cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.


Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.
2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
3. Subjects who are medically stable.
4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
5. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.

Exclusion Criteria:

1. Subjects who have had more than 2 episodes of CDI within the last 6 months.
2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
3. GI surgery within 6 weeks before the day of randomization
4. Have known immunodeficiency disorder, such as HIV Infection
5. Pregnant or breast feeding females.
6. Concurrent acute life-threatening diseases.
7. Inability to tolerate oral liquids.
8. Have an absolute neutrophil count \< 1000/mm3 at screening
VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway

The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism in HCC growth, proliferation and apoptosis.

Several studies have documented the elevated expression of VEGF and its receptors in ICC cell lines and tumor tissues. Another study observed that the elevation of VEGF promotes the growth. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ICC cells and its possible mechanism in regulating ICC growth.Therefore,we try to clarify the mechanism of VEGF signal in ICC growth,proliferation and apoptosis.

Eligibility Criteria:
Inclusion Criteria:

1. hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma and CA199\>100U/L；or two or more dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma
2. Child-Pugh A or B
3. well preserved renal and hematopoietic Function
4. receive complete surgical therapy
5. achieve complete section accessed by contrast-enhanced CT

Exclusion Criteria:

1. incomplete section
2. Child-Pugh C
3. combination with other hepatobiliary disease
4. suffer from other tumors concurrently or in last five years
Detecting a Volume Deficit During Spontaneous Breathing

13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask fitted with an inspiratory and expiratory resistor. A brachial arterial catheter was used to measure blood pressure and thus systolic pressure variation and pulse contour analysis determined stroke volume and thereby cardiac output in order to detect a central volume deficit.

Thirteen healthy volunteers (4 women) at an age of 25 years (range 18-36) were recruited through www.forsøgsperson.dk.

The volunteers were placed on a tilt table and provided with a facemask with an opening of 30-33 mm. A Hook ring was fitted with an inspiratory resistor, an expiratory resistor, a combination of the two resistors, or with no resistance and each resistor provides a 7.5 cmH2O threshold resistance. Each resistor was applied for two minutes with variables obtained in the last minute. The table was then tilted 45° head-up to accumulating blood in the legs and therefore a reduction in the central blood volume. Conversely, 20° head-down tilt was used to expand the central blood volume. For each volunteer measurements with the four respiratory interventions was randomized, whereas the tilt table position was in fixed order: supine, head-up tilt, and head-down tilt.

Three-lead ECG recorded heart rate. A 20 G arterial catheter was placed in the brachial artery of the non-dominant arm and connected to a transducer for reading of blood pressure and stroke volume variation (Vigileo-Flotrac™, version 1.07, Edwards Lifesciences, Nyon, Switzerland). Also SV and CO variation and the arterial pressure curve were recorded for subsequent determination of arterial pressure variations. Additionally, a catheter was placed via a brachial vein to the superior caval vein for recording of central venous pressure and SvO2. While the subjects were breathing spontaneously, the respiratory rate was measured by capnography and peripheral oxygen saturation by fingerprobe.

Variation in the arterial pulse pressure (PPV) was 100 x ((PPmax - PPmin) / ((PPmax + PPmin)/2)), where PPmax and PPmin is the maximal and minimal difference between systolic and diastolic pressure during the respiratory cycle, respectively. By the same formula systolic pressure variation (SPV) was calculated.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* lactating
* any regular or acute use of medicine
Acceptability of the NuvaRing Among Students

The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.

For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* over 18
* student enrolled in college or graduate program
* Not have used the contraceptive patch or oral contraceptives within the last month
* Never have used a contraceptive vaginal ring
* Interested in using hormonal contraceptives, specifically NuvaRing and oral contraceptive pills for next 3 months
* In general good health
* Premenopausal with the ability to menstruate

Exclusion Criteria:

* Known or suspected pregnancy
* Pregnancy within 2 months of trial medication
* Past use of any contraceptive vaginal ring
* Hypersensitivity or allergy to NuvaRing or Oral Contraceptives
* Use of investigational drug within 2 months of start of trial medication
* Use of the contraceptive patch or oral contraceptives within past month
* Use of any injectable contraception within 6 months of trial medication
* Planning pregnancy in next 6 months
A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and neck) and negatively impacts survival and other outcomes, but many patients have difficulty quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far have had limited success. This is a pilot randomized controlled trial designed to determine if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates for cancer patients who smoke.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of head and neck or thoracic (including lung) cancer
* Undergoing radiation at Johns Hopkins Radiation Oncology for 5 or more weeks
* English-speaking and able to provide informed consent
* Smoked any cigarettes in previous 14 days

Exclusion Criteria:

* Palliative radiation
* Undergoing stereotactic radiosurgery
* Pregnant or breastfeeding
Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes

Breastfeeding has been associated with decreased obesity. However, this relationship is not as clear in children who have been exposed to GDM and the mechanisms involved are little known. The overall objective of the project is to study the mechanisms of breastfeeding on the growth of children in women who have had a GDM. More specifically, the project want to compare the macronutrient and hormone composition of breast milk of women with and without GDM. Investigators also want to associate the levels of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without DG and the growth of the child. A total of 60 women (30 with GDM and 30 without GDM) will collect breastmilk at 2 months postpartum.

