cyrilzakka/clinical-trials huggingface dataset:
Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery

The creation of pneumoperitoneum during laparoscopic surgery can have significant effects on the respiratory system including decreased respiratory system compliance, decreased vital capacity and functional residual capacity and atelectasis formation. Intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an important role in respiratory management during laparoscopic surgery. The aim of this study is to determine whether setting of PEEP guided by measurement of pleural pressure would improve oxygenation and respiratory system compliance during laparoscopic surgery.

As minimally invasive procedure with numerous advantages compared with open surgery, laparoscopic surgery has been substantially performed worldwide. The creation of pneumoperitoneum during laparoscopic surgery, however, can have significant effects on the respiratory system including decreased respiratory system compliance, decreased vital capacity and functional residual capacity and atelectasis formation. These pathophysiologic changes may put patients at risk of postoperative pulmonary complications. Therefore, intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an important role in respiratory management during laparoscopic surgery. Nevertheless, there is no consensus on the optimal PEEP level and the best method to set PEEP during laparoscopic surgery. In patients with acute respiratory distress syndrome, PEEP set according to pleural pressure measured by using esophageal balloon catheter significantly has beneficial effects in terms of oxygenation, compliance and possible mortality. The aim of this study is to determine whether setting of PEEP guided by measurement of pleural pressure would improve oxygenation and respiratory system compliance during laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age of equal or more than 18 years old undergoing laparoscopic gynecologic surgery with anticipated surgical duration of more than 2 hours

Exclusion Criteria:

* Patients with ASA physical status of equal or more than 3
* Patients with significant cardiovascular or respiratory diseases
* Patients with significant pathological lesion in pharynx and esophagus that preclude placement of esophageal balloon catheter
* Patients with contraindications for PEEP titration such as increased intracranial pressure or unstable hemodynamic
* Patients with arrhythmias
* Patients who refuse to provide written informed consent
* Patients undergoing surgery with duration of less than 2 hours
Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia

Total knee replacement is very common in Germany. After surgery patients have severe pain in the knee; initiation of the physiotherapy, however, is important in the first three days after surgery. Continuous femoral blockade and continuous (lumbar) epidural analgesia are commonly used after surgery. Both methods are used in Germany. Both methods have advantages and disadvantages. We wanted to answer the question which method of analgesia - after total knee replacement - is better concerning complications and function (after 3 months) ?


Eligibility Criteria:
Inclusion Criteria:

* age 18 -80 years
* ASA I-III
* Surgery: total knee replacement
* informed consent

Exclusion Criteria:

* obesity
* contraindication for epidural anesthesia
* coagulation disorders
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
* Have positive antinuclear antibodies (ANA)
* Agree not to become pregnant throughout the course of the trial
* Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

Exclusion Criteria:

* Have active severe Lupus kidney disease
* Have active Central Nervous System or peripheral neurologic disease
* Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
* Have active or recent infection within 30 days of screening
* Have had a serious infection within 90 days of randomization
* Have evidence or test positive for Hepatitis B
* Have Hepatitis C
* Are human immunodeficiency virus (HIV) positive
* Have evidence of active or latent tuberculosis (TB)
* Presence of significant laboratory abnormalities at screening
* Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
* Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
* Have changed your dose of antimalarial drug in the past 30 days
* Have changed your dose of immunosuppressive drug in the past 90 days
* Have previously received rituximab
Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

This trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. Scrambler therapy is a type of treatment that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of MC5-A scrambler therapy (scrambler therapy \[ST\]) in reducing chemotherapy-induced painful peripheral neuropathy (CIPPN).

II. Evaluate the change in pain score before and after 2 weeks (Monday-Friday) of the final ST treatment.

III. Assess for changes in other symptom burden (i.e insomnia, feeling of well-being, depression and anxiety) after 2 weeks (Monday-Friday) ST treatment.

