cyrilzakka/clinical-trials huggingface dataset:
Preparation Prior to Colonoscopy in Children

Colonoscopy is a routinely performed examination of children and adolescents in the diagnostic process of inflammatory bowel disease (IBD). It is necessary that the bowel is clean so the colonoscopy can be optimally performed. The cleansing of the bowel by means of laxatives prior to the examination is, however, considered difficult by many children. Getting smaller children to cooperate and to drink a substantial volume of laxative fluid prior to the examination can be particularly difficult. There are several possible cleansing procedures and combinations of procedures for the cleansing of the colon, for example by means of polyethylene glycol and sodium picosulphate, which are the two most commonly used methods. Cleansing by means of polyethylene glycol can, due to the necessary intake of a substantial quantity of fluid, be particularly frustrating for patients. Often the only way to carry out the preparation is with the insertion of a nasogastric tube, which can cause discomfort for some children. Cleansing the colon by means of sodium picosulphate, which involves an intake of a small quantity of fluid, has been suggested to be a good sufficient method resulting with a satisfactory result in terms of bowel cleanliness. However, studies have so far encompassed only a smaller number of children and further studies are needed to confirm that there is no difference between the two methods in terms of resultant bowel cleanliness.

The purpose of this randomized controlled study is to compare preparation by means of polyethylene glycol and preparation with sodium picosulphate prior to colonoscopy in children.

One hundred children scheduled for colonoscopy in southern Sweden will be randomized into either patient group 1 (for preparation with polyethylene glycol) or patient group 2 (for preparation with sodium picosulphate). For the random sampling, data-driven selection will be implemented. A CONSORT Flowchart (2012) will be encompassed by the study. To assess the cleanliness of the intestinal tract (and volume of fluid in the intestine), the Ottawa Scale will be used (Rostom \& Jolicoeur, 2009). All colonoscopy examinations will be performed by the same paediatric gastroenterologist, to whom no information about which preparation method was used by each child will be disclosed. Furthermore, the gastroenterologist will, meet with the children first after the investigation has been completed. All information regarding the investigation will be given to the patient by the admitting physician. During the colonoscopy the gastroenterologist will evaluate the intestinal cleanliness and submit the reports in sealed coded envelopes to the nurse in charge of the patient.


Eligibility Criteria:
Inclusion Criteria:

* elective colonoscopy

Exclusion Criteria:

* not Swedish speaking
A Participatory Parental Intervention Promoting Physical Activity in Preschools

The aim of this study is to test whether a parent-focused participatory intervention in addition to gym lessons can enhance preschoolers physical activity compared to gym lessons alone.

Over the last 20 years, physical activity (PA) in children has rapidly decreased in both developed and developing nations. More effective interventions to prevent inactivity in childhood thus are urgently needed. The preschool years, including the adiposity rebound period, might represent a good window of opportunity. Study literature suggests that targeting parents is crucial for lasting changes in young childrens' behavior. However, it is not known which methods are effective for involving parents in physical activity promotion. Consistent with experience from community-based participatory research, encouraging parents to participate the intervention in terms of content and structure might lead to higher intervention effectivity and sustainability. In our study, we therefore "enriched" a child-centered physical activity intervention in preschools (twice weekly gym lessons over 6 months) with a parent-focused participatory community intervention component.

Eligibility Criteria:
Inclusion Criteria:

* age 3-6 years

Exclusion Criteria:

* severe atopic dermatitis,
* serious acute infectious diseases,
* physical malformations, and
* severe physical disabilities.
Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)

Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy

Intralesional use by inject of adipose derived stem cells

Eligibility Criteria:
Inclusion Criteria:

1. -Signed informed consent
2. -Previously diagnosed bilateral limbic obstruction
3. -Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
4. -Suffering chronic keratopathy accomplishing the following criteria:

   * Confirmed limbic obstruction with an impression cytology
   * Repeated usual treatment failure for this pathology

Exclusion Criteria:

1. -Having suffered a neoplasia in the previous 5 years
2. -Local anesthesia allergies
3. -Patients having participate in any other study in the previous 90 days to the inclusion
4. -Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
5. -Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
6. -Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
7. -Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
8. -Patients who have suffering major surgery or severe trauma in the prior 6 months
9. -Pregnant or breastfeeding women
Fundoplication in Laparoscopic PEH Repair Based on FLIP

Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.

