cyrilzakka/clinical-trials huggingface dataset:
A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.

This study aims to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years old undergoing hip fracture surgery.

The study aim to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years undergoing hip fracture surgery. This study was conducted at the Tata Main Hospital in Jamshedpur, India. The study was designed as a prospective observational study, with data collected from June 2022 to June 2023. The study's primary objective was to predict mortality in patients undergoing hip fracture surgery. The study also investigated secondary outcomes such as the need for postoperative ventilator and ionotropic support, the occurrence of acute kidney injury, cardiac morbidity, and the presence of pulmonary embolism and deep vein thrombosis, as well as length of stay.

Eligibility Criteria:
Inclusion Criteria: Age more than or equal to 60 years, Underwent Hip fracture surgeries, of Either Sex

-

Exclusion Criteria: Age less than 60 years of age, Hip fractures not undergoing any invasive surgery, Implant removals planned for healed hip fractures, Re-explorations during the same admission in which primary surgery was conducted

-
Effect of Dexmedetomidine on the Inflammatory Response After One-lung Ventilation

The postoperative inflammatory response is significant in lung resection surgery because of major operation and one-lung ventilation. Dexmedetomidine has been shown to reduce pro-inflammatory cytokine levels and improve clinical outcomes. The aim of this study was to determine the effects of dexmedetomidine on inflammatory responses after lung resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective video-assisted thoracoscopic surgery (VATS) lobectomy
* 20 \< age \< 75
* American Society of Anesthesiologists (ASA) classification I\~II

Exclusion Criteria:

* preoperative inflammation (CRP\>10ng/#, WBC\>10,000/mm3, body temperature \>38#)
* steroid administration within 1 month
* hematologic / autoimmune disease
* congestive heart failure (NYHA class III\~IV) or significant arrhythmia
* severe obstructive / restrictive pulmonary disease
* previous history of thoracic surgery
Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.

The purpose of this study is to test whether breathing control exercises embedded in occupational therapy sessions have an impact on quality of life and dyspnea in patients with chronic obstructive pulmonary disease (COPD).

Dyspnea is one of the most important and debilitating symptoms in patients with COPD and is often the starting point to the vicious cycle of physical inactivity. As a consequence of increased dyspnea, patients adapt themselves by reducing the amount of all activities of daily living performed, with a consequent reduction in quality of life.

Occupational therapists are involved in pulmonary rehabilitation programs aiming to improve the biopsychosocial condition of COPD patients. However, the specific roles and intervention of occupational therapists are not well-defined, and standardized protocols are lacking. The implementation of breathing control exercises in occupational therapy sessions, aiming among other things to regulate patient's breathing during their activities of daily living, could be a starting point for a more effective management of patients with COPD. This could ultimately participate in the improvement of quality of life in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnostic of COPD
* Severity of COPD: global initiative for chronic obstructive lung disease (GOLD) classification III or IV
* Undergoing a pulmonary rehabilitation program in J. Bracops Hospital

Exclusion Criteria:

* Cardiac or orthopedic complications limiting participation in occupational therapy sessions
* Active smoking
* Inability to understand the French language orally or in writing
* Cognitive impairments limiting understanding of instructions and participation in occupational therapy sessions
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain

This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.

This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine:

* effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and
* compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older
* Willingness and ability to give written consent
* Smoking at least 10 cigarettes per day for at least 1 year
* Baseline expired carbon-monoxide level of at least 10 ppm
* Weigh at least 100 lbs.
* English-speaking
* One person per household
* At least 1 prior quit attempt
* Concern about gaining weight. This will be assessed using a questionnaire that will provide a rating system to determine qualified participants.

Exclusion Criteria:

* Pregnant or nursing women or women attempting to conceive
* Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension
* Current alcohol dependence
* Current use of opiates, and/or a urine toxicology screen positive for opiates
* Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
* Evidence of significant hepatocellular injury as evidenced by AST or ALT \>3 x normal or elevated bilirubin
* History of cirrhosis
* Body mass index (BMI) greater than 35
* History of anorexia nervosa or bulimia
* Current major depression
* Currently taking Toprol-XL (or metoprolol succinate)
* History of seizure disorder or serious brain injury
* Current use of smokeless tobacco, pipes, cigars, nicotine gum, nicotine patch, nicotine inhaler, nicotine lozenge, nicotine nasal spray, or bupropion
* Previous hypersensitivity to bupropion
* Patients requiring concomitant therapy with any psychotropic drug
* Participation in the Framing Messages for Smoking Cessation With Bupropion study (HIC#: 10880)
Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?