SECONDARY OBJECTIVES:

I. To evaluate the following with the treatment of ST:

Ia. Assess for changes in therapy induced neuropathy assessment scale (TNAS). Ib. Assess for changes in using pain medications. Ic. Assess for changes in daily physical activities/functional status. Id. Assess for changes in quality of life using European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (chemotherapy induced peripheral neuropathy) chemotherapy-induced neuropathic pain (CIPN) 20 questionnaire.

Ie. Assess overall satisfaction with the ST treatment using Global Impression of Change questionnaire.

TERTIARY (EXPLORATORY) OBJECTIVE:

I. Determine the change in sensation after 2 weeks (Monday-Friday) of the final ST treatment.

OUTLINE:

Patients undergo scrambler therapy over 30-45 minutes once daily (QD) Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.

After completion of study, patients are followed up weekly for 3 weeks and at 4 weeks after the last day of scrambler therapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of cancer and suffer from CIPN for at least 3 months after the end of their last cancer chemotherapy
* Have average pain intensity of at least 4/10
* Be in stable clinical situation (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled) in the month following the enrollment)
* Can give a written informed consent

Exclusion Criteria:

* Pre-existence or history of seizure
* Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy (i.e. idiopathic peripheral neuropathy, diabetic neuropathy
* Pregnancy
* Present with pacemaker or implantable defibrillators
* Present or past psychotropic substances and alcohol dependence
* Inability to understand patients' information and informed consent
* Skin lesion at the electrode placement site
Effectiveness of Nursing Case Management for Lung Cancer Patients

The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center.

Purpose: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance, patients' satisfaction with healthcare, and staffs' satisfaction with case management.

Methods: The study will employ a quasi-experimental research design. The patients with new-diagnosed lung cancer and accepting case management will be assigned to the experimental group； The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management will be assigned to the control group；The third group is the patients with non-new-diagnosed lung cancer and with accepting case management. The staffs are the doctors within the lung cancer medical team.

The lung cancer case management database, patients' satisfaction questionnaire, and staffs' satisfaction questionnaire will be used to measure the effectiveness. Statistical software SPSS for Windows version 17.0 will be used to analyze the data.

Expected results: The research outcome will to confirm the impact of case management on the lung cancer patients and could be the reference data for future cancer case management model.

Eligibility Criteria:
Inclusion Criteria:

* patients with lung cancer

Exclusion Criteria:

* younger than 20 years old
Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes

Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations \>0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells.

The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent for participation of the study, given before undergoing any study-specific procedures.
2. 18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
3. Clinical diagnose of T1D
4. Five or more years duration of disease
5. HbA1C between 45 and 75 mmol/mol
6. Fasting plasma C-peptide concentration \>1.5 pmol/l.

Exclusion Criteria:

1. Inability to provide informed consent
2. Mental incapacity
3. Unwillingness or language barrier precluding adequate understanding or cooperation
4. Ongoing or planned pregnancy within the next 12 months
5. Inadequate or no use of contraceptives
6. Ongoing breast feeding
7. Known sight-threatening retinopathy
8. Creatinine clearance \<60 ml/min
9. Life-threatening cardiovascular disease
10. History of drug/alcohol abuse
11. Known or suspected allergy to trial product or related product
12. Recurrent assisted hypoglycemias
13. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
14. Uncontrolled hypertension (180/105 mmHg or above)
15. History of acute or chronic pancreatitis
16. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
17. Personal history of non-familial medullary thyroid carcinoma.
18. Any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results
Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
* Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved summary of product characteristics (SPC)
* HbA1c, 7.0 - 11.0 % (both inclusive)
* Body Mass Index (BMI), 25.0 - 37.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Metformin contraindication according to local practice
* Thiazolidinedione (TZD) treatments within the previous three months prior to Visit 1
* Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Adipose Tissue and Polycystic Ovary Syndrome (PCOS)(EIFFEL)

The purpose of this study is to collect data to help understand why some women develop Polycystic Ovary Syndrome (PCOS) associated with decreased lower-body fat.

Epigenetics may represent a new regulator mechanism explaining gluteal vs. abdominal fat differences.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age \> 20 and \< 40
* Weight stable (change of less than 3 kg in the last 8 weeks)
* BMI \< 40 kg/m2 or \> 27 kg/m2

Supplemental inclusion criteria for PCOS women:

* NIH criteria - confirmed by subjects' medical records.

Exclusion Criteria:

* Male
* Women who are pregnant or lactating (breast feeding)
* Post-menopausal women
* Women with hysterectomy
* Diagnosed with diabetes, or have a fasting blood sugar \> 126 mg/dL.
* Untreated or symptomatic thyroid disease.
* Impaired kidney or liver function, as evidenced by your blood work
* Hypertension/ high blood pressure or are taking blood pressure medications
* Use of oral contraceptives or hormone replacement therapy.
* History of drug or alcohol abuse (\> 3 drinks per day) in the last 5 years, or psychiatric disease prohibiting adherence to study protocol.
* History of cancer within the last 5 years.
* History of organ transplant.
* History of HIV, active Hepatitis B or C, or Tuberculosis.
* History of heart attack/ myocardial infarction.
* Presence of clinically significant abnormalities on EKG.
* Current smokers (smoking within the past 3 months)
* Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], etc.). Metformin for women with PCOS is allowed.
The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects were randomly assigned to the test group and the control group according to 3:1.

This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). One group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (TSH) levels are normal\], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine. All patients received the same amount of radioactive iodine (30mCi±1.5mCi or 1.11GBq of 131I). Approximately 9 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer;
* Patients who were at 18\~75 years old (male or female).
* Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation.
* Serum TSH ≤ 0.5 mU/L；
* Women of childbearing age are HCG-negative;
* Low iodine diet before enrollment for more than 4 weeks;
* Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program.

Exclusion Criteria:

* Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection);
* Patients who have used any water-soluble radiographic contrast agent intravenously, underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months before administration;
* Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);
* Before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia;
* Pregnant or lactating women;
* Patients who are allergic to rhTSH and its excipients;
* Patients with positive infection-related tests : Includes hepatitis C、syphilis and AIDS;
* Participated in any drug or medical device clinical trial within 1 month prior to the trial.
DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up

This study is being undertaken to:

* evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment of dermal nasolabial fold wrinkles at 13 months following the last application of study treatment.
* Document the types and incidence of adverse events reported with DL6049 (injectable poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events will be assessed for an additional 12 months following discharge from the main study in subjects treated with DL6049.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must sign a statement of IC and HIPAA authorization. In addition subjects must provide a separate release for use of their photographs in publications; any subject has a right to refuse the photo release without jeopardizing their ability to participate in the study.
* Subjects must be 18-75 yrs of age, of any race or sex
* Female subjects must be post-menopausal for at least 1 yr or have had a hysterectomy; or have a had a tubal ligation; or if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e, oral/systemic contraceptives, IUD, or spermicide in combination with barrier method of contraception).
* Subjects seeking augmentation therapy for bilateral correction of nasolabial folds. Subjects must have a score of greater than or equal to 2 and less than or equal to 4 on the photo-numeric wrinkle assessment scale (assessed by a blinded evaluator) of both the left and right nasolabial fold at Visit 1.

Exclusion Criteria:

* Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (e.g.,lidocaine, etc.), bovine collagen, latex, silicone, carmellose, or mannitol.
* Subjects with a known history of keloids or bleeding disorders.
* Subjects with an active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease).
* Subjects with active hepatitis within the past year.
* Subjects who are pregnant (confirmation by pregnancy testing),or plan to become pregnant within the study timeframe, or who are nursing.
* Subjects who plan to undergo major facial surgery (e.g., rhinoplasty with or without implant, facelift, congenital defect repair, etc. during the course of the study.
* Subjects with clinically important disease as judged by the investigator within 3 months of the study (e.g., significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases, etc.) including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (e.g., severe asthma, rheumatoid arthritis, etc.).
* Subjects who have used exclusionary medications/treatments.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
CTCs for High Grade Glioma

The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it shrinks). Our hope is that CTCs will provide a more accurate description of tumor state for high grade glioma patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma
* Age 18 or older
* Signed informed consent

Exclusion Criteria: