cyrilzakka/clinical-trials huggingface dataset:
Effect of Shotblocker and Palm Stimulator

This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.

It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research,

  * Those who will receive vitamin B injection ordered by physician due to B12 deficiency,
  * Conscious and oriented,
  * Able to understand and speak Turkish,
  * Age range is between 18-65,
  * Having no vision or hearing problems,
  * Pain score of 2 or less when evaluated with a visual analog scale,
  * Able to lie in the right lateral position where injection can be administered,
  * Those who have not had an IM injection into the right ventrogluteal area in the last week,
  * Body mass index is within the normal range (25.0-29.9 kg/m2) according to WHO,
  * Those who have not used any analgesics or muscle relaxants in the last 24 hours,
  * Does not have any problems such as hardness, mass, edema or infection in the area to be injected,
  * According to his own statement, he has no psychiatric diagnosis,

Exclusion Criteria:

* Having pain anywhere in the body,

  * Narcotic type or different analgesic area before application,
  * Pregnant or suspected of pregnancy,
  * Individuals in menstrual period,
  * Receiving chemotherapy and radiotherapy treatment,
  * Those who have migraine, are in the postoperative period, have nerve damage, neuropathy and a vascular disease,
  * Those who have disabilities in grasping their hands,
Validation of a Combined Symptom and Medication Score in Patients Suffering From Allergic Rhinoconjunctivitis

This study is a mere data collection without predefined intervention. Patients aged 12 years or older who suffer from allergic rhinitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with anti-allergic medication may take part. The treatment follows the normal medical practice in accordance with national medical guidelines. During the study, data are collected during 3 visits with regard to allergic complaints of a patient and intake of anti-allergic medication. The first visit takes place before allergen exposure, the second visit at the peak of allergen exposure and the third visit after allergen exposure. The allergen exposure is defined as the enhanced exposure to house dust mites during the heating period or the respective pollen season. During the visits, the patients will be asked to complete questionnaires with regard to their quality of life and rhinitis control. Furthermore during allergen exposure, the patients document their allergic complaints and intake of anti-allergic medication in a diary. The diary entries are used to generate the Combined Symptom and Medication Score (CSMS) which will be validated in the course of this study. The validation will be performed by comparing the CSMS with the scores from the already validated questionnaires.

This study is a prospective, mulit-center data collection without predefined intervention. Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication may take part. The treatment follows the normal medical practice in accordance with national medical guidelines. During the study, data are collected during 3 visits with regard to allergic symptoms of a patient and intake of symptomatic medication. The first visit takes place before allergen exposure, the second visit at the peak of allergen exposure and the third visit after allergen exposure. The allergen exposure ist defined as the enhanced exposure to house dust mites during the heating period or the respective pollen season. During the visits, the patients will be asked to complete questionnaires \[the rhinitis quality of life questionnaire (RQLQ, Visit 1, 2 and 3) and the rhinitis control assessment test (RCAT, visit 2)\]. Furthermore during allergen exposure, the patients document allergic symptoms and intake of symptomatic medication in a diary. These diary entries are used to generate the Combined Symptom and Medication Score (CSMS) which will be validated in the course of this study. The validation will be performed by comparing the CSMS with the scores from the already validated RQLQ and RCAT.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis induced by house dust mites, tree pollen or grass pollen and who are treated exclusively with symptomatic medication

Exclusion Criteria:

* Allergen-specific immunotherapy
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males

The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 35 years
* Weight between 50 and 80 kg
* Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
* Judged as eligible as a study object following the screening test by the investigator
* Volunteers to participate in the study, who are capable of giving written informed consent

Exclusion Criteria:

* Known hypersensitivity to drugs
* History of drug or alcohol abuse
* Received other investigational drug within 4 months of the trial drug administration
* Had \> 400 mL of whole blood drawn within 3 months of the trial drug administration
* Had \> 400 mL of blood components drawn within 1 month of the trial drug administration
* Used any drug within 10 days of the trial drug administration
* Engaged in strenuous exercise within 5 days of the trial drug administration
* Consumed alcohol within 3 days of the trial drug administration
* Judged as ineligible for the study participation by the investigator for a reason other than above
Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle modification to facilitate appetite control and weight loss in overweight and obese individuals.


