cyrilzakka/clinical-trials huggingface dataset:
HAI Via Interventionally Implanted Port Catheter Systems

Procedures to provide interventional implantation of a port catheter system into the hepatic artery and adjacent regional chemotherapy of the liver are optimized in the scope of an open, single-arm trial in patients with metastases and cancers confined to the liver. The primary objective is the improvement of indication, implantation procedure, and regional chemotherapy. Secondary objectives are port patency, comparison of complications with a historical collective of patients provided with a surgical hepatic arterial port device (colorectal cancer patients only), progression free and overall survival, efficacy of maintaining regional chemotherapy with 5-FU in combination with systemic treatment in patients with extrahepatic progression, quality of life.

Inclusion criteria:

* histologically confirmed hepatic cancer without symptomatic extrahepatic manifestation.
* non-resectable disease or hepatic resection or ablation in between the past 8 weeks.
* measurable disease (at least before hepatic resection)
* Karnofsky performance status =\> 70%, or ECOG status 0-2
* \>18 years of age
* life expectancy \> 6 months
* compliance of the patient
* written informed consent

Exclusion criteria:

* second neoplasia within the past 3 years, except for non-melanotic skin cancer, adequately treated Ca in situ of cervix uteri, or adequately resected second colorectal cancer (in patients with liver metastases of colorectal cancer)
* symptomatic extrahepatic disease, in particular disseminated bone metastases, brain metastases
* liver cirrhosis with portal hypertension, active hepatitis B or C, previous percutaneous radiotherapy of the liver
* active infection
* history of gastric or duodenal ulcer
* symptomatic or uncontrolled peripheral arterial occlusive disease, history of stenosis of the renal artery.
* history of dilatative cardiomyopathy, vitium of mitral or aortic valve, persisting foramen ovale, atrial fibrillation
* artificial heart valve or vascular
* history of diabetic microangiopathy
* uncontrolled hyperthyriodism
* other severe concomitant disease (heart failure \>NYHA 2°, respiratory failure, renal failure \>stage2, liver failure (TPZ \<50%).
* inherited or acquired immunodeficiency syndrome
* contraindication against 5-FU
* pregnancy and nursing, no contraception
* limited contractual capability.

After enrollment, an a port catheter catheter system is interventionally implanted into the hepatic artery and the patient is scheduled for regional chemotherapy according one out of 8 pre-defined chemotherapy schedules. All regimens are based on 5-fluorouracil and leucovorin, and optionally contain intraarterial mitomycin, oxaliplatin, or additional intravenous irinotecan.

Patients are followed up and evaluated for primary and secondary endpoints. After the inclusion of 50 patients treated and follow up at our institution, the study population has been extended to 100 patients in 8/2004.

Eligibility Criteria:
Inclusion Criteria:

see above

Exclusion Criteria:

see above
Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients

This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.

The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem cell implantation therapy in intervertebral disc degeneration patients.

The use of allogenic mesenchymal stem cells from the umbilical cord was chosen because patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that autologous mesenchymal stem cell administration is not possible in terms of taking the source of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.

This study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA and Frankel scale, as well as assessment of the widening of the lumbar region using the Schober Test), changes in the structure of the intervertebral discs (through MRI examination and grading the degree of intervertebral disc degeneration), conduction function spinal cord nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the quality of life status of patients using the Oswestry Disability Index.

Eligibility Criteria:
Inclusion Criteria:

1. Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
2. No history of metabolic, autoimun and genetic disease(s).
3. No active infection (HbsAg, HIV, CMV, Rubella).
4. Agree to participate the study by signing informed consent form.

Exclusion Criteria:

1. Patients under 20 years old.
2. Declined to participate in the study.
A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis

This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).


Eligibility Criteria:
Inclusion Criteria:

* 19 Years to 80 Years
* Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at least 12 weeks prior to screening
* Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening

Exclusion Criteria:

* Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class Ⅳ at screening
* Any of the following laboratory values at screening:

  1. Patients with severe liver impairment (AST or ALT \> 2 times the upper limit of normal)
  2. Patients with renal disease,immunodeficiency disease and peptic ulcer
  3. Patients with pleural effusion and ascites
Time Restricted Eating for the Treatment of Type 2 Diabetes

Innovative lifestyle strategies to treat type 2 diabetes (T2DM) are critically needed. At present, daily calorie restriction (CR) is the main diet prescribed to patients with T2DM for weight loss. However, many patients find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day.

In light of these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE is effective for weight loss and improved glycemic control in patients with obesity and prediabetes. However no long-term randomized controlled trial has examined whether TRE is safe and effective for patients with obesity and T2DM.

This study is a 6-month randomized, controlled trial that aims to compare the effects of TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours per day, on change in body weight (%), glycemic control, and cardiometabolic risk factors, in adults with obesity and T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* BMI between 30 and 50 kg/m2
* Previously diagnosed with type 2 diabetes
* HbA1c between 6.5 and 11%
* Sedentary or lightly active

Exclusion Criteria:

* HbA1c below 6.5 or greater than 11%
* Have a history of cardiovascular disease
* History of eating disorders (anorexia, bulimia, or binge eating disorder)
* Not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4%)
* Eating within less than a 10 hour window at baseline
* Perimenopausal (menses does not appear every 27-32d)
* Pregnant, or trying to become pregnant
* Night shift workers
* Smokers
Impact of Gender and Pubertal Status on Human Plasmacytoid Dendritic Cells. PLASMACYTOKID

Differences in pDCs function related to gender have been demonstrated in adults but have never been addressed in children. Yet, differences in immune responses related to gender also exist in children, both in responses to pathogens and susceptibility to autoimmune diseases. The investigators suppose that these differences are partly linked to difference in pDCs functions. This study aim is to compare pDCs functions in children based on gender and pubertal status. This study will be performed in healthy children, boys with Klinefelter syndrome and girls with Turner syndrome.

There are differences in immune responses according to gender. Women have stronger responses against pathogens, especially viruses but are also more susceptible to develop autoimmune diseases. These points reflect more robust innate and adaptive responses in women. Plasmacytoid dendritic cells (pDCs) are key actor of innate immune responses through their ability to produce large amounts of type 1 Interferons (IFN1) secondary to stimulation of their toll like receptors (TLR) 7 and 9 by nucleic acids. Thus, pDCs play a major beneficial role in antiviral responses. In autoimmune diseases like Systemic Erythematous Lupus, pDCs also play a role, mostly deleterious, through inappropriate production of IFN1 upon stimulation of their TLR's by self nucleic acids. In these diseases, pDCs from women have been demonstrated to produce more IFN1 as compared to men, a phenomenon that can be linked to both hormonal and genetic factors. Indeed, the investigators research team demonstrated that IFN1 production by human pDCs can be increased by oestradiol through a specific receptor present in pDCs. Regarding genetics, some studies recently shown in a humanized mouse model, that pDCs developing from female hematopoietic precursor cells have an enhanced TLR 7 mediated IFN1 response as compared to male ones. These results indicate that X chromosome dosage could contribute independently to the enhanced TLR 7 mediated response of pDCs from women. Although some genes implicated in IFN1 production are on the X chromosome, including TLR 7, the mechanism underlying this observation are presently unknown.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients (0-18 years old):

   * Group 1 : Age\<8 years old
   * Group 2 : Age\>12 years old
2. Body weight \>10kgs
3. Pubescent (group 2) or non-pubescent (group 1)
4. Written consent of parents

Exclusion Criteria:

1. Active infectious disease
2. Known perturbations of immune and/or inflammatory systems
3. Oral or subcutaneous contraception in pubescent girls
Ultrasound Evaluation of Laryngeal Mask Airway (LMA) Placement in Pediatric Patients and Its Relationship to Postoperative Complications

This study was designed to improve understanding of some respiratory reactions that can occur after surgery, such as difficulty breathing or persistent cough. These events, technically called PRAE (postoperative respiratory complications), are common reactions in children who have undergone surgery, and our aim is to find out if there are signs that can help us predict them, reducing their incidence in the future.

During surgery, the child will receive general anesthesia, which will put him or her to sleep and not feel pain. In this context, a laryngeal mask airway (LMA) will be used to help the child breathe. The laryngeal mask airway is a soft device that is placed in the throat and allows the airway to be kept open, making breathing possible. This is a standard tool that will be used during surgery regardless of participation in the study.

The aim of this study is to better understand the relationship between the correct positioning of the laryngeal mask airway, measured by a specific ultrasound score, and the frequency of postoperative respiratory events in pediatric patients. As previously stated, these complications are common and well known in pediatric anesthesia practice, and the study aims to explore whether adequate ultrasound assessment can help predict and prevent them in the future. The study aims to observe the position of the laryngeal mask airway through a simple ultrasound and verify whether there is a relationship between the way the mask is positioned and the possibility of postoperative respiratory events. This type of ultrasound is non-invasive and does not add risk to the child.

This ultrasound check will take place without affecting the normal treatment of the patient and does not involve any additional risk or discomfort.

The study is purely observational: this means that we will collect information without modifying in any way the care already foreseen for the child.

The laryngeal mask airway and neck ultrasound are already part of standard medical practice, and the study does not present any additional risks. In this case, it is only a matter of reporting in all children who will participate in the study the "results" of ecological story of the neck (which we will process according to a score) and to evaluate whether there is a relationship between this score and the occurrence of respiratory adverse events upon awakening.

The overall duration of the study is 24 months. In total, we expect to include about 340 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery under general anesthesia with laryngeal mask airway placement.

Exclusion Criteria:

* Patients without the need for invasive airway management or undergoing surgery requiring orotracheal intubation.
* Patients with known craniofacial malformations.
* Patients undergoing neck surgery.
Mobile Behavioral Parent Training for Childhood ADHD: Pilot Trial

The goal of the study is to develop and pilot a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder. The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies.

The main questions to answer are:

Is parenting feedback provided by a smartphone application acceptable to caregivers? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?

In the pilot trial, participants (parents/caregivers) will be randomly assigned to either (1) use the positive parenting intervention phone application (mobile Behavioral Parent Training: mBPT) or (2) use mBPT and receive brief, personalized phone prompts throughout their participation that target parenting behavior and intervention engagement.


Eligibility Criteria:
Inclusion Criteria:

* currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD
* ages 7 -12
* has at least one parent or primary caregiver who is willing to participate and is able to access the intervention at home via smartphone.

Exclusion Criteria:

* N/A
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis
* At least 10 pack year smoking history
* Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
* An FEV1/FVC ratio of less than or equal to 0.70

Exclusion Criteria:

* Current diagnosis of asthma
* Other respiratory disorder other than COPD
* Abnormal and clinical significant ECG
* Chest x-ray clinically significant abnormality not believed to be due to COPD
* Body Mass Index of greater than or equal to 40/kg/m2
* Use of Long Term Oxygen Therapy
* Lung resection surgery
* Women pregnant or lactating at Visit 1
* Previously diagnosed cancer unless in complete remission for 2 years at Visit 1
Lactobacillus Preparation on the Incidence of Diarrhea

The purpose of this trial is to clarify the impact of lactobacillus preparation on the incidence of diarrhea in ICU-admitted patients.

