cyrilzakka/clinical-trials huggingface dataset:
Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children

Children undergoing surgery and anesthesia are often negatively impacted by anxiety and fear in the preoperative period. Routine inhalational anesthetic induction is a unique aspect of pediatric anesthesia. Inhalation inductions are usually initiated with sevoflurane with or without nitrous oxide. While less pungent than other volatile agents, sevoflurane at high concentrations and flows used for inhalation inductions still causes children to often repel from the smell. This can lead to an unpleasant interaction and cause heightened anxiety for any subsequent procedures.

Olfactory senses are processed in the hippocampus and amygdala and tied to emotion and memory. Parosmia is the distortion of smell perception which can utilized to the pediatric anesthesiologists advantage. It has been demonstrated that using this phenomenon, the anesthesiologist can induce a better smell for the child leading to improved cooperation during an inhalation induction. However, limitations of this study include lack of randomization, small sample size, and use of a nominal scale of yes or no for face mask acceptance. The investigators identified no other studies to validate this potentially powerful tool to optimize anesthetic induction for pediatric patients.

The overall objective of this pilot randomized trial is to determine the feasibility of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia.


Eligibility Criteria:
Inclusion Criteria:

* Ages of 5-12 years old
* American Society of Anesthesiologist physical status classification system (ASA) I and II
* Patients coming from home

Exclusion Criteria:

* Patients undergoing emergent surgery
* Patients who have not adequately maintained preoperative nothing per mouth/os (NPO) status
* Patients with inability to communicate verbally
* Tracheostomy patients
* ASA III , IV, V patients
Comparison of CPAP and Gamow Bag Ventilation to Treat HAPE

High altitude pulmonary edema (HAPE) is mostly treated with supplemental oxygen, nifedipine 30mg twice a day, rest, limiting cold exposure and descent (simulated or actual) Gamow Bag provides simulated descent and buy time for actual descent. CPAP is claimed to be effective in many case reports to treat HAPE temporarily until actual descent is taken place. This study aims to evaluate the role of CPAP in treating HAPE at those high altitude stations where Gamow bag is not available and immediate descent is not possible.

Background:

Swenson described HAPE in 2002, as a form of hydrostatic acute pulmonary edema with an alteration of alveolar-capillary permeability. Overall prevalence of AMS is 10-20% while incidence of HAPE, HACE or mixed incidence is 2-3%. Highest reported incidence of HAPE among Indian soldiers climbing to Siachen glacier is 15.5%. At 1500-2400m, A series of 52 patients admitted for HAPE over a period of 9 years was reported in literature..

Scientific rationale:

Positive pressure has been used to increase altitude tolerance since the 1940s under simulated altitudes. PEEP applied via face mask increased SpO2 and decreased AMS symptoms. CPAP was used after ascent to 3205 m on Mount Cook in New Zealand where it improved SpO2 and reduced symptoms of HAPE. A CPAP helmet providing 15 cmH20 CPAP improved SpO2 in a single HAPE patient (at 5300 m) from 56% to 74%.-1st case report. A study at Thorang La pass (5416 m) in October 2010 in the Nepal Himalaya found that nasal continuous positive airway pressure (CPAP) is useful as an additional modality to treat presumed high altitude pulmonary edema (HAPE)- 2nd case report.

Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Age 18-45 years
* Previously fit and no comorbids
* Suspected HAPE

  --arrived in the past 01 week on the post
* Expected evacuation from post more than 8 hours

Exclusion Criteria:

* Symptoms suggest acute infective etiology.
* Symptoms after one week of stay at HA
* Altered mental status.
* Disturbed balance
* Visual impairment
* Severe headache
* A speedy evacuation to a lower height is available
Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation

This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.

This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation;
* Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions;
* No suitable HLA matching haploidentical donor available;
* There are suitable unrelated HLA mismatched (HLA high-resolution typing\<9/10) donors;
* The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.

Exclusion Criteria:

* Patients with severe liver and kidney function (alanine aminotransferase\>2.5 times the upper limit of normal, blood creatinine\>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction\<50%, severe obstructive or restrictive ventilation dysfunction);
* Merge active infections;
* Eastern Cooperative Oncology Group Performance Status (ECOG) score ≥ 2 points;
* Secondary tumors with merged activity;
* Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;
* Combine other allo hematopoietic stem cell transplantation (HSCT) contraindications.
Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia

HINEX Jelly is a jelly high protein supplement. This report is to investigate whether jelly high protein supplement can achieve greater muscle mass, muscle strength, physical performance and nutritional status in sarcopenia or possible sarcopenia subjects. It is 20 weeks randomized, crossover, self-controlled trials. The screening, recruitment and trial period were carried out from Feb, 2022 to Mar, 2023. Patients were randomized to either a self-controlled phase,which intake 400\~500 kcal breakfast, or a supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100\~200 kcal food at breakfast per day, for 8 weeks. After a 4-week washout they cross over to the alternate treatment. The anthropometric measurements, sarcopenia parameters, nutritional assessment and hematology assessment data were measured at the week 0,8,12,20 and 24-hour dietary record were recorded at week 1,8,13,20.

Parameters of sarcopenia, including the muscle mass assessment, handgrip strength and physical performance assessment.Muscle mass and body composition were measured by bioelectrical impedance analysis (BIA). A hand dynamometer was used to measure handgrip strength. Physical performance was measured by short physical performance battery (SPPB), 6-meter gait speed and 5-time chair stand test. Mini nutritional assessment (MNA) used to measure nutritional status. The hematology assessment including total protein, albumin, pre-albumin, transferrin, c-reactive protein (CRP), vitamin D, calcium, glucose, insulin, homeostasis model assessment-estimated insulin resistance (HOMA-IR), total cholesterol, triacylglycerol, creatinine, creatine-kinase, alkaline phosphatase, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT) and complete blood count.

Eligibility Criteria:
Inclusion Criteria:

* 40-85 years old, middle-aged and elderly subjects with possible sarcopenia or sarcopenia. According to AWGS 2019, possible sarcopenia is defined as (1) handgrip strength \< 28 kg in men and \< 18 kg in women or (2) 5-time chair stand test ≥ 12 seconds; sarcopenia is defined as meet (1) or (2) plus appendicular skeletal muscle mass index (ASMI) \< 7.0 kg/m2 in men and \< 5.7 kg/m2 in women.

Exclusion Criteria:

* BMI\>35 kg/m2, Taking any special diet (i.e. vegan), be allergic to ingredient (i.e. milk or soy bean) and any seriously acute or chronic lung, liver, kidney, gastrointestinal, cancers diseases history.
Postoperative REcurrence and DynamICs of T Cell Subsets in Crohn's Disease

It is assumed that gut inflammation and lesions characterizing flares of Crohn's disease (CD) result from an aberrant T-cell mediated immune responses characterized by a complex balance between peripheral and lamina propria regulatory and effector T cell subsets. Because most of CD patients who undergo a surgery experienced a postoperative endoscopic recurrence of the disease (70 % at one year) leading to a clinical recurrence (10 % per year), the "model" of postoperative recurrence in CD represents a privileged situation that mimicks what happens in the gut of CD patients in clinical remission before the occurrence of further flares. It is likely that the same factors which underlie the immunopathogenesis of CD at its early stages also contribute to disease recurrence in the postoperative setting. Indeed, the postoperative state is performed for intent of disease remission and this situation represents probably an ideal setting to investigate the dynamics of most of T cell subsets in the peripheral and mucosal compartments because one may argue that removal of the diseased segment of bowel resets the disease to its earliest phases, providing an interesting window to better understand which T cell subsets predispose to disease recurrence.

That is the reason why this model will be used in the present project i) to understand better the immunopathogenesis of CD relapse; ii) to identify novel and promising immune cell-associated biomarkers capable to predict relapse of the disease and finally iii) to identify potential specific therapeutic target associated with T cell subsets involved in the initiation of disease.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Men or non-pregnant women
* Patients with a diagnosis of Crohn's disease who undergo an ileo-colonic curative resection
* No change of the postoperative treatment before assessing an endoscopic recurrence during the one-year post surgery follow-up period
* Informed consent given

Exclusion Criteria:

* Pregnancy
* History of disease, including mental/emotional disorder, that might interfere with their participation in the study
* Inability to comply with the protocol requirements
* Inability to fill in the diary cards
Wound Infections Following Implant Removal

In the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWIs) should be less than 5%. However, rates of 10-12% following implant removal, specifically after foot, ankle and lower leg fractures are reported. Currently, surgeons decide individually if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation.

Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in patients scheduled for implant removal following a foot, ankle or lower leg fracture, to assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs.

With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided alpha=5%, including 15% lost to follow up).

If the assumption of the investigators, that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of care. This will reduce the incidence of POWIs and consequently will lead to less physical and social disabilities and health care use. In addition, it will decrease the rate of use of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of €3.5 million per year.

See study protocol

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years and ≤75 years of all ethnic backgrounds
* Implant removal following foot, ankle and/or lower leg surgery

Exclusion Criteria:

* Removing and re-implanting osteosynthesis material in the same session
* Active wound infection or (plate) fistula
* Antibiotic treatment at time of elective implant removal for a concomitant disease or infection
* A medical history of an allergic reaction to a cephalosporin, penicillin, or any other β-lactam antibiotic.
* Insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate.
* Kidney disease (eGFR \<60 ml/min/1.73m\^2).
* Treatment with probenecide, anticoagulants (see SPC)
* Pregnancy and lactation
Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children

Objective: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. Methods: Fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on Breath Alert® portable breath meter) were randomly allocated to two groups (n = 26). Group 1: brushing, dental floss and aPDT applied to middle third of the dorsum of the tongue. Group 2: brushing, dental floss and tongue scraper. Breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. The normality of the data will be determined using the Shapiro-Wilk test. Parametric data will be submitted to analysis of variance and nonparametric data will be compared using the Kruskal-Wallis test. The results of each treatment in the different periods of the study will be compared using the Wilcoxon test.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mouth breathing (performed using the calibrated Glatzel mirror test, water retention test and a questionnaire);
* Halitosis presenting a score equal or greater than 2, in the Breath Alert analysis.

Exclusion Criteria:

* Nasal breathers;
* Dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
* Undergoing orthodontic and/or orthopedic treatment;
* Undergoing cancer treatment;
* Systemic alterations (gastrointestinal, renal, hepatic);
* Under antibiotic treatment for up to 1 month before the research;
* Fissured or grooved tongue.
fNIRs, Listening Effort, and Speech Intelligibility

The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Adults with hearing loss will be asked to repeat the final word from low-context sentences in noise at two SNRs; a hard SNR (individually-measured SNR-50), and an easy SNR (SNR-50 + 10 dB) both without and with hearing aids set to a directional mode. The procedure will be a within-subject repeated measures. Stimuli will be randomized.

See above.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-99 years) with ≥3 months hearing aid experience
* binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss
* fluent in English

Exclusion Criteria:

* children/teenagers
* normal hearing or hearing loss exceeding N6 (severe) by 10 dB
Minimal Water Exchange Versus Left Water Exchange in Unsedated Colonoscopy

Minimal water exchange colonoscopy is theoretically more convenient and faster than water exchange colonoscopy. But few studies compared the differences between the two methods. Therefore, we attempted to evaluate the effect of minimal water exchange colonoscopy prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 years for unsedated colonoscopy for colorectal cancer screening, polyp surveillance, or polyp resection were enrolled.

Exclusion Criteria:

* Patients who underwent sedation or analgesia before colonoscopy, and were reluctant to cooperate or provide informed consent. Those who were suffering from too serious diseases to tolerate the examination. The intestinal segment was incomplete or the colonoscopy did not reach the cecum.
Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility will be confirmed by radiographic and clinical examination
* People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking \>3 on an 11-point scale
* varus knee malalignment on standing anteroposterior lower limb x-ray.

Exclusion Criteria:

* advanced radiographic knee OA (Kellgren and Lawrence stage 4
* knee surgery or intra-articular corticosteroid injection within 6 months
* current or past (within 4 weeks) oral corticosteroid use
* systemic arthritic conditions
* history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
* any other muscular, joint or neurological condition affecting lower limb function
* ankle/foot pathology or pain that precludes the use of insoles
* use of foot orthotics within past 6 months and
* use of footwear that does not accomodate an insole.
Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.

Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment.

Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment compared to Tell Show Do technique (control group) using modified Frankl scale.

Eligibility Criteria:
Inclusion Criteria:

* Children: 6 to 9 years old ADHD children
* Teeth: Teeth requiring dental treatment or preventive measure.

Exclusion Criteria:

* Non ADHD children.
* ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
* Refusal of participation
Nutritional and Dietary Treatment Study for Children/Adults With Autism

70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Half of the participants will be randomized into a treatment study, and half will be randomized to no changes in their current treatments. Treatments will be added in a sequential manner over 12 months, including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the participants throughout the study.

A group of 50 neurotypical children and adults, of similar age and gender, will be included for comparison.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria - Autism Group

1. Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician
2. Verification of diagnosis by an ADOS evaluation (conducted by ASU staff)
3. Age of 2.5 years to 60 years

Enrollment Criteria - Non-autism Group

1. No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc.
2. No first-degree relatives of individuals with autism (no siblings or parents)
3. Age of 2.5 years to 60 years -

Exclusion Criteria:

Exclusion Criteria - Autism Group

1. Major changes in behavioral or medical treatments in the previous two months, or intention to make such changes during the 12 months of the study.
2. Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months

Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months

-
Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout

The purpose of this study is to compare the incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.

A prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. The incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat treatment.

Eligibility Criteria:
Ages Eligible for Study: more than 20 years

Inclusion Criteria:

1. Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria
2. Acute gout attack during the last 12 months

Exclusion Criteria:

1. Acute gout attack in the last 2 weeks
2. Urate-lowering therapy in the last 4 weeks
3. Secondary hyperuricemia
4. Creatinine ≥2.0 mg/dL
5. AST or ALT ≥2x upper limits of normal
6. Heart failure (NYHA III-IV)
7. Hypersensitivity to colchicine, NSAID or febuxostat
8. Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate
9. Inability to comply with the protocol requirements
10. The judgement of the investigator that the patient was not an appropriate candidate