cyrilzakka/clinical-trials huggingface dataset:
Form, Fit, and Function of INVSENSOR00061

The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a full-term newborn (37 weeks) - up to 18 months of age.
* The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.

Exclusion Criteria:

* Subject has underdeveloped skin.
* Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
* Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Muscle Fiber Fragment Treatment for Urinary Incontinence

This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator
* Patients between the ages of 18 and 75 years
* Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions.
* Patients with cystometric capacity of bladder \> 100 ml
* Patients with normal renal function
* Patients with a history of primary incontinence

Exclusion Criteria:

* Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder
* Patients with an active urinary tract infection as evidenced by positive urine culture
* Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas
* Patients requiring concomitant use of or treatment with immunosuppressive agents
* Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study
* Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)
* Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study
* Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study
* Patients with urinary incontinence other than the categories being investigated
* Patients with significant (\>grade 2) pelvic organ prolapse
* Patients with vaginal prolapse beyond introitus
* Patients with neurological disorders
* Patients with abnormal bladder capacity (i.e., less than 100 cc)
* Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment
Surgical Classification of Abnormal Placentation

Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.


Eligibility Criteria:
Inclusion Criteria:

* abnormal placental site (placenta previa)

Exclusion Criteria:

* refusal to participate in the study
* cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)
Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder

The purpose of this study is to test the hypothesis:

Primary hypothesis: Participants in the dialectical behavior therapy group have greater reductions in the frequency and severity of suicidal and non-suicidal self-injurious behaviors compared to participants in the alternative treatment group.

Secondary Hypotheses: Participants in dialectical behavior therapy group have improved treatment outcomes compared to participants in alternative treatment, including mental health service utilization, symptoms of borderline personality and depression symptoms, suicidal thought and hopelessness, disability, and quality of life.

This study will be a 3-year randomized control trial. Patients will be referred from any mental health services in Taipei area who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder. Inclusion criteria include subjects who fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder, 18-60 years of age, sign the informed consent, have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years, and at least one of which is in the 3 months preceding enrollment. The exclusion criteria include psychotic disorder, bipolar I disorder, severe physical illness, and mental retardation. Outcome measures will be obtained at pre-treatment, 4-month, 8-month and post-treatment (12-month) during 1-year protocol. Using semi-structured interview and a battery of self-report forms, a range of symptoms and behaviors associated with Borderline Personality Disorder will be assessed including suicidal thought, suicide attempt, depression, hopelessness, quality of life, disability, service utilization, and function. Measures are selected based on previous outcome studies of dialectical behavior therapy. Outcome variables will be evaluated by blinded assessors.

Eligibility Criteria:
Inclusion Criteria:

* meeting DSM-IV criteria for borderline personality disorder
* 18-60 years of age
* have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years,
* at least one episode of suicidal is in the 3 months preceding enrollment
* agreement to participate in evaluation of the program.

Exclusion Criteria:

* bipolar I disorder, delirium, dementia, mental retardation, or a diagnosis of substance dependence in the preceding 30 days
* living outside of Taipei area
* having any serious medical condition likely to require hospitalization within the next year (e.g. cancer)
* and having plans to leave the Taipei area in the next 1 year
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach
* Men or women less than 80 years of age
* Performance status 0 or 1
* Life expectancy \>12 weeks
* Adequate organ-function
* Written informed consent

Key Exclusion Criteria:

* Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months
* Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach
* Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry
* Prior cumulative dose of \>300 mg/m2 of epirubicin
* Grade ≥ 2 side-effects from previous chemotherapy
Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Is 18 years or older; male or female.
2. Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.
3. Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.
4. Has an ankle brachial index (ABI) \>0.8.
5. Has a venous ulcer with duration less than 24 months.
6. Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present:

   Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation
7. Is currently using Profore as their standard of care.
8. Has not received antibiotics for 6 weeks prior to enrollment.

Exclusion Criteria

1. Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid \[carboxymethylceullose\], silver).
2. Is currently on antibiotics.
3. Has a negative venous duplex.
4. Is unable to tolerate 4 layer compression.
5. Is unable to continue contact with the investigator for a period of at least two weeks.
6. Is unwilling or unable to comply with the study protocol.
A Dose-response Study With Strontium Malonate in Postmenopausal Women

The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.

275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g Protelos® or placebo.

Patients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.

Apart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (at least 12 months since last menstruation).
* BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).
* 50 years of age.
* BMI\<30 kg/m2.
* Total S-Ca level within normal range.
* Ability to read and understand the information given.
* The patient has signed an informed consent form according to ICH E6 and local requirements before any study specific procedure is carried out.
* Ability to comply with study procedures.

Exclusion Criteria:

* History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).
* History of alcohol or drug abuse.
* Metabolic bone disease (e.g. pagets disease, bone cancer).
* History of VTE/DVT.
* History of kidney transplant.
* Bilateral oophorectomy.
* Relevant and treated reduced kidney or liver function.
* Any malignancy within the last 5 years (except basal cell carcinoma)
* Any chronic condition likely to affect absorption (e.g. Crohns disease, gluten enteropathy).
* Known genetic pre-disposition to VTE/DVT
* Known hypersensitivity to any of the active substances or excipients.
* 25-OH-vitamin D level below 25 nmol/L
* Any previous treatment with bisphosphonates, Strontium or fluoride.
* Treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, HRT, SERMs, PTH, phosphorus).
* Treatment during the last week with tetracycline, ciprofloxacin or loop diuretics.
* PTH out of normal range
* Use of any drug known to influence the coagulation process (aspirin and other NSAID allowed)
* Prothrombin time out of normal range (sec or INR)
* Inclusion in another clinical study within 30 days before randomization or during this study
Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas

Background: The association of transcatheter arterial chemotherapy infusion (TAC) with percutaneous ablation (PT) has been introduced as a method to increase the ablative zone. The aim of this study was to evaluate the efficacy of PT and TAC performed in a single session for HCCs between 30 and 50 mm or oligonodular up to 30 mm.

Methods: Thirty patients with a histologically proven HCC, uninodular between 30 and 50 mm or oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination treatment ("PT+TAC group"). A "control" group consisted of 34 patients with uninodular HCC up to 30 mm without any poor prognostic criteria treated with PT alone ("PT group").


Eligibility Criteria:
Inclusion Criteria:

- hepatocellular carcinoma pouved by pathology,

Exclusion Criteria:

- metastases
Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome

Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.


Eligibility Criteria:
Inclusion Criteria:

* patients with moderate or severe ARDS (Berlin definition)
* receiving mechanical ventilation (\>48h estimated length)
* Transthoracic echocardiography performed during the first 36h after ICU admission

Exclusion Criteria:

* pregnancy
* protected or deprived of Liberty major
* chronic respiratory disease
* history of clinical right heart failure
* chronic heart failure with LVEF \< 35%
* severe valvular heart disease
* under 18 or protected-adults
Light Therapy in Cardiopulmonary Bypass Surgery

The goal of this study is to determine whether or not exposure to blue spectrum light reduces acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass. Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate postoperative period.

Light modifies the biology and physiology of mammals, including humans. The cellular biology of both the immune system, as well as, the cells comprising tissues and organs (e.g., kidney, liver) are under the regulation of light and exhibit circadian rhythms. Studies show that the severity of organ injury varies with the time of the day, the duration of the day, and the season. This variation is due to the biology of circadian rhythms, and light is the principle environmental cue entraining circadian biology. More recent data suggest that modulating the spectrum of light to which an organism is exposed may therapeutically modulate the cellular response to stress or injury. Specifically, exposure to a short (24 hour) photoperiod of high illuminance, blue spectrum light attenuated liver and kidney injury when animals were subjected to ischemia/reperfusion (I/R), a model in which the blood flow to an organ is temporarily reduced and then restored. A predominant cause of organ injury in this model is the misdirected and exacerbated inflammation of a type of immune cell called the neutrophil. However, blue light inhibited neutrophil infiltration into the ischemic kidney and liver, and thereby reduced inflammation and neutrophil-mediated organ injury.

Cardiopulmonary bypass (CPB) surgery is an operation characterized by excessive inflammation and a high risk of organ injury, particularly acute kidney injury (AKI). Thus, we hypothesize that exposure to blue light, by comparison to standard environmental, white fluorescent light, will reduce inflammation, organ injury and improve the outcome of patients undergoing CPB.

Eligibility Criteria:
Inclusion Criteria:

* age greater than or equal to 18 years
* undergoing cardiopulmonary bypass surgery

Exclusion Criteria:

* Blindness
* Immunocompromised or immunosuppressed state
* Anticipated survival \< 24 hours
Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation

Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"


Eligibility Criteria:
Inclusion Criteria:

* Patient adult male or female (age 18 years), kidney transplantation for less than one year (transplant from a living donor or deceased), with acute humoral rejection defined by :
* The deterioration of renal function assessed by serum creatinine increase of more than 20% compared to the best value, OR
* In the first 28 days after transplantation, no significant creatinine decrease, AND
* At least 2 of the 3 following criteria:

  * tissue damage such as (a) acute tubular necrosis, (b) presence of monocytes or granulocytes in the CPT and / or glomeruli and / or capillary thrombosis, (c) intimal arteritis / fibrinoid necrosis
  * C4d level of CPT and / or presence of Ig or complement in lesions of fibrinoid necrosis
  * Presence of HLA antibodies directed against the donor. Patient having given his written consent to participate in the clinical trial.

Exclusion Criteria:

* Pregnant or lactating
* Women during their reproductive years without effective contraception,
* A patient with multiple organ transplants,
* Patients with clinically active infection by HCV uncontrolled
* Patients with active infection, or suspected of infection by HIV or HBV, and tuberculosis,
* Patients with heart failure class IV (NYHA) cardiac disease or uncontrolled
* Patients for whom vaccination is scheduled,
* Patient with disabilities did not allow an understanding of the requirements of the test
* Patient in safeguarding justice, guardianship or trusteeship,
* Patient with cons-indication to rituximab (known hypersensitivity to any component or murine protein)
* Patient had previously received rituximab within 3 months before inclusion
* Patient participation in another clinical trial
The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography

The purpose of this study is to evaluate the effect of back muscle activations on idiopathic scoliosis

* Design: Prospective study
* Setting: hospital rehabilitation department
* Intervention: Participants were asked to walk with a surface electromyography(EMG) attached to their back muscles. After repeating the same process with different leg lengths discrepancy (0cm, 0.5cm, 1cm), participants are compared the main outcome measures.
* Main outcome measures: surface electromyography(EMG)

Eligibility Criteria:
Inclusion Criteria:

* Healthy children (5 to 12 years old)

Exclusion Criteria:

* Children with leg length discrepancy over 0.5cm
* Children complaining of acute low back pain
* Children with spinal scoliosis
* Children with cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
* Children who underwent spinal surgery
Pharmacokinetics of Oral Thiamine

Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.

The aims of this study are to:

* Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers;
* Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55

Exclusion Criteria:

* Non dietary thiamine supplement within two weeks of the start of the study or during the study
* History of thiamine deficiency
* Anemia (Hgb\<10)
* History of gastrointestinal absorption disorders
* Taking prescription or over-the-counter medication
* Pregnant or breast feeding a child
* Alcohol and or drug abuse
* Smoker
Apatinib for Inoperable Advanced Chondrosarcoma

Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced chondrosarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of two Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated chondrosarcoma.


Eligibility Criteria:
Inclusion Criteria:

* 1) histologically confirmed high-grade sarcoma;
* 2) initial treatment in the orthopedic oncology departments of the two affiliated hospitals of Peking University;
* 3) tumors not amenable to curative treatment or inclusion in clinical trials;
* 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
* 5) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) ;
* 6) Eastern Cooperative Oncology Group performance status 0 or 1;
* 7) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

* had central nervous system metastasis;
* had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
* had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
* had pleural or peritoneal effusion that needs to be handled by surgical treatment;
* combined with other infections or wounds;
* pregnant or breastfeeding.
The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2

To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.

The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1
* Body mass index 18-25

Exclusion Criteria:

* Allergy to study medication
* Earlier trauma or surgery to lower limb
* Diabetes Mellitus