cyrilzakka/clinical-trials huggingface dataset:
A Prospective Analysis of Failures of Oral Implants

The purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).

The treatment begins with screening against inclusion and exclusion criteria. The patients will then be informed of the design of the study through the reading of the Form for Patient Information and the Informed Consent in Swedish and verbally.

All dental implants to be inserted will be included in the study. Some surgical, implant, loading, prosthetic variables of the study will be decided according to the surgeon's criteria and patient's decisions.

Data will be collected in specific forms, and will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and complications.

Besides descriptive statistics, Kaplan-Meier analysis will be used to estimate implant survival/failure rates (an estimator for estimating the survival function from lifetime data), and multivariate Cox proportional hazards models will be used to identify prognostic variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a minimum age of 18 years;
* Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.

Exclusion Criteria:

* Age less than 18 years;
* General contraindications for implant surgery;
* Subjects with an untreated systemic disease. A complete medical report will permit the disqualification of subjects with an untreated systemic disease. Patients with a systemic disease such as diabetes or hypertension will not be excluded, as long as these pathologies were treated and stabilized within normal biologic parameters.
Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants

The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG) tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental outcome at the age of three years.

Aim of the study was to observe if there is a correlation of the aEEG tracings of the first weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as prognostic tool.

From the first week of life on aEEG-recordings were obtained on a weekly basis and the results of the first eight weeks of life were analyzed for this study.

aEEG-tracings were analyzed with regard to background activity (percentages of continuous and discontinuous patterns), the presence/absence of sleep-wake-cycles and the occurrence of seizure activity. These items where summed up in a score including three grades (normal, moderately and severely abnormal).

The aEEG was recorded as a single channel EEG from biparietal surface disk electrodes using a CFM (CFM 5330, Lectromed Devices Ltd., UK) or the CFM 6000 (Olympic Medical, USA). Assessment of neurodevelopmental outcome was done at three years of age by assessment of the Bayley Scales of Infant Development II (BSID-II) During the study period from January 1st 2000, and December 31st 2002 a total of 284 preterm infants less than 30 weeks´ gestational age were admitted to the neonatal intensive care unit of the Medical University of Vienna. Neurodevelopmental outcome could be obtained in 148/284 infants at the age of three years and these infants therefore fulfilled the inclusion criteria for this study

Eligibility Criteria:
Inclusion Criteria:

* gestational age \< 30 weeks

Exclusion Criteria:

* brain malformation
* inborn error of metabolism
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?

Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor to IBS in adults, we hypothesize that children with this disorder have a significantly greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To prove this, we will first aim to determine the prevalence of SIBO in both healthy children and those with CAP. We will do this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To do this we will randomize, in a double-blinded fashion, the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a placebo. After completion of the treatment we will evaluate all these patients for eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will also assess for symptom improvement by re-administering questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be between the ages of 8 and 18
* Subjects must be able to swallow pills
* Healthy Controls must be siblings, other family members or friends of the CAP subjects or children who are undergoing an overnight fast in order to obtain AM labs for another purpose other than this study.
* Female CAP subjects who are sexually active or who may become sexually active during the study will be required to practice an effective method of birth control (e.g., oral contraceptives, contraceptive patch or injection, IUD, double barrier method) before entering into the study.
* All CAP subjects must meet the Rome II Criteria for Functional Bowel Disorders Associated with Abdominal Pain or Discomfort in Children

Exclusion Criteria:

Subjects will be excluded if they:

* have a history of inflammatory bowel diseases, diabetes, cirrhosis or other liver disease, juvenile rheumatoid arthritis, systemic lupus, a history of bowel resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria).
* have been treated with antibiotics or probiotics within the past 2 months.
* have a history of TB infection or positive Mantoux test performed at screening
* have a history of allergy to rifampin or rifaximin
Iperia/Sentus QP Study

The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to understand the nature of the study and provides written informed consent.
* Patient meets a standard indication for CRT-D (Sentus QP group) or ICD therapy.
* Patient is able and willing to complete the planned follow-up visits at the investigational site.
* Patient accepts the Home Monitoring® concept.
* Age is ≥ 18 years.
* Sentus QP group only: Patient is a candidate for a new (de novo) implant or an upgrade from an existing ICD or pacemaker utilizing a BIOTRONIK Sentus QP lead

Exclusion Criteria:

* Patient has a standard contraindication for CRT-D (Sentus QP group) or ICD therapy.
* Sentus QP group only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead.
* Sentus QP group only: Cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.
* Patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.
* Patient is pregnant or breastfeeding.
* Life expectancy of less than 3 months
* Participating in another cardiac clinical investigation with active treatment arm.
Transpacific TAVR Registry

This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.

