cyrilzakka/clinical-trials huggingface dataset:
Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo in constipated patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients at least 18 years of age
* Constipated according to ROME I criteria
* On average, fewer than 3 satisfactory BMs per week during the observation period
* If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
* Are otherwise in good health, as judged by a physical examination
* In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

* Patients with heme positive stool at screening. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion.
* Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results.
* Patients with known or suspected perforation or obstruction.
* History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
* Patients with a known history of organic cause for their constipation.
* Patients meeting the ROME definition of Irritable Bowel Syndrome
* Patients currently taking any of the following medications that are known to effect bowel habits:

  * Antidiarrheals
  * Antacids containing magnesium or aluminum salts
  * Anticholinergics
  * Antispasmodic agents
  * Erythromycin and other macrolides
  * Octreotide
  * Lotronex, Zofran, or other 5-HT3 antagonists
  * Zelnorm, or other 5-HT4 agonists
  * Opiods/narcotic analgesics
  * Prokinetics
  * Serotonin re-uptake inhibitors or tricyclic antidepressants
  * Calcium antagonists
* Patients who are breastfeeding, pregnant, or intend to become pregnant during the study.
* Female patients of childbearing potential who refuse a pregnancy test.
* Patients with a known allergy to corn or polyethylene glycol.
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Patients who, within the past 30 days have participated in an investigational clinical study
* Patients that have undergone a colonoscopy within 30 days of beginning the 14 day observation period.
* Patients that are currently taking, or have previously been treated with polyethyleneglycol3350
Carotegrast Methyl in Ulcerative Colitis

Carotegrast methyl, an oral α4-integrin inhibitor, was recently approved in Japan for the treatment of active ulcerative colitis (UC). However, real-world data regarding its efficacy and safety remain scarce. This study aimed to assess the clinical effectiveness and safety profile of carotegrast methyl in patients with active UC.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with UC based on endoscopic and histological findings
* Patients with clinically and endoscopically moderate UC who were eligible for outpatient treatment (however, patients in clinical remission or with mild clinical activity but endoscopically moderate UC were also considered eligible as an exception)
* Patients who exhibited an inadequate response to or intolerance of 5-ASA formulations (including topical agents) or budesonide formulations (including topical agents)
* Patients who provided informed consent for endoscopic examinations at the start of treatment and during the treatment period
* Patients who agreed to blood sampling and fecal biomarker tests

Exclusion Criteria:

* Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)
* Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)
* Patients with a history of malignancy
* Patients with severe hepatic dysfunction
* Pregnant women or those planning pregnancy
* Patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis
Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery

Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate.

Following Siliso study we found a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake durong labour. However due to some limitations no clear conclusion could be drawn.

The present study is designed to examine the relationship between a high calory oral intake (\>44 kCal/hour during labour) and the rate of instrumental delivery.


Eligibility Criteria:
Inclusion Criteria:

* nulliparous women
* singleton pregnancy
* social insurance
* uncomplicated pregnancy
* no contraindication to vaginal delivery

Exclusion Criteria:

* scheduled caesarean section
* labor \< 37 weeks of gestational age
* cervical dilation \> 8cm at inclusion
* scheduled induced delivery
* contraindication to pushing effort during labor and delivery
* BMI \> 40 kg/m2
* medical history of daibetes mellitus, hypertension, heart disease
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 swollen and at least 6 tender joints
* C-reactive Protein (CRP) \> Upper Limit Normal (ULN)
* Prior inadequate response from biologic therapy
* Stable regimens of concomitant RA therapies

Exclusion Criteria:

* Unstable medical conditions
Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.

Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. Using antioxidants during perioperative period may help improve this condition. Vitamin E and zinc have antioxidant effects. In this study, the effects of oral co-administration of zinc and vitamin E supplements on short-term postoperative outcomes in cardiac surgery patients will be investigated.

Cardiac surgery is a life-saving invasive procedure that may often be associated with significant postoperative complications. Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. This is a post-ischemic complication that occurs when blood circulation is restored and causes inflammation and oxidative damage. Cardiac surgery with reperfusion injury can adversely affect the prognosis. Thus, reducing the extend of reperfusion injury and its associated pathways can be considered an important clinical issue. Reducing oxidative stress and inflammation may play an important role in the outcomes of heart surgery. Using antioxidants in pre or post surgery may help improve this condition. Vitamin E is a well-known fat-soluble antioxidant that prevents lipid peroxidation. Zinc has several roles including antioxidant effects. Zinc acts as a cofactor for important enzymes that contribute to the proper functioning of the antioxidant defense system. In addition, the mineral is involved in reducing free radicals by inducing metallothionein synthesis and circulating zinc concentration decreases significantly after surgery. In this study, the effects of oral co-administration of zinc and vitamin E supplements shortly before and after surgery on short-term postoperative outcomes, plasma concentrations of biomarkers of oxidative stress and inflammation in patients will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for open heart surgery (coronary artery bypass grafting)

Exclusion Criteria:

* Frequent use of multivitamin, zinc, vitamin E, vitamin C, omega-3 supplements over the past month
* Active cancer, chronic rheumatic disease, ESRD, liver cirrhosis, severe infection (WBC\> 12000 mm3) before surgery
* Continued use of corticosteroids or NSAIDs for two weeks prior to admission (except A.S.A)
Organizational Skill Training (OST) in Schools

The primary aim of this project is to address the need for an effective school-based intervention for elementary school-aged students with Organization, Time Management, and Planning (OTMP) deficits by adapting an evidence-supported clinic-based intervention so that it can be implemented in school settings. Investigators are learning to adapt an individual, clinic based program (OST-C) for children diagnosed with Attention Deficit Hyperactive Disorder (ADHD) to children with OTMP problems. Investigators will be collecting data . To this end, investigators will be collecting data on implementation (such as feasibility and acceptability), program development (what changes to the individual OST-C program were made based on findings during this study) and limited outcome data (repeated measures collection and pre- and post-treatment collection on a small sample, no control group).


Eligibility Criteria:
Inclusion Criteria:

* Children will be recruited based on their parents' interest level in having them participate in a program to improve their organizational skills.
* Investigators will consider feedback from their 3rd to 5th grade general education or inclusion classroom teacher based on OTMP problems difficulties that interfere with functioning (difficulty in morning routine or end-of-day packing up routine, a high percentage of incomplete or missing assignments, messy desk or Seat Sack).
* Investigators will not use specific cutoffs on normed measures for determining eligibility based on these difficulties, as the intention is to develop a program that can be easily disseminated.
* Availability to attend twice-weekly sessions with the OTMP trainer either during the school day (during a time when they would not be pulled from academic content) or during after-school hours.

Exclusion Criteria:

* Children with Mental Retardation will not participate in the study, due to the difficulty they would likely have understanding the content of the sessions.
Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME

The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility Criteria:
Inclusion Criteria:

1. age: 20-80 years
2. biopsy-proven adenocarcinoma of the rectum
3. clinical staging (c or yc): T0-3, N0-2, M0
4. Rectal cancer located 3-12 cm from the anal verge
5. ECOG performance status: 2 or less
6. BMI: less than 30

Exclusion Criteria:

1. Synchronous colon cancer or other malignancy
2. Obstructing rectal cancer
3. Pregnant or breast-feeding
4. Receiving any other study agents
5. Fecal incontinence
6. History of prior colorectal cancer or inflammatory bowel disease
7. Tumor size: more than 7cm in long diameter
8. CRM: mesorectal fascia involvement or less than 1 mm on MRI
Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers

This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFuge™ system in diabetic patients with diabetic foot ulcers. In particular, it will be evaluated whether the microsized fat graft will be able to shorten the healing times of these wounds. Patients will be randomized to the treatment group with adipose tissue processed with the SyntrFuge™ system (injection of autologous microsized adipose tissue) or to the control group represented by the standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have Diabetic Foot Ulcer located at the plantar or dorsal aspect of the foot or the heel with a surface area of 1.0cm2 - 25cm2
2. Index ulcer has been present for greater than four weeks
3. Diabetics included will be those with HbA1c ≤ 12%
4. Subjects aged 18 - 85, inclusive
5. The target ulcer has been offloaded for at least 14 days

Exclusion Criteria:

1. Subjects without decisional capacity
2. Subjects unable to give informed, written consent
3. Subjects with active infection (redness, swelling, pain, suppuration)
4. Subjects with active osteomyelitis to the index ulcer
5. Subjects with previous treatment with Negative Pressure Wound Therapy, growth factors, radiation, hyperbaric O2, or bioengineered tissue product within 30 days of Screening
6. Subjects with a previous diagnosis of HIV or Hep C
7. Subject is pregnant or breast feeding
8. Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
9. Subjects under corticosteroid therapy, unless taking dose of 5mg/dl or less
10. Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
Effect of Laser Treatment on Capillary Malformations

In this research study investigators want to learn more about capillary malformations which are also known as port wine stains.

Investigators are asking children with capillary malformations (port wine stains) to be in the research, because investigators do not have a good idea of what to expect from the current treatments of these malformations. These malformations are treated with laser as clinically indicated and there are no standardized methods to assess improvement.

