cyrilzakka/clinical-trials huggingface dataset:
the Efficacy and Safety of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity

This study was conducted to investigated the effects of daily supplementation of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity.

This study was a 8-week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into Blueberry Yeast Fermentation Freeze Dying Powder extract 2.07 g or placebo group. The investigated measured Natural Killer cell activity, Cytokines, Upper respiratory infection questionnaire score, etc.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 50 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 3 months before the screening
* Those who have a body mass index(BMI) of less than 18.5 kg / m2 or greater than 35 kg / m2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage

Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the beginning of colonoscopy. MEI works by creating an electromagnetic field of very low intensity. By that the position of the endoscope can be displayed virtually on a monitor. The use of MEI has been shown to reduce the formation of loops and to ease the removal of existing loops during the investigation. Furthermore, as loops favour the occurrence of pain when the scope is moved forward, patients who underwent colonoscopy with MEI reported less pain at the end of the procedure.

Sedation is used widely during colonoscopy for it has improved the tolerability of the investigation. Most of the patients demand for sedation. In Germany Propofol is recommended as the first-line sedative when endoscopy it is performed in an outpatient setting. The use of Propofol involves the danger of respiratory complications. One reason for the application of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We therefore planned this prospective controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* medical indication for colonoscopy
* age \>18 years
* written consent given by patient
* investigation under sedation with propofol

Exclusion Criteria:

* application of any other sedative than propofol
* age \< 18 years
* pregnant women
* patients denying written consent
* ASA class IV, V and VI
* indication for colonoscopy: emergency (e.g. severe rectal bleeding)
* allergy to propofol
* pre-existing hypotension, bradycardia or hypoxemia
* history of sedation accidents
Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes.

To overcome these problems and avoid the complications of over or underhydration, we use the Goal-directed fluid therapy(GDFT) guided by Inferior vena cava(IVC) collapsibility index approach in which dynamic parameters of volume responsiveness as a guide for fluid therapy. This will ensure that the fluids given were deficient from the circulation and improve the recovery of the patients according to enhanced recovery after surgery(ERAS) protocols.

Eligibility Criteria:
Inclusion Criteria:

* Patient's acceptance.
* Patients planned for elective lower limb surgery under spinal anesthesia.
* Both sexes
* Body Mass Index(BMI): \<35
* Age: 21 \~ 65 years
* American Society of Anesthesiologists(ASA) Physical Status Classification System: Class I \& II
* Duration of surgery 2\~3 hours

Exclusion Criteria:

* Advanced kidney, liver, respiratory or cardiovascular disease.
* Contraindication for spinal anesthesia.
* Patients shifted to general anesthesia for any reason.
Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma

Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages.

In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown.

The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.


Eligibility Criteria:
Inclusion Criteria:

Age:18-70 years

Histologically verified squamous carcinoma of the thoracic esophagus.

Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.

Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.

Joined the study voluntarily and signed informed consent form

No surgical contraindications

No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN

Exclusion Criteria:

Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).

Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.

Invasion of the tracheobronchial tree or aorta

Tracheoesophageal fistula

Concurrent pregnancy or lactation

Severe diabetes mellitus with poor blood glucose control

History of a second malignancy

Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.

Patients undergoing esophageal reconstruction with jejunum.

Patients have allergy reaction or contraindications to taxanes.
Radiological and Functional Outcomes of Internal Fixation Methods for Ipsilateral Femoral Neck and Shaft Fractures in Young Adult Patients

Does the single construct produce more favourable radiological and functional outcomes with less complication when it is compared to dual constructs for fixation of ipsilateral femoral neck and shaft fractures in young adult patients at one year follow up?

The investigators will do follow up for internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients at one year and observe does single construct will give favourable outcomes versus dual constructs?

Eligibility Criteria:
Inclusion Criteria:

* Age of the patients from 18 to 55 years
* Recent fracture within one week
* Ipsilateral Neck and shaft femur fractures according to AO Classification including 31 B (all types of neck ) and 32 A,B and C ( all types of shaft femur )

Exclusion Criteria:

* Open fractures GIII
* patients more than 55 and less than 18 years old
* Patient with comorbidities: uncontrolled D.M, renal patient, neurological deficits.
Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients

Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)

International study with sites in the Czech Republic and Poland


Eligibility Criteria:
* Relapsed or progressive low-grade/follicular NHL who are candidates for rituximab therapy
* Patients who were on other therapy including CHOP or radiation
* Previous therapy must have concluded 30 days prior to enrollment
* Demonstrable CD20-positive tumor population in lymph nodes or bone marrow
Pharmacogenomic Testing in Major Depressive Disorder

This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate clinical impact of pharmacogenomic testing on the treatment of major depressive disorder. Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group (guided group) and treatment as usual group (TAU group). The primary hypothesis is the pharmacogenomic-guided treatment group will demonstrate significantly higher percent improvement in depression score compared to treatment-as-usual group.

