cyrilzakka/clinical-trials huggingface dataset:
Treatment of Bacterial Vaginosis Combined With Human Lactobacilli

The primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.

Nine of the vaginal Lactobacillus strains isolated from healthy Swedish women and characterized in the present study were selected for the clinical trial.All women with symptomatic BV fulfilling the inclusion criteria were consecutively offered to participate in a prospective study of adjuvant lactobacilli given in addition to antibiotics. Women included were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections. Exclusion criteria were patients with hormonal intrauterine device without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection.

Eligibility Criteria:
Inclusion Criteria:

* were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections.

Exclusion Criteria:

* Exclusion criteria were patients with hormonal IUD without regular menstruation; women infected with Chlamydia trachomatis or with Trichomonas vaginalis, or with a clinical candida infection
Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee

The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee
* Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices
* Pain score ≥40 mm of the index knee
* Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen

Exclusion Criteria:

* Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site
* Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
* Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments
* A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments
C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented congenital C1-INH deficiency
* Acute HAE attack
* Participation in base study CE1145_3001 (NCT00168103)

Key Exclusion Criteria:

* Acquired angioedema
* Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)

The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged from 22 to 65 years (inclusive).
* Smoking, healthy subject as judged by the Investigator.
* Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.
The ParkCycle Study: Aerobic Exercise in PD

The primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.

Neuroprotective therapy (i.e. therapy that slows the disease process) is an unmet medical need in Parkinson's disease (PD). Animal studies have shown that 'intensive' exercise improves motor function and may have neuroprotective properties. The promising animal results have not been translated to patients with PD so far. This is a two-cluster randomised control trial in which twenty patients (10 at each site) will undergo a 6-month exercise intervention on a stationary virtual reality bike and twenty patients (10 at each site)will serve as controls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease according to the UK Queen Square Brain Bank Criteria
* Hoehn \& Yahr disease stages I-II
* Age between 30 and 75 years
* Having insufficient physical activity according to the ACSM guideline for adults, 50-64 years old with a chronic condition
* Untreated with anti-parkinsonian medication or receiving medication, for less than two years, medication-responsive without fluctuations.

Exclusion Criteria:

* Unclear diagnosis with Red Flags
* Advanced problems in cognitive functioning: Mini Mental State Examination (MMSE)19 score \< 24
* Serious co-morbidity: neurological or orthopedic disorder that severely affects movement; known by specialist or medical practitioner
* Pulmonary diseases; known by specialist or medical practitioner
* Stroke
* High risk of cardiovascular complications:

  * Hypertension (systole \>150 and diastole \> 100)
  * Diabetes Mellitus; known by specialist or medical practitioner
  * Cardiac valve defect (especially aortic valve stenosis); known by specialist or medical practitioner
  * Cardiac rhythm disorder; known by specialist or medical practitioner
  * Heart failure; known by specialist or medical practitioner
* Use of ß-blockers
* Not able to complete American (for Cleveland site) or Dutch questionnaires (for the Nijmegen site)
* Daily institutionalized care
* Contra-indications for fMRI:

  * Pregnancy
  * Metallic implants or electronic devices
  * Previous seizure
  * Claustrophobia
  * Not able to keep the head still for longer period, i.e. due to severe head tremor
An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants

The purpose of this study is to investigate BMS-986165 given as a tablet in healthy male participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy male participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb). BMI = weight (kg)/(height \[m\])2 at screening
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.732

Exclusion Criteria:

* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening

Other protocol defined inclusion/exclusion criteria could apply
ECG AI-Guided Screening for Low Ejection Fraction

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Primary care clinicians who are part of a participating care team that care for adult patients and have the ability to order ECG and TTE (this includes physicians, nurse practitioners, and physician assistants).

Exclusion Criteria:

* Primary care clinicians working in pediatrics, acute care, nursing homes, and resident care teams.
Improving Health in Low Income Women Following the Birth of a Child

This study will evaluate a community-based program to improve diet and physical activity in women during the first 12 months following the birth of a child. The program is designed to complement existing federal programs for low-income families and is directed toward low-income, postpartum, multi-ethnic women.

The postpartum period is a window of opportunity to promote behaviors that reduce the risk of chronic disease and benefit reproductive health. The Expanded Food and Nutrition Education Program (EFNEP) is an educational program delivered by community-based paraprofessional's that aims to improve dietary and activity patterns among low income, multi-ethnic women during the postpartum period. This study will evaluate the efficacy of the EFNEP to impact the diet and activity patterns of women.

Women were recruited through the Special Supplemental Food Program for Women, Infants, and Children (WIC) and randomized to either the EFNEP group or a usual care group. Women in both groups will receive standard WIC care consisting of nutrition-risk and breastfeeding educational messages at postpartum and follow-up visits. Women in the EFNEP group participated in an additional two component intervention that included five home visits and motivational telephone calls from project staff.

Primary study outcomes were assessed at Months 1 and 12. Primary outcomes included fruit and vegetable intake, saturated fat intake, and physical activity. Secondary outcomes will include Body Mass Index and indicators of fat mass and distribution. The study will also analyze mediating and modifying factors, including social support and norms, perceived health status, smoking, television viewing, food insecurity, food and activity access, and utilization of federal programs and health care.

Eligibility Criteria:
Inclusion Criteria:

* Less than 20 weeks postpartum
* Receive services of USDA's Special Supplemental Food Program for Women, Infants, and Children (WIC)

Exclusion Criteria:

* Less than 18 years of age upon recruitment
High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.

Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours .

Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm - Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotics
* Age between 18-70 years
* Hepatic encephalopathy -Grade 3-4
* Patients receiving Lactulose/Rifaximin for 48 hours and not showing improvement in Hepatic encephalopathy(Persistent Grade 3/4)

Exclusion Criteria:

* Concomitant participation in an other clinical trial
* Patient receiving sedatives(propofol,etc) 24 hours prior.
* Patients with severe cardiopulmonary disease
* Pregnancy
* Human Immunodeficiency Virus
* Hepatocellular Carcinoma or extrahepatic malignancy
* Active uncontrolled sepsis with hemodynamic instability
* Chronic renal insufficiency on treatment with haemodialysis
* Uncontrolled bleed or patients in DIC
* Extremely moribund patients with expected survival of less than 48 hours on high vasopressor support
* Patients with moderate-severe Acute Respiratory Distress Syndrome (ARDS).
* Patients with Non Hepatic Coma.
Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste

Patients taking chemotherapeutic agents often do not comply well with their dosing regiment since many of these medications cause a metallic taste in the mouth. The primary intent is to determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth associated with various chemotherapeutic agents. This clinical study a randomized, double-blind, single-treatment, parallel design with a placebo as the control. The duration of the trial will be 1 month.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
2. Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
3. Subject is between the ages of 18 and 75 years inclusive.
4. Subject will not have professional cleaning during the 3-month trial.
5. Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
6. Subject has a minimum of 16 natural teeth and a complaint of moderate to severe medication associated metallic taste.
7. Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Colgate® Cavity Protection Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
8. Subject agrees to refrain from the use of other oral care products not supplied by the study center
9. Subject agrees to be compliant with study procedures.
10. Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.

Exclusion Criteria:

1. Subject has a condition that requires prophylactic antibiotics for dental examinations and treatments (e.g., has a history of valvular heart disease or a recently placed prosthetic joint).
2. Subject has disqualifying acute or chronic medical illness as judged by the Principal Investigator.
3. Subject is currently taking phenytoin, cyclosporin, nifedipine or any other drug that has been shown to cause gingival enlargement or affect the gingivae.
4. Subject has taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen) within one week prior to baseline examination. Subjects taking long-term aspirin (81 mg/day) may be included in the trial, but subjects taking a larger dose will be excluded. Subjects taking blood thinners such as Coumadin (warfarin), Lovenox, or Plavix will be excluded.
5. Subject is pregnant (based on pregnancy result) or lactating.
Epiduo Pediatric Acne Study

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acne vulgaris with facial involvement
* Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
* A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline

Exclusion Criteria:

* Acne nodule or acne cyst
* Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
* Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
* Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study
Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses

It is believed that imiquimod 5% cream has the potential to be an effective treatment for actinic keratoses. The purpose of this study is to evaluate the duration of the effect of topical imiquimod 5% topical cream for the treatment of actinic keratoses.

This study will assess the safety and efficacy of imiquimod 5% cream applied to actinic keratoses on the head to reduce the size of lesions. The objective is to analyze the effect of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is applied 3 times per week for 4 weeks in 1 or 2 cycles. The complete clearance rate is defined as the proportion of subjects with no clinically visible AK lesions in the treatment area at the end of cycle 1 or the end of cycle 2.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Have a total of 4 to 8 clinically typical, discrete, non-hyperkeratotic, non-hypertrophic AK lesions located within a contiguous 25 cm2 treatment area (balding scalp or face, but not both).
* Free of any significant findings (e.g. tattoos) in the potential application site area that may impair examination of treatment or surrounding area.
* Willing to eliminate tanning bed/sun parlor use for duration of study.

Exclusion Criteria:

* Evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease.
* Any dermatological disease and or condition in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (e.g. rosacea, psoriasis, atopic dermatitis, eczema).
* Confirmed SCC, BCC anywhere on the head.
* Share a household where there is a person participating in a concurrent clinical study of imiquimod or being treated with imiquimod 5% topical cream.
* Active chemical dependency or alcoholism, as assessed by investigator.
* Females who are pregnant, breast-feeding or considering becoming pregnant while on the study.
* Females with childbearing unwilling to practice an effective method of contraception, as defined by the investigator for the duration of the study as well as one month after completion.
* Received any treatment, products or procedures within the designated time period prior to the prestudy visit as listed on page 4 of the protocol (Version 03 dd March 2003).
Blood Collection Biorepository for Liver Disease Research

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

The Biorepository at the University at Buffalo has been established to collect biological samples from patients with various types of liver disease. The objectives of this biorepository are to stimulate collaboration between clinicians and researchers, to bolster training of junior investigators and to promote multidisciplinary integration to advance translational medicine and to improve the health of patients all over the country. The purpose of this biorepository is to support investigators and to provide them with high quality specimens to promote their efforts in new discoveries or perfecting treatment of patients with liver diseases caused by Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Human Immunodeficiency Virus (HIV). The goal is to obtain samples that represent patients seen in the clinics of medical centers in Western NY and from some of the rarer diseases encountered in these clinics. The ultimate goal is to develop the biorepository as Western New York's resource for clinically annotated human samples that can be used to conduct research that could lead to significant advances in patient care.

Eligibility Criteria:
Inclusion Criteria:

* This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples.
* Children and teenagers will be special populations considered in this protocol.

Exclusion Criteria:

* Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.
Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis

The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars.

The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars. Patients were clinically and radiographically examined and their eligibility assessed and preoperative pain was measured using the numerical rating scale (NRS). Patients were randomly assigned to one of 2 groups: experimental group (2% mepivacaine) and the control group (4% articaine). After 15 minutes of the inferior alveolar nerve block (IANB), patients reporting lip numbness had their molars accessed. No-to-mild pain response was considered success during root canal preparation.

Eligibility Criteria:
Inclusion Criteria:

* Patients in good health (American Society of Anesthesiologists Class I or II).
* Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
* Age range between 18 to 50 years.
* Patients who can understand Numerical Rating Scale (NRS).
* Positive patient acceptance and the ability to sign an informed consent.

Exclusion Criteria:

* Pregnant females.
* Patients allergic to articaine, mepivacaine and/or any used medication or material.
* Patients having active sites of pathosis in the area of injection.
* Patients having active pain in more than one molar.
* Patients who had taken analgesics in the 12 hours preceding treatment.