cyrilzakka/clinical-trials huggingface dataset:
Adolescent Knee Pain (AK-Pain) Prognostic Tool

The overall aim of this study is to develop and test a prognostic tool for knee pain in children and adolescents to be used in general practice.

By using the tool, general practitioners will be able to allocate the patient to a category of risk (e.g. low/medium/high) of recurrent or persistent knee pain at 3 months and 6 months, and to subsequently provide a treatment that is specific to the category of risk of the patient.

One in three children and adolescents experience knee pain, and one in two will have a poor long-term prognosis with low quality of life and impaired physical activity levels.

Every year 119 - 200 children and adolescents per 10,000 registered patients consult their general practitioner for knee pain, and a variety of treatments are delivered, despite similar symptoms and patients' characteristics. However, the proportion of children and adolescents with a poor prognosis is high, which suggests that there is an urgent need to support the general practitioners in identifying those at high risk of a poor outcome early on, in order to better allocate resources.

This project will develop a user-friendly prognostic tool to support general practitioners' management of children and adolescents' knee pain.

Clinically relevant prognostic factors for child and adolescent knee pain were identified using systematic reviews and meta-analysis of individual participant data. Following feedback from general practitioners and children and adolescents on the content and understanding, the tool was piloted and implemented in general practice.

A cohort of approximately 300 children and adolescents will be recruited from general practices and followed-up for up to 6 months (the baseline starting date is July 2019 and the follow-up will end in July 2020) Clinically meaningful risk groups (e.g. low/medium/high) for the recurrence and persistence of knee pain (at 3- and 6-months) will be identified.

This tool will allow general practitioners to provide children and adolescents an optimal stratified care, by matching treatments to patients' prognostic profile.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents (aged 8-19 years old) who consult their general practitioner because of their knee pain (of both traumatic and non-traumatic origin) during a period of recruitment of 6 months (starting in July 2019)

Exclusion Criteria:

* Age below 8 years old or over 19 years old
* Consultation for musculoskeletal pain only in a body region different from the knee
* Pain originated by different conditions (e.g. cancer, infections)
* Child is vulnerable (e.g. he/she has experienced a recent trauma and the distress may have an impact on the self-report making it not valid)
* Inability to take part to the study because of inability to understand or comply
Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants

Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of vitamin D deficiency in early preterm infants is unknown. The American Academy of Pediatrics recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. This study assesses vitamin D status at birth and during hospital stay in infants delivered delivered at earlier than or at 32 weeks gestation. We also assess the adequacy of intake relative to the target set by the American Academy of Pediatrics for children.

Vitamin D is important for bone health. Deficiency of vitamin D is widespread and is associated with a variety of diseases. Preterm infants are susceptible osteopenia of prematurity (OP). Vitamin D deficiency may contribute to OP. The American Academy of Pediatrics (AAP) recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. Whether this level of intake or target serum concentration are achieved in early preterm infants is unknown. We hypothesize that because early preterm infants are sequestered in the Newborn Intensive Care Units for an extended period of time, they will be deficient in vitamin D and that the current nutritional intake may not be adequate in meeting the AAP recommendation. We assessed the concentration of serum 25-hydroxyvitamin-D in parturient mothers and in their newborns if they were less than 32 week gestation. We monitored vitamin D intake during hospitalization in the Newborn Intensive Care Unit and serum 25-hydroxyvitamin-D at discharge.

Eligibility Criteria:
Inclusion Criteria:

* All neonates delivered at or less than 32 weeks gestation were eligible.

Exclusion Criteria:

* Infants with lethal congenital malformation
* Infants that were not expected to survive to discharge
* Infants delivered from multiple gestation
Effect of Periodontal Treatment on Adipokine Levels

The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM).

