cyrilzakka/clinical-trials huggingface dataset:
The Role of Satiety in the Effect of Portion Size on Intake

The study uses a crossover design in which the portion size of food is varied at each meal. Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights. The first visit will be a screening visit, at which subjects will complete the consent form, have their height and weight measured, and rate the taste of the study food. Test meals will be scheduled once a week for four weeks. At visits 2-5, subjects will eat lunch and rate characteristics of the meal. At visit 6, subjects will complete various questionnaires. The objective of this study is to determine whether any individual characteristics related to satiety influence the effect of portion size on intake.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to travel to Penn State University Park campus weekly for meals
* Be a man or woman 18 - 60 years old
* Regularly eat 3 meals/day
* Be willing to avoid alcohol the day before and during test days
* Have a body mass index between 18.0 and 35.0 kg/m-squared
* Be willing to refrain from eating after 10 pm the evening before test sessions

Exclusion Criteria:

* A smoker
* An athlete in training
* Pregnant or breastfeeding at the time of screening
* Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
* Currently dieting to gain or lose weight
* Have a health condition that affects appetite
* Have participated in a similar study in our lab in the past year
Inflammatory Markers: HOLEP Versus TURP

Aim of the study is to compare the systemic inflammatory markers and surgical stress response in patients undergoing HOLEP or TUR-P surgery.

Benign prostatic hyperplasia (BPH) is the most common disease in aging men worldwide, causing significant difficulties and resulting in bladder outlet obstruction. Basically, surgical techniques in patients with BPH are transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HOLEP), and open prostoactemy surgery. There are many studies comparing the clinical outcomes of TURP and HOLEP surgery. However, to the best of our knowledge, there has not been a study comparing the effects of these two types of surgery on inflammatory markers and stress hormones.

Eligibility Criteria:
Inclusion Criteria:

* ASA scores I-III patients
* having benign prostatic hyperplasia
* undergoing HOLEP or TURP surgery under general anesthesia

Exclusion Criteria:

* immune system disease,
* diabetes mellitus,
* malignancy other than prostate disease,
* history of steroid use,
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis

The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.

The purpose of this multi-center, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the effectiveness and safety of two doses of pentosan polysulfate sodium (100 mg once a day and 100 mg three times a day) versus placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis. The hypothesis of the study is that there is no treatment difference in the proportion of responders at study endpoint (Week 24). Effectiveness will be assessed based on the reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) total score. Safety assessments include vital signs, laboratory tests, adverse events and physical exams. Patients will receive one of the following study treatments by mouth each day for 24 weeks: pentosan polysulfate sodium 100 mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, and one matching placebo capsule in the afternoon and evening; pentosan polysulfate sodium 100 mg capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, afternoon and evening; placebo group - one placebo capsule in the morning, afternoon and evening

Eligibility Criteria:
Inclusion Criteria:

* Must have a total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a score of \> 0 on each of the 4 questions on the ICSI
* must have experienced bladder pain, urinary urgency and urinary frequency, each not related to a urinary tract infection, for at least 6 months prior to entry into the study
* must have averaged \>= 10 voids per day (\>=30 voids over 3 consecutive days) and averaged \>= 1 void at night
* urine culture showing no evidence of urinary tract infection
* urine cytology showing no evidence of neoplastic cells

Exclusion Criteria:

* Scheduled for or use of intravesical therapy (eg, bladder distention, dimethyl sulfoxide) during or within 4 weeks prior to the study
* patients who have had cytoscopic evaluation within 4 weeks prior to the study
* patients who are currently (within last month) receiving other medications that may affect symptoms of interstitial cystitis (ie, antidepressants, antihistamines, antispasmodics, anticholinergics)
* patients who are chronic users of Schedule II narcotics or who are using any scheduled narcotics at the time of study entry
* patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such as tissue plasminogen activator and streptokinase
Improving Coping to Reduce Suicide Risk Following ED Discharge

The researchers hope to learn whether an electronic safety plan (ESP) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ED) discharge. From this study, the researchers also hope to learn how to best carry out the ESP and text messaging program to improve outcomes for patients after ED discharge.


Eligibility Criteria:
Inclusion Criteria:

Individuals presenting to an ED with either:

1. actual, interrupted, or aborted attempt in the last 4 weeks
2. suicidal ideation within the last week

Exclusion Criteria:

* Severe cognitive impairment or altered mental status (psychosis, manic state)
* Severe aggression/agitation,
* Being admitted or transferred into inpatient care,
* Patient not owning a cell phone with text messaging capability
Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus

To compare the change in glycemic control from baseline to endpoint (last available posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes receiving either glimepiride or metformin as monotherapy.