Capillary malformations, specifically port wine stains, occur in one of every 12,000 live births (0.3% of newborns) with 90% on the face or neck. Pulsed dye laser therapy targeted at hemoglobin (i.e., 585 nm ± 5 nm) is commonly used to lessen the visual coloration and increase skin lightness. Presently, the outcomes of laser treatment are difficult to predict, in part due to the difficulty in quantifying the tissue changes with visual inspection methods. Quantitative skin imaging methods are currently being applied to measure the features and response to treatment for infantile hemangiomas. The current study proposes to apply these methods in the treatment of capillary malformations, e.g., port wine stains. The purpose is to determine (1) the effects of laser treatment on capillary malformations (using quantitative skin imaging methods and standard clinical assessment and (2) the relationships between the imaging outcomes immediately after treatment and after healing. In the within-subject design we aim to measure color, temperature, blood concentration and tissue mechanical properties for the capillary malformation relative to an un-involved site at baseline (prior to treatment), immediately following laser surgery and over time. Imaging outputs will be compared to the standard clinical evaluation in up to 100 patients from the Hemangioma and Vascular Malformation Center (HVMC) at regular intervals to determine changes over time. Skin sites will be imaged for color (size, erythema, blue color, lightness, excess erythema, uniformity), thermography, blood concentration and tissue mechanical properties (e.g., elasticity). Skin characteristics will be examined at baseline, prior to surgery, immediately following laser treatment, just prior to discharge and at 2 and 4-6 weeks following treatment. For subjects receiving multiple laser treatments, the procedures will be repeated after each surgery. Enrollment will occur over 2 years. Patients will be evaluated for a period of up to 6 months following the last surgery. We expect the research to provide objective measures to clarify the effectiveness of laser treatment and permit effective measurement of tumor response for therapeutic protocols.

Eligibility Criteria:
Inclusion Criteria:

* age 0-17
* Diagnosis of a capillary malformation
* Scheduled to undergo laser treatment of the capillary malformation
* Able to tolerate imaging procedures

Exclusion Criteria:

* Not scheduled to undergo laser treatment for capillary malformation
* Other vascular anomaly
* Not able to tolerate imaging procedures
Effects of Berry Nectars Sweetened With Inverted Sugar on Post-meal Blood Sugar

Berries have been shown to improve postprandial glucose and insulin responses to sucrose. During processing and storage of berry products, sucrose is inverted to glucose and fructose. The effects of berries on the glycemic response induced by inverted sugar are not known. The purpose of this study is to determine whether berries are effective in lowering the postprandial glucose and insulin responses induced by inverted sugar.


Eligibility Criteria:
Inclusion Criteria:

* BMI 20-28 kg/m2
* Normal fasting plasma glucose

Exclusion Criteria:

* Smoking
* Diabetes or other chronic disease
* Antibiotic medication within the past 3 months
* Blood donation within the past month
"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.

The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70
* ASA class I, II, and III
* undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery

Exclusion Criteria:

* patients undergoing emergency surgeries
* pregnant patients
* patients with end stage renal disease or chronic kidney disease(GFR less than 60)
* patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
* patients' refusal
* patients with allergy to recuronium
Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome

From 1999, several studies have showed that the use of vasoconstrictors in association with albumin are effective in the treatment of hepatorenal syndrome (HRS). The rationale of the use of vasoconstrictors together with albumin in the treatment of this severe complication of portal hypertension in patients with cirrhosis is to correct the reduction of the effective circulating volume due to the splanchnic arterial vasodilatation.In most of these studies terlipressin, a derivate of vasopressin, has been used as vasoconstrictor as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr. In some studies midodrine, an alpha-adrenergic agonist, given by mouth has been used as vasoconstrictor at a dose ranging from 2.5 up to 12.5 tid together with octreotide, an inhibitor of the release of glucagon, given subcutaneously at a dose ranging from 10 µg upt to 200 µg tid. To the day, there isn't a study comparing terlipressin + albumin versus midodrine + octreotide + albumin in the treatment of HRS in patients with cirrhosis.Thus, the aim of the study is to compare terlipressin + albumin vs midodrine + octreotide + albumin in the treatment of the HRS in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis and diagnosis of HRS type 1 or 2,serum creatinine \> 2.5 mg/dl

Exclusion Criteria:

* Diagnosis of HCC with a staging beyond the Milan Criteria di Milano
* Septic shock (systolic arterial pressure \< 90 mmHg
* Significant heart or respiratory failure
* Peripheral arteriophaty clinically significant
* Previous heart stroke or significant alteration of the ECG
Registry of Subject Treated With ClariFix

A multi-center, prospective, non-randomized, observational registry to asses the results of the ClariFix(TM) device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Participant is scheduled to receive treatment with the ClariFix device in accordance with the ClariFix Instructions for Use.
* Participant is able to provide consent and willing to adhere to the study visit schedule.

Exclusion Criteria:

* Participant is scheduled to have additional treatment and/or procedures completed at the same time of treatment with the ClariFix device.
* Participant is scheduled to have additional nasal or sinus treatments and/or procedures completed within 3 months of treatment with the ClariFix device.
Study of Sc-FOS for Pouchitis Prevention

The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.


Eligibility Criteria:
Inclusion criteria:

1. Age 18-65 years.
2. History of ulcerative colitis
3. Ileostomy closure after IPAA
4. Ability to give appropriate consent

Exclusion Criteria:

1. Crohn's disease.
2. Perianal disease (including abscess, fissure, or stricture)
3. Pregnancy
4. Lactation
5. Concurrent treatment for IBD or pouchitis