cyrilzakka/clinical-trials huggingface dataset:
Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage

This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.

Hemorrhagic stroke caused by an intracerebral hemorrhage (ICH) is a common (roughly 15% of all strokes) and devastating disease with high rates of mortality and morbidity. The most important potentially modifiable prognostic factor after acute diagnosis of an ICH is hematoma expansion.

The investigators hypothesize that in hyperacute ICH patients a treatment target can be detected with a diagnostic, cerebral DSA. The DSA is the goldstandard for the visualization of brain vessels. A treatment target would be a vessel from which contrast media extravasates as a sign of an active bleeding. If such a target could be identified, it could lay the rationale for future trials which would evaluate if stopping the bleeding directly at the origin improves patient outcomes. The only intervention in this study is an additional diagnostic cerebral DSA. This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an acute spontaneous ICH based on non-contrast CT
* Time from symptom onset to anticipated start of cerebral DSA of under 3 hours
* Agreement of the treating physician to perform DSA
* Informed consent documented by signature or fulfilling the criteria for emergency consent procedures (deferral of consent)

Exclusion Criteria:

* High probability that the etiology of the bleeding is a ruptured aneurysm, an arteriovenous malformation or an amyloid angiopathy as judged by the treating physician
* Any time critical surgical or minimal invasive intervention is planned
* Evidence of an ongoing pregnancy, a negative pregnancy test is mandatory in all persons of childbearing potential
* Contraindications against the use of iodine contrast media
* Known severe kidney insufficiency (Glomerular filtration rate \< 30 ml/min)
Mainz Outcome Predictor Studies: An Observational Clinical Trial Investigating Predictors for Postoperative Outcome

The purpose of this study is to determine whether psychological and social factors in addition to medical (physiological) conditions may contribute significantly to the prediction of the postoperative outcome.

Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life.

Different factors contribute to the recovery process after surgical intervention. However, little is known about the predictive value of single factors.

In addition to medical (physical) factors, depression, anxiety, somatization and avoiding coping styles are considered as relevant for the successful recovery process. These factors may be defined as "psychological distress" and could be used as predictors for perioperative complications and failed surgical treatment.

Postoperative outcome is defined (1) as postoperative complications and organ dysfunction and (2) alteration of quality of life.

Our sample includes adults undergoing extensive surgical interventions in trauma and orthopaedic surgery, urology, general surgery, and neurosurgery. The defined variables are measured using standardized and validated questionnaires prior to surgery and in follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Minimum Age 18 Years
* German language in speaking and writing
* Capability of giving consent
* written informed consent

Exclusion Criteria:

* Delirium, dementia or other mental disorders with significant cerebral dysfunction
* People under guardianship
* simultaneous participation in other clinical studies
Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults with PKP2 Mutation-associated ARVC

This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.

The RIDGE-1™ open-label Safety, Tolerability, Dose-finding, PD and Cardiac Transgene Expression Study will enroll up to 15 patients in two planned dose cohorts. Patients in each cohort will receive a single intravenous (IV) dose of TN-401. Following Data Safety Monitoring Board (DSMB) review of each dose cohort, the next dose cohort will be initiated. DSMB review will also be needed to expand the dose cohorts. The dose for Cohorts 1/1a will be 3E13 (3 × 1013) vg/kg and the dose for Cohorts 2/2a will be 6E13 (6 × 1013) vg/kg.

Eligibility Criteria:
Inclusion Criteria:

* PKP2 mutation (pathogenic or likely pathogenic)
* Arrhythmogenic Right Ventricular Cardiomyopathy as defined by the 2010 revised Task Force Criteria
* Left Ventricular Ejection Fraction ≥50%
* Functioning Implantable Cardiac Defibrillator with remote integration capabilities at least 9 months prior to Screening
* NYHA Functional Class I, II, or III
* Frequent premature ventricular contractions (PVCs)

Exclusion Criteria:

* Ventricular tachycardia (VT) ablation within 6 months of Screening or planned VT ablation within 6 months after Screening
* High AAV9 neutralizing antibody titer
* Prior myocardial infarction
* Right Ventricular Heart Failure
* Class IV Heart Failure
* Clinically significant renal disease
* Clinically significant liver disease
Evaluation of a Soft Exoskeleton to Support Forward Leaning and Lifting

In this study the LiftSuit version 2.0 designed by Auxivo AG will be used. The LiftSuit is a soft wearable device that is designed to support workers perform physically demanding tasks including repetitive lifting and working in forward leaning positions. It is put on like a backpack and attached to the body using fabric bands and cuffs. Besides soft fabric parts the LiftSuit contains elastics elements. The elastic elements can be flexibly exchanged by the experimenter. For this experiment elastic elements of known stiffness will be hooked into the fabric frame.

