cyrilzakka/clinical-trials huggingface dataset:
MisOpRostol Effect on Second Trimester Abortion Blood Loss

Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described.

We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care. Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. A quantified blood loss (QBL) will be measured during the procedure and participants will complete a survey to assess symptoms. Our primary outcome is quantified blood loss. Secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant people, 18 years of age or older; intrauterine pregnancy between 18/0-23/6 weeks of gestational age (by ultrasound dating performed prior to same day of enrollment visit) consented for an induced abortion; English or Spanish speaking, able to consent for a research study, literate in English or Spanish.

Exclusion Criteria:

* known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.
Ultrasound-guided Versus Blind Technique in Medial Brachial Cutaneous Nerve and Intercostobrachial Nerve Blocks

The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow. The anesthesia of the posterior and the medial side of the arm requires a selective block of the medial brachial cutaneous nerve and the intercostobrachial nerve, for example to improve the tolerance of the inflatable tourniquet used by the surgeons. There are two techniques to achieve this block : the blind technique (without ultrasound) and the ultrasound-guided technique. At the moment, there are no studies which compare these two techniques. So, the purpose of this study is to determine the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercostobrachial nerve block, in the axilla.

For purposes of this single-blind monocentric study, 84 patients are randomized into two groups (42 patients for each), upon enrolment into the study.

In the first group, the blind technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : it consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.

In the second group, the ultrasound-guided technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.

The aim is to evaluate the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercosto-brachial nerve block, in the axilla

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years
* Surgery of the distal upper limb : hand, forearm, lower third of the arm ,including the elbow
* Urgent or planned surgery
* Locoregional anesthesia : axillary brachial plexus block, completed by a medial brachial cutaneous nerve block and an intercostobrachial nerve block
* Local anesthetic used : mepivacaine 10mg/ml
* In the absence of patient objections

Exclusion Criteria:

* Pregnancy
* Adults under guardianship
* Locoregional anesthesia contraindications
* Local anesthetic used : ropivacaine 0,75%
Aligning With Schools To Help Manage Asthma (Project ASTHMA)

Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.

Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All students will receive NHLBI guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. The asthma assessment will include spirometry testing. All enrolled students and parents will receive asthma education at the time of enrollment. Eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by SBHCs. In collaboration with the student's PCP, the SBHCs' mid-level providers will prescribe the preventive medication to the students in the intervention group. These students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. Students and their parents will be responsible to administer the evening and non-school day doses. Students randomized to the usual care group will be referred back to their PCP for further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.

Eligibility Criteria:
Inclusion Criteria:

* Active asthma
* Diagnosed with asthma for at least 12 months
* Enrolled in the school-based health center
* Persistent asthma as defined by NAEPP-EPR3 guidelines OR at least 1 hospitalizations OR at least 2 ED/urgent care visits OR at least 2 courses of oral steroids for asthma in the previous 12 months for asthma

Exclusion Criteria:

* Underlying heart or lung disease other than asthma
* Student has well controlled asthma
Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)

Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve patients with hepatitis C
* Patients treated with PegIntron pen and Rebetol
* Patients receiving patient assistance program

Exclusion Criteria:

* Not applicable
A Prospective Post-Marketing Observational Safety Study of Verzenios® (Abemaciclib) Among Breast Cancer Patients in China Verzenios® (Abemaciclib) Among Breast

This PMSS is a single-country, prospective, observational study primarily designed to estimate the incidence of AEs and SAEs among Chinese patients with breast cancer after receiving Verzenios® over a period of approximately 24 weeks in a routine clinical practice. According to the pivotal studies (MONARCH 2, 3 and MONARCH plus), the most frequent treatment-emergent adverse events (TEAEs) generally reported occurred at an early time (within 28 days after treatment initiation) point during treatment (Dickler et al. 2017); hence, each patient enrolled in the study will have the first follow-up visit at 4 ± 1 weeks after the first abemaciclib treatment for regular safety monitoring. Since most reported TEAEs occur within 6 months, patients will return to the clinic after receiving Verzenios for 6 months to carry out the routine effectiveness evaluation in the normal clinical practice setting. The observational duration for primary objective is set as 24 ± 4 weeks. Moreover, the effectiveness related variables including ORR, DCR, EFS rate, and OS rate, if available, will be investigated as the secondary objectives of the study and patients will be followed for 24 ± 4 weeks and up to 2 years (only for EFS rate and OS rate) after initiation of Verzenios. Approximately 30 hospitals across China are planned for participation in this study. This study plans to enroll approximately 1500 patients (detailed in Section 9.5) and both safety and effectiveness of Verzenios will be evaluated. The observation period for each patient will be either until the last Verzenios treatment (if patients discontinue Verzenios before the follow-up duration of 24 weeks for safety and effectiveness \[EFS rate and OS rate will be assessed at 52 weeks and 104 weeks\], 30 days follow-up will be carried out for safety events), or follow-up discontinuation (for example, death), whichever comes first. Visits will be performed at baseline (baseline visit), 4 weeks (Visit 1), 12 weeks (Visit 2), and 24 weeks (Visit 3) of treatment for safety and effectiveness assessments. Follow-up visits will be performed at 52 weeks (Visit 4) and 104 weeks (Visit 5) of treatment for OS rate assessment.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old at enrolment
* diagnosed with HR-positive, HER2-negative breast cancer
* prescribed with Verzenios by the investigators and started (or planned to start shortly) Verzenios treatment in the routine care of the patient
* provide written consent to the release of their data after being informed of the study.

Exclusion Criteria:

* have been administered Verzenios before study enrollment
* are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
* are pregnant or breastfeeding or intend to become pregnant within the duration of the study
* contraindicated for the use of Verzenios according to the China approved label.
Patient Satisfaction With Propofol for Out Patient Colonoscopy

The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.

Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed.

Patients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.

Eligibility Criteria:
Inclusion Criteria:

- Patients having an outpatient colonoscopy

Exclusion Criteria:

- High risk patients (ASA IV \& V) who are not candidates for colonoscopy in an outpatient center will be excluded.
Use of the French Healthcare Insurance Database

Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).

Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths). This cancer is closely associated with the presence of chronic liver underlying disease and early diagnosis following a systematic surveillance of cirrhotic patients could improve disease-free survival in patients declaring HCC. However, the risk-benefit ratio of such monitoring is discussed. Nevertheless, it is recommended in patients with liver cirrhosis, from which the prevalence is estimated between 0.3% and 0.6% in the French population. This debate can lead to a failure to comply with recommendations and promote a large variability in the management of the surveillance of HCC in patients with cirrhosis in practice. Data acquisition regarding the current situation in France is required.

The objective of this project is to use this database to document current practices concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The primary analysis will focus on multivariate modelling of the deviation rate from the recommendations (advising the realisation of at least two echodoppler ultrasonographies yearly) with a competitive risk model, taking into account gender, social status, Charlson index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly number of visits to a hepatologist during follow-up. It is estimated that more than 86,000 patients with a minimum follow-up of 3 years will be included in the analysis

Eligibility Criteria:
Inclusion Criteria:

- Cirrhotic patients aged between 18 and 75 years.

(A cirrhotic patient will be defined as a presenting a first occurrence of a codes used in hospitalisation for cirrhosis or as a motive for granting an ALD 6 (cirrhosis motivated) financial support )

Exclusion Criteria:

- None
Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy

The purpose of this study is to evaluate a multimodal analgesic protocol used in minimally invasive surgery for myomectomies (laparoscopic myomectomy (LM) and laparoscopically assisted myomectomy (LAM)).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic intramural and or subserous myomas
* ASA score 1-2
* Without contraindication to nonsteroidal anti-inflammatory agents
* Patients have to be able to understand and follow medical instructions
* They need to have satisfactory hygiene and accommodation conditions
* They have to live not more than 2 hours away from the department
* Easy telephone contact is required

Exclusion Criteria:

* Ovarian disease
* Previous medical treatment for ovarian suppression, pregnancy, abnormal Papanicolaou (Pap) test smear or hyperplasia (with or without atypia) in case of endometrial biopsy
Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing

What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years?

Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been reported from several European countries including the UK. This can result in poor symptom control and increased risk of asthma related deaths.

