cyrilzakka/clinical-trials huggingface dataset:
Phase III Study Treatment of CLL B and C

GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in case of response. Experimental arm consisted of high dose therapy with autologous CD34+ purified progenitor cell support, used as consolidation of Complete Remission or Very Good Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses of fludarabine in case of insufficient response.

The aim of the prospective randomized GOELAMS LLC 98 trial reported here was to compare two therapeutic strategies in previously untreated B and C Binet stages B-CLL patients less than 60 years old. Conventional chemotherapy (Arm A) consisted of six monthly courses of CHOP, i.e. vincristin IV 1 mg/m2 on day 1, doxorubicin IV 25 mg/m2 on day 1, cyclophosphamide (Cy) 300 mg/m2 and prednisone 40 mg/m2 both given orally from day 1 to day 5, followed by 6 CHOP courses every other 3 months in case of response. Fludarabine (25 mg/m2 /d IV for 5 consecutive days) was used in case of non response (stable disease or progression) after 3 CHOP courses. This conventional therapy was compared to high dose therapy with autologous CD34+ purified progenitor cell support (Arm B), used as consolidation of Complete Remission (CR) or Very Good Partial Response (VGPR, defined by \>50 % tumoral response and bone marrow lymphocyte infiltration \<30%) obtained after 3 monthly courses of CHOP. In the absence of CR or VGPR, 3 to 6 monthly-courses of fludarabine were performed before mobilization with Cy 4 g/m2 + G-CSF administration. The conditioning regimen included TBI 12 Gy and Cy 60 mg /kg /d for 2 days.

Eligibility Criteria:
Inclusion Criteria:

* CLL with Lymphocitis \> 15.10 9/L
* B-CLL stage B or C
* Patients \> 18 years old and \< 60 years old
* No previous treatment of CLL
* ECOG performance status \< 2
* Good cardiac function
* Patient's written informed consent

Exclusion Criteria:

* B-CLL stage A
* Age \> 60 years old
* previous treatment of CLL
* ECOG performance status \> 2
* Cardiac or pneumo Insufficency
* hepatic or renal Insufficency
* Seropositivity HIV
* Previous other malignancy
* Fertile male and female patients who cannot or do not wish to use an effective method of contraception
* Any coexisting medical or psychological condition that would preclude participation to the required study procedures
* NOt signed Patient's informed consent
The Effects of Lowering Dietary Carbohydrates on Health, Exercise Performance and Wellbeing-related Outcomes

The aim of the study is to investigate the long-term effects of the ketogenic diet and exercise (including interactions) on health markers, exercise performance and wellbeing outcomes in sedentary overweight individuals.

Intentional nutritional ketosis induced by the low carbohydrate diet is an intensively discussed topic of many scientific as well as non-scientific discussions throughout the areas of healthy living, the sports sciences and often used now for the prevention and treatment of chronic diseases. It has been demonstrated that long-term low-carbohydrate diet is more effective for weight loss and cardiovascular and metabolic risk factor reduction than a low-fat diet. In light of conflicting theories of best practice surrounding a polarized topic that impacts human health and daily work performance, the primary aim of this research project is to examine how low-carbohydrate ketogenic diets affect health markers, exercise performance and wellbeing outcomes in sedentary overweight individuals. Each study subject will be randomized into one of the four arms of the study and will undergo a 12-week intervention, with the exception of the study subjects in the control group, who will undergo no intervention for the period of 12 weeks.

The project outcomes are of immense importance for the investigator's global human health, focus on a unique holistic perspective and have the potential to contribute towards much-needed adjustments in public health recommendations.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25.00 - 40.00 kg/m2
* non-smokers
* non-excessive alcohol intake (self-reported, ≥ to 2 drinks/day for men or ≥1 drink/day for women)
* willing to accept random assignment
* low active individuals over the last 1 year, i.e. no specific sports training or regular exercise (up to once a week) and self-reported physical activity \< 150 min/week (IPAQ)
* no evidence of liver, renal, metabolic, and cardiopulmonary disease and dis-eases contraindicating physical activity, no cancer, no psychiatric illness
* Physical Activity Readiness Questionnaire (PAR-Q) pass
* body weight stable for the last 2 months and not actively on a weight loss plan
* prediabetes state allowed (impaired fasting glucose level, i.e. 5.6 - 6.9 mmol/l; HbA1c 5.7 - 6.4 %)

Exclusion Criteria:

* pregnancy, lactation
* any specific diet (e.g. vegetarian)
* use of hypoglycemic, lipid-lowering, antihypertensive, psychiatric medications or medications known to affect body weight or energy expenditure; any medication not noted allowed if the individual had been stable while taking such medication for at least 3 months prior to baseline data collection
The Effectiveness of PACE Label on Reducing Food Consumption and Increasing Physical Activity Levels

