cyrilzakka/clinical-trials huggingface dataset:
Using Point-of-Care-Ultrasound (POCUS) to Assess Gastric Contents Among Fasting Pre-operative Patients Taking GLP-1 Agonists.

Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.


Eligibility Criteria:
Inclusion Criteria:

* GLP-1 agonist use within previous 30 days
* Appropriately fasted per standard guidelines

Exclusion Criteria:

* History of gastric surgery / gastric volume reduction
* Critical illness
* Inability to provide informed consent
* \<18 years of age
Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine in Asthma Patients

The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients whose control levels are partly controlled or uncontrolled.

Period: 2012-2013 Observation Time: 0 week, 4 week

Matters investigated:

1. QOL determination using SF-36 v2
2. Medication compliance (VAS scale)
3. Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma control, concomitant drugs, comorbidities, smoking, alcohol, work

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 20 years of age
* Outpatients
* Patients with mild or moderate persistent asthma
* Patients with phlegm
* Patients whose levels of asthma control are partly controlled or uncontrolled
* Patients who are planned to treat MUCODYNE
* Patients who voluntarily submitted written consent forms upon participation in this study

Exclusion Criteria:

* Patients with a history of adverse reactions to carbocisteine
* Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease
* Patients with the possibility of pregnancy or suspected pregnancy
* Patients with complication of malignancy
* Current smoker
* Patients with definitive diagnosis for COPD
* Other patients whom investigators or subinvestigators considered inappropriate to participate in this study
Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer

This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.

Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion Criteria:

-
Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia

The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged \> 18 years residing in Australia.
* Planned travel for 14 to 28 days starting in the next 30 days to selected countries in Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam.
* Willing to participate in the clinical study and available for all planned study activities through approximately 28 days post-travel.
* Access to a smartphone and mobile phone services while traveling (either by local SIM card, WiFi, or international roaming service on the individual's home-country mobile phone).

Exclusion Criteria:

* Unable or unwilling to provide adequate informed consent.
Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice

Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection. Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement about what antibiotic treatment that should be given. An RCT with the three most common antibiotics used, will support data for revision of national guidelines.

Comparison of phenoxymethylpenicillin, doxycycline and amoxicillin for Erythema migrans in Norwegian general practice. Every patient receives 14 days of antibiotic treatment. There are blood samples for measurement of Borrelia antibody level at day 1, 14 and 90 and questionnaires on subjective health complaints (SHC) at day 1, 90 and 360. Side symptoms and side effects are registered. For volunteers there is an additional PCR-analysis on punch biopsy from the EM for subgrouping of the Borrelia bacteria. TBE-antibodies are measured on day 14. Antibody levels and SHC-scores are compared to healthy blood donors.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Erythema migrans
* Over the age of 18
* Signing an concent form after information in writing

Exclusion Criteria:

* Allergic to any of the three drugs in the study
* Under the age of 18
* Pregnancy
* Dementia or known drug abuse
* Antibiotic treatment last 14 days
* Concommitant Chemotherapy or immunomodulating therapy
* Concommitant use of medicine with potential interaction (defined in protocol)
Strengthening Running Program in Novice Runners

The objectives of the study are comparing the risk of injury and the running performance among novice runners with two different training programmes. The first programme has less running volume but more strengthening than the second one which is a normal running programme with no specific strengthening program.

This study will provide necessary information for a multicentric study to come. The information needed for this bigger study are the sample size, the attrition rate, the drop-out rate and the feasibility of the timeline.

The objectives of the study are comparing the risk of injury and the running performance among novice runners with two different training programmes. The first programme has less running volume but more strengthening than the second one which is a normal running programme with no specific strengthening program.

Hypothesis: A training programme with less running but strengthening exercises based on interval technique and strength could have similar or better results regarding running related injuries and performance compared to a normal training programme.