This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing TAVR
* Informed consent
Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs

Different scoring systems were developed for risk prediction and adjustment of morbidity from perforated duodenal ulcer. However, these scoring systems are not routinely used in perforated duodenal ulcer patient in everyday clinical practice. Identification of patient with a high risk of adverse outcomes following surgery is important for clinical decision-making which can assist in risk stratification and triage e.g. timing and extent of pre-operative respiratory and circulatory stabilization, postoperative admission to a high dependency unit (HDU), the level and extent of monitoring, and inclusion in specific perioperative care protocols.

Few studies assessed and compared the accuracy indices of PULP with BOEY and ASA in predicting post PPU repair 30-day morbidity Further, the efficacy must be verified in individual settings like ours. So we wish to assess its efficacy in BPKIHS-a tertiary referral center of eastern Nepal.

Perforated peptic ulcer disease (PPU) is an important indication for emergency surgery, complicating 2%-10% of peptic ulcer disease. In the context of modern peptic ulcer therapy, the incidence of PPU has been declining over the past two decades, but mortality has not followed a commensurate decline, in spite of advances in operative strategy and perioperative care.

Omental patch repair of duodenal ulcer perforation is both simpler than and as effective as definitive ulcer surgery in the emergency situation.

However,mortality due to ulcer perforation treated by simple closure and/or other methods is still around 10%. Factors reported to affect mortality in duodenal ulcer perforations in other series are old age, co-morbidity, preoperative hypotension, large size of the perforation, delay in presentation, and, delay in operation .

Several scoring systems have been proposed for the predictions of 30-day morbidity and mortality of perforated peptic ulcer (PPU) in order to risk stratify patients subject to their anticipated complications, and accordingly direct the required attention to high-risk patients. Scoring systems most commonly used include ASA (American Society of Anesthesiologists), Boey and peptic ulcer perforation score (PULP). Each comprises 3-11 demographic, clinical and biochemical variables that consider only pre-operative, or include pre/intra -operative and laboratory findings. Clinical scoring systems need good diagnostic accuracy in order to risk stratify patients correctly.

Eligibility Criteria:
Inclusion Criteria:

* All patient with perforated duodenal ulcer managed surgically

Exclusion Criteria:

* Perforated other organs eg: gastric ulcer or intestinal perforation Incomplete data available in database
Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents

Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.

The study "Prevention of Coronary Restenosis" examines the effectiveness of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines.

In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital centres. Their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. In addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care.

In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a BMS was recruited. These patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years


Eligibility Criteria:
Inclusion Criteria:

* indication for implantation of a coronary stent
* de novo lesions \< or = 30 mm in patients with diabetes
* de novo lesions 12-30 mm or RVD 2.5-3.00 mm in patients without diabetes

Exclusion Criteria:

* acute MI
* lesion length \>30 mm
* in-stent restenosis
* distal lesion in RVD \< 2.25 mm
* lesion in left main or bypass vessel
* contraindication to Clopidogrel
Articaine 4% Versus Lidocaine 2% for Local Anesthesia of MIH-affected Maxillary Molars

Comparison of injection pain with lidocaine and articaine. Comparison of the efficacy of lidocaine and articaine during treatment of MIH- maxillary molars.

Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children, aged 6-12years old

Background and Aims: Some dentists have difficulty obtaining effective anesthesia when treating MIH molars.

There are no studies comparing the effectiveness of lidocaine and articaine in MIH-maxillary molars.

Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty six cooperative children , aged 6-12 years old. Each child was randomly assigned to either articaine 4% or lidocaine 2% in their first session with the second solution being used at the second session.

Eligibility Criteria:
Inclusion Criteria:

* Absolute positive or positive behavior according to the Frankel Scale.
* child is not under the effect of any analgesics or sedatives and their weight was more than 20 kg.
* Healthy, both physically and mentally
* A child with a MIH-affected maxillary permanent first molar on the right and left sides .

Exclusion Criteria:

* children who are uncooperative
* allergic anesthetics used in the study
* children who show inflammation in the injection site.
Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus

To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c \>7.0% and \<11.5%.


