cyrilzakka/clinical-trials huggingface dataset:
Enhanced Care for Patients With Complex Multimorbidity in Primary Care

Introduction Patients living with a chronic disease often have more than one chronic condition, which is referred to as multimorbidity. Multimorbidity is associated with decreased quality of life, functional decline, polypharmacy, and increased healthcare utilization. Patients with multimorbidity often have a high symptom- and treatment burden, and have to attend multiple appointments, often at numerous locations, and comply with complex or even conflicting advice and drug regimens, resulting in an increased risk of depression and low quality of life. In Denmark, general practice is the key organizational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centered care. However, caring for patients with multimorbidity is a complex and time-consuming task and the organization of chronic care in general practice is organized around individual conditions.

Research question The objective of the study is to evaluate the effectiveness of a complex intervention consisting of a prolonged consultation and a strengthened cross-sectoral collaboration for patients with complex multimorbidity listed in participating practices on the patients' health-related quality of life, health and use of health-services.

Methods

Design:

A pragmatic, adaptive, cluster-randomized, non-blinded, parallel-group trial conducted in general practice in all regions in Denmark evaluating a complex intervention.


Eligibility Criteria:
Inclusion Criteria:

Adult (18 years or older) patients listed at participating GPs living in their own home with

* Two or more chronic conditions from two of ten diagnosis groups OR who were identified by the GP with complex multimorbidity (see box 1)
* At least one contact with secondary care in 2022 or 2023.
* Prescribed at least five prescription drugs
Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy

The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.


Eligibility Criteria:
Inclusion Criteria:

1 - All women who will subject to office Hysterosocpy for gynecological problems

Exclusion Criteria:

1. All patients have current vaginitis or urinary tract infection before the hysteroscopy
2. Diabetic women.
3. Women with body mass index \> 25 kg/m2.
Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing

The aim of this study is to test the clinical effectiveness of IOE tube using individually customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when unconscious patients have no choice but tube feeding.

According to standard Guideine of videofluoroscopic swallow study(VFSS), Patients referred to dysphagia(swallowing dysfunction)who were required to tube feeding and medically stable of vital sign, and agreed to participate. Participants with swallowing dysfunction who were classified into three groups (nasogastric tube, traditional intermittent (IOE) tube, individual 3D printed guiding tube) according to VFSS.

Both traditional IOE tube and individual 3D printed guiding tube groups will receive training about procedure prior to the first feeding. All participants will be evaluated with satisfaction for tube feeding (EORTC QLQ-H\&N35) in 3 days from the start day of the tube feeding. On the day of oral feeding, participants will be evaluated with the questionnaires and clinical examination. If the participant is discharged in a state maintain the tube feeding, investigated further length stay at leaving the hospital. On the 1 month, 3 month from tube feeding, the investigators will follow-up and measure the questionnaires and clinical examination.

Eligibility Criteria:
Inclusion Criteria:

* Dysphagia patients to check in VFSS (videofluoroscopic swallow study)
* Patients participating in the study agreement
* Oral feeding is not possible (Need tube feeding)

Exclusion Criteria:

* Patient to reject the participation
* Crico-pharyngeal incoordination
* Impaired esophageal peristalsis
* Impaired GI tract
* Observed esophageal reflux
Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette

The aim of this study is to shed light on the importance of nicotine pharmacokinetics in switching to a reduced-harm product by fully matching the nicotine pharmacokinetics of smokers' usual brands of cigarettes.

The primary objective is to ascertain the degree of smoking reduction when smokers attempt to switch to an e-cigarette that matches peak nicotine concentrations of a cigarette.


Eligibility Criteria:
Inclusion Criteria:

1. Has signed the ICF and is able to understand the information provided in the ICF.
2. Is 22 to 65 years of age (inclusive) at screening.
3. Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months.
4. Expired air CO reading of at least 10 ppm as assessed at the screening session.
5. Interested in switching to an electronic cigarette.
6. Willing and able to comply with the requirements of the study.
7. Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

1. Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., vital signs, physical examination, ECG, concomitant medications and medical history).
2. PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
3. Planned use of an FDA-approved smoking cessation product during the study.
4. High Blood Pressure (systolic \>150 mm Hg, diastolic \>95 mm Hg) at screening.
5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2 at screening.
6. Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
7. Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
8. Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics).
9. Use of any of these products in the past 30 days:

   1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, phencyclidine (PCP), or opiates without a medical prescription);
   2. Experimental (investigational) drugs that are unknown to participant;
   3. Chronic opiate use.
10. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black \& Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
11. Pregnant or nursing (by self-report) or positive pregnancy test.
12. Enrollment is complete.
Study of the Impact of the COVID-19 Pandemic on the Management of Type 2 Diabetic Patients in a Sample in the Paris Region

The Covid-19 crisis is undoubtedly the most significant event of the early 21st century. The pandemic has profoundly changed our way of life, whether as human beings, but also as patients or caregivers. This pandemic of an incredible magnitude, after having been minimized, blew a wind of fear on the whole world because of the unknown that the SARS-CoV2 virus represented. The world scientific community being destabilized, a great majority of states decided to apply a containment. In France, a strict containment was applied between March 17, 2020 and May 11, 2020 (1 month and 23 days, about 8 weeks). Diabetic and obese patients were designated as "at risk" for infection by COVID 19. Type 2 diabetes is one of the most common chronic diseases in general practice. Its regular management, we know, is largely related to lifestyle, which is particularly important in controlling the disease and preventing complications. During the first months of the pandemic, we witnessed many emergency room visits of patients with chronic pathologies, in full decompensation, due to a lack of follow-up but also due to a lack of treatment. After the first containment, in the endocrinology department of the Paris Saint-Joseph hospital, we observed that many patients had a clear imbalance of their diabetes compared to their previous history.

The main objective of this study is to show that the COVID-19 pandemic, and more precisely the strict confinement applied in France from March 17, 2020 to May 11, 2020, had an impact on diabetes control in the study population. The secondary objectives are to study the explanatory covariates via the modification of the lifestyle of diabetic patients (decrease in physical activity, increase in poor dietary habits, psychological impact related to the situation, difficulties in accessing care, modification of work arrangements).


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patients with type 2 diabetes
* Patient consulting their attending physician for the follow-up of their diabetes OR Patient consulting the GHPSJ diabetes service for the follow-up of their diabetes
* Patients who have an attending physician who follows their diabetes
* Patients living in the Paris region
* Francophone patients
* Patients who do not object to the use of their data for this research

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes

Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).

Women will be recruited with a singleton pregnancy up to 12 weeks gestation. Participants will be randomized 1/1 to 780 pump or standard of care (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections). Participants will be stratified according to study center, baseline Hba1c, and method of insulin delivery (pump or injections). Participants will be followed-up till delivery. To account for differences in the type of continuous glucose monitoring (CGM) used between the intervention group and the control group, the same CGM system as in the 780 insulin pump group (Guardian™ Sensor 3 and once available the Guardian 4 sensor) will be used in a blinded manner in the control group to collect CGM data during at least four different time points in pregnancy: at 14-17 weeks, 20-23 weeks, 26-29 weeks and 33-36 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women with type 1 diabetes (T1DM), diagnosed with T1DM at least 1 year before pregnancy
* Age 18-45 years
* A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed gestational age up to 11 weeks and 6 days.
* Treated with intensive insulin treatment (either MDI or insulin pump). A closed-loop system can only be used in manual mode.
* Have a booking HbA1c (measurement taken at the first antenatal clinic visit after confirmed pregnancy) level ≤10%.
* Participants need to speak and understand Flemish, French or English and have e-mail access.

Exclusion Criteria:

* The use of a closed-loop insulin delivery system in auto mode.
* A twin (multiple) pregnancy
* A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician)
* Medications known to interfere with glucose metabolism
* An insulin dose of ≥1.5 units/kg
* Known allergy to adhesives due to infusion set and/or CGM
Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting

TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age;
* Patients with confirmed leading diagnosis of asthma with or without concomitant COPD;
* Physician decision to start fixed triple therapy with ICS/LABA/LAMA (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum);
* Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.

Exclusion Criteria:

* Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis

Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours.

In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.
2. presence of small esophageal varices, defined as varices \< 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
3. age ≥ 18 years

Exclusion Criteria:

* pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control
* allergic to sandostatin
* high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)
* Child Turcotte Pugh Class C cirrhosis
* hepatocellular carcinoma
* evidence of ongoing alcohol or illicit drug abuse within 6 months of the study
* serum creatinine greater than 2 mg/dL
* platelet count below 50,000 per microliter
* prothrombin time 4 seconds or more greater than control
* human immunodeficiency virus (HIV) positive
* symptomatic gallstones
* previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena
* previous history of variceal bleeding
* history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation
* use of any investigational drug within 1 month prior to screening and
* current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).
Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers

To investigate physical fitness and activity levels in children with epilepsy and compare the results with healthy peers.

Many individuals with epilepsy are physically inactive due to the fear of seizures triggered by physical activity/ exercise, and the advices given by the family members and the health care professionals to avoid intense activity . In two studies performed about this subject, this is the probable reason why adult patients with epilepsy have a weaker physical fitness than healthy individuals in the control group. However; in a study of Drawskowski et al., the avoidance of activity and exercise in individuals with epilepsy was investigated, and it was reported that the injuries and seizure problems were rare even during very intense physical activity.

Eligibility Criteria:
Inclusion Criteria:

* children who were diagnosed with epilepsy
* children who can independently continue formal education,
* children who do not need special education
* children who have no additional neurological and neuromuscular disease (epilepsy only)
* children who have a normal or higher cognitive level according to the WISC-R intelligence test
* children who were volunteers to participate in the study
* children whose parents volunteers to participate in the study

Exclusion Criteria:

* The disappearance of volunteerism
Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis

The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and root planing in patients with chronic periodontitis leads to host inflammatory response modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open new vistas in treatment of chronic periodontitis.

A RCT was carried out to check the efficacy of Montelukast as an adjunct to scaling and root planing. The patients were randomised to either test group (SRP + Montelukast) and control group (SRP). Clinical parameters were assessed at baseline, 3 weeks and 6 weeks. Serum C-reactive protein levels were assessed at baseline, 3 weeks and 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients within age group of 30 to 55 years.
2. Systemically healthy individuals.
3. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria

Exclusion Criteria:

1. Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy),
2. Smoking,
3. Chronic alcoholics,
4. Pregnancy or lactation,
5. Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013,
6. Confirmed or suspected intolerance to Montelukast,
7. Periodontal therapy done within the January 2012 to Jun 2013.
e-IMPAQc Systematic Assessment of Patient Reported Outcomes in Cancer Care

Purpose: The Electronic Implementation of Patient and Caregiver Reported Outcomes across cancer centres in Quebec project, or e-IMPAQc, was launched in 2017. e-IMPAQc's goal is to actively engage patients, their caregivers, healthcare professionals (HCPs), managers, policy makers, researchers and IT personnel to co-develop, implement, and evaluate an evidence-informed electronic patient-reported outcomes (e-PRO) screening and management program across Quebec.

Methods: e-IMPAQc built on the Improving Patient Experience and Health Outcomes Collaborative (iPEHOC) project, the first initiative in the province to implement e-PRO screening and was rolled out in three phases. e-IMPAQc has five main components: 1) primary and secondary standardized e-PRO questionnaires and algorithm; 2) summary report for clinicians with alert system; 3) summary report for patients, with tailored notifications regarding symptom severity; 4) self-management fact sheets library; and 5) clinical dashboard. Phase 1 included initiating change management and the co-development of the e-PRO algorithm with patients, their caregivers, HCPs, managers, policy makers, researchers and IT personnel (herein collectively referred as stakeholders) across seven cancer centres. The iPEHOC algorithm was used as a starting point given its successful implementation in one of the participating cancer centres for several years. Phase 1 also included feasibility work to establish a caregiver-reported outcomes (CROs) algorithm as well as the identification and configuration of appropriate electronic platforms on which to house e-IMPAQc. In Phase 2 the focus was on preparing for imminent implementation through workflow mapping and putting in place implementation support (e.g., site coordinators). A pilot of e-IMPAQc (excluding CROs) was also undertaken at one of the participating centres. In Phase 3, e-IMPAQc is being sequentially rolled out to as many cancer centres as possible and then evaluated. Qualitative and quantitative methods are used to document the process of implementation, patient and caregiver, and knowledge transfer (KT) outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Receiving cancer care at designated center

Exclusion Criteria:

* Unable to speak English or French
* Unable to use email and internet
Validation of Downloadable Mobile Snore Applications by Polysomnography (PSG)

The aim of this study is to validate the downloadable mobile snore applications by polysomnography.

Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Mobile snore applications are convenient and accessible for patients to monitor the progress of OSA by themselves, but there are no reliable PSG-validated applications.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign inform consent with aged more than 20 years old
* Mild to moderate OSA, AHI (apnea-hypopnea index) \< 30

Exclusion Criteria:

* Significant lung disease
* Skeletal facial framework problems
* Central apnea
* Receiving acupuncture in recent 2 weeks
* Taking hypnotic drugs
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.


Eligibility Criteria:
Inclusion criteria:

* Participants must be able to provide informed consent.
* Have documented HIV-1 infection.
* Have not received more than 14 days of prior treatment with antiretroviral drugs.
* Meet laboratory test criteria.
* Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
* Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

* Enrolled in other HIV treatment studies.
* Pregnant or breastfeeding.