This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.

Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. In a study by Nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. Of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling.

However, the splitting of a cast is not without risks in itself. Once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. This loosening has been associated with a loss of reduction. If the loss or reduction is substantial, it may require a re-reduction or operation to correct. In addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. Thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. They can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.

Eligibility Criteria:
Inclusion Criteria:

* A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures.
* Forearm fractures that require closed reduction (with or without conscious sedation)
* Patients between the ages of 3 and 12 years old

Exclusion Criteria:

1. Specific exclusions

   * Age less than 3 or greater than 12
   * Patients presenting with an associated neurological or vascular injury caused by the fracture
   * Patients presenting with an open fracture
   * Patients requiring operative treatment following the initial fracture evaluation
   * Ipsilateral upper extremity fracture
   * Patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort
2. Generic exclusion: "Subjects not meeting all inclusion criteria."
The Effect of RECO-18 on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer

How to improve the fertility of infertile women has become a hot topic in the field of assisted reproduction. Animal experiment has shown that RECO-18 significantly improved the female fertility in mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Therefore the investigators aim to conduct a pilot study to explore the effect of RECO-18 in infertile women undergoing assisted reproduction treatment. This study is a prospective, randomized, controlled clinical study. The treatment group takes RECO-18 while the control group takes the multi-vitamins. The primary indicator is the ongoing pregnancy rate at 12 weeks' gestation; the secondary indicators are the number of oocytes retrieved, the normal fertilization rate and the rate of high quality embryos, implantation rate, clinical pregnancy rate, and early miscarriage rate.

Mitochondrial function is closely related to oocyte quality in female. Deficiency of multiple micronutrients is common in infertile women, and supplementation with multiple micronutrients has antioxidant effects to reduce the damage of oxidative stress to fertility, and helps to improve the outcomes of assisted reproductive treatment. RECO-18 is a functional food containing a variety of plant extracts and enzymatic soy phospholipids. In in vivo and in vitro senescent models, the investigators found RECO-18 to improve oocyte quality mainly by regulating the mitochondrial apoptosis pathway. The investigators also found RECO-18 significantly improved the fertility of mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Based on the animal experiments, the investigators intend to conduct a clinical trial to explore whether RECO-18 plays a role in improving oocyte and embryo quality and pregnancy outcomes in infertile women undergoing in vitro fertilization-embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* female, 20 to 40 years old
* the 1st or 2nd cycle of IVF/ICSI treatment
* BMI≤30Kg/m2
* with bilateral ovaries
* be eligible for IVF/ICSI treatment

Exclusion Criteria:

* Repeated implantation failures (with previous 3 or more IVF/ICSI failures)
* moderate to severe endometriosis
* untreated hydrosalpinx
* untreated endometrial disease
* contraindications for assisted reproductive techniques or gestation
* a history of ovarian surgery
* expected poor ovarian response (POR) or previous POR
* polycystic ovarian syndrome
* participants in clinical trials of other drugs within one month prior to enrollment; • hypersensitivity to follicle-stimulating hormone α, FSH, human menopausal gonadotropin, LH or excipients
* uncontrolled endocrine diseases (such as hyperthyroidism, hypothyroidism, adrenal gland disease, obesity, etc.)
* percutaneous epididymal sperm aspiration or testicular sperm aspiration
Evaluation of the Effect of IHHT on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With MS.

The aim of this study is to assess the effect of interval hypoxy-hyperoxic training (IHHT) on the arterial stiffness and elasticity of the liver tissue in patients with metabolic syndrome and on other components of the metabolic syndrome, and the possibility of their reversible recovery after training.

