cyrilzakka/clinical-trials huggingface dataset:
Effect of Shock Waves Therapy on Chronic Anal Fissure

the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure

Design of the study:

A prospective, randomized, blind, paired (right/left) comparison.

Materials:

Measurement tool:

* healing of anal fissure,
* Wexner Constipation Scoring System
* anal pain intensity by means of a 10-point visual analogue scale (VAS)

Therapeutic instruments:

•. shock waves

• topical application of 0.4% glyceryl trinitrate (GTN) ointment

Methods:

• Testing procedures: The assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment.

• Treatment procedures: Patients will be assigned randomly into two groups equal in number: shock waves Group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control Group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (GTN) ointment only..

Eligibility Criteria:
Inclusion Criteria:

* patient with chronic anal fissure
* symptomatic for at least 6 months
* failed conservative measures

Exclusion Criteria:

* Pregnant women,
* cardiac patients,
* patients with a pacemaker,
* low molecular heparin or warfarin treatment,
* neurological disease,
Effect of Using Image Standardization Device for Dental Photography Standerdizatuon in Comparison to Individualized Photography In Vivo Study

This randomized clinical trial aimed to evaluate the effect of Image Standardization Device (ISD) on standardization of clinical images from the same entry point (patient right 45o).

Digital photography is highly important on multiple levels and has become associated with modern dentistry. Its application in dental practice is simple, quick, and extremely useful for procedures documentation, patient education, and conducting clinical research, resulting in several benefits for dentists in the terms of examination, diagnosis, treatment planning, progress and monitoring treatment outcomes. On the other hand, digital photography becomes significant tool for patient reassurance as showing before and after photos of several procedures helps in patient relaxation and understanding from the start, as well as improves the patient-dentist trust.

In the terms of producing decent digital dental photographs, standardization in several aspects of the photographic equipment, environment, and patient position become a critical issue for successful reproducible photographs.

Different standardization methods have been mentioned in the literature, some of them discussed the standardization characteristics in the terms of camera settings and adjustment using tripod only with standardized camera/patient distance, lighting, and background color. Other studies discussed standardization from a different point of view regarding the standardized patient head position and fixed camera/ patient distance using various devices slightly resembles the ISD used in this study.

The methodology of the current study included a total of twenty patients, photographed with ISD taking duplicate photographs and using individualized photography as a control group via conventional Tripod from the same photography point at 45º from the patient's right side to study the effect of the image standardization device in photograph standardization over conventional imaging methods. The Intervention used in this study was bleaching that was done before taking the same photographs once again from the same projections to reproduce the same images using both methods.

The assessment was done by measuring in millimeters the horizontal and vertical measurements of the canine in each patient by using a ruler tool on digital software and comparing them with the reference standard which was the canine's real measurements.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with full set of anterior teeth willing to participate in the study in return to perform dental bleaching procedures

Exclusion Criteria:

* Patients with missing anterior teeth
* Patients with fillings in labial surface of anterior teeth
* Patients with prosthodontics in anterior teeth
* Patients with dental sensitivity
* Patients under 16 years old (bleaching age restrictions)
A Study to Evaluate AZP531 in Healthy Volunteers, Overweight/Obese Volunteers and Patients With Type 2 Diabetes Mellitus

Objectives:

Primary Objectives

* To investigate the safety and tolerability of single ascending doses of AZP- 531 in healthy volunteers.
* To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in overweight/obese volunteers.
* To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in patients with type 2 diabetes mellitus.

Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses.

Exploratory Objectives

• To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated ghrelin (UAG)


Eligibility Criteria:
Inclusion Criteria:

* Part A: Healthy male volunteers, aged 18 to 50 years (inclusive) with a body mass index (BMI) of 20 to 28 kg/m2 (inclusive).
* Part B: Female (of non-childbearing potential) and male overweight/obese volunteers, aged 18 to 65 years (inclusive) with a BMI of 28 to 38 kg/m2 (inclusive).
* Part C: Female (of non-childbearing potential) and male patients with a confirmed diagnosis of type 2 diabetes mellitus for at least 3 months

Exclusion Criteria:

* Part A: Females and male volunteers who smoke and/or use other nicotine products within 6 months of screening are excluded.
* Part B: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) and any clinically significant abnormalities in physical examination, electrocardiogram (ECG), clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator.
* Part C: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year), any clinically significant abnormalities other than those attributed to type 2 diabetes mellitus in physical examination, ECG, clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator, and estimated glomerular filtration rate \<40 mL\*min-1\*1.73m-2 calculated by the Modification of Diet in Renal Disease formula.
Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* men and non-pregnant, non-breastfeeding women
* anticipated to be severely immobilized for at least 24 hours after randomization
* hospitalized with one of the following

  * congestive heart failure
  * acute respiratory failure,
  * acute infection without septic shock,
  * acute rheumatic disorders
  * acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria:

* a condition requiring prolonged anticoagulation or anti-platelets
* active bleeding or at high risk of bleeding
* contraindication to anticoagulant therapy
* general conditions in which subjects are not suitable to participate in the study
Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer

The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for locally advanced rectal cancer.

