cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Monitoring Neuromuscular Blockade the Flexor Hallucis Compared to the Adductor Pollicis

Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist.

However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient extubation , leading in some cases to single injections lack of control of the reversal of the patient.

To overcome these technical difficulties, a group nerve / muscle looks interesting and often easily accessible to the anesthesiologist.

The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis brevis muscle and allows quick access to monitoring the reversal before the end of the intervention.

The primary outcome was to compare the speed of recovery from neuromuscular block flexor hallux versus that of the adductor pollicis.

The secondary objective was to compare the speed of installation of deep neuromuscular block flexor hallucis versus that of the adductor pollicis.

This is a prospective, exploratory, uncontrolled, single-center for routine care.

Are included all aged patients over 18 years, ASA I or II, without guardianship, having no known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach, predictable difficult intubation .


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* Any elective surgery with single or multiple injection Atracurium for which hand and foot are accessible at the same time.
* ASA I or II patients
* free subject, without guardianship or subordination
* No opposition given by the patient after information

Exclusion Criteria:

* under 18 years
* known neuromyopathy
* Diabetics
* Emergency surgery and a full stomach
* predictable difficult intubation
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer

This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment subjects must have a pathological diagnosis of HER2-positive primary invasive breast cancer with an immunohistochemistry (IHC) score of 3 +, or 2 + and HER2 gene amplification by in situ hybridization (ISH) (ratio of HER2/CEP17 ≥ 2.0).
* The invasive tumor had to measure no more than 3cm and with histologically confirmed lymph node-negative or one lymph node micrometastasis (T ≤ 3 cm, N0/N1mi, M0).
* Tumor should has known ER/PR hormone receptor status.
* All patients must be women above18 years old with Eastern Cooperative Oncology Group score 0 to 1.
* Adequate hematopoietic function and organ function as defined as follows: neutrophil count ≥ 1.5 x 109/L; Platelet count ≥ 90 × 109/L; Hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × ULN; alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN; serum creatinine Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
* left ventricular ejection fraction (LVEF) ≥ 50% and Electrocardiogram Fridericia-corrected QT interval (QTcF) ≤ 480 ms.
* Provide written informed consent.

Exclusion Criteria:

* Clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry.
* Previous treatment with chemotherapeutic drugs, or tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib or pyrotinib, etc.).
* Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
* Inability to swallow, chronic diarrhea, or intestinal obstruction.
* Known to be allergic to the drug components.
* Have a history of immunodeficiency, including HIV positive, HCV positive, active viral hepatitis B or other immunodeficiency diseases.
* Have a history of organ transplantation.
* Pregnant, lactating female patients, or female patients who are unwilling to take effective contraceptive.
* Any heart disease, including: (1) arrhythmia; (2) myocardial infarction; (3) heart failure.
* Any other concomitant diseases assessed by investigator as unsuitable for study.
* Previous history of definite neurological or psychiatric disorders.
* Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval.
Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry

Exclusion Criteria:

Postoperative residual or recurrent tumor Evidence of distant metastases Previous irradiation for the tumor in the same location Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)

This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge.


Eligibility Criteria:
Inclusion criteria:

* No signs or symptoms of rhinitis outside of the relevant airborne allergen season.

Exclusion criteria:

* History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.
* Symptoms of rhinitis at inclusion indicated by total VAS score of \>40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score \>20.
* Subjects not showing a nasal response to allergen concentration =\< 10,000 BU/ml.
* Subjects with positive skin prick test for Dust House Mite.
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency

To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency

Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study. To evaluate the feasibility , safety and effectiveness of Transcatheter aortic valve system.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years old;
2. Subjects with symptomatic severe aortic valve regurgitation.
3. NYHA Functional Class ≥II.
4. Life expectancy after aortic valve implantation thought to be \>1 year，
5. Native valvular or peripheral vascular anatomy is appropriate for TAVR.
6. Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery (defined as a risk of operative mortality after 30 days\>50%，or severe irreversible comorbidities or other factors affecting surgery (e.g., porcelain aorta, frailty, chest malformation, severe liver disease, severe lung disease, etc.)), or patients at high risk of surgery（Euroscore≥20%, or STS≥8）,or patient not agree open surgery.
7. Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.

Exclusion Criteria:

1. Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤20mm,or ≥28mm
2. Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥ 2x normal and/or elevated Tn (WHO definition).
3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).
4. Hematological abnormality, defined as: Leukopenia (WBC \<3×109/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet count\<50×109/L), history of bleeding diathesis or coagulopathy.
5. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%.
6. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.
7. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure.
8. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA.
9. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine , clopidogrel and high polymer material, or sensitivity to contrast media, which cannot be adequately pre-medicated.
10. Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.
Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions

The purpose of this study is to perform an in-depth analysis of the molecular pathways involved in lesions responding to current treatment and lesions not responding to current treatment

Treatment strategy: combination of oral mini-pulse of methylprednisolone 16mg twice a week + phototherapy Ultraviolet B (UVB) TL01, 2 times a week.

One skin biopsy will be performed at baseline and two skin biopsies at month 3 and month 6 on the same area forearms (excluding skin folds) Blood samples will be taken (30 mL) at week 0, week 12, week 24 for the measurement of pro-inflammatory cytokines and chemokines ligands in blood sera.

Principal Objective:

The aim of this study is to perform an in-depth analysis of vitiligo skin and blood samples taken during the course of a standard therapy to identify pathways involved in the repigmentation.

Secondary Objectives:

* Evolution of Vitiligo Disease in relation of patient profile
* Evolution of the activity of vitiligo in relation of patient profile The statistical and bioinformatics analyzes will be carried out on the data resulting from research with correlation to clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Subject: male or female aged ≥ 18 years and ≤ 65 years
* Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved \>5% excluding hands and feet, with lesions located on arms
* Active non-segmental vitiligo is defined by:

  * Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND
  * Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination.
* Able to read, understand, and give documented informed consent
* Registered in the French Social Security
* Patients that could receive the combination of oral steroids and phototherapy according the recommendation
* Signed informed consent form

Exclusion Criteria:

* Segmental or mixed vitiligo
* Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures.
* Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD\<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:

1. AST and ALT ≤ 3 times upper limit of normal range for age,
2. Serum creatinine ≤ 1.6 mg/dl,
3. Direct bilirubin ≤2.0 mg/dl,
4. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion Criteria:

1. Active, uncontrolled infection
2. Active hepatitis B or hepatitis C
3. HIV Infection
4. Class III/IV cardiovascular disability according to the New York Heart Association Classification
5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
6. Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
Long-Term Efficacy and Safety Extension Study of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0 mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).

This is a multi-center, multinational, extension study to evaluate 2 dose regimens of BMN 110 treatment in patients with MPS IVA who completed MOR-004.

The last study visit assessments for MOR-004 will constitute Baseline for this study. The first study drug dose of this protocol will occur on Week 0 of MOR-005, which is the same as the last visit (Week 24) of MOR-004. Initially, the study will be double-blind with patients previously randomized to BMN 110 in MOR-004 remaining on their assigned BMN 110 dose regimen (qw or qow dosing). The MOR-004 placebo patients will be re-randomized (1:1 ratio) to one of the 2 BMN 110 dose regimen groups: 2.0 mg/kg/qw or 2.0 mg/kg/qow.

There will be two study parts:

* Part 1 - randomized double-blind until the optimal BMN 110 dose regimen has been determined, based on the final primary efficacy analysis from MOR-004
* Part 2 - open-label BMN 110 treatment with the single optimal dose regimen

Eligibility Criteria:
Inclusion Criteria:

* Must have completed MOR-004
* Is willing and able to provide written, signed informed consent. Or in the case of patients under the age of 18 (or other age as defined by regional law or regulation), provide written assent (if required) and have written informed consent, signed by a legally authorize representative, after the nature of the study has been explained, and prior to performance of research-related procedures.
* If sexually active, must be willing to use an acceptable method of contraception while participating in the study.
* If female, of childbearing potential, must have a negative pregnancy test at Baseline and be willing to have additional pregnancy tests done during the study.

Exclusion Criteria:

* Is pregnant or breastfeeding, at Baseline, or planning to become pregnant (self or partner) at any time during the study.
* Has used any investigational product (other than BMN 110 in MOR-004), or investigational medical device, within 30 days prior to Baseline; or is required to use any investigational agent prior to completion of all scheduled study assessments.
* Was enrolled in a previous BMN 110 study, other than MOR-004.
* Has a concurrent disease or condition, including but not limited to, symptomatic cervical spine instability, clinically significant spinal cord compression, or severe cardiac disease that would interfere with study participation, or pose a safety risk, as determined by the Investigator.
* Has any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
Trunk Extensor Endurance Training Versus Scapular Mobilization in Patient With Thoracic Kyphosis

To compare the effect of Trunk extensor endurance training and scapular mobilization on thoracic pain in patient with thoracic kyphosis.

To compare the effect of Trunk extensor endurance training and scapular mobilization on kyphotic angle in patient with thoracic kyphosis To compare the effect of Trunk extensor endurance training and scapular mobilization on shoulder ROM in patient with thoracic kyphosis


Eligibility Criteria:
Inclusion Criteria:

* Both gender (Male and female)
* Age 20-40
* Postural kyphosis
* Kyphotic angle exceeds 40°
* Thoracic pain\>3

Exclusion Criteria:

* Thoracic, Scapular and clavicle abnormalities
* Vertebral fractures, history of trauma or spinal surgery
* History of prolonged use steroid (more than 6 months),rheumatologic conditions
* Cardiac, autoimmune diseases
* Structural kyphosis(X-ray findings)
* Scoliosis(x-ray findings)
* Cancer, neurological disorders, metastasis, or inflammatory
* Osteoporosis, Pregnancy or any genetic conditions affecting their bones, muscles or cartilage.
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Cross-sectional Study

In Denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. One approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. The immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style.

The purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention.

The investigators have the following research questions:

1. Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?
2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes?
3. How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?

The study design is cross-sectional and will be based on a lifestyle intervention, as it is practiced in a real life setting at Ubberup folk high school. The investigators will recruit former participants of this lifestyle style intervention. 50 % who maintained a weight loss and a healthy life style and 50 % who did not.


Eligibility Criteria:
Inclusion Criteria:

* Former participants of Ubberup Folk High School

Exclusion Criteria:

* Gastric Bypass Surgery or Gastric Banding
Herbal Tonic Fertile Supplement(ZO2C5)

The purpose of this study is to determine whether the effect of mixed herbals drug (citrus, citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male infertility: oligospermia

In the last few years, a marked decrease in the quality of semen has been reported. Infertility is one of the major health problems in 10 to 15% of couples' lives; from which approximately 50% of couple's infertility is due to Male factors. The aim of the present study was to evaluate an herbal mixed effects on spermatogenesis and the normal production of sperm. Researchers have reported that using antioxidants and vitamins A, B, C, E, flavonoids, Sulfur compounds, terpenoids and phenolic compounds in the daily diet can protect sperm. In this study the investigators aimed to assess synergistic effect of these herbal compounds in male Infertility. 700 mg tablet for 180 consequence days/daily will be advising, for 40 patients semen samples in 1th and 180 day after treatment will take, in andrology lab according WHO method:samples put into 2 mL of medium (Hams F10) containing 0.5% bovine serum albumin. After 5 min incubation at 37oC (with 5% CO), the sperm samples were determined using the standard haemocytometric method, and sperm motility was analyzed by microscope (Olympus IX70) at 10 field and reported as the mean of motile sperm according to WHO methods . The sperm abnormality was evaluated according to the standard method of Narayana .Briefly, smears of the sperm suspension were made on clean glass slides and stained with periodic acid-Schiff's reaction haematoxylin. The stained smears were observed under a light microscopic with 40× magnification. The sperms were classified into normal and abnormal. The total sperm abnormality was expressed as percentage incidence. Other biochemical tests will be doing according the our research protocol and thesis for blood samples for measure LH, Testosterone, TAC, Glc and Cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* all patients suffering from oligospermia are included

Exclusion Criteria:

* any diseases
Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period

Perioperative stress may increase the incidence of adverse events in the cardiovascular system and lead to poor prognosis. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist, which can inhibit stress response and reduce hemodynamic fluctuations. In different usage plans, dexmedetomidine can have different effects on hemodynamics, myocardial electrical activity, cardiac function. The main purpose was to observe its effects on myocardial electrophysiology and cardiac function during perioperative period. The secondary purpose was to explore the optimal dose of dexmedetomidine that has the least adverse effects on perioperative electrocardia action and cardiac function


Eligibility Criteria:
Inclusion Criteria:

* Ages ranged from 18 to 65
* ASA I\~II
* patients undergoing elective general anesthesia
* the surgery time for 1\~3 h

Exclusion Criteria:

* Preoperative ECG abnormalities, including QTc ≥440 ms (male), 460ms (female)
* abnormal cardiac conduction, prolonged QT syndrome
* heart disease history, such as pacemaker implantation, unstable angina, congestive heart failure, Heart valve disease
* antiarrhythmic drugs (β-receptor blockers, calcium channel blockers, tricyclic antidepressants, etc.) that can prolong the QT interval taken within one week before surgery
* coronary heart disease, non-sinus Heart rhythm, bradycardia, tachycardia, other arrhythmia, etc
* intraoperative HR≤45 beats/min and need drugs to increase heart rate
* previous allergy to dexmedetomidine
* preoperative electrolyte abnormalities
* emergency surgery, neurological or mental disorders , Liver and kidney dysfunction
* patients who use analgesic pumps after surgery
* refusal of patients