cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Long-Acting Muscarinic Antagonists in COPD

In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients.

In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3).
* On inhaled corticosteroids / long-acting beta agonists
* FEV1 30-80% predicted and FEV1/FVC \<70%.
* Smoking history ≥10 pack-years.
* Ability to give informed consent
* Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being

Exclusion Criteria:

* Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis
* A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required)
* Any clinically significant medical condition that may endanger the health or safety of the participant
* Known or suspected sensitivity to/intolerance of investigational medicinal product
* Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
* Pregnancy or lactation
* Unable to comply with the procedures of the protocol
Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit

The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.

The epidural space can be confirmed by loss of resistance (LOR) technique. However, LOR has very low specificity, although its sensitivity is high. Especially, cysts between ligaments, clefts in ligamentum flavum, paraspinal muscle and nonspecific spaces between muscles make false LOR.

Epidural wave form analysis (EWA) is very simple and reliable method which can substitue the LOR technique. If the epidural needle is located correctly in the epidural space, the investigators can observe a pulsatile wave and this pulsatile wave corresponds to arterial wave. Generally, sensitivity of EWA through needle is known to be superior to the sensitivity of EWA through catheter and most studies were focused on catheter EWA.

Cervical epidural space shows high false LOR rate and Lee et al demonstrated that false LOR at cervical epidural space was 68.7%. Therefore, nonspecificity of LOR technique require substitution method which can confirm epidural space.

Eligibility Criteria:
Inclusion Criteria:

* Cerivical Herniated nucleusus
* Cerivical spinal stenosis
* acute herpes zoster

Exclusion Criteria:

* Coagulopathy
* Infectious cervical disease
* Pregnancy
Planning for SUCCESS

Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and Suppression) is a project to improve the connection to community care for HIV infected persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.

Hypothesis: Participants who receive the intervention will be more likely to link to medical care after jail release than similar participants who do not receive the intervention.

Rationale and objective: This project aims to make sure HIV positive persons leaving jail maintain medical care. Case managers will use strength based case management and phone texting technology to improve release's connections to care in the community.

This study will have extensive tracking of outcomes. The key outcome will be whether HIV infected participants receiving an intervention experience suppression of their viral load after release from jail . The investigators wish to demonstrate the ability to recruit participants into the SUCCESS intervention and repeatedly check community medical records to see how well their infection is being controlled after they linked to care. Investigators also want to conduct a survey at baseline, 3 months and 12 months.

Investigators will compare the viral load of participants receiving the intervention to participants passing through the jail who do not receive the outcome.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected (HIV+); age of or over 18 years;
* Mentally able to give consent; understand spoken English;
* Detained or sentenced in either the Fulton County Jail or the Atlanta City Detention Center; and
* Likely to leave within 6 weeks

Exclusion Criteria:

* Unable to give consent because of mental illness or inebriation;
* A recent participant in a randomized trial conducted by the investigators of an intervention to increase retention in HIV care (e.g., ARTAS)
Resistance Training and Milk Supplementation

Post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains.

The investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men.

The aim of this investigation was to compare the effects of high protein milk supplementation (daily and after training sessions) during 6 weeks of resistance training on skeletal muscle regulatory markers, hormonal responses and body composition in resistance-trained men. Specific aims of the study are to:

To investigate the extent to which high protein milk supplementation will improve anabolic factors, lean body mass, fat mass and decrease catabolic markers after 6 weeks of resistance training in resistance-trained men.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-35 years of age
* Healthy Males
* Experienced at resistance training (at least 1 year of prior structured resistance training 3 x week).

Exclusion Criteria:

* smoking
* chronic alcohol consumption
* having any medical issues and diseases
* lactose intolerance
* the consumption of any dietary supplements (including vitamins or protein supplements) or medications for 6 months prior to participation
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)

This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose, study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is designed to determine the proportion of patients with a platelet count =50,000/µL after 42 days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count at day 22.

A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of SB-497119-GR, a thrombopoietin receptor agonist, administered at 30, 50, and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenia purpura

Eligibility Criteria:
Inclusion criteria:

* Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count.
* Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
* Normal PT and PTT.