The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin (IL)-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM). A total of 80 patients; 20 healthy, 20 T2DM with periodontitis (P), 20 T2DM periodontally healthy, 20 systemically healthy with P were included in this study. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received NSPT in 4 sessions. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary levels of adipokines and IL-1β were analyzed using a flow cytometry-based technique of Lumina® map™. Data were analyzed using appropriate statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus should be diagnosed for ≥1 year and HbA1c level should be at least %6,5
* Periodontitis should be diagnosed for at least 4 teeth with probing depth ≥5 mm with bleeding on probing (BOP) and also radiographic alveolar bone loss should be presence
* Presence of at least 15 teeth

Exclusion Criteria:

* Received antibiotic treatment in the previous 3 months
* Smokers
* Pregnancy and lactation
* Received periodontal treatment in the previous 6 months
* Presence of less than 15 teeth
* Having major diabetic complications
Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back

ABSTRACT: Low back pain is one of the most frequent causes of incapacity. The prevalence of this syndrome is 60-85% for the survival of the individuals. Among the most promising strategies of low back pain intervention, is the physical activity that is usually associated with a long list of health benefits.

Purpose: evaluate the efficacy of a protocol of exercises to low back pain rehabilitation under supervision of physiatry service and rehabilitation in the Hospital de Clínicas de Porto Alegre compared with same protocol performed at home in regards to pain.

Methods: Randomized clinical trial with a sample of 122 subjects of the community of both sex, with ages between 30 to 55, with low back pain complain. These subjects will accomplish during 12 weeks protocol of exercises from "Exercises to low back pain" Physiatry and Rehabilitation service from HCPA, randomized in two groups: group 1 will complete all the protocol of exercises with orientation and attendance directly from a professional of physical education, in the Service of Physiatry and Rehabilitation in HCPA. Group 2 will complete one session of the protocol of exercises with orientation and attendance directly from a professional of Physical Education, in the service of Physiatry and Rehabilitation of HCPA, to clarify any doubts about the protocol. The further sessions will be completed at home, along weekly monitoring of the researchers through phone calls, the patients of this group will receive a manual with the sequence of the exercises.

Eligibility Criteria:
Inclusion Criteria:

* ages between 30 and 55
* Pain should be without radiation to lower body
* Pain with more than 12 weeks of evolution.
* Visual Analog Scale of Pain (VAS) should present a pattern above 3 (moderate).

Exclusion Criteria:

* Patients with Exclusion Criteria: will be excluded those patients that present musculoskeletal impairment in lower body,
* After surgery and anesthetic block.
* individuals affected with comorbidities
* Patients with rheumatic diseases, recent fractures, tumors, pregnant women, smokers and general practitioners of physical activity.
* Subjects who are unable to attend the hospital twice a week.
Cost Effectiveness of Language Services in Hospital Emergency Departments (EDs)

Numerous studies suggest that the use of in-person, professionally trained medical interpreters can reduce health care costs associated with diagnosing and treating patients with limited English proficiency. However, few studies have specifically addressed the question of the cost-effectiveness of language services in health care settings. This study used a randomized controlled study design to compare the cost-effectiveness of using professional interpreters with Spanish-speaking patients seen in hospital emergency departments (EDs) versus using the usual language services available to these patients. The main goal of the study was to estimate the effect that professional interpreters have on resource utilization and patient/provider satisfaction in the ED compared to the language services usually offered in these settings. Our hypothesis was that use of trained interpreters would lead to more cost-effective provision of ED services.


Eligibility Criteria:
Inclusion Criteria:

* limited English proficient (LEP) Spanish-speaking patients
* adults aged 18 or older
* LEP parents of children seen in emergency departments

Exclusion Criteria:

* cognitively impaired, comatose, or traumatized patients
* healthy volunteers
* prisoners
* hospital employees
Neurobehavioral Responses to Multisensory Stimulation Module in Preterm Neonates

Preterm neonates who receive multi-sensory stimulation exhibit more neurobehavioral development than those who don't.

This study will be conducted at Neonatal Intensive Care Unit (NICU) of Alexandria University Children's Hospital (AUCH) at Smouha, Alexandria, egypt.

A sample of 60 preterm neonates.The study subjects will be randomly assigned into two equal groups (control and multi-sensory stimulation groups) using random number table. Each group will be comprised of 30 neonates. The first neonate will be assigned to the control group and the second neonate will be assigned to the multi-sensory stimulation group.

Control group: Preterm neonates will receive only routine care of the unit. Multi-Sensory Stimulation group: Preterm neonates will receive multi-sensory stimulation intervention beside routine care of the unit.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ranges from 32 and 36 weeks.
* The preterm infant's 5 min Apgar is 6 and more.