To a large extent, variability in antidepressant efficacy can be explained by genetic variations that affect medication-metabolizing enzymes, drug transporters, and medication targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in improving treatment of major depressive disorder. One of the major barriers towards successful implementation of pharmacogenomic testing for patients with major depressive disorder is lack of systematic evaluation of impact of this approach in routine clinical care settings. The major goal of this study is to systematically evaluate impact of comprehensive pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of major depressive disorder (MDD)
2. Prescription of index antidepressant medications
3. Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)

Exclusion Criteria:

1. Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
2. Active diagnosis of substance abuse or dependence
3. Current suicidal ideation
4. Previous suicidal attempts
5. A person has already had pharmacogenetic testing done.
A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)

Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.


Eligibility Criteria:
Inclusion Criteria:

* Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
* Patient is age 18 or older.
* Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing.
* Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.

Exclusion Criteria:

* Patient has an associated or suspected neurological disease.
* Patient is on anti-coagulation therapy.
* Patient has received an investigational drug or device in the past 60 days.

For patients having URP measurements at selected sites:

* Patient has an active lesion or present injury to perineum or urethra.Patient has a urethral obstruction.
* Patient has an unreduced cystocele \> Stage 1. (Reduction of prolapse prior to URP testing is required.) Reduction of Cystocele (if applicable). Patients should be seated in a semi-fowler's position with head of bed at 40-60 degrees.

Carefully place a half of a speculum into the vagina, reducing prolapse to less than stage 1. Be careful not to over extend or elongate the vaginal length.

The half of a speculum must be placed with pressure emphasis on the posterior and apical areas. Anterior wall pressure or urethral pressure must be avoided at all times.

* The subject has active infection upon urine dipstick analysis, defined as ≥+1 leukocytes or ≥+1 nitrates (Must reschedule appointment after UTI resolves.)
Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients

Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of PDAC patients. Studies have shown that the prognosis of PBTC is worse than that of PHC, which is partly attributed to the relatively late clinical presentation of PBTC patients and the lack of overt symptoms such as obstructive jaundice, which is common in PHC. However, it has also been shown that the worse survival of PBTC compared to PHC is not related to the disease stage. Previous studies have investigated the molecular differences between PHC and PBTC and found that the frequency of SMAD4 mutation in PBTC was significantly higher than that in PHC at early stages (I-II). In the late stage (III-IV), PBTC had higher mutation frequency of Kirsten rat sarcoma viral oncogene homolog (KRAS) and mitogen-activated protein kinase (MAPK) pathway, but lower frequency of genomic alterations which can be targeted by drugs. The above genetic and molecular differences may be related to the clinical differences between PHC and PBTC.

However, the differences in microbial composition and metabolism between PHC and PBTC have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. In this study, the investigators aimed to analyze the microbial and metabolic differences between PHC and PBTC through 16S ribosomal ribonucleic acid (rRNA) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of PDAC at different anatomical positions.


Eligibility Criteria:
Inclusion Criteria:

1. Participants aged above 18 years.
2. Patients who signed informed consent.
3. PDAC patients diagnosed via postoperative pathology.

Exclusion Criteria:

1. Comorbidity with other cancers.
2. Underwent preoperative chemotherapy, radiotherapy, or other biological treatment.
3. Use of antibiotics, probiotics or prebiotics in the previous month.
Pilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression.

\*\*This study never received IRB approval and no participants were ever enrolled\*\* The purpose of this study is to determine if adding over the counter nutritional supplements will have a benefit to participants currently taking prescribed antidepressants who have not experienced complete remission of their depression symptoms.

Inclusion Criteria:

Detroit VA Patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms as defined by "feeling their normal selves"

Randomized into two groups:

Experimental: will receive month supply of deplin 15mg, L-tyrosine 6g/d into 2 divided doses, and L-tryptophan 2g/d into 2 divided doses.

Control: will receive month supply of deplin 15mg , and 2 placebo pills.

Beck Depression Scale (BDI-2) to be administered at baseline and every 2 weeks for 1 month.

Eligibility Criteria:
\*\*This study never received IRB approval and no participants were enrolled\*\*

Inclusion Criteria:

* Veterans Administration Medical Center patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms.
Adipose Tissue & Uremia

Many metabolic disturbances, such as protein-energy wasting, inulin resistance, and dyslipidemia are common features of chronic kidney disease (CKD). However, to date, the underlying mechanisms of these disturbances remain elusive. Many in vitro studies have demonstrated that white adipose cells exhibit dysfunctions in conditions that mimics uremic environment. In good agreement, several animal experiments have reported that chronic kidney disease was associated with lipoatrophy, adipose tissue dysfunction and ectopic lipid redistribution. The goal of this protocol is to collect and study structural and metabolic properties of white adipose tissue in CKD stage V patients to evidence adipose tissue dysfunction associated with CKD. The primary outcome measure will be the cellularity of the adipose tissue (i.e. size of the adipose cells) and the secondary measure to study the gene expression profile using microarray and metabolic properties of adipose tissue (i.e. lipogenesis). To this end, 15 male adult volunteers and 15 non-diabetic and non-dialyzed CKD stage V patients, matched for age, gender and body mass index (BMI) will be recruited at the Departments of Nephrology or Urology of Lyon University Hospital (Lyon, France). The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective urologic surgery (i.e. peritoneal dialysis catheter for CKD patients and radical prostatectomy for non CKD patients).


Eligibility Criteria:
Inclusion Criteria:

CKD (Chronic Kidney Disease) and non-CKD patients:

* At least 18 years of age
* Able and willing to provide informed consent
* Male gender
* Normal fasting glucose (less than 6 mmol/l )
* No evidence of significant concurrent illness
* BMI \<30 kg/m2
* Non acidotic (bicarbonate \>20 mmol/L)
* Normal coagulation profile

CKD patients:

• eGFR (estimated Glomerular Filtration Rate)\< 25 mL/min/m2 before the beginning of renal suppletion therapy

Non-CKD patients:

• eGFR \>50 mL/min/m2

Exclusion Criteria:

* A known diagnosis of diabetes mellitus
* enrolled in a other study that may confound results of this study.
* Have been treated with: corticosteroids or insulin or oral diabetic medications within 8 days prior to study entry
* Unwilling and/or not able to give written consent
* Patient with active systemic bacterial, viral or fungal infections
A Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease

This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost tool for rehabilitation.

Auditory rythmic cueing is a method consisting in presenting a regular auditory stimulus (metronom or music) when someone is walking. It is known to improve gait in pathologies such as Parkinson's disease. It has also an effect on general timing abilities (e.g. tapping the beat of the music). This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overal, we propose to test a low-cost tool for rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* age \< 18
* good understanding of the nature, the goal and the methodology of the study
* signing of the informed consent
* being insured with a social security
* Diagnostic of idiopathic Parkinson's disease following the Queen Square Brain Bank (Hughes, 1992)
* Hoehn et Yahr between 2 and 3
* mild to moderate walk and speech deficits (Item MDS-UPDRS)
* stable therapy one month before inclusion for all the duration of the study

Exclusion Criteria:

* Atypic Parkinson Syndrom (oculomotor troubles, early falls, hallucinations, MoCA\<20, early dysautonomy)
* dystonia ou dyskinesia preventing from using a tablet (item MDS-UPDRS4.2 \>2)
* Unable to move without help (walking stick, walker, wheelchair) (item MDS-UPDRS 2.12 \>2)
* adult protected by law
* deprivation of liberty
* High propability of non compliance to the protocol
* pregnant women, nursing women
* moderate to severe auditory trouble
* Severe walk fluctuations item MDS-UPDRS 4.4 \>2)
* Pacemaker or neurosensorial device or heart defebrillator
* Cochlear implants
* ferromagnetic external bodies claose to the brain
* Metallic prothesis
* agitated, non cooperative patient
* claustrophobic patient
* neuro-surgical shunt valves
* dental appliance
Hospitalizations in Neonatal Period and Early Discharge of Maternity

in the past 2 decades the number of early discharge of maternity is increasing. The aim of this study is to observe if an early maternity discharge increase the rate of hospitalization during the neonatal period.

All infants with maximum 28 days old who are hospitalized at the Hospital center of Nancy: through emergency unit of children's hospital or maternity, through intensive care unit of children's hospital.


Eligibility Criteria:
Inclusion Criteria:

* infants hospitalized maximum at the aged of 28 days (day 28 included)
* infants already discharged from maternity
* infants hospitalized in Hospital Center NANCY: at Children's
* informed by the study, parents did not refused to participate to the study

Exclusion Criteria:

* more than 28 days old
* infants transferred from maternity without discharge at home.