Eligibility Criteria:
Inclusion Criteria:

* 21-75 years of age
* Body Mass Index of 25-45 inclusive

Exclusion Criteria:

* major medical psychiatric conditions
* medications know to effect weight
* full or partial dentures
* 18 or fewer teeth
* regular gum chewing (≥ 2 pieces/day)
* use of any tobacco product
* sensitivity to the following ingredients (mint, magnolia bark, eggs, or English Muffins)
* history of PKU
* sensitivity or allergy to aspartame
* current/history of alcohol abuse or addiction (within 5 year)
* recreational drug use
* recent significant weight change (+/- 5% in previous 6 months)
* currently pregnant or nursing and willingness not to get pregnant during course of study
* participation in any other research studies
* proximity to clinic (within one hour)
* access to reliable transportation
TIMECARD(TaIwan Network of Post-arrest ManagEment for CARDiac Arrest)IIRegistry

This study aims to collect the post-cardiac arrest patients with ICU admission.

The purpose of this study is to establish protocolized and standard post-arrest care as well as constitute a multicenter registry of post-arrest survivors, and thus to develop the Taiwan predictive model of cardiac arrest survivors. The registry system may help evaluate the severity of disease illness and improve the post-arrest care.

Eligibility Criteria:
Inclusion Criteria:

* non-traumatic cardiac arrest patients
* Admitted to the ICU

Exclusion Criteria:

* Below 18 year old
* Pregnant
* Terminal illness or not receiving medical treatment
* When emergency ICU crowded can not provide Critical Care
Shock Waves Therapy Combined With Leg Stretching in Patients With Plantar Fasciitis

The aim of this study is to evaluate the efficacy of a combination treatment consisting of ESWT and stretching of different muscles in the lower body compared to ESWT treatment alone in patients with plantar fasciitis.

Background: Plantar fasciitis is the most common cause of pain in the heel of the foot, manifested by the presence of pain in the antero-internal part of the calcaneus. Currently, there is ample evidence of the efficacy of both shock waves and stretching in their treatment, however, no study has proven what results are obtained by combining the application of shock waves with stretching in different leg muscles.

Objectives: The main objective of the study is to compare the effects of OC treatment in conjunction with leg-length stretches against shock waves alone in reducing pain in patients with PF. The secondary objectives will be to observe the effects of both treatments on disability and activity limitation in both the short and medium term.

Materials and Methods: A double-blind randomized clinical trial will be conducted. A total of 52 subjects (26 in each group) will participate in the study, divided into one group that will undergo shockwave therapy plus real stretching (experimental group) and another that will undergo shockwave therapy plus placebo stretching (control group). The primary variable of the study will be pain, and secondary variables will include changes in disability and activity limitation.

Eligibility Criteria:
Inclusion Criteria:

* Presence of pain in the medial area of the sole of the foot lasting 3 or more months.
* Being diagnosed with plantar fasciitis by one of the physical therapists participating in the study.
* Have a pain level equal to or greater than 3 on the Visual Analogue Scale (VAS).

Exclusion Criteria:

* Presence of bilateral plantar fasciitis.
* Signs of neurological abnormalities.
* Infections and malignant tumors.
* History of presence of dysfunction in the lower extremity.
* Pregnant women
* Have been treated with shock waves in the previous 12 months.
The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion

Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack.

Objective To determine whether nicorandil can improve left ventricular myocardial strain in patients with CTO.

Methods Patients with CTO were included and were randomized to the nicorandil group and the control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire (SAQ) survey were performed at baseline and at 3 months. Participants were randomized according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter)

Exclusion Criteria:

* successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases
Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth

The purpose of this study is to investigate the effects of double fortification (iron and zinc) in synbiotic milk (L.plantarum Dad13 and fructooligosaccharides) on under 5 years stunted children growth, gut microbiota composition, blood zinc and hemoglobin level, and cognitive level.

