cyrilzakka/clinical-trials huggingface dataset:
A Trial of Photodynamic Therapy With HPPH for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx

Recent literature suggests that certain patients with squamous cell cancers of the head and neck region may benefit from photodynamic therapy whether or not they may have received prior therapy, e.g. radiation therapy

We propose to initiate a Phase 1 a clinical trial using HPPH and 665 nm light in patients with cancer of the oral cavity and/or oropharynx, including lesions of moderate to severe dysplasia, squamous carcinoma in situ and T1 squamous cells carcinoma. The study will employ a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating from 100 J/cm2 to 125 and 140 J/cm2, respectively. The primary goal is the determination of the maximally tolerated PDT dose. Preliminary evidence for PDT efficacy wil also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe dysplasia and/or squamous carcinoma-in-situ of the oral cavity and/or oropharynx.
* Patients with T1 squamous cell carcinoma of the oral cavity and/or oropharynx.
* Patient may have primary and/or recurrent lesions to be treated.
* Diagnosis must confirmed by biopsy.
* Prior therapy of any type is allowed.
* Male or female patients at least 18 years old. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control or be sterile.
* Patients must have an ECOG score of 0-2 (Appendix A 1 ).
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

* Patients with T2 or greater squamous cell carcinoma.
* True tongue base lesions (as determined by the treating physician).
* Patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
* Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
* Patients with impaired hepatic (alkaline phosphatase (hepatic) or SGOT;:3 times the upper normal limits).
* Patients with minimal impairment of renal function (total serum bilirubin;: 2 mg/dl, serum creatinine;: 2 mg/dl)
* Unwilling or unable to follow protocol requirements.
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug and or light treatment.
* Patients on concurrent chemotherapy or radiation therapy or less than 4 weeks after the last dose of chemotherapy or radiation therapy.

Inclusion of Women and Minorities:

* Both men and women and members of all races and ethnic groups are eligible for this study.
Optimal Blood Sampling Site for Point of Care Lactate Assessment

The study was to compare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT \>/= 7)

Following a hip fracture, surgical treatment is advocated to improve pain and mobility. Most patients are elderly and a majority of them are frail. Current best practice tariff and National Institute for health and care excellence guidelines recommends that all those patients who undergo an operation should be performed within 36 hours from the time of injury to optimise recovery and function. The patients need to be medically optimised to undergo a major operation to have their hip fracture fixed. The adequacy of resuscitation is monitored by several clinical and biochemical markers. One of the important markers of resuscitation is serum lactate levels. This is used routinely in polytrauma patients. (Moran and Forward, 2012) The initial interest in lactate in hip fracture patients was based on the philosophy that a hip fracture in a frail elderly patient may be equivalent to a polytrauma in a young fit patient. Subsequently, high serum lactate levels on admission in hip fracture patients have been shown to be associated with higher mortality1. However, at present, this is not routinely monitored in hip fracture patients. Measurement of serum lactate levels presents logistics difficulties, as the blood sample has to be taken to an analyser and analysed within 20 minutes. Hence the investigators want to use a point of care electronic hand held device - the Lactate Pro 2. The investigators have already tested this device against the laboratory analysers and it has been proven to be accurate. However in preliminary testing the investigators found a significant difference between fingertip and earlobe samples in volunteers. The volunteers do not represent our population of interest, which are hip fracture patients. The investigators aim is to determine which sample site; earlobe or fingertip, for Lactate Pro 2 testing best matches venous forearm samples upon which the association of higher mortality with high lactate was based.

Any risk to the patients participating in this study would be very small. The inclusion criteria to participate in this research study is a patient who has had a recent hip fracture awaiting surgery with a Mental Test score of 7/10 or above and is able to consent.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 18 years or above.
* Diagnosed with an acute hip fracture.
* Have a mental test score of 7/10 or greater on assessment during admission.
* Participant is willing to consent to the study.