Background: More people are at the risk of chronic disease as the prevalence of obesity increases. It is therefore essential to find ways of helping consumers to make a lower calorie food choice. Current evidence indicates that current food labelling is changing food choices and consumption, but it is of limited effectiveness. Purpose: The purpose of this study is to assess the efficacy of physical activity calorie equivalent (PACE) food labelling on food selection and consumption using a randomised experimental design in pop-up café. Method: This study as a randomised controlled experimental trial (RCT) was conducted in a research kitchen at Loughborough University. Participants were blinded to the exact purpose of the study and randomised to either exposure to PACE labelling plus calorie food labelling or calorie labelling only and asked to select food/drinks for their consumption, in the pop-up café up to a maximum value cost of £10. The study outcomes were the amount of money spent, the number of calories selected, and the amount of food consumed after exposure to the two different types of food labels.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* healthy

Exclusion Criteria:

* allergic to the foods in the pop up café
* chronic disease such as insulin-dependent diabetes
* BMI lower than 16 kg/m2.
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine

To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects on the pharmacokinetics (PK) of tolterodine and its metabolites.

In addition, the safety of these products will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of two years after menopause
* Body weight (at screening) ≥ 40.0 kg and \< 70.0 kg
* Body mass index (BMI) (at screening) ≥ 17.6 kg/m2 and \< 26.4 kg/m2
* Healthy, as judged by the investigator/sub-investigator based on medical history and the results of physical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission (at single dosing phase) to immediately before study medication.

Exclusion Criteria:

* Received or scheduled to receive any investigational drugs in other clinical trials, post-marketing studies, or clinical studies within 120 days before the screening or during the period from the screening to hospitalization (Day -2).
* Donated or scheduled to donate 400 mL of whole blood within 90 days before the screening or during the period from the screening to hospitalization (Day -2), 200 mL of whole blood within 30 days before the screening or during the period from the screening to hospitalization (Day -2), or blood components within 14 days before the screening or during the period from the screening to hospitalization (Day -2).
* Any deviation of the laboratory tests at screening or hospitalization (Day -2).
* A deviation from the normal range of blood pressure, pulse rae, or body temperature at screening or hospitalization (Day -2) Supine blood pressure: Systolic blood pressure: ≥90 mmHg, ≤140 mmHg, Diastolic blood pressure: ≥40 mmHg, ≤90 mmHg Supine pulse rate; ≥40 bpm, ≤99 bpm Axillary body temperature; ≥35.0°C, ≤37.0°C
* History of drug allergies
* Upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before hospitalization (Day -2)
* Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury, and hepatic impairment)
* Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment)
* Concurrent or previous GI disease (e.g., ileus paralytic, gastric atony, intestinal atony, colitis ulcerative, peptic ulcer and gastroesophageal reflux esophagitis; except for a history of appendicitis).
* Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)
* Concurrent or previous endocrine disease (e.g., hyperthyroidism and blood growth hormone abnormal)
* Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
* Previous use of mirabegron or tolterodine
* Excessive smoking or drinking habit
A Study of BKM120 in Adult Japanese Patients With Advanced Solid Tumors

In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
2. At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.
3. Age ≥ 20 years
4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
5. Life expectancy of ≥ 12 weeks
6. Patients must have the laboratory values

Exclusion Criteria:

1. Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
2. Prior treatment with a PI3K inhibitor
3. Patients with any peripheral neuropathy ≥ CTCAE grade 2
4. Patients with unresolved diarrhea ≥ CTCAE grade 2
5. Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply
Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass

The hypothesis of this study is that surgical techniques primarily designed for weight loss, ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

Therefore the present study intends to evaluate such impact on patients submitted to two of the most common techniques available, the Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy.

In order to determine if weight loss surgeries do indeed ameliorate GERD in morbidly obese patients, esophageal syndromes will be evaluated following the Montreal Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.

Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH \< 4 for at least 4% of its total monitoring time.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 Kg/m2, or BMI \> 35 Kg/m2 along with clinical comorbidities (such as Diabetes Mellitus, Systemic Arterial Hypertension or Articular Lesions)
* Been unable to loose or sustain weight loss after 2 years medical and nutritional treatments.

