cyrilzakka/clinical-trials huggingface dataset:
Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair

The purpose of this study is to determine whether immunonutrition and pre operative nutrition can reduce lenght of respirator support, lenght of stay in the ICU and incidence of post operative infections

Elective surgical repair of a Thoraco (Abdominal) Aneurysm Aorta (T(A)AA) is associated with high mortality and morbidity. Important complications are renal failure, paraplegia and respiratory failure.

A retrospective study we performed also revealed high post operative infection rates and high incidence of respiratory failure.

Improving immune status may reduce the occurrence of infections due to immune chances. Immunonutrition may enhance the patient's immune system. Many clinical trials of immunonutrition in critically ill and surgical patients have been performed. In meta-analyses it has been shown that immunonutrition results in lower infections rates and shorter 'length of stay' in hospital after major surgery. Immunonutrition has not been studied yet in TAA(A) surgery. Controversy exists in septic patients.

We designed a prospective randomized placebo controlled trial to study the effect of immunonutrition on time on ventilatorsupport, lenght of stay in the intensive care unit and incidence of postoperative infections after TAA(A) surgery. Patients start with oral supplements besides their normal diet 5 days before surgery. After the operation, the nutrition is continued by protocol and administered by nasogastric tube until normal entral feeding is possible. The control group wil receive iso caloric and iso nitrogen nutrition.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective surgical repair Thoracic or thoraco abdominal aneurysm

Exclusion Criteria:

* endovascular repair
* pregnancy
* immunodeficiency
* use of immunosuppressiva
* chronic obstructive lung disease
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).


Eligibility Criteria:
Key Inclusion Criteria:

1. Having histological confirmed diagnosis of malignancy
2. Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
3. Having received prior cancer therapy regimen(s) for advanced disease.
4. At least 1 measurable lesion as defined per RECIST Version (v) 1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
6. Adequate organ function

Key Exclusion Criteria:

1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
2. Active leptomeningeal disease or uncontrolled brain metastasis.
3. Clinically significant pleural effusion, pericardial effusion or ascites
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. Any active malignancy
6. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug
7. Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.)
8. Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
9. Having severe chronic or active infections
10. A known history of human immunodeficiency virus infection
11. Child - Pugh B or greater cirrhosis
12. Any major surgical procedure ≤ 28 days before the first dose of study drug
13. Prior allogeneic stem cell transplantation or organ transplantation

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).


Eligibility Criteria:
Inclusion Criteria:

* Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history
* Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold)
* Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS) in the investigator's opinion
* Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (\>=) 3 at the screening and baseline visit
* Must agree to daily use (throughout the entirety of the study) of one of the following over-the-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath

Exclusion Criteria:

* Any other active skin disease or condition (example, bacterial, fungal or viral infection) that could have interfered with assessment of HS
* Has a draining fistula count of greater than (\>) 20 at the baseline visit
* Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit
* Receipt of systemic non-biologic therapies for the treatment of HS less than (\<) 4 Weeks prior to the baseline visit
* Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 Weeks prior to the baseline visit
Anti-Diabetic Medications to Fight PD and LBD

The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease or Lewy Body Dementia (diagnosis confirmed by neurologist at Mayo Clinic) with stable neurological treatment in the past approximately three months.
* Glucose intolerance or mild diabetes: The American Diabetes Association criteria for pre-diabetes/ glucose intolerance includes fasting glucose 100-125, random glucose 140-199, or hemoglobin A1C 5.7-6.4% and diabetes is \> 125 mg/dL, \> 200 mg/dL, and 6.5% or greater, respectively (40). It has been previously reported that 50-80% of individuals with Parkinson's disease have abnormal glucose tolerance (17), so this should not limit recruitment.

Exclusion Criteria:

* Use of insulin or other anti-diabetes medications other than metformin.
* Contraindication to taking a DPP4 inhibitor or SGLT2 inhibitor including: allergy, history of angioedema, pancreatitis, active gallbladder disease, renal impairment with EGFR \< 45).
* Bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia.
* Use of high dose steroids.
* Current systemic chemotherapy.
* Pregnancy or breastfeeding.
* Recent (within 30 days) or recurrent (defined as more than one in the past 12 months) urinary tract infection or yeast infection.
* Other contraindication that would make study participation unsafe or make study related data unable to be interpreted.
Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue

Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.

Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48.

The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week.

After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment.

Secondary objectives include:

1. cardiorespiratory fitness,
2. quality of life;
3. adherence to the training program;
4. adherence to international recommendations,
5. body composition,
6. employment status

Eligibility Criteria:
Inclusion Criteria:

* 18-65
* history of breast or colon cancer
* no evidence of disease
* end of treatment in the last five years
* able to understand the questionnaire PERFORM
* able to manage the accelerometer

Exclusion Criteria:

* mobility limitation
* treatment with beta-blockers
* exclusion criteria for CPET
Effects of Red Light LED Therapy on Body Contouring

Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after one 28 minute treatment period. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.

The FB Professional therapy program uses the FB Professional LED device for fat removal using LED red light therapy. This multi-site study reviews results from 70 randomly selected patients after a single treatment using the FB Professional LED device.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years or older.
* May be male or female.
* Generally good health.

Exclusion Criteria:

* Minors.
* Open wounds or sores.
* Pacemaker.
* Photosensitivity.
* Epilepsy.
* Any form of cancer.
* Severe kidney or liver problems.
* Thyroid problems.
* Pregnant or nursing.
ZIAGEN® Post-marketing Surveillance

An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Eligibility Criteria:
All subjects must satisfy the following criteria.

* Subject who is treated in combination with other antiretroviral agents for the treatment of HIV infection.
* Subject who is considered to follow this post marketing surveillance protocol by the investigator.
* Subject who is treated with ZIAGEN® according to the prescribing information. As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe ZIAGEN® according to the prescribing information which approved in Korea.
* Subjects with hypersensitivity to ZIAGEN® or ingredients
* Subjects with moderate or severe hepatic impairment
* Subject with end-stage renal disease
Anorexia Nervosa Genetics Initiative

The Anorexia Nervosa Genetics Initiative (ANGI) is the largest and most rigorous genetic investigation of eating disorders ever conducted. Researchers in the United States, Sweden, Australia, and Denmark will collect clinical information and blood samples from over 13,000 individuals with anorexia nervosa and individuals without an eating disorder.

ANGI represents a global effort to detect genetic variation that contributes to this potentially life-threatening illness. The goal of the research study is to transform knowledge about the causes of eating disorders to work toward greater understanding and ultimately a cure.

If you have suffered from anorexia nervosa at any point in your life, you can help us achieve this goal. Your contribution would include a brief questionnaire and a blood sample. If you have never had anorexia nervosa, but still want to contribute, we invite your participation as well.

Participation in this genetics study requires participants to answer some questions online, about eating behaviors (about 15-30 minutes) and to provide a single blood sample that should take only a few minutes.

To obtain the blood sample, investigators will mail you a kit which participants would take to their primary care provider or your local laboratory to have them draw a small sample of blood (about 40 mL, which is less than three tablespoons). The study is also working with a mobile phlebotomy company that can come to your home or location of your choice to draw your blood and ship it at no cost to you. Once the sample is drawn, participants or the mobile phlebotomist will place it in a box and contact FedEx for pick up. There is no cost for the FedEx shipment. Participants will also fill out the reimbursement form and send it and the receipt to our office. Investigators will reimburse participants for the cost of the blood draw. The samples will be studied directly or reprogrammed prior to further study.

Eligibility Criteria:
Inclusion Criteria:

* Lifetime history of anorexia nervosa (cases)

Exclusion Criteria:

* None
SALpingectomy for STERilization (SALSTER)

The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function.

SALSTER Study

In the last years, the management of Fallopian tubes in benign surgery has drawn a lot of attention due to rising evidence showing that some aggressive forms of ovarian cancer may originate from the distal Fallopian tubes. Concerns were raised about the implications of salpingectomy to surgical outcome and function of the ovaries. The SALSTER study attempts to evaluate the effect of salpingectomy, in regards to surgical outcomes and ovarian function, in women seeking permanent contraception with tubal ligation.

The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function. Complications will be assessed primarily at eight weeks post-surgery according to the Clavien-Dindo classification and the existing complications questionnaires in the Swedish National Quality Register of Gynecological Surgery (GynOp). Ovarian function will be primarily assessed by determining the age of natural menopause, measured through questionnaires on bleeding pattern in GynOp every other year. Approximately 900 patients will be recruited.

In a subset of patients, the difference in Anti-Müllerian Hormone (AMH) levels from the time of surgery and 1-year after surgery will be compared between the groups. Approximately 180 patients will be recruited.

The study is expected to start in the beginning of 2019 and the first results are expected in 2021.

Eligibility Criteria:
Inclusion Criteria:

* Planned laparoscopic sterilization
* Willing to be randomized

Exclusion Criteria:

* Women older than 49
* Not understanding the oral or written study information
* Previous malignancy involving radiation, chemotherapy or endocrine treatment affecting ovarian function
The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization

The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies pre-treated with stem cell transplantation after mobilization, and the results were compared simultaneously in the groups applying different mobilization protocols.

Treatment programs The mobilization protocol is.

1. etoposide 0.1 grams per square meter qd d1-3
2. algocytidine 0.5 grams per square meter q12h d1-3
3. whitening injection (subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group on the second day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after chemotherapy until the end of collection).

In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells in peripheral blood was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage of CD34+ was \>0.1% and peripheral blood leukocytes were \>3.5×109/L.

Collection was stopped when the CD34+ cell count was \>5×106/kg, and no more than three attempts were made. Collection was considered a failure when CD34+ cells collected in any of the three attempts did not reach 2×106/kg.

Eligibility Criteria:
Inclusion Criteria:

1. Malignant lymphoma diagnosed by histology and/or cytology; expected survival \> 3 months.
2. Patients evaluated for disease in complete or partial remission.
3. Normal bone marrow hematopoietic function; no significant cardiac or pulmonary dysfunction.
4. Liver function and biochemical tests need to meet the following criteria. ALT and AST ≤ 1.5×ULN. TBIL≤1.5×ULN. Blood creatinine ≤ 1.5 × ULN.
5. PS score of 0-2.
6. Age ≥ 18.
7. Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and be willing to use an appropriate method of contraception for the duration of the trial.

Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant and cooperated with the follow-up.

Exclusion Criteria:

1. Pregnant or lactating women.
2. having other hematological disorders affecting the hematopoietic function of the bone marrow
3. those with acute or active infections who have received systemic anti-infective therapy within 72h
4. who are allergic to the study drug or other G-CSF products, or to biological agents expressed by E. coli
5. Those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study
6. Other conditions that, in the judgment of the investigator, are not suitable for inclusion in this study.
An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer

This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV)
* Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start

Exclusion Criteria:

* Not agreeing to be followed-up (for a maximum of 24 months)
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine

The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.


Eligibility Criteria:
Inclusion Criteria:

* Established history of migraines for at least 1 year;
* Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month;
* Migraines must have first started before age 50.

Exclusion Criteria:

* Most frequent headache type is not migraine;
* Failed 3 or more studies of effective migraine-preventing medications;
* Overuse of pain medications to treat migraines;
* Not willing to stop use of migraine-preventing medications;
* Significant serious concomitant diseases.
Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis

INTRODUCTION: The Osteoarthritis (OA) is the most common type of joint disease, its features include joint space narrowing, osteophytes formation of the joint margins, motor deficit, reduced strength, and persistent pain. As a treatment option physiotherapy has several resources for the patient approach. However, the effect of treatment is not only the application of therapeutic techniques and resources but also to existing contextual factors such as the therapeutic alliance. OBJECTIVE: To assess the effects of an intervention with the focus on positive therapeutic alliance in subjects OA knee on pain and disability. METHODS: This is a randomized study of two arms with a blind evaluator. 40 subjects were randomized into 2 groups: group 1 "Kinesio Taping® KT" group 2 " Kinesio Taping® with therapeutic alliance KT+AT". Both groups received the application of Kinesio Taping® method as the concepts of the original method. The group "KT+AT" session was conducted in order to increase the relationship between the therapist and the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients with both sexes from 40 to 80 years old
* who underwent imaging examination evidencing grade II or III knee osteoarthritis according to the Kellgren and Lawrence classification
* who were referred to the physiotherapy service by a physician.

Exclusion Criteria:

* Patients who are unable to walk
* with a history of cancer
* associated neurological diseases
* morbid obesity