cyrilzakka/clinical-trials huggingface dataset:
Prevention of Eating Disorders Through Optimization of Protective Factors

The goal of thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth (15-20). We target youth at these ages who experience a subjective sense of body dissatisfaction, and are thus at increased risk of developing an eating disorder.

The prevention program is based on improving protective factors such as body appreciation, body image flexibility, intuitive eating, and acceptance. It will be compared to a credible placebo (expressive writing).

Research area and aims:

Eating disorders (EDs) are common and cause significant morbidity and mortality. Due to stigma, only 25% seek help and only 50% fully recover after receiving treatments. Large-scale prevention is urgently needed to reduce the emergence and burden of EDs at a population level. However, current prevention programs do not meet requirements for efficient and economically attractive large-scale implementation. The main aim of this project is to investigate the efficacy and cost-effectiveness of a scalable, brief, and interactive prevention program based on reinforcement of protective factors against EDs using a randomized controlled design. A focus on protective factors disrupts the processes by which risk factors increase the probability for EDs to emerge and minimizes the risks for stigmatization.

Research questions:

1. How effective is an internet-based prevention program, that reinforces protective factors against EDs, in reducing the onset of EDs 6, 12, 24, and 36 months post-intervention?
2. Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors (mediators)?
3. Is prevention of EDs based on reinforcement of protective factors cost-effective?
4. How do the participant experience their participation in these two interventions?

Other research questions concern gender differences in enrollment and compliance, potential moderators of outcome, participation in booster sessions, and potential risk for stigma.

Eligibility Criteria:
Inclusion Criteria: Youth and young people (15-20 years) with a subjective experience of body dissatisfaction.

Exclusion Criteria: Indications of depression, or suicidality, as well as presence of an eating disorder, or other conditions that may require medical attention, or conditions that makes it impossible to complete the intervention (e.g., not being able to read and write in Swedish).
TOETVA Feasibility and Complications - Single Center First Experience

All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center

Exclusion Criteria:

* Patients who did not undergo (or will not undergo) a TOETVA at the investigators' center
Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women
* age 45-65 years
* prediabetic or have at least 2 features of metabolic syndrome

Exclusion Criteria:

* on hormone therapy
* diabetes
* heart disease
* alcohol consumption of \>2 drinks per day
* significant circadian disruption
* having care-taking responsibilities that significantly affect sleep
* shift work or irregular lifestyle
* uncontrolled sleep apnea or other uncontrolled sleep disorder
* extreme early or late chronotypes
* significant psychiatric disorders
* taking ADHD medications
* diagnosed dysregulated eating behaviors
* smoking \>5 cigarettes/day or 30 pack-year history
* participating in formal weight loss program
* not weight stable
Validation of the San Francisco Syncope Rule

This study was designed to validate the "San Francisco Syncope Rule". This set of rules was derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency Department who had an episode of syncope (passed out) or near syncope (almost passed out). A rule that considers patients with an abnormal ECG, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event and require admission.

This study was designed to validate the "San Francisco Syncope Rule". This set of rules was derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency Department who had an episode of syncope or near syncope.

A rule that considers patients with an abnormal ECG, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event/serious outcome and require admission. Serious outcomes include the following: death,myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ED visit and hospitalization for a related event.

In Quinn's derivation trial, the sensitivity of the rule was 96%.

Eligibility Criteria:
Inclusion Criteria: Acute syncope or near syncope as a reason for the ED visit

Exclusion Criteria: Altered mental status, alcohol or illicit drug-related loss of consciousness, Definite seizure, Transient loss of consciousness caused by head trauma
A Phase 3 Study in Participants With Moderate to Severe Psoriasis

This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
* Candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control during the study
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin (IL)-17 antagonists, including LY2439821
* Serious disorder or illness other than plaque psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women.
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent;
* Adapted soft contact lens wearer;
* Vision correctable to 20/30 \[(0.2 logMAR (logarithm of the minimum angle of resolution)\] or better in each eye at distance;
* Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing multifocal contact lenses;
* Currently wearing monovision;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications which could contraindicate contact lens wear;
* Eye injury or surgery within 12 weeks prior to enrollment;
* Prior refractive surgery;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Other protocol-specified exclusion criteria may apply.
Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage

evaluation of serum CA125 level and yolk sac morphology in women with threatened miscarriage is very important to predict pregnancy outcome


Eligibility Criteria:
Inclusion Criteria:

* pregnant women between 20-40 years. Pregnancy between 6-10 weeks. single intrauterine spontaneous pregnancy. vaginal bleeding or bloody vaginal discharge with or without pelvic pain for patients with threatened miscarriage.