Pre-operative radiotherapy (RT) or chemo-radiotherapy (CRT) is internationally accepted as standard practice in the management of locally advanced rectal cancer.

Multiple randomised trials have proved pre-operative CRT and RT, compared to surgery alone, reduce local recurrence, even prior to optimal surgery, and may improve survival for T3 circumferential resection margin (CRM) negative patients.

This study aims to determine if 3-DCRT or IMRT result in lower incidence of grade 2 GI toxicities.

Acute toxicities will be assessed weekly during radiotherapy, and at 2 and 4 week post treatment.

Late toxicities will be assessed at 3, 6, 9, 12, 18, 24 months post treatment, and annually to 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pre-operative pelvic chemo-radiotherapy for histologically confirmed rectal adenocarcinoma, with the following staging: cT3N0-2, cT4N0-2, cT(any)N1-2, cT(any)N(any) CRM at-risk \[AJCC version V\]
* Staging / imaging of pelvis with MRI, and CT Thorax/Abdomen
* No evidence of metastatic disease
* ECOG Performance Status 0 - 2
* Age \> or equal to 18 years
* Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

* Previous radiotherapy to the pelvic region
* Patients in whom induction chemotherapy has been delivered prior to chemo- radiotherapy
* History of inflammatory bowel disease
* Previous hip replacement
* Previous bowel surgery (excluding procedures/operations which would not result in small bowel adhesions - at the discretion of the Principal Investigator)
* Patients with other syndromes/conditions associated with increased radiosensitivity
* Any other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
* Pregnancy or lactation at the time of proposed randomisation
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
SCD-HeFT 10 Year Follow-up

No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and the longest average follow-up at 45.5 months. This study changed the national reimbursement policy for ICD therapy and remains the reference point for all other ICD evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. Despite the outcome, the role of ICD therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of therapy. The purpose of this trial is to track down the remaining patients for a one-time follow-up regarding key outcome data.

Long-term outcome data for implantable cardioverter defibrillator (ICD) therapy is sorely needed. We will acquire these data by re-approaching the patient population from the original Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).\[Bardy 2005\] This research is supported by the National Heart Lung and Blood Institute of the National Institutes of Health.

SCD-HeFT was originally conducted from 1997 to 2003. It demonstrated unequivocally that ICD's save lives in patients with heart failure compared to placebo or amiodarone. More than 26 peer-reviewed publications, including three NEJM papers, have resulted from this work.\[Bardy 2005, Poole 2008, Mark 2008\] Despite the quality of SCD-HeFT and the evidence of the life-saving ability of ICD therapy, the role of ICD therapy in the management of patients with heart failure continues to be questioned. This study will provide long-term follow-up of the SCD-HeFT patients, which will now exceed 10 years on average.

Eligibility Criteria:
Inclusion Criteria:

This is a one time follow-up on patients previously enrolled. -

Exclusion Criteria:

This is a one time follow-up on patients previously enrolled.

-
Prospective Multi-Center Study on Vanguard With E1 Bearing

Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population

E1™ Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E. Biomet Inc, has received FDA clearance to market tibial polyethylene components made of E1™ for use in the Vanguard total knee replacement system.

Vanguard Total Knee System™ The Vanguard™ Knee System was designed to incorporate features from prior designs, including: ACG, Maxim, \& Ascent. The Vanguard Knee includes a streamlined design, rounded sagittal profile, and a deeper trochlear groove. The femoral component is available in Cruciate Retaining (CR), Posterior Stabilizing (PS), and Super Stabilized (SSK). Tibial Bearings are available in various levels of constraint required by the surgeon (CR, PS, AS, etc.).

For this study, ONLY Vanguard with PS Bearing will be used.

The purpose of the study is to evaluate clinical performance of Vanguard Knee with E1 Bearing in TKA in Korean patient population. The clinical performance will be evaluated based on patient outcomes, radiographic assessment and survivorship.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included in this study if they received Vanguard knee with E1 Bearing per the approved indications for use for Vanguard Knee. Specifically

* Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved
* Correction of varus, valgus, or posttraumatic deformity
* Correction or revision of unsuccessful osteotomy

Exclusion Criteria:

Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Vanguard™ Knee and the E1™ Tibial Bearing. These indications are stated below:

Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement

Relative contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands

The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Chinese origin
* Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions

Exclusion Criteria:

* Any previous non-permanent implant/filler in the hands
* Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline
* Any previous hand surgery
* Any fibrosis or scarring or deformities on the hands
* Advanced photoaged/photodamaged skin
Diagnostic Approach of Deep Vein Thrombosis in Primary Care

To asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care. To describe the differential diagnosis and the strength of association between each outcome variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional, multicentric study.

The participants are the patients referred from the 15 primary care centers (400.000 inhabitants) to the Hospital de la Santa Creu i Sant Pau emergency department with suspected DVT. We will enter physical examination and anamnesis variables, Wells and Oudega's rules variables, D-Dimer value and ultrasonography result. The outcome variables are the cost (€) of each possible way of diagnostic approach and the effectiveness will be measured by the ultrasonography result, which confirms or excludes the diagnosis. The sample will include 437 patients. A decision tree will be developed to analyze the different diagnostic options in DVT cases, using standard notation.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau

Exclusion Criteria:

* anticoagulant treatment
* patients who will not be able to follow control visit
* patients with oncologic treatment
Dental Age Estimation by Different Methods in Patients With Amelogenesis Imperfecta

The aim of this study is to investigate whether there is a significant difference in dental age between children with amelogenesis imperfecta (AI) and healthy controls using Cameriere European formula and London Atlas. If there is a significant difference in dental age between children with AI and healthy controls, it is aimed to create a new formula.

One of the developmental enamel defects, amelogenesis imperfecta (AI), is also known as enamel hypoplasia/hypomineralization. It is a rare inherited disease that affects the enamel structure, amount and component in primary and permanent teeth, and it has been reported to be accompanied by some dental anomalies and nephrocalcinosis. Dental anomalies and nephrocalcinosis can affect tooth development, and there are limited studies examining tooth development in these individuals.Dental age is widely evaluated by pedodontists, forensic dentists and orthodontists. While a delay in tooth development may be associated with growth retardation and learning difficulties, dental age determination can also be used for forensic age determination for children whose birth information is uncertain. A clear assessment of maturation in children with continued growth is important in establishing a dental treatment plan.

Dental age is widely evaluated by pedodontists, forensic dentists and orthodontists. While a delay in tooth development may be associated with growth retardation and learning difficulties, dental age determination can also be used for forensic age determination for children whose birth information is uncertain. A clear assessment of maturation in children with continued growth is important in establishing a dental treatment plan.

There are two basic approaches to dental age determination in children:

1. evaluation of eruption of teeth in the oral cavity,
2. evaluation of the development and mineralization of crowns and roots on dental radiographs.

In many methods, the developmental stages of different numbers of permanent teeth are used.

One of the most widely used methods of dental age determination recently is the European formula of Cameriere et al., which is calculated based on open apex. It has been reported that this method has been tested on different population groups, and the results are accurate and reliable.

An atlas method was proposed by a group of London researchers in 2010. The Atlas shows all the teeth array images of certain age groups as a schematic series. Age determination is made by deciding which reference image matches the individual's panoramic radiography image more.

Eligibility Criteria:
Inclusion Criteria:

* 5-13 years old
* Healthy children
* Children with AI
* Patients without missing left mandibular permanent teeth on panoramic radiography

Exclusion Criteria:

* Children older than 5 years old and younger than 14 years (children that cannot be assessed by the Willems and Cameriere method)
* Poor quality panoramic radiography
* Patients who have received orthodontic treatment
* Patients who received restorative or endodontic treatment
Promoting Clinical Preventive Services Among Adults With Disabilities

Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a participatory action research project to test an intervention package combining a resource kit with peer mentoring in improving consumer education about primary preventive services

Adults with disabilities use primary preventive health care services (basic screenings, immunizations, and hevior health counseling) at rates below those recommended by the US Preventive Services Task Force and Healthy People 2010. This projects is to carry out a community-based campaign to increase preventive care knowledge and service use among adults with physical disabilities. Focus group methodology will be used to determine the specific preventive service priorities of the disability community so that targeted resource materials for consumers and physicians can be developed. Second, a randomized control group experiment will be implemented to evaluate the effectiveness of the targeted resource materials, followed by dissemination of the Preventive Services Resource Kits.

Eligibility Criteria:
Inclusion Criteria:

* primary residence in Northern Virginia presence of a physical disability at least 18 years old

Exclusion Criteria:

-
Validation of the Zigzag Tracking Task Test for the Evaluation of Handwriting Difficulties in Writer's Cramp

Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm.

Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy).

The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.


Eligibility Criteria:
Inclusion Criteria:

* scholarship in French language, at least until 16 years old
* writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders)
* prescription of botulinum neurotoxin injection
* prescription de novo or absence of injection in the last 3 months
* informed consent
* medical insurance coverage

Exclusion Criteria:

* writing tremor
* -other neurological disease with effect on handwriting
* pain or traumatism of the upper limb, with effect on handwriting
* non-corrected visual disturbances
* patient living outside the region where the study will be held (Ile-de-France)
* participation in another research with a potential impact on evaluation criteria
* pregnant or breast feeding patient
* patient under judiciary protection