Eligibility Criteria:
INCLUSION CRITERIA:

1. Subjects who had type 2 diabetes treated with diet and exercise only for at least 2 weeks prior to randomization, or who were previously or currently treated with an oral agent and had not responded to diet, exercise, and oral therapy for at least 3 months (documented by an HbA1c \>7.5%).
2. Subjects who completed glimepiride pharmacokinetic Study HOE 490/4045 at preselected sites within 3 weeks prior to the screening period were also permitted to enroll.
3. Subjects were required to be negative for islet cell antigen (ICA) and glutamic acid decarboxylase (GAD) autoantibodies and to have a C-peptide level at 90 minutes of ≥ 1.5 ng/mL. The HbA1c was required to be \>7.1% at screening and \<12.0% on the day of randomization.

EXCLUSION CRITERIA:

Subjects meeting any of the following criteria were not to be included in the study:

1. A history of an acute metabolic complication such as diabetic ketoacidosis within 3 months before screening
2. On insulin therapy, or had received insulin for \>6 weeks, 3 months prior to randomization
3. On weight-reduction medication
4. Known hypersensitivity to biguanides, sulfonamides, or insulin
5. Pregnant or lactating females
6. Clinically significant renal (serum creatinine level \>1.0 mg/dL) or hepatic disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>2.5 times the upper limits of normal \[ULN\])
7. GI disorders that may interfere with the absorption of the study drugs
8. Chronic use of medications known to affect glucose levels such as intermittent use of systemic corticosteroids or large dose of inhaled steroids
9. Clinically significant laboratory abnormality on screening laboratory tests or any medical condition that in the opinion of the investigator would affect the outcome of the study
10. History of drug or alcohol abuse
11. Treatment with any investigational product in the last 3 months before study entry
12. History of noncompliance with regard to follow-up medical care
13. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study
Relationship Between Hamstring Length and Gluteus Maximums in Mechanical Low Back Pain

The aim of this study was to determine the correlation between hamstring length and gluteus maximus strength with and without normalization in patients with mechanical low back pain

seventy-three patients diagnosed as mechanical low back pain. Firstly, gluteus maximus (GM) strength was measured isometrically as a force (kg) and then converted to torque (Nm). GM strength was normalized for body weight and height using the following formula: % (body weight × h) = torque (N × m) ×100 / body weight (N) × h (m), then assessment of hamstring length flexibility using the active knee extension method.

Data was collected and the correlation was determined.

Eligibility Criteria:
Inclusion criteria:

* Patients diagnosed as mechanical low back pain (MLBP) with very high grade mechanical inflammatory low back pain (MIL) index.
* Age ranged from 18 to 40 years.
* Body mass index ranged from 25 to 30 kg/m2

Exclusion Criteria:

* History of previous fractures, surgeries, malignancies, trauma, rheumatoid arthritis, spondylosis, and spondylolisthesis.
* History of lower limb injuries in the last six months before the study.
* Inability to correctly produce maximal Gluteus Maximus contraction in a pain-free ROM.
Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in IBS-D Patients

Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea.

Irritable bowel syndrome (IBS) is a common functional disorder which affect around 10% of the general population. Abdominal pain and discomfort are associated with transit disorders (diarrhea, constipation, alternating). IBS is defined by Rome III criteria.

For clinicians, IBS remains difficult to treat while its pathophysiology remains not completely understood. Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three abnormalities found in IBS patients. Visceral hypersensitivity is present in 60% of the patients, while intestinal permeability is increased in a subgroup of IBS with diarrhea. Low grade inflammation could be identify with faecal calprotectin dosage. The link between this three abnormalities is not clear.

The goal of our study is to describe the prevalence of these three abnormalities in IBS-Diarrhea population and to look for a correlation between low grade inflammation, visceral hypersensitivity, increased intestinal permeability and clinical phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* IBS-Diarrhoea according to Rome III criteria,
* Faecal calprotectin ≤200 µg/g in the last two months
* Effective contraception since 1 month for women in childbearing age

Exclusion Criteria:

* Patients with organic and/or inflammatory digestive disease
* IBS with constipation or alternating
* Treatment such as anti-inflammatory, probiotic in the last three months
* Patient with blood dyscrasia disorder known or identified , anticoagulant or antiplatelet treatments
* Small intestinal bacterial overgrowth (identified by a glucose breath test)
* Hypersensitivity to Normacol
* Severe renal failure
* Anal pathology (anal fissure, hemorrhoidal thrombosis)
* Pregnant or breastfeeding women
* Person with administrative or judicial decision or under legal protection measure
* Patient participating in another trial in the last two weeks
* Diet based in grapes
Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain

this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age from 40 to 65 years old participated in this study, 2
* Having neck pain for more than 6 months with a grade five or greater on the visual analog scale
* Having one or more trigger points in the upper trapezius muscle,
* A significant increase in neck muscle EMG activity indicates the presence of tender points.

