cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Systane® Balance in Dry Eye Subjects

The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

This study was conducted in India.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent and willing and able to attend all study visits;
* Dry eye in both eyes diagnosed by an ophthalmologist;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant or breastfeeding;
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
* Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
* Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
* Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
* Other protocol-specified exclusion criteria may apply.
Tutorial of Clinical Trial Registration

The present study aimed to determine whether infants disorders of regulation of states are associated with perinatal anxiety, and further to explore the efficacy of the behavioral intervention in enhancing positive interactions between mothers and their infants and thus ameliorating infants' disorders of regulation of states.

The subjects were recruited from the hospitalized pregnant women waiting for delivery from the department of gynecology and obstetrics of the first affiliated hospital of Xi'an Jiaotong university. A total of 200 perinatal anxiety women were divided to two group(behavioral intervention group and control group) according to mental health assessment. Inclusion criteria were applied: 1. mother aged 18-40 years; 2. First-time mother, full-term and singleton pregnancy; 3.the Hamilton Anxiety Scale(HAMA) score ≥14; 4.birth with no intrapartum complications; and 5. Apgar score \> 8 at the first, fifth, and tenth minutes after birth. Exclusion criteria were as follows: any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke,atrial fibrillation, peripheral arterial disease, and other severe diseases.Preterm infants (\< 37 weeks gestation) and multiple births were excluded from the current analysis. All the subjects completed the infants behavior and regulation of states assessment by the NBAS and were followed to 8 weeks postpartum. Mother-newborn pairs were randomly divided into NBO intervention group and control group. NBO intervention was performed once a week until 2 months. 2 ml peripheral blood was collected in the pregnant woman before delivery and in the newborns within 3 days postpartum.The serum fraction was removed after centrifugation and stored at -20°C. Levels of serum cortisol in mothers and newborns were determined using Chemiluminescence analysis (CLIA) and a radio immunoassay. All sample analyses were performed by the first affiliated hospital of Xi'an Jiaotong university chemistry laboratory. Laboratory personnel were blinded to mother and infant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* mother aged 18-40 years;
* first-time mother, full-term and singleton pregnancy;
* the Hamilton Anxiety Scale(HAMA) score ≥14;
* the birth with no intrapartum complications;
* Apgar score \> 8 at the first, fifth, and tenth minutes after birth.

Exclusion Criteria:

* any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke, atrial fibrillation, peripheral arterial disease, and other severe diseases;
* preterm infants (\< 37 weeks gestation);
* multiple births;
* infants with congenital anomalies, signs of illness, or high-risk factors.
Allergy Immunotherapy for the Reduction of Asthma

In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. These risks include a history of asthma in the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new and has been practiced for many years to treat asthma and environmental allergies in older children and adults, but has not yet been systematically studied in young children.


Eligibility Criteria:
Inclusion Criteria:

* Children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
* Positive skin tests or specific Immunoglobulin E (IgE) antibody titers to at least one of common airborne allergens: Dust Mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
* The child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions OR 2 of the following minor conditions:

  * Major criteria: History of atopic dermatitis and/or parental history of asthma.
  * Minor criteria: MD-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.

Exclusion Criteria:

* The child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant atrial or ventricular septum defect or heart murmur).
* The child was born following 35 or less weeks of gestation.
* Parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
* The child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
* The child has chronic lung disease of prematurity (CLDP), cystic fibrosis or any other chronic lung disease.
* The child ever received immunotherapy.
* The child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
* History of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.
Misoprostol Versus Dilapan-S for Cervical Preparation

The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.


Eligibility Criteria:
Inclusion Criteria:

* medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
* gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
* proficient in English or Spanish
* agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction

Exclusion Criteria:

* less than 18 years old
* cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
* inflammatory bowel disease
* contraindication to misoprostol use
* known intolerance or allergy to misoprostol or Dilapan-S
* inability to give informed consent
Evaluation of Central Compartment Dissection Without Thyroidectomy

In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In the course of clinical work, if the patient can achieve R0 resection, most of the patients do not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.To evaluate the practicable, thoroughness and Clinical value of bilateral central compartment dissection while preserve contrary thyroid glands.

In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In the course of clinical work, if the patient can achieve R0 resection, most of the patients do not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.This study assesses new procedures by adjusting the sequence of procedures. complications and the thoroughness of the operation were evaluated, thus Clinical value of bilateral central compartment dissection with preserve contrary thyroid glands were ananlyed.