Exclusion criteria:

* History of clotting disorder.
* Females who are pregnant or are receiving hormone replacement therapy or systemic contraceptives.
* History of alcohol/drug abuse or dependence within 1 year.
* Use of aspirin, aspirin-containing compounds, salicylates, antacids, rosuvastatin, pravastatin, non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.
* History of HIV infection or active infection with Hepatitis B or C.
Obstructive Sleep Apnea and Diabetes Mellitus

The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve glycemic control and vascular function in OSA patients with type II diabetes mellitus. This study aims to investigate the therapeutic effects of nCPAP on glycemic control and vascular function in patients with OSA and type II diabetes mellitus.

Obstructive sleep apnoea (OSA) has been reported to be common (17%) in patients with diabetes mellitus (DM). Both OSA and DM are highly associated with cardiovascular morbidity and mortality. There is growing evidence that OSA may trigger or worsen pre-existing adverse metabolic profile indicative of cardiovascular risk. Treatment of OSA with nasal Continuous Positive Airway Pressure (nCPAP) has been shown to reduce blood pressure and hence to reduce the risk of atherogenesis. In patients with DM, the therapeutic effect of nCPAP is still not known, it would be important to delineate any independent effect of OSA on DM and the therapeutic effect of nCPAP on glycemic control to reduce the long term risk of macrovascular and microvascular complications.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with type II DM on a stable medication regimen (on diet / oral hypoglycaemic agents / insulin injections)
2. Age 25 - 70 years
3. HbA1C \> 7%
4. AHI \>= 15
5. Able to give written informed consent

Exclusion Criteria:

1. Patients with severe co-existing illness or poor functional performance
2. Patients with peripheral vascular diseases, vasculitis / Raynaud's syndrome or thrombocytopenia
3. Sleep disorders other than OSA
4. Patients who refuse nCPAP treatment for OSA
5. Excessive sleepiness causing potential harm (e.g. driver)
6. HbA1C \>=7%
7. Habitual drinker (defined as more than 3 times a week)
8. Pregnant or lactating women
Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

The investigators intend to test in a single center, clinical pilot efficacy study the primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled pharmacotherapy is efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale (HAMD).


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with a major depressive episode (MDE) according to DSM-IV Diagnosis Criteria derived from the SCID.
* Patient has not had an acceptable clinical response due to failure (resistance) with at least two treatments from different treatment categories during the current MDE.
* Patient has a score ≥ 20 on the 24-item Hamilton Rating Scale of Depression.
* Patient is able to give his informed consent to participate in this study and he is able to fulfill the requirements of the study.
* Patient is a male or nonpregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
* Convulsive therapy clinically indicated

Exclusion Criteria:

* Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnesia, or other cognitive disorders per DSM-IV.
* Patient has had or has currently a diagnosis of non-affective psychotic disorder per DSM-IV.
* Patient has had alcohol or substance dependence within the previous 12 months or abuse within the previous six months other than nicotine dependence or abuse.
* Patient has a history or diagnosis of clinically relevant cardiac disease.
* Patient has a history or diagnosis of clinically relevant injury or disease of the central nervous system.
* Patient has magnetic material in the head.
* Patient has implanted medical devices such as cardiac pacemaker, vagus nerve stimulator, medical pumps etc.
Promoting The Self-Regulation Of Energy Intake

The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.

The intervention program was developed and piloted. Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions). Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the BMI percentile range. No parental BMI effects are expected.

Eligibility Criteria:
Inclusion Criteria:

* Parents whose children attend Head Start with the sample of children equally split on gender and ethnicity,
* with representation from ages 3 to 6 years.

Exclusion Criteria:

* Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.
Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants

Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula with high proportion of palmitic acid in the sn-2 position.

Design \& setting: A single-center, open label study. A breast fed group will serve as reference. The study will be conducted in Guangzhou from 2010.1\~2010.12.

Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in each group. They are required to be healthy, term-infant, and with normal birth weight, and have no medications known to affect their growth and development.

Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for at least 3 month.

Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool characteristics questionnaire, general health examination, and behavior and habit questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.

