cyrilzakka/clinical-trials huggingface dataset:
Sedation Protocols and Skeletal Muscle Metabolism in Mechanical Ventilated Patients

To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.


Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilated for more than 48h
* 18-80 years
* stay in ICU for more than 5 days

Exclusion Criteria

* already participated in other clinical trials
* pregnancy or lactation
* lower limb amputation
* primary neuro-muscular disease
* disseminated tumor or accepted special therapy
* alcohol abuse
* severe liver dysfunction(Child-Push C)
* unstable angina/acute myocardial infarction
* heart rates\<50bpm
* all kinds dialysis
* severe burn
* epidural anesthesia
* severe neurological disease（acute stroke, uncontrollable epilepsy, severe dementia, etc）
Protection of Rectum From High Radiation Doses Using a Spacer

The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.

Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low-dose brachytherapy will be recruited. The subjects will be randomized to receive either diluted or non-diluted DuraSeal product as a spacer between prostate and rectum. Diluted or non-diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. If the subject is randomized to receive non-diluted DuraSeal, the procedure will be identical with the exception the DuraSeal components will not be diluted. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, and 4, 8 and 12 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 12 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer patients with planned low-dose brachytherapy for the treatment of prostate cancer

Exclusion Criteria:

* not willing to participate this study
Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders

The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD.

Temporomandibular disorder (TMD) is a general term that refers to disorders associated with the temporomandibular joint (TMJ) and the masticatory muscles. Among the main symptoms are pre-auricular pain (in the region of the TMJ) and/or pain in the masticatory muscles.

It's usual to observe that subjects with TMD also present cervical alteration. Beside this, cervical postural alterations produced by muscle tension can influence mandibular position.

The intervention protocol was based on manual therapy, stabilization exercises and stretching.

The technique are:.

1. Upper cervical flexion mobilization;
2. C5 central posterior-anterior mobilization;
3. Stabilization exercise: Cranio-cervical flexor stabilization exercise
4. Stretching of muscles: upper trapezius, scalenes, semispinalis capitis; splenius capitis, sternocleidomastoid

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with myogenic or mixed temporomandibular disorders

Exclusion Criteria:

* Patients diagnosed with arthrogenic or discogenic temporomandibular disorders
Exercise Park Equipment for Improving Physical Function and Physical Activity Levels in the Elderly

Exercise park equipments for the elderly are designed taking into account the physical and cognitive capabilities and needs of elderly individuals. These equipments are usually built in public spaces, and may be part of public health initiatives to promote active lifestyles in the elderly.

Previous research has provided clear evidence on the short-term efficacy of exercise programs in improving physical function and level of physical activity in community-dwelling elderly. The goal of this randomized clinical trial is to assess whether an exercise intervention conducted in an exercise park equipment is able to achieve sustained improvements in physical function and level of physical activity, that are maintained for at least 3 months after the end of the intervention. The target population are community-dwelling elderly that are insufficiently active.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 70 years or more
* Insufficiently active, defined as a person who does not meet the physical activity recommendations of World Health Organization (30 minutes per day of moderate physical activity (including active leisure and travel), 5 days a week; or 30 minutes per day of vigorous physical activity, 3 days a week).

Exclusion Criteria:

* The individual refers not being able to walk 400 meters in 15 minutes or less without having to sit, lean, use a walker or require the assistance of another person.
* Moderate or severe cognitive impairment (MiniMental \<19).
* Serious disease that limits physical activity (heart disease, cancer, chronic respiratory disease, joint replacements in the last 12 months, severe limitations of range of motion).
* Serious mental illness that prevents participation.
* Prescription of neuroleptic medication.
Application of Hyaluronic Acid in the Treatment of Periodontitis

The aim of the present investigation will be evaluated the healing of suprabony defects following surgical flap elevation and hyaluronic acid application respect to surgical flap elevation alone.

A total of 80 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group and no-hyaluronic acid group.

The objective of the study will be compare the healing of suprabony defects following treatment with either open flap debridement (OFD) and application of hyaluronic acid (HA) with OFD alone.

Eighty patients with suprabony periodontal defects will be randomly assigned to treatment with open flap debridement and application of hyaluronic acid (HA Group) or open flap debridement alone (No-HA Group).

Primary outcome will be Clinical Attachment Level (CAL) gain, while the secondary outcomes will be Probing Depth (PD) and Gingival Recession (GR).

After local anesthesia, an access flap will be prepared. Depending on the mesiodistal width of the interproximal space, two different incision techniques will be selected to access the suprabony defect area. The modified papilla preservation technique (MMPT) will be used at sites with an interproximal width \> 2 mm, whereas the simplified papilla preservation technique (SPPT) will be applied at sites with an interproximal width ≤ 2 mm. Then, a mucoperiosteal flap will be reflected.

Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler.

