cyrilzakka/clinical-trials huggingface dataset:
Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer

Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of SCLC.
* First recurrence of SCLC after therapy with one prior chemotherapy regimen at initial diagnosis.
* Relapsed SCLC of any duration (both sensitive and resistant relapse).
* ECOG performance status of \</= 2.
* Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.
* No prior therapy with bevacizumab or any other VEGF inhibitor or topotecan

Exclusion Criteria:

* Uncontrolled emesis, regardless of etiology.
* Active uncontrolled infection.
* GI conditions or drugs that could impact absorption of oral topotecan.
* Known hypersensitivity to any component of topotecan capsule or compounds chemically related to topotecan.
* Uncontrolled hypertension with BP\>150/100.
* Prior h/o hypertensive crisis or encephalopathy.
* NYHA Grade II or greater congestive heart failure.
* H/O myocardial infarction within 6 months.
* H/O stroke or TIA within 6 months.
* H/O thrombotic or hemorrhagic disorders.
* Clinically significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days.
* Anticipation of need for major surgical procedure during the study.
* Minor surgical procedures within 7 days prior to treatment start (placement of vascular access devices is permitted).
* H/O abdominal fistula, GI perforation, or intra-abdominal abscess within prior 6 months. Serious, non-healing wound, active ulcer, or untreated bone fracture. - H/O hemoptysis within prior 1 month.
* Concurrent radiotherapy.
* H/O whole lung radiation within 90 days prior to start of treatment.
* Presence or h/o central nervous system or brain metastases.
* H/o another malignancy other than SCLC.
* Concurrent chemotherapy, immunotherapy, or investigational therapy for the treatment of small cell lung cancer.
Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis

OBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving interferon gamma in combination with calcitriol to the rate of treatment failure in patients receiving calcitriol alone.

II. Compare the number of adverse events or clinical manifestations of disease progression occurring in these patients.

III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and rate of infection in these patients.

PROTOCOL OUTLINE: This is a randomized, placebo controlled, open label study. Patients are randomized to one of two arms (interferon gamma in combination with calcitriol or calcitriol alone).

Arm I: Patients receive calcitriol once daily. Interferon gamma is administered by subcutaneous injection three times a week.

Arm II: Patients receive calcitriol once daily. Patients may continue treatment in the absence of toxicity and disease progression. If disease progression is diagnosed in the control group, patients will then receive interferon gamma in combination with calcitriol.

Patients are followed every 4 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Biopsy and x-ray confirmed primary osteopetrosis
* Presence of anemia and/or cranial nerve compression

--Prior/Concurrent Therapy--

* Biologic therapy: No prior/concurrent bone marrow transplantation No prior interferon gamma No other investigational biologic agents
* Chemotherapy: No prior/concurrent chemotherapeutic agents for bone marrow transplantation
* Endocrine therapy: Prior/concurrent corticosteroid as supportive therapy allowed
* Radiotherapy: Not specified
* Surgery: At least 5 days since major surgery
* Other: Prior/concurrent calcitriol as supportive therapy allowed Prior/concurrent transfusion as supportive therapy allowed Prior/concurrent dietary therapy allowed

--Patient Characteristics--

* Age: 2 months to 10 years
* Performance status: Not specified
* Life expectancy: At least 6 months
* Hematopoietic: Not specified
* Hepatic: Bilirubin less than 2 mg/dL
* Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min
* Pulmonary: No uncorrected airway obstruction
* Other: No active infection requiring intravenous antibiotics No known seizure disorder not related to hypocalcemia No uncorrected hydrocephalus No MRI evidence of cerebral atrophy Must maintain or gain body weight No sleep apnea No thrombocytopenia No massive splenomegaly
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)

This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.

This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI \> 85%.

The intervention group will:

* have baseline and follow up blood work (fasting insulin, glucose, lipid panel)
* have baseline and follow up BMI, blood pressure measurements
* see a dietician-minimum of three visits during study
* attend monthly, four hour sessions. These sessions include:

  1. registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power)
  2. one hour of exercise (including strength training)
  3. educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
  4. projects/games
  5. empowerment tools such as leading exercises and presenting food labels for discussion

The control group will have:

1. baseline and follow up blood work (fasting insulin, glucose, lipid panel)
2. baseline and follow up BMI and blood pressure measurements
3. visits to dietician (minimum of three visits during study)
4. standard education on nutrition and exercise given during office visit with primary care doctor

Eligibility Criteria:
Inclusion Criteria:

* Ages 10-20 years
* BMI\>85%

Exclusion Criteria:

* Endocrine disorder
* On psychotropic medications
Inspiratory Muscular Training

Objectives: To evaluate regional lung ventilation distribution in patients suffering from chronic heart failure (CHF) after completing inspiratory muscle training (IMT) and correlate it with functional capacity and quality of life among these individuals. Methods and Results: Nineteen CHF patients were randomly assigned to two groups: Control and IMT. Before and after muscle training, subjects were submitted to assessment protocol for respiratory muscles, digital spirometry, optoelectronic plethysmography (OEP), the six-minute walk test (6MWT) and a quality of life questionnaire (MLHFQ). There was no difference in lung function following the 12-week training period in either group. However, the IMT group showed an increase in actual and predicted MIP, higher MLFHQ score and greater distance walked in the 6MWT, as well as a reduction in the Borg scale after the 6 MWT in relation to the control. For the OEP, IMT group members exhibited higher values for total chest wall volume (Vcw), abdominal rib cage volume (Vrc,a) and abdominal volume (Vab) when compared to the control. Conclusions: For patients with CHF, IMT proved efficient in improving muscle strength, functional capacity and quality of life. The present study also analyzed the distribution behavior of lung volumes for the thoracoabdominal system in this population, showing that larger abdominal rib cage and abdomen volumes may result in more effective diaphragmatic contraction.


Eligibility Criteria:
Inclusion Criteria:

* sedentary adults diagnosed with functional class II and II CHF in accordance with the New York Heart Association (NYHA);
* in stage B or C according to American College of Sports Medicine guidelines;
* with left ventricle ejection fraction lower than 45% (evaluated by echocardiogram in a period ≤ 1 year);
* cardiomegaly confirmed by increased left ventricle end-diastolic (LVDD) and end-systolic diameter (LVESD) associated with a cardiac index (CI) \>0.5 according to chest X-rays;
* inspiratory muscle weakness (MIP \<70% of predicted values);
* clinical stability with no change in medication for at least three months and sedentary (no regular physical activity performed in the previous six months or not accumulating 30 minutes or more of moderate physical activity - 3 to 6 METs - on most week days).

Exclusion Criteria:

* patients exhibiting unstable angina, myocardial infarction or prior heart surgery up to three months before beginning the investigation;
* orthopedic, infectious or chronic metabolic diseases;
* treatment with steroids, hormones or chemotherapy;
* ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC) \< 70% of predicted, characterizing an obstructive respiratory disorder;
* respiratory diseases, smokers and ex-smokers with a history of cigarettes/day for more than 10 years.
The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study

This protocol is intended to test whether a focused nutritional intervention in hospitalized patients with type 2 diabetes can have an impact on long term eating habits, physical activity and anthropometric parameters.

The rational is to use the food tray as a means of conveying simple and practical nutritonal and behavioral messages.

Patients hospitalized at Hadassah Medical Center who have type 2 diabetes will relieve a focused nutritional intervention using mainly the food tray during the hospitalization. The intervention will be administered by the hospital nutrition team.

At baseline (upon admission) - medical data will be collected as well as nutritional and behavioral questionnaires will be administered. The intervention will take place during the hospitalization period. Follow up using the same tools will be performed at 3 and 12 month.

We believe that the hospitalization period, even for reasons non related to diabetes, is a window of opportunity to implement lifestyle changes.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years
* Diagnosis of type 2 diabetes
* Speaking and reading Hebrew

Exclusion Criteria:

* Chronic medical condition requiring a specific diet
* Non Hebrew speaking
* Pregnant women
Prospective Quality Register of Patients With Confirmed Covid-19 at Oslo University Hospital

Covid-19 is a recently emerging infectious disease with a very large impact on health care world-wide. The disease is still poorly described. It is an urgent need for better clinical characteristics. A prospective, quality register is therefore established for increasing the knowledge about the disease, the covid patients and the prognosis.

All patient hospitalized at Oslo University Hospital, Ullevål, is prospectively registered in the approved quality register. Background, clinical and paraclinical data is harvested and registered, as well as treatment and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed covid-19
* hospitalized

Exclusion Criteria:

* None
Electroacupuncture Analgesia for EUS: a Randomized Controlled Trial

Endoscopic ultrasound (EUS) has evolved to become an important diagnostic tool and its interventional role is rapidly expanding. In order to improve patient's comfort and satisfaction during and after procedure, the use of sedation is usually recommended. However, sedation may be associated with serious adverse events of including hypotension, aspiration and respiratory depression. Moreover, the cost of performing the procedure would be increased due to the costs of the medications and the need of additional personnel in monitoring of the patient. As a result, the drive to seek alternative and safer approaches of pain-relief during EUS is ever present. Electroacupuncture (EA) has been used in Traditional Chinese Medicine (TCM) for more than 2000 years. The benefits and success of EA in treatment of acute and chronic pain of various origins have been well-recognised. Many researches have been performed to address the role of EA in treating pain and anxiety during OGD and colonoscopy. However, only limited data is availabe in the Chinese and the Western literature concerning the use of EA in EUS. Therefore it is worthwhile to conduct a well-designed study to evaluate the role of EA in treating pain during EUS.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients (aged between 18 and 80 years) undergoing first-time elective day-case EUS, patients with American Society of Anesthesiologists (ASA) grading I-II, and informed consent available.

Exclusion Criteria:

* Patients with previous experience of acupuncture, patients with coagulopathy, patients with previous history of upper gastrointestinal surgery, patients who are diagnosed with irritable bowel syndrome according to Rome III criteria, 12 patients with chronic pain syndrome, patients with psychiatric disorder, patients with poor cognitive function, patients with renal impairment, patients with obstructive sleep apnea syndrome, patients with cardiac arrhythmias, patients with cardiac pacemaker, patients who are pregnant, and patients who are allergic to the acupuncture needles or Propofol/Alfentanil.
Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.


Eligibility Criteria:
Inclusion Criteria:

* Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal.

Exclusion Criteria:

* lung disease
* current smoking or discontinued smoking within past 6 months
Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

The goal of this clinical trial is to investigate the efficacy and safety of Weifuchun tablet in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. The main questions it aims to answer are: Does Weifuchun tablet promote the regression of gastric intestinal metaplasia in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Weifuchun tablet? Researchers will compare the effectiveness of Weifuchun tablet in treating gastric intestinal metaplasia with that of folic acid, as suggested by the Chinese consensus on management of gastric epithelial precancerous conditions and lesions (2020). Participants will: Take Weifuchun tablets or folic acid every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* patients aged from 18 to 75 years old.
* patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.
* patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.

Exclusion Criteria:

* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins.
* a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.
* a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.
* breastfeeding or pregnancy.
* a history of substance abuse or alcohol abuse within the past one year.
* patients with severe mental illness.
* refusal to undergo drug treatment.
* refusal to sign informed consent.
Effect of Rectus Sheath Block on Diaphragmatic Function After Elective Upper Abdominal Surgery

This study will be undertaken to investigate the respiratory and analgesic effects of ultrasound guided rectus sheath block analgesia after elective abdominal surgery with midline incision.

A major proportion of pain experienced by patients undergoing abdominal surgeries is due to somatic pain signals derived from the abdominal wall. The central portion of anterior abdominal wall components (skin, muscles and parietal peritoneum) is innervated by sensory neurons branching from the anterior rami of spinal nerves T7 to T1. These neurons lie between the rectus abdominis muscle and posterior rectus sheath, and pierce the rectus muscle close to the midline. The tendinous intersections of the rectus muscle do not fuse with the posterior rectus sheath, thereby allowing the injectate to spread cephalo-caudally within this potential space. Rectus sheath (RS) block has been described for any midline abdominal incisions (epigastric and umbilical hernia repairs). As visceral pain becomes attenuated by the 2nd postoperative day, rectus sheath block can also be administered for midline laparotomy.

