cyrilzakka/clinical-trials huggingface dataset:
Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children

Objectives:

A lot of children who injure their ankles come to the emergency department for an evaluation, and often an X-ray of the ankle is obtained to determine if a bone fracture is present. In more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be treated with rest, ice, elevation, and pain medications. X-rays obtained in the emergency departments are time consuming, often uncomfortable for the patient, and expose children to radiation, the long-term effects of which are not yet fully understand by doctors or scientists. Bedside ultrasound is a non-invasive and a non-painful device that does not produce radiation. It was been shown to determine the presence of bone fracture in childrens' wrists and forearms just as well as X-rays do. In our study, the investigators would like to determine if a bedside ultrasound can also be used to evaluate ankle fractures in children.

Research Procedures:

In our study, the investigators will ask the parents and children, who are scheduled to get an X-ray of their ankle in the emergency department, to examine their ankles with an ultrasound machine as well. Since the bedside ultrasound is not significantly time-consuming, does not require patients to remain still, and is readily available in the department, the procedure will be performed while kids are waiting to get an X-ray, getting registered, or awaiting further treatment. On the data collection form, the investigators will document the patients' names, birthdates, medical record numbers so that their X-ray results can be compared to the ultrasound results for the purpose of the study. The information will be stored in a secure cabinet in a locked office. The investigators will also document which side is injured, where the patient feels pain and what the ankle looks like to help perform the ultrasound. The results of both the ultrasound and X-ray will be documented for each patient.


Eligibility Criteria:
Inclusion Criteria:

* age 2-18 years old
* ankle ray ordered in ER

Exclusion Criteria:

* open fracture
* multi-system trauma/other significant injuries
* history of ankle fractures? (Same ankle broken within past year)
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers
* 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ sitSBP \<140 mmHg, 50 mmHg ≤ sitDBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who cannot consume the high-fat meal provided during this clinical trial
* Subjects who judged ineligible by the investigator
Spirometric Predicted Values in Bolivia

There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.

There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines.

The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata.

Anthropometric variables recorded: age, sex, weight, standing and sitting height.

Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.

Eligibility Criteria:
Inclusion Criteria:

* healthy and non-smokers

Exclusion Criteria:

* unhealthy smokers
* subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache

Cluster headache is also called suicide headache due to excruciating nocturnal attacks. There are few treatment options available. Inhalation of oxygen has shown to abort the attacks.

Continuous positive airway pressure (CPAP) is a machine used during sleep to treat respiratory failure. Automatic CPAP machines adjust the air pressure through the night to keep the upper airways patent.

Single reports have shown a high prevalence of obstructive sleep apnea in people suffering from cluster headache, and positive effects of CPAP treatment, but no randomized controlled trial has been conducted so far.

If proven effective CPAP would make an affordable treatment option for many patients within the existing healthcare system.

This is a single center study carried out in collaboration between the neurological, neurophysiological and thoracic departments at St. Olavs Hospital in Trondheim.

Participants will keep sleep and headache diaries in a baseline period of 4 weeks, then receive treatment (CPAP or sham-CPAP at nighttime) during 8 weeks, have a 4 week wash out period followed by a second treatment period of 8 weeks (CPAP or sham-CPAP). Finally there will be follow-up during 1 month.

Throughout the whole study (7 months) participants keep a headache diary. Participants must maintain current preventive and sleep medication regimens during the whole study period, and may use acute medication of choice (sumatriptan, oxygen or other).

Sleep registration in all participants will be done by polysomnography(PSG). An Ultra Wide Band radar/movement sensor device will be used to detect sleep patterns, together with wrist pulse oximetry and wrist actigraphy during PSG and the last week of each treatment period.

Neurophysiologic tests such as temperature and pressure thresholds will be measured before PSG and after each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Fulfils the diagnostic criteria for chronic cluster headache according to ICHD-3 beta 3.1.2.
* is able to separate cluster headache attacks from other types of headache.
* agrees to maintain current preventive headache and sleep medication regimens (no change in type, frequency, or dose) during the whole study period.
* Signed informed consent.

Exclusion Criteria:

* disorders with contraindications for use of continuous positive airway pressure (e.g. unable to remove the ventilation mask due to a movement disorders).
* Nightly cluster headache attacks
* Pregnancy or planned pregnancy
* having had a change in type, dosage or dose frequency of preventive headache or sleep medications \< 1 months prior to inclusion.
* Severe depression or other psychiatric disorder that may interfere with the treatment.
* Abuse of alcohol or illicit drugs.
* Other severe chronic pain conditions
An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Participants with solid tumors or lymphoproliferative disease
* Participants receiving chemotherapy
* Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (\<) 11 g/dL or 6.83 millimoles per liter (mmol/L)
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Resistant hypertension
* Acute chronic bleeding within 3 months prior to study
* Iron deficiency that is unmanageable prior to study
* Hypersensitivity to the active substance or any of the excipients of the product
* Pregnant or breastfeeding women
* Epoetin treatment within 6 months prior to study
Effects of Isolated and Integrated Core Stability Training in Fast Bowlers

The objective of this study will be to compare the effects of isolated and integrated core stability training on power, balance and performance in fast bowlers.

Athletes consistently strive for improved performance, often incorporating strength and conditioning routines that inevitably include elements of core strengthening. The crucial question emerges: how does enhancing core strength and stability contribute to elevated athletic performance? Before delving into this issue, it is essential to clarify the concept of core strength and stability. The core consists of both passive and active components, including bones, muscles, and ligaments in the lumbar spine, pelvis, and hips. Core strength is characterized by the capacity of the core muscles to produce and sustain force. In contrast, core stability emphasizes the significance of passive and active stabilizing elements within the lumbo-pelvic area. Beyond mere strength, core stability denotes the adeptness of these stabilizers to uphold proper trunk and hip posture, equilibrium, and control during both stationary and kinetic activities. It can be conceptualized as the ability to sustain command over the core while exerting core strength or when met with external disruptions.

The objective of this study will be to compare the effects of isolated and integrated core stability training on power, balance and performance in fast bowlers. This study will be a Randomized Clinical trial. Data will be collected fromPakistan Sports Board, Lahore. Subjects fulfilling the inclusion criteria will be included in this study. Baseline measurements will be taken before the application of interventions. Treatment will be then given to control and intervention group according to their allocation. Post-Treatment values for the baseline measures will be taken. Pre, 6th week and 12th week post treatment values will be analyzed. All subjects received a total of three treatment sessions in a week over the period of 12 weeks. The data will be analyzed using SPSS v 25.

Eligibility Criteria:
Inclusion Criteria:

* • Age group: 18 to 28 years. Individuals younger than 18 needed parental consent, and those older than 30 faced a higher likelihood of degeneration in the thoracic and lumbar spine region

  * No history of lower back pain
  * Gender: Male. Considering the differences in anatomy and physiology between males and females, it was deemed advantageous to concentrate solely on one gender to ensure continued homogeneity
  * They had actively participated in Action Cricket within one of the intermediate leagues for a minimum of six months

Exclusion Criteria:

* Athletes with physical disability and major health problems.
* Not willing to participate.
* Patients with MSK disorders.
* Female athletes will not be included because of anatomical and physiological differences.
* Participants with a recent history of significant injuries, especially those related to the core or lower extremities, as this could confound the study results.
Assessment of Vertical Ridge Augmentation for Posterior Mandible by Computer Guided Onlay vs Free Hand Onlay Graft

for patients with vertical bone loss in posterior mandible area......invistigators use chin blocks for vertical augmentation...i compare between using guide for positiong the block with the desired position using special surgical guide versus position the block with free hand technique

• The CBCT scan images will be imported into a computer software (Mimics15, Materialise, Leuven, Belgium) for the reformatting of the retrieved DICOM images and reconstruction of three-dimensional virtual model of both the donor and recipient sites.

The virtual model will be imported into a second software (3-Matic, Materialise, Leuven, Belgium) specialized in designing medical devices and surgical stents.

* The 1st surgical guide will be designed to guide the harvesting of two bilateral bone blocks ensuring that each block is designed with the superior osteotomy line more than 5 mm away from the apices of the anterior teeth and the inferior line more than 5 mm away from the inferior border of the mandible and the medial line 5 mm away from the symphysis, with two screw holes in the symphysis area to fixate the guide to the bone.
* The 2nd surgical guide will be designed to guide the fixation of the onlay graft, the design will include two screw holes placed with minimum 2mm safety margin below the inferior alveolar canal to fixate the guide in place, and two more screw holes placed supracrestal to fixate the graft to the guide superiorly.
* Finally, the surgical guide will be printed using fused deposition modeling technology with acrylonitrile butadiene styrene (ABS) plastic material. All guides will be sterilized using 2.4% gluteraldehyde for 12 hours prior to the surgery. All surgeries will be performed by the same surgeon.

Eligibility Criteria:
Inclusion Criteria:

- Age range from 25-55 years. No sex predilection. 8

* Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
* Edentulous bilateral posterior mandible with vertically deficient alveolar ridge that is less than 7mm measured from the crest of the alveolar ridge to the inferior alveolar canal.
* Normal vertical dimension with normal inter-arch space.
* The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent posterior teeth.

Exclusion Criteria:

* • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.

  * Previous grafting procedures in the edentulous area
Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain

Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain.