Hyaluronic acid will be applied to exposed roots surface only in HA Group followed, for both groups, by a tension-free primary closure of the interdental papillae and of the mucoperiostal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing material.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with periodontitis
* Age ≥ 18 years old
* Single-rooted and multi-rooted teeth
* Presence of suprabony periodontal defects at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth in either the maxilla or the mandible with a PD ≥ 5 mm after completion of non-surgical periodontal treatment and re-evaluation
* Intrabony defect with an intraosseous component \< 2 mm

Exclusion Criteria:

* Patients with systemic diseases
* Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to surgery
* Pregnant or lactating
* Tobacco smokers (≥ 10 cigarettes per day)
* Multi-rooted teeth with furcation involvement
* Increased tooth mobility (grade II and III)
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract

Prevention of dental caries has taken a great importance in the last decade. The use of herbal and natural products became mandatory to avoid the side effects of commercially available medications. Aim of the study; the aim was to investigate the anti-cariogenic effect of miswak and grape seed extract (GSE).

Patients used Miswak sticks, grape seed extract mouth wash and fluoride mouthwash twice daily for three month. Saliva samples were collected at base line and after one month and three month. Assessment of bacterial count and saliva buffering capacity were performed at base line and after one and three month.

Eligibility Criteria:
Inclusion Criteria:

* Patients with high caries risk
* Males or females
* Medically free patients
* Patients approving to participate in the study

Exclusion Criteria:

* Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
* Patients had history of professional cleaning in the last 15 days
* Patients with exposed pulp
* Evidence of parafunctional habits
* Patients with developmental dental anomalies
* Patients undergoing or will start orthodontic treatment
* Patients with removable prosthesis
* Periapical Abscess or Fistula
Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).

Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
* patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
* the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.
Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges facilitated by the electronic health record (EHR) with follow-up text messaging on the uptake of CRC screening. The primary outcome is CRC screening completion at 3 years. Patient and clinician factors impacting the experience and effectiveness of the intervention will be explored through surveys and qualitative interviews.

Despite effective strategies for prevention, early detection, and treatment, colorectal cancer (CRC) remains the second leading cause of cancer death in the United States (US). While there have been considerable policy and system-level efforts to increase CRC screening rates, uptake remains well below national goals of 80% participation. Members of racial and ethnic minorities are even further behind. Approaches to increase population-based screening can consider \[1\] how screening is encouraged by targeting the clinicians who typically order or recommend the procedure or the patient who completes it; and \[2\] the kind of screening offered (e.g., colonoscopy or fecal immunochemical testing \[FIT\]). This project simultaneously tests interventions along both of these dimensions.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 50-72
* Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
* Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, MT-sDNA in the last 3 years).

Exclusion Criteria:

* Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
* History of total colectomy, dementia or metastatic cancer
* Currently on hospice or receiving palliative care
* Uninsured or self-pay patients
* Currently scheduled for a colonoscopy or sigmoidoscopy
* Active order for multitarget stool DNA testing (MT-sDNA)
* History of paraplegia or quadriplegia
* Elevated chance of mortality within 3 years according to mortality risk algorithm
* Active order for Fecal Immunochemical Test (FIT) in the last 60 days
* Positive stool test (FIT or MT-sDNA) result in the last 5 years
Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis

This phase II trial studies the long-term side effects of ruxolitinib in treating patients with myelofibrosis. Collecting data about the long-term safety and tolerability of ruxolitinib may better help future patients with myelofibrosis.

PRIMARY OBJECTIVES:

I. To collect long term safety and tolerability data in patients with myelofibrosis previously treated with ruxolitinib on protocol 2007-0169.

OUTLINE:

Patients continue to receive ruxolitinib orally (PO) once daily (QD) or twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
3. Ability and agreement to attend protocol-specified visits at the study site
4. Able to comprehend and willing to sign the informed consent form
5. Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment

Exclusion Criteria:

1. none
French CAC-HIV Cohort Study

Clinical study:

* Methods: observational transversal two-arm cohort study including adults living with HIV (PLHIV) and HIV negative subjects (HIV-) at intermediate cardiovascular risk. No study specific interventions were performed.
* Participants: consecutively recruited at two large public hospitals in Paris and Annecy, France where participants were referred for routine cardiac risk stratification.
* Recruitment: was from June 2013 until April 2016.
* Data: anonymous study data were collected during the ambulatory visit. No follow-up was conducted.

Study objectives:

* Primary: compare coronary artery calcification (CAC) score between PLHIV and HIV- in order to bridge gaps in current knowledge.
* Secondary: assess parameters linked to CAC score including predictors and their prevalence, association with carotid/femoral atherosclerosis, and cardiovascular risk scores (ASCVD and HEART score).

Study hypotheses:

* Primary: CAC scores would not be different between PLHIV and HIV-
* Secondary: prevalence of traditional CV risk factors would be lower in PLHIV but that HIV-related nontraditional CV risk factors (including lower grade chronic inflammation, immune dysregulation, and ARV exposure duration) would be associated with higher CAC scores and higher CV risk scores

Study Rational:

* PLHIV have an increased risk of atherosclerotic cardiovascular events compared to the general population. Primary prevention for PLHIV is important but challenging as traditional cardiovascular risk scores do not account for HIV-related factors.
* Computed tomography coronary artery calcium (CAC) score using the Agatston score is useful for detecting and quantifying coronary calcifications. In the general population, CAC score is predictive of future cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Present one or more cardiovascular risk factor
* Complete comprehensive cardiovascular assessment including a valid CAC score, vascular evaluation, interview for demographic, clinical and medical history and a medical workup.

Exclusion Criteria:

* Age younger than 18 years old
* History of established cardiovascular disease.
Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.

Recently published studies demonstrated very high event free survival for patients with a normal interim PET/CT and a high hazard ratio for progression of an interim positive (pathological)study. These findings strongly support the integration of interim PET as a decision point for adjustment of chemotherapy.This study use the minimal therapy considered safe according to the predefined risk factors for patients with interim negative PET. Those with pathologic interim study considered as higher risk patients will have dose escalation of therapy.remission rate ,event free survival and overall survival will be evaluated.

study aim is to tailor the therapy in order to administer the lowest cumulative dose of therapy yet considered safe in order to reduce both early and late therapy related complications.

patients will be divided according to risk factors to sub groups of early favorable, early unfavorable, advanced disease with score less then 3 points or higher then 3 points.

Early Interim PET will be carried out Further therapy will be based on the study results.

Eligibility Criteria:
Inclusion Criteria:

* Hodgkin lymphoma patients
* age 18-60 for those with early disease and advanced disease with score less then 3
* age 18-60 years for patients with advanced disease score 3 or higher classical Hodgkin lymphoma
* WBC more then 3500
* platelets more then 100000
* creatinin less then 2.0 mg
* bilirubin less then 2.0 mg
* absolute neutrophil count more then 1000 unless bone marrow involvement If marrow involve, patient with lower count but ANC of 1000 may be included.

Exclusion Criteria:

* Positive serology for HIV
* bilirubin more then 2 mg/dl
* creatinin more then 2 mg/dl
* lactating woman or pregnant
* patient older then 60 years with high risk disease of score 3 or more
Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry

Visiting anxious and fearful children is an inevitable prospect of the daily work of every dentist who treats pediatric patients. Dentists have been using a wide variety of non-pharmacological and some pharmacologic techniques to assist them in the management of children with anxiety. One strategy which seems promising for pain control in stressful medical situations is teaching the child to use behavioral and cognitive coping skills or a combination of both techniques. An alternative technique to non-pharmacologic approaches in children being anxious and lacking in cooperative ability is sedative technique such as nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation and combinations of cognitive-behavioral strategies in eliminating children's uncooperative behaviors and dental anxiety, the aim of this study was to compare the effectiveness of inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy to reduce dental anxiety in preschool children.


Eligibility Criteria:
Inclusion Criteria:

* Age between3 to 6.5 year of old
* Presence of moderate to severe dental anxiety
* Parents' acceptance to cooperate in sampling process and 2 sessions of dental treatment
* Presence of at least one mandibular primary molar needed pulp treatment
* positive dental history

Exclusion Criteria:

* current episodes of medications or drug therapy
* systemic or congenital disorders
* mental retardation
The Effects of Chicken Extract and a Peptide Supplement for the Prevention of Cognitive Decline in Non-demented Elderly Adults

This trial investigates the effect of a chicken extract supplement and a peptide supplement on cognitive function and potential mechanisms of action of cognitive decline during ageing, among non-demented elderly adults using a three-arm, randomized, placebo-controlled clinical trial design.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at 55 - 75 years of age
* Baseline cognition:
* Normal cognition with feelings of cognitive decline (subjective cognitive decline) OR
* Mild cognitive impairment (MCI+) with memory impairment
* Agree to participate in the study and provide written informed consent

Exclusion Criteria:

* Inadequate visual and auditory acuity to allow neuropsychological testing
* Significant cerebrovascular disease
* History of allergy to chicken meat
* Diagnosis of Alzheimer's disease (AD) with dementia or any other dementia
* Clinical dementia rating (CDR) score of \> 0.5 at screening
* Evidence of other neurological, psychiatric or physical illness that can produce cognitive deterioration per investigator's judgment
* Inability or unwillingness to undergo PET scan
* Current diagnosis or history of alcoholism or substance addiction
* Regular use of any medication in the past 6 months that may affect cognitive functioning
* Regular use of cognitive enhancing supplements in the past 6 months
* Subjects with excessive blood donation or blood drawn prior to baseline
* Persons with a history of cardiovascular disease or any other cardiovascular or cerebrovascular diseases which investigators deem unsuitable to participate in the clinical study.