cyrilzakka/clinical-trials huggingface dataset:
CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)

Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.


Eligibility Criteria:
Inclusion Criteria:

* ulcerative colitis (verified by mucosal histology and endoscopy)
* Clinically active ulcerative colitis (SCCAI ≥ 3)

Exclusion Criteria:

* Endoscopically inactive disease (Endoscopic Mayo Score of 0)
* Lactose or milk protein intolerance
* Celiac disease
* Not able to understand or speak Danish.
* Pregnant or nursing.
* Growth of pathogenic bacteria in stool culture from 4 weeks before and until randomization (Salmonella, Campylobacter, Yersinia or Clostridium Difficile.)
Obesity and Financial Incentives

Investigate whether economic incentives help obese individuals to lose weight.


Eligibility Criteria:
Inclusion Criteria:

* BMI above 30
* age between 18 anf 75
* registered residence in the German federal state of Baden-Württemberg

Exclusion Criteria:

* considerable language barriers
* pregnancy
* psychological disorders
* eating disorders
* tumor disease within last five years
* abuse of alcohol
* abuse of drugs
* serious general diseases
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Drug naive
* Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
* Fasting C-peptide ≥1.0 ng/mL
* Body mass index ≤40 kg/m²

Exclusion Criteria:

* Recent cardiac or cerebrovascular event
* Elevated serum creatinine
Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)

This study is:

* A single-center, randomized, prospective controlled trial.
* To prove superiority of active pain management group compared to control group by the percent of pain intensity difference of outpatients with lung cancer pain.
* 204 patients will be recruited.

* The recruited patients in both group will be provided the education about pain-killer, and received medicines including opioids according to their numeric rating scale (NRS)
* Active management group will be provided additional telephone counseling and dosage modification by specialized nurse for cancer pain.
* The percent of pain intensity difference (%PID)

  * PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with lung cancer.
* The patients with uncontrolled lung cancer pain - more than and equal NRS 4 pain during previous 24 hours for background pain, or more than and equal 3 times/day for breakthrough painkiller medication.
* Over 20 year-old male or female.
* The patients can be able to received telephone counseling by investigator's decision.

Exclusion Criteria:

* Drug or alcohol abusers.
* Child-bearing women or pregnant women.
* The patients with moderate to severe psychiatric problems.
* The patients who have hypersensitivity to opioids.
ArmeoSenso - Reward

This study investigates the use of motivating/rewarding features in a computer based arm rehabilitation program. Half of the subjects will take part, besides receiving standard therapy, in a computer based program delivering a game like scenario with visual effects and monetary rewards in case of successful level completion, while the other half will take part in a similar program without visual effects or the possibility to earn money.

Rewards not only increase motivation to train, but have also been shown to influence motor skill learning via activation of dopaminergic brain structures. In goal oriented tasks, receiving information about goal achievement has a rewarding value, which is further increased if performance has monetary consequences. Computer games often strengthen this kind of information by presenting explosions and other salient stimuli when a goal is achieved (e.g. a target has been reached). The current study investigates the outcome of an arm rehabilitation program, based on such a computer game delivered in two versions. Stroke patients are asked to use their impaired arms to perform goal oriented movements. Movements are translated into movements of a virtual arm on a computer screen. Goals are "meteors", threatening to destroy a planet on which they fall, if not caught by the virtual arm. One version of the computer game delivers state of the art graphics including a number of visual effects and, if the planet was protected successfully, information about a monetary reward, whereas the other version of the program delivers schematic graphic objects only. Training time and intensity are kept constant and outcome measures, including standard clinical motor assessments, are compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* stroke survivor (max. 100 days post-stroke)
* upper extremity motor deficits
* patient can lift the paretic arm against gravity
* patient can move the hand at least 20x20 cm in a horizontal plane
* patient is able and willing to participate
* patient has signed informed consent

Exclusion Criteria:

* severe aphasia (impairing verbal instructions)
* severe dementia (impairing the capability to understand instructions)
* severe depression (impairing motivation to train)
* relevant (in the judgement of the investigator) impairment of visual perception, (impairing perception of goals and feedback on the computer screen)
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

The purpose of this study is to determine the efficacy and safety of Topiramate in comparison to Carbamazepine in Benign rolandic epilepsy.

