cyrilzakka/clinical-trials huggingface dataset:
Docusate/Senna for the Treatment of Diabetic Gastroparesis

The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years, male and non-pregnant, non-lactating females
* Diagnosis of type 1 or type 2 diabetes mellitus
* Clinical diagnosis of diabetic gastroparesis

Exclusion Criteria:

* Diagnosed idiopathic gastroparesis
* A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
* A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed rectal bleeding
* Gastrointestinal cancer
* Any active cancer
* Prior gastric surgery
* End-stage heart disease, liver disease, lung disease
* Known or suspected drug abuse
* Any condition requiring use of daily narcotics
* Concurrent usage of mineral oil or products containing mineral oil
* Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna
This Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure

The purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.

In this prospective study, 40 patients undergoing elective surgery were included. Patients were divided into four groups of 10 patients. The control group (Group C) was not subjected to laparoscopic intervention. Laparoscopic surgery was respectively performed with an intra-abdominal pressure of 9, 12 and 15 mmHg in Groups L (low), M (medium), and H (high pressure). Intraocular pressure was measured binocularly in each patient at three different time (before, during and end of surgery) using a contact tonometer.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 30 kg/m2 or less
* American Society of Anesthesiologists (ASA) status I-II

Exclusion Criteria:

* Pre-existing eye disease,
* Cardiovascular or neuromuscular disease,
* Difficult intubation,
* The use of any antihypertensive agents.
Clinical and Histological Analysis of Human Gingival Phenotypes

The goal of this observational study is to compare the composition of the human gingiva in different gingival phenotypes. The main questions to answer are:

* Is there any difference in the cellular composition of the gingiva between thin and thick gingival phenotype?
* Is there any difference in the molecular composition of the gingiva between thin and thick gingival phenotype?

The participants were divided in two groups (thin and thick phenotype) and a biopsy of healthy gingiva was obtained from each one them. The biopsies were analyzed histologically and the collected data will be analyzed statistically in order to identify possible differences between the gingival phenotypes.

Healthy volunteers were assigned in one of two groups:

* Group 1: Thin gingiva, when the free gingiva was evaluated as transparent, after the insertion of a periodontal probe (Hu-Friedy XP-23/QW, Hu-Friedy,Chicago,IL,USA) in the middle of the facial dentogingival sulcus of a maxillary central incisor
* Group 2: Thick gingiva: when the free gingiva was evaluated as non-transparent, using the same methodology.

A full thickness sample of the oral mucosa of each one of the participants was collected under local anaesthesia. The sample had a rectangular shape, with a length of 4 millimeters and a width of 1 millimeter. It had a vertical orientation and it was expanding at the both sides of the mucogingival junction.

The oral mucosa samples were processed for histological and immunohistochemical analysis. Staining with haematoxylin-eosin was performed in order to describe the tissue histologically and also calculate the total number of the cells it contained. Immunohistochemical staining with anti-Vimentin,anti-Cluster of Differentiation 68, anti-Ki-67 and anti-Smooth Muscle Actin antibodies was applied for the calculation of the numbers of fibroblasts, macrophages, Ki-67-positive cells and Smooth muscle actin positive cells respectively. Immunohistochemical staining was also performed in order to determine the levels of expression of Collagen I, Collagen V, Elastin and Hyaluronic acid.

Whole slide images of the specimens were acquired with the use of the NanoZoomer 2.0HT (Hamamatsu Pho-tonics K.K., Hamamatsu, Japan). Cell counting will be performed automatically using an image analysis software (QuPath 3.0). The levels of molecular expression will be assessed with the use of the same software and will be expressed as a percentage of the area of the connective tissue that is occupied by the investigated molecules.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Attachment loss or Probing depths greater than 2 millimeters at the maxillary central incisors
* Altered passive eruption of the maxillary incisors
* Previous surgery or orthodontic treatment in the anterior maxilla
* Medical conditions or medication affecting soft tissue metabolism
* Tooth crowding or abnormal angulation or abrasion of the maxillary incisors
* Restorations at the buccal surface of the maxillary central incisors
* Smoking
* Pregnancy or lactation
Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in patients. The current standard treatment for mild to moderate UC (MTMUC) includes 5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients continue to experience disease symptoms and flare-ups. These patients require higher dosages of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy which comprises higher risk of hazardous side effects.

Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively studied in the context of inflammatory diseases. In humans, a controlled study using curcumin as an adjusted therapy to 5ASA medication has shown it to be superior to placebo in maintaining remission in MTMUC patients . A small, preliminary open label study has also shown efficacy in reducing disease symptoms and inflammatory markers in this group of patients .

This data provides bases for investigating an integrative approach to optimize the current standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA medication and curcumin could benefit this subgroup of patients and reduce morbidity and perhaps need for escalating pharmacological intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UC as confirmed by endoscopic or histologic criteria as established by RomeIII
* Disease activity score of \>5 and ≤13 according to the Simple clinical colitis activity index (SCCAI)
* Patient on stable 5 ASA medication dose for at least 4 weeks prior to inclusion
* Patients who receive immunosuppressant or biological therapy (azathioprine, 6-mercaptopurine, infliximab or methotrexate) must be on stable dose for at least 3 months prior to inclusion
* Patients who receive topical therapy (5ASA or steroidal), must be on stable dose for a least 2 weeks prior to inclusion
* Patient had hemoglobin of \>10 g/dl.
* Able and willing to give written consent

Exclusion Criteria:

* Patient with renal or liver disease, sever cardiovascular disease, chronic pancreatitis, diabetes mellitus or gallstone.
* Patient with laboratory abnormalities indicating anemia (hemoglobin \<10), leucopenia, thrombocytopenia, abnormal coagulation.
* Patient with infection, sepsis or pneumonia.
* Pregnant or nursing women.
* Unable or unwilling to receive CURCUMIN therapy.
iP2P Mentorship Program for Teen HF Patients

The iPeer2Peer (iP2P) program is an online peer support mentorship program that provides modelling and reinforcement by trained young adult peer mentors to adolescent mentees with the same condition. A waitlist hybrid implementation-effectiveness type 3 pilot randomized controlled trial design will be employed across four sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-25 years of age) who will undergo training in mentoring and the use of eHealth technology. Mentor-mentee pairings will connect over 15 weeks through video calls and text messaging to provide peer support and encourage disease self-management skills. Data will be collected using standardized instruments and interviews across three time points.


Eligibility Criteria:
Mentee inclusion criteria:

1. patient with a cardiac diagnosis,
2. at least 4 months post-diagnosis,
3. between the ages of 12 and 17 years,
4. able to speak and read English, and
5. willingness to commit to 5-10 texts and/or calls of 20-30 minutes each with a peer mentor over a period of 15 weeks.

Mentor inclusion criteria:

1. patient with a cardiac diagnosis,
2. between the ages of 18 and 30 years,
3. able to speak and read English,
4. nominated by a member of their health care team as a good mentor based on maturity and emotional stability,
5. willingness to commit to peer mentor training (20 hours) via the PHIPA-compliant version of Zoom or Microsoft Teams and mentoring adolescent participants (once paired with mentee, 5-10 texts and/or calls of 20-30 minutes over a period of 15 weeks),
6. good communication skills (as assessed by a healthcare provider), and
7. previous experience in a professional environment (e.g., as a camp counsellor, part time job, volunteering) is an asset.

Exclusion Criteria:

1. significant cognitive impairments as assessed by a qualified healthcare provider,
2. a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their heart failure care regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and
3. participating in other peer support or self-management interventions.
Psoas Density in Colorectal Cancer

Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams.

Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.


Eligibility Criteria:
Inclusion Criteria:

Patient criteria:

* Having a major colorectal resection for the treatment of cancer
* Elective or emergency surgery
* Adults, defined as age ≥18 years of age (no maximum limit)
* Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
* Operation performed between 31st Aug 2013 - 31st Aug 2019

Exclusion Criteria:

* Not having a preoperative CT scan with contrast
Tooth Wear Monitoring Using Intraoral Scanner

The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. Forty-six participants were selected according to the established inclusion and exclusion criteria. Monitoring of tooth wear, evaluation of possible aetiological factors, as well as patient satisfaction with the use of the intraoral scanner were carried out.

The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. The specific objectives were (1) to determine whether the intraoral scanner is capable of detecting tooth wear superior to traditional visual indices, (2) to identify whether any aetiological factors may be associated with tooth tissue loss, (3) to establish a degree of patient satisfaction with the intraoral scanner as a diagnostic tool. Forty-six participants were selected according to the established inclusion and exclusion criteria. The protocol was accepted by the Regional Ethics Committee of the Community of Madrid. Digitisation of the dental arches was recorded at 3 types of evaluation: 0, 6 months and 12 months. The recording of possible etiologic factors was carried out at the three established evaluation times. The evaluation of satisfaction was recorded at the third evaluation time.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age
* patients who were to stay at the university for more than one and a half years
* patients who agreed to sign the informed consent form.