Eligibility Criteria:
Inclusion Criteria:

* At least 2 years since diagnosis of type 2 diabetes mellitus
* Received subcutaneous (sc) insulin for at least 3 months
* Body Mass Index \<44 kg/m2
* HbA1c\>7.0% and \<11.5%
* Serum creatinine \<2.0 mg/dL for males and \<1.8 mg/dL for females
* Baseline FVC and FEV1\>70% and \< 125% of predicted normal

Exclusion Criteria:

* Significant hepatic disease (AST/ALT3 x ULN)
* Diagnosis of Type 1 diabetes
* Severe complications of diabetes
* History of moderate to severe ketoacidosis within the past 3 months
* Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days
* Diagnosis of HIV
* Positive serology for hepatitis B or C
* COPD, emphysema, or asthma
* Current smokers or smoking history within the past 6 months
* Major psychiatric disorder precluding satisfactory completion of protocol
* Clinically significant heart disease disease, stroke or heart attack within the past 6 months
* Treatment with an investigational drug within 30 days
* Previous treatment with Technosphere/Insulin
* History of malignancy in the past 5 years except basal cell carcinoma
* Anemia (hemoglobin \<10.5 g/dL for females and \<11.5 g/dL (for males)
* Women who were pregnant of lactating
* History of hypersensitivity to drugs resembling FDKP carrier products
* Treatment with another inhaled insulin product during the duration of the study
Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure

The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent (\>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days
* Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3)
* Male or female 18 - 65 years
* Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination
* Willing and able to provide written informed consent prior to participation in the clinical investigation
* Willing and able to comply with all study related procedure

Exclusion Criteria:

* Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST(radioallergosorbent test)
* Ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1)
* Systemic steroid treatment less than 4 weeks before the inclusion in the study
* Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture
* History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
* Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
* Current malignancy of any kind
* Known allergy to polyvinylchloride or medicinal liquid paraffin
* Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk
* Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region
* Previous treated with radiation on the face, head or neck regions
* Female patients who are pregnant or nursing, or become pregnant at any time from first visit at ENT(Ear, Nose and Throat) - clinic until treatment day (second visit)
* Female patients: unwilling to use adequate contraceptive between first and last visit
* Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
Mobilisation and Breathing Exercises After Abdominal Surgery at Sahlgrenska University Hospital

The aim of the study is to evaluate the effect of a new care strategy, including earlier and more intensive mobilization and individually adapted breathing exercises, regarding length of stay, recovery, complications and which factors predict interventions early in the postoperative course after various abdominal surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* undergoing elective or emergency open, or robot-assisted abdominal surgery
* has an expected anesthesia time of over 4 hours
* is extubated on the operating table
* planned overnight stay in the postoperative ward.

Exclusion Criteria:

* plastic, trauma, transplant or orthopedic surgery.
Precision Diets for Diabetes Prevention

With this study the investigators want to understand the physiological differences for people developing pre-diabetes and diabetes. The investigators hypothesize that different individuals go through different paths in the development of the disease. By understanding the personal mechanism for developing disease, the investigators will find a personalized approach to prevent that development. The investigators are also hoping to be able to find a biomarker that will pinpoint to the particular defect and thus, diagnose the problem at an earlier stage and have the information to give personalized diet recommendations to prevent the development of diabetes more effectively.

At present, individuals with prediabetes or diabetes are grouped together as a single entity, but almost certainly they represent a mix of different gene-environment interactions that lead to one of four dominant physiologic mechanisms underlying their dysglycemia. 1- liver insulin resistance, 2- muscle insulin resistance, 3- impaired insulin secretion, 4- impaired incretin hormone secretion. Gaps that we are addressing here are extremely important - first, we will define a composite biomarker to identify different subphenotypes of prediabetes based on the four known physiologic mechanisms that contribute differentially in each individual to glucose elevations, which we hypothesize will also be reflected in their "glucotype". Importantly, because both continuous glucose monitor and administration of standardized meal testing and metabolic tests are not practical in the clinic, the development of a composite biomarker comprised of select multi-omics measures and clinical variables will enable clinicians and possibly patients (without clinician) to easily identify the specific diet that will yield optimal health results.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older;
* Not be pregnant, if female;

Exclusion Criteria:

* Have major organ disease, hypertension defined as \>160/100, pregnant/lactating, diabetogenic medications, malabsorptive disorders like celiac sprue, others, heavy alcohol use, use of weight loss medications or specific diets, weight change \> 2 kg in the last three weeks, history of bariatric surgery.
* Any medical condition that physicians believe would interfere with study participation or evaluation of results.
* Mental incapacity a nd/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.