Benign rolandic epilepsy (BRE) is a common seizure disorder confined solely to children. The disorder is marked clinically by nocturnal generalized tonic-clonic seizures and diurnal seizures consisting of simple partial seizures consisting of brief unilateral facial clonic activity, dysphasia, and drooling. The EEG abnormalities are unique, consisting of generally high amplitude, centrotemporal spikes that are activated by sleep. The seizures typically begin in the first decade and almost always stop by age 16 years. The seizures are usually infrequent although clusters of seizures do occur. When the physician elects to treat, the seizures are usually easily controlled. This is a randomized, open label, active controlled, multi-center based clinical trial to determine the efficacy and safety of Topiramate comparing with Carbamazepine in Benign rolandic epilepsy. The study hypothesis is that topiramate will be more effective in treatment of Benign rolandic epilepsy than Carbamazepine, as evaluated by seizure-free rate at 24 weeks and Intellectual Functioning : KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for Children-Revised) and is generally well-tolerated.

Topiramate (target dose) 4mg/kg/day, B.I.D, oral, for 24 weeks, carbamazepine(target dose) 30mg/kg/day, B.I.D, oral, for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects whose guardians submitted written consent
* Subjects with more than 2 seizures in last 1 year
* Subjects showing one of the following additional criteria
* Psychological burden due to seizure
* Seizure in daytime
* More than 3 seizures in last 6 month
* Convulsive seizure

Exclusion Criteria:

* Abnormalities on MRI, EEG
* Mental retardation
* History of seizure relapse
* Seizures due to organic causes
* Medically serious acute or chronic disease or progressive and degenerative disorders
* Patients who have received an investigational medication
Predictors of Infective Endocarditis Among Patients Managed for Staphylococcus Aureus Bacteremia, Particularly Staphylococcus Aureus Bacteriuria, and Time to Blood Culture Positivity

Staphylococcus aureus is a frequent cause of primary or secondary bacteremia. It is also responsible for many cases of infective endocarditis, for which the therapeutic management is specific. The frequency of infective endocarditis among Staphylococcus aureus bacteremias varies between 2.7% and 23.4%. Many factors associated with the risk of developing endocarditis in patients with S. aureus bacteremia have been described. Two parameters of potential interest remain excluded from this work: blood culture growth time, a marker of bacterial inoculum, and the presence of bacteriuria, which is common during bacteremia. The objective of this study is to evaluate the interest of these two parameters in the prediction of the presence of endocarditis during S. aureus bacteremia. Investigators will conduct a retrospective study including all patients managed for Staphylococcus aureus bacteremia and in whom a urine culture was performed.

The primary objective is to describe the factors associated with the occurrence of endocarditis in patients managed for S. aureus bacteremia and who received a urine cytobacteriological examination (UCE).

The secondary objectives are: to evaluate the factors associated with the occurrence of S. aureus bacteriuria in patients with S. aureus bacteremia and to evaluate the risk factors for mortality in patients managed for S. aureus bacteremia.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age for whom:

  * Blood cultures returned positive for S. aureus
  * A cytobacteriological examination of the urine was performed concomitantly with the positive blood culture for S. aureus
  * Has been tested for infective endocarditis by echocardiography.
* French-speaking patient

Exclusion Criteria:

* Patient with S. aureus bacteremia who has not had an ECBU or echocardiography performed
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his or her data for this research
Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study

3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is started for the evaluation of this tool as a means for achieving total resection of brain tumors at greater safety.

The degree of resection as judged by the surgeon is recorded at the end of surgery for each patient, and then compared with the postoperative MRI. Neurological status before and after surgery, QOL before surgery and at follow-up as well as survival is recorded.

Eligibility Criteria:
Inclusion Criteria:

* Supratentorial glioma

Exclusion Criteria:

* Not willing to participate in study
Detection of LADA in a Hospital in the Mexican Southeast

Patients with Latent Autoimmune Diabetes in Adults (LADA) show autoantibodies that indicate an autoimmune pathogenesis. Glutamic acid decarboxylase autoantibodies (GADA) are most prevalent islet autoantibodies in European patients with LADA. In this sense, it is considered that it is sufficient to determine GADA to identify subjects with LADA from patients with T2D for research purposes. Therefore, the aim was to investigated the presence of GADA in serum of subjects with T2D and its relationship with clinical criteria, metabolic control, drug treatment, and diabetes complications to identify possible patients with LADA in a hospital in southeastern Mexico is worthwhile.

The sample was recruited at the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez", in the period from January 2020 to May 2021. The diagnosis was based in accordance with World Health Organization (WHO, 1999) criteria. Inclusion criteria: 1) patients previously diagnosed with T2D, 2) absence of insulin requirement for at least 6 months after diagnosis, 3) \> 30 and \< 50 years old at diabetes diagnosis, 4) BMI \< 40 kg/m2, 5) subjects who agreed to participate in the study and signed the informed consent before the interview.

Serum GADA and other biochemical concentrations were determined by an enzymatic immunoassay method (Human Anti-Glutamic Acid Decarboxylase ELISA Kit; MyBioSource).


Eligibility Criteria:
Inclusion Criteria:

* patients previously diagnosed with T2D,
* absence of insulin requirement for at least 6 months after diagnosis,
* \> 30 and \< 50 years old at diabetes diagnosis,
* BMI \< 40 kg/m2,
* subjects who agreed to participate in the study and signed the informed consent before the interview.

Exclusion Criteria:

• patients with other types of diabetes, and subjects who did not agree to participate.
A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section

The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.


Eligibility Criteria:
Inclusion Criteria:

* elective cesarean
* previous cesarean (\<4)
* cesarean for distocia

Exclusion Criteria:

* emergency cesarean ( fetal distress)
* risk of obstetrical bleeding
* maternal coagulation defects
* adnexial mass
* uterin myoma at incision site
A Study to Evaluate Rivoceranib Plus Best Supportive Care Compared to Placebo Plus Best Supportive Care in Participants With Gastric Cancer

The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best supportive care (BSC) compared to placebo plus BSC in participants with advanced or metastatic gastric cancer (GC).


Eligibility Criteria:
Inclusion Criteria:

1. Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction.
2. Locally advanced unresectable or metastatic disease that has progressed since last treatment.
3. One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
4. Failure or intolerance to at least 2 prior lines of standard chemotherapies with each containing one or more of the following agents:

   * fluoropyrimidine (intravenous \[IV\] 5-fluorouracil \[5-FU\] capecitabine, or S-1),
   * platinum (cisplatin or oxaliplatin),
   * taxanes (paclitaxel or docetaxel) or epirubicin,
   * irinotecan,
   * trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive,
   * ramucirumab
   * nivolumab
   * pembrolizumab
5. Disease progression within 6 months after the last treatment.
6. Adequate bone-marrow, renal and liver function.
7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
8. Expected survival of ≥12 weeks, in the opinion of the investigator.

Exclusion Criteria:

1. History of another malignancy within 2 years prior to randomization except for the following: Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (CIS); Curatively treated cervical CIS; Thyroid papillary cancer with prior treatment; Carcinoma of the skin without melanomatous features; Prostate cancer which had been surgically or medically treated and not likely to recur within 2 years.
2. Central nervous system (CNS) metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization.
3. Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 1 week in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.).
4. Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the participant at risk.
5. Participants who had therapeutic paracentesis of ascites (\>1 Liter \[L\]) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (\>1L) within 3 months of starting study treatment.
6. Previous treatment with rivoceranib.
7. Known hypersensitivity to rivoceranib or components of the formulation.
8. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.
Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery

This is a Phase 2, multicenter, open-label, single-arm, sequential cohort study to be conducted in up to 30 subjects. The study will evaluate subjects undergoing primary, elective, off-pump CABG surgery with median sternotomy.


Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent prior to initiation of any study related procedures
* Male or female subjects at least 18 years of age
* Subject is accepted for primary, elective off-pump CABG surgery with planned sternotomy without other planned concomitant cardiac surgical procedures
* New York Heart Association (NYHA) Class III or less heart failure
* Available for follow-up assessments

Exclusion Criteria:

* Prior surgery with median sternotomy
* Prior CABG surgery
* Women of childbearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives,barrier methods, or other contraception deemed adequate by the investigator); women who are pregnant or lactating
* Stroke within the previous 6 months
* History of stroke with residual neurological deficit
* Intracranial neoplasm, arteriovenous malformation or aneurysm
* Any prior exposure to NU172
* Contraindication to unfractionated heparin
* Refusal to undergo blood transfusion, should it be necessary
* Symptomatic gout
* Serum uric acid \>11mg/dL at screening
* Known bleeding diathesis
* Known thrombotic diathesis
* Participation in any study of an investigational device, drug or biologic within 30 days prior to planned surgery
* Any other disease or condition that, in the judgment of the investigator would interfere with the subject's ability to comply with study procedures and requirements
Preventing Central Catheter-Associated Bloodstream Infections

The research is an algorithm study focused on nursing care in order to prevent Central Catheter-Associated Bloodstream Infections in intensive care units. The algorithm prepared with infection control measures related to central catheter care will be applied with intensive care nurses and the effect of the algorithm on central catheter-related bloodstream infections will be examined. In practice, a 20-day preliminary assessment, a three-month intervention period, and a three-month post-intervention planning were made.

In the light of literature review and guidelines, intensive care nurses will care for central catheters through an algorithm created with infection control measures.

Nurse-focused algorithm content to prevent central catheter-related bloodstream infections Hand hygiene practice Use of personal protective equipment according to infection control measures Evaluation of the catheter insertion site in terms of redness, swelling, tenderness, discharge, bleeding Use of \>0.5% chlorhexidine solution containing 70% alcohol for skin antisepsis at the catheter insertion site (if there is no chlorhexidine, povidone iodine + 70% alcohol solution is used) Changing the transparent, semi-permeable dressings every 5-7 days and gauze dressings every 48 hours for catheter dressing Catheter dressing with aseptic technique Use of sterile, preservative-free saline for flushing and locking in order to ensure the lumen of the catheter.

Aseptic conditions should be observed if the junction of the catheter and the infusion set (Hub) is to be touched.

Keeping the used triple taps closed Changing IV fluid sets and connection tools at appropriate times Daily assessment of CVC requirement The research will be carried out in the 1st, 2nd and 3rd Level Intensive Care Units of Bilecik Training and Research Hospital in Bilecik, Turkey. Infection rates will be compared in the study. In the study, the date of June 2021 will be taken as a preliminary assessment and training time for nurses. July-September 2021 will be the intervention period of the study, and October-December 2021 will be the post-intervention period.

Eligibility Criteria:
Inclusion Criteria:

* A central venous catheter was inserted in the intensive care unit or before the intensive care unit admission, and being followed up in the intensive care unit with a central venous catheter.

Exclusion Criteria:

* Patients whose central venous catheter was terminated during intensive care follow-up.
Step Down FSH Approach and Late Follicular Phase in Progesterone Level

Step-down approach and late follicular phase progesterone level

The study will be performed using the stimulation medication Gonal-F which is a recombinant FSH-preparation. Due to application as pen-device, it allows reduction of the stimulation dosage in steps of 12.5IU.

It is important to evaluate the dynamics of progesterone-rise after final oocyte maturation, as this dynamic might also have an influence on the receptivity of the endometrium.

Eligibility Criteria:
Inclusion Criteria:

* Primary / secondary infertility with the indication for IVF/ICSI
* Patients age 18 - 40 years
* 60 kg up to and including 90 kg
* BMI of 18-32 kg/m2
* Menstrual cycle length of 24-35 days

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

Exclusion criteria:

* presence or history of an endocrine abnormality
* abnormal outcome of blood biochemistry or hematology
* relevant ovarian-, tubal- or uterine-pathology that could interfere with the ovarian stimulation treatment
* history of ovarian hyper-response (more than 30 follicles ≥ 11 mm) or ovarian hyper-stimulation syndrome (OHSS), polycystic ovary syndrome (PCOS)
* History of poor ovarian response, according to the Rotterdam-criteria (Ferrarretti et al.)
* ovarian reserve parameter, indicating the risk of poor ovarian response (AFC \< 5 and AMH \< 0,5ng/ml) (14)