In a first step participants will try on the LiftSuit exoskeleton and adjust it to their body under supervision of the experimenter. When the LiftSuit exoskeleton is adjusted to the participant it is taken off to allow placement of sensors. The sensors used to record heart rate (Polar H9 heart rate monitor, Polar Electro Europe AG, Germany), muscle activity from 8 muscles in the back and hip region (Delsys Trigno, Delsys Europe, United Kingdom) and movement kinematics (OptiTrack motion capture system, NaturalPoint Inc., USA) will be placed by the experimenter (or participant him/herself). To verify that the electromyography sensors, are working and to obtain normalization values, participants will be instructed to conduct maximal voluntary contractions of each muscle that are being recorded. If needed single sensors can be replaced. After this the exoskeleton will be put back on.

Eligibility Criteria:
Inclusion Criteria:

* Included will be volunteers of both sexes within working age (18 to 65 years).

Exclusion Criteria:

* Participants will be excluded if they cannot perform the tasks (squat lifting and forward leaning) due to physical limitations. Furthermore, people who report acute joint or muscle pain or stiffness, or a self-reported history of such problems will be excluded.
Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE

Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the increase of allergen-specific serum IgE levels following nasal exposure to recombinant allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal provocation and serum IgE levels will be followed during eight weeks after nasal provocation.


Eligibility Criteria:
Inclusion Criteria:

* male or female 18-50 years of age
* moderate to severe allergic rhinitis to grass and/or birch pollen for at least two seasons according to history
* sensitization to rPhl p 5 and rBet v 1 as demonstrated by UniCAP within a range from 3.0-80 kUA/l and a positive (wheal diameter \>= 3 mm larger than the negative control and half of the histamine control) SPT with rPhl p 5 and rBet v 1 at 20 µg/ml
* willingness to comply with the study protocol
* written informed consent

Exclusion Criteria:

* perennial allergic rhinitis
* history of asthma necessitating treatment
* FEV1 \<70% of predicted value
* abnormalities at auscultation of heart or lungs
* history of anaphylaxis
* severe atopic dermatitis
* total serum IgE \>2000 kU/l
* previous or ongoing immunotherapy (subcutaneous or sublingual) to grass or birch pollen
* nasal provocation testing during the previous six month
* known allergy/intolerance to fluticasone propionate or loratadine
* known allergy/intolerance to cellulose, polysorbate, phenylethyl alcohol, benzalkonium chloride
* contraindications for the use of INCS:
* acute or chronic infections of the upper respiratory tract
* surgery of the nose during the previous year
* hypersensitivity to components of the drug
* contraindications for nasal provocation test
* acute rhinosinusitis
* acute allergic reaction of the immediate type at other organs
* nasal polyposis or significant nasal anatomical deformities
* vasomotor rhinitis
* autoimmune disease, chronic or acute infectious disease, malignancy
* severe psychological disorder
* treatment with systemic or topical (intranasal, inhaled, external) corticosteroids from 3 month prior to the study
* treatment with other immunosuppressant drugs from 6 month prior to the study
* treatment with antihistamines or disodium cromoglycate from 2 weeks prior to the study
* treatment with intranasal adrenergic drugs from 3 days prior to the study
* treatment with systemic adrenergic drugs
* treatment with psychopharmacological drugs from 2 weeks prior to the study
* cardiovascular or pulmonary disease
* contraindication for adrenaline
* participation in any other clinical trial within the previous 3 month
* pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method
* a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
* known alcohol or drug addiction or abuse
* unlikelihood to be able to complete the study
Urine Cadmium Levels in Predicting Pancreatic Cancer Risk in Patients With Chronic Pancreatitis

RATIONALE: Measuring cadmium levels in urine samples from patients with chronic pancreatitis may help doctors predict which patients may develop pancreatic cancer. It may also help the study of cancer in the future.

PURPOSE: This clinical trial is studying urine cadmium levels in predicting pancreatic cancer risk in patients with chronic pancreatitis.

OBJECTIVES:

Primary

* Obtain urine samples and questionnaire data on cadmium exposure in patients with chronic pancreatitis.
* Analyze these data to determine risk of pancreatic cancer using urine cadmium levels.

Secondary

* Analyze these data in conjunction with data on serum CA 19-9, to determine whether urinary cadmium has clinical utility in predicting pancreatic cancer.
* Determine the sensitivity, specificity, and positive and negative predictive values for the cadmium test alone, CA 19-9 alone, and both tests together.

OUTLINE: This is a pilot study.

Patients complete a questionnaire over approximately 20 minutes on lifetime exposure to cadmium, including dietary, occupational, and recreational exposure, smoking history, and residence. Patients also provide a urine sample that is analyzed by atomic absorption spectrophotometry. Serum CA 19-9 levels are obtained from medical record if available.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinical diagnosis of chronic pancreatitis
* Being seen in the Department of Gastroenterology at Wake Forest University Baptist Medical Center

PATIENT CHARACTERISTICS:

* No type II diabetes
* Able to understand and respond to questionnaire
* Able to provide urine specimen
* Speaks English

PRIOR CONCURRENT THERAPY:

* Not specified
Creatine Supplementation in Pediatric Rheumatology

Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in healthy and elderly people. The investigators speculate that creatine supplementation could have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting and bone mass loss.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis
* physically inactive
* stable pharmacological treatment

Exclusion Criteria:

* macroalbuminuria
* GFR \< 30 mL/min/1.73m2
* use of oral anticontraceptive agents
* pregnancy
* diabetes mellitus
* hypothyroidism
Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration.


Eligibility Criteria:
Inclusion Criteria:

* Male or female above 18 or below 65 years old
* Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)
* Written informed consent

Exclusion Criteria:

* Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months
* Patient who has an history of psychiatric diseases, such as:

  * anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be \< 10
  * depression according to the DSM IV criteria; the score of the HAMD (Hamilton depression scale) must be \< 10
  * mania
  * schizophrenia
  * dementia
* Patient who has an history of neurologic diseases, such as:

  * Parkinson syndrome
  * crania cerebral trauma post syndrome
  * brain tumor
  * fibromyalgia
* Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic
* Patient with an hypersomnia or a sleep apnea syndrome
* Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea
* Patient with a Restless Leg Syndrome
* Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator, or any known clinically significant disease which may induce a risk for the patient in participating to the trial
* Breast feeding or pregnant female, or female with no efficient contraception method
* Patient with non-stabilised thyroid dysfunction
* Patient with a known allergy to Eschscholtzia Californica or its compounds
* Patient with alcohol or drug dependency
* Patient drinking tea, coffee or Coca-Cola after 4 p.m.
Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction

Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these patients and typically, obstetric management involves interventional delivery, particularly problematic when remote from term. This study assess the hypothesis that epidural local anesthetics may improve UPBF in these patients.

Women with sonographic uterine artery flow abnormalities and either PE or IUGR (or both) were randomized to either ACET or non ACET control. Both groups were able to receive standard therapies (in-hospital monitoring, magnesium and anti-hypertensives as appropriate). The first five days of the therapeutic arm (ACET) consisted of a dose-finding trial, where epidural ropivacaine infusions (10ml/hr for 24 hours) of 0•04%, 0•06%, 0•08% and 0•1% and a saline placebo were each administered via tunneled epidural catheters in a randomized, double-blinded, cross-over design over five consecutive days; all three women received all doses. Doppler measurement of flow in the uterine artery was performed at baseline and at the end of each dose period. The ideal dose for an individual was determined to be lowest dose of drug giving maximal effect without side effects; in the second stage of the study, this dose was administered until delivery with the addition of a second placebo day to during this period.

Eligibility Criteria:
Inclusion Criteria:

* 1. Reliable gestational age based upon an ultrasound crown-rump length performed between 7 to 14 completed weeks gestation. If the ultrasound date matches the date of the last menstrual period (LMP) within 7 days, the LMP date is used, otherwise the ultrasound date is used.

  2. Gestational age at the time of enrollment between 28 to 32 weeks (based upon 1.) and need for in-hospital observation or treatment REGARDLESS of the study.

  3. Presence of uterine artery notching in ultrasound scan. 4. EITHER 4a or 4b (if both, the patient is enrolled as for 4a): 4a. Pre-eclampsia: Women must have criteria #1 and #2 Criterion #1: Hypertension (\> 140/90) at rest, measured twice, at least 6 hours apart.