Prospective Randomized Controlled Trial in which patients who meet criteria will be randomized to receive a concurrent fundoplication or no fundoplication at the time of paraesophageal hernia repair. Patients with known objective gastroesophageal reflux disease prior to surgery, those found to have a short esophagus in the operating room or defective gastroesophageal reflux barrier by intra-operative impedance planimetry measurements and/or endoscopic valve grade will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic paraesophageal hernia repair

Exclusion Criteria:

* History of a prior hiatal hernia/paraesophageal hernia repair
* Patients with objective GERD preoperatively
* Intra-operative short esophagus
* Defective gastroesophageal reflux barrier as determined by impedance planimetry (FLIP)
* Defective gastroesophageal reflux barrier as determined by intra-operative endoscopy
Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples from patients with non-small cell lung cancer and from healthy volunteers.

OBJECTIVES:

* Measure plasma cathepsin D levels in patients with non-small cell lung cancer and in healthy volunteers using mass spectometry.
* Measure fatty acid synthase levels in these patients and healthy volunteers using mass spectometry.

OUTLINE: Blood samples are collected from patients and healthy volunteers to measure the levels of cathepsin D and fatty acid synthase by proteomic profiling and mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

Non-Small Cell Lung Cancer Patients

* Documented diagnosis of non-small cell lung cancer, any stage and any time point in the course of treatment (i.e., at diagnosis, during any treatment, and during post treatment surveillance)
* Measurable disease by CT scan within the past 4 weeks

Healthy volunteer

* Non-smoking, defined as \< 5 packs/year history of smoking and cessation of smoking ≥ 6 months ago OR a never smoker

  * Not regularly exposed (i.e., daily) to second-hand smoke

Exclusion Criteria:

* Severe underlying lung disease (i.e., chronic obstructive pulmonary disease with FEV_1 \< 1.0 L, pulmonary fibrosis, bronchiectasis, cystic fibrosis, etc.) as determined by enrolling researcher.

Written consent must be given for both subjects and controls.
Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction

Coronary artery disease (CAD) is the leading cause of death worldwide. Dietary patterns and functional foods may play an important role in the management of cardiovascular risk factors such as overweight and dyslipidemia, as well as inflammation and oxidative stress. However, little is known regarding the effect of diets or specific nutrients on these parameters in individuals with acute myocardial infarction (AMI). The Brazilian Cardioprotective Diet (DicaBr) is based on Brazilian nutritional guidelines and also in a unique and ludic nutritional strategy. In a pilot study, this diet was effective in reducing blood pressure (intragroup comparison) and body weight (intergroup comparison) in individuals with established cardiovascular disease (CVD). However, the effectiveness of this dietary pattern supplemented with different kind of nuts is unknown. The aim of this study is to evaluate the effect of the DicaBr supplemented or not with 30g/day of different nuts on cardiometabolic parameters in patients with recent AMI. In this parallel randomized controlled trial, 388 patients ≥40 years with a recent diagnosis of AMI (60 to 180 days) will be allocated to one of two study groups: 1) DicaBr group (DCB, control group); or 2) DicaBr group supplemented with mixed nuts (DCBN, intervention group). All patients will receive the same dietary prescription, the DCBN group also will receive 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazilian nuts). A pilot study including 100 individuals who will receive only peanuts (30g/day) will be conducted. The primary outcome will be LDL-cholesterol (LDL-c) levels after 16 weeks. In the baseline and at the end of the study (16 weeks), lipid and glycemic profile and anthropometric indexes will be evaluated in both groups; inflammatory and oxidative stress markers, and adipokines will be evaluated in a subsample. It is expected that DicaBr supplemented with nuts will be superior to DicaBr alone to benefit patients with AMI regarding cardiometabolic parameters.