The study will included 60 patients with metabolic syndrome (alimentary obesity (large waist, that measures at least 89 centimeters for women, and 102 centimeters for men), high blood pressure (130/85 mm Hg or higher), dislipidemia (triglyceride level 150 mg/dL (1.7 mmol/L) or higher of this type of fat found in blood; reduced high-density lipoprotein (HDL) cholesterol less than 40 mg/dL (1.04 mmol/L) in men, or less than 50 mg/dL (1.3 mmol/L) in women of HDL cholesterol), elevated fasting blood sugar (100 mg/dL (5,6 mmol/L) or higher). All patients were random separated into two groups: trial (30 pers., who will undergo 15 procedures of the IHHT, 5 days a week for 3 weeks), and control (30 pers., who will undergo 15 placebo procedures simulating IHHT, 5 days a week for 3 weeks). Before and after procedures of IHHT all patients will undergo laboratory and instrumental examinations, wich include arterial stiffness measurement, making by Fukuda Denshi VS-100 VaSera, measurement of liver tissue elasticity and fibrosis, making by elastography on FibroScan (Echosense, XL-sensor), and laboratory analysis (lipid profile, fasting blood sugar, trimethylamin N-oxyde (TMAO), Toll-like receptors 4,7,9). After 6 month of IHHT all patients will undergo the same laboratory and instrumental examinations to assess the duration of the effect.

Eligibility Criteria:
Inclusion Criteria:

* Patient's written informed consent.
* The presence of metabolic syndrome: as having three or more of the following traits, including traits you're taking medication to control:
* Large waist - A waistline that measures at least 35 inches (89 centimeters) for women and 40 inches (102 centimeters) for men;
* High triglyceride level - 150 milligrams per deciliter (mg/dL), or 1.7 millimoles per liter (mmol/L), or higher of this type of fat found in blood;
* Reduced "good" or HDL cholesterol - Less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women of high-density lipoprotein (HDL) cholesterol;
* Increased blood pressure - 130/85 millimeters of mercury (mm Hg) or higher;
* Elevated fasting blood sugar - 100 mg/dL (5.6 mmol/L) or higher.
* Must be able to come to the hospital 5 days per week, for 3 weeks.

Exclusion Criteria:

* Refusal from further participation in the study.
* Individual intolerance to hypoxia.
* Cirrhosis of the liver with liver failure class C according to the classification of Child-Pugh.
* Alcohol use 140 g / week or more for men, and 70 g / week or more for women.
* Patients with positive serological reactions to hepatitis B and C.
* Chronic kidney disease (GFR less than 30 ml / min / 1.73 m 2).
* Pregnancy, lactation.
SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer

Stereotactic ablative Body Radiotherapy (SBRT) is an advanced radiation technique that allows for precise delivery of higher radiation doses in fewer treatment sessions, resulting in a shorter overall treatment duration. The available clinical evidence suggests that SBRT is highly effective in controlling localized prostate cancer (PCa) with acceptable side effects.

On the other side, dose escalation is a commonly employed strategy in radiotherapy for prostate cancer. Recent studies have confirmed a dose-response relationship, demonstrating improved biochemical control with focal dose escalation to the identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) of the prostate.

The hypothesis of this study is that the combination prostate SBRT with focal dose intensification on the DIL with preservation of the prostatic urethra, would lead to a higher probability of local control without a significant increase in toxicity compared to standard clinical practice.

This is a prospective single-arm phase II study designed to evaluate the effectiveness, safety and impact on quality of life of focal dose intensification using SBRT technology and extreme hypofractionated radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Primary localized PCa, cN0 and cM0, intermediate or high-risk disease according to NCCN 2023
* Signed written informed consent for this study
* T2-T3a clinical stage with visible DIL on mpMRI
* ECOG 0-1
* Desirable prostate volume (not mandatory) \< 80 cc or \> 80 cc if urinary function is preserved and dosimetrically feasible
* IPSS ≤ 18 (International Prostate Symptom Score)

Exclusion Criteria:

* Unresolved previous prostatitis, symptomatic urethral stenosis
* Bilateral hip prosthesis
* T3b-4 clinical stage or N1
* M1 (presence of distant metastases)
* Previous surgery at the prostate level (Transurethral Resection of the Prostate) within the last 6 months
Flash-free Brackets and Dental Plaque

This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.

