cyrilzakka/clinical-trials huggingface dataset:
Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary

Multi-centre, open-label, prospective, uncontrolled, single-arm, non-interventional study (NIS) with objective to collect and evaluate data concerning treatment with Rhinospray Plus in everyday curative routine treatment of acute rhinitis

Study Design:

open, observational, single-arm, uncontrolled

Eligibility Criteria:
Inclusion criteria:

1. Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent
2. Male and female ambulatory outpatients being seen in a participating physicians office for routine care
3. Patients with a clinical diagnosis of Rhinitis acuta
4. Patient having the cognitive and functional abilities for answering the symptom specific questions
5. Patients having expressed the willingness to participate in this observational study
6. Patients at and above the age of 6
7. Rhinospray Plus naive patients (patients who have not used Rhinospray Plus before)

Exclusion criteria:

1. Uncooperative patients based on physicians judgement
2. Patients with any conditions making the application of Rhinospray plus contraindicated
3. Patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems
4. Withdraw of Informed Consent
5. Pregnancy or breast-feeding as stated in the Summary of Product Characteristic (SmPC)
6. Patients with clinical diagnosis of allergic rhinitis
Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery

This is a retrospective study to compare postoperative pain intensity in patients going laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS), without ERAS and open colorectal surgery.

This study is a matched case-control study. Control patients will be matched to ERAS cases in a 1:1:1 ratio (laparoscopic surgery with ERAS protocol : laparoscopic surgery without ERAS protocol : open surgery).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colorectal surgery under ERAS program and those with the same sort of laparoscopic surgery without ERAS program as well as those with open colorectal surgery with complete required recorded data.

Exclusion Criteria:

* 1. Patients with incomplete required data on record.
* 2. Those with any major intraoperative or postoperative complications.
Prevalence of Subclinical Vertebral Fractures in Rheumatoid Arthritis and Ankylosing Spondylitis

Study of prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis

Detection of the prevalence of subclinical vertebral fractures in Rheumatoid Arthritis and Ankylosing spondylitis Study the relation between vertebral fractures and some clinical data like demographics data, disease duration and disease severity

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling ACR/EULAR 2010 rheumatoid arthritis classification criteria.

Patients diagnosed as ankylosing spondylitis according to ASAS criteria (2000). Age (18-50).

Exclusion Criteria:

* Patient with other autoimmune Rheumatic disease other than RA and AS. Infections including hepatitis C or B, HIV, tuberculosis. RA and AS patients with known vertebral fractures. Malignancy, hypogonadism, thyroid problems, chronic kidney disease, Hypoparathyroidism, Type 1 DM.

Pregnancy and breast-feeding.
New Media Obesity Treatment in Community Health Centers

This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.

This is a patient randomized trial in which patients will be randomized into one of two treatment arms: 1) standard primary care; or 2) primary care plus a 12-month eHealth behavioral intervention (iOTA), which includes interactive self-monitoring and feedback, tailored skills training materials, 18 telephone counseling calls, and primary care provider counseling. The primary outcome is weight change at 12 months. Participants will be 351 adult male and female patients from local community health centers with obesity and a related comorbidity.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 visit in the previous 12 months to an adult medicine, internal medicine, or family practice provider at a participating community health center
* BMI between 30.0-45.0 kg/m2 and weight ≤ 320 pounds
* Diagnosis of hypertension or diabetes

Exclusion Criteria:

* Current pregnancy
* Pregnancy in previous 12 months
* Heart attack/stroke in previous 2 years
* Active cancer diagnosis
* Current participation in another weight loss study
Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 to ≤70 years
* Body Mass Index: ≥18 and ≤35 kg/m2
* Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion Criteria:

* Type 2 diabetes mellitus
* Serum C-peptide \>1.0 ng/mL
* HbA1c \>10.0%
* History of hypersensitivity to any of the components in the study medication
* Treatment with any other investigational drug in the last 30 days before dosing.
* Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.
The Effect of Music Listening in Rehabilitation of Subacute Stroke

Music listening has many positive effects on the brain. This study aims to find out if people with stroke get better results with their rehabilitation if they listen to music during their passive hours. The study is a randomized controlled trial with people who are at a rehabilitation center care after stroke at Tampere University Hospital. The control group gets standard rehabilitation. Music group gets standard rehabilitation and in addition they listen to music one hour a day during four weeks. Physiotherapists, occupational therapists and speech therapists test how well the participant's walking, use of hand and speech improve. The main goal is to find out if the improvement is better with music listening. The study also monitors effects of music listening on mood in rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* hemispheric stroke (ischemic or intracerebral hemorrhage) during last 4 weeks OR spinal cord injury in last 6 months, causing a need of intensive rehabilitation

