cyrilzakka/clinical-trials huggingface dataset:
Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.

The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials

Eligibility Criteria:
Inclusion Criteria:

* 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:

Clinical:

1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
3. Presence of at least one primary molar with deep carious lesion.
4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.

Radiographic:

1. Extensive caries approaching to the pulp.
2. Presence of at least two-thirds of root length.

Exclusion Criteria:

* A child's tooth with any of the following criteria:

Clinical findings:

1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
4. History of administering analgesics 12 hours before tooth obturation.

Radiographic findings:

1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
2. Presence of pathological internal/external root resorption.
3. Absence of underlying permanent successor.
Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia

The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients with AIDS dementia.

Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

Patients are randomized to receive either placebo or one of two oral doses of CPI-1189 daily. Patients are assessed for safety and tolerability during Weeks 2, 6, and 10. At Week 10, efficacy assessments are also made. For those who volunteer, a sample of cerebrospinal fluid is obtained at baseline and at Week 10. Blood samples for CPI-1189 pharmacokinetic trough measurements are taken at Weeks 2 and 10. The open-label phase starts at Week 11. At Weeks 13 and 16, a safety evaluation is performed. At the end of the open-label phase, Week 22, a final set of safety and efficacy assessments and a blood sample for CPI-1189 pharmacokinetic trough measurement are obtained.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 18 years old.
* Have symptoms of AIDS dementia including forgetfulness, loss of concentration, slow mental processing, or a loss of muscle control.
* Have been on stable anti-HIV drug therapy for the past 6 weeks (if you are taking anti-HIV drugs).

Exclusion Criteria

You will not be eligible for this study if you:

* Have certain serious medical conditions, such as a mental disorder or an opportunistic (AIDS-related) infection.
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse from sleep. Here the investigators test the idea that the medication called "tiagabine" improves slow wave sleep and reduces OSA severity. The investigators will also test whether tiagabine raises the arousal threshold (more negative esophageal pressure), and whether detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with this intervention.

The current study tests the primary hypothesis that tiagabine improves sleep apnea severity in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine non-REM sleep; hypopneas defined by 3% desaturation or arousal). The investigators test three secondary hypotheses that tiagabine:

1. increases the proportion of total sleep time in slow wave sleep
2. raises the non-REM arousal threshold (more negative esophageal pressure) via (1).
3. is preferentially effective in patients whose OSA phenotype predicts that an increase in the arousal threshold is sufficient to resolve OSA versus those without such favorable physiology. Favorable physiology is defined here as having a low ventilatory drive at which stable breathing is theoretically feasible ("stable Vdrive" is \<100% above eupneic ventilatory drive) due to any combination of a "high" upper airway muscle response, "good" passive anatomy (high Vpassive), and "low" steady-state loop gain (see Owens RL et al SLEEP 2014; Wellman A et al J Appl Physiol 2011, 2013; Eckert DJ et al 2013 AJRCCM).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed OSA (moderate-to-severe; apnea hypopnea index \>15 events/hr)

Exclusion Criteria:

* History of seizures
Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?

The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* COPD patients

Exclusion Criteria:

* Patients who not performed not at least 5 sessions of the pulmonary rehabilitation program
* Occurence of an adverse event that prevents further rehabilitation
* Exacerbation in the previous month
Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct

Congenital nasolacrimal duct obstruction (CNLDO) occurs in approximately 10 to 20% of all term newborns, and is the most common cause of persistent tearing and ocular discharge in children. CNLDO causes symptoms in up to 6% of children during the first year of life. The first clinical signs appear during the first month of life in 95% of cases and usually consist of tearing and debris on the eyelashes ("mattering"). Mucopurulent eye discharge occurs commonly in infants with CNLDO and, in the absence of other signs of infection, suggests bacterial overgrowth in the stagnant tear pool of the lacrimal sac.

This study investigates whether early administration of Euphrasia eye drops (Weleda AG, Arlesheim) in preterm neonates presenting with first ocular discharge with or without tearing and reddened eye fosters the resolution of the ocular discharge and reduces the need for topical antibiotic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates (with a gestational age of 24 to 37 weeks)
* Presenting with first signs of a congestion of the nasolacrimal duct, i.e. white, yellow, or green ocular discharge with or without tearing and reddened eye.
* Written informed consent by the parents or legal guardians

Exclusion Criteria:

* Congenital abnormalities of the eye
* Ophtalmia neonatorum
* Severe asphyxia
* Sepsis
* Intracranial bleeding (intraventricular hemorrhage ≥ grade III)
Deep Learning for Classification of Scheimpflug Corneal Tomography Images

Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the affected patients and prevents postoperative complications in patients with keratoconus considering refractive surgery. Machine learning approaches have been widely used for image classification. Here, we will assess the ability of deep learning to enable high-performance image classification of the color-coded corneal maps obtained by Scheimpflug camera in patients with keratoconus, subclinical keratoconus, and normal individuals.


Eligibility Criteria:
Inclusion Criteria:

Keratoconus group:

* Presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.
* irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by Pińero and colleagues :
* focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones
* focal areas with diopteric (D) values \>47.0D
* inferior- superior(I-S) asymmetry measured to be \> 1.4 D
* Angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis(SRAX) .