However, the effects of rectus sheath block analgesia on the respiratory function after abdominal surgery with midline incisions are still under investigation.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-50 years.
* Sex: both males and females.
* BMI\< 30kg/m2.
* ASA physical status: 1, II and III.
* Elective abdominal surgery with midline incisions.

Exclusion Criteria:

* Patient refusal.
* Infection at injection site
* Coagulation disorders.
* Allergy to study medications.
* Pregnancy.
* Respiratory tract infection within the last 2 weeks.
* Urgent abdominal surgery
Efficacy Evaluation of Dai Dai Flower on Body Weight

To assess the Dai Dai flower extract on body weight control


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female aged between 20 and 60 years old
* Body mass index (BMI) ≥ 24 (kg/m\^2) or body fat mass ≥ 25%

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study
* Participate weight control or fat loss human studies before 3 months of this study
* History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).
* Person who has received major surgery or bariatric surgery (according to medical history).
* Person who has received constant drug use.
* People with mental illness
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population

The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve
2. Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use)
3. High risk for surgery as assessed by the heart team
4. Has signed the Patient Informed Consent Form \>= 18 years

Exclusion Criteria:

General:

1. Echocardiographic evidence of intracardiac thrombus or vegetation
2. Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF
3. Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible
4. Severe ventricular dysfunction with LVEF \<20%
5. Evidence of active endocarditis or other acute infections
6. Renal failure requiring continuous renal replacement therapy
7. Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
8. Life expectancy ≤ 12 months due to other medical illness
9. Currently participating in another investigational drug or device study

Patients with native aortic valve disease:

1. Unicuspid or bicuspid aortic valve
2. Non-calcified aortic stenosis
3. Combined aortic valve disease with predominant aortic regurgitation \> 3
4. Distance between aortic valve basal plane and the orifice of the lowest coronary artery \< 8 mm

Patients with degenerated surgical bioprosthetic aortic valves:

1. Low position of the coronary ostia, especially in combination with shallow sinuses
2. Internal diameter of the bioprosthesis is ≤16 mm or \>28 mm
3. Partially detached leaflets that in the aortic position may obstruct a coronary ostium
Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection

Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and its treatment continues to fuel the debate on how to manage it appropriately.

One stage and two stage exchange surgery both are the conventional surgical procedures for chronic PJI commonly used to date.

Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional impairment between surgeries and a high socio-economic coast) encouraged many surgical teams to adopt one stage exchange surgery which provides equivalent or better outcomes. However one stage surgery encounters a major conceptual difficulty when it comes to implant the new prosthesis in a surgical site microbiologically undetermined and potentially contaminated.

Investigators suppose the new prosthesis is implanted in a contaminated setting regardless of bacteria type and antibiotic therapy duration before arthroplasty.

The total lack of data answering this question motivated the conception of this prospective study in order to describe the microbiological setting where is implanted the new prosthesis with one stage exchange surgery after surgical excision and antibiotic therapy initiation in chronic PJI.

Study duration: Two weeks. Recruitment period: 18 months. Maximal duration of data collection: Two weeks. Investigator center: monocenter study. Mean patient inclusion per year: 70 patients per year.

Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Aged over 18 years
* PJI documented preoperatively by joint fluid culture according to Musculoskeletal Infection Society Definition
* Monoarticular PJI
* PJI management validated at the weekly cross-disciplinary conciliation meeting
* PJI treated with one stage surgery and intravenous antibiotherapy adjusted to preoperative aspiration results.

Exclusion Criteria:

* patient who does not meet eligibility criteria
* Negative preoperative aspiration culture
* PJI du to fungi
* Patient lawfully deprived of his liberty
* Patient insured under social security scheme