Exclusion Criteria:

* Taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy)
* Taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period,
* Presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities
Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women

To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and to study the effect of mode of delivery on female sexual function.

1. transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae" (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.
2. answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.

Exclusion Criteria:

1. Refused consent.
2. Previous vaginal or cesarean delivery.
3. Severe mental illness.
4. Severe physical handicap or difficulties in communication.
5. Women without postpartum active sexual life or separate from their spouse.
6. Past history of sexual dysfunction.
A Pilot Study Non-Invasive Guidance for Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries

Back injuries are the most common reason people seeking for effective treatment. One of the most common treatments in sports medicine for muscular injuries is therapeutic ultrasound, which is designed to heat the injured tissue and increase the flow of blood to promote healing.

Researchers at Beckman Laser institute, using a technology developed at University of California, Irvine. The device call Diffuse Optical Spectroscopy, this device developed with harmless light that can measures and detect the change of blood flow, oxygen level, temperature and muscle tissue in lower back during therapeutic ultrasound therapy treatment.

The researchers can provide information in real-time tissue change before, during, and after treatments that can determine the effectiveness of the treatment and speed up recovery time.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female over 18 years of age,
* No back injuries, No plan treatment
* Currently diagnose with back injuries, with plan treatment of therapeutic ultrasound

Exclusion Criteria:

* Minors
* Obese
* Pregnant
Residential Ventilation Systems and Filtration for Asthma Control in Adults

The goal of this study was to investigate the effectiveness of three common approaches to upgrading residential mechanical ventilation systems in existing homes for improving asthma-related health outcomes, reducing indoor pollutants of both indoor and outdoor origin, and maintaining adequate environmental conditions and ventilation rates in a cohort of adult asthmatics in existing homes in Chicago, IL.

The Breathe Easy Study utilized a quasi-randomized, within-subjects, parallel-group, pre-post intervention study design with four weeklong periods of indoor air quality (IAQ) and indoor environmental data collection for approximately one year before the installation of mechanical ventilation systems, followed by four weeklong periods of IAQ and indoor environmental data collection for approximately one year after the installation of mechanical ventilation systems, conducted from July 2017 through March 2020 in Chicago, IL. With the nature of a healthy home intervention study by installing residential mechanical ventilation systems within the timeframe, each participant received interventions in the middle of the study period, including continuous exhaust-only systems; intermittent powered central-fan-integrated-supply (CFIS) systems; or continuous balanced systems with an energy recovery ventilator. Thus, each participant served as their own control and there was no formal control group that did not receive intervention nor did they receive a sham/placebo intervention. Primary health outcome, asthma control, was assessed by using the Asthma Control Test (ACT) every month, and quality of life, stress, and other asthma-related health outcomes were assessed via the baseline and end-line surveys.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 90+ years.
* English speaking and writing.
* Able to provide consent.
* Chicago resident.
* Households with at least one occupant with asthma
* Non-smoking houses
* Participant-owned houses
* Participant's agreement to surveys and IAQ monitoring over 2 years

Exclusion Criteria:

* Houses outside Chicago, IL USA
* Houses with significant health and safety issues
Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention

As a single center, retrospective observation study in Guangdong Institute of Cardiovascular Diseases, this study included the main study population of patients who underwent coronary angiography and / or coronary intervention from January 2007 to Decemeber 2018. The hospitalization information was collected in the form of direct derivation of the case, and cardiac and renal adverse events were collected through outpatient recorder system. All-cause death information was obtained from the Public Security and matched to the electronic Clinical Management System of the Guangdong Provincial People's Hospital records.

This is a single center, retrospective observation study collecting data on 88938 coronary angiography and / or coronary intervention patients from January 2007 to Decemeber 2018. Data regarding demographic information, admission diagnoses and history of present illness, biomarkers and details on preventive hydration and medications will be collected. The primary endpoint of this study is All-cause mortality, and secondary endpoints are Adverse Cardiovascular and Kidney Events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred to CAG or PCI;

Exclusion Criteria:

-
Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery

This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.

PRIMARY OBJECTIVES:

I. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC).

II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).

III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC.

IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).

SECONDARY OBJECTIVES:

I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response.

II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables.

OUTLINE:

Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically confirmed breast cancer (by core needle biopsy)
* Women with \>= 2 cm clinically or radiologically measureable breast cancer
* Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
* Women competent to sign study specific written Informed Consent
* Women willing to comply with protocol requirements

Exclusion Criteria:

* Women who are pregnant
* Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
* Women who have had a prior history of breast cancer in the same breast
* Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent
* Women who cannot consent for themselves