Exclusion Criteria:

* Been previously submitted to any gastroesophageal surgical procedure
* Presence of chronical diseases that affects esophageal motility
* Do not tolerate any of the required exams
pMDT in Thoracic Surgery--The Process Implementation Stage

The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the thoracic surgery department of Peking University People's Hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

The postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that occurs immediately after surgery, and its nature is traumatic pain. It may develop into a chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at the initial state. It will seriously impact the physiology and psychology of a patient. According to the study, the postoperative acute pain is one of the risks for postoperative complications, and it may result in the death of a patient. However, the alleviation of a postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall cost for treatment of a patient.

The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the thoracic surgery department of Peking University People's Hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75, ASA I-II;
* Patients undergoing thoracoscopic surgery;
* Patients who can understand and fill in the self-evaluation;
* Patients who signed the Informed Consent Form.

Exclusion Criteria:

* Pregnant women;
* Patients with preoperative chronic pain and long-term opioid use;
* Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.
Comparative Effects of Two Conservative Treatments in Teres Major in Handball Athletes With Shoulder Pain

The aim of the study is to investigate the effects of the dry needling technique and diacutaneous fibrolysis technique in teres major muscles on pain, range of motion, strength extensibility and muscular properties of the soft tissues of the shoulder in athletes with shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Athletes with Shoulder pain
* Glenohumeral internal rotation deficit
* Presence of active MTrP in the teres major muscle

Exclusion Criteria:

* Previous surgery in the upper limb
* Previous physiotherapy treatments in the shoulder
* Dry needling contraindications
* Previous dry needling experience to mantain the blinding
Daily Disposable Contact Lens Tear Film Study

The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Be of legal age of consent and sign Informed Consent document.
* Willing and able to wear spherical contact lenses for 16 hours.
* Willing and able to wear spherical contact lenses within the available range of powers.
* Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality.
* Any use of systemic medications for which contact lens wear could be contraindicated.
* History of refractive surgery or irregular cornea.
* Currently enrolled in any clinical trial.
* Eye injury within twelve weeks prior to enrollment.
* Other protocol-defined exclusion criteria may apply.
The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

The study aims to:

1. Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE).
2. Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.

Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney.

Exclusion Criteria:

* Patients who are allergic to fluorescein sodium
* Patients who are unwilling to sign or give the informed consent form
* Patients with impaired cardiac, liver or renal function
* Patients with coagulopathy
* Patients with pregnancy or breastfeeding
Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]

Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.


Eligibility Criteria:
Inclusion Criteria:

* patients with tumoral obstruction of the distal biliary tract that have been treated by an EUS-CDS with a electrocautery enhanced LAMS

Exclusion Criteria:

* \< 18 years old
* refusal to participate
Advance Care Planning: Communicating With Outpatients for Vital Informed Decision

This Pre-Post, open-cohort design, pragmatic trial with 150 clinicians and will evaluate the effectiveness of the use of telehealth Advanced Care Planning (ACP) Program by comparing ACP documentation among 13,000 patients over 65

This study is investigating if the use of telehealth ACP Program will improve and sustain rates of ACP from the time that the intervention is implemented compared to two time periods prior to the intervention. The Comprehensive ACP Program combines two widely disseminated interventions to assess impact when used concurrently.

* One is VitalTalk clinician communication skills training (www.vitaltalk.org) during which the primary care clinicians will practice ACP with simulated patient actors under the guidance of a trained VitalTalk facilitator.
* The second is the ACP Decisions video decision aids (www.acpdecisions.org) which are directed to patients and provide education about ACP. This inclusive ACP approach treats patients and clinicians as equal stakeholders providing both with the communication skills and tools needed to make decisions about COVID-19 medical care before the toughest choices arise.
* The training is four cumulative hours, most of which is spent in communication skills work, and the remainder learning how to introduce the videos into one's practice. No patients participate in the training. The ambulatory practices included in this intervention gain access to the ACP Decisions videos, which can be introduced to patients. Videos may be seen in clinic or sent to patients' homes via an electronic or paper code.
* We will recruit up to 30 clinicians from participating clinics who completed the intervention training and ask them to complete a qualitative interview to learn about their experience with the ACP intervention.

Eligibility Criteria:
Inclusion Criteria:

* Clinic Eligibility: Clinics affiliated with Northwell Health may be included in the study.
* Clinician, Staff Eligibility: Any staff member identified by the site-PIs are affiliated with Northwell Health.
* Patient Eligibility: To be eligible for this study, individuals must be aged 65 or over, affiliated with the Northwell Health clinic. For each of the three periods of the study, those patients over the age of 65 who are engaged (e.g., seen in person, telehealth, etc.) with the clinic during that time period will be included in that time period

Exclusion Criteria:

* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.


Eligibility Criteria:
Inclusion Criteria:

* Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.

Exclusion Criteria:

* Serious, acute, or chronic illnesses are reasons for exclusion.