It has been suggested that both under- and over- diagnosis of childhood asthma in general practice could be improved by routinely using objective lung function testing for diagnosis and monitoring.

The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements - eNO) are already used routinely in UK hospitals, but are not usually available in general practice where most children are cared for.

Why is it important? - Availability of these tests will help health professionals in general practice to look after children with asthma better, and hopefully improve asthma control.

What will this study achieve? - Though it is believed that providing spirometry and eNO in general practice would be beneficial, there is little data on how this can be achieved. This study will employ both qualitative and quantitative measures in order to evaluate the resources required to implement routine spirometry and eNO testing for children in primary care; and to investigate the impact this would have on diagnosis in children with suspected asthma.

How? - The investigators will work with general practices in and around Leicestershire, UK. Firstly, to identify what the barriers are to implementing these tests, and secondly to train the practices to perform and interpret spirometry and eNO independently in children.

Children with suspected or previously diagnosed asthma will be invited for review and lung function testing. The investigators will record the time it takes to train general practices to perform and interpret spirometry and eNO independently, and the additional clinic capacity required to provide these tests.


Eligibility Criteria:
Inclusion Criteria:

1. On the practice asthma register or
2. Are prescribed regular (on repeat prescription) inhaled corticosteroids including beclometasone, fluticasone and budesonide and also search specifically for 'brands' that are commonly prescribed to include 'clenil', 'seretide', 'symbicort', and 'qvar' or
3. Have been prescribed ≥ 2 Salbutamol MDI's in the last 12 months or
4. Had a documented exacerbation of asthma in the last 12 months
5. Able and willing, in the opinion of the Investigator, to give informed consent

Exclusion Criteria:

1. Children who are unable to perform lung function tests for any reason
2. Children and young people \<5 years and \>16 years
3. Unable or unwilling, in the opinion of the Investigator, to give informed consent
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.

Studies have shown that approximately 50 % of older obese males, who are being treated for diabetes mellitus type 2, also exhibit low testosterone levels. Hypogonadism negatively affects glycemic control, exacerbates early cardio-vascular disease, causes osteoporosis, erectile disfunction, reduces lean body mass, accelerates the accumulation of visceral fat and leads to obesity.

Patients with diabetes mellitus type 2 and confirmed hypogonadism were enrolled into this randomized, double-blind, placebo-controlled clinical study. Placebo group patients were receiving placebo throughout the first year of this study and Testosterone group patients were receiving testosterone undecanoate during first year. Both groups were receiving testosterone undecanoate throughout the second year of this study.

Eligibility Criteria:
Inclusion Criteria:

* men aged \> 35 years
* body mass index \> 30 kg/m2
* confirmed hypogonadism
* type 2 diabetes mellitus treated with non-insulin therapy

Exclusion Criteria:

* previously treated hypogonadism
* the 2 diabetes mellitus treated with insulin therapy
* a history of current prostate or breast cancer
* severe benign prostatic hyperplasia
* elevated prostate-specific antigen (PSA \> 4.0 lg/l)
* severe heart failure
* acute coronary event or procedure during the six months leading up to the study
* chronic obstructive lung disease
* hypothyroidism
* severe obstructive sleep apnea (OSA)
* active infection
* rheumatoid arthritis
Effect of Physiological Ischemic Training on Patients With Atherosclerosis

To study whether the resistance training with blood flow obstruction in patients in early atherosclerosis period can produce a beneficial effect on preventing atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. LDL \> 3.11mmol/l and less than 5.63mmol/l;
2. No serious heart, blood vessel and other related diseases;
3. There were no skeletal and muscular diseases affecting sports training;
4. No regular exercise in the past half year (no more than 2 times a week, no more than 30 minutes each time);
5. Smoking less than 1 pack / year, no history of drinking.

Exclusion Criteria:

1. Haven't other serious heart and vascular diseases other than hyperlipidemia and / or bones and muscles that affect sports training Diseases;
2. Pregnant women and people with disabilities;
3. Other circumstances determined by the researcher not suitable for the study.
Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)

Exclusion Criteria:

* previous allergic reactions to the study medications,
* history of gastrectomy,
* use of antibiotics within the previous 4 weeks,
* pregnant or lactating women,
* coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).