cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial in Males With BPH (Enlarged Prostate)

A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH.

* Free study-related medical care provided.


Eligibility Criteria:
* Has been suffering for at least 6 months with any of the following symptoms:
* daytime or nighttime urinary frequency
* urgent feeling to urinate
* difficulty starting urinary stream
* interruption of urinary stream
* feeling of incomplete urination
* Has not had a previous episode of acute urinary retention
* Has not been diagnosed with prostate cancer
* Has not had previous prostate surgery
* Is not an insulin-dependent diabetic
A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150

Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability.

The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process.

The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months.

Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study.

Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* 12 to 62 years-of-age
* History of moderate or severe congenital hemophilia A or B with inhibitors to FVIII or FIX
* 4 or more bleeding episodes in the last 6 months before enrollment.

Exclusion Criteria:

* Clinically relevant coagulation disorder other than congenital hemophilia A or B with inhibitors
* History of coronary and/or peripheral atherosclerotic disease
* Disseminated intravascular coagulopathy, or stage 2 hypertension
* Angina pectoris
* Myocardial infarction
* Transient ischemic attack
* Stroke
* Congestive heart failure
* Thromboembolic event
Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
* Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
* Ability to comply with the study requirements
* Negative pregnancy test (Females)
* Healthy post-auricular skin for biopsy

Exclusion Criteria:

* Excessive dermatochalasis of the treatment area
* Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
* Total area to be treated exceeds 20 cm in length
* Physical attributes which may prevent assessment or treatment as judged by the evaluator
* Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
* Previous treatment with the sponsor's product
* History of active autoimmune disease or organ transplantation
* Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
* Active or chronic skin disease
* Known genetic disorders affecting fibroblasts or collagen
* Active systemic infection
* Requires chronic antibiotic or steroidal therapy
* Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
* Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
* Known allergic reactions to agents used in preparation of treatment
* Excessive exposure to sun without adequate sun protection
Gastric Acid Rebound Secretion Measured by Alkaline Tide

Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the Western population. These millions of patients are treated continuously with PPI for different periods, many for many years. Recently, rebound acid hypersecretion was recognized as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to daily PPI therapy causes increased acid-secretory capacity that appears when the drug is stopped. The transient increase in blood and urinary pH following gastric secretion has been termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral chloride bicarbonate exchanger. The investigators have shown in several studies that this phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal increased base excess maximally after 45 minutes and these changes parallel peak acid output measured in gastric aspirate. The investigators hypothesize that gradual step down cessation of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI cessation the investigators may prove this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Dyspepsia and reflux patients older than 18

Exclusion Criteria:

* patients on PPI, patients with severe diseases, younger than 18 y, older than 80 y, un-cooperative, COPD, uncompensated IHD, CRF
PFMT Educational Intervention for Patients With Advancer Breast Cancer

A PFMT educational intervention was designed for women with metastasic breast cancer. It consisted in a 120 min workshop and 8 weeks of non-supervised (but with follow-up) self-training. ICIQ, IQOL and ad hoc questions were performed before the workshop and after the 8 weeks training to see the prevalence of UI, the impact in their quality of life and the empowerment of self-training.

Urinary incontinence (UI) affects women of all ages and has a great impact on the quality of life. Cancer treatments such as chemotherapy or hormone therapy may play an important rol in the development and worsening of pelvic floor disorders. Little evidence on the prevalence and impact of UI in metastassis breast cancer women is known.

A protocol was designed to analyze the effect of a PFMT educational intervention on the UI and the impact on the QoL, as well as in the empowerment feeling of the participants. Feasibility of the protocol will be analized to design an optimal RCT for testing our hypothesis

During the usual visits, oncologist wil recruit women with advanced breast cancer who meet the inclusion criteria for the participation.

Eligibility Criteria:
Inclusion Criteria:

* Advanced breast cancer
* Over 18 years old
* ECOG≤2
* No inestable bone metastasis
* life expentancy\>6 months
* Literate in spanish

Exclusion Criteria:

* Physical exercise contraindications
* Intense pain
* Being pregnant
Working on Rapid Language Development in Toddlers

The goal of the study is to examine the effects of teaching parents to use language support strategies on language skills in toddlers with language delays. We hypothesize that children whose parents who learn to use language support strategies at home will have greater language skills than those children whose parents do not learn the strategies.

The goal of the proposed project is to conduct an efficacy trial to determine whether Enhanced Milieu Teaching (EMT) significantly improves language deficits in young children at high risk for persistent language delays. The target population is children ages 24 -36 months who exhibit significant co-occurring delays in productive and receptive language skills, who have cognitive skills within the range of normal development, and who do not have other identified disabilities. An empirically based and manualized language intervention, Enhanced Milieu Teaching (EMT), implemented by therapists and parents will be compared to community based "business as usual" services in a randomized experiment enrolling 120 children and their parents. Children assigned to the EMT group will receive 24, 1-hour sessions of direct intervention at home that will include teaching their parents to implement EMT procedures across activities. Children will be assessed at 4 time points (before and after intervention, at 6 months and 12 months post-intervention) allowing the description and comparison of individual language growth trajectories over a period of 18 months. In addition, we will examine the relation between language growth and emergent problems in behavior and social skill development to determine whether early language intervention can prevent these difficulties frequently associated with early language delays. Results from this study will determine the efficacy of parent-plus-therapist implemented EMT with a new population of children, provide evidence about the potential for preventing persistent language delays and secondary social effects of early language delays, and expand developmental theory linking persistent language delays to specific risk factors and behavioral outcomes. The results of this study will have specific policy implications related to early identification and the inclusion of young children with language delays as a target population for early intervention.

Eligibility Criteria:
Inclusion Criteria:

* Language delay

Exclusion Criteria:

* Hearing loss
* Language other than English as the home language
* Additional disabilities (e.g., autism, Down syndrome)
The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target

Objectives:

1. Decreased variability of Hgb
2. Increase the % of patients in target range c Increase in time that Hgb remains target range

Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below.

Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.

Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP.

The individual AMP will be utilized weekly during the 9 months of Phase 2.

The 3 objectives will be evaluated and updated weekly, Baseline to Year 1.

All Epo dosing recommendations must be reviewed by the treating physician who can either accept or modify doses at his/her discretion based on clinical event that are not includes in the transmitted data such as bleeding, infection, and hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Receiving hemodialysis in an out-patient dialysis unit

Exclusion Criteria:

* Not receiving EPOGEN as part of their standard medical care
* Patient refusal
Protecting Pregnant Women From Infectious Diseases

The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.

The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza vaccine and/or Tdap vaccine before delivery. A secondary research aim assesses whether the comprehensive package improves maternal knowledge, attitudes, and beliefs regarding maternal and infant vaccination. The intervention package will include evidence-based components aimed at the practice-level, provider-level, and patient level and will be tested through a cluster-randomized trial design. The primary outcome measure is influenza vaccine receipt during pregnancy. The secondary outcomes include 1) receipt of pertussis (Tdap) vaccination during pregnancy, and 2) changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination. The primary hypothesis is that implementation of a comprehensive vaccine promotion package in the obstetric setting will increase the likelihood that a pregnant woman receives an influenza and/or pertussis vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 - 50
* Currently pregnant
* Unvaccinated with 2012 - 2013 seasonal influenza vaccine
* Unvaccinated with Tdap vaccine during current pregnancy

Exclusion Criteria:

* Under 18 years of age or over 50
* Not currently pregnant
* Previous receipt of 2012 - 2013 seasonal influenza vaccine
* Previous receipt of Tdap vaccine during current pregnancy
* Does not speak English
Minimum Effective Volume of Lidocaine Costoclavicular Brachial Plexus Block

The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.

The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular ICB. Determination of the minimum effective volume of LA is important because it prevents the administration of an unnecessarily large (and potentially toxic) dose. Furthermore, when multiple blocks need to be performed at the same time in the same patient, knowledge of the minimum effective volume allows to the operator to preserve efficacy without sacrificing safety for each block.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 30

Exclusion Criteria:

* adults who are unable to give their own consent
* pre-existing neuropathy (assessed by history and physical examination)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
* allergy to local anesthetics
* pregnancy
* prior surgery in the infraclavicular region
* chronic pain syndromes requiring opioid intake at home
Metabolic Response of Intestinal Microbiota to Guar Gum Consumption

Some components of the diet are not absorbed in the small intestine and pass into the colon, where they may be fermented by the microbiota, releasing gas. A series of recent studies suggest that some non-absorbable, fermentable meal products (prebiotics) serve as substrate to colonic bacteria and change their composition, thereby producing beneficial effects to the host. These products are fermented by bacteria and at initial intake increase gas production; however, after 7-10 days administration some prebiotics induce an adaptation of intestinal microbiota towards more efficient metabolic pathways with less gas production. Hence, intestinal gas production may serve as an index of microbiota metabolic activity. Gas production may induce gas-related symptoms, such as flatulence, abdominal bloating and distention, and the symptoms improve when the microbiota adapts to the prebiotic and gas production declines. Guar gum is classified as a fiber, but it remains uncertain whether and to what extent it is fermented by colonic microbiota and whether it has prebiotic properties. Aim: to determine the metabolic reaction of intestinal microbiota in response to guar gum consumption, specifically, the extent of initial fermentation and subsequent adaptation.Design: Single-centre, single arm, open label, proof-of-concept study testing the effect of guar gum on microbiota metabolism and adaptation in healthy subjects Intervention: guar gum (8 g/d) will be administered for 18 days. Outcomes: during 4 days immediately before, at the beginning and at the end of the administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) perception of digestive sensations by daily scales; c) microbiota composition by fecal analysis; d) metabolites in urine.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* gastrointestinal symptoms
* recent (3 months) antibiotic intake
* change in dietary habits 4 weeks before
Optimisation and Quantification of Contrast Enhanced Computed Tomography Myocardial Fibrosis Imaging

Detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart conditions. Magnetic resonance imaging (MRI) can assess scarred heart muscle but it is time consuming, contraindicated for some patients and not tolerated by others. Computed tomography (CT) imaging has the potential to provide a rapid comprehensive assessment of the heart. This study will assess CT imaging of the heart muscle of patients who have previously undergone MRI of their heart. Using a state of the art CT scanner the investigators will develop a low radiation dose protocol to identify scarred heart muscle. The investigators will use and develop software techniques to analyse these images. This will enable us to develop a new way to identify and measure scarred heart muscle that will benefit patients with heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Presence of late enhancement on magnetic resonance imaging

Exclusion Criteria:

* age less than 40
* inability or unwillingness to undergo CT
* renal failure (serum creatinine \>200 umol/l or estimated glomerular filtration rate \<30 ml/min)
* hepatic failure
* allergy to iodinated contrast
* pregnancy
* breast feeding
* inability to undergo informed consent
* fast atrial fibrillation
Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON)

The overall objective of the proposed research is to test the hypothesis that Near-infrared Light-emitting Diode (NIR-LED) therapy will stimulate mitochondrial function, attenuate oxidative stress, and improve cell survival and vision in subjects with Leber's Hereditary Optic Neuropathy (LHON).

To determine the effects of short term (3 month) near-infrared light NIR-LED therapy on anatomic and functional abnormalities of LHON as assessed by a wide variety of ophthalmologic tests, including visual acuity, optical coherence tomography, pattern electroretinography (pERG) N95 retinal ganglion cell peak, fERG-PhNR (flash ERG - Photopic Negative Response), and fundus photography.

Eligibility Criteria:
Inclusion Criteria:

* Sex - male and female. Men are affected with visual loss more frequently than women, with a male predominance of \~85%. A minimum of 25% of men and 5% of women at risk for LHON experience visual loss.
* Age - 18 years or older. The onset of visual loss typically occurs between the ages of 15 and 35 years, but otherwise classic LHON has been reported in many individuals both younger and older, with a range of age at onset from 2 to 80 years.
* Diagnosis of LHON or a carrier of the gene mutation. Patient must be evaluated by molecular confirmation, with the 11778 and other mutations of Leber's Hereditary Optic Neuropathy stratified in later data analysis.
* Able \& willing to provide informed consent

Exclusion Criteria:

* Has an optic nerve disease other than LHON.
* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Participation in an investigational trial within 30 days of NIR-LED treatment that involved treatment with any drug that has not received regulatory approval at the time of study entry. (Note: subjects cannot receive another investigational drug while participating in the study during the first 6 months.)
* Major surgery within 28 days prior to participation or major surgery planned during the next 6 months. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40
* Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome
Modes of Ventilation During Laparoscopic Bariatric Surgery

During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and increase closing capacity resulting in increased resistance, decreased compliance, and increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to determine which is better able to support oxygenation and ventilation while limiting the peak inflating pressure (PIP).


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years.

Exclusion Criteria:

* None