cyrilzakka/clinical-trials huggingface dataset:
Study of the Quality of Life in School Aged-children with Posterior Urethral Valves

Posterior urethral valves (PUV) are the most common congenital obstructive lesion of the urethra, affecting from 1 per 3000 to 1 per 8000 live births. Valve ablation usually resolves the obstruction in PUV but patients still may suffer of deterioration in renal and urinary functions.

Renal insufficiency is the most feared long-term complication. Up to 50 % of the patients will develop chronic kidney disease (CKD), and up to 20 % will develop end-stage renal disease (ESRD) and ultimately will require kidney transplantation. PUV is the first urological cause of ESRD. Progression towards CKD depends on febrile urinary tract infections (UTIs), severity of a vesicoureteral reflux and bladder dysfunction.

Bladder dysfunction is due to an overactive and small poorly compliant bladder during infancy. Detrusor overactivity usually decreases in childhood and bladder capacity increases. The most common symptom of this bladder dysfunction is urinary incontinence. 60 % of children are continent at the age of 5 years old and 90 % at 10 years old. In case of persistent bladder dysfunction, medical treatment (anticholinergics, alpha-blockers) may be introduced, or even intermittent catheterizations.

Current scientific literature has very few studies on quality of life (QoL) in patients with PUV, mostly in adult patients and very small cohorts. Men treated for PUV in childhood had a good quality of life compared to the normative population, except for sleeping, eating and sexual activity. It seemed that the more severe the urological and nephrological functions were, the lower the QoL was. Children were only asked about intermittent urinary catheterization, and family point of view has never been collected. However, QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling, or after diagnosis in an infant with PUV.

Hence, the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life, as measured by the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).


Eligibility Criteria:
Inclusion Criteria:

* Male patients and their parents/relatives
* Aged 6 to 17 years old
* Treated for PUV in their first year of life between 2006 and 2018
* Managed in the Femme-Mère-Enfant Hospital in Lyon

Exclusion Criteria:

* Children with pre-existing severe cognitive and physical disability (physician's rating) from other condition
* Children enable to complete QoL questionnaire due to mental or communication impairment
Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus

OBJECTIVES:

I. Determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.

PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a year, and then annually thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Definitive diagnosis of pemphigus, including all of the following: Typical clinical lesions Histologically proven by skin or mucous membrane biopsy Pemphigus IgG autoantibodies in skin or mucous membrane by direct immunofluorescence (IF) Circulating pemphigus IgG autoantibodies in serum by indirect IF

Dependence on high-dose corticosteroids

Persistent disease activity despite treatment with mycophenolate mofetil or azathioprine, or inability to tolerate these drugs (for paraneoplastic pemphigus, persistent disease activity despite treatment with cyclosporine)

--Prior/Concurrent Therapy--

No concurrent cytotoxic therapy

--Patient Characteristics--

Performance status: Karnofsky 20-100%

Renal: Creatinine no greater than 2.5 mg/dL

Cardiovascular: LVEF at least 40%

Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other: Not pregnant Fertile patients must use effective contraception during and for 9 months after study Not preterminal or moribund
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.

Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (PK) of INS1007 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE).

Eligibility Criteria:
Inclusion Criteria:

1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
2. Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
3. Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Exclusion Criteria:

1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
3. Are current smokers
4. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
5. Have any acute infections, (including respiratory infections)
Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults

the goal of this Randomized controlled cross over trial is to compare the effects of meal sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose response among healthy adults in the UAE. the main question it aims to answer is what is the effect of meal sequence of vegetable and protein first followed by carbohydrates (VPF) compared to a standard mixed meal (SMM) on the postprandial glucose level and insulin response among healthy adults in the UAE. Participants will consume two is caloric test meals in random order (SMM and VPF meal sequences) separated by a 7-10-day washout period then blood sample will be collected at fasting ,30min,60min and 120mon for glucose and insulin and hunger ration will be done as well .Researchers will compare the effect of the two meals on postprandial blood glucose, insuline and hunger rating.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were age of 18-59 years
* Emirati, Gulf Cooperation Council (GCC), and Arabs ethnicity
* BMI: 18.5-29.9 kg/m2
* Fasting blood glucose level less than 100 mg/dL
* Non-smoker
* no genetic or metabolic diseases
* no known medical condition.

Exclusion Criteria:

* any participants with pre-existing diabetes
* Pregnant and breastfeeding women
* Participants with behaviors or/and health conditions that are known to affect glucose or -- insulin concentrations, such as smoking, gastrointestinal conditions, bariatric surgery, gastroparesis and reactive hypoglycemia
* Participants who consumed medication that might affect glucose or insulin response
* Participants with reported allergy or intolerance to any of the meal components (White Basmati rice, grilled chicken, cucumber, tomato, and lettuce salad with lemon olive oil dressing).
Activity Counseling Trial (ACT)

To develop and evaluate the effectiveness of various intervention approaches, delivered in primary health-care settings, in increasing and maintaining habitual physical activity and cardiorespiratory fitness among sedentary men and women patients.

BACKGROUND:

A conference on physical activity sponsored by the National Heart, Lung, and Blood Institute (NHLBI) in August 1991 recommended that one priority area for research should be the development and evaluation of interventions for adoption and maintenance of physical activity including interventions that can be incorporated into primary care practice. The 1992 NHLBI Working Group Report on Primary Prevention of Hypertension identified physical inactivity as a risk factor for hypertension. Intervention research applicable to health-care settings is particularly important in light of national recommendations advising health-care professionals to intervene, including Healthy People 2000, the U.S. Preventive Services Task Force reports, and the American Heart Association.

DESIGN NARRATIVE:

Randomized, multicenter, demonstration and education study. Men and women primary care patients at three sites in Dallas, Palo Alto, and Memphis were randomized to two patient education intervention groups or to a standard care control group of physician advice. Intervention continued for two years for all participants. The primary outcomes were cardiorespiratory fitness and physical activity. Other outcomes were effects on blood pressure, lipoproteins, and weight; the long-term maintenance of these effects; and the cost-effectiveness of various intervention approaches. Recruitment took 15 months and has been completed with the accrual of 874 subjects.

The National Institute on Aging participated in the ACT through the addition of a measurement of arterial stiffness involving approximately 700 patients. The NIA tested the hypothesis that increases in physical activity resulting from educational interventions could reduce arterial stiffness.

Eligibility Criteria:
Sedentary men and women, free of coronary heart disease, who were patients in primary care settings.
Combination Methotrexate and Infliximab

Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of infliximab in patients with Ankylosing Spondylitis.

Forty consecutive patients will be recruited from the rheumatology clinic of the Prince of Wales Hospital with AS meeting the modified New York criteria with active disease as defined (see below). They will be randomized to receive MTX 7.5 mg/week initially with a weekly 2.5mg increment until 15mg/week dosage is reached,( i.e by week 6) or a placebo together with folic acid 5mg daily for a period of 16 week. After 16 weeks, all patients will receive infliximab at 5 mg/kg per dose, at weeks 16, 18, and 22 (3 doses), and will continue with MTX 15 mg/week or placebo. Thereafter, they will be followed up at week 30, 38 weeks. MRI changes in the sacroiliac joints (SI) before and after infliximab treatment.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilled the AS:meeting the modified New York criteria
* Active disease despite NSAID treatment defined as:
* Spinal inflammation ≧ 30 and a score of 30 on at least two of the other three domains
* Back pain
* Patient global assessment of disease activity
* Physical function
* Informed consent

Exclusion Criteria:

* Complete ankylosis of the spine
* On sulphasalazine
* Previous use of TNF inhibitors
* Multiple use of NSAIDS
* Prednisolone \> 10mg/day
* Changes of NSAIDS or dose of prednisolone within 2 weeks of baseline
* Little or no ability for self-care
* Received intra-articular,intramuscular, or intravenous corticosteroids in the 4 weeks before screening
* Infected joint prosthesis during the previous 5 years
* Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months
* Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis
* Active tuberculosis requiring treatment within the previous 3 years
* Opportunistic infections such as herpes zoster within the previous 2 months
* Any evidence of active cytomegalovirus; active Pneumocystis carinii; or drug-resistant atypical mycobacterial infection
* Known hypersensitivity to murine proteins
* Current signs or symptoms of severe,progressive,or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
* A history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie,lymph nodes in the posterior triangle or the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly;
* Any known malignant disease except basal cell carcinoma currently or in the past 5 years.
* A hemoglobin level \< 8.5 gm/dl, a white blood cell count \< 3.5 × 10\^9/liter, a platelet count \< 100 × 10\^9/liter, a serum creatinine level \> 150 µmol/l, serum transaminase levels 1.25 times the upper limit of normal, or alkaline phosphatase levels \> 2 times the upper limit of normal.
Chinese Women and Mammography Screening

This study examined whether a culturally-tailored video has a greater impact on increasing mammography use in Chinese American women and improving barriers to mammography screening compared to a generic, non-tailored video and a printed fact sheet (control group).

This study examined the efficacy of a culturally-tailored video in increasing mammography use among non-adherent Chinese women (vs. a generic video and control fact sheet). A total of 671 Chinese American women from metropolitan Washington, DC and New York city were enrolled to participate in this study. The majority of participants were recruited from on-site community events and some were recruited through public advertisement and referrals. Participants who completed baseline assessment were randomized to one of the three groups: 1) viewing an 18-minute cultural video, 2) viewing an 18-minute generic video, and 3) reading a fact sheet (control group). Participants were interviewed twice after intervention:1) process evaluation 2-4 weeks post intervention regarding participants' feedback on the materials and repeated key measures of knowledge, cultural views, and health beliefs and 2) outcome evaluation six-months post intervention that assesses actual receipt of mammography use.

Eligibility Criteria:
Inclusion Criteria:

* Chinese American women had not had a mammography in the past 12 months
* Chinese American women had no personal history of breast cancer
* Chinese American women had no mammogram scheduled when enrolled

Exclusion Criteria:

* Non-Chinese Women
* Regular mammography users
Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System

Ventavis it's a treatment for pulmonary hypertension, administered by an inhaler called I-Neb.

In these patients, the non compliance of the treatment becomes its ineffective and increases the complications and mortality of the disease.

It is therefore important to know which the adherence of patients to their treatment is and try to promote it.

One possibility to reach a good level of adherence is the patient education regarding the drug administration and also to comply as better is possible the recommendations of the physician.

For this reason, the objective of our study is to demonstrate improvement in the level of treatment compliance when they follow a strategy of continuing education, assessed by the device and software called Insight.

The only special procedure to participate in the study then is that patients involved could receive more training than usual.

Investigators expect involving in this study around 50 patients in treatment with Ventavis and diagnosed of Pulmonary Arterial Hypertension in 10-12 hospitals throughout Spain.

The patients who participated in the study will be followed for 12 months from inclusion in the study and will perform around 5 visits in total.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years of age.
* Patients in New York Heart Association (NYHA) functional class II-IV pulmonary hypertension who are treated with Ventavis at least three months before and who use -neb ® AAD ® system.
* Patients who accepted participation in the study and sign informed consent.
* Patients with ability to understand and follow the instructions and are able to participate for the duration of the study.

exclusion Criteria:

* Patients with severe cognitive impairment.
* Geographically unstable patients who can not be followed during the 12 month study.
* Patients who have a life expectancy of at least 12 months.
* Patients who are participating in another study at the time of inclusion. .
Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus

Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal \[(t=0 min) start of the meal\]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) \>= 12 months.
* Treated with multiple daily insulin injections or CSII \>= 12 months.
* Current total daily insulin treatment \< 1.2 (I)U/kg/day.
* Current total daily bolus insulin treatment \< 0.7 (I)U/kg/day.
* Usual Insulin bolus dose between 0.8 and 2 (I)U per 10 g CH (both inclusive). Expecting prandial insulin dose range for standardised meal test between 5 and 12 (I)U.
* BMI 18.5-28.0 kg/m\^2 (both inclusive).
* HbA1c \<= 9.0% by local laboratory analysis
* Fasting C-peptide \<= 0.3 nmol/L.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products.
* Type 2 diabetes mellitus.
* Previous participation in this trial. Participation is defined as randomised.
* Participation in any Clinical Trial within 3 months prior to this trial.
* Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
* Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
* Women of child bearing potential, not willing to use contraceptive methods.
Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients

This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Palliative care (PC) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of PC into the care of patients enrolled on experimental clinical trials.

Primary Objective

* To qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a Phase I clinical trial.

Eligible Parent Research Participants (PRPs) who consent will participate in one audio recorded interview in which they are asked about 8-10 questions. The interview can be conducted in person, over the phone, or WebEx/Zoom (audio only). The interview will last about 30 to 60 minutes. PRPs can opt to complete interviews immediately or at a scheduled date that is convenient to the PRP.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver is 18 years of age or older
* Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian
* If more than 1 set of parents are involved in the patient's care (e.g., 2 biologic and 2 stepparents or partners) involved, the caregiver with legal decision- making responsibilities will be eligible for participation
* Caregiver is comfortable speaking and reading English

Exclusion Criteria:

* Those who do not meet inclusion criteria
START-J: SiTAgliptin in eldeRly Trial in Japan

The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)
2. Signed informed consent obtained before any trial-related activities
3. Treatment with diet and exercise for 12 weeks and longer at screening
4. Age =\>60 y.o.
5. Male and Female
6. HbA1c 6.9%=\< \<8.9%

Exclusion Criteria:

1. Active proliferative retinopathy or maculopathy requiring treatment
2. Liver dysfunction (\>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr\>1.5mg/dL in male, Cr\>1.3mg/dL in female, eGFR\<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
3. Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
4. Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
5. Previous history of severe allergy to pharmaceutical products
6. Systemic glucocorticoids users or potential users
7. Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
8. Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis