cyrilzakka/clinical-trials huggingface dataset:
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients at least 18 years of age
* Constipated according to ROME I criteria
* If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, double- barrier method, 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 that is not associated with hemorrhoids or anal fissures.
* Patients with hypo- or hyperthyroidism as determined by medical history.
* Patients with severe renal impairment.
* Patients with moderate or severe hepatic impairment.
* Patients with known or suspected perforation or obstruction.
* History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
* Patients with symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions.
* Patients with a known history of organic cause for their constipation.
* Patients currently taking, or planning to take 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 tegaserod (or any of its excipients) or polyethyleneglycol.
* 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 screening
* Patients that are currently taking, or have previously been treated with polyethyleneglycol3350 or tegaserod.
Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus

Aim:

The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type 2 diabetes.

Methods:

A prospective study will be performed in 20 uncontrolled patients previously treated with dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8 mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule.

* The following variables were assessed before (basal values) and after 4 months of each treatment period:

  1. Hormonal and metabolic determinations: fasting plasma glucose, insulin, catecholamine, lipid profile and HbA1 levels.
  2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity, platelet aggregation, fibrinogen and plasminogen levels.
  3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at the end of each treatment period, a 12-hour metabolic profile including measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at fasting and every 2 hours (7:00 am to 7:00 pm)will be done

Measurements were be made at fasting

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes patients with fasting glucose values \>7.78 mmol/L and/or glycated hemoglobin exceeding 1.0% or more the normal range (4-8.5%) after 2 or more months of a diet therapy

Exclusion Criteria:

* any severe concomitant illness
* nephropathy (serum creatinine \>1.6 mg/dL and microalbuminuria)
* uncontrolled hypertension (BP \>190x120 mmHg)
* stroke
* peripheral vascular disease
* marked dyslipidemia (total cholesterol\>6.5mM/L and triglycerides levels \>2.8mM/L)
* coagulopathy
* proliferative retinopathy and use of hypolipemic and anticoagulant medications or autonomic neuropathy
* assessed by blood pressure response to standing
* beat-to -beat heart rate variation
* Valsalva maneuver and handgrip test.
High Intensity Phototherapy: Double vs. Single

Intensive phototherapy in form of double light is used worldwide in the treatment of severe neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency of phototherapy. This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using light emitting diodes, and whether there is an upper limit for the efficacy of phototherapy.

Hyperbilirubinemia occurs in 60 - 80 % of newborns during the first days of life, among others because of immaturity of the enzyme uridin-glukuronosyl-transferase (UGT1A1) in the liver. In seldom cases with very high total serum bilirubin concentration (TsB), bilirubin can cross the blood-brain barrier and the deposition of unconjugated bilirubin in the central nervous system may cause acute bilirubin encephalopathy (ABE). This can progress to chronic bilirubin encephalopathy (CBE), a devastating condition, which unfortunately still occurs, even in industrialised countries.

Hyperbilirubinemia gets severe for 2 - 6 % of infants born at term or late preterm, which means, they need treatment to prevent ABE and the treatment of choice is phototherapy due to its efficacy and safety. Hereby bilirubin in the skin and plasma is converted to photobilirubins; they are water-soluble and can be excreted through the liver without conjugation. They are presumably non-toxic. In most departments, single phototherapy is first choice. To avoid the above-mentioned damaging condition, it is very important to optimize phototherapy.

Former fluorescent tubes were used as light source, but now light emission diodes (LED) are used.

This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using LED, and whether there is an upper limit for the efficacy of phototherapy.

It is a prospective, randomised controlled study. The infants will be randomized to either 1: Conventional phototherapy with blue LED light from above and a distance from light source to mattress of 30 cm, giving a light irradiance of 66 µW/cm2/nm or 2: Conventional phototherapy combined with a light blanket (Bilisoft) with a light irradiance by the skin of 39 µW/cm2/nm. TsB will be measured at start and after 12 - and 24 h of treatment. Based on the calculation of strength 72 infants will be needed in this study. As statistical methods t-tests will be used and multiple linear regression models will be used to adjust for confounding.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy newborn infants with hyperbilirubinemia without signs of hemolytic disease
* gestational age ≥33 weeks
* birth weight ≥1800 g
* The infants should be treatable in a cradle

Exclusion Criteria:

* Infants fulfilling the indications for exchange transfusion or double phototherapy due to a very high initial or rapidly increasing TsB will not be enrolled.
From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy

Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients.

