cyrilzakka/clinical-trials huggingface dataset:
Combination Treatment for Advanced Liver Cancer

The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.


Eligibility Criteria:
Inclusion Criteria:

* (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI;
* (2) Child-Pugh classification grade A or B；
* （3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

Exclusion Criteria:

* advanced liver disease (bilirubin levels \>3 mg/dL, ASTor ALT \>5 × upper limit of normal)；
* Tumor invade the Inferior Vena Cava, extrahepatic spread;
* contraindications for doxorubicin or oxaliplatin chemotherapy;
* any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
* renal failure,cardiac ejection fraction \<50 %) or end-stage disease；
* patients who were not capable of cooperation during the procedure.
Visual Guidelines and Tutoring in Pediatric Urological Surgery

The aim of this study is checking impact of visual guidelines (picture book) and tutoring in pediatric urologic surgery

The number of operations in pediatric urology performed on the basis of one day surgery has been increased tremendously over the last years. The shortening of the hospital admission intends to increase the efficacy of the health system, however at the same time puts an additional burdening regarding the postoperative care on the parents of the operated children. The parents often have no or has little experience with regards to the basic medical education. The lack of the proper tutoring in terms of possible complications, normal postoperative period may cause unnecessary patients and parents anxiety, visit to the emergency room or calls to the medical stuff, and in some case delay medical attention which can cause major surgery related complications. Visual guidelines and tutoring of the patients upon surgery may avoid these undesirable effects of the early hospital discharge

Patients and methods:

The investigators are proposing prospective study of 3 groups of patients which undergo the most often urological surgery Group 1 penile surgery, Group 2 inguinal surgery. Group 3 renal surgery required nephrostomy tube leave or drainage. Each group will be divided into two subgroups (20 patients each) with and without visual tutoring prior to the surgery. Visual tutoring will include the photograph pictures reflecting different stage of the convalescent period following surgery. The parents will be asked to answer on questionnaire regarding the level of anxiety before surgery, immediately after surgery, week and 3-6 months after surgery. The number of parents calls to the hospital staff, emergency or outpatient clinic visit will be recorded and compared between two groups. The statistical analysis will performed utilizing Graph Pad Prism version 5.00 for Windows, (Graph Pad software, San Diego, California, chi square and Fisher test), considering p value of \<0.05 as significant).

Eligibility Criteria:
Inclusion Criteria:

* children with indications for penile, inguinal or kidney surgery

Exclusion Criteria:

* prior urological procedure (recurrent cases)
Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes

The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
* Age 30 or older on the day the cataract surgery is performed.
* Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
* Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

* Study eye with zonular laxity or dehiscence.
* Study eye with diabetes with any evidence of retinopathy.
* Study eye with history of uveitis.
* Subjects taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* Study eye with history of ocular herpes simplex virus.
Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis

A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol, a phytocannabinoid is performed. This approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses, because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore, cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an antipsychotic medication that is not primarily based upon an antidopaminergic but upon different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive medication in at least a subgroup of schizophrenic and schizophreniform patients and may be expected to show additional anxiolytic effects and only minor side effects.

The control condition in this parallel design will be an established neuroleptic treatment with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment strategies on side effects and neuropsychological functioning.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia or schizophreniform psychosis according to DSM-IV.
* BPRS score \>36 and BPRS psychosis cluster \> 12.
* Ability to provide written informed consent.
* Participants are required an adequate contraception.

Exclusion Criteria:

* Any severe neurological or somatic disorder.
* Other psychiatric disorders including addictive disorders.
* Positive urine drug screening for any compound except benzodiazepines.
* No pregnancy or breast feeding.
Antagonistic Interaction CB1-paracetamol

Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of Paracetamol in healthy volunteers

Double Blind, cross-over, randomized and controlled versus placebo, study in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* between 18 and 40 years old
* written consent given

Exclusion Criteria:

* Rimonabant or paracetamol hypersensibility
* Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
* Concomitant medication
* Chronical diseases
The Effect of Wild Blueberry Consumption on Glucose Regulation in Healthy Adults

The objective of the study is to determine how wild blueberry consumption affects glucose regulation, gastrointestinal hormones and satiety in healthy adults.