Other data collected:

Waist circumference, DXA, Fasted blood sample, Oral glucose tolerance test, Breastfeeding habits, Food habits, Baby's height et weight.

Eligibility Criteria:
Inclusion Criteria:

* Breastfeeding women

Exclusion Criteria:

* Type 1 or type 2 diabetes
* Preterm birth
* History of bariatric surgery
* Multiple births
Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus

Attention deficit hyperactivity disorder (ADHD) patients have some problem with sustained attention. The dorsal anterior cingulate cortex (dACC) plays a key role for attention control. It has been found that the dACC has strong functional connectivity with ipsilateral motor area and parietal gyrus. Repetitive Transcranial Magnetic Stimulation (rTMS) is a sage and painless technique to activate cortical areas. The deep brain structure can be activated via stimulating superficial cortex by rTMS. For investigating the mechanism of sustained attention, this project is using functional magnetic resonance imaging (fMRI) to individualize the precise localization in motor area and parietal gyrus, and combining rTMS to activate the dACC.

Healthy subject is recruiting in this project. High rTMS will be performed. The 10-Hz stimulation is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses with 27-s duration per train).

Eligibility Criteria:
Inclusion Criteria:

* There are activation in dACC, motor area and parietal gyrus during the task fMRI
* The head motion less than 2 mm in translation or 2 degrees in rotation in any direction during the resting-state fMRI

Exclusion Criteria:

* Without any neuropsychiatric conditions
* No head injury or history of epilepsy
* Not on any medications
Weight, Energy, Lipids, and the Liver (WELL) Study

The research study is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in hepatic lipid accumulation, visceral adipose tissue and postprandial lipid, markers of inflammation and energy metabolism in participants who consume 3 study foods per day for 16 week, while maintaining their body weight.

The study objectives include:

1. To determine the impact of dietary soybean oil on ectopic liver fat and visceral adipose in adults with nonalcoholic fatty liver disease (NAFLD) or similar diagnosis
2. To evaluate the effect of soybean oil supplementation on postprandial lipids, markers of inflammation and energy metabolism
3. To measure the strength of the association of change in plasma linoleic acid with changes in ectopic liver fat, visceral adipose, and postprandial lipids, markers of inflammation and energy metabolism
4. To explore emerging mechanistic targets of LA-rich soybean oils that are linked with reduced liver fat and better cardiometabolic health

Eligibility Criteria:
Inclusion Criteria:

* Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
* Body Mass Index of 20-55 kg/m2

Exclusion Criteria:

* Unstable management of heart failure, heart disease events within 3 months, a need for heart surgeries or procedures, and/or the use of a pacemaker or defibrillator
* Current or previous diagnosis of severe kidney failure or diseases, some liver and pulmonary diseases
* Severe or uncontrolled circulatory diseases and autoimmune diseases
* Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
* Current or previous diagnosis of type 1 diabetes
* Use of Vitamin E supplements or Actos and Glucagon-like Peptide-1 medications for less than 1 months prior to enrolling.
* Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) that would prevent participants from tolerating the study foods
* Food Allergy or intolerances
* Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
* Use of medications where consuming the food products would be contraindicated
* Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling
* Hyperthyroidism
* Pregnancy and lactation
* Alcohol or drug abuse
* Inability to access veins for venipuncture
* Claustrophobia
* Metal implants or metallic foreign objects in the body
The Effect of E-health Video Towards Enhancing Cervical Cancer Screening

The aim of this quasi-experimental study is to evaluate the women's motivation related to cervical cancer screening. The experiment group will receive the e-health video KaSEH and brochure as the intervention. Where as, the control group will receive brochure as the intervention. There is three phase of evaluation which are pre-intervention, intra-intervention and post-intervention. The evaluation will be assess using the self-administered questionnaire based on Protection Motivation Theory. The estimated duration of this quasi-experiment is six month.


Eligibility Criteria:
Inclusion Criteria:

* Women who have never undergone cervical cancer screening.

Exclusion Criteria:

* Women who have been diagnosed or are cervical cancer patients
* Women who have been diagnosed with any cancer of the gynecological system such as cancer of the vulva, vagina, uterus, fallopian tubes and ovaries.
Sensitivity and Specificity of NGAL in an Emergency Room Population

Hypothesis: In patients that present to an urban emergency room, a single urine neutrophil gelatinase-associated lipocalin (NGAL) measurement can classify their kidney disease as stable chronic kidney disease, acute tubular necrosis, urinary outlet obstruction or pre-renal azotemia.

The purpose of this study is to determine whether urinary NGAL levels are able to distinguish the classical categories of renal disease. Previous studies have strongly suggested that this protein marks those with fulminant renal dysfunction with greater sensitivity and time resolution than currently used markers. Studies to date have been in highly selected populations: children and adults following cardiac surgery, infants with cardiovascular anomalies, and patients with known chronic kidney disease. Demonstration of similarly robust sensitivity and specificity in a broad Emergency Room population would strengthen the conception of NGAL as a marker of early or advancing kidney dysfunction. Most importantly, if NGAL can distinguish between types of renal disease at presentation in the ER, it might have important implications regarding ER management of these common presentations. For example, it could reduce diagnostic ambiguity and lag time from hours or days to seconds.

Eligibility Criteria:
Inclusion Criteria:

A. Must be greater than or equal to 18 years of age

B. Must satisfy the following age and sex stratified serum creatinine levels:

1. men between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
2. women between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
3. men older than 50 with serum creatinine greater than 1.0mg/dl
4. women older than 50 with serum creatinine greater than 0.8mg/dl

C. All pts greater than or equal to 18 years of age without kidney failure defined by B
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis

To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.


Eligibility Criteria:
Inclusion Criteria:

* Patients with fragile bone fracture
* Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
* Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
* Ambulatory

Exclusion Criteria:

* Patients with disease lowering bone volume secondarily (secondary osteoporosis)
* Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
* Patient with disorder delaying the passage of food through esophagus
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea

the aim of this study will be to investigate the effect of lumbar proprioception training on primary dysmenorrhea.

Although previous studies reported the effect of physiotherapy practices through therapeutic exercises on primary dysmenorrhea as core muscles strengthening, core stability exercises, connective tissue massage and classical massage, relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga and Pilates. None of them have investigated the effect of lumbar proprioception training on primary dysmenorrhea. Therefore, this study will be the first one which aims to investigate the effect of lumbar proprioception training on primary dysmenorrhea. This trial will include 2 groups; group A composed of 20 females that will receive hot packs and pelvic rocking exercises for 4 weeks and group B also composed of 20 females that will receive hot packs and pelvic rocking exercises in addition to lumbar proprioception training for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All females will have moderate to severe primary dysmenorrhea (as determined by WaLIDD Scale).
* Their ages will range from 18 to 22 years old.
* All females will be virginal and non-smokers.
* Their BMI will be range from 20-25 kg/m2
* They have regular menstrual cycle with menstrual cycle length of 28-30 days.
* They have persistent primary dysmenorrhea of more than 6 months

Exclusion Criteria:

* They shouldn't have musculoskeletal or neurological disorders, chronic LBP or sacroiliac dysfunction, diabetes, pelvic pathology or any gynecological disease.
* They shouldn't experience a stressful event in the last 6 month.
* Attending regular exercise training in the last 6 months.
* Taking medications or vitamin and mineral supplements due to other medical conditions.
A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment (P05815)

Hypogonadal males, particularly those whose condition manifested later in life, may experience common symptoms associated with their hypogonadism. Questionnaires developed to assess these symptoms need to be tested. The primary purpose of this study is to test or validate the Patient-Reported Symptom Measure, Androgen Deficiency Quality of Life Questionnaire and the Patient Global Impression Scale.


Eligibility Criteria:
Inclusion Criteria:

Men with late-onset hypogonadism who are either on testosterone treatment or naïve of treatment:

* have symptoms of androgen deficiency at screening (after wash-out if applicable) i.e. with a positive score on the Androgen Deficiency in the Aging Male (ADAM) Questionnaire (a "yes" answer to questions 1 or 7 or any three other questions).
* morning total T levels of \<=3 ng/mL (\<=300 ng/dL; \<=10.4 nmol/l) on two separate days prior to randomization (after appropriate wash-out, if applicable).
* calculated free T \<=0.074 ng/mL.
* at least 50 and at most 75 years of age.
* BMI of at least 18 kg/m\^2 or at most 32 kg/m\^2

Inclusion Criteria for Normogonadal Men:

* morning total T levels \<=3 ng/mL (\<=300 ng/dL; \<=10.4 nmol/L).
* calculated free T \<=0.074 ng/mL.
* at least 50 and at most 75 years of age.
* BMI of at least 18 kg/m\^2 or at most 32 kg/m\^2

Exclusion Criteria:

* History or current diagnosis of prostate cancer or any clinically significant finding on prostate examination
* Severe obstructive symptoms of benign prostate hypertrophy
* Prostate specific antigen (PSA) levels greater than 4 ng/mL at screening
* History or current diagnosis of carcinoma of the breast
* Known chronic polycythemia and/or hematocrit greater than 50% at screening
* Treatment-naïve subjects with hyperprolactinemia at screening (serum prolactin level \>=50 ng/mL)
* Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator
* clinically significant abnormal physical finding prior to randomization
* sensitive to trial medication or its components
* History or presence of hepatic or renal disorder considered as clinically relevant in the opinion of the investigator.

Exclusion Criteria for Normogonadal Men:

* Presence or previous diagnosis of androgen deficiency.
* Previous or present use of testosterone preparations
* Use of medication within the 12 weeks prior to the visit that may interfere with the objectives of the trial: hypothalamic/pituitary hormones and analogues (e.g., gonadotropins, ACTH, STH, Gn-RH agonists and antagonists, etc.); sex steroid
* Any other disease that in the opinion of the investigator might compromise or confound the subject's symptomatology (e.g., presence of clinically significant depression or other psychiatric disorders, unstable endocrine disorder, sleep apnea, cardiovascular and cerebrovascular diseases, etc.)