Almost all patients in ICU are treated with antibiotics for the effective control of various infections. However, antibiotics-associated diarrhea is another matter of concern. Many previous studies were proved that the use of probiotic lactobacillus preparation can reduce antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to perform a similar study in severely ill patients in ICU.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted in intensive care unit
* Age more than 19

Exclusion Criteria:

* Diarrhea occurence within 1 week of ICU admission
* Recent history of probiotics use (within 1 month)
* GI obstruction
* History of abnormal symptoms and sign for the probiotics use (rash, edema, sepsis, etc.)
* immunocompromized patients
Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older.
* Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: \> 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Exclusion Criteria:

* Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
* Clinically significant outflow obstruction
* Uncontrolled narrow angle glaucoma, urinary, or gastric retention
* Severe renal or hepatic impairment
* Chronic severe constipation or history of diagnosed GI obstructive disease
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Diagnosis or history of neurogenic bladder
* History of bladder or pelvic cancer
Retinal Nerve Fiber Layer Thickness Analysis With Cirrus HD OCT Versus Stratus Optical Coherence Tomography (OCT)

The Cirrus HD OCT, a new spectral domain optical coherence tomography (OCT), has better resolution than the previous time domain Stratus OCT. Discriminating ability of these two OCTs for diagnosis of glaucoma and judgement of disease progression will be studied.

The Cirrus HD OCT is a new spectral domain OCT. Even though its resolution and speed are much better than the previous time domain Stratus OCT, its diagnostic power for glaucoma detection and judgement of disease progression should be directly compared with Stratus OCT. In the present study, we will review the data of peripapillary retinal nerve fiber layer thickness measurement using the Cirrus HD OCT and Stratus OCT. Their discriminating ability for diagnosis of glaucoma and judgement of disease progression will be compared using the ROC curves and Cohen's kappa.

Eligibility Criteria:
Inclusion Criteria:

* Retinal nerve fiber layer analysis with Cirrus OCT and Stratus OCT within 1 month

Exclusion Criteria:

* Intraocular surgeries history
* DM
* High refractive error ( \< -4.00 diopters, or \> + 4.00 diopters)
* Media opacity
Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.

The general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).


Eligibility Criteria:
Inclusion Criteria:

* • An individual must be \>18 years of age

Have diagnosed type 2 diabetic mellitus by one of the following criteria:

o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year).

If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be \>25kg/m2 at the time of diagnosis.

Diagnosed kidney attributed to diabetes by one of the following criteria:3

* Macroalbuminuria (ACR \>300mg/g, or)
* Microalbuminuria (ACR between 30-300 mg/g) or in the presence of diabetic retinopathy (although is recognized that about 1/3 of type 2 diabetics do not have retinopathy by fundoscopic exam).
* An elevated ACR should have been confirmed in the absence of urinary tract infections with 2 additional first-void specimens collected over 3-6 months.
* At least 2 of 3 samples should fall within the range of micro or macroalbuminuria.

  * An estimated Glomerular filtration rate (GFR) of between 90 ml/min and 30 ml/min measured by (GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units).
  * Individuals must be able to provide informed consent
  * Perform walking exercise testing on a treadmill
  * Be able to participate in a 12-week supervised exercise program.

Exclusion Criteria:

* • Patients are currently exercising

  * Requiring dialysis
  * Have an Hematocrit \<30%
  * Uncontrolled hypertension (\>200/100mmHg)
  * Peripheral vascular disease.
  * An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease., or having undergone a coronary revascularization within the past 6 months prior to enrollment.
Characterization of Corticospinal Excitability During Progressive Skin Cooling

This study characterizes the changes in corticospinal excitability that accompany basic cold stress via skin cooling that result in reduced skin or core temperature and shivering.

Cold stress is known to impair both fine and gross motor movement. Reductions in performance may have life threatening consequences in survival situations where maintenance of muscle control is necessary. Much of the effects cooling has on muscle performance is directly due to its effects on muscle tissue itself, whereas less is known about the effects on the central nervous system. Therefore, the purpose of the study was to characterize corticospinal excitability that accompanies basic cold stress via progressive skin cooling, resulting in reductions in skin (Tsk) or core (Tco) temperature and shivering.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Right Handed
* Pass Magnetic Stimulation Safety Checklist
* Pass Medical Screening Questionnaire

Exclusion Criteria:

* Left Handed
* Any adverse responses to cold exposure (Raynaud's Syndrome)
* Cardiorespiratory Disease