Aim: The aim of this split-mouth study was to compare conventional and adhesive flash-free-bracket systems in terms of plaque retention, white spot lesion formation, biomarker levels and select microbes in gingival crevicular fluid (GCF).

Materials \& Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations, quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria content. Data were analyzed by Wilcoxon on dependent samples.

Eligibility Criteria:
Inclusion Criteria:

* being systemically healthy
* having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning.

Exclusion Criteria:

-
Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)

A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with inhaled steroids.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric Bronchial Asthma Patients Aged 6 To 14 Years (At The Beginning Of The Treatment Period)
* The Severity Must Be Mild, Moderate Or Severe, Persistent Bronchial Asthma
* The Patient Must Have Symptoms That Can Be Used As Efficacy Variables (Such As Repeated Coughing And Mild Or Moderate Asthma Attacks) During The Observation Period, And Must Be Using Inhaled Steroids

Exclusion Criteria:

* Patient Using Anti-Asthma Treatment Or Therapy Including corticosteroids Or Oral Anti-Allergic Drugs
* Patient With Complications That Will Impair The Judgment Of Efficacy Of This Drug
* Patient With Convulsive Disorders Such As Epilepsy Or Such A History
* Patient With Liver Disease, Renal Impairment, Heart Disease Or Such Other Complication
Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining

with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity.

The whitening effect of strawberry is due to the presence of malic acid, which acts as a natural astringent to remove surface discoloration. The ellagic acid content in strawberry is ranging from 0.43 to 4.64 mg/g dry weight. The more amount of ellagic acid will produce more potential OH clusters as a powerful oxidizer thus make the more effective bleaching process. Ellagic acid releases the OH and H radicals which will react with the tooth enamel organic molecules and disrupt the electron conjugation, as well as changing the energy absorption in the tooth enamel organic molecules to form smaller organic molecules with a lighter color. Ellagic acid has an OH cluster, not COOH cluster like any other acids. The electronegativity of the OH group will be easier to break and react with the organic molecules of tooth enamel.

Eligibility Criteria:
Inclusion Criteria:

Participant inclusion criteria:

1. At least 18 years old.
2. Good general and oral health.
3. six present maxillary anterior teeth.

Tooth inclusion criteria:

1. yellowing of teeth due to age.
2. stains due to coffee or tea.
3. light tetracycline stain.

   * Exclusion Criteria:

participant exclusion criteria:

1. patients undergoing radiotherapy or chemotherapy.
2. Pregnant females or breast feeders.
3. Bruxism and patients who reported tooth sensitivity.

Tooth exclusion criteria:

1. Hypoplastic enamel.
2. carious lesion.
3. sensitive recession area or sensitive tooth.
4. Amalgam staining.
5. Non vital tooth.
6. Discolration due to pulp trauma or necrosis.
7. presence of non carious cervical lesion.
fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

The study aims to explore the effectiveness of neurofeedback training on improving attention and inhibitory control of children with attention-deficit/hyperactivity disorder (ADHD) in Hong Kong. This study will contribute to the current understanding of the alternative treatments for ADHD, and hopefully help to mobilize more resources to support children with ADHD. The programme includes the following components:

Participants will be randomly assigned to the neurofeedback training group (with virtual reality \[VR\] technology applied), the computerized cognitive training group, or the waitlist control group. All participants will complete a total of 16 training sessions in 8 weeks (twice a week), and each session will last around 35 to 60 mins.

To investigate the intervention effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory prior to the intervention (i.e., Time 1), immediately after the 8-week training (i.e., Time 2), and 2 months after the training (i.e., Time 3, a 2-month follow up). The assessment will take around 1 hour and it will be conducted at the laboratory at the University of Hong Kong. Also, parents and teachers will be asked to complete a questionnaire assessing children's behaviours at home and schools at 3 timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 7- 12
* Clinical diagnosis of ADHD
* Significant teacher- or parent-reported attention problems during screening

Exclusion Criteria:

* IQ under 70, as measured on Raven's Progressive Matrices
* Hearing, visual, or physical impairments that might hinder participation in the training and assessment activities
* Clinical diagnosis and suspected cases of Autism Spectrum Disorder (ASD)
* Prior or current participation in NFT
* Current participation in a psychotherapeutic treatment