cyrilzakka/clinical-trials huggingface dataset:
Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses

Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. The purpose of the study was to evaluate the cost of both strategies in comparison to their success rate.

The primary criterion will be the cost-utility ratio (ICER) at 12 months follow-up.

The secondary criteria will be:

* quality of life;
* pain;
* persistence or recurrence of infection;
* occurrence of complications ;
* necessity for reoperation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Chronically infected total hip or knee arthroplasty requiring implant exchange
* Affiliation to a social security system
* Signed informed consent
* Effective contraception during all study

Exclusion Criteria:

* Repeat exchange after failure of a prior treatment for infection
* Multiple implant infection
* Infection due to mycobacteria or fungus
* Pregnancy / Breast feeding
* Patient under judicial protection
* Impossibility to give informed consent for any reason
* Participation to another study
A Trial of CM-AT in Children With Autism

The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.

Autism is currently a significant cause of disability in the pediatric population. Treatment is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a powder taken three times a day.

Eligibility Criteria:
Inclusion Criteria:

* Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD)

Exclusion Criteria:

* Patient weighing \< 11kg (24.2 lbs.)
* Demonstrated previous allergy to porcine (pork) products
* Previous history of severe head trauma or stroke, seizure within one year of entering study or uncontrolled systemic disease
* Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease
* Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion)
* Use of of any stimulant medication must be discontinued 5 days prior to entering the study.
* Subject must have a stable dose of SSRI's for at least 30 days.
Application of Cheek Acupuncture in Vaginal Tightening Surgery

A large number of studies have shown that acupuncture can reduce perioperative pain in patients. Cheek acupuncture therapy is a new acupuncture treatment, which belongs to the microneedle system, that is, acupuncture at specific acupoint on the face, which can relieve patients' pain. In this study, the efficacy and safety of cheek acupuncture in patients undergoing vaginal tightening surgery was verified by observing the consumption of opioid, intraoperative hemodynamics, dosage of oral remedial analgesics, postoperative quality of recovery, patient satisfaction, incidence of side effects, etc.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-60 years, undergoing vaginal tightening surgery
* American Society of Anesthesiologists (ASA) physical status I to II
* Voluntary participation and signed an informed consent form

Exclusion Criteria:

* Acute and/or chronic pain before surgery
* History of congenital heart disease, arrhythmia, or hypertension
* History of severe mental or neurological diseases, drug or psychotropic drug abuse
* Cognitive dysfunction or inability to communicate.
* The acupuncture acupoints are infected
* Coagulation disorders
* Patients with mandibular or zygomatic bone osteotomy
Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.

Sedative drugs are widely-used during endoscopic procedures. The administration of these drugs contain the potential hazard of breathing and cardiac complications. Moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. We assume this also to be true related to short anesthesia during colonoscopy. Patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. We compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.

Eligibility Criteria:
Inclusion Criteria:

* colonoscopy indicated

Exclusion Criteria:

* patient denies sedation
* prior saturation \< 90%
* prior heart rate \< 50 bpm
* prior blood pressure \< 90 mmHg
Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases

Endoscopic implantation of plastic or covered metal stents is widely used in a variety of benign pancreaticobiliary diseases, including duct stricture, large or difficult stones, bile or pancreatic juice leak, etc. There are some late-stage adverse events after stent insertion, such as stent occlusion, proximal or distal migration, secondary duct injury and failure of stent removal, etc. The longer the stents were inserted, more likely the adverse events would happen.

Although the optimal time of stent placement has not been well established, it has been recommended that plastic stent should be removed/exchanged within 3-4 months and covered metal stent be removed within 6 months. However, it was not uncommon that patients with stent implantation did not follow the recommendation of further stent management by endoscopists.

Many methods have been used to improve the adherence of patients in medical service. With the advance of mobile technology and popular use of mobile phones, it was believed that the patient-centered outcome could be improved by mobile telecommunication with the timely support of a patient by a health professional. Thus we hypothesize that mobile technology, reminding the patients the necessity of stent management in time by short message service (SMS), might increase the patient adherence in patients with benign pancreaticobiliary diseases after ERCP.


Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 years old with plastic or covered stent implantation for the drainage of bile or pancreatic juice.

Exclusion Criteria:

* primary or secondary sclerosing cholangitis;
* malignant or suspected malignant stricture of biliary or pancreatic duct;
* implantation of pancreatic duct stent for prevention of post-ERCP pancreatitis;
* expected survival time less than 6 months;
* plan of surgery within 6 months;
* pregnant or lactating women;
* patients who could not give informed consent.
Hemostatic Procedure After Biopsy of the Cervix

Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.


Eligibility Criteria:
Inclusion Criteria:

* abnormal pap smear
* first colposcopy ever

Exclusion Criteria:

* pregnancy
* bleeding disorder
* the use of blood thinner
* language barrier
* unwillingness to participate
Curcumin (Tumeric) in the Treatment of Irritable Bowel Syndrome: A Randomized-Controlled Trial

Evidence exists to support low-grade inflammation as the inciting factor leading to visceral hypersensitivity and alteration in motility in irritable bowel syndrome.In the medical literature,there is ample in vitro and in vivo evidence supporting turmeric and its derivative curcumin as an antitumor, anti-inflammatory and antioxidant agent. We propose a randomized, placebo-controlled, double blinded, parallel treatment study evaluating the effects of turmeric on the symptoms of irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

Patients from the hospitals and clinics of the Southern California Permanente Medical Group who conform to the Rome III criteria and

* Age 18 years and above,
* Male or female,
* Able to give consent and follow the treatment plan and be able to answer surveys.
* Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study.

Exclusion Criteria:

* Any of the following: diabetes, HIV disease, use of anticoagulants or antiplatelet medication, abnormal coagulation or thrombocytopenia, biliary obstruction, inflammatory bowel, symptomatic gallstones, celiac disease, ongoing use of medications known to cause or exacerbate symptoms of IBS and chronic, daily users of IBS medications.
* Use of scheduled IBS medications for 4 weeks prior to and during the treatment period.
Efficacy of Chlorhexidine as a Final Irrigant in Single-visit Root Canal Treatment

Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated in single versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% CHX before obturation. The other teeth were treated in multiple visits (MV) with calcium hydroxide dressing. All patients were recalled and investigated clinically and radiographically for 24 months.

The aim of the study was to evaluate postoperative pain and radiographic evidence of periapical healing in teeth with apical periodontitis treated in a single visit with an additional final irrigation using 2% chlorhexidine and to compare the results with conventional multiple-visit root canal treatment (RCT) with an intracanal calcium hydroxide dressing as a control group. Ninety asymptomatic maxillary anterior teeth with periapical lesions were treated by a single operator using the step-back technique with manual instrumentation with 2.5% sodium hypochlorite (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. Half of the teeth were randomly assigned to the single-visit (SV) group and received an additional final rinse with 2% chlorhexidine (CHX) before obturation. The other teeth were treated in multiple visits (MV), after completion of root canal instrumentation calcium hydroxide paste was placed into the root canal and root canal obturation was performed in second visit. All patients were recalled and investigated clinically and radiographically for 24 months. Postoperative pain at 24-48 hours and changes in apical bone density indicating radiographic healing were evaluated statistically using the Mann-Whitney U-test followed by the Friedman and the Wilcoxon tests (α=.05).

Eligibility Criteria:
Inclusion Criteria:

* patients with a non-contributory medical history,
* mature maxillary anterior teeth with periapical lesions (\< 5 mm),
* diagnosed as asymptomatic apical periodontitis.

Exclusion Criteria:

* clinical symptoms, drainage,
* more than 5 mm loss of periodontal attachment,
* previous endodontic treatment,
* non-restorable tooth.
Use of 3D Ultrasound to Predict Anal Sphincter Defects

Injury to the muscles of the back passage (anal canal) is a relatively common problem. This injury can result in problems with bowel control later in life and usually occurs during vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently women who have sustained injury to the muscles of the back passage undergo an ultrasound scan by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of the back passage has healed i.e is intact or has a defect. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the defects and hence avoid inserting the probe into the back passage. In addition to getting the above information using 3D ultrasound scan, the investigators would also like to identify injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury to this muscle are known to develop prolapse later on in life.


Eligibility Criteria:
Inclusion Criteria:

* Women who sustained an obstetric anal sphincter injury referred to the perineal clinic

Exclusion Criteria:

* None
Effects of THW and rhTSH in Glomerular Filtration Rate During RIT

To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.

Radioiodine therapy in thyroid carcinoma is a procedure performed for over six decades, and there is a vast literature in respect of its value in the complementary treatment of this neoplasia. This procedure also promotes a reliable follow-up based on sequential thyroglobulin dosages and makes possible to reduce the disease recurrence rate. One of the main aspects of the patients preparation before receiving the radioiodine consists in promoting stimulation for an effective uptake of the radioiodine, obtained either by endogenously TSH level elevation after post-surgical thyroid hormone withdrawal, or exogenously after use of recombinant human TSH. This last alternative does not demand suspension of thyroid hormone reposition after total thyroidectomy. Although not fully comprehended, it is known that hypothyroidism results in renal function hazard, which is reverted after hormonal reposition. It is also known that renal function modifies the radioiodine residence time and that the longer this time, the greater the patient's radiation exposure will be, and consequently with undesired irradiation of healthy tissues and organs. So theoretically stimulating the patient with recombinant human TSH could avoid the transient deficient renal function, promoting a lower radioiodine residence time and consequently lowering radiation exposure in this therapy.

This project aims to evaluate the effects of the different stimulation, endogenous and exogenous, over renal function by glomerular filtration rate determined by 51Cr-EDTA. This will be a controlled and randomized study in which 44 patients that has clinical indication of remnant ablative radioiodine treatment will be prepared by either one of the TSH stimulation procedures. Additionally radiation dosimetry calculus will be done to analyze the levels of the patient's radiation exposure associated with each of the uptake stimulation procedures for radioiodine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Normal Renal Function

Exclusion Criteria:

* Abnormal Renal Function
* Renal metastasis
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy

the present randomized placebo-controlled study aimed to evaluate the effect of green tea extract administration on the clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with peripheral neuropathy

Exclusion Criteria:

* Patients under treatment of diabetic peripheral neuropathy.
* Patients with other causes of peripheral neuropathy.
CoolLoop Paroxysmal Atrial Fibrillation

This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed CoolLoop® cryoablation catheter.

A further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.


Eligibility Criteria:
Inclusion Criteria:

* age 18 - 70 years
* symptomatic paroxysmal Atrial fibrillation (AF)
* a minimum of three episodes of paroxysmal AF
* at least one episode of paroxysmal AF within the last 6 months documented by ECG
* signed and dated informed consent documented by the patient
* female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation

Exclusion Criteria:

* left atrial diameter \> 50 mm in the short axis as assessed by transthoracic echocardiography
* advanced structural heart disease including

  * moderate-to-severe valvular stenosis or regurgitation,
  * previous valve replacement or valve repair,
  * congenital heart disease,
  * left ventricular ejection fraction \< 45% during sinus rhythm,
  * congestive heart failure New York Heart Association (NYHA) III or IV,
  * coronary artery bypass graft surgery within the last 3 months
* chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs
* severe respiratory insufficiency
* known bleeding diathesis
* intolerance of Heparin and/or intolerance of oral anticoagulation
* previous AF ablation
* permanent pacemaker
* left atrial thrombus
* intramural or intracardiac thrombus or tumor, or other conditions that may result in difficulties advancing the CoolLoop® cryoablation catheter into the left atrium
* access to the vascular system via the right or left femoral vein is not possible
* transseptal puncture cannot be achieved due to a previous operation or intervention at the interatrial septum (e.g. closure of a patent foramen ovale or atrial septal defect)
* contraindication for transesophageal echocardiography or fluoroscopy
* impaired renal function (glomerular filtration rate \<30 ml/min.)
* history or increased risk of intracranial hemorrhage
* history of cerebral ischemic stroke or transient ischemic cerebral attacks within the last 180 days prior to enrolment
* severe comorbidity
* hyperthyreosis
* any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he / she were to participate in the study or confound the ability to interpret data from the study
* any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form
* pregnant or lactating females
* other severe conditions, which makes the patient unsuitable to participate in the study, as judged by the Investigator
* live-expectancy \< 1 year
* the patient is active in another clinical trial
Chronic Anterior Shoulder Instability in the Military

Anterior shoulder instability is a chronic condition that occurs after an anteromedial dislocation. Its prevalence is high in athletes but has been little studied in the armed forces. In general, patients with a first episode of dislocation have a 1 in 2 chance of experiencing at least one recurrence. The more recurrences there are, the more damage there is to the joint and the greater the disability for the patient. The decree determining the medical aptitude of military personnel emphasizes the need to have recourse to a specialized consultation to determine the classification of the soldier after a first episode of dislocation. In the absence of data collected specifically in the military population, classification is based on the surgeon's experience and extrapolation of results obtained in the general population.


Eligibility Criteria:
Inclusion Criteria:

* Military member with a first episode of true anterior glenohumeral shoulder dislocation,
* Male or female,
* Major,
* Having a sufficient level of reading/writing of the French language,
* Did not object to participating in the study.

Exclusion Criteria:

* Patient with a history of homolateral shoulder dislocation or surgery on the affected shoulder,
* Collagen disease confirmed by genetic testing,
* Inflammatory arthropathy,
* History of rotator cuff injury,
* Insufficient French reading/writing skills,
* Under legal protection,
* Objection to participating in the study.
Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study

Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.

Patients over the age of 20 with an acute traumatic isolated digital nerve injury to any of the fingers and not in the thumb will be investigated for inclusion in the study. After informed written consent a sealed envelope randomisation will allocate patients to treatment with either surgical exposure and epineural suture or non-operative treatment in a cast. Due to the nature of treatment arms the allocation will not be blinded. Clinical follow-up and investigation of primary and secondary outcomes will be conducted at 3 weeks, 3 months, 6 months and 1 year after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of isolated traumatic digital nerve injury in digits 2, 3, 4 or 5.
* Patient age =\> 20 years on day of injury.
* Injury location on volar aspect of finger.
* Acute sensory dysfunction in suspected digital nerve injury area.

Exclusion Criteria:

* Digital nerve injury ot the thumb
* Digital nerve injury in the palm of the hand (i e proximal to the finger base)
* Patient does not speak or read the Swedish language.
* Abusive drug or alcohol use
* Dementia.
* Injury mor than 7 days at dianosis AND/OR operative treatment cannot be offered within 10 days from injury.
* Neurologic disease.
* Ongoing infektion in the injured finger.
* concomittant tendoninjury or fracture in injured or adjacent finger.
* Injury mechanism is of blunt or crush charachter