Exclusion Criteria:

* severe hearing loss preventing music listening
* previous condition of neurological disease of dementia that significantly affects daily functions
* active drug use or acute psychiatric condition
* unable to understand given information and give consent to participate
* for spinal cord injury patients: acute traumatic brain injury or stroke
Observation of B-lines in Pulmonary Echography, During Open Abdominal Surgery

There is no a reliable marker of intraoperative fluid excess or overload. The use of lung ultrasound in other settings, such as emergency room and critical care patients, helps us to determine if a patient has a condition of augmented intrathoracic fluid, that could be related to several circumstances, such as fluid overload, but also to heart failure, in example.

Nevertheless, there is no information regarding the basal incidence of this finding, to ascertain if could be eventually used as a potential marker of fluid overload. This protocol looks for the incidence of the finding of B-Lines, which are related to fluid overload, in patients undergoing open abdominal surgery.

The presence of B-lines will be observed in 4 spaces at each evaluation: Anterior-superior, and infero-lateral, by each side.

The times of evaluation will be prior to intubation, after intubation, every one hour of surgery, at the end of the surgery prior to extubation, and after 2 hours in the postoperative care unit.

Other variables addressed will be the vital signs, parameters related to a diminished intravascular status (ie, pulse pressure variability), central venous pressure, volume changes (reposition, bleeding, diuresis), and requirements of blood products.

A correlation with baseline characteristics of patients will be observed; nevertheless, this study is directed as primary endpoint to evaluate the incidence of the B-lines in echography, and the sample size was calculated following this endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to open abdominal surgery Older than 18 years.

Exclusion Criteria:

* Previous thoracic surgery, BMI over 30 kg/m2 Baseline respiratory alterations related to preoperative supplementary oxygen requirements Evident malformations of the thoracic wall If the position required for the surgery does not allow the echographic windows required for the protocol
Urethral Functional Profile Length Before Radical Prostatectomy as an Early Postoperative Continence Predictor

Urinary incontinence (UI) is one of the most common complications of radical prostatectomy (RP). Impaired urethral sphincter function is generally considered to be the most important contributing factor of UI however, the mechanism of onset and recovery of urinary continence has not been fully elucidated. In this research, the urodynamic method of Urethral Pressure Profile (UPP) was used to evaluate Functional Urethral Length (FUL) and Maximal Urethral Closure Pressure (MUCP) and correlate with the postprostatectomy continence recovery. Objective of this research is to evaluate preoperative FUL and MUCP as an early continence recovery predictors after open retropubic RP (ORRP).

The research was conducted at the Department of Urology of the University Hospital Centre Zagreb on a group of 43 patients in the period from July 15th , 2019 to May 07th , 2021.The severity of UI and bothersome were assessed using fully validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and number of pads used in 24h. Patients were interviewed about the use of urinary pads and asked to fill out the ICIQ-UI SF before and 2, 8, 16 and 24 weeks after RP.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with localized prostate cancer
2. Open Retropubic Radical Prostatectomy (ORRP) is planned as a treatment

Exclusion Criteria:

1. Incontinent patients prior to ORRP
2. Previous surgery in the area of the prostatic urethra
3. Previous procedures that can damage the innervation of the pelvis
4. Radiotherapy performed in the pelvic area prior to ORRP
5. Adjuvant radiotherapy in the first postoperative year
Latinos Understanding the Need for Adherence in Diabetes

The Latinos Understanding the Need for Adherence in Diabetes (LUNA-D) study, is a randomized controlled trial testing the effectiveness of an integrated behavioral health and primary care chronic care disease management intervention for low income Latino patients with type-2 diabetes mellitus (T2DM) that have 2 or more chronic health conditions. LUNA-D focuses on diabetes management and behavioral health care integration.

LUNA-D proposes to test the ability of a fully integrated behavioral health and primary care diabetes management intervention in a federally-qualified community health care setting to improve multiple clinical and behavioral outcomes. LUNA-D will recruit non-insulin using adult type two diabetes mellitus (T2DM) patients with two or more chronic diseases. Half will be randomized to the Special Intervention (SI) arm and half to the Usual Care (UC) arm. The SI is an intensive intervention including fully integrated clinical visits with a medical provider (MP) co-located with a behavioral health counselor (BHC) and peer-led evidence-based group health education sessions and proactive care coordination. Usual Care is represented by passive appointments with the primary care physician and passive referrals to behavioral health and traditional health education. Biological measurements will be taken at baseline, 3-, 6-, 9- and 12-months to detect changes in glycemic control. Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study.

Eligibility Criteria:
Inclusion Criteria:

This study targets non-insulin using T2DM patients with 2 or more chronic conditions. The primary eligibility criteria are as follows:

* Self-identify as Hispanic/Latino
* Be a registered \& established patient of SYH
* 18 years of age or older
* Have an established diagnosis of T2DM (but not currently using insulin)
* Not currently participating in any other diabetes or CVD intervention program
* Have 2 or more CVD risk factors (e.g., depression, anxiety, hypertension, dyslipidemia, obesity, or smoking)

Exclusion Criteria:

Individuals will be excluded if they:

* Are pregnant or planning to get pregnant (temporary exclusion, may qualify 6-months postpartum)
* Have plans to move out of the area in the next 12 months
* Have pre-existing health problems so severe as to prohibit informed consent and study attendance
* Have severe diabetes, including renal disease and/or on dialysis
* Have severe psychosocial conditions under the care of a psychiatrist (e.g., severe depression, bipolar disorder, or schizophrenia)
A Phase III Long Term Study of K-877 Extended Release Tablet

To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with dyslipidemia had to be age 20 years or older at written informed consent
2. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
3. Patients with the fasting serum TG \>= 150 mg/dL twice consecutively at Screening

Exclusion Criteria:

1. Patients with a fasting serum TG \> 1000 mg/dL at Screening
2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
3. Patients with uncontrolled thyroid disease
4. Patients with type 1 diabetes and uncontrolled diabetes \[HbA1c(NGSP) \>= 10.0 % at Screening\]
5. Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg)
6. Patients with an AST or ALT three times the upper limit at Screening
7. Patients with an CK five times the upper limit at Screening
8. Patients with cirrhosis or those with biliary obstruction
9. Patients with acute myocardial infarction within 3 months before obtaining informed consent
10. Patients with heart failure class III or higher according to NYHA cardiac function classification
11. Patients with malignant tumor or those who are judged to have a high risk of recurrence
12. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
13. Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods
14. Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
15. Patients who have received K-877 (pemafibrate)
16. Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks
17. Patients who have been determined inappropriate by the investigator, etc
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma

This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer)
* Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test
* Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be \>/= 28 days; patients must have recovered fully from toxicities of all prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Evaluable disease (measurable for disease progression according to RECIST criteria)
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Active CNS lesions
* History of or known spinal cord compression or carcinomatous meningitis
* Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
* Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
* Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
* Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug
A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cleansing with Plenvu

Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred for diagnostic colonoscopy
* Age between 40 and 85 years old
* Ability of normal oral ingestion
* Able to give informed consent by the patient or the legal representative

Exclusion Criteria:

* Participant has a history of (partial) colectomy, excluding appendectomy
* Inability of oral ingestion
* Chronic severe constipation, defined as the need for daily laxative use of any kind or the need to use laxatives to obtain defaecation.
* Uncontrolled coagulopathy
* Pregnancy
* Premenopausal women not adhering to any contraceptive method
* Inflammatory bowel disease
* Lynch syndrome
* Familial adenomatosis polyposis syndrome
* Serrated polyposis syndrome
* hypersensitivity to the active substances of PLENVU as listed in the SmPC section 6.1
* gastrointestinal obstruction or perforation
* ileus
* gastric emptying disorders (e.g. gastroparesis, gastric retention, etc.)
* phenylketonuria (due to the presence of aspartame in PLENVU)
* glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbate in PLENVU)
* toxic megacolon
* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER

The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.

The secondary objectives of this study are:

* To assess the feasibility of measuring the diaphragmatic excursion in the context of emergency management (ratio of measured patients / included patients).
* To evaluate the time required for the measurement.
* To assess the intra-rater reproducibility of measurements of diaphragmatic excursion (comparison of first and second measures).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has acute respiratory distress defined by a respiratory rate \> 25, and / or signs of struggle and hypoxia, oxygen saturation (SpO2) \<90% and / or pH \<7.35 and carbon dioxide partial pressure (pCO2) \> 6 kPa (45 mm Hg)
* The patient breathes spontaneously (no respirator)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient or his/her representative refuses to sign the consent
* It is impossible to correctly inform the patient, or to correctly inform his/her representative
* The patient is pregnant, parturient, or breastfeeding
* The patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, Lou Gehrig's disease, Myasthenia ...).
* Patient admitted with respiratory support treatment in progress
* Patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements