cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine

To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid® sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.

This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format.

Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population, and indication as well as with local guidelines.

The postmarketing observational study is observational in nature. Its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. Follow-up of patients should enable two patient visits during this period.

The screening/inclusion visit (Visit 1) will be performed when the decision for Klacid SR therapy in a daily dose of 1000 mg is made. The second visit of the patient will occur 10 - 16 days from the screening/inclusion Visit (upon physician's decision). The physician can change the numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Men, women 18 years with

  1. Acute tracheitis.
  2. Acute tracheobronchitis.
  3. Acute bronchitis.
  4. Mild community-acquired pneumonia.
  5. Acute exacerbation of chronic bronchitis.
* To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.

Exclusion Criteria:

* Known hypersensitivity to macrolide antibiotics
* Documented renal impairment (creatinine clearance under 30 ml/min)
* Concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine
* Pregnancy
* Breast feeding
Efficacy of Early Stage Alzheimer's Support Groups

The purpose of this study is to evaluate the impact of an Early Stage Memory Loss Support Group (ESSG) and Education Seminar (ES) on quality of life, mood, social support, distress about memory loss, and interpersonal relationships of memory loss participants and their caregivers.

With recent advances in diagnostic procedures and treatment options, many individuals with AD are now diagnosed early in the disease. Early diagnosis has many benefits: treatment can be started sooner, legal and financial planning can be addressed while the individual is able to participate in decision-making, and support services can be mobilized earlier. However, early diagnosis may also have negative consequences for the diagnosed individual's quality of life. Thus, diagnosis creates an obligation to help individuals and their families learn more about AD and cope with the impact of the diagnosis. Many Alzheimer's Association chapters have begun providing early stage support groups that focus on enhancing quality of life for participants and their caregivers. Anecdotal reports suggest that these groups improve quality of life of participants, but some individuals may also experience decreases in quality of life associated with stress, depression, or family conflict as a result of discussing current and future losses in the group. Thus, there is a need to systematically evaluate the benefits of these groups.

This study will evaluate and compare the efficacy of a structured, 8-session Early Stage Support Group intervention (ESSG) and a half-day Education Seminar (ES). Participants with early stage memory loss and their caregivers will be randomly assigned to either ESSG or ES. Both are presented by the Alzheimer's Association Western \& Central Washington State Chapter.

Eligibility Criteria:
Inclusion Criteria:

* Dementia diagnosis confirmed by primary care physician
* Early stage dementia, defined as a Mini Mental State Exam score of 18 or higher, and a Clinical Dementia Rating of 1 or less
* Care partner who will attend groups and complete study assessments
* Aware of memory loss (verbally acknowledges memory loss and/or expresses concern about memory)
* Comfortable in a group separate from family members
* No significant history of mental illness (no hospitalization or medication for psychotic disorder within the past 2 years)
* Consent to research participation (participant, care partner, legal representative)
* Remain in the community for the 6 month duration of the study
Prospective Case Series to Assess Complications of Using Distal Ulna Locking Plate of I.T.S.

Background of the study:

Various studies show that the outcome of unstable distal ulna fractures after open reduction and internal fixation is better than closed reduction. The previous plate system for the distal ulna fractures is applied exclusively on the extensor side. This often leads to irritation of the extensor tendons, as well as problems with pronation and supination. With the new shape of the angle-stable distal ulna plate, the investigator hopes that the stability of the fracture osteosynthesis will remain the same and that it will be better tolerated with regard to the surrounding soft tissue, especially the extensor tendons. In this way, an otherwise practically unavoidable removal of osteosynthesis material could - at least in some cases - be avoided and some patients spared a follow-up operation.

With this in mind, the investigator tries to achieve the greatest possible reconstruction and stability for early functional follow-up treatment with a slightly bulky implant placed in the tendon-free area.

With this study, the application and usability of the new angle-stable plate system should be determined and documented.