Exclusion Criteria:

* pregnant women
* patients who planned to modify the oral situation with orthodontic, surgical and/or rehabilitative treatments
* patients who had some kind of personal or academic relationship with the investigators of this study.
Gefitinib and Capecitabine in Treating Patients With Advanced Solid Tumors

This phase I trial is studying the side effects and best dose of gefitinib and capecitabine in treating patients with advanced solid tumors. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and capecitabine may kill more tumor cells

OBJECTIVES:

I. Determine the maximum tolerated dose of gefitinib and capecitabine in patients with advanced solid tumors.

II. Determine the dose-limiting toxic effects of this regimen in these patients.

III. Determine the pharmacologic profile of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gefitinib and capecitabine.

Patients receive oral gefitinib once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 11-41 patients will be accrued for this study within 2.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
* No uncontrolled brain metastases, including symptomatic lesions or lesions requiring treatment (e.g., glucocorticoids and/or anticonvulsants)
* Performance status - ECOG 0-2
* At least 12 weeks
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 2.5 times upper limit of normal (5 times ULN if liver metastases present)
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No active infections
* No other serious concurrent systemic disorders that would preclude study participation
* No other malignancy
* No prior hypersensitivity to sulfonamide-based drugs, nonsteroidal anti-inflammatory drugs, or fluorouracil
* No documented dihydropyrimidine dehydrogenase deficiency
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent immunotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No concurrent hormonal therapy
* At least 28 days since prior radiotherapy
* No concurrent radiotherapy
* At least 4 weeks since prior investigational agents
* No other concurrent experimental medications
* No concurrent drugs known to induce cytochrome P450 3A4 (e.g., rifampin, phenytoin, carbamazepine, or barbiturates)
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery

The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.

Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted for an orthopedic surgical procedure
* All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA

Exclusion Criteria:

* Pregnancy
* Serious systemic illness due to renal, cardiac or hepatic disease
* Inability to complete follow-up assessments
* Allergy or intolerance to retapamulin
* BMI \> 30
* Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy
* Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled
* Antibiotics administered during the course of the study will be recorded (name, dose and dates)
Comparison of the Effectiveness of Bowel Preparations Before Colonoscopy

Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could be suitable substitution of polyethylene glycol.

This study will be unicenter, randomized and single blind. It focuses on studying the effectiveness of four preparations for bowel cleansing before colonoscopy. Polyethylenglycol (PEG) will be compared as a gold standard of bowel cleansing with low volume preparations: Sulfate-based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium citric-acid and sodium picosulfate. The effectiveness will be rated according to a quality of bowel preparation (Boston Bowel Preparation Scale) and detection of a colorectal neoplasia. The aim of this project is to compare the effectiveness of each four preparations.

Primary endpoint: To compare a quality of bowel preparation. Secondary endpoint: To compare a detection of colorectal neoplasia in those preparations.

Main hypothesis: PEG as a gold standard of bowel cleansing preparation is not worse than the other compared preparations.

Secondary hypothesis: PEG is not worse in detection of colorectal neoplasia than the other compared preparations.

Methods: There will be 400 patients included in the project with all indications for colonoscopy (age ≥ 18 years, no upper age limit) except the exclusion criteria. The patients will be offered to participate in the study at the Endoscopy unit when arranging the examination. In case of agreement they will sign informed consent and they will be educated about the correct process of bowel preparation. They also get all the instructions in printed version and questionnaire of preparation tolerability. The advantages for the patients in study will be earlier date of colonoscopy. On the day of colonoscopy, the patients will submit the questionnaire and undergo standard colonoscopy examination.

The quality of a bowel cleansing will be evaluated by the experienced endoscopists who will be blinded about a type of bowel preparation. The effectiveness will be assessed by the degree of bowel cleansing (Boston Bowel Preparation Scale) and ADR, aADR and number of cancers diagnosed. The GE unit staff will record all results in the on-line study database. Results will be statistically evaluated in Institute of Biostatistics and Analyses, Masaryk University, IBA MU).

Eligibility Criteria:
Inclusion Criteria:

• Individuls ≥ 18 years old undergoing colonoscopy for all indications except exclusion criteria

Exclusion Criteria:

* Active idiopathic bowel disease
* Chronic renal insufficiency
* Serious internal comorbidity
* Planned therapeutic colonoscopy
* No informed consent signed (with the study and/or with the colonoscopy)