Healthy men and women (ages 21 - 65 years) were recruited to take part in a randomized, placebo controlled crossover design study. Subjects were screened to determine their health status (e.g. height, weight, body mass index, blood pressure and medical history). Subjects were randomly assigned to a sequence of two treatments with two study periods. The treatments are frozen wild blueberries and a placebo developed to match calories and fiber of the frozen wild blueberries. The subjects were asked to avoid high polyphenol foods in their typical diet for 7 days and consume one of the two treatments as a dietary intervention. After the seventh day subjects consumed a test meal along with either the wild blueberry or placebo. Blood was collected to determine glucose and satiety hormone levels.

Eligibility Criteria:
Inclusion Criteria:

* Male or female

Exclusion Criteria:

* BMI \< 20 and \> 30 kg/m²
* Pregnant women or women who plan on becoming pregnant during the study
* Postpartum women
* Lactating women
* Diabetes Mellitus
* Kidney disease
* Liver disease
* GI Disease
* Certain cancers
* Smokers
* Blueberry allergies
The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery

Randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery.

Rationale: the laparoscopic approach reduced trauma as compared to open surgery, however, the pressure used to create a PNP with sufficient surgical workspace still leads to significant tissue injury. Prior studies show that the use of low-pressure pneumoperitoneum (PNP) during laparoscopic surgery reduced postoperative pain scores, cumulative opioid consumption and improved bowel function recovery. Deep neuromuscular blockade (NMB) as compared to moderate NMB decreases the amount of intra-abdominal pressure required to achieve similar surgical conditions and enables the use of low-pressure PNP without compromising the quality of the surgical field and patient safety. Therefore, the use of deep NMB with low-pressure PNP could be a significant addition to the conventional Enhanced Recovery After Surgery (ERAS) protocols.

Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery.

Study design: a multi-center, blinded, randomized controlled clinical trial.

Study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis.

Intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group A): low pressure PNP (8 mmHg) with deep NMB (PTC 1-2) or the control group (group B): normal pressure PNP (12 mmHg) with moderate NMB (TOF count 1-2).

Primary endpoint: Quality of recovery score (QoR-40) 24 hours after surgery.

Secondary endpoints: QoR-40 score (day 3 and 7 after surgery), McGill pain- and RAND-36 score (1 day before and 3 months after surgery), pain scores, PONV, analgesia use, length of hospital stay, postoperative complications, surgical conditions and time to reach discharge criteria.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for laparoscopic colorectal surgery with a primary anastomosis
* Obtained informed consent
* Age over 18 years

Exclusion Criteria:

* Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
* Primary colostomy
* Neo-adjuvant chemotherapy
* Chronic use of analgesics or psychotropic drugs
* Use of NSAIDs shorter than 5 days before surgery
* Known or suspected allergy to rocuronium of sugammadex
* Neuromuscular disease
* Indication for rapid sequence induction
* Severe liver- or renal disease (creatinine clearance \<30ml/min)
* BMI \>35 kg/m²
* Deficiency of vitamin K dependent clotting factors or coagulopathy
Homoeopathic Association in Aortic Valve Surgery

Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a pilot study; a confirmative study will be set up if this study is positive.

The study treatment will start the day before surgery, and will comprise 5 granules of each homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5 days, in addition to all routine treatments.) Two groups of 45 patients will be included. Patients have to be over 18 years, to undergo aortic valve surgery only, have no known allergy to one of the study drugs, sign a consent form, and must not have received anti inflammatory drug in the 3 days before surgery. The primary criteria include the amount of drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up phone call is given to the patients 30 days after their surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years, undergoing aortic valve surgery with extra corporeal circulation

Exclusion Criteria:

* acute infectious or inflammatory concomitant disease, known allergy to one of the investigational products, Patients who did not sign the study consent form, patients having received during the 3 days before surgery any corticoids or non steroid anti-inflammatory drug, patient undergoing a surgery other than surgery of the aortic valve in the same intervention, patient undergoing an iterative cardiac surgery, patients under 18 years, patient over 18 years under the protection of the law.
Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty

Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome.

The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled for elective septo-rhinoplasty surgery

Exclusion Criteria:

* Patients with hypertension or coronary artery disease,
* Patients with renal, hepatic or cerebral insufficiency,
* Patients with coagulopathy or receiving drugs influencing blood coagulation,
* Patients with known sensitivity to any of the study drug
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes

The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration.

The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.


Eligibility Criteria:
Inclusion criteria:

* Stable Type 1 diabetes of \> 2 year duration
* No clinically significant change in treatment regimen for T1D
* Age ≥ 18 years and ≤ 55 years
* HbA1c \< 7.0%
* Positive GAD65 and/or IA-2 auto-antibodies
* Peak C-peptide \> 100 pM following IV injection of 1 mg glucagon
* Body-mass index (BMI) \> 18 and \< 28 kg/m2
* Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study

Exclusion criteria:

* Current infection or history of infection
* Positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
* History of tuberculosis or positive PPD test
* Presence of foot, leg, or decubitus ulcers
* Current immunosuppressive treatment or documented immunodeficiency
* History of severe allergic or anaphylactic reactions
* History of asthma requiring systemic corticosteroid therapy
* Coronary intervention (PCI, stent placement) or hospitalization for cardiovascular condition within the last 12 months
* Uncontrolled hypertension
* History of congestive heart failure (NYHA Class III or IV)
* History of a coronary event within the last 12 months
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
* History of malignancy within the last 5 years
* Receipt of a live (attenuated) vaccine within the last 3 months

Other protocol-defined inclusion/exclusion criteria may apply
A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)

This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject.

  * Advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent
  * TNBC is defined as:
* \<1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR
* Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

* Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.
* Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).
* Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to SC-005 or excipient contained in the drug formulation.
Muscle Fatigue and Foot Biomechanics

Medial longitudinal arch (MLA) is a curve of the foot located at the medial side of the body and protection of the height of the MLA is an important factor for limb health.

This study was planned with the aim of investigating the response of the MLA height to the repetitive muscle activity and determine the gender-related differences.


Eligibility Criteria:
Inclusion Criteria:

* healthy young females and males who want to participate to the study

Exclusion Criteria:

* have orthopedic, physiologic, psychiatric, neurologic or systemic disorders
* have present medication
Comparison of AmnioFix Laser and Standard of Care Treatment

This is a comparison trial with novel application of AmnioFix and a control arm. Patients electively being treated with facial lasers will be assigned to receive AmnioFix in addition to the normal standard of care placed on half of their face after laser procedure, and normal post laser standard of care alone on the other half of their face. The investigators will investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic factors. The study is designed to compare AmnioFix to the current standard of laser care.

AmnioFix is a dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. Amniotic membrane is a unique material and its composition contains collagen types I, III, IV, V, and VII. Amniotic membrane is composed of structural extracellular matrix (ECM), that also contains specialized proteins fibronectin, laminins, proteoglycans and glycosaminoglycans. In addition, amniotic membrane contains essential, active, healing growth factors such as epidermal growth factor (EGF), transforming growth factor beta (TGF-b), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF).

The study is designed to compare AmnioFix to the current standard of laser care.

* Patients coming in for fraction or total ablative resurfacing with any methods will be studied
* patients will be assessed prior to any treatment by clinician
* additionally patients will participate in a clinician constructed survey
* patients will be assessed on a rating scale of 1-4 based on erythema, edema/induration, oozing/drainage, and epithelialization
* preoperative photos will be taken of patients
* laser resurfacing will proceed under clinician guidance, and under clinician selected settings
* repeat photographs
* patients will be randomized as to which side of the face receives AmnioFix treatment, and which side receives standard of care
* epifix will be applied appropriatly
* repeat photographs and repeat assessment on 1-4 scale
* patients will follow up at day 1, 4, 7, 14, and 28 +/-3 days to repeat scoring and photography

Eligibility Criteria:
Inclusion Criteria:

* adult patients ages 18-100 seeking laser facial treatment

Exclusion Criteria:

* patients with treatment areas with active or latent infection
* patient with a disorder that would create an unacceptable risk of post-operative complications
Efficacy of Dextrose Prolotherapy Compare With ESWT in the Treatment of Chronic Rotator Cuff Tendinopathy

To compare the efficacy of dextrose solution injection with ESWT for pain reduction in rotator cuff tendinopathy.

Additionally, secondary objective is to evaluate DASH and active range of motion of shoulder joint


Eligibility Criteria:
Inclusion Criteria:

* Chronic shoulder pain for at least 3 months
* Unilateral affected side
* History of unsuccessful conservative treatment
* Age 18 years or older

Exclusion Criteria:

* Rotator cuff complete tear
* Local or generalized arthritis
* Previous shoulder surgery
* Previous history allergy to local anesthesia
* Pregnancy
* Current infectious or tumorous disease
* Dysfunction in the neck or thoracic region of both
* Coagulation disturbance