Exclusion Criteria:

* The participant will not enter the study if

  1. There are Injuries other than isolated hip fracture
  2. Age \<18 years
  3. They are not willing to consent for the study
  4. They have a mental test score less than 7/10 at the time of admission.
Expectations About the COVID-19 Vaccines

This study collects information on expectations and attitudes towards the COVID-19 vaccines in participants about to receive a COVID-19 vaccine. This information will be linked to data on side effect occurrence collected in an independent study.

General hypothesis: Negative expectations and attitudes towards the vaccine are associated with a higher risk of side effects

Eligibility Criteria:
Inclusion Criteria:

* Must have signed up to receive a COVID-19 vaccine in Denmark
* Participants are also a part of the ENFORCE study from which outcome data is obtained
* Must be able to read and understand Danish
Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects

The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research on Glycemic Index (GI) diets has been largely developed, however the combination with metformin in humans was not investigated yet. We hypothesized that the low-GI diet in combination with metformin would elicit greater improvements on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects. This study aims to evaluate the metabolic effects of the adoption of dietary advice to follow caloric restriction high/low GI diets, and low-GI diet associated with metformin on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects.

All groups (Low/High-GI and Low-GI + Metformin) showed significant reduction in anthropometric parameters, but only Low-GI and Low-GI + Metformin groups have an improvement in body composition parameters. In addition, the Low-GI group achieved better results in metabolism of carbohydrates (glucose, insulin, Cederholm Index, and HOMA-β) and lipids (Chol, TAG, LDL-C, VLDL-C, and TC/HDL-c). These results show the benefits of Low-GI diet on metabolic parameters in overweight or obese type 1 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Participants were adults (18-50 y), with body mass index (BMI) between 25-35 kg/m².
* Subjects with adequate glycemic and insulinemic response after oral glucose tolerance test: Hypocaloric diet with predominating high glycemic index foods;
* Subjects with altered glycemic response presented at the 120 min point either glycemia \<140mg/dL and insulin level \>40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods;
* Subjects with impaired glucose tolerance presented at the 120 min point glycemia 140 - 199mg/dL and insulin \>40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods and metformin.

Exclusion Criteria:

* Smokers
* Pregnant or lactating
* Diagnosis of any metabolic diseases
* Were under medication and therapeutic diet, except oral contraceptive for women.
Glargine U300 Hospital Trial

The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.

Several randomized clinical trials done previously in medicine and surgical patients with T2D have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in lower rate of hospital complications. Glargine U300 results in similar improvement but in lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and diabetes in the hospital setting. This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

Eligibility Criteria:
Inclusion Criteria:

* Males or females between \> 18 years admitted to a general medicine or surgical service.
* Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.
* Subjects must have an admission/randomization BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 mEq/L, pH \< 7.30, or positive serum or urinary ketones).

Exclusion Criteria:

* Subjects with increased BG concentration, but without a known history of diabetes.
* Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).
* Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
* Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR\< 30 ml/min).
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
* Female subjects who are pregnant or breast feeding at time of enrollment into the study.
Feasibility of a Web-based, Peer-supported Exercise Program for Patients With Hip and/or Knee Osteoarthritis

In this project, a web-based exercise program is developed in co-creation between specialized health care, the Norwegian Association for Rheumatic diseases (NRF) and a group of experienced patient representatives. The project emerges from the evidence that exercise is recommended as first-line treatment for patients with chronic diseases like hip- and knee-osteoarthritis (OA). However, the number of patients in need of targeted exercise will increase considerably the next decades, and their treatment needs cannot be fully handled within the health care system. Development of innovative and effective treatment trajectories and follow-up strategies is urgently required. Peer-support is recognized as an effective way to increase patients' long-term adherence to exercise. Thus, patient-organizations may be an unutilized resource in support and follow-up of patients who need long-term exercise as part of their treatment plan. After discharge from examination in hospital, patients with hip/knee OA will be recruited to follow-up in a novel web-based, peer-supported exercise program, and the feasibility of the intervention will be evaluated.

The study will be conducted as a pre-post single-arm feasibility study comprising 50 participants.

The main objective of the study will be to evaluate the feasibility of the web-based, peer-supported exercise intervention in patients with hip and/or knee OA.

Specific research objectives are:

* to assess feasibility of intervention delivery, data collection, eligibility and inclusion/exclusion criteria and intervention fidelity
* to assess the responsiveness of relevant primary and secondary outcome measures

In the feasibility study, all participants will be allocated to an intervention group, receiving a 12-week web-based, peer-supported aerobic exercise program including weekly motivational messages. Patients between 40 and 80 years of age that are not candidates for surgery will be recruited from Diakonhjemmet Hospital, Oslo, Norway.

To assess and evaluate feasibility, we will report on descriptive statistics. Responsiveness will be assessed using Receiver Operating Curve (ROC) analyses.

Eligibility Criteria:
Inclusion Criteria:

• patients with hip and/or knee osteoarthritis being referred to Diakonhjemmet Hospital

Exclusion Criteria:

* candidate for surgery
* unable to understand or write Norwegian
* unable to walk unaided and continuously for 15 minutes
* absolute or relative contradictions to maximal exercise testing
* have relatives with sudden death before 40 years of age
* have first-degree relatives with hypertrophic cardiomyopathy
Using Boned-Apatite Cement at the Time of Extraction for Ridge Preservation at These Sites

To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extration only as negative control.

Dental implants have become in the past ten years a popular and promising treatment in the rehabilitation of missing teeth. However, using implants depends on adequate alveolar bone volume. Anatomical restrictions are mostly present in posterior mandibular and maxillary regions. Alveolar bone loss usually occurs because of active periodontal disease, trauma or teeth extractions.

Teeth extractions are associated with some loss of alveolar bone in the horizontal and vertical dimensions. This loss is more pronounced when teeth are extracted because of periodontal disease. Bone grafts from different origins (autogenic, allogenic, xenogenic or alloplastic) can partly reduce the alveolar bone loss. Different ridge preservation techniques were succesfully used in clinical trials, using membranes only or as a combination of membranes and bone substitutes.

Synthetic bone grafts have been proven successfully for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years , and in orthopedics for more than 100 years . Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and doesn't alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Appatite may improve stability during bone remodeling.

This study includes patients who need extractions of incisors, canines or premolars. The extraction sockets must be mostly intact with a maximum 4 mm of one wall missing in the vertical dimension.

30 patients who need extractions from region of interest, with no extended bony defects, will be enrolled from the department of Periodontology, school of graduate dentistry, Rambam Health Care Campus

Eligibility Criteria:
Inclusion Criteria:

* Informed consent properly described and signed.
* Patients who need extractions of molars for dental or periodontal reasons.
* At least 18 years old.
* Need for future dental implants in the extraction areas.

Exclusion Criteria:

* No informed consent.
* Pregnant women.
* Women who breastfeed.
* Patients treated with drugs influencing metabolism of bone such as bisphosphonates.
* Heavy smokers (more than 20 cigarettes per day).
* Patients with dentures pressing on the area of extractions/bone grafts
Clinical Utility of the SPEAC® System: A Case Series

The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
* The subject's first reported seizure must be within the last 5 years.
* Male or Female between the ages 22 and 99.
* If female and of childbearing potential, subject must agree to not become pregnant during the trial.
* Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
* Subject or Primary Caregiver must be competent to follow all study procedures.
* Subject must be willing to use the Seizure Monitoring and Alerting System for a long period of time (up to 90 days), for a minimum of 30 hours/ week.

Exclusion Criteria:

* The subject cannot be pregnant, or nursing.
* The subject cannot be sensitive or allergic to adhesives or tapes.
Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls

Forty heart transplant recipients and forty age and sex mathced systemically healthy patients were included. Periodontal examination was performed and a questionnaire was applied to record demographic data, systemic health and dental behavior data.

Patients who had heart transplantion surgery at between 2003 to 2017 were screened during routine outpatient visits. The patients who have history of periodontal treatment within the previous year, history of antibiotic use during the preceding 6 months, clinically non-stable patients were excluded . 40 cardiac transplant patiets who met these criteria included into this study. Each member of the transplant group was mathched with a patient in the systemically healthy control group by age and gender and smoking status. 40 systemically healthy subjects with no history of periodontal treatment within the previous year and no history of antibiotic use during the preceding 6 months were recruited.

Medical Data Hospital records were reviewed and data were collected using a standardised form that included demographic information (age, gender) and medical information such as smoking history, presence of systemic disease, post transplant time, medication regimen/dosages. Assesment of Oral Hygeine Behaviour Patients were also asked to complete a standardised anamnestic questionnaire. Questions were about their personal oral hygeine behaviour (toothbrush, dental floss etc.), whether their dental visit was routine or complaint-oriented. For the transplant group one more question about whether a dental check up or comprehensive dental treatment had occured before transplantation was added.

Clinical Examination In both groups, periodontal examination was performed by one calibrated periodontist at the Deperatment of Periodontology, Başkent University. All subjects recieved a comprehensive periodontal examination including plaque index (PI); gingival index (GI); gingival recession (GR); bleeding on probing (BOP); Probing depth (PD); clinical attachment level (CAL).

According to the clinical and radiographic evaluation the patients were categorized due to their periodontal status. The patients were diagnosed with periodontally healthy, gingivitis or periodontitis. Patients were diagnosed with periodontally healthy if they have \<10% bleeding sites with probing depths ≤3 mm; whereas patients who have \>10% bleeding sites with probing depths ≤3 mm were diagnosed with gingivitis. Patients who had probing depths ≥ 4 mm, interproximal, CAL of ≥2 mm or ≥3 mm at ≥2 non-adjacent teeth .9,25,26

Eligibility Criteria:
For transplant group:

Inclusion criteria:

* Having heart transplantation surgery
* be clinically stable

Exclusion criteria

* History of periodontal treatment within the previous year,
* history of antibiotic use during the preceding 6 months,
* being clinically non-stable For healthy group Inclusion criteria
* being systemically healthy
* no history of periodontal treatment within the previous year
* no history of antibiotic use during the preceding 6 months exclusion criteria Having a systemic disease
Isocyanate Antigens and T Cells That Cause Asthma

To investigate whether isocyanate-induced asthma is dependent on isocyanate antigen-driven T-cell mediated, airway inflammation.

BACKGROUND:

Isocyanates are a group of highly reactive widely used low-molecular weight chemicals, and are the most commonly reported cause of occupation asthma in developed countries. Yet, the mechanisms by which isocyanates cause asthma are not well defined.

DESIGN NARRATIVE:

The study investigates isocyanate antigen-driven T-cell responses in vitro-, following in vivo exposure using patient samples acquired through collaboration with ongoing field epidemiological and clinical studies. The study compares isocyanate antigen-reactive T-cells from primary exposure sites (skin/lung) with those from blood, to evaluate potential routes of sensitization and identify diagnostic indicators of isocyanate sensitivity/susceptibility. Specifically, the study : generates and characterizes hexamethylene diisocyanate (HDI) antigens including isocyanate metabolites, and isocyanate conjugated t normal human and foreign proteins; evaluates the T-cell antigenicity of the HDI antigens, based on blood and lung lymphocyte proliferation, cytokine production, and phenotype in order to identify the molecular form of HDI that initiates airway cytokine production in asthma patients; establishes T-cell lines from the skin, lung and peripheral blood of HDI asthma patients and characterizes the phenotype, antigen specificity, cytokine production and TCR expression of isocyanate responsive T-cells in these different compartments; compares isocyanate responsive of T-cells found in the skin, lung and blood and correlates with clinical sensitivity to determine characteristics associated with exposure and sensitization leading to clinical asthma.

The study was renewed in FY 2002 to extend follow-up and analysis through March 2007.

Eligibility Criteria:
No eligibility criteria