cyrilzakka/clinical-trials huggingface dataset:
Effect of Topical Sinonasal Antibiotics

In this study, patients who have had previous endoscopic sinus surgery and present with an acute exacerbation of chronic rhinosinusitis will be offered endoscopic-guided, culture-directed antibiotic therapy. They will then be randomized to receive oral or intranasal topical antibiotics. Both of these are considered standard of care, but there is some limited data suggesting superiority of topical antibiotics especially if guided by culture and in patients who have undergone previous surgery. However, a study that directly compares the two has not been published. Modified Lund-Kennedy endoscopic finding scores and subjective SNOT-22 questionnaires will be collected before and at 3-4 weeks after treatment. Medication-related sided effects will be noted and analyzed. After 6-8 month follow-up, we will analyze the rate of recurrence of exacerbations, need for further antibiotics, need for revision surgery, and SNOT-22 scores based on oral versus topical antibiotic treatment. Our objective is to evaluate both short and long-term response to both oral and topical administration of antibiotics in this patient population in order to determine if either route of administration is superior to the other.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have documented CRS refractory to initial medical management and have undergone sinus surgery (opening of at least one sinus ostium, exclusive of sole balloon dilation), and those with an acute exacerbation of CRS with sinus mucopurulence on exam.

Exclusion Criteria:

* Patients less than 18 years of age, and those that have taken an antibiotic regimen in the previous 2 weeks before culture.
Mind-body Therapies for Injury-related Pain Management in Elite Athletes

This study will utilize a replicated single case experimental design (RSCD) to investigate the effectiveness of a brief mindfulness meditation (MM) vs clinical hypnosis (HYP) training for improving pain in injured elite athletes. The primary outcome is change in pain intensity. It is hypothesized that: (1) both treatments will engender clinically meaningful improvement in pain intensity; (2) change in cognitive processes will be a unique mechanism underlying improved pain outcome in MM, and (3) change in cognitive content will be a unique mechanism underlying improved pain outcome in HYP. This research program has the potential to reduce athletes' uncertainty around pain, time out with injury and improve pain management during rehabilitation and recovery from injury.

The proposed program of research will utilize our current understanding of the Behavioral Inhibition System and Behavioral Activation System (BIS-BAS) model of pain and mind-body therapies and apply it to pain experienced by injured elite athletes. This study will be a replicated single case experimental design (RSCD), which will investigate the effectiveness of a brief mindfulness meditation (MM) vs clinical hypnosis (HYP) training for improving the primary outcome of pain intensity in injured elite athletes. It will also investigate the potential mechanism role of change in cognitive content and cognitive processes in underlying the effects of these mind-body therapies. It is hypothesized that: (1) both treatments will engender clinically meaningful improvement in pain intensity; (2) change in cognitive processes will be a unique mechanism underlying improved pain outcome in MM, and (3) change in cognitive content will be a unique mechanism underlying improved pain outcome in HYP. This research program has the potential to reduce athletes' uncertainty around pain, time out with injury and improve pain management during rehabilitation and recovery from injury.

Eligibility Criteria:
Inclusion Criteria:

* be an elite athlete (i.e., competing at international or division 1 varsity level),
* currently have a sport or exercise-related injury that resulted in an average pain intensity greater than or equal to 3 on a 0-10 numerical rating scale in the past week, and for which the predicted recovery time at the point of study enrolment is greater than 5 weeks,
* Be 18 or over.
* Read, speak, and understand the English language.
* Have access to the internet on a computer or smartphone.
* Have access to a set of headphones.
* Be willing to be randomly assigned to both conditions and listen to five 20-minute treatment sessions.
* Be willing to participate in a daily survey for 25 consecutive days.
Intermittent Parasite Clearance (IPC) in Schools: Impact on Malaria, Anaemia and Cognition

Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria infection, clinical illness and death. By the time they reach school, many children have already acquired some clinical immunity and the ability to limit parasite growth, and thus most infections are asymptomatic and will go undetected and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage may bring education, as well as health, benefits.

Intermittent parasite clearance (IPC) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes, and may usefully supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a policy of universal coverage of nets.

This study seeks to establish whether intermittent parasite clearance undertaken once a year at the end of the malaria transmission season can reduce malaria parasite carriage and anaemia amongst school-going children already using insecticide-treated nets, and its consequent impact on school attendance and performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes in areas of seasonal malaria transmission.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in participating elementary schooled
* provision of parental consent

Exclusion Criteria:

* lack of consent
* chronic conditions which limit regular school attendance
* clinical malaria on the day of scheduled treatment (as defined as febrile, with a positive result in a rapid diagnostic test for malaria).
MK0524A Phase IIb Study (0524A-011)(COMPLETED)

Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone.

Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking \> 50mg at screening
* Must be willing to complete electronic diary

Exclusion Criteria:

* Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT)
* You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive
* You consume more than 14 alcoholic drinks per week or more than 2 drinks per day
Efficacy and Safety of Camrelizumab in Real-World Prospective Study

This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.

Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC. This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent and volunteer to participate in the study;
2. Non-small cell lung cancer confirmed by histological/cytopathological tests;
3. Age ≥18;
4. The investigators determined that patients should receive camrelizumab alone or in combination.

Exclusion Criteria:

1. Patients who are also receiving other immunomedications or therapies;
2. Patients participating in other interventional studies;
3. Patients complicated with other malignant tumors;
4. Women who have been confirmed to be pregnant or lactating;
5. The Investigator considers the patient unsuitable for participation in any other condition of the study.
A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students

Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). The aim of the trial is to test the effect of a mobile health application called "GGBI: Positive Body Image" in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing Body Image Disorders (BIDs).

Hypothesis: Participants using "GGBI: Positive Body Image" immediately following baseline assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use "GGBI: Positive Body Image" in this phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the investigators expect that participants gains in the iApp group would be maintained at follow-up (Time 2; T2).


Eligibility Criteria:
Inclusion Criteria:

* Presence of Body Image Disorder symptoms

Exclusion Criteria:

* Presence of a full-blown Body Image Disorder
* Presence of a psychotic/schizophrenic disorder
* Current treatment for a Body Image Disorder
Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery

Endometritis, an infection of the uterus in the postpartum period, has been shown to complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal cleansing prior to cesarean delivery has been shown to minimize the presence of micro-organisms and risk of infection. Although povidone-iodine is the most commonly used anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine gluconate, on the other hand, has demonstrated superior disinfectant properties in several clinical trials, as compared to povidone iodine. In this randomized, comparator controlled, study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.

This is a randomized, comparator controlled, study of intrapartum vaginal preparation with either chlorhexidine gluconate or povidone-iodine solution. Women undergoing non-emergent cesarean delivery will be randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% providone-iodine solution.

The study will have two arms that will be randomized in a 1:1 ratio. After inclusion criteria have been satisfied, subjects in the comparator control arm will receive vaginal preparation with 10% provodone-iodine solution prior the skin incision. Subjects in the study arm will receive vaginal preparation with chlorohexidine gluconate 4% solution. The selected skin preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. A block randomization method will be used to control for variations in care. Both groups will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Richmond University Medical Center that have a non-emergent cesarean delivery

Exclusion Criteria:

* Emergent cesarean delivery, less than 18 years of age, chorioamnionitis before randomization, intrapartum fever prior to randomization, or known or suspected allergy to chlorhexidine or iodine.
Incisional Hernia in Infants and Children

the study of development of incisional hernia in infants and children at a tertiary level experience.

Background: incisional hernia in children and infants (IHCI) represents a major complication following exploration. The condition is associated with prolonged hospital stay, readmission and the need for another operation to treat the resulting incisional hernia. The incidence is variable worldwide. The leading causes are still indeterminate as well as the management strategy. We aimed at studying IHCI at a tertiary level hospital as regard presenting symptoms, methods of management and its impact on the quality of life of patients.

Methods: a retrospective study included all infants and children presented with incisional hernia. Patients were categorized in to two groups according to the age of presentation, group A patients younger than two years of age and group B patients older than two years. All data related to the first operation in addition to data related to repair of the incisional hernia were collected in special charts.

Eligibility Criteria:
Inclusion Criteria:

* all infants and children with incisional hernia

Exclusion Criteria:

* congenital abdominal wall defects
Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection

To determine the predictive factors of endometrial ablation failure in the management of uterine bleeding.

This is a retrospective cohort study for women who have been treated with Thermal endometrial ablation due to uterine bleeding. The main purpose of this study is to demonstrate the possible risk factors associated with endometrial ablation failure causing patients to need subsequent gynecological procedures or undergoing hysterectomy for definitive treatment. Such efforts are made in order to anticipate the morbidity and mortality associated with patients in such conditions and to effectively stratify those patients to appropriate treatment techniques.

Eligibility Criteria:
Inclusion Criteria:

* All patients who had their endometrial ablation at Jordan University Hospital.

Exclusion Criteria:

* Patients whose index ablation or subsequent re-intervention could not be confirmed in detailed operative reports were excluded
Estrogen Treatment (Oral vs. Patches) in Turner Syndrome

The study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome. These are girls who are very short and whose ovaries do not work. We will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH therapy.

Girls with Turner Syndrome, between the ages of 10-16 years, were chosen as the study population. The study requires 3 overnight admissions to an in-patient Clinical Research Center(CRC). A baseline study is performed using stable isotope tracers of leucine, glycerol and glucose and serial blood sampling to measure protein and fat metabolism. Indirect calorimetry is used to measure substrate oxidation rates and total energy expenditure. DEXA scan is used to measure bone mineral density and body composition. Once the baseline study is complete subjects are randomly assigned to receive either estrogen orally or through a patch placed onto the skin in increasing doses changed every 2 weeks. After 6 weeks of estrogen treatment a second metabolic study, identical to the first, is performed, followed by a wash out period of 4 weeks. Subsequently, the subjects are switched to the alternate form of estrogen. At the end of 6 weeks a third and final metabolic study is repeated. All subjects continue to be on growth hormone throughout the study procedures.

Eligibility Criteria:
Inclusion Criteria:Girls with Turner syndrome 10-16 years old who are receiving growth hormone treatment.

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Exclusion Criteria:Systemic disease or concomitant treatment wtih Oxandrolone. Significant obesity or chronic steroid use.

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The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods

The primary objective of the study is to determine the accuracy of CEUS in characterizing (as benign or malignant) focal liver lesions for which CT, MRI and/or PET have not been conclusive.

The study conducted will be a non-profit, observational, non-pharmacological, cross-sectional, but also partly cohort, retrospective and prospective study. The study is cross-sectional in nature, but will require 6 months of follow-up to evaluate the gold standard reference outcome in patients diagnosed with a benign pathology that does not require further investigations, and in patients with suspected malignant lesion for which histological diagnosis has not been performed on biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* CEUS performed performed in the last 6 months a CT, MRI and/or PET not decisive in characterizing a liver lesion.
* Obtaining informed consent.

Exclusion Criteria:

* Technical impossibility to perform the ultrasound evaluation.
* Documented allergy to the ultrasound contrast medium.
Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump

Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump

This is a prospective 36-month Phase IIIb/IV clinical safety trial that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. All patients will be entered after signing an IRB approved informed consent. Patients will be followed for the duration of their treatment with Gablofen® (baclofen injection) 3 mg/mL using the SynchroMed® II Programmable Pump or until the study is terminated. Patients will be evaluated for clinical complications associated with the use of intrathecal baclofen that are considered signs and symptoms of an inflammatory granuloma, specifically new radicular pain at the level of the catheter tip, and/or spinal cord compression. An MRI scan with and without infusion will be performed (with consent of the patient) to evaluate the potential presence of an inflammatory granuloma if clinical signs exist. Events that may be related to an inflammatory granuloma will be classified as a definite granuloma, possible granuloma, other catheter related problem (confirmed not caused by a granuloma), or other clinical sequelae caused by the underlying disease or other infusion system related event.

Eligibility Criteria:
Inclusion Criteria:

* 4 years of age or older
* Subjects must be clinically diagnosed with sever spasticity and be receiving intrathecal baclofen
* Subjects must have a SynchroMed® II Pump already implanted
* Current treatment with intrathecal baclofen should be at the 2 mg/mL concentration
* Life expectancy greater than or equal to 12 months
* Signed written informed consent
* Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures

Exclusion Criteria:

* History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which is allowed
* History of any allergic reaction to baclofen
* History of inflammatory granulomas with an intrathecal infusion pump
* Any previous history of neuroleptic malignant syndrome or malignant hyperthermia
* As a result of medical review and physical examination, the Investigator considers the subject unfit for the study
Endothelial Function in Patients With Pulmonary Arterial Hypertension

The objectives of the current study are to identify and evaluate new prognostic non-invasive and serological markers in patients with pulmonary hypertension. The focus will be on L-arginine metabolism and to clarify its influence on endothelial function.

The objectives of the current study are to identify and evaluate new prognostic non-invasive and serological markers in patients with pulmonary hypertension. The focus will be on L-arginine metabolism and to clarify its influence on endothelial function. The investigators also want to evaluate differences in plasma concentrations of L-arginine/NO metabolites and non-invasively assessed endothelial function based on specific PH-therapy.

Furthermore, the investigators aim to transfer the results gained from the investigators study population to in-vitro systems in order to carefully characterize the involved signal transduction pathways. Thereby the investigators hope to identify potentially new therapeutic targets in PH or patient subgroups preferably benefitting from established therapeutic options.

Eligibility Criteria:
Inclusion Criteria:

* proven PH (by right heart catheterization, PAP \>25 mmHg, within last 12 months)
* age \>18 years
* Dana Point classification I or IV (all subgroups)
* declaration of consent

Exclusion Criteria:

* Pulmonary Hypertension not proven by right heart catheterization
* Eisenmenger's syndrome/reaction
* PH other than Dana Point I and IV
* alcohol or drug abuse
* non-compliance due to any cause (e.g. severe psychiatric disorder)
Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans

Pineapple (Ananas comosus) is a tropical fruit that is rich in antioxidents, enzymes and vitamins. It is used worldwide due to their anti-inflammatory and analgesic properties. The effect of pineapple Juice on the Pharmacokinetics of celecoxib and montelukast in Humans was studied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (body mass index between 21 to 25 kg/m2).

Exclusion Criteria:

* Smokers.
* Drug abuse.
* Abnormal level of kidney or liver functions.