Statistical analysis: t-test, rank test and chi-square test will be used to examine the significance of change from baseline to follow-up visit between the formula-fed and breast-fed groups for effectiveness measures


Eligibility Criteria:
Inclusion Criteria:

* Parental/legal guardian written informed consent.
* The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
* Term infant of Chinese origin born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal Unltra-Sound (US) and/or physical examination.
* Birth weight appropriate for gestational age (AGA), 2500-4000g (between 10th\~ 90th percentile of body weight at same gestation age).
* The infant is apparent healthy at birth and entry to study.
* Apgar after 5 minutes \>7.
* Enrolled within their first 14 days after birth.
* The infant is a product of normal pregnancy and delivery including C-section.
* Patental ability to attend visits, interviews and willing to fill questionnaires.

Exclusion Criteria:

* Mother health condition: (psychological of physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant.
* The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth.
* The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
* The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
* The infant is a carry of HBV (HBsAb positive).
Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis

Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory response. Since MMP-8 can be used as a predictive biomarker for treatment response; our research aimed to investigate clinically the effectiveness of intra-pocket application of Cymbopogon citratus (lemongrass oil) gel and biochemically on MMP-8 levels in gingival crevicular fluid (GCF) of stage II periodontitis patients.

Methods: A randomized controlled clinical trial was conducted on forty patients with stage II periodontitis, divided equally into two groups. Group-I (test) was managed by SRP with intra-pocket application of 2% lemongrass oil gel. Group-II (control) was managed by SRP with intra-pocket application of a placebo gel. Periodontal pocket depth (PPD) and clinical attachment loss (CAL) were measured for both groups, before treatment and twelve weeks after. Moreover, GCF was collected from both groups at baseline, one week, and twelve weeks after treatment. Then analysed by Enzyme-linked Assay (ELISA) technique.


Eligibility Criteria:
Inclusion Criteria:

* systemically healthy individuals of both sexes having moderate periodontitis (stage II), CAL 3-4mm, with an age ranging from 25 to 45 years old.
* patients with no history of previous periodontal therapy or taken any antibiotic therapy for the past six months

Exclusion Criteria:

* history of smoking, previous adverse reaction to the products (or similar products) used in this study, grade C category that has rapid rate of progression, and pregnant or lactating women
CES1 Crossover Trial of Clopidogrel and Ticagrelor

The purpose of this investigation is to evaluate when genetic variation in the carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor. We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel platelet aggregation while having a minimal effect in ticagrelor-treated subjects.

Specific Aim: To conduct a prospective randomized crossover study of clopidogrel and ticagrelor in healthy individuals stratified by CES1 genotype. Participants will be recruited by CES1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet aggregometry performed pre- and post-drug administration in order to assess the interaction of genotype and drug choice on on-treatment platelet function.


Eligibility Criteria:
Inclusion Criteria:

* Of Amish descent
* Age 18 to 75 years
* Participant in the Phamacogenomics of Anti-Platelet Intervention (PAPI-1) Study or other Amish Research Center study, or a family member of an Amish Research Center study participant.

Exclusion Criteria:

* Clopidogrel or ticagrelor allergy
* Platelet count \< 100,000 mm3 or \> 500,000 mm3
* Hematocrit (Hct) \< 32% or \> 50%
* Blood pressure \> 160/95 mm Hg
* Co-existing malignancy
* Creatinine \> 2.0 mg/dl
* Aspartate transaminase (AST) or alanine transaminase (ALT) \> 2 times the upper limit of normal
* Thyroid-stimulating hormone (TSH) \< 0.40 or \> 5.50 mU/L
* Pregnant or breast feeding
* History of gastrointestinal bleeding, a major life-threatening bleeding event, active pathological bleeding, bleeding diathesis, or coagulopathy
* History of stroke or transient ischemic attack, deep vein thrombosis, or atrial fibrillation
* History of myocardial infarction, coronary artery bypass surgery, unstable angina, or angioplasty
* History of sick sinus syndrome, 2nd or 3rd degree atrioventricular block, or bradycardia-related syncope
* Type 1 or Type 2 diabetes mellitus
* Surgery in the past 3 months or planned surgery in the next 3 months
* Participant cannot willingly and safely discontinue medications that, in the opinion of the study physician would affect the outcomes to be measured for at least 1 week prior to study initiation through completion of the study
* Participant is unwilling to discontinue taking vitamins and/or supplements that, in the opinion of the study physician would affect the outcomes to be measured for 1 week prior to the study initiation through the the completion of the study
* Any other condition that would place prospective participants at unacceptable risk or render them unable to meet the requirements of the protocol in the opinion of the site investigator