cyrilzakka/clinical-trials huggingface dataset:
Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling

We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence.

Chronic constipation is a common problem in childhood, accounting for almost 3% of consultations in pediatric practice. In many children constipation is accompanied by overflow soiling (fecal incontinence). This condition often gives rise to behavioral, social, and emotional problems.

We plan to develop a disease-specific instrument to assess HRQoL in children with constipation and fecal incontinence. We hypothesize that HRQoL is worse in children with fecal incontinence compared to children with constipation but no fecal incontinence. The instrument will involve both parent and child self-reporting measures and will enable researchers to evaluate how disease and treatment strategies impact both child and parent perceptions of quality of life. In the long run this will enable physicians to develop a child friendly approach to management of chronic constipation and fecal incontinence.

Eligibility Criteria:
Inclusion criteria:

1. Age 2-18 years
2. Child and parents fluent in English
3. Child must meet one of the following criteria;

A. Constipation and fecal incontinence: must include 2 or more of the following in a child with insufficient criteria for a diagnosis of IBS (criteria fulfilled at least once per week for at least 2 months before diagnosis in a child over 4 years of age and for at least one month in a child less than 4 years of age):

1. Two or fewer defecations in the toilet per week
2. At least 1 episode of fecal incontinence per week
3. History of retentive posturing or excessive volitional stool retention
4. History of painful or hard bowel movements
5. Presence of a large fecal mass in the rectum
6. History of large diameter stools that may obstruct the toilet

B. Constipation predominant IBS: must include the following, once a week for at least 2 months:

1. Abdominal pain/discomfort, associated with 2 of the following:

   * improved with defecation
   * onset associated with 2 or less stools per week
   * onset associated with hard or lump stool
2. no evidence of inflammatory, anatomic, metabolic or neoplastic processes.

C. Non retentive fecal incontinence: must include all of the following in a child with a developmental age of at least 4 years (criteria fulfilled at least once per week for at least 2 months before diagnosis) \[4\]:

1. Defecation into places inappropriate to the social context at least once per month.
2. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms
3. No evidence of fecal retention.

Exclusion criteria:

1. Children with developmental delays and children over 12 years of age who are unable to understand the questionnaires.
2. Associated chronic disease which may have an impact on quality of life such as cerebral palsy, spine deformity or malformations, learning difficulties, severe mental illness, celiac disease, etc.
3. Child and parents not fluent in English.
Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden

The purpose of this study is to determine whether screening for atrial fibrillation by intermittent ECG recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 75-76 years of age living in the region of Stockholm or Halland

Exclusion Criteria:

* Not fulfilling the inclusion criteria
Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. The study team would like to test if the device will impact the gastrointestinal (GI) symptoms and gastric motility in study participants with gastroparesis.

This study aims to assess if the device will impact the (GI) symptoms and gastric motility in study participants with gastroparesis. This will be done over a 12 week period during which each participant will undergo two visits. There will be two total visits that each follow the same schedule. During the first visit, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. This test will entail an EGG, ECG, and water satiety drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the study device. Half of the patients will be assigned to the sham group and half will be assigned to the treatment group. Each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. Following the first 8 week period, subjects will return to the study site to undergo visit two. This will follow the same format as visit 1. At this time, subjects will become unblinded. Those who received sham stimulation will be trained on the correct locations for each TEA device and will receive an additional 4 weeks of treatment with the device.

Note: The gastric emptying breathalyzer test (GEBT) was removed, and the two-day visits were shortened to one-day to improve patient recruitment and retention.

Eligibility Criteria:
Inclusion Criteria:

* At least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening.
* Documented delayed gastric emptying within past 3 years
* Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes)

Exclusion Criteria:

* Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube
* History of gastric surgery such as fundoplication, gastrectomy, or vagotomy
* Symptoms suggestive of gastroparesis with no diagnosis of diabetes
* Pregnancy or expect to conceive during the course of the study
* Uncontrolled diabetes mellitus (HbA1c \> 11%).
* Having any implanted medical device, such as cardiac pacemaker or Entera device
The Effectiveness of Specialist Seating Provision for Nursing Home Residents

A randomized control study aimed to investigate if suitable individualized seating provision is effective for adult nursing home residents in reducing the incidence of pressure ulcers, and increasing their quality of life and functioning.

The United Kingdom (UK) population demographics confirm that older people are considered to be the fastest-growing group in the population (Dunnell, 2008). In 2007, 9.8 million people were aged over 65; however, by 2032 this figure is projected to rise to 16.1 million (Dunnell, 2008). Many of these older adults will have complex health and social care needs sometimes requiring nursing home care. A high standard and quality of care within our nursing homes is essential, to be able to deal with this growing population safely and to the highest standard possible, including the provision of individualised seating assessment, prescription and provision. An individually prescribed seating system should be based upon the assessment of the person's abilities and needs, and should best position and support them for comfort and function.

When seating is not clinically suitable for the user there are many physiological and psychological implications for the user. For example, often pressure ulcers may develop. Pressure ulcers are currently a major concern for the NHS due to their prevalence, the cost of treatments and the impact on the person. Pressure ulcers can often be related to poor seating and indeed good seating can contribute to prevention and contribute to healing (Anton, 2005). Current expenditure by the NHS in the UK on pressure sores is £2.1bn annually. This equates to approximately £10,500 per sore (Bennett et al, 2004). Anecdotal evidence suggests that correct seating provision could be instrumental in depleting this cost by preventing pressure ulcers through investment in chairs before ulcers develop. This project set out to explore this topic via empirical research methods.

Research Question To identify the importance of individualised seating in reducing postural difficulties for adult residents in nursing homes.

Methods A pragmatic RCT design with qualitative and quantitative tools was used. These included: pulse oximeter readings of oxygen saturation levels and pulse rate; Braden scale of pressure risk; caregiver questionnaire; digital photographs of seated posture; and demographic information.

Participants Forty residents were recruited from three nursing homes in N.Ireland, and were randomly assigned to either the control group (continue to use existing chair) or the intervention group (use an individually configured seating system) for the 12- week trial period. At the end of the 12- week trial period there were 18 participants in each group.

Eligibility Criteria:
Inclusion Criteria:

* Adult living in one of the three nursing home facilities

Exclusion Criteria:

* Determined to be at a high risk of developing pressure ulcers (as per Braden Scale assessment)
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with AS in comparison with patients receiving other TNF blockers. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment. Patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier. For switched patients, their assessment schedule will be re-started from the day of switch. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients with active AS
* Patients who meet the following conditions can be enrolled:

  i) The RemsimaTM cohort will include all patients who will start RemsimaTM at the time of enrolment in accordance to the approved product label ii) Patients who have started to be treated with an established anti -TNF such as Infliximab (Remicade®), Etanercept, Adalimumab and etc. within 6 months
* Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of RemsimaTM.
* Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records

Exclusion Criteria:

* Patients with a history of hypersensitivity to infliximab
* Patients with a current or past history of chronic infection
* Current diagnosis of TB or severe or chronic infections (e.g. sepsis, abscess or opportunistic infections or invasive fungal infections), or a past diagnosis of TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
* Recent exposure to persons with active TB, or a positive test result for latent TB (defined as a positive interferon-γ release assay \[IGRA\] with a negative examination of chest X-ray) at Screening.
* Patients with moderate or severe heart failure (NYHA class III/IV).
A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan

The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell carcinoma (aRCC) in the real-world setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of Renal Cell Carcinoma (RCC)
* No prior systemic therapy for RCC
* Participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
* International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor

Exclusion Criteria:

* Participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan
* Pregnant and/or lactating women
* Participants who are judged to be inappropriate by investigator

Other protocol-defined inclusion/exclusion criteria apply.
Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease

Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy

One arm. Six sessions in two weeks. Classification in complete response (resolution of all signs of GVHD), partial response (improvement of at least one grade) or absence of response (Glucksberg criteria). Tapering depending on patient condition during weeks 2 to 10. Final evaluation at week 10. Steroid therapy tapering at the discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* 0 to 30 years
* Acute GVHD refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days)
* patient consent and/or parent consent

Exclusion Criteria:

* less of 10 kgs BW
* clinical or biological state precluding the apheresis
* previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)
Topiramate Trial for Pathological Gamblers

Objectives: Pathological gambling (PG) is a prevalent disorder with no approved pharmacological treatment. Previous reports suggest that topiramate could be useful in reducing impulsivity in PG, and craving in other addictions. The goal of this study was to investigate the effectiveness of topiramate combined with brief cognitive restructuring in treating PG. Methods: 38 PG patients were randomized to either topiramate (N=18) or placebo (N=20) in a 12-week double-blind trial; all patients received brief cognitive restructuring. The main outcome measures were craving, gambling behaviour, gambling cognitive distortions, impulsivity, depression and social adjustment.


Eligibility Criteria:
Inclusion Criteria:

* current Diagnostic and Statistical Manual Fourth Edition Text Revised (DSM-IV-TR) diagnosis of pathological gambling
* a betting frequency of at least once a week in the last 30 days
* women within fertility age had to be already practicing an acceptable contraception method and to be negative at a pregnancy test.