Criterion #2: Proteinuria:

EITHER: At least 0.1 g/l in two random samples at least 6 hours apart. OR: At least 0.3g in a 24 hour collection.

4b Intrauterine growth retardation (IUGR): Women must have criteria #1 and #2. Criterion #1: Ultrasound abdominal circumference below 10th percentile. Criterion #2: Established IUGR for at least 2 weeks.

Exclusion Criteria:

* at the time of enrollment: active labor, severe pre-eclampsia, (resting blood pressure ≥ 160mmHg systolic or 110 diastolic, recorded on at least two occasions 6 hours apart), known fetal anomaly, intrauterine infection, placental anomalies (previa, abruption, circumvallate, infarction), twins, and refusal of consent.
Efficacy of Dietary Education and Education on Phosphate Binder Use in Hemodialysis Patients

Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. And most phosphate in human is derived from the food. The purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients.

Hyperphosphatemia is an independent risk factor for mortality among dialysis patients. Hyperphosphatemia is associated with increased incidence of cardiovascular diseases, and is a mediator to the development of hyperparathyroidism and mineral bone disorder. Phosphate is usually obtained by food intake, and it can be removed by hemodialysis. However, the efficacy of removal is limited, so that dietary education and proper intake of phosphate binder is essential.

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease patients whose dialysis vintage is more than 3 months

Exclusion Criteria:

* Patients with liver cirrhosis
* Pregnant patients
* Patients with alimentary tract malabsorption diseases
* History of recent alcohol or drug abuse
* Patients receiving chemotherapy for solid organ tumor
* History of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.)
* Patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)
Evaluation Of The Effect Of Surface Properties On The Stabılıty Of The Different Implants

This randomised clinical study aims to evaluate different surfaced implants (alkali-modified surfaced implants or sand-blasted surfaced implants) stability with resonance frequency analysis(RFA).

This is randomised controlled double blind study. Fourteen patients (8 women and 6 men;age 43.7 ± 8.56 years) who were attending the Oral and Maxillofacial Surgery Department and scheduled for implant placement surgery were included in this study. Dental implants were placed using one-stage protocol. After adminstration of local anesthesia (Ultracain DS; Aventis Pharmaceuticals, Istanbul, Turkey ), an incision was made on the alveolar ridge. A total of 50 implants (Impladent implants from the Lasak) were placed in the not site assignement mandibular premolar/molar sites according to the manufacturer's instructions. To prevent bias which implant to the right or left to make the decision investigators decided by envelope. The person making the measurement does not know which surface implant is made to the patient. An equal number of implants were applied simultaneously with different surfaces. The patient does not know where the implant is placed. All used implants were 3.7 width, 10mm. height and same design for standardization this study. Investigators obtained good primarly stability and placed a healing cap for 45 implants . 3 sandblasted and acid-and alkali-treated surface straight (bioactive)implants and 2 sandblasted surface straight implants were excluded in this study for bad primary stability. Investigators used to measure implant stability with Osstell ISQ ( Integration diagnostic AB, Savedalen, Sweden) for each implant at the time of surgery before flap closure, 2. week,6. week and 12. week postoperatively.This device was used in both buccolingual and mesiodistal direction. The Smartpegs (Integration Diagnostics AB, Göteborg, Sweden) were compressed and the measurements were performed by the same surgeon for standardization of the stability measurements. The measurements were taken twice in the buccolingual direction and twice in the mesiodistal direction. The arithmetic mean of the 2 measurements from each direction was regarded as the representative ISQ of that implant. In addition, each implant was clinically evaluated at all visits for mobility, pain, and signs of infection.

Eligibility Criteria:
Inclusion Criteria:

1.A healthy medical condition (ASA 1 and ASA 2 according to the American Society of Anesthesiologists classification) 2.The ability to withstand the stress of dental implant surgery 3.The need for bilateral implant-supported rehabilitation in the mandibular premolar/molar area.

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Exclusion Criteria:

1. An active infection or severe inflammation in the areas intended for implant placement
2. Metabolic bone disorder
3. Uncontrolled diabetes
4. Hematologic disorder
5. Need for bone augmentation
6. The smokers
7. Drug users (anti-inflammatory agents, bisphosphonates)
8. Pregnant patients