Eligibility Criteria:
Inclusion Criteria:

Tumor diameter less than 1cm The tumor is located in the lower part of the gland No lateral cervical lymph node metastases Traditional open surgery

Exclusion Criteria:

Select the endoscopic surgery or robotic surgery patients Tumor invades the surrounding trachea and esophagus Patients refused to participate
A Randomized Trial of Vaccine Adherence in Young Injection Drug Users

The purpose of this study is to compare the effects of (a) immunization setting and (b) outreach worker support on young injection drug users' (IDU) adherence to a multiple dose immunization schedule with a combined hepatitis A virus (HAV) inactivated and hepatitis B virus (HBV) recombinant vaccine.

This is a research trial consisting of a cross-sectional screening study and a prospective cohort study (randomized, 2x2 factorial design). The primary aim of the study is to evaluate the effects of immunization setting and outreach worker support on young IDU's adherence to a multiple dose immunization schedule with a combined HAV and HBV vaccine. Secondarily, the study will 1) explore the feasibility of a remote immunization network and web-based vaccine registry to improve immunization coverage of transient young IDU, 2) examine the effect of hepatitis C virus (HCV) infection in vaccine effectiveness, and 3) assess behavior change and vaccine attitudes in young IDU participating in a preventive vaccine trial.

Subjects in the screening study complete an interview, receive counseling and testing for HIV, HAV, HBV and HCV, and return in one week for test results and risk reduction counseling. Subjects eligible for the cohort study receive their first immunizations at enrollment and then are randomized to receive subsequent vaccines at either a set of syringe exchange programs (SEP) or at a public health adult immunization clinic (AIC). Subjects also are randomized to receive vaccine reminders from an outreach worker or no outreach worker support. Each subject receives a total of 4 immunizations over 6 months. Follow up visits include interviews, counseling, and viral testing. Study participation is for 12 months.

Eligibility Criteria:
Inclusion Criteria (screening study):

* age 14-29 at screening
* injected drugs in the prior 30 days

Exclusion Criteria (screening study):

* Prior positive HIV antibody test
* Prior HBV immunization

Inclusion Criteria (vaccine cohort):

* participated in the screening study
* tested negative for HIV-1 antibody and HBV markers in the screening study
* returned for screening test results within 30 days of testing
Place of Echocardiography in IV Fluid Therapy in Patients With Septic Shock and Left Ventricular Systolic Dysfunction

IV fluid therapy remains an essential haemodynamic objective in the treatment strategy of septic shock. Left ventricular systolic dysfunction secondary to sepsis is observed in 40% and up to 65% of the population concerned. However, the capacity of the various indices to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction have not been clearly defined. Measurement of parameters reflecting filling pressures during transthoracic echocardiography (TTE) is one of the methods used to evaluate cardiac function and estimate the filling reserve, but with no strong evidence. Right heart catheterization with determination of cardiac output by pulmonary thermodilution can also be used to measure the various parameters commonly used to predict the response to IV fluid therapy. Very few data are available with no reliable and clinically relevant data in this population with septic shock and left ventricular systolic dysfunction (LVEF ≤ 40%) and the response to IV fluid therapy monitored by dynamic indices obtained by transpulmonary thermodilution and right heart catheterization. Consequently, the capacity of the various indices of preload dependence to predict the response to IV fluid therapy in septic shock with left ventricular systolic dysfunction remains difficult to define.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock with cardiovascular dysfunction despite norepinephrine,
* Left ventricular systolic dysfunction defined by transthoracic echocardiography and LVEF ≤ 40%
* Fluid challenge decided by the patient's attending physician according to the optimization of cardiac output in septic shock protocol,
* IV fluid therapy with 500 ml of crystalloid solution.
* Haemodynamic monitoring decided by the patient's referring physician not involved in the study, according to the department's usual practice by transthoracic echocardiography and thermodilution monitoring.
* Sedated, on mechanical ventilation, and adapted to the ventilator.
* Patients who have received oral information and written documentation (with a copy filed in the medical records) on awakening.
* The trusted person designated for each patient has received the same oral and written information.

Exclusion Criteria:

Patients under the age of 18 years, pregnant women, patients under judicial protection or deprived of their freedom, Amputation of one or both lower limbs Contraindication to passive leg raising (e.g.: severe IC, etc.), Cardiac tamponade or aortic dissection with uncontrolled active bleeding. No indication for IV fluid therapy
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis

The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated autologous bone marrow cells as a new therapy in patients with established osteoporosis by a prospective, single-center, open, non-randomized and unblinded clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with established osteoporosis according to standard clinical criteria.
* Patients who give their written informed consent to participate in the study consent.
* Meet all the inclusion criteria

Exclusion Criteria:

