cyrilzakka/clinical-trials huggingface dataset:
Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth.

An open, prospective, randomized, multicenter study focused on the ridge diminution in case of grafting of fresh extraction sockets with Bio-Oss Collagen, Bio-Gide (Geistlich Pharma, Wolhusen, Switzerland), placing Dentsply implants (Astra Tech System).

The removal of at least 2 adjacent teeth would cause more advanced hard tissue loss during healing than that occurring after removal of a single tooth with adjacent teeth present. In order to maintain the dimension of the ridge following tooth removal, bone grafts and bone substitutes have also been placed in the extraction socket. So far no data have been reported on the effect of removal of multiple adjacent teeth on bone loss at various aspects of the edentulous sites. Furthermore, the potential effect on ridge contraction of implant placement in multiple fresh extraction sites is not documented. Therefore, the objective of the study is to evaluate the possibility of counteracting un favourable ridge modeling after multiple tooth extractions by placing mineral bovine bone in the extraction sockets and covering the wound with a native collagen membrane. In addition, the possibility of placing implants in the grafted sites is evaluated after six month of healing. For these purpose 40 subjects with 2 or more fresh adjacent extraction sites in need of two or more implants replacing teeth will be enrolled. Ridge dimensional changes will be measured after 6 months of healing; marginal bone loss will be measured after 3-years follow-up from the baseline (prosthetic delivery).

Eligibility Criteria:
Inclusion Criteria:intact extraction sockets following removal of the natural teeth defined by:

* a marginal dehiscence defect of any of the facial bone walls of 3 mm
* no facial fenestration present in the apical of the marginal bone crest

Exclusion Criteria:

* untreated rampant caries and uncontrolled periodontal disease
* uncontrolled diabetes or any other systemic or local disease or condition that would compromise post-operative healing
* unable or unwilling to return for follow-up or unlikely to be able to comply with study procedures according to investigators judgement.
GLUCOME USABILITY STUDY

The GlucoMe device, in its original packaging, along with the user manual and QuickStart guide will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution.

Ten (10) subjects identified as potential end users of the GlucoMe device will receive the user manual. An additional ten (10) subjects also identified as potential end users of the GlucoMe device will NOT receive the user manual. All subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device.

The observer and user post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Twenty (20) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Subjects will be asked to sign informed consent. The GlucoMe device, in its original packaging, along with the user manual and QuickStart guide will be provided to the patient in a simulated home-use environment. The patient labeling will be in the format intended for distribution.

Ten (10) subjects identified as potential end users of the GlucoMe device will receive the user manual and QuickStart guide. An additional ten (10) subjects also identified as potential end users of the GlucoMe device will not receive the user manual, but will receive the QuickStart guide. All subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device.

The observer examination and user post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female equal to or greater than 18 years of age.
2. Subject is a potential candidate for purchasing the GlucoMe device (e.g., subjects diagnosed with diabetes type 1 or 2).
3. Subject has facility with both hands.
4. Subject monitors himself.
5. Subject knows how to download and install apps.
6. Subject is capable of understanding and is willing to sign informed consent.

Exclusion Criteria:

1. Subject has dementia.
2. Subject has mental disorders.
3. Subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.).
4. Subject does not monitor himself.
5. Subject is visually impaired.
6. Subject cannot draw blood samples from fingertip.
Are the Pancreatic Serum Proteins Pancreatic Stone Protein (PSP) and Pancreatitis-Associated Protein (PAP) Predictive for the Development of Sepsis? Retrospective Study in Trauma Patients With Soft Tissue Defects.

Retrospective analysis of PSP- and PAP-serum levels in trauma patients with soft tissue defects and possible correlation with the incidence and onset of infection and sepsis.


Eligibility Criteria:
Inclusion criteria:

* Trauma patients submitted to the university hospital Zurich, aged 18-65 with soft tissue defects

Exclusion criteria:

* Patients with known immunocompromising illnesses, drug abuse or infectious diseases.
A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy elderly male and female ≥65 years old.
* Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.
* Be able to understand and comply with the requirements of the study as judged by the investigator(s).

Exclusion Criteria:

* History of any clinically significant medical or neurologic disease or disorder.
* History of gastrointestinal surgery or unintentional rapid weight loss.
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.
PPI Therapy Impact on GERD After Sleeve Gastrectomy

The trial would to try to establish:

* The best post-operative PPI prescription protocol after Sleeve Gastrectomy
* The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)
* The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ

45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)

GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months

Eligibility Criteria:
Inclusion Criteria:

* Patients candidates for primary SG
* Patients adhering to the follow-up protocol
* Age between 18 and 65 years
* No BMI limits

Exclusion Criteria:

* Gastric and/or esophageal diseases (routine preoperative endoscopy)
* Patients candidate for revisional bariatric surgery
* Chronic preoperative PPI therapy
* Using of PPI treatment for postoperative complications
* Conversion to open surgery
* Patients allergic to PPI
* Patients undergoing concomitant surgery
* Patients with hiatal hernia undergoing concomitant cruroplasty
Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

The aim of this pilot study was to determine the effect of physiotherapy on impairments and health-related quality of life in people with a painful osteoporotic spinal fracture. It is hypothesised that physiotherapy will reduce impairments and improve quality of life in this patient group.


Eligibility Criteria:
Inclusion Criteria:

* if female, at least five years post-menopause
* aged \> 50 years
* primary osteoporosis defined as DXA T score \< -2.5 at either the spine or proximal femur with at least one morphometric vertebral crush fracture sustained between 3 months to 2 years previously
* back pain/discomfort in thoracic or lumbar region felt at least weekly within the last 6 months
* stable dose of medication for treatment of osteoporosis (eg. hormone replacement therapy, bisphosphonates)
* community dwelling and able to attend for treatment
* English speaking

Exclusion Criteria:

* secondary causes of bone loss such as osteomalacia, glucocorticoid medication etc.
* co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
* acute vertebral fracture in past 3 months
* signs and symptoms arising from nerve root compression
* back pain radiating into the lower limb
* previous participation in a formal pain management program for back pain
* physiotherapy for back pain in the past 6 months
* allergic reaction to adhesive tape or poor skin condition that would prevent use of tape
NAD-brain: a Pharmacokinetic Study of NAD Replenishment Therapy

The objective of the NAD-brain study is to determine the blood and brain pharmacokinetics of NAD replenishment therapy (NRT) using Nicotinamide Riboside (NR) or Nicotinamide Mononucleotide (NMN).

The NAD-brain study will perform a parallel assessment of NAD replenishment therapy (NRT) pharmacokinetics in the blood and brain of healthy human subjects. A total of 6 healthy individuals (3 men and 3 women) will undergo repeated blood sampling and 31P-MRS brain scans during two 20-day periods, each of which will start with 8 days of daily intake of Nicotinamide Riboside (NR) 600mg x 2, or Nicotinamide Mononucleotide (NMN) 600mg x 2. The two 20-day periods will be 14 days apart to allow for washout of the previous compound.

Moreover, a total of 6 healthy individuals (3 men and 3 women) and 6 individuals with Parkinson's disease (3 men and 3 women) will receive NR 1200 mg daily (600 mg x 2) for 4 weeks, with a total measurement/assessment period of 7 weeks, and undergo repeated blood sampling and 31P-MRS brain scans once per week during this time.

Blood will be analyzed for NAD-metabolites. The simultaneous change in NAD-metabolism over time in blood and brain will be assessed and blood and brain pharmacokinetics for NRT in humans will be established.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-85 years at the time of enrollment.
* Neurologically healthy at the time of enrollment.

Exclusion Criteria:

* History of acute or chronic neurological disorder affecting the central nervous system (CNS). Migraine, cluster headache, and tension headache are allowed, but not on the day of the study visits.
* Impaired renal function.
* Impaired hepatic function.
* Severe hematological disease.
* Any psychiatric disorder that would interfere with compliance in the study.
* Any severe somatic illness that would make the individual unable to comply and participate in the study.
* Mitochondrial disease.
* Use of high dose vitamin B3 supplementation within 30 days of enrolment.
Hemodynamic Effects of Chronic Ketosis.

Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and \>50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

We have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF).

Presently there are no data on the clinical cardiovascular effects of long-term oral ketone-supplementation in patients with chronic HF.

In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFrEF.


Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure with NYHA II-III
* Left ventricular ejection fraction ≤40%
* Negative urine-HCG for women with childbearing potential

Exclusion Criteria:

* Known diabetes or HbA1c ≥48 mmol/mol
* Significant cardiac valve disease
* Severe stable angina pectoris
* Age \<18 years
Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients

Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and renal transplant biopsies of patients affected by polyomavirus.

Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and renal transplant biopsies of patients affected by polyomavirus.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of a kidney or kidney pancreas transplant diagnosed with biopsy proven interstitial nephritis due to polyomavirus.
* Age 18 to 70 years.
* Capable of providing written informed consent.

Exclusion Criteria:

* Age less than 18 years or greater than 70 years.
* Patient is on chronic warfarin or heparin therapy or has a disease that puts them at risk of bleeding.
Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct

At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is the most commonly used alternative, surgery having higher morbidity and mortality rates, unacceptable especially in palliative situation. Recent developments in interventional endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25 to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of this study are to compare the morbidity rate, feasibility and efficacy of these techniques.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* Karnofsky \>= 50%
* biliary stenosis (malignant or benign stricture)with failure of endoscopic retrograde cholangiopancreatography
* signed informed consent

Exclusion Criteria:

* isolated biliary stenosis of right hepatic canal
* percutaneous biliary drainage \< 10 days
* laparotomy \< 10 days
* contra-indication to the procedure
* pregnant women
Assessment of the Accuracy of PET/MR in Detection and Monitoring Response of Bone Metastases

The great promise of PET/MR for assessment of skeletal metastatic involvement is derived from the extensive experience with stand- alone MR, but initial data on the use of PET/MR for assessment of bone pathology indicate that PET/MR introduces unique issues that should be addressed when determining its role in this clinical scenario.

In this study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline PET/CT prior to treatment. Baseline studies and follow up studies of the patients referred post treatment, will be reviewed.

The main goal of the study is to asses the accuracy of PET/MR in detection and monitoring response of bone metastases.


Eligibility Criteria:
Inclusion Criteria:

150 patients having metastatic skeletal involvement on baseline PET/CT prior to treatment

Exclusion Criteria:

1. Age \<18.
2. Pregnant or breast feeding patients.
A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation

The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
* A total body weight greater than (\>) 50 kg
* Participants of non-childbearing potential

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Hypersensitivity to any component of the investigational drug product

Other protocol defined Inclusion/Exclusion criteria may apply.
The COLON Study: Colorectal Cancer Cohort

The main aim of this observational, prospective cohort study is to assess associations of diet and other lifestyle factors with colorectal cancer recurrence, survival and quality of life.

The COLON study is a multi-centre prospective cohort study among incident colorectal cancer patients recruited from 12 hospitals in the Netherlands. Patients with colorectal cancer are invited upon diagnosis. Upon recruitment, after 6 months, 2 years and 5 years, patients fill out food-frequency questionnaires; questionnaires about dietary supplement use, physical activity, weight, height, and quality of life; and donate blood samples. Diagnostic CT-scans are collected to assess cross-sectional areas of skeletal muscle, subcutaneous fat, visceral fat and intermuscular fat, and to assess muscle attenuation. Blood samples are biobanked to facilitate future analyse of biomarkers, nutrients, DNA etc. Analysis of serum 25-hydroxy vitamin D levels, B-vitamins and metabolomic profiles are scheduled. A subgroup of patients with colon cancer is asked to provide faecal samples before and at several time points after colon resection to study changes in gut microbiota during treatment. For all patients, information on vital status is retrieved by linkage with national registries. Information on clinical characteristics, including treatment-related toxicity and co-morbidity data, is gathered from linkage with the Netherlands Cancer Registry and with hospital databases or medical records. Hazard ratios will be calculated for dietary and lifestyle factors at diagnosis in relation to recurrence and survival. Repeated measures analyses will be performed to assess changes over time in dietary and other factors in relation to recurrence and survival.

The aim is to recruit at least 2000 patients with available data and blood samples.

Eligibility Criteria:
Inclusion Criteria:

- Patients newly diagnosed with colorectal cancer in one of the participating hospitals

Exclusion Criteria:

* Non-Dutch speaking
* A history of colorectal cancer or (partial) bowel resection
* Chronic inflammatory bowel disease
* Hereditary colorectal cancer syndromes (Lynch syndrome, FAP, Peutz-Jegher)
* Dementia or another mental condition that makes it impossible to fill out questionnaires
Quality of Life Validation in Laryngitis

The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect).


Eligibility Criteria:
Inclusion Criteria:

* New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment

Exclusion Criteria:

* Unable to comply with study requirements.