The experimentation will take place in Louvain-la-Neuve in Belgium. Most of the common trainings will take place on the 400m outdoor track field of of the University. A sample of local university students will be drawned. The sex proportion of the participants should be representative of the population (non-runners population), thus 50/50. They will have to be non-runners in good and healthy condition. A non-runner is defined as someone who did not practice regular running at least twice a week for the last 6 months and could not perform a 10km at enrolment.

50 participants will take part in this experimentation. They will be randomized into 2 groups of 25. The investifator hypothesize that 40 participants will follow the study until the end.

Eligibility Criteria:
Inclusion Criteria:

1. they were between 18 and 30 years
2. matched our definition of novice runners
3. had not sustained a musculoskeletal injury in the past six months
4. agreed to subscribe to an online application and to report each running training on this platform.

A novice runner was defined as someone who has not been running more than once a week for more than six months. The participants were systematically excluded if they did not match the interval of age, were not considered as novice runners, i.e., ran twice or more times a week for more than six months

Exclusion Criteria:

* They were also excluded if they had sustained an injury in the last 6 months or suffered from any musculoskeletal or neurological disorders
Treatment of Hot Flushes in Breast Cancer Patients With Acupuncture

In a randomized 3-group clinical study acupuncture is used for the relief of menopausal hot flushes and sleep disturbances in women treated for breastcancer.

The three groups consists of 35 women given acupuncture once a week five times and 35 women given shamacupuncture once a week five times and 35 women with no kind of treatment. Se-estradiol and endorphin is measured before and after the acupuncture.

We want to state that acupuncture given five times once a week has a significant better effect on hot flushes and sleeping disturbances than shamacupuncture or no treatment at all.

We also want to measure if there are any changes in se-estradiol and endorphine

Breast cancer patients often have a higher prevalance of menopausal symptoms with hor flushes and sleeping disturbances than women in the general population, and hormone replacement therapy is not considered suitable for breast cancer patients because an increase in oestrogen is contraindicated.

There has been some evidence that acupuncture is suitable treatment for hot flushes and therefore we had a small pilotproject where 25 women treated for breast cancer were given a course of classical body acupuncture with one 15 min treatment session per week for 5 weeks. The effekt was remarkable.

We want to prove if this effekt is significantly better than shamacupuncture or to no treatment at all.

This is a prospective, randomized and doubbleblinded study:

35 women get classical body acupuncture once a week 5 times 35 women get shamacupuncture once a week 5 times 35 women get no acupuncture. Se-estradiol and se-endorphine will be measure before start of the first acupuncture and after the first and fifth acupuncture. The women with no treatment will have blodsamples too in the beginning and at the end of the fifth week.

Eligibility Criteria:
Inclusion Criteria:

* Women older than 35 years treated for breastcancer having hot flushes and sleeping disturbances.It is not allowed to take estrogen as tablets or plaster.

Exclusion Criteria:

* Failing to give consent
* Any use of estrogen as tablets or plaster
Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death

This study evaluates the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.

The subcutaneous ICD (S-ICD) is a system without transvenous leads that has been proven to safely provide defibrillation for patients at risk of sudden cardiac death due to ventricular tachyarrhythmias. However this system is currently not able to perform anti tachycardia pacing (ATP) which can terminate some VT, thus avoiding painful shocks.

Ideally slow VT should be managed with RF ablation while fast VT causing hemodynamic consequences should be treated with ICD shocks combined with medications. Typically, ICDs in secondary prevention patients are programmed to intervene at 10 msec at least above the clinical VT. In cases of hemodynamically stable VT this can result in unnecessary therapies and lead to ICD shocks. S-ICD can safely manage fast VTs while slower hemodynamically VTs can be managed with ablation.

This approach can avoid transvenous ICD related complications and unnecessary ICD interventions such as ATP which can accelerate VT to ICD shock zone. However, the benefit of this management strategy compared to conventional transvenous ICD programming has not been studied in patients who receive the device for the secondary prevention of sudden cardiac death.

Eligibility Criteria:
Inclusion Criteria:

* Any scar related sustained VT or VF
* Class I, IIa, or IIb indication for secondary prevention ICD therapy per ESC Guidelines
* Age ≥ 22 years on a date of consent
* LVEF ≤ 40%
* Positive ECG screening for S-ICD

Exclusion Criteria:

* A requirement for antibradycardia pacing or CRTD
* Subjects with an existing ICD, CRT, CRT-D, or pacemaker device.
* Contraindications for S-ICD implantation
* Contraindications for VT ablation
* Serious known concomitant disease with a life expectancy of \< 1 year
* Elderly patients \>80 years of age
* NYHA class IV or need for mechanical LV support (ECMO)
* Pregnancy or nursing
* Unwilling or unable to give informed consent
The Effect of Pneumoperitoneum on Intracranial Pressure in Pediatric Laparoscopic Surgery: Ultrasonographic Measurement of Optic Nerve Sheath Diameter

The pneumoperitoneum during laparoscopic surgery in pediatrics has the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study aims to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

1. pediatric patients (under 9 yrs) scheduled for undergoing laparoscopic surgery under general anesthesia

Exclusion Criteria:

1. Patients with previous history of neurologic disease or neurosurgery, ocular disease or ocular surgery
Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC, respectable NSCLC stage IIIa T1-2 N2 or or unresectable stage IIIb 2.KPS\>70% 3.Hb\>10g/dl,ANC\>2.0x109/L,Plt.\>100x109/L4.T-bil.\<1xULN,creatinine\<1xULN,creatinine clearance \>60 ml/min,GPT/GOT\<2.5xULN,ALP\<5xULN

Exclusion Criteria:

* 1.Brain meta.2..Prior surgery,R/T, C/t or immunotherapy for NSCLC
Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability

Background:

Around 15% of the global population has some form of disability. Rights to obtain proper health care is an emphasis in the United Nationals Convention on the Right of People with Disability. Due to the importance of improving vision health for people with disabilities, studies on how to identify vision problems becomes extremely important in policy formulation for all countries. Among all types of disabilities, people with intellectual disability (ID) are among the ones where vision problems are the hardest to detect.

Currently, no caregiver assessable scales are available, as a result, adults with ID are at high risk of delayed diagnose for common ocular conditions. Objectives: This is a one-year project.

The objective of this study is two folds:

1. To develop an item bank of ocular conditions of adults with ID;
2. To develop a scale for caregivers to detect ocular conditions for adults with ID, and to validate the reliability, construct validity and responsiveness of the scale.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20 and above
2. Primary caregivers for at least one adult with ID (have disability identification or (and) certification).

Exclusion Criteria:

1. Unable to communicate in Mandarin or Taiwanese.(Primarycaregivers)
2. Unable to cooperate with eye examination.(ID)
Ultrasound Evaluation of Uterine Healing After Vaginal Repair of Cesarean Scar Defect (CSD)

Cesarean scar defect is one of the complications after cesarean section (CSD). CSD may be further caused many long term complications, such as abnormal uterine bleeding, infertility, uterine scar pregnancy and uterine rupture. Vaginal repair due to CSDs is a minimally invasive and effective method that maintains fertility. The main concern linked to surgery is the quality of healing of the myometrial incision. However, no diagnostic method has yet been widely accepted to assess the healing process. Thus, the authors investigated uterine healing after vaginal repair with two-dimensional (2D) power Doppler ultrasound (PDU) in this study.

The inclusion criteria were CSD patients who had one or more cesarean deliveries, patients who had intermenstrual spotting after the cesarean section or those in which the thickness of the residual myometrium (TRM) was less than 3.0 mm at the preoperative stage.

Patients who had a history of endocrine disorders, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section were excluded from this study.

After vaginal repair, all patients were followed by traditional 2D US scanning and Doppler velocimetry on Days: 0, 2, 30, 60 and 90. Authors evaluated: scar diameter and Doppler velocimetry and resistance index (RI) of the uterine arteries, at their ascending branch.

