cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.

Post-extraction implants are an alternative to traditional implant placement on completely healed bone, in order to reduce the number of surgical interventions, shorten treatment time, maintain bone architecture and thus provide better aesthetics. This study focuses on evaluating the results obtained by opting for different immediate placement of single dental implants protocols in a fresh alveolus, and its general objective is to compare implant stability and marginal bone loss (MBL) in implants installed post-extraction. For this, the investigators will placement Grand Morse Acqua or NeoPoros implants (Helix GM - Neodent, Curitiba, Brazil), in early loading protocols, with or without low level laser photobiomodulation (LLLT), in patients attending the Master of Oral Medicine, Oral Surgery and Implantology of the University of Santiago de Compostela for oral rehabilitation using osseointegrated single dental implants in the maxillary and/or mandibular region.


Eligibility Criteria:
Inclusion Criteria:

* Patients satisfying all inclusion criteria and none of the exclusion criteria will be informed verbally and in writing about the study and signed the informed consent form.
* The implant area is free of infection
* Patients without systemic pathology or medical and general contraindications that are absolute contraindications for surgical procedures;
* Adults who agree to take part in the study and signed the informed consent form.
* Smokers of less than 5 cigarettes/day.
* Not to be completely edentulous.
* Need for extraction of at least one tooth.
* Post-extraction bone area (fresh alveolus).
* Patients with sufficient bone height to obtain primary stability for implant installation (2 mm longer than the largest root).
* Edentulous areas with sufficient mesial-distal, buccolingual and interocclusal space for the placement of an anatomical restoration with a prosthetic space of at least 5 mm.

Exclusion Criteria:

* Immunosuppressed.
* Smokers of more than 5 cigarettes/day.
* Bleeding rate greater than 30 %.
* Presence of active or uncontrolled periodontal disease;
* Patients with less than 2 mm of keratinised gingiva.
* Implants with primary stability with ISQ \< 50
* When this is not possible, assume a security margin to the inferior dental nerve of at least 1 mm.
* Previus history of local radiotherapy in the head and neck region.
Preoperative Prehabilitation Program For Geriatric Patients in a Rural Healthcare Setting

The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.

The study will include patients who require elective major abdominal surgery. The study will compare patients who received standard of care to patients who received a prehabilitation program before surgery.

The prehabilitation program will take place for 4-6 weeks before your surgery and will include:

* Review of frailty risk analysis calculator score obtained in the frailty study (#2212-74)
* Review of lab results including complete blood count, creatinine, albumin, and prealbumin
* Review of chronic conditions
* An office visit or telehealth visit to review instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease.
* Drinking Surgery Immunonutrition shake twice daily for 5 days before surgery.
* Educational information and video instruction
* Weekly phone calls to motivate, ensure adherence, and assess progress.
* Measurements of hand grip strength and body weight

Eligibility Criteria:
Inclusion Criteria:

* Subjects over age 60 who require elective major abdominal surgery

Exclusion Criteria:

* pregnant women
A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement

The purpose of this study is to compare the the Nexgen knee replacement system using cementless fixation with the same system using cemented fixation. At minimum 2-year follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and cemented fixation will demonstrate no differences in clinical outcome based on Oxford and Knee Society scores, patient-assessed visual analog pain, clinical complications, radiographic fixation and implant survivorship.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of osteoarthritis of the knee
* Patients undergoing primary total knee replacement

Exclusion Criteria:

* Age over 75 years old
* Prior unicondylar knee arthroplasty
* Grossly porotic bone or bone defects requiring bone grafting
* Bone cuts not sufficiently accurate for cementless fixation
Effect of Dexmedetomidine As Adjuvant to Ropivacaine for Brachial Plexus Block

Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II patients, weight 45 to 74 kg
* Elective upper limb surgery under brachial plexus block

Exclusion Criteria:

* known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine
* Pregnant or lactating mothers
* Hepatic, renal or cardiopulmonary abnormalities
* Long term analgesic therapy
Internet-based CBT After Stroke Pilot

Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. Cognitive behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to improve quality of life and reduce costs. This study aims to test the feasibility of internet-based CBT combined with a telephone/email based coaching service after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Acute ischemic stroke within the past 3 months
* Regular access to the internet, sufficient to allow a minimum of interactions with the internet daily, either through a personal smartphone or web-based internet browser.
* Subject is willing and able to participate in internet-based cognitive behavioral therapy
* Can participate in the program in English
* Willingness and ability to sign informed consent by the patient
* Symptoms of mild to moderately depressed mood, defined as a score of 5-19 on the Patient Health Questionnaire-9 at the time of study enrollment.

Exclusion Criteria:

* Severely depressed patients, defined by a score of 20+ on the Patient Health Questionnare-9 are excluded
* Patients with an active bipolar disorder diagnosis are excluded
* Patients with personality disorder diagnoses are excluded
* Patients with active suicidality or past suicide attempts are excluded
* History of schizophrenia or schizoaffective disorder
* Active participation in face-to-face psychotherapy prior to stroke
* Patients with a history of dementia are excluded
* Patients with aphasia, defined as a score of 1 or greater on NIH Stroke Scale Item 9 are excluded.
* Patients without regular internet access through a computer, tablet or smartphone are excluded.
* Subjects requiring long-term inpatient nursing care are excluded. For patients enrolled as inpatients, individuals being discharged to both home and acute rehab are eligible. Individuals being discharged to a skilled nursing facility or hospice are excluded.
* Expected life expectancy less than 6 months or other inability to comply with study follow-up.
* Pregnant women and prisoners are excluded
Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria

The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate:

1. Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
2. Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits


Eligibility Criteria:
Inclusion Criteria:

* blood pressure \> 130/80 \<180/105 mmHg at the end of the wash-out
* type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c \<7%)
* microalbuminuria in the upper range of normal (\> 200 \<300 mg/24 h)

Exclusion Criteria:

* Pregnancy, lactation or women of childbearing age
* Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out
* History of hypertensive encephalopathy or cerebrovascular accident within 6 months
* Secondary hypertension
* Heart Failure
* Myocardial infarction within 6 months
* Angina pectoris, clinically significant valvular disease or arrhythmia
* Alteration indices of liver function or renal
* Known hypersensitivity to ACE inhibitors
* All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study
Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas

When patients arrive in the waiting room of the MRI department, patients will be given the briefing note explaining the purpose of the study and how it is going. During the consultation, the radiologist will check the inclusion and non-inclusion criteria, and will take the time to answer all of the patient's questions about the study (or his family member by telephone if the patient does not is not in a condition to give its consent).

The MRI examination will be performed on a 3T multi-parametric MRI. If the neurological disorder presented by the patient does not require an injection as part of routine care, only a high resolution 3D T2 sequence on the nasosinus cavities and the olfactory tract, called bFFE-Xd for approximately 2 min.

If the neurological disorder presented by the patient requires an injection as part of current care, the examination will be completed with the nasosinus and olfactory 3D bFFE-Xd sequence, and the following additional sequences performed after post injection: a

* 3D FABIR 0.9 sequence covering the brain, dedicated to exploring the subarachnoid spaces;
* a 3D T1 TSE 0.7 sequence covering the brain looking for meningeal or encephalic contrast enhancement,
* FLAIR HR coronal sequence (high resolution) exploring the limbic system.
* Optional: a 3D FLAIR "labyrinth" sequence in the event of hearing / balance problems; a DCE infusion sequence (T1-WI) on the olfactory tract if olfactory disorder, which will be the first sequence made at the time of injection.


Eligibility Criteria:
Inclusion Criteria:

Patient\> 18 years old Express consent to participate in the study Affiliate or beneficiary of a social security scheme Patient with suspected SARS-CoV-2 infection in an epidemic context, confirmed or not by PCR, or close contact with a case confirmed by PCR, typical chest scanner (non-systematized frosted glass areas predominantly sub-pleural, and at a later stage of alveolar condensation without excavations, nodules or masses) or positive serology; Patient to benefit from a brain MRI for an indication within the scope of care

Exclusion Criteria:

Patient benefiting from a legal protection measure Pregnant or breastfeeding woman
Evaluation of Efficacy of Online Real-time Home CPR Training Program

The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.

Bystander CPR(cardiopulmonary resuscitation) is important for the survival of out-of-hospital cardiac arrest patients. CPR training for the general public is important to improve the rate and quality of bystander CPR. Conventional CPR education was conducted under face-to-face contact with instructors and multiple trainees gathered at a training center, but after the coronavirus disease 2019 pandemic, face-to-face training became difficult. To overcome this limitation the investigators have developed a new real-time home CPR training program. The training program delivers Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) to each participants homes and the participants use an application specifically developed for CPR training that automatically connects wirelessly to the Little Anne QCPR mannequin through Bluetooth so that the instructor can give real-time feedback on chest compression quality to participants.

The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. Chest compression quality at the start of both training programs and after completion of the programs will be measured by Little Anne QCPR mannequins used in the training programs. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.

Eligibility Criteria:
Inclusion Criteria:

* Adults without prior CPR training within 6 months

Exclusion Criteria:

* Healthcare providers
Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach

New research suggests that about 1 in 8 children may be diagnosed with an autism spectrum disorder (ASD) in the United States. This could be due to several reasons which remain unknown. This study invites mothers who have given birth to children in the United States to share their experiences with diet and supplementation during pregnancy. The purpose of this study is to understand the role of a mother's diet, social standing, and supplementation with folate or folic acid may have on her child's future development of autism. Comparisons will be made between mothers of children who have a child with an official ASD diagnosis from a clinician to mothers of children without an ASD diagnosis. Findings from this study can be used to help identify risk factors for ASD risk.

Autism spectrum disorders (ASD) are a broad range of conditions characterized by social skills, repetitive behaviors, speech, and nonverbal communication challenges. Current prevalence estimates assert that 2.3% of children aged eight years or older live with an ASD, an increase from 1.5% in 2012. Estimates suggest that 1 in 44 children will be diagnosed with ASD. A child diagnosed on the spectrum faces several challenges and may require support from a caregiver, possibly across the lifespan. ASD etiology remains elusive, but research suggests there may be a link to genetic, environmental, and dietary risk factors while in-utero.

Further evidence suggests a folate/folic acid link during the peri-conceptual period. Prior folate/folic acid studies suggest a U-shaped relationship between maternal multivitamin supplementation. High maternal plasma folate and B12 levels are associated with the risk of ASD.

This study aims to apply a case-control approach to understand the role of folate/folic over- or under-supplementation, maternal sociodemographics, and diet during pregnancy on ASD risk.

Eligibility Criteria:
Inclusion Criteria:

* Mothers 18 years or older with a child aged 3-12 years who have an official ASD diagnosis from a clinician
* Mothers 18 years or older of children aged 3-12 years who do not have an ASD diagnosis so comparisons can be made between groups

Exclusion Criteria:

* Mothers outside of the United States
* Mothers less than 18 years of age
* Mothers who have not given birth to their child or who used a surrogate
Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients with Type 1 Diabetes

Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.

Patients with type 1 diabetes and obesity are at risk of "double diabetes". Bariatric surgery may be indicated for these patients, to combat insulin resistance. Nevertheless, post-operative patients are at risk of hypoglycemia.

At the same time, patients with type 1 diabetes can benefit from a hybrid closed loop insulin pump to improve diabetes control and reduce the occurrence of hypoglycemia.

In type 1 diabetic patients who have undergone bariatric surgery and are treated with a hybrid closed loop insulin pump, continuous glucose measurement can be studied. In the medium and long term, the efficacy and safety of this system in this context will be described.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* With type 1 diabetes for \> 1 year
* Obese (BMI≥30)
* Having undergone bariatric surgery
* On a hybrid closed-loop insulin pump
* Not pregnant
* No hybrid closed-loop insulin pump discontinuation for more than 45 days after surgery

Exclusion Criteria:

- Patient informed and opposed to data use
Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates

The goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). The main question\[s\] it aims to answer are:

* Is the procedure effective in reducing BMI to the target level in 12 months?
* Which is the effect on weight loss, quality of life and obesity-related comorbidities?

Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (i.e., age between 18 and 70 years).
* BMI ≥ 35 kg/m²;
* Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
* Signed informed consent.

Exclusion Criteria:

* Clinically significant portal hypertension at upper endoscopy: F3 or F1/F2 with red signs oesophageal varices, gastric varices or severe hypertensive gastropathy;
* Upper gastro-intestinal bleeding (gastric or esophageal) in the previous six months;
* CHILD C class;
* Clinically or ultrasound-detected ascites in the 15 days before the procedure. Only mild ascitic effusion in the pelvis will be accepted;
* Spontaneous bacterial peritonitis in the previous 6 months;
* Hepatocellular carcinoma with extra hepatic spread;
* Previous stomach, oesophagus or duodenum surgery;
* Technical non-feasibility in the opinion of the endoscopist;
* Clinical signs of active infection;
* Unstable cardiac disease or chronic heart failure;
* Platelet count less than 70.000;
* International Normalized Ratio ≥ 1,5;
* Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
* Acute liver failure;
* Easy to bleed during diagnostic endoscopy;
* Active drugs or alcohol abuse;
* Pregnancy, lactation (desire to become pregnant during study duration);
* Enrolment in other clinical studies;
* Contraindication to general anaesthesia;
* Contraindication to endoscopic procedure;
* Other conditions to exclude the subject in investigators opinion;
* Refusal to sign informed consent.
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury

The purpose of this open trial is to investigate the feasibility, acceptability, and effect of metacognitive therapy in patients with prolonged post-concussive symptoms after mild traumatic brain injury.


Eligibility Criteria:
Patients with prolonged recovery after mild TBI (GCS \>12) will be recruited to our study if they have post concussive symptoms \> 6 months after injury.

Patients will be recruited from an ongoing cohort study investigating mild and moderate TBI at St. Olavs Hospital and Trondheim Municipality Emergency Clinic, and in addition (as of October 2017) among TBI patients at St Olavs Hospital who were not included in the cohort study.

Inclusion criteria

* Aged ≥between 16 and \< 60 years
* Have sustained a traumatic brain injury

Exclusion criteria

* Severe TBI (GCS score 8 or less)
* Non fluency in Norwegian
* Living outside of Norway
* Major other trauma with high risk of disability lasting more than 3 months.
* Major incidental intracranial findings in acute MRI e.g. cyst, tumor, malformation, infarctions.
* Severe psychiatric, neurological or medical disease, including: Psychotic disorders, bipolar disorder, ongoing severe depressive episode

  * Personality disorders affecting adherence to the research protocol
  * Alcohol/drug abuse affecting adherence to the research protocol
  * Mental retardation, autism or other severe developmental disorders
  * Prior complicated mild, moderate or severe TBI
  * Stroke or other acquired brain injuries
  * Progressive neurological disorders (e.g. Parkinson's disease, MS)
  * Advanced cancer, heart- or respiratory disease or other somatic diseases that interfere with function.
  * Major other trauma e.g. spinal cord injury

In addition to exclusion criteria already employed in the cohort study, patients with co-occurring psychiatric disorders that necessitate referral to specific treatment according to existing guidelines will be excluded from the current intervention study.