Exclusion Criteria:

* medical disorders with pregnancy. History of recurrent miscarriage. Any maternal disease that would cause an increase in CA125 level. Local gynecological disorders e.g. fibroid. Presence of any uterine malformation. History of congenital abnormalities in previous pregnancy Presence of multiple pregnancy. Presence of anembryonic sac. Absent fetal heart pulsation.
ED Tracking Sheet Implementation

The purpose of this study is to assess whether implementation of an ED Sepsis Tracking Sheet effects the percentage of goal-directed sepsis criteria met in a tertiary care academic Emergency Department.

Sepsis remains a common cause of morbidity and mortality in the hospital setting. Accurate diagnosis and timely initiation of therapy are important drivers of patient-centered outcomes in sepsis management. Compliance with the core measures listed in the surviving sepsis campaign guidelines has been variable.

An ED-specific Sepsis Tracking Sheet (STS) - a tool for implementing and documenting critical actions in sepsis management - was created at our institution by a team of physicians, nurses, and ED pharmacists. Dedicated ED pharmacists were instructed to fill this sheet within one hour of the sepsis-specific best practice advisory (BPA) being activated in the ED. Core measures associated with the one hour and three hour sepsis bundles were tracked and outcomes were compared pre- and post-implementation of the STS.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Initially evaluated in the DHMC Lebanon Emergency Department
* Activated sepsis BPA upon initial presentation (triage history consistent with infection combined with 2 or more SIRS criteria? Are these the criteria that trigger our sepsis BPA?)

Exclusion Criteria:

* Patients who are transferred to the DHMC Lebanon Emergency Department from another facility
* Patients with absent data regarding one or more of the goal-directed sepsis criteria
* Patients who did not initially meet criteria to trigger the sepsis BPA, but developed sepsis later in their hospital course
Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery

Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery

Current standard of care for pain management includes a multimodal approach of peristernal and fifth intercoastal infiltration with 0.25% bupivacaine with epinepherine combined with immediate post operative IV acetaminophen, followed by scheduled oral acetaminophen and supplemental IV and PO narcotics. This practice is beneficial since it controls most of the direct surgical site pain for at least 6 hours, however, after the local anesthetic dissipates, pain is usually managed with the use of opioids combined with scheduled oral acetaminophen.

Opioids are the most commonly used medications to control pain early after surgery because of their high potency. However, their undesirable effects and risk of dependence become limitations.

The Investigators believe Liposomal Bupivacaine would be beneficial in this population due to its quick onset of action and prolonged half-life associated with liposomal formulation ranging from 23.8 to 34.1 hours. The primary endpoint will be a 20% reduction in opioids use.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* All open heart surgeries from September 1, 2019 - September 30, 2020
* Able to read, comprehend and sign the informed consent form

Exclusion Criteria:

* Pregnancy
* \< 18 years old and prisoners
* Not able to sign informed consent, including patients with an (LAR) legally authorized representative
* Patients with chronic pain requiring scheduled narcotic use
* Stage 4 kidney disease, Child Pugh score suggestive of liver cirrhosis/ disease
* Recent MI within 7 days of scheduled Cardiac surgery
* Known allergy to Liposomal Bupivacaine or derivative of
* Have or is currently involved in a Research Study within 30 days of scheduled surgery
Tranexamic Acid in Orthopaedic Trauma Surgery

Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (\>300mL) is expected.

The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.


Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation
* Expected blood loss is greater than 300 mL
* Age ≥ 18
* Skeletal maturity

Exclusion Criteria:

* Pregnant or breastfeeding
* Patients taking oral contraceptives
* Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)
* Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)
* Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)
* Renal Insufficiency (creatinine greater than 1.5mg/dL)
* Open fractures
Effects of Proprioceptive Activities on Hand Function in Chronic Stroke Patients

To determine effects of proprioceptive activities on hand function in chronic stroke patients

Stroke is causing the long term disability worldwide. The patient in the chronic phase of stroke may suffer from long term hand disability along with both motor and sensory dysfunction. That causes hindrance in performing the ADLs. As the hand is the important organ performing major functions of daily living .So the early restoration of the motor as well as sensory function is necessary.

The motive of this study IS to determine effects of proprioceptive activities on hand function in chronic stroke patients. Total 40 chronic stroke patients will be included in the study. They will be randomly allocated in two groups by lottery method that fulfills the inclusion criteria of the study. In group A patients will be recruited and proprioceptive activities will be given to the affected hand for 3 days /week for 2 months. On the other hand in group B conventional therapy will be given for 3 days /week for 2 months. In sensory training graphesthesia and stereognosis will be checked by modified subtest of sensory integration praxis test and Byl-Cheney-Boczai Sensory Discriminator Test respectively. The motor task will be assessed by the wolf motor test. As a baseline treatment hot pack for 15 min will be given to both of the groups

Eligibility Criteria:
Inclusion Criteria:

* Either right or left sided hemiplegic patients post stroke 6 months to 4 years
* Can partially open and close hand and able to elevate arm to at least 60 degrees and bend to 45-60 degree against gravity.

Exclusion Criteria:

* Patient with TBI, neuromuscular degenerative diseases, diabetes, heart disease, fracture of hand ,.muscular skeletal injuries of hand or birth deformities of hand
* Patients having any known or diagnosed psychological condition or unable to follow the command for exercise.
Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings

The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.

The secondary objectives are to evaluate:

* the performance of the dressing
* the comfort, conformability and the acceptability of the dressing
* pain before and during dressing removal on the last visit

A prospective, randomized clinical investigation will be conducted at two to three sites in Belgium and Sweden.

Male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation.

100 evaluable patients (i.e. 50 subjects per arm). The treatment arm (either Mepilex Border Post-Op or Aquacel Surgical) Patient eligibility will be established before treatment randomization. Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. Eligible patients will be randomized to receive Mepilex Border Post-Op or Aquacel surgical in a ratio of 1:1 provided.

Eligibility Criteria:
Inclusion Criteria, enrolment phase

1. Age ≥ 18 years
2. Have an expected total length of stay of 4 postoperative days or more
3. Plan for elective primary arthroplasty of the hip or knee
4. Plan for incision size \> 18 cm
5. Give their written informed consent to participate

Inclusion Criteria, randomization phase

1. Undergoing elective primary arthroplasty of the hip or knee

Exclusion Criteria,enrolment phase

1. Known allergy or hypersensitivity to any of the components of the dressings
2. Multitrauma
3. Undergoing arthroplasty due to tumour
4. Wound at the surgical site prior to surgery
5. Neurological deficit of operated side ,hemiplegia, etc.
6. Documented skin disease at time of enrolment, as judged by the investigator
7. Previously enrolled in the present investigation
8. Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator
9. Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor.

Exclusion Criteria, randomization phase

1. Dressing size does not fit the incision area, over 18 cm
2. Complications that would increase wound risks if investigation dressing is applied
3. Postoperative drain
Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MM according to the SWOG criteria (annex 1)
* previously untreated (localized radiotherapy is allowed)
* symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
* with measurable levels of paraprotein in the serum (\> 1g/dl) or in the urine (\> 0.2g/24h)
* age \< 75 years
* able to understand and to given an informed consent
* male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures.
* no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone.

Exclusion Criteria:

* life expectancy \< 2 months
* ECOG performance status \> 2 (annex 3)
* proven amyloidosis
* positive HIV serology
* antecedents of severe psychiatric disease
* severe diabetes contraindicating the use of high-dose corticoïds
* \> NCI grade 2 peripheral neuropathy (Annex IV)
* serum biochemical values as follow

  * creatinin level \> 200mmol/l
  * bilirubin, transaminases or gGT \> 3 the upper normal limit
* use of any experimental drugs within 30 days of baseline
rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia

This is a monocentric prospective, randomized, double-blind placebo-controlled study. It is designed to evaluate the superiority of the rTMS over sham treatment of depressive symptoms in the context of dementia. It is aimed at a population ≥ 65 years old, with affective BPSD. We wish to recruit 44 participants, with an estimated rate of potential drop out of 20%. Patients will be randomly assigned to the sham or rTMS group. The sham stimulation reproduces the procedure in all the steps, has the same duration and differs exclusively by the device setting. After inclusion, both groups will receive 15 sessions distributed over 5 days a week for 3 weeks


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by their and their proxy's signature (Appendix Informed Consent Form)
* Consent for MRI
* Age ≥ 65 years
* Clinical dementia Rating Scale (CDR) ≥ 1
* NPI-Q Σ (\*Anxiety + \* Apathy/Indifference + \* Dysphoria/Depression) ≥ 3
* Cornell Scale for Depression in Dementia (CSDD) ≥ 10

Exclusion Criteria:

* History of schizophrenia, bipolar disorder, schizoaffective disorder
* History of macroscopic stroke.
* Unstable somatic pathologies
* Insufficient collaboration for the rTMS procedure
* Drug freeness or drug adjustment as clinically required is not an exclusion criterion.
* The proxy refuses to give consent in case of lack of capacity, or in any case where the participant expresses a wish not to participate/continue in the study.
* Any contraindications to performing an MRI (cf CRF) and rTMS (aneurysm clips or coils, stents in the neck or brain, deep brain stimulators, electrodes to monitor brain activity, metal implants in the ears and eyes, facial tattoos with metallic or magnetically sensitive ink) procedure