The picture of precisely coordinated immune adaptations over time at the maternal-fetal interface level and altered in pregnancy complications, could reveal a specific "immune clock" in tumors. The study aims to decipher mechanisms of immunodeficiency by helping to predict recurrence in patients with endometrial cancer and identify molecular pathways that are turned on or off in progression from lesions early to advanced neoplasia. This will allow the discovery of potential immunotherapy targets to interfere with the immune escape activation process or to reactivate/re-educate the immune response.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years;
* Histological diagnosis of endometrial hyperplasia with and without atypia, carcinoma of the endometrium histotype endometrioid at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma that are subjected to surgery;
* Adequate biological material to be able to carry out the analyzes previously described;
* Written informed consent (only for patients in the prospective part and/or in follow-up);
* For the retrospective part: availability of samples adequately stored at the Institute biobank and availability of follow-up data.

Exclusion Criteria:

* Comorbidities not controlled with adequate medical therapy;
* Infections of the endometrial cavity (pyometra);
* Synchronous tumors;
* Neoadjuvant treatments;
* Previous radiation treatments on the pelvic region.
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.

Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.

Eligibility Criteria:
Inclusion Criteria:

* Severe nausea and vomiting for at least 6 months
* Documented delayed gastric emptying
* Failed extensive medical treatment

Exclusion Criteria:

* Previous gastric surgery
* Pregnancy or planned pregnancy
* Primary eating or swallowing disorders
* Scheduled or planned MRI testing
Exploring the Recovery Function of Sleep in Neurodegeneration

The overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. To this end, the investigators will follow an exploratory approach in a preferably broad data set collected in patients with neurodegenerative diseases associated with abnormal protein aggregation and in healthy humans.

First, the investigators want to assess the relationship between sleep parameters (e.g. sleep intensity) and behavioral/cognitive performance and subjective measures (e.g. sleep quality, mood, and sleepiness) in patients with neurodegenerative disorders associated with abnormal protein aggregation. Healthy subjects will be assessed for procedure validation and reference purposes. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Good general health or confirmed diagnosis of neurodegenerative disease associated with abnormal protein aggregation along international criteria
* Age above 18 years
* In ambulant setting: ability to apply the ambulant EEG device for the duration of the study, either alone or with help of co-habitant if MoCA \< 20

Exclusion Criteria:

* Failure to give informed consent
* Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
* Known or suspected non-compliance, drug- or medication abuse
* Inability to hear the tones to be applied during sleep in auditory stimulation experiments
* Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
* Regular intake of drugs that may alter the relationship between sleep and outcome variables under investigation (opioids, benzodiazepines and z-drugs (nonbenzodiazepines)).
* Clinically significant concomitant disease states
* Too high (disease) burden for patients
* Additional non-medical exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving eye tracking)
Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.

OBJECTIVES:

* Determine the toxicity and tolerance of sequential therapy with prolonged
* Determine the response rate and time to progression in this patient
* Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route.

OUTLINE:

* Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses.
* Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.

PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery

  * Stage IC, II, III, or IV

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* SGOT no greater than 3 times upper limit of normal
* Bilirubin no greater than 2.0 mg/dL
* No clinically significant hepatic disorder

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
* No clinically significant renal disorder

Cardiovascular:

* No clinically significant cardiovascular condition

Other:

* Normal GI function allowing reliable administration of oral medication
* No active infection requiring systemic medical therapy within past week
* No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder)
* No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No dementia or altered mental status that would preclude consent
* Not pregnant
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for ovarian epithelial carcinoma

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy for ovarian epithelial carcinoma

Surgery:

* See Disease Characteristics
Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots throughout the body that can damage major organs and cause death. TTP is treated with plasma exchange (also called "plasmapheresis"). Patients who do not respond initially to plasma exchange often are helped by later treatment with rituximab. The purpose of this study is to see whether combining low doses of rituximab with plasma exchange will help patients get better sooner and reduce the chance of getting TTP again.

This is a pilot safety/efficacy study of adjuvant low dose rituximab (100 mg/week x 4 doses) plus standard plasma exchange and corticosteroids for the treatment of thrombotic thrombocytopenic purpura (TTP) with severe ADAMTS13 deficiency. Results for study subjects will be compared to historical controls treated initially with plasma exchange and corticosteroids. This study proposes to test the hypothesis that adjuvant low dose rituximab may decrease the incidence of a composite primary endpoint (exacerbations or refractory disease) in acquired TTP with severe ADAMTS13 deficiency. A novel ADAMTS13 assay will be used to identify patients with TTP and severe ADAMTS13 deficiency for enrollment, and to assess the utility of ADAMST13 as a biomarker for response to therapy and prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or greater
2. Diagnosis of suspected thrombotic thrombocytopenic purpura (TTP)

   1. Platelet count of \< 80,000 for newly diagnosed patients and \< 120,000 for relapsed patients
   2. Microangiopathic hemolytic anemia with RBC fragmentation
   3. LDH \>1 x ULN
3. Subjects who will receive treatment for TTP with plasma exchange
4. Subjects who have not started the 5th plasma exchange
5. Plasma ADAMTS13 activity \<10%

Exclusion Criteria:

1. Treatment for TTP within the past 2 months
2. Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures) or clinical evidence of enteric infection with E. coli O157:H7 or related organism
3. Currently under treatment for cancer (subjects with localized skin carcinoma will be accepted)
4. Microangiopathic hemolytic anemia due to a mechanical heart valve
5. Severe hypertension, as defined by systolic BP \>180 AND diastolic BP \>120, or papilledema
6. Organ or stem cell transplant
7. Use of calcineurin inhibitors (sirolimus, tacrolimus, cyclosporin A) within 6 months prior to diagnosis of TTP
8. Disseminated intravascular coagulation as defined by:

   a. INR \>2.0 (unrelated to anticoagulation, unresponsive to Vitamin K) or b. Fibrinogen \<100 mg/dl
9. Pregnancy
10. Known congenital TTP.
11. Rituximab within the previous year.
12. HIV history or positive serology
13. History of hepatitis B or positive serology for HBsAg or Anti-HBc
14. Persistent or unexplained platelet count below 150,000/μL within 3 months of current TTP presentation
15. Hypersensitivities or allergies to murine and/or humanized antibodies
16. Current participation in trials of investigational therapies or devices, other than central catheters
Mazindol for Cocaine Abuse - 2

The purpose of this study is to evaluate high and low dose mazindol for cocaine abuse.


Eligibility Criteria:
Please contact site for information.
Feeding Study - Effects Post-cardiac Surgery

The purpose of this randomized trial is to clarify the role of enteral nutrition (EN) on the relationship between cardiopulmonary bypass-induced inflammation and insulin resistance by investigating the effects of two different feeding strategies in infants following cardiac surgery. The study's primary objective is to determine if early and higher volume feeding modifies the relationship between the severity of postoperative systemic inflammation and insulin resistance.

Good nutrition is important for patients after surgery. Patients who are given food tend to have fewer infections, better wound healing, and are possibly discharged more quickly from the intensive care unit and hospital. However, the best time to start feeds and the speed at which they can be increased is unclear. This may be particularly true for young children who have undergone heart surgery using a heart-lung bypass machine (bypass surgery). Bypass surgery can cause inflammation that can change the way the body uses energy and nutrients. Specifically, after bypass the body can become insensitive to insulin (insulin resistant), which means that the cells in the body don't take up sugar from the blood like they are supposed to, and this may lead to complications from the surgery. In a recent study we found that inflammation and insulin resistance was not associated with as many complications in children who were being fed. We are not sure if feeding changed the way in which the body responded after surgery or if doctors chose to feed only patients who were already recovering well. In general, doctors often hesitate to feed patients immediately after surgery because they worry that the body may not be ready for food although there is not much information to prove that this worry is correct. Starting feeds early using a structured feeding plan may be good during the recovery from heart surgery, even in our most vulnerable patients. We therefore designed this study to see if starting feeds early after bypass surgery and increasing them more quickly than our usual routine would decrease inflammation and insulin resistance. We will only study children younger than 6 months of age because they are at higher risk of complications from bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* less than 6 months of age
* weight \> 2.5kg
* surgery using cardiopulmonary bypass
* expected duration of ventilation \> 6 hours

Exclusion Criteria:

* cardiac transplantation
* prematurity (\<37 weeks gestation AND under 28 days of life)
* intrauterine growth restriction
* NEC
* structural gastrointestinal anomalies
* known preoperative feeding intolerance
* diabetes or known metabolic disorder
* preoperative liver or renal dysfunction
* postoperative contraindication to enteral feeding as determined by clinical team
* previous enrollment at an earlier operation
* in the opinion of the clinical or research team the patient is too well to participate, such that slow escalation to feeds would lead to hunger and therefore be considered inappropriate.
Regeneration of Immature Teeth. Case Series

This clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically.

All teeth will be disinfected using either triple antibiotic paste (a mixture of metronidazole, ciprofloxacin and amoxicillin mixed with sterile glycole) or non setting calcium hydroxide applied to the pulp space with a sterile lentulospiral and then closed temporarily with a sterile sponge and temporary restoration for 2-3 weeks to allow disinfection of the canals teeth will be reentered under rubber dam isolation and all intracanal medicaments will be washed out from the canal using 10 ml of 2.5% sodium hypochlorite and 20 ml of Ethylene diamine tetra acetic acid (EDTA). Then, a sterile endodontic file will be inserted past the canal terminus into the periapical tissues to induce bleeding to fill the canal space as much as possible and subsequently sealed with a double coronal seal using bioceramic repair material and composite filling. All the teeth will be monitored clinically and radiographically on a biannual basis.

Eligibility Criteria:
Inclusion Criteria:

1. Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.
2. An immature/open apex.
3. Tooth does not need post and core restoration.
4. Medically healthy patients with no known allergy to used materials.

Exclusion Criteria:

1. Medically compromised patient,
2. Teeth with periodontal involvement
3. Teeth with vertical root fractures,
4. Non-restorable teeth,