* Patients with concomitant systemic disease in the opinion of the investigator.
* Patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular arthritis.
* Current patients with neoplasm or history of any malignancy in the last 10 years except basal carcinoma or epidermoid skin.
* Patients with genetic disorders that are associated with secondary osteoporosis: Hemochromatosis, hypophosphatasia, osteogenesis imperfecta, Ehlers-Danlos syndrome, Marfan syndrome, Riley Day, porphyria, storage diseases syndrome.
* Patients receiving immunosuppressive chemotherapy or that could interfere with the process of cell proliferation.
* Transplant patients: bone marrow, kidney, liver, heart, lung.
* Patients with clinical criteria and anesthetics that contraindicate well sedation or bone marrow extraction.
* Patients participating in a clinical trial in the last 6 months.
* Patients with positive serology for hepatitis B, hepatitis C or HIV.
* Patients with inability to understand informed consent.
* Patients who are pregnant or breast-feeding actively.
* Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.
Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages

this study aims to correlate mandibular indices and different ages in a sample of Egyptian population.

this study is an observational cross sectional study to correlate the mandibular radiomorphometric indices with age in sample of egyptian population using CBCT scans at faculty of dentistry cairo university

Eligibility Criteria:
Inclusion Criteria:

* Egyptian individuals with different ages starting from 10 - 70 years.
* Females and males of the mentioned ages.

Exclusion Criteria:

* Individuals younger than 10 and older than 70 years old.
* Presence of a large pathological lesions in the mandible at the areas intended for measurements.
* Patients of severely resorbed mandibular bone.
* Patients with any bony deformity at the inferior border of the mandible.
* Patients with fracture at the areas to be examined.
* Patients with evident radiographic asymmetry.
* Patients with evident radiographic abnormality suggestive of systemic disease predisposing to osteoporosis.
* Patients with current postoperative surgical defect healing at the areas intended for measurements.
* Patients with mandibular reconstruction
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
* HCV RNA ≥ 10,000 IU/mL at screening
* Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit
* Liver transplant ≥ 6 months and ≤ 12 years prior to screening
* Naive to all nucleotide/nucleoside treatments for chronic HCV infection

Exclusion Criteria:

* Multiorgan transplant that includes heart or lung recipient
* Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant
* Current use of corticosteroids at any dose \> 5mg of prednisone/day (or equivalent dose of corticosteroid)
* Infection with hepatitis B virus (HBV) or HIV at screening
* Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
Neuropathic Pain Syndrome Patient Study (MK-0000-072)

The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
* Patient is able to complete questionnaires in either English or Spanish
* Patient is at least 18 years of age

Exclusion Criteria:

* Patient is either pregnant or breastfeeding
* Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
* Patient has a history of congestive heart failure
* Patient has a seizure disorder
* Patient has a history of drug and/or alcohol abuse within the past 1 year
* Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain
* Patient has had cancer (except basal cell carcinoma) within the past two years
* Patient anticipates the need for surgery while participating in the study
* Patient has a reported history of hepatitis B, C, or HIV infection
* Patient has another type of pain that is more painful than the nerve pain
* Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder
* Patient is involved in litigation or receives worker's compensation related to nerve pain
Isoflurane at Subanesthetic Concentrations - 6

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
Clostridium Histolyticum Collagenase Injection for Urethral Disease

The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.

This is an open-label, pilot study to explore the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures. Subjects will be followed for 2 years from the initial drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age ≥ 18 years
* Failed prior proven conservative measures, including DVIU or balloon dilation of the stricture will be included in this study
* Able and willing to undergo regular intervention as well as evaluation as described below will be included in the study
* With a single stricture \<2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study.
* Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study
* Must be competent to understand the information given in IRB approved ICF and must sign the form prior to the initiation of any study procedure

Exclusion Criteria:

* Has not yet undergone proven non-invasive measures, including DVIU or balloon dilation.
* Multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram, voiding cystourethrogram, or urethral ultrasonography.
* Corporal spongiosum tissues \< 5 mm in depth at proposed injection site
* Grade 5 spongiofibrosis
* Age \<18
* Females
* Prior urethroplasty
* Urethral fistula
* History of penile cancer, prostate cancer, or urinary tract malignancy (bladder, urethral, ureteral, or kidney).
* History of radiation (external or brachytherapy) to the pelvic organs, penis or groin.
* History of autoimmune or inflammatory bowel disease
* Contraindication to suprapubic tube placement
* Pre-procedure PVR \>250mL
* Allergy or sensitivity to CHC
* Bleeding disorder or anticoagulant use other than aspirin up to 150mg/day
* Untreated urinary tract infection
* Inability to perform intermittent self-catheterization
* Participation in another clinical study or treatment with an investigational drug or device
* Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol