cyrilzakka/clinical-trials huggingface dataset:
Community Based Multiple Risk Factors Intervention Strategy

Randomized controlled trial of CORFIS Programme.

The study objectives are as follows:

1. To determine the efficacy of a community based multiple risk factors interventional strategy (CORFIS) for a treatment period of 6 months in patients on treatment for HT, DM or HL.
2. The intervention shall consist of a purpose design and systematically organized disease management program that employ multi-faceted interventions incorporating various specific measures to maximize both clinician (as investigator) adherence with treatment guideline and patient adherence with treatment.

It should be obvious to all that we urgently need to improve the management of the various risk factors for cardiovascular (CVD) and chronic kidney diseases (CKD); the 3 most important of which are Hypertension (HT), Diabetes mellitus (DM), Hyperlipidaemias (HL). It is not just that these are highly prevalent in our community, they are also poorly managed and controlled, with resulting highly costly and adverse health impact on our population. It should also be equally obvious that we need a better approach to manage these risk factors in our community. There have been considerable advances in our understanding of these risk factors and in our knowledge of the variety of approaches to achieving control of these risk factors including the role of self-monitoring and self-management education, medical nutrition therapy, physical activity, psychological counseling, and various drug therapy options.

This study is a multi-center, open label, parallel group randomized trial designed to demonstrate the effectiveness of a community based multiple risk factors interventional strategy (CORFIS).

750 patients on treatment for HT, DM or HL from 75 general practices (GPs) who meet inclusion/exclusion criteria will be enrolled into the trial. Among the 75 selected GPs, 50 of them will be randomly allocated to CORFIS and 25 to routine care.

After initial screening, patients will attend clinic for baseline examination. Study prescribed visits for efficacy and safety assessments will occur monthly for 6 months. Hence there will be a total of 7 visits.

Eligibility Criteria:
Inclusion criteria:

1. Patients diagnosed by participating GP to have Hypertension and/or Diabetes mellitus and/or Hyperlipidaemias, and currently on drug treatment for one or more of these conditions
2. Patients age 18 years and above.
3. Written informed consent obtained from patients.

Exclusion criteria:

1. Pregnant or nursing women.
2. History of unstable angina, acute myocardial infarction or coronary revascularisation procedure in the preceding 6 months.
3. Clinically significant valvular heart disease.
4. Overt heart failure or history of heart failure in the preceding 6 months
5. Stroke in the preceding 6 months.
6. Serum creatinine more than 150umol/l in the preceding 6 months.
Plexin B2 Gene Expression and Polymorphisms in Psoriasis

Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.

Study Setting: Qena University Hospital, Department of Dermatology ,Venereology\& Andrology.

Study subjects: the study will include psoriasis Vulgaris patients who Come to the out patients dermatologic clinic and matching inclusion \& exclusion criteria as follow, from 9/2021 up to 3/2023 and then patients will be divided to each group equally as follow:

Group 1: Patients will be treated with NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.

Group 2: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Group 3: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.

Group 4: 30 healthy individuals un related , age, sex , BMI matched with volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris.
* patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication

Exclusion Criteria:

Pregnancy , lactation \& women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal \& liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
Impact of Asthma Treatments on Daily Activities

The primary objective of this web-based, cross-sectional study is to assess and compare the ability to sleep, work or go to school, and to participate in leisure activities among subjects who are receiving Xolair treatment and subjects who were eligible to receive Xolair, but instead have been using Advair for at least 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Have asthma and allergies
* Currently taking Xolair® or Advair®
* Started Xolair® treatment within the last 4 to 12 months OR have been taking Advair® for at least 12 months
* Between 18 and 55 years of age
* A non-smoker for at least 6 months
* Have internet access
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy

This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue.

Approximately 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme

  1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or
  2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL
* Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL
* Age ≥ 18
* At least one bi-dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification
* Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
* QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);
* Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria:

* Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
* Known lymphomatous involvement of the central nervous system
* Uncontrolled clinically significant illness
* Ongoing or history of drug-induced pneumonitis
* History of clinically significant cardiovascular abnormalities
* History of clinically significant GI conditions
* Known history of, or active HIV infection
Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children

The aim of the project is to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP).

A cross-sectional case-control study design to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP). Controls are natural lefthanded typical developing children and adolescents.Case and controls are matched for age, gender and activity level.

Eligibility Criteria:
Inclusion Criteria:

* typical developing
* lefthanded
* NBPP or healthy
* righthanded parents
* 6-23 years

Exclusion Criteria:

* history of other locomotor or neurological disorder than NBPP
* history of brain surgery
* history of psychiatric disorder
Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters, however, are unclear. The investigators design an adequately powered randomized controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that they would need to enroll 132 incident peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of catheter dysfunction requiring intervention.

The objective of the present study is to evaluate the a priori hypothesis that straight peritoneal dialysis catheters would improve the treatment outcomes of peritoneal dialysis. The early and late catheter complications, as well as catheter survival, will be compared between peritoneal dialysis patients who are randomized to straight and coiled Tenckhoff catheters.

Eligibility Criteria:
Inclusion Criteria:

* requires dialysis catheter insertion for maintenance peritoneal dialysis
* aged 18 or older
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* known contraindication to peritoneal dialysis
* participation in another interventional study within last 30 days of randomization
* history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures
The Use of Emergency Department by Syrian Refugees and the Increasing Cost of Health Care

Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were forced to leave their homes and sought refuge in neighboring countries.

Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were forced to leave their homes and sought refuge in neighboring countries (). In the result influx of the thousands of Syrian migrants who continue to cross into world, all the world especially the European countries faced with a huge refugee problem. Emergency medicine is play key role of being healthcare's safety net, being the last resort for those with no primary healthcare and no alternatives.

The aim of this study was to evaluate the use of Emergency Department by Syrian refugees and total and costs of their health care.

Eligibility Criteria:
Inclusion Criteria:

* Adult Syrian patients who visited the Emergency Department were included in the study.

Exclusion Criteria:

* Patients below 18 years of age
* Emergency Department returns during same day
* Patients with missing data in hospital medical record were excluded from the study.
Meals-for-Moms: Experimental Grocery Store Study

This is a study about how the price of foods affects food buying choices at the grocery store. The price of foods can have a big impact on what people choose to buy and prices change over time. This study is being done to see how changes in food prices affect what mothers choose for their families.

It is well known that the price of a given food affects the amount of that individuals will purchase. Yet little is known about how specific groups, such as obese/overweight individuals and those with lower incomes, change their food purchasing decisions depending food price changes. Evidence shows that these groups have lower quality diets and worse health outcomes than their normal weight and higher income counterparts. Therefore, it is important to gain a better understanding of how food prices changes affect purchasing decisions among these population groups in order to develop targeted nutrition interventions to improve their diet quality. To investigate this the researchers will create a laboratory-based grocery store, in which pictures of foods will be used in lieu of actual foods. Food prices will be indicated on each picture. Participants will be given play money and a budget, and asked to "purchase" foods in the mock grocery store. The price of foods will be changed throughout the study to investigate how participants change their purchasing decisions based on these price changes.

Eligibility Criteria:
Inclusion Criteria:

* Have at least one child up to 18 years of age residing in the household
* Primary grocery shopper for the household
* No health conditions or food practices that substantially limit choice
* Not currently pregnant
* Consent to study design

Exclusion Criteria:

* Male
* \< 18 years of age
* Not a mother, or children not living with subject in their household
* No children below the age of 18 years of age
* Not the primary grocery shopper for their household
* Health conditions or food practices that substantially limit food choice
* Currently pregnant
Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection

The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are:

* To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy.
* Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery.

For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.

At present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia.

The investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. In the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored.

In the protocol，participants will be randomized in a 1:1 ratio to the control or experimental groups. The experimental group received a continuous infusion of lidocaineThe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. The control group received only standard intravenous analgesia。In addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.

Eligibility Criteria:
Inclusion Criteria:

1. participants ages 18-70 years.
2. participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery.
3. American Society of Anesthesiologists classification (ASA)I-III.

Exclusion Criteria:

1. severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III.
2. hypersensitivity to lidocaine,History of local anesthetic poisoning.
3. severe renal or hepatic dysfunction.
4. body mass index (BMI)\>35 kg m-2.
5. severe pleural adhesions.
Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (IHCIS)

Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured patients (age \>= 18 years and \< 65 years). Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US "real-world" setting. Another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design. Analyses of health insurance claims data from a large commercially insured population will be employed in the current study. Study subjects will consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. Analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).


Eligibility Criteria:
Inclusion Criteria:

* Evidence of two or more medical encounters with a diagnosis of kidney cancer (ICD-9-CM 189.0) or malignant neoplasm of the renal pelvis (189.1), and
* Two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (ICD-9-CM 197.XX-199.0, excluding 198.0 \[kidney metastasis\]) on different days \<120 days apart (the date of the earliest such encounter will be designated the "index date").

Exclusion Criteria:

* evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced TCC, or
* Evidence of cystoscopy, biopsy of the bladder, or radical cystectomy
* Subjects with evidence of any other primary cancer
The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD

The goal of this clinical trial is to compare in the pk/pd profiles of magisterial dexamfetamine and Tentin in adults with Attention Deficit Hyperactivity Disorder (ADHD). The main question\[s\] it aims to answer are:

Q1: is there a difference between pk/pd profiles of the two forms of dexamfetamine?

Q2: how does the pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD?

Participants will:

* take the Quantified behavior Test for analysis of objective effects.
* undergo blood sampling for analysis of the plasma concentration of dexamphetamine.
* undergo blood pressure and heart rate measurements.
* fill out 4 types of questionnaires.

Researchers will compare the outcomes between magisterial dexamphetamine and Tentin use in a crossover setting.

Objectives The primary objective is to compare the pharmacological profile of the magisterial form of dexamfetamine sulfate to the pharmacological profile of the brand-name form of dexamfetamine (Tentin©) in adult patients diagnosed with attention deficit hyperactivity disorder (ADHD) and assess whether there is a difference between pk/pd profiles of the two forms of dexamfetamine. The secondary objective is to assess how pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD.

Measurements At three moments (0, 60 and 120 minutes after drug administration) on each intervention-day, participants will complete the QbTest to assess objective performance and the QbPerformance to assess subjective performance. At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will undergo blood sampling to determine dexamfetamine plasma concentrations and vital sign measurements for safety monitoring and possible outcome-effects. At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will fill out questionnaires to assess subjective experiences.

Eligibility Criteria:
Inclusion Criteria:

* Participant is aged ≥ 18 years at time of screening.
* Participant is diagnosed with ADHD according to the DSM 5 criteria.
* Participant has switched from Tentin© to magisterial dexamfetamine due to the adverse effects of Tentin.
* Participant is being treated adequately with dexamphetamine, as determined by their practitioner, at time of screening.
* Participant or their legal representative is able and willing to provide written informed consent.
* Participant is able and willing to comply with the study protocol (e.g. swallow capsules, have blood samples taken, can visit the outpatient clinic twice).
* Participant has not participated in another study in the past three months.

Exclusion Criteria:

* Participant has a disorder that might affect drug absorption (e.g. gastrointestinal, metabolic, endocrine or liver disorder).
* Participant is allergic to the ingredients of the capsules.
Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy.

We wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.

We hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.


Eligibility Criteria:
Inclusion Criteria:

* Planned ambulatory knee arthroscopy, except cruciate ligament surgery
* American Society of Anesthesiologists (ASA) class 1-3

Exclusion Criteria:

* Cannot cooperate
* Do not speak or understand Danish
* Daily use of opioid analgesics
* Allergy towards any of the drugs used in the investigation
* Medicine abuse (at the investigators discretion)
* Alcohol abuse, as defined by the National Board of Health
* General anesthesia contraindicated, or the patient wants spinal anesthesia
* Visualization of necessary structures by ultrasound not possible, or block not possible for other technical reasons