Clinically the bioartificial liver replacement tissue for patients with end-stage hepatic disease has been developed as a first application. In this procedure autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The cells are processed according to SOPs in a special perfusion procedure and prepared on several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After completion of the laboratory process the biotissues are implanted into the mesentery of the small intestine during a second operation. The cells are growing controlled on the matrix, take on the capillaries of the patient and thus connect to the blood circulation. The implanted cells multiply by a specific factor and independently take over the metabolic function of the original liver after two to four weeks. In the following process the carrier matrix dissolves completely and implanted cells develop into liver cell tissue.


Eligibility Criteria:
Main Inclusion Criteria:

* endstage liver disease
* stable and non-improving liver condition for at least 3 month
* alcoholic liver cirrhosis: proven alcohol abstinence for 6 month or more
* patient in bad general condition

Main Exclusion Criteria:

* pregnancy
* drug addiction (except alcohol)
* psychiatric disease
* HIV positive
* sepsis
* peritoneal carcinosis
* hereditary liver disease
* acute liver failure
Study of the Clinical Features of Autoimmune Hepatitis

The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH). At phase 1, the investigators focus on studying of the clinical characteristics of acute autoimmune hepatitis, and then will study the difference about treatment effects between acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that drug induced AIH have some special characteristics that may be beneficial to distinguish it with durg induced liver disease. Therefore the investigators will do some studies about drug induced AIH or other disease which maybe related to the onset of AIH.

Now this study has been researched at phase 1, the investigators focus on studying the difference between acute AIH and chronic AIH. In this phase, the investigators analysed the serum biochemical results such as ALT,AST,IgG,PT,INR and so on, and also compared the histological performance. Finally, we compared the percentages of biochemical remission in the two groups, and the time from initial treatment to biochemical remission has also been put into the analysis. Now, the investigators are preparing for submitting the manuscript of phase 1.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of autoimmune hepatitis

Exclusion Criteria:

* Other causes of liver disease, such as viral hepatitis, drug induced liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, overlap syndrome and so on.