Exclusion Criteria:

* History of cardiopulmonary resuscitation or surgery.
* History of intraventricular hemorrhage grade II and above.
* Major congenital malformations
SUBLIVAC® Birch PROBE Study

Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic complaints triggered by birch pollen.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 ≥ 70%) due to birch pollen for at least 2 years.
* Use of anti-allergy symptomatic medication in the last birch pollen season (in case of a season with low pollen counts, in one of the two previous years).
* No seasonal allergic complaints induced by birch, grasses or mugwort pollen for at least 4 weeks in the absence of rescue medication during at least the last 2 weeks before the baseline.
* A positive SPT (diameter ≥3 mm) for birch pollen and a positive specific serum anti birch IgE-test (\>1 U/ml).
* A positive TNPT with a birch allergen extract containing a concentration of 10, 100 or 1000 AU/ml at the baseline visit.
* Age 18 years and older.
* Subjects shall give a written informed consent.

Exclusion Criteria:

* A positive SPT (diameter ≥ 3mm) for hazel or alder and the maintenance dose will not be reached before 8 October 2009.
* A positive SPT (diameter ≥ 3mm) for pets and symptoms related to concomitant sensitization to pets while having these animals at home.
* A positive SPT (diameter ≥ 3mm) for house dust mite or moulds and clinically relevant symptoms related to concomitant sensitization to house dust mite or moulds, based on the investigator's research (TNPT for example).
* Allergy to any of the excipients of SUBLIVAC Birch or Staloral Birch.
* Chronic asthma or emphysema, particularly with an FEV1 \< 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days.
* Specific findings for nose and mouth at screening or rhinoscopy before TNPT.
* Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
* Inflammation or infection of the target organ (nose, eyes and lungs).
* Severe atopic dermatitis requiring systemic immuno-suppressive medication.
* Allergen specific immunotherapy treatment for a period longer than 3 months within the last 5 years.
* History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
* A positive pregnancy test, lactation or inadequate contraceptive measures. (adequate measures: oral contraceptives, IUD, condom use and having no sexual relationship with a man)
* Alcohol- or drug abuse.
* Lack of co-operation or severe psychological disorders.
* Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
* Low compliance or inability to understand instructions/study documents
* Completed or ongoing treatment with anti-IgE-antibody
* Patients being in any relationship or dependence with the sponsor or investigator
REmote COnditioning in Out-of-Hospital Cardiac Arrest

Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* Out-of-hospital cardiac arrest, whatever the initial cardiac rhythm (shockable or non-shockable) or the duration of no-flow and low-flow,
* Presence of a witness who may or may not have started cardiopulmonary resuscitation, or patient seen alive in the 30 minutes prior to the cardiac arrest,
* Hospitalisation in critical care (intensive care unit or cardiac intensive care unit) for less than 3 hours,
* Informed consent obtained from a close relative (exceptionally from the patient himself if his condition permits) or, failing this, use of the emergency procedure by the investigator.

Exclusion Criteria:

* Traumatic cardiac arrest
* Patient on extracorporeal circulatory assistance
* Cardiac arrest for which continuation of resuscitation does not appear justified (unavoidable death, terminal stage of an irreversible disease, etc.)
* Contraindication of the use of brachial cuff on both arms (arteriovenous fistula, lymphoedema or severe peripheral vascular pathology, unstable humeral fracture, continuous infusion into an upper limb vein of an essential drug such as a catecholamine, radial arterial catheter for continuous invasive measurement of blood pressure)
* Pregnant, parturient, or breast-feeding women
* Patients deprived of their liberty by a judicial or administrative decision,
* Patients under legal protection (guardianship, curatorship),
* Patient not affiliated to a social security scheme or beneficiary of a similar scheme,
* Previous inclusion in the study,
* Subject participating in other interventional research that may interfere with the present study according to the investigator's judgement or that includes an exclusion period still in progress at inclusion
Sleep Disturbances in the 2nd and 3rd Trimester

Sleep disorders and disturbances are mostly underestimated in clinical practice. Moreover, this problem is generally neglected by the pregnant themselves. Today, it is important to underline any problem that may have an affect to improve the quality of life during pregnancy.

This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the second and third trimesters of pregnancy.

Women with uncomplicated pregnancy in the second or third trimester who apply for the routine check will be included.