Suspicious group:

• Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (forme fruste keratoconus).

Normal group:

* Refractive surgery candidates
* Refractive error of less than 8.0 D sphere
* Less than 3.0 D of astigmatism
* without clinical, topographic or tomographic signs of keratoconus or suspect keratoconus.

Exclusion Criteria:

* Systemic disease
* Other corneal disease such as pellucid marginal degeneration
* History of trauma
* Corneal surgery such as corneal cross- linking for progressive keratoconus.
Stapler Post-market Observational Study

The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility Criteria:
Inclusion Criteria:

* Age at study entry is at least 18 years.
* Patient must sign and date the informed consent form prior to the index-procedure.
* Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
* Patient has a BMI ≥ 40 kg/m.

Exclusion Criteria:

* Patient is pregnant.
* History of bariatric surgery.
* Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.
"Bony Changes Around Dental Implant in Free Fibular Graft Versus Non-Vascularized Iliac Crest Graft"

The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction.

The main question it aims to answer are:

• evaluate the bony changes around dental implants and it's survival rate in both groups

The current prospective study was conducted on 10 patients that were selected and admitted for early or delayed mandibular reconstructive surgery from the outpatient who were referred to the department of Oral and Maxillofacial Surgery Faculty of Dentisry, Ain Shams University in the period from January 2018 till June 2022.

The patients in this study were divided into two groups. First group endured non-vascularized iliac crest grafting with delayed implant insertion while the second group endured vascularized fibular flap with delayed implant insertion. Implant placement was done six months after performing reconstructive surgery.At the second stage surgery, all succeeded implants were loaded with fixed implant supported prothesis. Follow- up was done 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.

Crestal bone stability was analyzed using CBCT radiographs along with the percentages of of the survived implants and ISQ values were measured using an ostell device.

Eligibility Criteria:
Inclusion Criteria:

* patients following traumatic injuries
* gunshot injuries
* tumor ablative surgeries
* osteomylitis and osteonecrosis affecting the mandible

Exclusion Criteria:

* cardiovascular or pulmonary disease
* vascular or bone disorder
* previous fractures or surgeries related to the donor site
Collection of Information-Rich Type 1 Diabetes Data

The aim of this clinical study was to obtain type 1 diabetes data to identify models for glucose prediction and control and to construct a physiological pharmaco-kinetic/pharmaco-dynamic computer model of a type 1 diabetic person.


Eligibility Criteria:
Inclusion Criteria:

* diabetes duration \> 5 years
* HbA1c \< or = 7.2%
* CSII treated for \> 3 months
* Capable of being moderately, physically active for 20 minutes

Exclusion Criteria:

* symptoms of diabetic late complications except simplex retinopathy
* pregnancy or nursing
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients

Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of essential thrombocythaemia - high risk profile
* Previously untreated with a cytoreductive agent
* Females of childbearing potential must have a negative urine pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study

Exclusion Criteria:

* Diagnosis of any other myeloproliferative disorder
* Any known cause for a secondary thrombocytosis
* Anti-coagulant and anti-aggregant therapies
* Known or suspected heart disease
* Left Ventricular Ejection Fraction \< 55%
Pre-formed Alloreactivity in Renal Transplant Recipients

This investigator-initiated study will analyse the role of pre-formed alloreactive T cells on acute rejection episodes and graft outcome in kidney transplant recipients after living donation.

In recipients of solid organ transplants, preformed alloreactive T cells may mediate acute rejections and compromise long-term graft survival. Previous studies on the role of alloreactive T cells in transplantation were hampered by the fact that experimental assays to quantify alloreactivity were technically demanding and not suitable for use in a clinical setting. Based on a recent development of a whole-blood assay, alloreactive T cells may be quantified and characterised within one day. This assay therefore provides the experimental basis to study the development and the role of alloreactive T cells in a clinical setting in patients after renal transplantation. This will be performed in a multicenter study in living donor renal transplant recipients where preformed alloreactivity of the recipient towards the living donor will be determined and associated with standard clinical parameters of graft function and long-term graft outcome on follow-up. In addition, the development of donor-specific antibodies will be analysed after transplantation. If this project was able to provide evidence for a role of alloreactive T cells in acute rejection episodes or long-term graft function, this assay may in future be used to guide individualized immunosuppressive drug treatment early after transplantation. It will thereby aid in distinguishing patients where standard immunosuppressive drug regimens are sufficient from the minor population of patients at high risk for rejection who will benefit from intensified drug regimens.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* First or second renal transplantation
* Living donor renal transplantation
* Recipient older than 18 years
* Negative cross match
* Planed quadruple, Tacrolimus-based (low-dose) immunosuppressive drug regimen (Tacrolimus, 2g MMF starting dose, (methyl)prednisolone according to center practice, basiliximab at day 0 and day 4)
* Planned start of Tacrolimus (Advagraf®) 3 to 10 days prior to transplantation (trough levels 5-10 ng/ml during the first 3 months, 5-7 ng/ml thereafter)

Exclusion Criteria:

* Planed T-cell depleting induction therapy
* Pregnancy
* Pre-existing, moderate to high dose immunosuppressive medication
* Pre-existing, severe lymphopenia (\&amp;lt; 400/µl)
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.

Study design was changed and an amendment was prepared accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Tolerated the first dose level of Rotigotine in a previous study in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria
* Is expected to benefit from participation, in the opinion of the investigator
* Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and study patch application/removal, according to the judgment of the investigator

Exclusion Criteria:

* Previously participated in this study
* Is experiencing an ongoing serious adverse event (SAE) that is assessed to be related to Rotigotine by the investigator or sponsor
* Pregnant or nursing or is a female of childbearing potential who is not surgically sterile or does not consistently use 2 combined medically acceptable methods of birth control (including at least 1 barrier method), unless not sexually active
* Any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate
* Active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since the Last Visit" version of the Columbia Suicide Severity Rating Scale (C-SSRS) of the final evaluation visit of the previous Rotigotine study
Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

The aim of the study is to investigate the possible protective effect of empagliflozin in patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2 inhibitors treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl peptidase-4 inhibitors, metformin ± basal insulin.

Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old.

Exclusion Criteria:

* Breastfeeding female.
* Pregnant female.
* Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m2.
* Patients with type 1 diabetes mellitus.
* Patients with diabetic ketoacidosis.
* Patients with urinary tract infections.
* Dehydrated patients till normalized.
* Lower limb amputation patients.
* SGLT2 inhibitors hypersensitivity.
* Severe hepatic patients.
* Patients on neuroprotective drugs.
The Feasibility of Following the Crohn's Diet

A research team from King's College London are investigating how diet can be used as a treatment for Crohn's disease. The investigators have designed a new diet and eventually wish to test whether the diet can be used to manage Crohn's disease and reduce gut inflammation. Before doing this, the investigators need to find out how practical it is for people to follow the diet for 14 days by conducting this 'feasibility' study. A feasibility study is a small study that aims to highlight any issues before informing the design of a larger research trial.

The diet the investigators have designed is called the Crohn's Diet. The evidence for this diet is based on recent research which suggests that certain food ingredients may be involved in triggering gut inflammation.

The study's primary aim is to assess the practicalities of following the Crohn's Diet. It will also assess compliance to the Crohn's Diet and if following it changes the nutritional balance from the normal diet.


Eligibility Criteria:
Inclusion Criteria will include:

1. Adults aged ≥18 years with a diagnosis of Crohn's disease
2. Stable Crohn's disease (as defined as self-reported: no change in Crohn's disease medication in the last 3 months; no Crohn's disease surgery in the last 6 months; no hospital admissions related to Crohn's disease in the last 6 months; no new perianal Crohn's disease in the last 6 months).
3. Individuals with a Body Mass Index (BMI) of ≥ 18.5 kg/m2
4. Individuals able to give informed consent
5. Individuals able to understand and read English
6. Individuals willing to provide consent in this study which involves a dietary change for 14 days

Exclusion Criteria will include:

1. Unexplained/unintentional weight loss in the past 6 months
2. Major co-morbidities; for example, diabetes, coeliac disease, major active psychiatric conditions or current eating disorders.
3. Current Crohn's disease therapy with any of the following: corticosteroids, exclusive or partial enteral nutrition (liquid nutrition), and any participants prescribed oral nutrition supplements for nutrition support.
4. Individuals who report to be pregnant or lactating
5. Individuals with specific, complex dietary needs (based on the dietitian's judgment), such as multiple food allergies, in which the additional burden of the Crohn's Diet would pose a nutrition risk.
Vestibular Rehabilitation and Severe Traumatic Brain Injury

Severe brain injury (sTBI) is one of the most common causes of long-term disability and is considered the most frequent cause of mortality and serious disability in young adults in industrialized countries. It is defined as an alteration of brain function with loss of consciousness in the acute phase for at least 24 hours (Glasgow Coma Scale (GCS) \<8) and it can induce a wide range of deficit, including cognitive-behavioural, motors, psychics, language, vision, coordination and balance impairments. Chronic vestibular symptoms such as dizziness and balance deficits (both static and dynamic postural instability) are present in patients with brain injury. These aspects can cause functions limitation and psychological distress, negatively impacting negatively on subjects' quality of life and social reintegration and are considered unfavourable prognostic factors of the recovery process. The literature supports the use of vestibular rehabilitation techniques in patients with mild and moderate brain injury, however, to date, no studies investigated the effect of vestibular rehabilitation in sTBI patients. The main aim of this randomized controlled trail is to verify the effect of a personalized vestibular training on balance and gait disorders in sTBI patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 65 years;
* Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)
* Level of cognitive functioning (LCF) ≥7;
* Ability to understand verbal commands and the informed consent.
* Presence of static and dynamic balance impairments.
* Functional Ambulation Classification (FAC) ≥ 3

Exclusion Criteria:

* Glasgow coma scale (GCS) score \>8
* Level of cognitive functioning (LCF) \<7
* Inability to understand verbal commands
* Absence of static and dynamic balance impairments.
* Functional Ambulation Classification (FAC) \< 3