cyrilzakka/clinical-trials huggingface dataset:
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Patients who participated in this study included those who had completed participation in the study CRFB002A2301 (ANCHOR; NCT00061594), newly diagnosed patients, as well as previously diagnosed patients who had had recent disease progression.

Inclusion Criteria:

* Male or female patients \> 50 years of age
* Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
* The total area of CNV (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area
* The total lesion area must be \<= 12 disc areas
* Patients who have a BCVA (best corrected visual acuity) score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like (Early Treatment of Diabetic Retinopathy Study) grading charts (approximately 20/40 to 20/320)

Exclusion Criteria:

* Patients who have a BCVA of \< 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
* Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding Day 1
* Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.
Screening for Metabolic Problems in Mothers of Children With Autism and Typically Developing Children

The purpose of this research study is to screen for metabolic abnormalities that are maternal risk factors for having a child with autism.

The study will involve recruitment of 30 mothers of young children with ASD (ages 3-5 years) and 30 mothers of non-ASD children of similar age, respectively labelled ASD-moms and non-ASD-moms. In Phase 1, the levels of certain folate-related and oxidative stress biomarkers (folate, vitamin B12, vitamin E, homocysteine, methylmalonic acid, urinary isoprostanes) and MTHFR mutation analysis will be measured in all the mothers. The investigators expect that approximately 40-50% of the ASD-mothers and approximately 5-10% of the non-ASD-mothers will have abnormal homocysteine levels. In Phase 2, for those mothers with abnormal homocysteine levels, the investigators will treat them with a standard prenatal supplement for 4 weeks, and re-measure their biomarkers. The investigators expect 75-100% of the non-ASD mothers to respond, but only 25-50% of the ASD-mothers to respond. In Phase 3, for those mothers who did not respond to the standard prenatal supplement, the investigators will treat them with an optimized prenatal supplement for 4 weeks and remeasure their biomarkers. The investigators expect that 75-100% of the mothers of both groups will respond to this improved prenatal supplement.

Eligibility Criteria:
Mothers of children with autism (age 3-5) or typically-developing children (age 3-5) who are not currently taking prenatal vitamins/multivitamins.
Brief Influenza Vaccine Education to Pregnant Women

The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* 18 years of age or older
* in at least the second trimester of pregnancy
* Cantonese speaking
* Hong Kong resident
* no serious medical or obstetrical complications
* have not yet received the influenza vaccine in this pregnancy
* staying in Hong Kong for at least two weeks after delivery.

Exclusion Criteria:

* not entitled to health benefits in Hong Kong (NEP)
Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery

The purpose of this study is to determine whether separate- versus same-day preoperative consultation affects time to treatment (start to finish), utilization rate of Mohs, rate of case cancellations, cost, and patient satisfaction. The investigators hypothesize that patients with same-day preoperative consultation will have a shorter time between cancer diagnosis and removal but, only when coordination of care is needed, longer time between removal and consultation with other specialists, as compared to patients with separate-day consultation. The investigators anticipate that patients with same-day preoperative consultation will have a decrease in travel cost as compared to patients with separate-day consultation. The investigators expect that there will be no difference in various satisfaction matters between groups, with the exception of potentially greater convenience reported by patients in the same-day preoperative consultation group. Finally, the investigators hypothesize that there will be no difference between groups in regards to rates of surgery cancellation.

Procedure: Prospective trial which randomly assigns patients to either separate- or same-day preoperative consultation for Mohs surgery. A phone consultation will take place, which will assist in determining whether the patient is appropriate for enrollment into the study. If so, the patient will be randomized to either separate-day or same-day preoperative consultation.

Materials: Patient survey

Methods of data collection: The patient-specific data obtained from the medical record will include: Patient age, number of previous skin cancers, preoperative size, history of cutaneous surgery, employment status, and distance between home address and dermatology facility. Outcome measures that will be obtained from the medical record will include: Time between cancer diagnosis, removal and defect repair, rate of proceeding with Mohs as opposed to other treatment options, and rate of cancelling surgery (due to site discrepancy, anticoagulation issues). A survey will be used to assess patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer

Exclusion Criteria:

* Patients would be excluded if there is a lack of indication for Mohs
* Significant comorbidities, or
* In the case of a high-risk location or tumor size, for which in advance it is known that they will need consultation with other specialties
5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

In the treatment of lateral epicondylitis, 5% dextrose prolotherapy is aimed to be more reliable than 15% prolotherapy in terms of side effects and to show that it is similar in terms of efficacy in treatment.

For this prospective randomized controlled study, volunteer patients who met the inclusion criteria and applied to the Health Sciences University, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Outpatient Clinic will be included in the study. Participants who volunteered for the study will be divided into study groups and control groups by stratified randomization. A total of 26 volunteers will be recruited.