This is a randomized control trial to compare the effects of core stabilization versus generalized antenatal exercises for lumbopelvic pain in pregnant women. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated by core stability exercises and group B will be treated by generalized antenatal exercises and group C will receive basic antenatal education. Group A and B will have three treatment sessions per week for 4 weeks. Females will be evaluated at baseline and 2nd and 4th week . Females will be screened by Patricks faber test, piriformis /FAIR test, p4/posterior pelvic pain provocation test and assessed by visual analogue scale (VAS) and pregnant women quality of life questionnaire (QOL- GRAV).

Eligibility Criteria:
Inclusion Criteria:

* 2nd Trimester of Pregnancy
* Multigravida
* Patients having Lumbopelvic pain
* Working women and housewives

Exclusion Criteria:

* Hx of Metabolic Disease
* Hx of Pelvic Fracture and Surgery
* Radiculopathy
* Participants with absolute contraindications for the exercise
Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine

Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.

Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.

All patients who were switched to a doravirine-based regimen from date of its availability in the center (September 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on July 2021).

Minor resistances in a basal genotype to NNRTI or previous failure to NNRTI as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years HIV-1 infected subjects.
* Switched to a doravirine-based ART regimen under clinician criteria.

Exclusion Criteria:

* Doravirine major resistance mutations (accessory mutations are allowed).
* Major mutations to any of the other drugs combined with doravirine.
* Pregnancy, active tuberculosis or any condition that contraindicate the use of doravirine.
Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy

Modiﬁed radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with signiﬁcant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain .

Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound inﬁltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia for patients about to undergo breast surgery.

Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus muscle in the mid-axillary line and spares the pectoral nerves.

We assumed that SAPB could safely provide a better analgesic proﬁle with an opioid-sparing effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.


Eligibility Criteria:
Inclusion Criteria:

* 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery

Exclusion Criteria:

* Patient refusal.
* Patient with significant neurological , psychiatric or neuromuscular disease
* Alcoholism .
* Drug abuse .
* Pregnancy or lactating women .
* Suspected Coagulopathy .
* Morbid obesity .
* Known allergy to study medications .
* Septicaemia and local infection at the block site.
Sleep Position Pattern Recording

The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth.

Individuals who are eligible to the study and provided consent to participate will be asked to:

1. Wear the Skiin Garment system for the duration of their time in the hospital (minimum 1 nights until they are discharged from hospital).
2. Complete a study completion questionnaire about their experience with the device and the study.

The Skiin Garment system is composed by biosensing garments presented in different form factors (bra, chest band, or underwear). It captures physiological metrics and relay information from a pod to local hub with Bluetooth.

The true body position will be obtained using visual observations and cameras.

Eligibility Criteria:
Inclusion Criteria:

* Assigned female at birth
* Currently pregnant
* Admission to MUMC Antenatal Clinic with anticipation of being admitted for greater than 24 hours
* Able and willing to provide informed consent to participate

Exclusion Criteria:

* Unestablished gestational dating (based on first-trimester ultrasound)
* Known maternal cardiac or pulmonary disorder
* Known sleep disorders (i.e., sleep apnea, periodic limb movement disorder, etc.)
* Known fetal chromosomal or structural abnormalities
* Known highly sensitive skin/skin sensitivities to textile electrodes
Effects of Square-stepping Exercise Training on the Attention, Dynamic Balance and Lower Extremity Motor Coordination

Physical activity plays an indispensable role to lead a healthy life. Square-stepping exercises (SSE) are aerobic exercises. Our study was designed to investigate the effects of square-stepping exercise training on the attention, dynamic balance and lower extremity motor coordination of sedentary healthy young individuals.

A total of 112 volunteers within the age range of 20-25 participated in the research. Participants were randomly divided into two groups, as 56 participants were study group (28 females, 28 males) and 56 participants were control group (28 females, 28 males). Demographic data and exercise habit of the individuals were documented. Stroop Test was used to assess Attention, Four-step Square Test was used to assess Dynamic Balance and Lower-extremity Motor Coordination Test was used to assess Motor Coordination. Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training.


Eligibility Criteria:
Inclusion Criteria:

* Being within the age range of 20-25,
* Not continuing any exercise program for the last 1 year,
* Not having any disease impacting neurological, orthopedic or lower extremity system,
* Not having surgery history on lower extremity,
* Not having visual and hearing problem.

Exclusion Criteria:

* Having visual and hearing problem,
* Neurological problem debilitating one's walking,
* Having psychiatric or orthopedic problem
* Having surgery history on lower extremity.
Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy

It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.

In the present study, the children will be followed-up during the treatment with the new formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.

Eligibility Criteria:
Inclusion Criteria:

* Children with cow's milk allergy

Exclusion Criteria:

* Children without cow's milk allergy