This is a parallel, quadruple-blind, randomized controlled trial to determine the effects of double fortification (iron and zinc) in synbiotic milk (containing 7 billion CFU L.plantarum Dad13 and 4 g fructooligosaccharides) on the gut microbiota composition, body height and weight, blood zinc and hemoglobin level, and cognitive level in under 5 years stunted children subjects. The duration of the study is 4 months, including a 2-week pre test and informed consent before randomization of subjects into treatment or control group, a 12-week intervention period, and a 2-week post test after the end of intervention. During the intervention period, subjects will be instructed to take 100 ml of fortified synbiotic milk or non-fortified synbiotic milk per day. They will also be asked to document consumed milk, any unusual symptoms or side effects of treatment. Diet will be monitored via 24-h dietary recalls and SQ-FFQ before and after treatment respectively. Changes in the gut microbiota composition will be determined by measuring bacterial population levels (Bifidobacteria, Lactobacillus, Enterobacteria, Prevotella, and Bacteroides) in stool sampled collected at baseline and 12 weeks by qPCR. Metabolic markers (calprotectin, hemoglobin, and zinc level) will be measured at baseline and 12-weeks in serum and plasma using biochemical and immuno-assay. Changes in the cognitive level, height for age Z-score collected at baseline and 12 weeks using Bayley Scales of Infant Development, 2nd Edition .

Eligibility Criteria:
Inclusion Criteria:

* age between 2 year to 5 years
* height per age z-score under -2 (stunting)
* parents sign inform consent form

Exclusion Criteria:

* have congenital abnormality
* lactose intolerant
* use antibiotic for more than 2 weeks
* consume micronutrient supplement (especially iron and zinc) in the last 3 months
* diagnose with chronic diseases and infection that interfere metabolism (i.e. tuberculosis, HIV, autoimmune disease, diabetes mellitus type 1)
* suffer marasmus and/or kwashiorkor
* not willing to continue the intervention
The Effects of Serum Vitamin D and IVF Outcome

The purpose of this study is to investigate whether an association exists between serum vitamin D levels and IVF treatment outcome


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing IVF, ICSI or FET treatment at Birmingham Womens Fertility Centre

Exclusion Criteria:

* None
A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

The goal of this retrospective cohort study is to investigate the effects of compound amino acid capsule on nutrition, calcium and phosphorus metabolism in maintenance hemodialysis(MHD) patients. The main questions it aims to answer are:

1. Can compound amino acid capsule improve the nutritional status of MHD patients?
2. Can compound amino acid capsule help to correct the calcium and phosphorus metabolism imbalance of MHD patients?
3. Is compound amino acid capsule safe for MHD patients? We will collect the medical history and laboratory data of MHD patients who regularly took compound amino acid capsule for 9 months or did not use the same preparation in previous medical experience. We focus on the difference of serum albumin level between the treatment group and the control group within 9 months, as well as prealbumin, hemoglobin, ferritin, calcium, phosphorus, 1,25-OH 2-D3 and intact parathyroid hormone (iPTH).


Eligibility Criteria:
Inclusion Criteria:

* Patients who received maintenance hemodialysis (≥ 3 months) in Renji Hospital;
* Regularly participate in the routine laboratory examination of the hemodialysis center every 3 months;
* Inclusion criteria of the treatment group: regular treatment with compound amino acid capsule for 9 months (2 tablets, 3 times a day, orally);
* Inclusion criteria of the control group: no compound amino acid capsules or similar nutritional supplement were taken.

Exclusion Criteria:

* Severe heart failure (NYHA III/IV);
* Human immunodeficiency virus positive or is suffering from other serious infectious diseases;
* Have a history of malignant tumor;
* Women during pregnancy or lactation;
* Exclusion criteria for treatment group: previous use of amino acids or compound ketoacid supplement
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE)
* Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V
* Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen

Exclusion Criteria:

* Pure ISN/RPS Class V membranous LN
* Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m\^2
* Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study
* End-stage renal disease

Other protocol-defined inclusion/exclusion criteria apply
Activity and Participation in Ambulatory Cerebral Palsy

The investigators would like to understand how the physical activity levels and body size of a child with cerebral palsy (CP) in a clinical situations versus out in the community relates to what they want to do in day to day life (participation in life). The investigators believe that what a child really does out in day to day life will predict life participation to a greater degree than what they do in a structured clinical situation (i.e. therapy session with therapist). The investigators think that increased body size with normal growth is related to less physical activity and participation in day to day life for children with cerebral palsy (CP) who can walk. This project will use a novel accelerometer to measure walking activity during day to day life.

We want to know how the physical activity of children with walking problems or cerebral palsy (CP) relates to what they do in their day to day lives.

We are looking for children who:

* Have walking problems that started before age 2
* Have any type of cerebral palsy (CP) or primary problem that is a developmental movement disorder
* May have hemiplegia, diplegia, walking quadriplegia, May have ataxia, spastic, mixed tone, athetoid, or dyskinetic
* Ages 2 years to less than 10 years
* Able to do some functional walking with or without help(walkers, gait trainers)
* Project requires a one time visit to Seattle Children's Hospital of about 2 hours.
* Children and/or parents will complete surveys.
* The child will be tested for their gross motor and walking skills like at a physical therapy session.
* The child will be given an ankle monitor to wear for 7-10 days.
* They will return the monitor by mail with a questionnaire about what they did the last week.
* Families will receive a print out of their child's walking activity

Eligibility Criteria:
Inclusion Criteria:

1. age 2 to \<10 years (30 per four age groups/2 year increments)
2. Gross Motor Function Classification System (GMFCS) levels I-III
3. diagnosis of cerebral palsy (CP) or developmental movement disorder that occurred prior to age two.

Exclusion Criteria:

1. visual impairment limiting physical activity
2. lower extremity botox injections in the last 3 months
3. uncontrolled seizure disorder impacting mobility skills
4. orthopedic or neurosurgery in the last 6 months.
Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia

The study investigated the effect of diaphragmatic breathing as an additional coping strategy during Virtual Reality Exposure Therapy in patients with aviophobia. The authors assumed that diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the VRET and to an enhanced treatment outcome

Patients with aviophobia received treatment in Virtual Reality with or without DB. The authors assumed that adding DB to VRET would enhance treatment effects by reducing fear during exposure, thus improving the processing of the feared situation. The authors hypothesized that, as a result, self-efficacy would be increased in comparison to VRET alone.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 65
* flying experience
* subjective rating of fear of flying \> 60 from 100

Exclusion Criteria:

* pregnancy
* heart disease
* current involvement in psychotherapy and/or pharmacotherapy
Imaging and Understanding BOS in Lung Transplantation

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years. We will follow these patients at 6 months and 1 year with Hyperpolarized Helium-3 Magnetic Resonance Imaging and image guided bronchial biopsies to detect early BOS and to better understand BO disease progression. The biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to BOS and to facilitate identification and validation of translatable pharmaceutical targets.

Eligibility Criteria:
Inclusion Criteria:

* Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
* Male or female
* 0 to 25 years of age.

Exclusion Criteria:

* Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
* Inability to perform 10 second breath hold for 3He MRI scan
* Bleeding disorders
Treatment Time Comparing Digital & Conventional Workflows

This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). The primary outcome was to investigate the treatment time of the overall operation. The null hypothesis of this RCT was that both workflows had comparable results with respect to the defined outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The participants having a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) were placed in a single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
* general medical health is healthy or has a well-controlled systemic disease.
* general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.

Exclusion Criteria:

* smoking more than 10 cigarettes per day.
* pregnancy.
* psychiatric disorder
* history of radiation therapy at the head and neck area.
* history of chemotherapy.
* history of bony pathologies such as osseous dysplasia, odontogenic cyst or tumor, etc.