Eligibility Criteria:
Inclusion Criteria: Patients ≥ 40 years with previous AMI (60 to 180 days).

Exclusion Criteria:

* Clinical indication of myocardial revascularization surgery (graf /bypass);
* HIV positive in treatment/AIDS;
* Chronic inflammatory diseases;
* Cancer;
* Chemical dependency/alcoholism;
* Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
* Pregnancy or lactation;
* Wheelchair users without conditions of anthropometric evaluation;
* Extreme obesity (BMI ≥40kg / m²);
* Use of dietary supplements;
* Rejection/allergy to oilseed consumption;
* Participation in other randomized studies at the time of enrollment.
Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation

Islet transplantation is a promising treatment of type 1 diabetes in selected cases. Results are however hampered by a relatively low number of islets surviving the transplantation into the liver, which currently is the site for transplantation. In the present study we compare a new transplantation site (intramuscular in the arm) to the golden standard (the liver) in patients undergoing kidney transplantation from the same donor. In half of the intramuscular transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient to, possibly, improve the immunological aspects of the transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 to 65 years of age.
* Ability to provide written informed consent.
* Mentally stable and able to comply with the procedures of the study protocol.
* Clinical history compatible with type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependence for \> 5 years at the time of enrolment.
* Absence of stimulated C-peptide \<0.1 nmol/L in response to a MMTT.
* All subjects must have received adequate medical treatment of their diabetes under the guidance from an experienced diabetologist.
* All subjects must have renal failure and be eligible for renal transplantation according to local criteria.

Exclusion Criteria:

* Patients with prior organ transplants
* Patients that qualify for local simultaneous pancreas-kidney transplantation program and who prefer that option
* Patients with body mass index BMI \> 28.
* Insulin requirement \> 1 Unit/kg/day. If the patient is on peritoneal dialysis the same limit is set when the extra carbohydrates in the dialysis fluids have been accounted for.
* Consistently abnormal liver function tests ( \> 1.5 x the upper limit of normal on two consecutive measurements \> 2 weeks apart)
* Unstable diabetic retinopathy
* Hypercoagulability disorder or coagulopathy or International normalized ratio (INR)\>1.5
* Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
* Patients with unstable cardiovascular status
* Patients with active infections, unless treatment is not judged necessary by the investigators
* Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
The Model and Effect Assessment of Training General Practitioner for Dementia Early Recognition

With the number of aged people increasing and the lifespan lengthen, dementia is becoming a great public challenge in China. Early recognition of dementia is crucial to improve the prognosis of dementia patients and decrease the society disease burden. It is a pity that the early recognition rate of dementia is less than 7% in China. Most of the aged people live in the community and general practitioners (GP) in community provide health service much more frequently than other medical workers. It is suggested that GPs should be the best one to screen dementia in its early period. However, most of GPs have not receive any training about dementia early recognition in China. It is imperative and meaningful to provide training to GPs for improve GPs' knowledge and skills about dementia early recognition. How to train GPs for early recognizing dementia and how about the training effect? Which training model may be better? We did not find consistent conclusion about these questions in China. This study aims to set up an effective and convenient model to training GPs in dementia early recognition. A total of 152 GPs in Beijing will be enrolled and be randomly divided into two groups. One group will firstly have lessons about dementia early recognition and then receive face-to-face supervision and key messages by Wechat about dementia early recognition once a month in the following 6 months. Another group will firstly have lessons about dementia early recognition and then receive face-to-face supervision and key messages by Wechat about dementia early recognition once a month in the following 3 months. The score of knowledge and attitude about dementia early recognition, the accuracy of analyzing dementia cases, the usage of dementia screening scales and the referral rate of dementia will be evaluated at different time point respectively. This study will provide evidence for training GPs effectively in dementia early recognition in the future and will promote dementia early recognition in community.


Eligibility Criteria:
Inclusion Criteria:

* General practitioner on-the-job and providing outpatient service
* Can complete the intervention and questionnaire;
* Providing informed consent voluntarily.