Exclusion Criteria:

* illiteracy
* breastfeeding for women
* previous history of alcohol abuse/dependence with current elevation of liver enzymes, or a present diagnosis of alcohol abuse/dependence
* past or current drug abuse/dependence, except for nicotine dependence
* history of current or past DSM-IV-TR diagnosis of bipolar disorder, schizophrenia, psychosis or any neuropsychiatric condition causing cognitive impairment
* a history of suicide attempt or acute suicide risk
* severe depression indicated by a score equal to or higher than 30 at the Beck Depression Inventory
* current participation in psychotherapy for pathological gambling, including Gamblers Anonymous in the past 3 months
* current use of mood stabilizers, antidepressants, antipsychotics, except occasional use of benzodiazepines
* cardiovascular disease including a history of heart attack, stroke, arrhythmia, cardiac failure in the past 5 years
* chronic or acute renal and liver failure
* a personal or family history of nephrolithiasis
* immunodeficiency
* any blood dyscrasia.
Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition

Ultrasound is one of the most important tools in pregnancy both for its diagnostic capacity, but also because it is not invasive.

For physiological pregnancy, the Italian guidelines provide for the execution of 3 ultrasounds: one in the first trimester (between 11 and 14 weeks), one in the second trimester (between 20 and 22 weeks) and one in the third (between 30 and 36 weeks). weeks).

Screening for cardiac abnormalities is done during second trimester ultrasound, also called structural ultrasound. However, the development of three-dimensional (3D) sonography has represented a dramatic shift in obstetrics as it allows for the acquisition of a volume of data rather than conventional planar or 2D scans. This method has allowed considerable progress in the study of the fetus in the initial stages of development and has opened new windows in the knowledge of anatomical malformations at an early age.

The possibility of detecting structural anomalies already during the first trimester of pregnancy allows, in fact, to provide the patient with additional time for counseling and for any genetic tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation

Exclusion Criteria:

* Less than 18 years old
* Multiple gestations
* Women with an altered state of consciousness, seriously ill, with mental handicaps;
Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian, fallopian tube, or peritoneal cancer.

OBJECTIVES: I. Determine the clinical activity of irofulven in patients with recurrent or persistent ovarian epithelial cancer. II. Characterize the pharmacokinetic profile of this drug in these patients. III. Determine the pharmacodynamic relationship between plasma concentrations and clinical activity or toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to the number of prior treatment regimens (1-2 vs 3 or more). Patients receive irofulven IV over 5 minutes on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks until death.

PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent ovarian epithelial cancer, primary fallopian tube cancer, or primary peritoneal cancer that failed prior standard chemotherapy Measurable disease No history of brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 2 months Hematopoietic: Granulocyte count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL (transfusion allowed) Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal ALT and AST no greater than 2.5 times normal PT or PTT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Urinalysis normal BUN normal Electrolytes normal Cardiovascular: No unstable or newly diagnosed angina pectoris within the past 6 months No myocardial infarction within the past 6 months No New York Heart Association class II-IV congestive heart failure Pulmonary: No chronic obstructive lung disease requiring oxygen supplementation therapy or medication Other: No medical or surgical complications requiring intervention, such as: Impending bowel obstruction Active infection No other life-threatening illness No non-skin malignancy or melanoma within the past 4.5 years except curatively treated other malignancy with low risk of recurrence or surgically cured stage I endometrial cancer No uncontrolled seizures Not pregnant or nursing HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior biologic therapy No prior bone marrow transplantation Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Recovered from prior endocrine therapy Radiotherapy: Recovered from prior radiotherapy No prior external beam radiotherapy Surgery: Recovered from prior surgery Other: At least 1 week since prior antibiotics
A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury

This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the treatment period and the treatment period.


Eligibility Criteria:
Inclusion Criteria:

Signed written informed consent; Male or female subjects 18 to 55 years of age; Spinal cord lesion/disease/injury at any level at least 3 months from injury. FISI (Fecal Incontinence Severity Index) \> 8 units. The patient is able to understand the treatment and is willing to comply with the prescribed regimen

Exclusion Criteria:

* Known allergy to experimental drug..
* Porphiria.
* Glaucoma.
* Pregnancy or lactation.
* Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
* Type 1 diabetes mellitus;
* Insulin treated type 2 diabetes mellitus.
* Renal insufficiency.
* Liver insufficiency.
* Malignant disease within 5 years of screening;
* Has hypertension (sitting blood pressure \> 140/90 mmHg at screening)
* History of rectal surgery.
* History of HIV, hepatitis B, hepatitis.
* Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin (at a dose above 250 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
* Use of tricyclic or monoamine-oxidase inhibors.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
* Unable to understand the use instruction for the coated suppository, as judged by the investigator.
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation

Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic heart failure
* moderate to severe mitral regurgitation
* 20 - 50% LVEF

Exclusion Criteria:

* mitral regurgitation of organic origins
* recent interventions
* severe comorbidities