New value of the study:

This system enables an optimal position of the plate on the distal ulna, on the one hand due to the position on the flexor side and on the other hand due to the new shape, adapted to the anatomy of the distal ulna. The locking system using angle-stable screws corresponds to the systems previously used by I.T.S.

Design:

Prospectively, handling, advantages and possible complications of the angle-stable, distal ulna plate; Company I.T.S. in the osteosynthesis of the unstable distal ulna fracture. A total of 20 patients with unstable distal ulna fractures are to be treated and evaluated over a period of 12 months according to the study design.

Risk/Benefit:

With the use of the angle-stable distal ulna plate, company I.T.S. the patients broken bone may heal better. However, it is also possible that the patient will not benefit directly from his/her participation in this clinical trial. The Expected Benefit of the Locking Distal Ulnar Plate; Company I.T.S. includes:

* Reduced risk of bone misalignment after surgery.
* Less risk of irritating tendons on the plate with the new location.
* A removal of the osteosynthesis material could possibly be avoided.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years
2. unstable distal ulna fractures

Fracture classification according to Biyani \[4\]: all types

Exclusion Criteria:

1. Age under 18 years old
2. stable fractures of the ulna
3. Patient had one before ulna fracture
4. Patient may result in physical or intellectual disability consent not grant
5. Patient is for more Check-ups not available (Abroad)
6. Patient does not have full legal capacity
7. Alcohol and drug abuse
8. Increased risk of anesthesia (from ASA 3)
Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye

The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective treatment of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* documented dry eye history
* ocular symptoms
* tear use
* dry eye ocular signs

Exclusion Criteria:

* Under 18
Comparison of Uterine Exteriorization Versus in Situ Repair at Cesarean Section: a Randomized Clinical Trial

There is no difference between extra-abdominal or in situ suture of the uterus in cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* indication of cesarean section
* gestational age \> 24 weeks

Exclusion Criteria:

* two or more cesarean sections
* chorioamnionitis
* hemorrhagic complications
* unable to consent
* previous abdominal surgery
Creatine Supplementation in Young Healthy Adults

The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance).

Creatine is a naturally occurring compound produced in the liver and brain. Creatine can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products (i.e. creatine supplementation).

Evidence-based research shows that creatine supplementation improves measures of body composition and muscle performance. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.

Eligibility Criteria:
Inclusion Criteria:

* if you are 18-39 years of age
* if you have not been performing resistance training for at least 4 weeks prior to the start of the study.

Exclusion Criteria:

* if you are pregnant or nursing
* have taken creatine monohydrate within 30 days prior to the start of the study
* if you have pre-existing allergies to the placebo (corn-starch maltodextrin)
Colorectal Cancer Detection by Means of Optical Fluoroscopy

The aim of the present prospective study was to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer.

For years, serum tumor markers have been studied for the diagnosis and follow-up of colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising results. However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated CEA levels also occur in patients with benign disease, as well as in patients with other carcinomas. Nevertheless, surveillance programs are often based on the CEA test and combination with other markers is at present a matter of research. Alternative methods based on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of cancer. Few studies have been reported on the application of native fluorescence spectroscopy of biofluids in the diagnosis of tumoral diseases. The above reported findings prompted us to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For this purpose, the blood of patients was collected and the fluorescence Preliminary measurements on plasma of patients bearing colon cancer showed that the fluorescence spectra were mainly characterized by the presence of an emission peaking at 620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of 405 nm was selected for the study. The fluorescence emission spectra were recorded in the range of 430-700 nm.

Eligibility criteria: Gastrointestinal disease or clinical symptoms related to colorectal cancer risk submitted to endoscopy. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome: investigated the possible role of the native fluorescence of blood plasma in the management of colorectal cancer (CRC) and its feasibility as a new tumor marker. Sample of blood was collected from asymptomatic blood donors and from CRC patients. The native fluorescence of blood plasma was measured using a conventional spectrofluorimeter.

