cyrilzakka/clinical-trials huggingface dataset:
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery

The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.


Eligibility Criteria:
Inclusion Criteria:

* Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
* Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
* Need for additional supportive hemostatic treatment
* Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes

Exclusion Criteria:

* Indication for emergency surgery
* Known coagulopathy (as judged relevant by the investigator)
* Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
* Patient unwilling to receive blood products
* Known current alcohol or drug abuse
* Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential
* Dry surgical field of the targeted application area
* Occurrence of any serious surgical complication
* Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding
* Application of topical hemostatic material on the liver resection wound
* Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment
Hydration and Exercise Performance in Cycling

This study will evaluate the effects manipulating ingested fluids can have on hydration status and cycling performance. There will be 4 different conditions.

Being dehydrated can decrease endurance exercise performance. The investigators wish to test which of three drinks is most effective at re-hydrating cyclists and if this affects performance. Subjects will undertake 4 tests: once dehydrated, once hydrated with water, once hydrated with a sports-specific drink, and once with an altered sports drink. Blood samples will be taken and expired gasses will be sampled at various time points throughout the tests for later analysis. A small amount of labelled water will be consumed with each drink, a technique which will allow us to quantify the absorption of each of the drinks.

Eligibility Criteria:
Inclusion Criteria:

* Highly trained cyclists (vo2max \>55 ml/kg/min, PPO (peak power output) \> 4 w/kg)
* Training at least 4 times a week
* Females must be taking an oral contraceptive, or using the contraceptive implant

Exclusion Criteria:

* Recent history of musculoskeletal injury
* Diagnosed cardiovascular disease
* Regular use of nutritional supplements that may interfere with the protocol
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.

To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.0 and 40.0 kg/m2 inclusive
* Male or female subjects between 18 and 75 years of age
* Stable dosage of medication for 30 days
* for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months

Exclusion Criteria:

* Functioning transplanted solid organ
* High tyramine diet
* Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects
Short Foot Exercises and Anti-pronation Taping on Low Back Pain Associated With Hyper Pronation

The aim of this randomized clinical trial is to find the comparison of Short foot exercises and anti-pronation taping on low back pain associated with hyper pronation on reducing back pain improving range of motion of foot, back and foot posture.

Low back pain is a musculoskeletal symptom which occur in all ages during life time with acute episode or chronic condition. Total of 619 million people are living with low back pain worldwide. Low back pain is the musculoskeletal condition that involves pain in region below costal margin and above inferior gluteal fold, along with pain there is also stiffness, limitation of range of motion, aggravated by movement and affected ability to perform daily life activities. Frequency and severity of low back pain are related to spinal loading that increase the strain on lumbar spine, these loads shift from foot (during heel strike) to leg and ultimately to the back.

Abnormal mechanical loading of lumbar spine due to poor postural control or muscular weakness is considered as risk factor for low back pain. The ability of ankle complex to provide stabilization and mobilization depends upon plantar pressure distribution. In particular, pronated foot causes internal rotation of tibia along with internal rotation of hip that cause femoral ante-version and increase in lumbar lordosis and deteriorate lumbopelvic alignment resulting in low back pain Short foot exercise (SFE) is considered more effective in terms of postural balance and excessive pronation. SFE is a widely used intervention that has been developed recently to improve ankle proprioception and global movement pattern, so as to elevate and support the medial longitudinal arch of the foot and to improve dynamic standing balance Anti-pronation taping is a technique that stimulate underlying sensory receptor either through the surface contact or stretch of skin that causes the sensory input to central nervous system to be altered hence it ultimately influences the execution and perception of movement. Low dye taping is effective in correcting over-pronated foot and also increase navicular height along with increase in reactive strength index. low dye taping not only improve arch height but also improves muscular activity The rationale for the use of these techniques is to compare the effect of short foot exercises and anti-pronation taping on low back pain associated with hyper-pronated foot and also on range of motion of foot and back along with the foot posture.

Eligibility Criteria:
Inclusion Criteria

* Both gender
* Age 25 to 45 years
* Foot hyper pronation (FPI ≥ +6)
* low back pain \> 3months (Pain, muscle stiffness, and muscle tension between lower costal margin and inferior gluteal fold)
* Low back pain with NPRS ≥ 3

Exclusion Criteria:

* Acute trauma or fracture of foot/ back (last 3 months)
* leg length discrepancy \>5mm
* Diagnosed with Spondylolisthesis, spondylitis
* Diagnosed with Lumbar radiculopathy, stenosis, fibromyalgia, plantar fasciitis
* Recent History of fall \< 3months
* Congenital hyper-pronation of foot
* Pregnancy
Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity

The objective of the present study was to compare the effects of a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base, versus a control dentifrice, containing exactly the same ingredients apart from strontium chloride and potassium nitrate, on the instant and lasting relief of DH.

Dentin hypersensitivity (DH) is a very common complaint that occurs in the general population. The intensity of the pain can be minor to very serious, which may prevent one from eating or performing ordinary oral hygiene practices. The most accepted mechanism by which DH occurs is hydrodynamic theory, which suggests that pain-producing stimuli cause rapid movement of fluid within the dentin tubules, as a result the free nerve endings, at the inner ends of the tubules or the periphery of the pulp, are excited and DH occurs. According to this theory, one approach to treat DH is reducing dentin tubule fluid movement through occluding open tubules. Strontium chloride was the first tubule-blocking ingredient used in dentifrice about fifty years ago and since that time a paucity of clinical studies have been carried out to test its effectiveness on DH. The other approach is to reduce the pulp nerve excitability by depolarizing the nerve endings, in which the most widely used material is potassium salts. Although there is limited clinical evidence that dentifrices containing strontium chloride or potassium nitrate alone, as the major desensitizing agent, has an effect on reducing DH, no clinical studies have shown the effectiveness of a dentifrice containing both strontium chloride and potassium nitrate in a silica base on alleviating DH.

Eligibility Criteria:
Inclusion Criteria:

* good oral and general health
* possessing at least two teeth (incisors, cuspids, bicuspids and first molars with exposed cervical dentin) with hypersensitivity on facial surfaces which satisfied a tactile hypersensitivity stimulus score of 10-50 grams of force (Yeaple probe) and an air blast stimulus score of 2 or 3(Schiff Cold Air Scale)
* provided informed consent and were available for the study duration

Exclusion Criteria:

* progressive periodontitis, with teeth that had extensive restoration, suspected pulpitis, caries, cracked enamel or that were used as abutments for removable partial dentures,
* had hypersensitive teeth with a mobility greater than one
* had received periodontal treatment including surgery during the last year
* had used any other anti-hypersensitivity dentifrice or taken part in any other clinical trial, used any desensitizing agents during the last three months, or allergic to the ingredients of the dentifrices were excluded
* pregnant or breastfeeding women
* had taken the following drugs during the last month: anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs or daily analgesics
Impact of a Mediator for Patient Intake in Emergency Departments

Violence in the workplace is becoming a serious phenomenon in the contemporary world of work. Hospital staff, like any employee working in contact with the public, is particularly exposed to this violence. In emergency departments, the number of patients treated and their heterogeneity, the problems of communicating with healthcare professionals, and waiting times, favor conflict situations. In the already tense context of the emergencies, the incivilities or violent acts have an impact on the well-being of professionals. In order to prevent these situations of violence, a solution could be to integrate a professional with specific skills into the teams to perform mediation functions between caregivers and patients.

The aim of the study is to evaluate the impact of the presence of a mediator in emergency services on personal (verbal or physical) attacks on professionals (caregivers, doctors, administrative staff).


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older.
* Registered at the reception of the emergency department between 8 am and 8 pm, excluding bank holidays.

Exclusion Criteria:

* Patient with psychiatric disorders or impairment of judgment related to the taking of toxic substances.
* Patients requiring medical care in less than 30 minutes (sort code).
The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery

The effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery.


Eligibility Criteria:
Inclusion Criteria:

* male patients (ASA physical status I and II) aged over 65 yrs and scheduled elective transurethral surgery

Exclusion Criteria:

* cardiovascular, renal, liver disease, or cerebrovascular disorder
Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.

Objective: The purpose of this study is to evaluate the safety and feasibility of intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in patients in the acute and sub-acute phase (\> 3 and \< 90 days after symptoms onset) of ischemic cerebral infarct in the middle cerebral artery territory.

Methods: 15 patients with cerebral infarct within the middle cerebral artery territory will be enrolled in this prospective, nonrandomized, open-labeled study. Up to 10 patients will receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the middle cerebral artery through percutaneous approach. The procedure is monitored by Transcranial Doppler (TCD) and electroencephalogram (EEG). Other 5 patients will receive up to 500x 10 6 autologous bone marrow cells injected intravenously. Changes in neurological deficits and improvements in functions will be evaluated at baseline and at regular intervals during follow-up ( 4 months). EEG and neuroimaging exams will be performed at baseline and at regular intervals during the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset
* neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory
* age between 18 and 75 years old
* NIHSS between 4 and 20
* spontaneous re-canalization of the middle cerebral artery documented by TCD or MRI
* signed informed consent

Exclusion Criteria:

* difficult in obtaining vascular access for percutaneous procedures
* vascular impossibility to reach the middle cerebral artery through percutaneous approach
* severe carotid stenosis( \>70%, by Doppler) related to the severe stroke
* neurological worsening (\>4 points in the NIHSS ) due to edema or intracerebral hemorrhage
* primary hematological disease
* neurodegenerative disorder
* previous stroke with mRS \> 2
* intracardiac thrombosis
* auto-imune disorders
* osteopathies that could increase the risk of bone marrow harvesting procedure
* thrombophilias
* liver failure
* chronic renal failure (creatinine \> 2mg/ml)
* life support dependence
* lacunar stroke
* pregnancy
* history of neoplasia or other comorbidity that could impact patient's short-term survival
* any condition that in the judgment of the investigator would place the patient under undue risk
Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia

To assess the long-term efficacy of the Menicon Z Night orthokeratology contact lens in controlling the progression of childhood myopia

This prospective, controlled, parallel, longitudinal study compared the axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group over a 7-year period.