Specific questionnaires will be used to measure the sleep disorders in addition to the socio-demographic measures:

Pittsburgh Sleep Quality Index, Insomnia Severity Index, Berlin Questionnaire and Stop-Bang Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 2nd or 3rd trimester of pregnancy

Exclusion Criteria:

* Complicated pregnancy
* Multiple pregnancy
* Known sleep disorder
Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren

This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18-60 years old
* Patients with systolic hypertension who met the 24 hour Ambulatory Blood Pressure Monitoring (ABPM) criteria (ABPM mean daytime Systolic Blood Pressure (SBP) \>= 135 mmHg and \< 160 mmHg)

Exclusion Criteria:

* Overt heart failure (HF) or a history of heart failure within preceding 6 months.
* Unstable angina pectoris.
* Type 1 or Type 2 diabetes mellitus or abnormal hemoglobin A1c(HbA1c)
* Body mass index (BMI) \> 30 kg/m2
* Subjects taking more than 2 antihypertensive medications.
* Use of other investigational drugs within 30 days of the time of enrollment
* Use of Tamsulosin hydrochloride and other alpha blockers.
* Use of Antiarrhythmic drugs, including digoxin.
* History of MI or cardiovascular attack (CVA) within the preceding 6 months.
* History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin
* Pregnant or nursing (lactating) women
Superficial Cervical Nerve Block vs NSAIDs for the Relief of Shoulder Pain After Laparoscopic Surgeries

Shoulder pain is frequently mentioned in recent literature following laparoscopic operations. Several pain relief strategies have been proposed to decrease shoulder tip pain post laparoscopic surgeries. This study will be conducted to compare the Superficial cervical nerve block vs. NSAIDs in terms of shoulder tip pain relief after laparoscopic surgeries.

The study will be conducted in the operating room and post anesthesia care unit (PACU) at Makassed General Hospital. This is a prospective double blind randomized clinical trial that will be conducted between June 2016 and June 2017 at Makassed General Hospital. Following the Institutional Review Board (IRB) approval, written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 groups. Group I will receive superficial cervical nerve block and intravenous saline. Group II will receive saline superficial cervical block and intravenous NSAID (Profenid).

All patients will receive general anesthesia. General anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen. Any hemodynamic change of 25% results in a gradual increase or decrease of the sevoflurane concentration.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic:

cholecystectomy, sleeve gastrectomy, mini bypass surgery, gastric plication

Exclusion Criteria:

* Patients with kidney disease (ACUTE OR CHRONIC)
* Patients with allergy to any medication used throughout the research
* Patients with gastroesophageal reflux disease (GERD), peptic ulcer or duodenal ulcer disease
* Patients with shoulder neck pain or complications pre-operatively
Effects of Behavioral Contingencies on Effects of Nitrous Oxide - 12

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine the effects of different behavioral contingencies in modulating the reinforcing effects of nitrous oxide in healthy volunteers.


Eligibility Criteria:
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The Energy Conservation Education Intervention

Fatigue is the most common symptom reported by 70 - 85 % of people with end-stage kidney disease (ESKD) receiving haemodialysis (HD). Educational interventions involving energy conservation strategies are helpful in reducing fatigue. However, the effectiveness of energy conservation has not been previously studied in people with ESKD receiving HD. This study aims to develop and evaluate the effectiveness of energy conservation education intervention for people with end-stage kidney disease receiving haemodialysis (EVEREST) in Nepal.

Symptom Management Theory (SMT) will guide this study. A pragmatic cluster randomised controlled trial (pCRT) will be conducted in one dialysis centre in Nepal. People on HD who meet the eligibility criteria will be invited to participate. The primary outcome is fatigue severity and the secondary outcome are other renal symptoms, occupational performance and health-related quality of life. Intention to treat analysis will occur and will include a change in the primary and secondary outcome. The study will provide evidence about the feasibility and effectiveness of EVEREST for symptom management.


Eligibility Criteria:
Inclusion Criteria:

Participants diagnosed with ESKD and undergoing haemodialysis for ≥ 3 months, aged 18 years and above, able to speak and understand Nepali language and willing to participate will be included in this study.

Exclusion Criteria:

Participants who are in the early stage of CKD or not dependent on HD, those acutely ill, diagnosed with cognitive impairment and those who are not willing to participate will be excluded.