A solution to be used for prolotherapy is containing 30% dextrose, 2% lidocaine, and physiological saline.

In the beginning, all patients were asked about gender, age, body mass index, education level, occupation, duration of complaint, dominant side and affected extremity, previous treatments, and when the last treatment was applied.

Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week.

Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.

Patients in the control group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose, initially (0.) Week 3 and Week 6. The injection will be made with the same method as the study group.

Measurements; will be evaluated at baseline (week 0), immediately after treatment at Week 3, Week 6, and Week 12.

Patients; In the evaluation of the visual analog scale (VAS), quick Disabilities of the Arm, Shoulder and Hand (QDASH), Grip strength, hand dynamometer measurements, and adverse events during the study period will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Pain score ≥3 according to VAS for more than 3 months in the lateral elbow joint
* tenderness on palpation over the lateral epicondyle
* Positiveness in at least two of the tests specific to lateral epicondylitis(LE) (Mills test, resistant middle finger extension and cozen test),
* \> 20 years old , \< 60 years old

Exclusion Criteria:

* Patients who received physical therapy modalities and/or steroid injections in the last 3 months,
* Having a history of malignancy,
* Pregnant cases,
* Those who have bone and joint diseases in the neck, shoulder and elbow,
* Patients with infection in the treatment area,
* Patients with arrhythmia or pacemaker in the heart,
* Patients receiving coagulation disorder or anticoagulant therapy,
* Those with local dermatological problems,
* Patients with a history of surgery in the elbow joint,
* Having a tendon tear
* Presence of nerve involvement
* Lack of cooperation and refusal to participate in the study due to cognitive dysfunction
Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan

Seroprevalence of pertussis among older children and adolescents in Kazakhstan: A cross sectional study.

Justification: to describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) in a population aged 10-18 years old according to sociodemographic characteristics, vaccination history, and risk factors of pertussis infection.

Pertussis due to infection with Bordetella pertussis (B pertussis) is a well-known cause of persistent cough primarily affecting infants and young children. Repeated administration of the vaccine is often needed to reduce the disease burden and control its transmission. At this time, no data are available on the epidemiology of pertussis in adolescents and adults in Kazakhstan.

The aim of the present study is to estimate the prevalence of pertussis infection in different age groups in Kazakh children and adolescents using the anti-pertussis toxin (PT) antibodies (IgA and IgG) as specific marker of pertussis infection or vaccination. The serosurvey will be conducted in 4 different regions: Aktobe, Karaganda, Taldykorgan, and Shymkent.

Participants (≥ 10 years \& \< 19 years) attending the study centers will be asked to participate in the study. The adolescent participants and the parents/guardian(s) of all participants will be informed about the procedures and data handling. Written informed consent from one parent/guardian needs to be obtained by the physician before any blood samples can be taken.

Upon obtaining informed consent for participant parent/guardian, the study coordinator will complete an investigation form (IF) for each participant and collect serum samples. The specimens will be coded by a unique participant number and delivered to the laboratory in charge of the assay. The specimens will be used for serological analyses.

Eligibility Criteria:
Inclusion Criteria:

10-18 years old

* Informed consent obtained from parents or guardian(s) and assent from patient.
* Enrollment following a visit at the study center.
* Documented vaccination history

Exclusion Criteria:

Inclusion criteria:

* 10-18 years old
* Informed consent obtained from parents or guardian(s) and assent from patient.
* Enrollment following a visit at the study center.
* Documented vaccination history

Exclusion criteria:

* ≤10 years and ≥ 19 years
* Pertussis immunization during the last 12 months
* No informed consent obtained from one parent or guardian.
* Immunocompromised patients
* Patients with acute infectious diseases
Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury

The retrospective study investigates the part of responsibility of neuromuscular disorders associated with chronic hemiparesis in walking impairment.

After injury to the central nervous system, walking disorders are associated with complex neuromuscular mechanisms that alter the direction and intensity of the descending control, reflex reactions to kinematic changes and the mechanical components of soft tissues. The dissociated analysis of these mechanisms and their interactions during multi-segmental movements and especially during walking is poorly described. However, a quantified assessment of the responsibility of each of the neuromuscular mechanisms in the functional disorder would guide the choice of treatments. 3D gait laboratories provide kinematic data from synchronized walking to surface electromyograms as part of additional assessments to assist in the follow-up of patients with chronic hemiparesis. Retrospective analysis of these data would help to better characterize muscular activation disorders and passive resistance to movement during walking in this population.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Person who performed tridimensional gait analysis in laboratory
* Person who had a stroke at least 6 months before the gait analysis

Exclusion Criteria:

* Any other neurological pathology or gait disorders
* Botulinum toxin injection in the last 3 months before the gait analysis
Coaching in Childhood Asthma

Asthma among low-income, minority children remains a prime example of health disparities that are resistant to change. Demonstrations of reductions in disproportionate hospitalizations in controlled trials are limited. We performed a controlled clinical trial of an Asthma Coach to reduce hospitalizations among low-income, African American children.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of children with asthma 2-8 years of age and hospitalized for an acute exacerbation, with Medicaid insurance, and living in St. Louis City

Exclusion Criteria:

* Other respiratory disease present
Bioabsorbable Versus Durable Polymer Drug Eluting Stent (DES): a Meta-analysis

Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease.

Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Previous studies suggested that BP-DES are at least as effective as durable polymer drug eluting stents (PP-DES). Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease. Medline and Web databases were searched for studies comparing BP-DES and PP-DES for obstructive coronary disease, reporting rates of overall mortality, target lesion revascularization (TLR), myocardial infarction (MI), binary restenosis and late lumen loss (LLL) with a follow-up ≥ 6 months. Odds ratios (ORs) will be computed from individual studies and pooled according to a fixed effect (e.g. inverse variance weighting) or random effect model in case of statistical heterogeneity. Given the a priori heterogeneous nature of the observational analyses, separate subgroup analysis of studies with PLA bioabsorbable polymer loaded with biolimus A19 (BP-BES) is prespecified.

Eligibility Criteria:
Inclusion Criteria:

* randomized studies
* studies reporting clinical outcomes as overall death and/or acute myocardial infarction and/or late stent thrombosis (ARC definition)\[\*\*\] and/or target lesion revascularization and/or late lumen loss
* follow up period longer than 6 months.

Exclusion Criteria:

* duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)
* inability to compute risk estimates due to absence of clinical event in one of the groups
* studies presenting composite major adverse cardiac event (MACE) and not individual end points.
Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer

This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.

All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor.

Induction preoperative therapy:

* Bevacizumab
* Trastuzumab
* ABI-007
* Carboplatin

Postoperative Adjuvant Therapy:

* Bevacizumab
* Trastuzumab

Eligibility Criteria:
Inclusion Criteria:

* Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
* Clinical stage T 1-4, N 0-3, M0
* FISH+ HER2 gene amplified breast cancer
* 18 years or older
* Normal cardiac function
* Performance status 0-2
* Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
* Previous diagnosis of noninvasive breast cancer is OK.
* Must have adequate bone marrow, renal and liver function.
* Pregnant or lactating females not allowed.
* Preexisting peripheral neuropathy must be equal to or less than grade 1
* Must have archived tumor tissue for tissue testing.

Exclusion Criteria:

You cannot be in this study if you any of the following:

* History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure
* Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
* No prior investigational drug within the last 30 days
* No prior trastuzumab or bevacizumab therapy

There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons.
Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata

The purpose of this study is to look at the safety, as well as the efficacy of hair transplantation compared with irritation with hypodermic needles in the treatment of subjects with refractory alopecia areata.

With this study, the investigators hope to demonstrate that trauma is just as effective as hair transplant in the treatment of recalcitrant alopecia areata of the scalp.

Alopecia areata is a recurrent, non-scarring type of hair loss that can affect any hair-bearing area. This disorder can present in many different manners. Though medically benign, alopecia areata can result in severe emotional and psychosocial stress in affected individuals. This disease can be treated by hair transplantation.

Hair transplantation is a procedure in which donor hair follicles are harvested from a section of a patient's scalp, and transplanted in another bald recipient area, at which time it will take root and continue to grow. Hairs generally continue to grow indefinitely

During this study, subjects with alopecia areata will have one area (or ½ of a large area) treated by hair transplant and another (or the other ½) treated by simple irritation with a large gauge sterile hypodermic needle.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have recalcitrant, quiescent, alopecia areata, non-responsive to treatment, for at least 6 months.
2. Subject must have one patch of alopecia areata greater than 5 cm diameter, of two patches of alopecia areata, each greater than 2.5 cm diameter.

Exclusion Criteria:

1. Subjects with active, progressive, alopecia areata.
2. Subjects who are actively experiencing significant spontaneous regrowth of terminal hair.
3. Subjects with autoimmune deficiency.
4. Subjects with a medical condition contraindicating use of anesthesia.
Irbesartan, Ciprofibrate and Their Combination Onto the Endothelial Functions

The rationale of the study is to clarify whether the supplementation of irbesartan with ciprofibrate could increase the antihypertensive effect, could improve the endothelial functions, and/or could affect the atherogenic small-dense LDL-, oxydized LDL concentrations, onto the paraoxinase activity and on the CRP and insulin levels.


Eligibility Criteria:
Inclusion Criteria:

* hypertensive + dyslipidemic + damaged endothelial function

Exclusion Criteria:

* hepatic and kidney damage,
* IDDM (Insulin Dependent Diabetes Mellitus)
* Freckson V type hyperlipoproteinaemia

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.