Eligibility Criteria:
Inclusion Criteria:

* Be 6 to 12 years of age, both ages inclusive
* A low-to-moderate level of myopia (between -0.75 and -4.00 D) and of astigmatism (≤ 1.00 D)
* Neophyte contact lens wearer
* Be successfully fitted with spectacles or orthokeratology contact lenses
* Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
* Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
* White European ethnicity

Exclusion Criteria:

* Systemic or ocular disease affecting ocular health
* Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
* Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
* CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
* Aphakic, amblyopic, and atopic individuals
* Refractive astigmatism ≥ ½ spherical refraction
* Previous contact lens wear
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).


Eligibility Criteria:
Inclusion Criteria:

* Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629)
* Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

* Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or M06-827 (NCT00408629)
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Paleolithic Diet and Exercise Study

If eating a "Paleolithic" diet helps improve these diseases, this would be the first step in both improving people's health as they get older as well as contributing to future national dietary guidelines for Americans.

Because genetic evolutionary changes occur slowly in Homo sapiens, and because the traditional diet of Homo sapiens underwent dramatic changes within recent times, modern humans are better physiologically adapted to a diet similar to the one their hominid ancestors evolved on than to the diet typical of modern industrialized societies. The investigators developed a computational model to estimate the net acid load of diets from the nutrient composition of the diet's component ingredients, and suggest that the majority of these hominid diets yield a negative net acid load (that is, yield a net base load), in addition to being low in sodium chloride, high in potassium-containing fruits and vegetables, and low in saturated fats, with the majority of the non-animal-source calories coming from fruits and vegetables, not from acid-producing grains, separated fats and oils, starches and refined sugars. According to paleonutritionists, Homo sapiens' recent switch from their ancestral Paleolithic-type diet to the modern Western diet has contributed in a major way to so-called age-related diseases of civilization. The investigators hypothesize and will test whether:

1. consuming a high-potassium, low-sodium, net base-producing "Paleolithic-type" diet, even in the short term, has detectable beneficial effects on cardiovascular physiology, serum lipid profiles, insulin sensitivity, and exercise performance; and
2. their computational model predicts the measured negative net acid loads of a net base-producing "Paleolithic-type" diet, using steady-state values of renal net acid excretion as the measure of the diet net acid load (a.k.a., net endogenous acid production), which will be of value in constructing net-base producing diets for modern consumption.

The long term complications of the combination of high blood pressure, high blood sugar and high fat and cholesterol levels, sometimes called the "metabolic syndrome", has been termed the number one medical problem in modern society today. If eating a "Paleolithic" diet helps improve these diseases, this would be the first step in both improving people's health as they get older as well as contributing to future national dietary guidelines for Americans.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years and \<= 55 years
* On no medications
* Body mass index (BMI) between 18 and 29.9 kg/m2
* Normal renal and hepatic function
* Subjects who report moderate intensity exercising \<= three times a week for 30 minutes or less, who then qualify by exercise testing with a VO2max at or below age- and gender-matched controls

Exclusion Criteria:

* Subjects who must follow a specific diet
* Subjects on any daily medications
* Subjects unwilling to follow the diet specified
* Subjects unable to do the exercise testing
* Pregnant women
* Subjects who are unable to understand the consent form.
Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver.

OBJECTIVES:

Primary

* Determine the 2-year recurrence-free survival of patients with minimal metastatic colorectal cancer after hepatic resection when treated with adjuvant monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine.

Secondary

* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Beginning 6-12 weeks after curative hepatic resection, patients receive monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine intracutaneously at separate sites on days 1, 15, 29, and 45, then subcutaneously monthly for 4 months.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 9 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed hepatic colorectal metastases
* Must have undergone complete resection of hepatic colorectal metastases with tumor-free margins (curative resection) at least 6, but no more than 10, weeks prior to study entry
* No evaluable or measurable disease after hepatic resection, documented by intraoperative palpation or imaging studies including intraoperative ultrasound, CT scan, or MRI
* No hereditary non-polyposis colon cancer type B
* No CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* CTC 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least 150,000/mm\^3

Hepatic:

* Bilirubin no greater than 2 mg/dL
* AST no greater than 2 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN

Gastrointestinal:

* No celiac disease
* No familial polyposis
* No Gardner's syndrome
* No Peutz-Jeghers syndrome

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No seizure disorders requiring continuous medication
* No history of clinically significant hypersensitivity reactions, including known hypersensitivity to rodent proteins
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior murine antibodies (e.g., oncoscint scan)
* No prior monoclonal antibody 3H1 anti-idiotype vaccine or monoclonal antibody 11D10 anti-idiotype vaccine

Chemotherapy:

* No concurrent chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* Prior treatment for primary lesion or hepatic metastases allowed
* No concurrent immunomodulatory therapy