cyrilzakka/clinical-trials huggingface dataset:
The Effects of Obesity and Protein Intake on the Kidney

The purpose of this study is to determine if being overweight and eating lots of protein causes separate changes in the kidney that lead to kidney disease over time. These questions are important because the number of people who have kidney disease is quickly growing. If being overweight and eating lots of protein is found to cause kidney disease, then doctors may be able to limit the number of people with kidney disease by recommending weight loss and eating less protein

The purpose of this study is to test the hypothesis that being obese leads to changes in kidney function that are independent of, and enhanced by, high dietary protein intake. Kidney function will be measured by the kidney's ability to filter blood and by the amount of protein in the urine. The hypothesis will be tested in the following manner: The first part of the study will involve a crossover design comparing kidney function in obese people with stable weights on a low and high protein diet ("Low/High Protein Study"). The second part of the study will compare kidney function in obese people before and after weight reduction surgery ("Before/After Surgery Study"). Since certain changes in kidney function may lead to kidney disease over time, it is important to confirm the effects of obesity and dietary protein intake on the kidney, especially with the current rise in obese people and the popularity of high protein diets.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Ability to give informed consent
* Not pregnant and using appropriate contraceptive methods, or not of childbearing potential
* BMI of 30 or higher

Exclusion Criteria:

* Iodine or shellfish allergy
* History of adverse reaction to intravenous contrast
* Dialysis dependence
* Diagnosis of diabetes mellitus or taking medicine for diabetes mellitus
Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse

Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

- Women with 3rd and 4th degree Apical prolapse

Exclusion Criteria:

* Patients with previous failed surgical intervention
* Patients with medical disorders that may interfere with surgical interventions .
* Patients with apical prolapsed complaining of stress urinary incontinence
Self Digital Photography for Assessing Elbow Range of Motion

Loss of elbow range of motion can significantly affect activities of daily living. Measuring elbow range of motion is critical for tracking post surgical outcomes. This study seeks to validate the ability to validate self photography as a means of followup through long distance correspondence.

Loss of elbow range of motion is common after trauma and can significantly affect activities of daily living. Patients across the country travel to tertiary referral centers to have this problem addressed. Followup is critical and can often be difficult given distances between patients home and their healthcare provider. Measuring postoperative outcomes requires accurate and reliable documentation of range of motion. Previously, the investigators have validated digital photography as a means of accurately measuring elbow range of motion. In that study, photographs were taken by a non-professional photographer. With the advance in personal technology, patients now have the ability to take photos themselves. This study seeks to validate self photography, which will ultimately improve patient follow up and improve clinical monitoring

Eligibility Criteria:
Inclusion Criteria:

* Elbow contracture in the sagittal place

Exclusion Criteria:

* Unable to read English
* Unable to forward flex shoulder to 90 degrees or hold their shoulder at 90 degrees for the duration of the examination
* Unable to tolerate the exercise due to pain
DESyne in Routine Clinical Practice

The purpose of this study is to evaluate effectiveness and safety of DESyne in Routine Clinical Practice


Eligibility Criteria:
Inclusion Criteria:

* Age 20 and more
* Intervention with DeSyne drug eluting coronary stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with DeSyne drug eluting coronary stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock
Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer

The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.

Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
* Unresectable, locally advanced or metastatic
* At least one uni-dimensional measurable lesion by RECIST criteria
* Age 18 to 75 years old
* Estimated life expectancy ≥3 months
* ECOG performance status ≤2
* Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
* Adequate kidney function (creatinine \< 1.5 mg/dL)
* Adequate liver function (bilirubin \< 2.0 mg/dL, transaminase levels \<2.5 times the upper normal limit)
* Written informed consent

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
* Presence of CNS metastasis, psychosis, or seizure
* Obvious bowel obstruction
* Evidence of serious gastrointestinal bleeding
* Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Other serious illness or medical conditions
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants

In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses).

The first specific aim will determine whether individualized and optimized nutrition during hospitalization results in improved growth in the neonatal intensive care unit (NICU) in extremely low gestational age (GA) neonates (ELGANs, \<29 weeks) and in small for GA (SGA, birth weight \<10th percentile for GA) preterm infants compared with optimized nutrition.

The second specific aim will determine whether individualized and optimized nutrition in the NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.

Hypotheses:

1. Primary hypothesis: In preterm infants (GA \<29 weeks or GA \<35 weeks and SGA) individualized and optimized nutrition will increase velocity of growth (weight gain velocity by 2 g x kg-1 x day-1 and length velocity by 0.2 cm per week) from birth to 36 weeks of postmenstrual age (GA plus postnatal age) or discharge (whichever comes first) in comparison with optimized nutrition.
2. Secondary hypotheses: Individualized and optimized nutrition will improve neurodevelopmental outcome and reduce the risk of disproportionate growth (excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.

Study design:

Double-blinded randomized controlled trial (RCT): After consent, 150 neonates will be randomized to one of two groups.

Study intervention: Patients will be randomized to either:

1. Control: optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen and albumin and velocity of growth (weight and length).
2. Intervention: Individualized and optimized nutrition: Milk fortification will be optimized as in control neonates. In addition, nutrition will be individualized every day. Milk fortification will be adjusted based on daily measurements of macronutrients in human milk using near-infrared analysis.

Randomization will be done by computer provided by a statistician using random block allocation and stratification by GA and size for age (AGA \[appropriate for GA\] 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks). Twins and multiples will be randomized to the same arm of the study.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<29 weeks GA and SGA infants \<35 weeks GA born at Parkland Health and Hospital System
* Maternal plan to breastfeed or to use milk from the donor milk bank
* From birth to 1 week of life

Exclusion Criteria:

* Patients on comfort care only
* Patients with major congenital abnormalities
* Patients who are too unstable for the first 7 days to have an accurate length measurement
Regional Midazolam in Quadratus Lumborum Block

Midazolam has been used in regional anesthesia of brachial plexus block; it has offered accepted postoperative pain relief. This study will use it in as an adjuvant to bupivacaine 0.25% in quadratus lumborum block in caesarean section

It is vital to apply adequate postoperative analgesia following Caesarean section (C-section), since it will affect the distinct surgical recovery requirements of the parturient. The ultrasound-guided quadratus lumborum block (QLB), first introduced by Blanco R. in 2007, has been recognized as an effective abdominal wall block approach, in which local anesthetic injected from the posterior abdomen will spread around the quadratus lumborum muscle and block the intermuscular nerves. In addition, such block is also closely related to multiple sympathetic fibres and is connected to the thoracic paravertebral space. Typically, QLB is found to be effective, which can provide satisfactory analgesic effect.

Midazolam is one of the clinically water-soluble benzodiazepines and effective to produce the analgesic effect through the neuraxial pathways. The organs and joints of humans have the benzodiazepine receptor, and midazolam is revealed to produce the analgesic effect through the gamma-aminobutyric acid receptors (GABA) in the spinal cord. Previous studies have reported that the midazolam (75 μg/kg) through the intraarticular route can decrease the pain intensity for arthroscopic knee surgery. In addition, the intrathecal midazolam (2 mg) is reported to prolong the duration of analgesia without any adverse effects following knee arthroscopies. Perineural midazolam has been also evaluated in brachial plexus block.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* age from 24 to 40 years old
* weight from 50 to 80 kg,
* normal singleton pregnancy with a gestation of at least 37 weeks

Exclusion Criteria:

* Coagulopathy
* maternal anatomic abnormalities in the block region
* localized infection
* incapable of comprehending or using the verbal rating pain scoring system
* Included medications allergy
* history of chronic pain or regular opioid use.
Incretins and Metabolism

Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic endocrine function and incretin metabolism are impaired. The investigators hypothesize that extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in subjects with type 2 diabetes.

Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief, somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject will undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or GIP. Glucose metabolism will be assessed using 13C-glucose stable isotope methodology combined with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and abdominal adipose biopsies will be taken to examine intracellular signalling.


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* BMI 18-35 kg/m2
* NGT or T2DM as classified by ADA criteria

Exclusion Criteria:

* Insulin dependency
* Smokers
* History of or presentation with cardiovascular disease, cancer, and chronic hematological, renal, hepatic, pulmonary disease
* Weight loss (\>2 kg in previous 6 months)
* Physical activity (\>150 mins/week)
Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter

The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.

In this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. To ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously.

Flushing will be done with sodium chloride 0.9 % solution.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with a port catheter
* Treated with systemic vancomycin and/or vancomycin "lock"

Exclusion Criteria:

* Age \> 18 years
* Active downgrading of care
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(3)

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348(3)

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-348(3) with coadministration of CKD-828, D097 and D337 in healthy adult volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who meet the blood pressure criteria during screening tests:

   * Systolic Blood Pressure: 90 to 139 mmHg
   * Diastolic Blood Pressure: 60 to 89 mmHg
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
5. Those who exceed an alcohol and cigarette consumption than below criteria

   * Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
   * Smoking: 20 cigarettes/day
6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.
Change in Social Media Use and Well-being Among College Students Receiving a One-week Exercise or Mindfulness Intervention

The investigators will be randomizing 150 college student participants with high levels of social media use into either a 1) control condition (no intervention), a 2) mindfulness meditation cognitive intervention, or 3) a social media reduction + exercise replacement intervention. Participants complete intervention activities daily for one week. The investigators will collect self-report and behavioral measures of social media use and related psychological constructs at three time points: baseline, immediately after the intervention period, and one-week after the intervention period.

The objective of this study is to test two cognitive and behavioral interventions designed to reduce social media use and psychological constructs related to social media use in a sample of university students.

The first cognitive intervention is a mindfulness meditation exercise taken from the Calm app centering around gratitude. Each meditation takes approximately 12 minutes to complete and is to be done daily for one week. The second behavioral intervention is asking participants to reduce social media use for 30 minutes daily for one week and replacing that time with physical exercise of the participants' choosing.

Aim 1: Compare psychological constructs related to mental health (well-being, stress, depression, anxiety, loneliness, social comparisons, etc.) before and after conducting two social media use interventions over a period of one week, compared to a control condition (no intervention).

Aim 2: Compare self-reported and behavioral (smartphone screen shots of social media use screen time) measures of social media use before and after two social media use interventions over a period of over one week, compared to a control condition (no intervention).

Aim 3: Examine mental health and social media use one week after the intervention period is complete (follow up), examining or testing whether effects last beyond the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* The participant is 18 or older.
* The participant must be a Johns Hopkins University student.
* Owning an iPhone or Android smartphone, with frequent use of social media use daily (\> 1 hour)
* Enabling and sharing screenshots of your smartphone use metrics, including number of last-week pickups, notifications received, and average screen time.
* Providing consent to participate.
* Only exercising 1 hour or less daily, on average.

Exclusion Criteria:

* younger than 18
* Not a Johns Hopkins University Student
* Doesn't own a smart phone
* Uses smartphone less than 1 hour daily
* Exercises more than 1 hour daily
IV Cocaine Abuse: A Laboratory Model - 3

The purpose of this study is to evaluate the effects of buprenorpine on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate dependent cocaine users.


Eligibility Criteria:
Please contact site for information.
Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer

Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Gender: female
* Age: 18 years and older
* Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
* Subject who have signed an informed consent form.

Exclusion Criteria:

* Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, prior to being "imaged" by RI4.0.
* Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
* Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
* Subjects who have undergone a mastectomy.
* Subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
* Subjects with prior breast reduction surgery or breast augmentation surgery.
* Subjects who have a fever on the day of their biopsy.
* Subjects who are pregnant.
* Subjects who are breast-feeding.
PMCs as a Treatment of Children With HSPM Using the HT

Hypomineralised primary second molars are primary molars with a developmental disorder of the enamel. Preformed metal crowns already have good results for the treatment of caries on primary molars. In this study the aim is to investigate the clinical success and overall survival of preformed metal crowns as a treatment for hypomineralised primary molars. The crowns were placed using the Hall technique which is a simplified way of placing these crowns.


Eligibility Criteria:
Inclusion Criteria:

* age 2-12 years
* American Society of Anesthesiologists(ASA)-score I: healthy patient
* hypomineralisation grade: 2-6
* caries with an International Caries Detection and Assessment System (ICDAS)- score: 0-3
* limited provoked pain complaint

Exclusion Criteria:

* caries with an ICDAS-score: 4-6
* pulpitis pain complaints
* infection (clinical and/or radiographic)
* \>1/3 root resorption
* allergies to the used materials