Eligibility Criteria:
Inclusion Criteria:

1. have one or more cesarean deliveries,
2. have intermenstrual spotting after the cesarean section or TRM was less than 3.0 mm at the preoperative stage
3. underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery
4. have vaginal repair of CSD
5. write consent for operation.

Exclusion Criteria:

1. have a history of endocrine disorders
2. have coagulation disorders
3. use of intrauterine devices
4. have sub-mucous myoma
5. have endometrial diseases
6. have endometrial cysts, uterine fibroids, and adenomyosis
Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care

Rapid tests are increasingly used in medical practice, notably to screen for HIV. Their use has been associated with a faster linkage to care and lower rates of loss to follow up. Rapid tests are also well accepted by patients and clinicians.

No rapid test is currently approved in Canada for screening of hepatitis C. Hepatitis C diagnosis is done through based on blood testing and the screening algorithm may require up to 3 visits to clarify the hepatitis C status.

The Oraquick HCV test is a rapid test done on blood or saliva that can replace the first step of the regular screening algorithm. With this test the initial screening and the confirmation test can be done in one visit.

The primary endpoint of this pilot-project is to evaluate clinical characteristics of Oracquick HCV (sensitivity, specificity, positive and negative predictive values) and to compare them to those of the standard screening algorithm in a population of active or ex-users of injected drugs. The project also intend to evaluate if the rapid test can reduce the rates of loss to follow up and increase the linkage to hepatitis C specialized care. This last endpoint will be evaluated through phone call follow up 6 months after the screening.

One hundred and fifty patients will be included. Half will be tested with the standard algorithm and the Oraquick HCV test (group A) and half will be tested only with the standard algorithm.

Results of group A will be used to determine the clinical characteristics of Oraquick HCV. Results of groups A and B will be used to evaluate rates of loss to follow up, costs avoided by the use of the rapid test and linkage to care of infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Indication of hepatitis C screening
* Active or ex-injection drug user

Exclusion Criteria:

* Known hepatitis C infection
* Unknown HIV status and patient refusing to HIV testing
Drug Coated Ballon in Critical Limb Ischemia

Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)

Critical limb ischemia (CLI) is the most advanced stage of peripheral artery disease (PAD); which is estimated to affect more than 200 million people worldwide.(1) CLI classified as Rutherford category (RC) 4-6, includes ischemic rest pain and tissue loss.(2) The first line revascularization strategy for patients with CLI is endovascular percutaneous transluminal angioplasty (PTA).(3) The treatment of femoropopliteal lesions displays a huge anatomic challenge as this segment serves various biomechanical functions, Which makes endovascular treatment is challenging.(4) Plain balloon (PB) angioplasty for femoropopliteal artery disease has a high rate of procedural success and an acceptable safety profile, in spite of initially encouraging technical success after femoropopliteal (PTA), postprocedural restenosis remains the major challenge(5) Excessive extracellular matrix material synthesized by activated smooth muscle cells (SMC) in the media of the arteries leads to Neointimal hyperplasia and restenosis.(6) Restenosis resulting in loss of primary patency, late lumen loss (LLL), occlusion and/or the need for target lesion revascularization (TLR).(7) Drug-coated balloons (DCBs) inhibit the neointimal hyperplasia, the biological mechanism of restenosis formation, by application of cytostatic agents in a local therapeutic concentration.(8) The antiproliferative paclitaxel (PTX) seems to be the most effective therapeutic agent for DCBs due to local retention in the arterial wall.(9)

Eligibility Criteria:
Inclusion criteria:

* Adults at least 18 years of age with critical lower limb ischemia (Rutherford category 4, 5), stenotic (≥70% by visual angiographic assessment) or occlusive lesions in the native SFA or PPA, and vessel diameter ≥4 and ≤6 mm were eligible.
* Total lesion length ≤190 mm (visual angiographic assessment).
* DE novo angioplasty
* Recurrent or recoil lesion

Exclusion criteria:

* pregnancy
* breast feeding
* iliac lesions
* Malignancy
* Patients with raised renal chemistry.
* Patients with contraindication to antiplatelet therapy.