cyrilzakka/clinical-trials huggingface dataset:
Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

This trial will address the impaired quality of life of young people with asthma, despite appropriate medicines. Research shows that young people report needing to calm themselves down during an asthma attack to control their breathing. Although physiotherapist- delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. The investigators have redesigned an adult training package to make it appropriate for young people and will now assess how effective such an intervention would be in this population. This study will include young people (12-17 years) with physician diagnosed asthma. The repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in Stages 1 and 2 of the Breathe 4 Teens (BREATHE4T) project. A self-guided, breathing retraining digital intervention has been developed, delivered via a mobile friendly, online platform.

The current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. Participants with access to the intervention will be compared to a usual care group. Asthma and quality of life of both groups will also be assessed at baseline, 2-month and 6-month time points. At the end of the 6 months, the control group will also be given access to the website.

The online nature of this study allows recruitment from across the United Kingdom. Recruitment methods would include primary care, hospital clinics, social media and posters. AsthmaUK will also provide publicity to assist recruitment.

The trial will aim to assess the acceptability, uptake and success in collecting follow up data and variance in asthma-related outcome measures. A parallel group design will be used with participants being randomised to intervention or normal management. The intervention will be a self-guided, breathing retraining digital intervention, delivered via a mobile-friendly, online platform. The intervention will continue to be used for 6 months after which both groups will be reassessed. The usual management control group will then have access to the intervention (delayed access).

Eligibility Criteria:
Inclusion Criteria:

* Young people aged 12-17 years
* Physician diagnosed asthma
* Impaired quality of life (\<85)
* Under the care of a general practitioner, community or hospital practitioner for their asthma

Exclusion Criteria:

* Co-existent respiratory conditions such as bronchiectasis
* Already using breathing techniques
* Already enrolled in another interventional study
* Lack of informed consent
* Learning difficulties
* Previously involved with Stages 1 and 2 of the study
Intervention for Smoking Cessation in Pre-Surgical Patients.

The goal of this clinical trial is to assess efficacy of an intensive pre-surgical intervention to quit smoking in smoking patients who will be operated on implant orthopedic surgery or general and urological surgery. The main question\[s\] it aims to answer are:

* Evaluate the efficacy of intensive pre surgical intervention to quit smoking compared to a brief intervention
* Evaluate the implementation of this protocol.

Participants will be randomized to 2 intervention groups (patients programmed for protesic implant orthopedic surgery in the first group, and general and urological surgery) and 2 control groups (stratified in the same manner as the intervention groups), and will be monitored through telematic check ups via phone calls.

1. Subject recruitment in pre surgical anesthesiology consults, data collection and randomization within 48 hours of said visit.
2. Subjects in the intensive intervention group will be sent to a specialized Preventive Medicine consult for smoking cessation, completing 6 visits (2 before surgical intervention, 4 visits withint the following 12 months). Subjects in the control group will receive brief advice on quitting smoking through a phone call the the same day randomization is performed. Both groups will receive follow up calls at months 1, 3, 6, and 12, after surgical intervetion. All patients will have their smoking habits evaluated and the relevant data about the surgical intervention collected the day of the intervention.
3. At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are necessary.
4. Data entry and quality control of the database will be performed periodically for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must 18 years old or older, and be able to consent.
* Surgery programmed for at least 4 weeks after inclusion in the study.
* Smokers

Exclusion Criteria:

* Pregnancy
* Already under treatment for smoking cessation
* Inability to consent due to cognitive impairment or language barrier.
* Non-primary knee or hip replacement surgery
* Participation in any study that forbids use of nicotine substitution therapy (dermal, oral)
The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Post Burn Scars

A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group received the standard treatment and treatment of postburn scars with Extracorporeal Shock Wave Therapy 512 impulses of 0.15mJ/mm 2 in each session, twice per week for 4 weeks.

The investigators assessed the appearance of scar with the Vancouver Scar Scale (VSS), pruritus and pain with Visual Analog Scale (VAS) before the start of the treatment and at 2 weeks and 5 months after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertrophic post burn scars of approximately 64 cm2 surface area.

Exclusion Criteria:

* Patients younger than 18 year.
* Pregnant women.
* Having a known skin condition (e.g. psoriasis, skin cancer etc.).
* Immunosuppression.
* Hemophilia .
* Matured scars.
* Scars located above the lungs, the bowels, the gonads or electronic implants.
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery

Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-60
* Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.

Exclusion Criteria:

* Subjects aged \<18 or \>60
* Subjects greater than 190 cm in height
* Patients scheduled for ligament reconstruction or surgery involving bone
* Daily use of narcotics for greater than one week pre-op
Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects

Comparison of efficacy and safety of glargine insulin and metformin as first line drug of patients insufficiently treated with lifestyle intervention. So far treatment also algorithm with lifestyle and metformin has not been evaluated in patients with type 2 diabetes and HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion and glycemic variability as determinants of oxidative stress will be measured by continuous glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As secondary objectives effect on endothelial function, renal function and biomarkers of low great inflammation will be evaluated. So far only scarce information on face to face comparison in ealy diabetes exists.