Eligibility Criteria:
Inclusion Criteria:

Gastrointestinal disease clinical symptoms related to colorectal cancer risk endoscopy

Exclusion Criteria:

Age younger than 18 years or more than 75 years, history of psychiatric illness, preoperative chemo/radiotherapy.
Ebastine Versus Mebeverine in IBS Patients

Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome

Trial rationale

1. To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine
2. To evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years

Primary objective To provide further evidence of the superiority of histamine 1 receptor antagonism as novel treatment for patients with non-constipated IBS, as compared to mebeverine, one of the spasmolytics currently used as first line treatment of IBS.

Secondary objective(s) To provide evidence that the histamine 1 receptor antagonist ebastine is more effective in reducing abdominal pain compared to the commonly used antispasmodic mebeverine


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Patients fulfilling the Rome IV criteria for non-constipated IBS (IBS-C subtypes will be excluded)
3. No organic cause that can explain the presenting symptoms (exclusion of coeliac disease (blood), lactose intolerance (breath test), inflammatory bowel disease and giardiasis (stool)
4. Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks
5. Age 18-65

Exclusion Criteria:

1. History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease, infectious gastroenteritis, motility disorder, serious liver kidney cardiac or pulmonary disease, known cardiac rhythm disorders, insuline-dependent diabetes, psychiatric diseases
2. Pregnancy, breast feeding
3. Medication: the use of antidepressants or antipsychotics, anti-allergic medication or drugs affecting gastrointestinal motility / visceral sensitivity (anti-cholinergics, antispasmodics, 5-HT3 antagonists, 5-HT4 agonists, loperamide, codeine, laxatives, analgesics: only paracetamol is allowed as analgetic, other analgesics are forbidden.), CYP3A4-inducing and inhibiting drugs. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, St. John's Wort and glucocorticoids.
4. Symptoms started following abdominal surgery
5. IBS constipation dominant (IBS-C)
6. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC of the respective medicinal products
Trunks Body Blocks for Postoperative Analgesia in Abdominal Surgery

This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery

This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery.

In abdominal surgeries, USG guided body blocks are performed for postoperative analgesia. For this purpose, Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks.

The aim of this study was to evaluate for postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

Eligibility Criteria:
Inclusion Criteria:

Abdominal surgery

Exclusion Criteria:

Cardio-respiratory disease Anti-inflammatory treatment Cognitive disorders Written consent form haven't get history of relevant drug allergy infection of the skin at the site of the needle puncture area coagulopathy
Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience

This study aimed to provide a recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list. In this way, we aimed to minimize confusion regarding dietary restrictions during colonoscopy preparation and ensure full compliance with the diet list. Our hypothesis is that this approach may enhance compliance with current recommendations and improve the quality of bowel preparation.

A total of 153 patients were included in this study. At the time of scheduling an outpatient colonoscopy, intervention group and control group were randomly assigned using a random-number generator for treatment allocation. The research protocol was explained during the colonoscopy appointment, and patients, when they agreed to follow their diet according to the recipe booklet, were accepted as part of the patient intervention group. A consent form was signed and collected. The nurse responsible for patient education in the endoscopy secretariat informed the patient that this booklet is an important component of bowel preparation and adhere strictly to the recipes in the booklet. The group who received the standard diet list and applied for their colonoscopy appointments were randomly designated as the control group. Bowel preparation was evaluated during the colonoscopy using the Boston Bowel Preparation Scale (BBPS). Cecal insertion and withdrawal times, polyp detection rate, utilization of the recipe resource, and patients' experiences related to colonoscopy were recorded.

The research team utilized freely available resources from general cookery recipe websites to create the recipe resource, adapting it to align with the recommendations for a low-residue diet (figure). Recipes were selected based on criteria such as being visually appealing, easy to prepare, and easily modifiable to comply with the low-residue diet. A dietitian examined the recipe resource to guarantee that the recipes followed low-residue diet guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All outpatients who apply for a colonoscopy appointment.