Exclusion Criteria:

* General practitioner who may take a long-term vacation during the study
* Providing less than once outpatient service every week;
* Having no condition to use Wechat;
* Refuse to join in this study.
PREvention of VENous ThromboEmbolism Following Radical Prostatectomy

The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP).

The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP). Currently, there is no standard practice for VTE prophylaxis after RP with the American Urological Association recommending "pharmacological or pneumatic mechanical prophylaxis" for high risk patients. Prior studies showed 30% of patients in the United States received no perioperative prophylaxis and less than 20% received pharmacologic agents, compared to 98% of patients receiving pharmacologic prophylaxis in the United Kingdom. Some urologists prescribe patients low molecular weight heparin (LMWH) after discharge for up to 30 days after surgery. Additionally, there are no established risks of pharmacologic prophylaxis for RP patients, but some urologists express concern about the potential impact of prophylaxis on the rate of postoperative lymphoceles or hematomas. At Johns Hopkins, patients do not routinely receive pharmacologic VTE prophylaxis in the perioperative setting for RP. Given the lack of standard practice and implications for patient safety, the investigators propose a prospective, stratified randomized controlled trial to evaluate the impact of perioperative pharmacologic prophylaxis on VTE following RP hypothesizing that it will prevent VTE events without significantly impacting the rate of postoperative bleeding or lymphoceles. The potential impact of surveillance bias with differential imaging between arms, effect of lymphadenectomy (yes/no and number of noted removed) or surgical approach (robotic and open), and differences by patients risk (comorbidity and VTE risk based on components of the Caprini score) or demographics will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men 18-100 years of age with histologically confirmed prostate cancer of any stage undergoing RP
* Patients who would have otherwise been eligible to receive routine post-RP care

Exclusion Criteria:

* Active treatment for VTE
* Patients judged by patients' urologist, primary care doctor, or in the preoperative evaluation center (PEC) to be unsafe to forgo pharmacologic prophylaxis or systemic anticoagulation postoperatively (whether or not patients are on systematic anticoagulation for indications other than VTE)
* Known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy)
* Epidural analgesia
* Spinal anesthesia
* Participation in a different trial that increases a patient's risk of VTE
Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients

Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.

The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).

Eligibility Criteria:
Inclusion Criteria:

* Patient with renal failure, on hemodialysis for at least 12 months;
* Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type);
* Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;
* Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy:
* Patient who signed an informed consent form to participate in the study

Exclusion Criteria:

* Known allergy to PEPA® ;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Patient with a chronic infection in progress;
* Patient with life expectancy \<6 months according to the investigator;
* Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.);
* Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease

This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease.

Participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain. They will complete a 3-month "baseline "with no use of hormonal contraception, and then a 3-month follow-up after receiving an injection of Depo-Provera. Participants will complete 6 to 7 in-person visits with a urine pregnancy test, blood draw, and surveys, as well as complete remote weekly surveys and monthly home pregnancy tests.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Female, aged 18-50 years old
3. Diagnosis of sickle cell disease (SS, SB0,SB+,SC)
4. Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months
5. At least 1 and no more than 10 medical presentations (e.g. hospitalization, emergency room visit, outpatient infusion visit) for sickle cell-related pain during the past year
6. Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month since last use of all hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study.
7. Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months
8. Access to a device with text-messaging capability
9. Must be able to read and understand English
10. Willing to comply with study procedures

Exclusion Criteria:

1. Chronic inflammatory conditions, such as lupus or inflammatory bowel disease
2. History of VTE or stroke
3. Current use of crizanlizumab, voxelotor, or red cell exchange transfusion, or history of hematopoietic stem cell transplantation
4. Current use of hormonal contraception or the copper intrauterine device
5. Current pregnancy or pregnancy within the last 6 months
6. Current lactation
7. Polycystic ovary syndrome or irregular periods
8. Blood pressure \>= 160 systolic or \>=100 diastolic at screening visit