Eligibility Criteria:
Inclusion Criteria:

* early type 2 diabetes (lower than 5 years known)
* male and female(35 to 75 years)
* HbA1c 7 to 8 %, if drug naive and \<= 8.5 with previous OAD intake
* Informed consent

Exclusion Criteria:

* any treatment more than one OAD at the same time
* treatment with one OAD \< 6 weeks time
* insulin treatment
* acute coronary syndrome \< 6 months
* severe liver disease
* alcohol abuse or drug addiction
* severe kidney disease
* acute critical illness with renal impairment
* i.v. application of iodine
* ketoacidosis
* acute or chronic illness witch may lead to hypoxia or cardial failure
* allergy against one of the drugs
* deficit in compliance or cooperation
* pregnancy or breast feeding
* women in fertile age without accepted contraceptive
Shaping the Health of Adolescents in Zimbabwe

The SHAZ! study was a randomized trial that compared a package of life skills education, reproductive health care services, and economic livelihood development to a control package of life skills education and reproductive health care services alone. SHAZ! enrolled young women 16 to 19 years old who had been orphaned and who were currently out of school and not infected with HIV. Individuals participated in the project for up to two years.


Eligibility Criteria:
Inclusion Criteria:

* 16 to 19 years old
* out of school
* orphaned
* willing to participate in intervention activities
* living in Chitungwiza

Exclusion Criteria:

* HIV infection
* currently pregnant
Adjunctive Atropine During Ketamine Sedation

* Ketamine seems an obvious choice in the setting of an emergency department
* Ketamine leads to increased production of salivary and tracheal secretions
* Antisialagogues(atropine)therefore have been recommended as a routine adjunct
* We compare atropine with placebo as an adjunct to ketamine sedation in children undergoing primary closure of lacerated wound

The degree of secretion was significantly less in the atropine group compared with the control group at the end of the procedure (VAS score: 16.5 ± 9.9 vs. 27.0 ± 15.9, atropine vs. control, p = 0.00). The change in the degree of secretion between the start and end of the procedure was significantly greater in the atropine group than in the control group (p = 0.00) (Fig. 2). However, the frequency of hypersalivation as predefined (VAS score ≥50) did not differ between the groups (p = 0.06).

The only complication that differed significantly between the two groups was tachycardia (p \> 0.05). Complications such as aspiration, laryngospasm, and apnea were not documented in the hospital. There were fewer interventions for hypersalivation in the atropine group, but the difference was not significant (p \> 0.05). As interventions, O2 administration and endotracheal intubation were not needed. After discharge, the control patients tended to have more complaints of nausea, vomiting, and ataxia, although the difference was not significant (p \> 0.05) Heart rate was increased significantly in the atropine group (p = 0.00). The frequency of tachycardia according to patient age was also significantly higher in the atropine group than in the control group (p = 0.00)

Eligibility Criteria:
Inclusion Criteria:

* Pediatric lacerated patients

Exclusion Criteria:

* Contraindication of ketamine or atropine
Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment

Our group has recently found that the choice of positive airway pressure mask can significantly affect the pressure required to adequately treat sleep disordered breathing. The goal of this study is to visualize the upper airway in the retropalatal and retroglossal region while using both oronasal and nasal masks with CPAP in order to investigate differences in upper airway dynamics that may occur between these two mask types.

It is known that oronasal masks are not as effective at opening the upper airway compared to nasal only continuous positive airway pressure (CPAP) masks in patients with sleep-disordered breathing. However, the physiological mechanism for this difference in efficacy is not known; although, it has been hypothesized to involve the retroglossal and/or retropalatal region of the upper airway. The objective of this study was to investigate differences in retroglossal and retropalatal anterior-posterior space with the use of oronasal vs. nasal CPAP masks using real-time cine magnetic resonance imaging (cMRI).

Eligibility Criteria:
Inclusion Criteria:

* AHI\> 30/hr
* 18-75 years of age

Exclusion Criteria:

* History of claustrophobia
* History of pacemaker, nerve stimulator, or any other metal implanted device
Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

The purpose of this study is to see if combination therapy with a "statin" medication and two additional agents that work differently than "statin" medications can further lower the so-called "bad cholesterol." One therapy is a prescription drug approved by the Food and Drug Administration to treat high cholesterol (Welchol). The other therapy is Minute Maid Heart Wise orange juice. This study juice is available in supermarkets and contains plant sterols that have been shown to lower cholesterol.

Coronary heart disease (CHD) is the primary cause of morbidity and mortality in the United States. Lowering LDL cholesterol in both patients with and without CHD reduces coronary events and death. Statin medications are the primary mechanism of lowering LDL cholesterol, but some patients do not reach their goal LDL with maximum tolerated statin doses and must utilize combination therapy to further lower cholesterol. Additionally, some patients prefer to utilize "natural" mechanisms to lower cholesterol. This prospective, double-blinded, randomized study will compare plant sterol (natural cholesterol treatment) with placebo in patients treated with combination statin and colesevelam therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high cholesterol being treated with a statin
* LDL cholesterol greater than 100
* Ability to swallow large tablets

Exclusion Criteria:

* Diabetes
* Use of other medications to treat high cholesterol
* History of liver disease
Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery

Serum procalcitonin levels will be considerably higher, for a longer period of time, in patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU methods.


Eligibility Criteria:
Inclusion Criteria:

* Female or male person ≥ 18 years of age
* Biopsy proven carcinoma
* Scheduled for cytoreductive surgery, with or without HIPEC
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
* Able to give informed consent for protocol participation

Exclusion Criteria:

* Participants are not able to understand or provide written informed consent
* Pre-operative anti-inflammatory medication use within 72 hours of their baseline blood draw
* Pre-operative infection treatment with corticosteroids within 72 hours of their baseline blood draw
* Immunosuppressive illness other than neoplasm
* Pregnant or lactating female
Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer

The purpose of this study is to determine whether radiation combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe and effective for patients with metastatic non-small cell lung cancer.

The prognosis of patients with metastatic non-small cell lung cancer was still poor for those unsuitable for target therapy or immunotherapy. This study is to include patients evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy to evaluate the efficacy and safety of receiving radiotherapy combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Histologically proven non-small-cell lung cancer；
3. Stage IV according to UICC stage system(version 7,2009), at least with three evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;
4. Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);
5. ECOG performance status: 0-1;
6. Life expectancy ≥ 3 months.
7. Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
8. Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;
9. Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;
10. Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

Exclusion Criteria:

1. Having received immunotherapy within 4 weeks prior to inclusion;
2. Allergic to GM-CSF, or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;
3. receiving treatment of other trials;
4. Any unstable systemic disease, including active infection, symptomatic congestive heart failure, myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;
5. unwilling to sign consent;
6. Women in pregnancy or lactation;
7. Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.
Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (\>60 yr) renal transplant recipients

12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy.
* Recipients 60 years of age or older.
* Signed informed consent.

Exclusion Criteria:

* Diabetes mellitus (WHO criteria).
* Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.
Study of NPF-08 in Patients Who Receive Colonoscopy

To study non-inferiority of intestinal cleansing effect in both NPF-08 1-day treatment group and NPF-08 2-day split dose group to the cleansing effect in Moviprep® 1-day treatment group, for the subjects who will receive endoscopy large bowel. If the non-inferiority will be validated, superiority of intestinal cleansing effect in both groups of NPF-08 will be studied.

Furthermore, for the assessment of safety of NPF-08, the adverse events and adverse drug reactions observed after the administration to post-examination period will be studied, compared to those at Moviprep® 1-day treatment group.


Eligibility Criteria:
Inclusion Criteria:

1. Japanese men and women aged 20 years or older at obtaining the written informed consent.
2. Patients who require colonoscopy (except for emergency colonoscopy)
3. Patients who have the ability to consent and submit the written informed consent by themselves.

Exclusion Criteria:

1. Patients who have or are suspected to have gastrointestinal obstruction.
2. Patients who have or are suspected to have intestinal perforation.
3. Patients who have or are suspected to have toxic megacolon.
4. Patients who have or are suspected to have gastric evacuation disorder (gastroparesis).
5. Patients with intestinal stenosis or high-grade constipation (stool frequency of 2 or less in a week or who have used laxative on a daily basis).
6. Patients with vomiting reflex or in whom accidental ingestion may occur.
7. Patients with a history of gastrointestinal surgery (except for appendicectomy).
8. Patients who were decided as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
9. Patients with renal impairment (urea nitrogen: 25mg/dL or more, or creatinine: 2mg/dL or more)
10. Patients with hepatic dysfunction (total bilirubin: 3.0mg/dL or more, ALT: 100IU/L or more or AST: 100IU/L or more)
11. Patients who have undergone or require therapy due to high-grade cardiac disease (including angina pectoris or myocardial infarction)
12. Patients with high risk of arrhythmia (with a history or complications of QT prolongation, myocardial infarction, angina pectoris, cardiac failure or cardiomyopathy)
13. Patients with dehydration.
14. Patients who were diagnosed with active inflammatory bowel disease at screening period.
15. Inpatients due to the reasons other than endoscopy large bowel.
16. Patients who have undergone nutritional control using total parenteral nutrition or enteral nutrition.
17. Women who are or may be pregnant, lactating or wish to become pregnant during the trial period.
18. Patients with a history or high-risk of seizure.
19. Patients with a history of shock or hypersensitivity for the active ingredient of the investigational product.
20. Patients who have received the other investigational product within 4 months before the written informed consent or who are participating in the other clinical trials.
21. Patients in whom Investigator/Sub-Investigator decided not to be eligible for this trial.