cyrilzakka/clinical-trials huggingface dataset:
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer

The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)
* Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy
* Available paraffin-embedded tissue to measure the expression levels of βIII tubulin
* Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field
* Karnofsky performance status of 70-100
* Life expectancy of at least 3 months
* Men and women, ages 18 years and older

Exclusion Criteria:

* Uncontrolled brain metastases
* Peripheral neuropathy greater than Grade 1
* Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
* Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
* Known HIV-positive status
* Absolute neutrophil count lower than 1500 cells mm\^3
* Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)
* Aspartate transaminase or alanine transaminase level higher than 2.5\*ULN
* Serum creatine level of 1.5 mg/dL or higher
* Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)
* Any prior antineoplastic systemic regimens.
Exercise Program on Quality of Life and Stress in Children Undergoing Hemodialysis

Despite the benefits of physical exercises among children with chronic illness, the children avoid to engage in different physical activities because their parent and the child also were faired to happen any complication to child. The lack of activity and sedentary life style among these children result in reduced quality of life in addition to behavioral and social problems and finally become independent in most of activities of daily living. Therefore, the primary aim of this study will to practice and teach the children exercise programs in order to improve the quality of life and reduce stress in children undergoing hemodialysis. Therefore aim of this study is to: Determine the effect of exercise program on quality of life and stress in children undergoing hemodialysis.

* The researcher will go to hospital and will take all children that present in hemodialysis unit, then will make random assignment of children to study or control group .The control group will receive routine care while the study group will receive exercise program.
* The exercise program will conduct three days per week giving an interval of 24 hours between sessions. In the first hour the child not make any activity, then first 20 min from second hour of hemodialysis the child will receive stretching exercise, first 20 min from third hour the child will receive range of motion exercise finally first 20 min from forth hour the child will practice isometric exercise.
* This procedure will continue for 2 months and the end of time the research will make posttest for both groups. The intensity for resistance training will determined individually. Depending up on the child exercise tolerance, each set will performed 10 gradually increase to 15 repetitions.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 6-18years with chronic renal failure.

  * All children are stable on dialysis for 2 months (Blood pressure under medical control and stable blood sugar).
  * All children are free from lower extremity graft and any lower limb pathology.
  * Children do not take exercise in 6 months before treatment.
  * Willing to participate in the study and attend the exercise schedule.
  * Children able to follow verbal commands.

Exclusion Criteria:

* Children with physical disabilities.
* Children on tranquilizers or sedative medications.
* Children with a femoral dialysis catheter\& internal jugular vein catheter
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma

The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.


Eligibility Criteria:
Inclusion Criteria:

* progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;
* Cohort 3 only: age must be \>= 2 and \<= 21 years

Exclusion Criteria:

* clinically significant unrelated systemic illness which would compromise the participant's ability to tolerate the investigational agent, or interfere with the study procedures or results;
* known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies;
* treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or other immunosuppressive agents;
* current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal or specific kinase inhibitor);
* history of solid organ transplant;
* other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer;
* active central nervous system disease
Cardiovascular Health Effects of Flavanol Rich Chocolate

In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 45-70 years old
* BMI between 25 and 32 kg/m2

Exclusion Criteria:

* Urine glucose concentrations outside normal ranges (\> 0,25 g/l)
* Fasting blood glucose \< 7.0 mmol/L)
* Systolic Bp \> 160 mmHg or diastolic Bp \> 100 mmHg
* Blood Hb values below 8.4 mmol/L
* Allergic to cow milk, dairy products or chocolate
* Vegetarian
* Tobacco smoker
* Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)
Trigeminal Neuralgia Electrophysiology

The study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. The evoked responses will be measured at two locations before and after the clinical rhizotomy including: the standard contralateral scalp (EEG) and at the gasserian ganglion through an FDA-approved recording electrode.


Eligibility Criteria:
Inclusion Criteria (TGN):

* Adults of 18 years or older
* Scheduled to undergo percutaneous rhizotomy for facial pain

Exclusion Criteria (TGN):

* Facial pain of unclear origin (i.e. not clearly TGN pain)
* Rhizotomy procedure canceled

Inclusion Criteria (Healthy controls)

* Adults of 18 years or older

Exclusion Criteria (Healthy Controls)

* Diagnosis or history of facial pain such as TMD or TGN
* History of migraine
* History of any functional pain disorder: fibromyalgia, IBS, CRPS
* Recent chronic pain (within last month)
* Unwilling to participate for two hours in lab
* Current acute pain
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)

The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair.
2. Patients with American Society of Anesthesiologists (ASA) grade I to III.
3. Patient ≥ 18 years of age at study entry.
4. Patient and investigator signed and dated the informed consent form prior to the index-procedure.

Exclusion Criteria:

1. Patient has a recurrent inguinal or femoral hernia.
2. Patient is treated using the Lichtenstein technique.
3. Patients with ASA grade IV and V.
4. Patient is allergic to the components of the 4DMESH®.
5. Presence of an infected site.
6. Patient has a life expectancy of less than 5 years.
7. Patient is unable / unwilling to provide informed consent.
8. Patient is unable to comply with the protocol or proposed follow-up visits.
9. Patient is enrolled in another study (BE/ES) / Participation in a clinical trial within 3 months prior to the initial visit (FR).
10. Patient is pregnant (BE/FR) / Pregnant women (ES).
11. Patient benefiting from a legal protection measure (minors, under guardianship, curatorship, safeguard of justice, future protection mandate or family empowerment) (FR).
12. Patient not benefiting from a social protection scheme (FR).
A New Method for Detection of Bacteria in the Bloodstream

The primary aim is to determine if this new technique will detect and identify bacteria in the blood sooner than standard blood cultures or identify patients who may be septic without growing bacteria in their cultures. These will be correlated with the data collected from medical records on presumed sepsis. These results will be linked to data concerning infection that will be available as part of routine care including blood counts and other laboratory values that would be part of the routine medical care such as a white blood cell count. The earlier the bacteria are identified and the appropriate antimicrobials are administered the better the patient outcome.

This study will involve additional blood samples to be taken during the routine clinical blood draw, while the subject is being treated for their burn/wounds. The additional research samples will be examined for bacteria. A second blood draw will be performed at approximately 24 hours of initial blood collection. The blood is being collected and then correlate with results of routine medical care blood cultures and clinical status of the subject (diagnosis of sepsis, hemodynamic instability). Data that will be abstracted from the current electronic medical record includes whether there is any type of catheter indwelling (brand name and type), insertion methods including place of insertion (Intensive Care Unit, Operating Room, Emergency Department), adherence to bundle, complications during insertion, colonization of the subject with bacteria (MRSA), and culture results obtained as part of clinical care. Demographics (subject's age) and diagnoses will also be captured as some studies have shown a higher risk of infection with certain processes (burns) and percentage of burn.

Eligibility Criteria:
Inclusion Criteria:

* Burn patient with ≥20 % total body surface area burns or non-burned wound care patient requiring wound care in the Burn Intensive Care Unit.
* Must weigh ≥ 50 kilograms

Exclusion Criteria:

* Pregnant or Lactating women
* Prisoners
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease

The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response \[CR\] and partial response \[PR\] defined by National Institutes of Health \[NIH\] consensus development project criteria \[2014\]).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are males or females aged \>= 19 years, 40kg to 80kg in weight
* Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as the National Institutes of Health (NIH) criteria (2014) below at any time post-hematopoietic cell transplant (post-HCT):

Refractory disease, defined as, 1) when cGVHD manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at \>=1 mg/kg/day for at least 2 weeks) or 2), 3) Persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks Dependent disease, defined as, 4), 5) when glucocorticoid (prednisolone doses greater than or equal to \[\>=\] 0.25 milligram per kilogram per day (mg/kg/day)or \>=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks.

* Participants must be receiving less than 3 systemic glucocorticoid therapies or other immunosuppressive therapies in addition to glucocorticoids for cGVHD for at least 4 weeks before Screening visit. The dose of steroids or Immunosuppressant must be stable for 14 days(2 weeks) prior to starting SCM-CGH or Placebo.
* Laboratory test sufficiency as follows; Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Serum creatinine \< 2 x upper limit of normal (ULN)

Exclusion Criteria:

* Active acute graft versus host disease (GVHD)
* Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
* Uncontrolled underlying disease such as moderate or severe infections and hemorrhage
* Severe Heart failure (NYHA class III/IV), congestive heart failure or arrhythmia requiring treatment
* History of allogenic hematopoietic stem cell more than once
* Positive reaction of a Penicillin test at screening
* History of relapse of causative diseases (ALL, CML, CLL, AML, NHL, multiple myeloma e.t.c.) with hematopoietic stem cell transplantation or diagnosed with secondary malignant diseases after hematopoietic stem cell transplantation
* History of Anti-thymocyte globulin(ATG) for 2 weeks before Screening visit
* History of pulmonary embolism or deep venous thrombosis for 24 weeks before Screening visit
Endoscopic Peroral Myotomy for Treatment of Achalasia

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.

This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.

16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy.

Primary outcome:

-eckhardt symptom score 3 month after therapy.

Secondary outcomes:

* Lower esophageal sphincter pressure at 3 month after therapy.
* Reflux symptoms at 3 month after therapy.

For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophagal-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.

A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.

Eligibility Criteria:
Inclusion criteria:

* Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis
* persons of age \> 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation
* Signed written informed consent.

Exclusion criteria:

* Patients with previous surgery of the stomach or esophagus
* Patients with known coagulopathy
* Previous achalasia-treatment with surgery
* Patients with liver cirrhosis and/or esophageal varices
* Active esophagitis
* Eosinophilic esophagitis
* Barrett's esophagus
* Pregnancy
* Stricture of the esophagus
* Malignant or premalignant esophageal lesion
* Candida esophagitis
* Hiatal hernia \> 2cm
European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.

Comparison of efficacy and safety between WEB and other endovascular techniques


Eligibility Criteria:
Main Inclusion Criteria:

* Patient is above 18 years of age at the time of consent
* Patient has an identified acutely ruptured intracranial aneurysm requiring endovascular treatment (for the purposes of this study an acutely ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days)
* Aneurysm dome diameter must be ≤ 10mm and within the diameter (and parent vessel diameter, as appropriate) range treatable by commercially available WEB devices as well as at least one other alternative commercially available endovascular treatment device used per hospital standard practice
* Aneurysm is located on the anterior communicating artery complex segment (ACom), internal carotid artery terminus (ICAt), anterior cerebral artery (ACA), middle cerebral artery (MCA), basilar apex, posterior communicating artery (PCom) or pericallosal artery
* Patient must be neurologically stable with a Hunt \& Hess score of I to III
* Patient or patient's legally authorized representative (LAR) has provided written informed consent

Main Exclusion Criteria:

* Aneurysm to be treated is unsuitable for endovascular treatment with commercially available WEB devices and/or all other available endovascular treatment techniques used per standard site practice
* Patient presenting as target aneurysm a blister like or dissecting aneurysm
* Patient has more than one aneurysm requiring treatment within 30 days of completion of treatment of the target aneurysm
* Patient with multiple aneurysms in whom ruptured aneurysm cannot be identified
* Patient has pre-morbid mRS \> 2
A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics

The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.

This is a 13-week, open-label (all people know the identity of the intervention), single-arm (one group of patients), multicenter, prospective, interventional study in Chinese patients. In a prospective, interventional study, the patients identified receive a treatment during the course of the research study and are followed forward in time for the outcome of the study. In China, there is still insufficient information about effectiveness, tolerability, and dosage strategy for directly switching from previous oral antipsychotics (drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in patients with acute symptoms. Acute symptoms are quick and severe form of illness in its early stage. In addition, there is also lack of information about bridging acute phase to long-term treatment. In this study, patients with multiple types of acute schizophrenia will be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks. After the acute treatment, the patients will continue to receive the prescribed medication and will be followed up for an additional 52 weeks to assess the outcomes related to long-term treatment.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of schizophrenia
* Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive
* Patients currently treated with antipsychotic are allowed to be recruited
* Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

* A primary diagnosis other than schizophrenia
* History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
* Clozapine use for treatment refractory schizophrenia
* Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
* Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months
Use of a Modified Propofol Emulsion in Adults

The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.

Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.

Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults, age ≥ 18 years and ≤ 80 years
* Anesthetic risk classified as ASA I-III
* Patients undergoing elective surgery under general anesthesia
* Signed informed consent

Exclusion Criteria:

* Simultaneous participation in another trial
* Known or suspected drug abuse
* Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication
* Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics)
* Patients taking lipid lowering drugs
* History of decompensated renal failure
* History of severe hepatic dysfunction, hepatic cirrhosis
* Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia
* History of convulsive disorders
* Decompensated cardiac insufficiency
* Hypovolemia
* Increased intracranial pressure
* Pregnancy (positive ß-HCG test) and lactation
* Emergency situation
* Patient who receives parenteral fat emulsion, e.g. intralipid
* Patients incapable of giving consent personally
* Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal