cyrilzakka/clinical-trials huggingface dataset:
Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study

The investigators have developed a hybrid computer- and person-delivered intervention, called "C-Raven" for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two \~20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. These sessions are followed by elective in vivo initiation of nicotine replacement therapy (NRT). Community health workers (CHWs) trained in smoking cessation and motivational interviewing provide 6 weeks of supportive follow up counseling. The investigators propose a pilot of the intervention package in the Tobacco Treatment and Lung Cancer Screening Clinic (TTLCSC) at Johns Hopkins Hospital, and the Johns Hopkins Broadway Center for Addiction, assessing feasibility and acceptability of using this tool in these clinical settings. In addition, the investigators will compare whether the use of a virtual counselor is associated with greater satisfaction and engagement with the program.

To this end, the investigators propose a two-arm randomized controlled trial, randomizing up to 90 individuals with tobacco use to the current CRAVEN program which includes a virtual counselor, to CRAVEN without a virtual counselor. Primary outcomes include intervention feasibility and acceptability. The investigators will secondarily examine uptake and maintenance of pharmacotherapy for tobacco cessation, readiness to quit smoking, and tobacco cessation (7 day abstinence) at 6 months, patient satisfaction by intervention arm and CHW engagement by intervention arm.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age receiving care in one of the two specified clinics
* Current daily smoker and has smoked \>100 cigarettes in their lifetime
* English speaking
* Cognitively able to understand proposed research design

Exclusion Criteria:

* Actively psychotic or other severe mental health symptoms
* Any contraindication to NRT use
* Hearing impaired (unable to listen to audio component of intervention)
The Effect of Tongue Cleaning in Periodontitis Patients

The aim of this study was to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue.

Volatile sulphur compounds (VSC's) are the most important causes of bad breath. Since the micro-organisms that produce VSC's are also periodopathogens, intuitively, one would think that there is a positive correlation between VSC levels in exhaled breath and periodontitis. However, not all periodontitis patients have bad breath. A possible explanation can be a positive relationship between tongue coating an bad breath. In the past, tongue cleaning was already researched in an oral healthy population. This research aimed to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue. Additionally changes in tongue coating; and patient perception about tongue cleaning was researched.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy patients
* periodontitis patients

Exclusion Criteria:

* already using a tongue cleaning device
* use of antibiotics the previous 6 months
* rinsing with a chlorhexidine mouth rinse the past month
* smokers
* patients who underwent periodontal therapy the past three years were not included.
Osteoporosis and Colles Fracture

The primary purpose of the retrospective study is to determine the incidence of osteoporosis in women with previous Colles Fracture. Secondly, to determine to which extent Colles Fracture has led to a diagnosis and/or treatment of osteoporosis.

The primary purpose of the prospective study is to determine the incidence of osteoporosis in women with an actual Colles Fracture. Secondly, to investigate the consistency between prospective and retrospective data.

Colles Fracture is known to be connected to decreased bone mineral density (BMD). Thus, it can be an early sign of osteoporosis and therefore an increased risk of new fractures.

The results of earlier studies have not been unambiguous in the respect of what extent decreased BMD in the wrist of women with Colles Fracture is synonymous of osteoporosis in the spine and the hip.

An earlier enquiry to the Danish Orthopedic Departments in 1995 showed that only 18 % of the departments diagnosed or referred patients with possible osteoporosis.

The two study designs enhance the possibilities of evaluating the relevance of Low Energy Fractures in the wrist to avoid new fractures and their relation to bone mineral density.

The results could also be a useful tool in quality assurance of the osteoporosis diagnostics.

Eligibility Criteria:
Inclusion Criteria:

Colles Fracture Women over 40 years Informed consent-

Exclusion Criteria:

High Energy Fracture Deceases or conditions that makes the participant unable to contribute to the investigation-
Screening TO Prevent ColoRectal Cancer (STOP CRC) Among At-Risk Chinese and Korean American Primary Care Patients

The objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients.

This study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 Chinese and Korean American men and 200 Chinese and Korean American women aged 50 to 75 eligible for colorectal cancer screening. Participants are recruited from primary care physician clinics. The study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. Those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. Those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. Investigators in the study develop an individualized screening plan using a theory-based online Decision Counseling Program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. Using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. Additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.

Eligibility Criteria:
Inclusion Criteria:

* Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening

Exclusion Criteria:

* Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.
Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation

Obesity is a well-established risk factor for the development of atrial fibrillation (AF), while the reduction of body weight was shown to reduce the risk of AF. However, little is known about the effect of different weight-reducing interventions on AF burden. The study will evaluate the effect of a complex program aimed at weight reduction on AF burden in subjects after catheter ablation for AF and at least 1st degree obesity. This will be investigated in randomized study design and compared with patients receiving standard care without specific obesity-related intervention. The weight loss program will consist of diet, lifestyle and exercise counselling and, in selected subjects, also bariatric surgery in order to achieve a sustained weight loss of \>10% of initial body weight. Secondary aims include identification of patient phenotypes with the most benefits from weight reduction as well as elucidation of potential pathomechanisms linking obesity and AF, with the main focus being on low-grade inflammation. The project will help to define the optimal weight-reducing regimen in AF and to tailor the interventions to individual patient needs.


Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal or persistent AF scheduled for primary RF ablation
* BMI ≥30 kg/m2
* Age 18-70 years
* Informed consent to the study

Exclusion Criteria:

* Previous ablation for AF
* Myocardial infarction, stroke or pulmonary embolism \< 3 months prior to inclusion
* left ventricular ejection fraction \< 40%
* Left atrium diameter \> 55 mm
* Active thyroid disease
* Chronic kidney disease stage IV-V (eGFR \< 0.5 ml/s)
* Chronic liver disease
* Active malignancy
* Inability to comply with study procedures
Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder

The patients will be randomly allocated into two equal groups (each 20 patients) using sealed opaque numbered envelopes:

Control Group (C Group) : Patients receive continuous US suprascapular nerve block only.

Gabapentin Group (G Group) : Patients receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time.

Both groups compared as regard:

Visual Analogue Scale Range of passive and active movements Patients satisfaction complication related to block The total dose of diclofenac sodium


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 18 Kg/m2 ≤ 30Kg/m2
* ASA I, II or III.
* Cooperative patients.

Exclusion Criteria:

* local infection at site of injection.
* coagulopathy
* previous history of mental disorders or chronic drug abuse (opioids, tranquilizers)
* known hypersensitivity to any of the drugs used in the study.
Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty

Effect of Erector Spinae Plane Block and iPACK block with Adductor Canal Block on pain management, and NLR and PLR following knee arthroplasty

Knee arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA classification I-III,
* Aged 20-100 years,
* scheduled for knee arthroplasty under spinal anaesthesia

Exclusion Criteria:

* Patients who have a history of bleeding diathesis,
* Take anticoagulant therapy,
* have a History of chronic pain before surgery,
* have Multiple trauma,
* cannot assess their pain (dementia),
* have been operated on under general anaesthesia,
* have an infection in the area
* do not accept the procedure
MRI in McArdle Disease (GSDV)

The aim of this study is to describe the degree of muscle wasting in patients with McArdle disease judged by MRI, quantitative magnetic resonance (DIXON) and T1 weighted images, and muscle strength, collected across multiple European sites and compared to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* GSDV or healthy controls

Exclusion Criteria:

* MRI contradictions
Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

This is a prospective, single-center, nonrandomized observational study to investigate the utility of urine lipoarabinomannan (LAM) as a test to identify individuals at very low risk for having a sputum culture positive for Nontuberculous Mycobacteria (NTM). The study is designed to evaluate if a urine test can eliminate the need for obtaining a sputum specimen to screen for NTM in individuals with Cystic Fibrosis (CF). The participants will be asked to provide 3 urine samples either in person or by mail over approximately 3 years. The 3 urine sample requests will be timed to coincide with their usual clinical care and routine sputum collection.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained online or in person from the participant
* Enrolled in the CFF Patient Registry (CFFPR)
* Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
* Diagnosis of CF consistent with the 2017 CFF Guidelines NTM culture status of negative (defined by a review of clinical and culture data with at least 3 years of clinical data available to review and at least one negative culture within the year prior to enrollment and no known history of previous positive cultures for pathogenic NTM)

Exclusion Criteria:

1. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care

GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring.

It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.

GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.

In this study, only the GlucoTab algorithm supported basalinsulin therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care and nursing homes requiring insulin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Elderly people, willing to be treated with a basal insulin therapy according to the GlucoTab system
* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥ 18 years
* Type 2 diabetes (treated with insulin therapy)
* Residents of participating nursing homes/domiciliary nursing care in the region of Camp de Tarragona (Spain).

Exclusion Criteria:

* type 1 diabetes mellitus
* intravenous insulin therapy
* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
* continuous subcutaneous insulin infusion
* gestational diabetes or pregnancy
* known or suspected allergy to insulin
* total parenteral nutrition
* any mental condition rendering the patient incapable of giving his/her consent
* any disease or condition which according to the investigator would interfere with the trial or the safety of the patient
Effects of a Recovery Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing

The investigation will be conducted as a double blinded, randomized, parallel between treatment conditions comparison design with two different groups ingesting a different supplement each one.

Following inclusion, familiarization and baseline assessments, the participants will be randomly allocated to receive either a multi-ingredient, post-workout supplement (REC) or maltodextrin (CHO). Thereafter, the participants will follow a 6-weeks resistance training mesocycle, involving three resistance training sessions (Monday, Wednesday and Friday) per week (18 sessions in total). Before and after the 6 weeks of intervention, the following assessments will be performed: (i) Body composition (fat mass and fat-free mass) via air displacement plethysmography (BodPod); (ii) muscle contractile properties on Vastus Medialis and Anterior Deltoids (via Tensiomyography; (iii) muscle structure of the Vastus Lateralis of the Quadriceps and the Elbow Flexors of dominant extremities via Ultrasound; (iv) Maximal Isometric Strength (Isometric Mid-Thigh Pull); (v) Upper and Lower Body Muscular Power (Medicine Ball Throw and Vertical Jump), (vi) Upper and Lower Muscular Endurance (30- Seconds Sit-to-Stand and 30-Seconds 16RM Bench Press), (vii) Immune System (via HemoCue WBC DIFF System).

The supplements will be ingested immediately (within 15 min) after each training session.

Energy Feeling Questionnaire will be filled immediately before warming up.

In addition, Rate of Perceived Exertion to training will be assessed 15 min after the completion of all workouts.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (no injuries, illnesses or medication intake).
* Between 45 and 65 years old.
* Active and familiarised with Resistance Training.

Exclusion Criteria:

* Unhealthy (illnesses or medication intake) or injured.
* Untrained.
* Young (\<45 y.o.) or elderly (\>65 y.o.).
Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo

This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:

* Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
* Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of advanced NSCLC not amenable to curative treatment. Participants enrolling in Part 2 of the study must have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
* no prior systemic therapies \[chemotherapy, et cetera (etc.)\] or pleurodesis with chemotherapy for this disease
* prior radiotherapy is allowed but must be completed at least 2 weeks before study enrollment and participant must be recovered from the acute toxic effects
* have a good performance status
* participant must sign an informed consent document

Exclusion Criteria:

* participant had myocardial infarction occurring less than 6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications
* participant is unable to swallow tablets
* participant is taking a certain medicine to control seizure activity, called "enzyme inducing antiepileptic drugs" and is not able to stop taking the medicine prior to enrolling in the study
* participant is unable to interrupt aspirin and/or other anti-inflammatory agents
* participant is unwilling or unable to take vitamin supplementation (folic acid and vitamin B12) or medications to prevent side effects
Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype found in Europe and North America and is responsible for sporadic infections except for travel associated diseases.

HEV had a principally asymptomatic form. However, it was recently demonstrated that it could lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver transplanted patients the infection could mimic a rejection and lead to the loss of the transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack of information about the prevalence of this disease.

In Canada the incidence of HEV infection was high (15-86% for liver transplanted children with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver \& kidney transplanted children whereas 7,4% in control. It was shown in a retrospective study that in liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.

This study will determined in a prospective approach the HEV prevalence in kidney, lung, heart and bone marrow transplanted children in Lyon.


Eligibility Criteria:
Inclusion Criteria:

* \<18 years old
* transplantation (heart, kidney, lung or bone marrow)
* protocol acceptance by family
* social security available

Exclusion Criteria:

* protocol rejection by family
Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S

This randomized prospective double-blind trial will be conducted on 80 Full-term pregnant females aged 21- 30 years presented for elective cesarean section under spinal anesthesia where they will be randomly allocated into two equal groups:-

* Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).
* Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ug naloxone.

The study aim is to evaluate the effect of adding an ultra-low dose of naloxone (20 ug) to hyperbaric bupivacaine (10 mg0 and fentanyl (25 ug) in spinal anesthesia for C.S.

Primary outcome: The incidence of pruritis Secondary outcome: The onset, the duration, the site, and the severity of pruritis.

This prospective randomized double-blind study will be carried out on 80 female patients who will be presented for elective C.S in the Obstetric department in Tanta university hospitals.

Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia will be included in the study.

The patients will be randomly allocated into two groups by the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - Group F (40 Patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml).

Group FN (40 patients): Patients in this group will receive spinal anesthesia with 10 mg hyperbaric bupivacaine (2 ml) plus 25 ug of fentanyl (0.5 ml) plus 20 ugs naloxone.

Once the patient will be admitted to the operating theatre, all monitors will be applied with introduction of 18-gauge peripheral venous cannula and starting fluid preload in the form of lactated ringer solution 7 ml/kg over 30 minutes. While the patient in a sitting position and under complete aseptic precautions, patients will receive spinal block at lumbar 3-4 or 4-5 intervertebral space with an injection of the pre-prepared local anesthetic mixture according to the group of patient. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at a rate of 4 liters/minute will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Full-term pregnant female aged 21- 30 years presented for elective cesarean section under spinal anesthesia.

Exclusion Criteria:

* Patients with pregnancy less than 36 weeks or more than 40 weeks
* Patients with hypertension, pre-eclampsia, or eclampsia.
* Patients with diabetes
* Patients with cardiovascular disease and /or arrhythmia.
* Patients with placenta previa, accreta, percreta.
* Obese patients with BMI \>36 Kg/m2
* Patients with height less than 160 Cm
* Multigravida
* Polyhydramnious patients