Exclusion Criteria:

* Patients with a history of prior colonoscopic procedures
* Using anticholinergic or gastrointestinal motility-reducing drugs
* Severe chronic kidney failure (GFR\<30 ml/min)
* Advanced heart failure (NYHA III-IV)
* History of abdominal surgery were not included in the study.
A Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)

Sleep disturbance is very common in patients with atopic dermatitis (AD) and is a major factor leading to impaired quality of life. Nocturnal scratching is one of the factors causing sleep disturbance in AD patients. This study aims to develop and validate a digital algorithm for accurately and reliably detecting and quantifying nocturnal scratch behaviors related to AD using wrist actigraphy data.

Wrist actigraphy is an investigational device being developed to detect and quantify scratching behaviors in patients with AD. This study will be conducted in 2 sequential stages: In Stage 1, an algorithm will be developed and in Stage 2 the algorithm developed will be validated. Adult healthy volunteers or participants with AD will be enrolled. Approximately 14 healthy volunteers, 14 AD patients with low disease activity and 28 AD patients with high disease activity will be enrolled in the study in 5 sites across the United States.

No drug will be administered as a part of this study.

Participants enrolled in this study may experience discomfort or inconvenience related to the study procedures. Participants will be enrolled and monitored overnight for two consecutive nights at an inpatient setting at a hospital or clinic. The impact of nocturnal scratching on sleep parameters will be assessed by videography, actigraphy, sleep headband and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers in general good health with no diagnosis of AD or any other dermatologic disorder that interferes with study assessments.
* For subjects with AD:
* Chronic AD with onset of symptoms at least 1 year prior to Day 1 and participant meets American Academy of Dermatology (AAD) criteria.
* Participant meets all of the following disease activity criteria:

  * For AD subjects with high disease activity (AD-High):

    * Pruritus over the last 7 days (numerical rating scale 7-Day version \[NRS-7\]) \>= 4 at the Screening and Day 1 visits.
    * At least one of the following:

      * Eczema Area and Severity Index (EASI) score \> 7 at the Screening and Day 1 visits; OR
      * Validated Investigator Global Assessment for AD (vIGA-AD) score \>= 3 at the Screening and Day 1 visits;
  * For AD subjects with low disease activity (AD-Low):

    * Pruritus over the last 7 days (NRS-7) \>= 2 at the Screening and Day 1 visits.
    * Does not meet AD-High criteria as described.
    * Satisfy at least one of the following:

      * EASI score \>= 3 at the Screening and Day 1 visits OR
      * vIGA-AD score \>= 1 at the Screening and Day 1 visits.

Exclusion Criteria:

* Significant eczema on wrists where devices will be worn that, in the opinion of the participant or investigator would likely lead to non-compliance.
* Interference (e.g., hairstyle) with the ability of Dreem 2 headband to collect sensor data.
* Unstable medical disorder or other condition that in the investigator's opinion may interfere with study procedures or study objectives.
Sleep Hygiene Education in Mothers With Preschool Children

The goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. The main questions it aims to answer are:

* What is the importance of sleep routine and environment in children with neurodevelopmental disorders?
* What kind of an effect does the awareness that mothers gain through sleep trainings have?

Participants will:

* Evaluations will be applied to all participants
* Divided into intervention and control groups
* The intervention group will be given "Sleep Training" and followed up for about 1 month.
* The results between the two groups will be compared

Researchers will compare intervention and control groups to see if turning a healthy sleep routine into a life habit


Eligibility Criteria:
Inclusion Criteria:

* Having a child with a neurodevelopmental disorder
* Be over 18 years old and literate
* Having a child(s) of pre-school age (3-6 years old)
* Communicating and collaborating

Exclusion Criteria:

* Having a neurological or psychiatric disease that prevents communication and cooperation