cyrilzakka/clinical-trials huggingface dataset:
Effect of Ketamine on Postoperative Clinical Outcomes

The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.

Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.

Eligibility Criteria:
Inclusion Criteria

1. Patients scheduled to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
2. Willingness and ability to sign an informed consent document
3. No allergies to anesthetic or analgesic medications
4. 18 - 80 years of age
5. American Society of Anesthesiologists (ASA) Class I - III adults of either sex

Exclusion Criteria

1. Inability to comprehend the pain assessment tools
2. Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
3. Patients with clinically-significant heart disease including arrhythmias and significant hypertension, brain aneurysms, prior history of cerebral vascular accident (CVA), or chronic renal insufficiency
4. Prior abdominal surgery
5. History of abdominal carcinomatosis
6. History of radiation enteritis;
7. Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes
8. Patients with seizures
9. Morbid obesity (body mass index \>40)
10. Pregnant or lactating women
11. Subjects with a history of alcohol or drug abuse within the past 3 months
12. Any other conditions or use of any medication which may interfere with the conduct of the study
13. Prophylactic Nasogastric Tube (NGT) use
14. Individuals with significant manic disorders including: schizophrenia, or bipolar disorder or psychosis
15. Individuals with asthma and/or thyroid diseases
The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction

This study will be a randomized, double-blind, crossover intervention to investigate the health effects of acute ingestion of pomegranate juice when consumed with a high fat meal. After one week of controlled dietary intervention, subjects will consume a high fat morning meal supplemented with either pomegranate juice or a juice-free sweetened beverage. After consumption of the breakfast meal, subjects will be assessed for endothelial function and postprandial meal response.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 25-70 years
* Body mass index (BMI) ≥ 19 and ≤ 38
* Willingness and ability to make scheduled appointments at clinical site as required by study protocol

Exclusion Criteria:

* Known (self-reported) allergy or adverse reaction to study foods
* Presence of kidney disease, liver disease, gout, untreated or unstable hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides \> 300 mg/dL
* Fasting glucose \> 126 mg/dL
* Use of cholesterol lowering medication
* Blood pressure \> 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
* Fingernails longer than 0.25 inch beyond the finger tip, or unwillingness to cut fingernails to this length during endothelial function testing
* History of bariatric or certain other surgeries related to weight control
* History of major surgery within 3 months of enrollment
* Smokers or other tobacco users (during 6 months prior to the start of the study)
* Antibiotic use during the intervention or for 3 months prior to the intervention period
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 6 months
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Non-invasive Brain Mapping of Movement Facilitation in Parkinson's Disease

Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use complimentary brain mapping techniques to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during recording of brain activity with EEG and MRI. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait.

The studies proposed here test the overarching hypothesis that different types of cues (visual targets, rhythmic auditory stimuli and reward incentives) facilitate movement through distinct neuroanatomic circuits and electrophysiological mechanisms, by leveraging known variability in behavioral cueing benefits across patients.

Aim 1 is to demonstrate behavioral dissociations between different forms of movement facilitation within patients and relate variability in cueing benefits to integrity of dissociable neuroanatomic circuits as measured by resting state and diffusion tensor magnetic resonance imaging (MRI). Aim 2 is to characterize the electrophysiological correlates of behavioral benefits for the different cue types using electroencephalography (EEG).

Patients will perform two computer tasks involving reaching and tapping movements during video recording of movements and electrophysiological recording of brain signals. Experimental manipulations involve different computer stimuli that manipulate the presence or absence of sensory and motivational movement cues. The same experimental manipulations are delivered to all individual subjects. 60 patients with Parkinson's disease and 30 healthy controls will perform the task during recording of brain waves from the scalp (EEG) and return for a second session to record brain activity with MRI. Each of the total of 2 sessions will last about 1.5 hours. Patients may be asked to delay taking their morning Parkinson's disease medications and perform clinical rating scales and questionnaires and undergo a movement disorders neurological exam.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease based on presence of at least 2 cardinal features (tremor, rigidity or bradykinesia) OR healthy adult with no neurologic disease
* Age \> 18 years old

Exclusion Criteria:

* Dementia as indicated by score on Montreal Cognitive Assessment \< 19
* Active hallucinations or psychosis
* Contraindications to MRI (metal implant, claustrophobia)
Prodromes of Menstrual Staphylococcal Toxic Shock

Menstrual staphylococcal toxic shock is a rare but severe disease, requiring intensive care in over 80% of cases. Menstrual staphylococcal toxic shock develops during the peri-menstrual period, in healthy young women colonized by a vaginal strain of Staphylococcus aureus secreting the Toxic shock syndrome toxin 1 (TSST-1) and not immune to it, in a favorable environment, i.e. wearing intravaginal menstrual protection (tampon, menstrual cup).

The rarity of the syndrome, its polymorphous clinical presentation and the absence of a totally specific biological examination make menstrual staphylococcal toxic shock a difficult pathology to diagnose. The reference clinical criteria correspond to the advanced picture of multivisceral failure, making it possible to classify cases a posteriori, but contribute to diagnostic delay and lack sensitivity.

Patient accounts suggest the presence of symptoms in the days preceding the development of toxic shock, and also during previous menstrual cycles.

The identification of prodromal symptoms could enable earlier management of menstrual staphylococcal toxic shock by removal of intra-vaginal sanitary protection, the main risk factor, before the disease becomes permanently established and requires intensive care.


Eligibility Criteria:
Inclusion Criteria :

+Case inclusion criteria:

* Women between 13 and 30 years old inclusive
* Clinical diagnosis of staphylococcal toxic shock syndrome: "confirmed" or "probable" according to Center Disease Control (CDC) criteria:

The 5 CDC clinical criteria for menstrual Staphylococcal Toxic Shock are:

* a fever above 39°C,
* arterial hypotension,
* generalized scarlatiniform erythroderma
* intense peeling of the palms or soles of the feet 7 to 14 days later,
* and systemic manifestations (at least three):

  * Digestive: vomiting, diarrhea
  * Muscular: myalgia, increase in serum creatine phosphokinase
  * Hyperemia of the vaginal, oropharyngeal and conjunctival mucous membranes
  * Renal: hyperuricemia, hypercreatininemia, leukocyturia without urinary infection,
  * Hepatic: increase in transaminases
  * Hematological: thrombocytopenia (\< 100,000 platelets/mm3)
  * Neurological: apart from episodes of fever or hypotension such as disorientation or altered consciousness.

In the presence of 4 criteria, the case is considered probable and 5 criteria as confirmed case.

* Detection of S. aureus strain carrying Toxic shock syndrome toxin-1 (TSST1) on vaginal samples.
* Onset of symptoms ≤ 72 hours before the start of menstruation and ≥ 72 hours after the end of menstruation.
* Use during the last 3 cycles of vaginal protection: tampon or menstrual cup.

  +Control inclusion criteria:
* Women between 13 and 30 years old inclusive
* Presence of menstruation
* Use of intimate periodic protection, tampon or menstrual cup, during the last 3 periods
* No history of toxic menstrual shock

Exclusion Criteria:

* Non-menstruating women
* Women protected by law
* Women (or relatives) who oppose the study
Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention

The investigators hypothesized that:

1) an intervention targeted at the prescribing physician would increase the rate of a metoclopramide discontinuation among patients prescribed the medication for questionable or unclear indications; and 2) the discontinuation would be durable.


Eligibility Criteria:
Inclusion Criteria:

* Physicians at University of Pennsylvania Health System who ordered an active metoclopramide prescription with a questionable indication.

Exclusion Criteria:

* Physicians-in-training (e.g., residents, fellows)
* Physicians how were investigators on this study
* Physicians serving on the the University of Pennsylvania Drug Use and Effects Committee or Information Technology Oversight Board
Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma (FOCUS)

This is a single-center study that will evaluate the safety and tolerability of removal of mucus plugs by bronchoscopy in patients with asthma. This protocol will also plan for the analysis of the features of the mucus plugs removed.

The investigators' research shows that a large subgroup of asthma patients have mucus plugs, and quantification of these plugs using a bronchopulmonary segment-based scoring system reveals a strong negative correlation between the CT (Computed Tomography) mucus plug score and FEV1 (Forced Expiratory Volume at 1 second). The FOCUS study is a single-center study that has the overarching goal to explore the biology of airway mucus plugs in asthma.

Through the FOCUS study, the investigators will initially explore the safety and tolerability of bronchoscopic removal of airway mucus plugs in patients with asthma and mucus plugs. They will then evaluate potential improvements in lung function outcomes in a dose-dependent manner (i.e., by removing mucus plugs from one lung vs both lungs). A secondary objective of the FOCUS study is to perform detailed cellular and molecular analyses of mucus and epithelial cells from airways impacted with mucus. With these biospecimens, the investigators intend to extend their preliminary findings that mucus plugged airways are characterized by intense type 2 inflammation, determine the mechanisms of epithelial and immune cell reprogramming, as well as how cellular reprogramming affects the promotion and persistence of type 2 airway inflammation.

Eligibility Criteria:
Protocol A:

Inclusion Criteria:

* Males or females between the ages 18 to 70 at the time of visit 1.
* Clinical history of asthma per patient report or medical record.
* Pre-bronchodilator FEV1 \< 80% predicted and ≥ 35% predicted
* CT mucus plug score \> 5.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Smoking of tobacco or other recreational inhalants in the last month and/or \>10 pack-year smoking history.
* History of other pulmonary disorders including cystic fibrosis and COPD (Chronic Obstructive Pulmonary Disease).
* History of unstable cardiovascular disease.
* BMI \> 45
* Current use of anticoagulant medications.
* Upper Respiratory Infection (URI) within the previous 6 weeks
* Currently pregnant and/or unwillingness to practice medically acceptable birth control or complete abstinence during the study
* History of COVID-19 (coronavirus disease) in the past 6 months.

Protocol B:

Inclusion Criteria:

* Males or females between the ages 18 to 80 at the time of visit 1.
* Undergoing clinically indicated bronchoscopy for removal of mucus plugs.
* Clinical history of airway disease (including asthma, COPD and bronchiectasis) per patient report or medical record.
* Written informed consent obtained from subject.

Exclusion Criteria:

* Upper Respiratory Infection (URI) in the past 30 days.
* History of COVID-19 in the past 30 days.
* Currently pregnant during the study.
Bone UltraSonic Scanner (BUSS): Validation Study

The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.

Study will conduct measurements in a group of postmenopausal women and use their DXA examination data as a control. BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Age 50-90 years
* Any race or ethnicity
* DXA spine and hip exam within one year

Exclusion Criteria:

* Open wounds or rashes on the testing area
* Active skin infection
* Recent tibia surgery
* Abnormal tibia anatomy
* Body Mass Index \> 34.9 kg/m2
* Current or previous tibial fracture on side of testing
* Stroke or with total or partial paralysis with residual disability lasting more than 3 months

Current or recent (within past 6 months) use of bone-active drugs:

* Bisphosphonates
* Calcitonin
* Estrogens or selective estrogen receptor modulator (SERM)
* Therapeutic doses of fluoride (\> 2mg/day)
* Teriparatide used currently or within past 3 months
* Drugs under research protocols, and
* Unstudied or unapproved drugs
* Presence of metabolic bone disease
Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses

the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy.
* Patients who possess all the psychophysical capabilities to be able to undergo the operation and all the check-ups with radiological tests included (e.g. all patients who are not willing to go to the institute for all the scheduled follow-up visits will be excluded) .
* Patients who have signed the "informed consent" approved by the Ethics Committee.
* Patients who are aged between 50-85.

Exclusion Criteria:

* Social conditions that prevent participation in the study in all its phases (homeless patients, with restrictions on personal freedom, etc.)
* Patients suffering from deep venous insufficiency of the lower extremities or with a personal or family history of deep venous thrombosis or pulmonary embolism
* Patients with a history of erysipelas in the lower extremities
* Patients suffering from neurological or psycho-cognitive disorders
* Patients suffering from post-traumatic arthrosis
* Patients who have already undergone prosthetic surgery and/or arthrodesis at the level of a lower limb joint
* Patients with axial knee deformities \>15°
* Pregnant female patients
* Patients with rheumatic diseases
Comparison of the Non-rebreather Mask With the Double-trunk Mask

This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of patients with severe hypoxemia.

The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.

Each included patient will wear the standard Non-Rebreather Mask (NRM) which is the standard delivery oxygen system for patients with acute severe hypoxemia. Then the patients will wear the DTM for 30 minutes. Finally the DTM will be replaced by the NRM for the next 30 minutes. The impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.

Eligibility Criteria:
Inclusion Criteria:

• Acute hypoxemia not corrected with nasal cannula

Exclusion Criteria:

* Chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia
* Confusion
* Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
Clinical, Prospective, Non-profit, Non-pharmacological Study on Geass Healing Abutment: Microbiological, Histological, and Immuno-histochemical Evaluation.

The health of peri-implant soft tissues is important for the long-term success rate of dental implants and the surface topography is pivotal in influencing it. Thus, the aim of this study was to evaluate, in human patients, the inflammatory mucosal microenvironment in the tissue surrounding a new, nanoscale, laser-treated healing abutment characterized by engineered nanopores versus a standard machined-surface.

The prospective clinical study will evaluate the effect of the presence of a laser-etched surface in the coronal portion of healing stumps in forming the coronal seal and reducing the accumulation of bacterial plaque around it. The screws will serve as their own control group since they have both a laser-etched and a smooth portion.

Primary objective:

To evaluate the adhesion of fibroblastic cells from the peri-implant mucosa on the surface of the healing stump through scanning electron microscope analysis, expressed in terms of the area covered by the cells.

Secondary objectives:

To evaluate the amount of bacterial adhesion around healing stumps with a laser-etched and smooth altered surface through scanning electron microscope analysis, expressed in terms of the area covered by the cells.

To evaluate the presence of hemidesmosomal structures through the expression of α-6 and β-4 integrins.

To evaluate bacterial adhesion on healing screws. To evaluate the healing of peri-implant soft tissues through clinical indices, such as Plaque Index and Gingival Index.

The healing period was 12 ± 4 weeks (T1) before the second surgical procedure, during which all healing abutments were placed. To prevent allocation bias among patients, each healing abutment was designed with two surfaces that alternated between laser-treated/machined and ma-chined/laser-treated. The experimental healing abutment was removed after 30 ± 7 days, which coincided with the soft tissue biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years
* Patients with no systemic and/or oral health disease
* At least six months of healing after tooth extraction
* Adequate dimension of the attached gingiva (\>2 mm) or keratinized tissue at the site selected and adequate residual bone crest

Exclusion Criteria:

* - Patients with poor oral hygiene
* Plaque score (PS) and bleeding on probing (BOP) more than 25%
* Patients with active periodontal disease
* Insufficient bone thickness for implant insertion and bone augmentation procedures
* patients who necessitate immediate implant loading protocols
* Uncontrolled diabetes mellitus
* Immune diseases
* Patients who smoke more than 10 cig/die
Evaluation of Patients With Non-cardiac Chest Pain

The purpose of this study is to find out how common diseases of the esophagus can cause chest pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause of chest pain in patients that do not have heart problems. The study test is called PillCam Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso will be compared to findings during conventional upper endoscopy.

Non-cardiac chest pain (NCCP) is defined by recurrent episodes of retrosternal chest pain in the absence of significant cardiovascular disease after a thorough cardiac evaluation. It accounts for 2-5% of all emergency department visits. Studies examining the prevalence of esophago-gastric lesions in patients with NCCP referred to gastroenterologists have found esophagitis, esophageal ulcers, hiatal hernias, gastritis, and gastric ulcers in 62% of patients. Advances in endoscopic technologies, particularly, the introduction of the wireless video-capsule (PillCam Eso) allows for the possibility of direct visualization of the upper gastrointestinal tract in the emergency department. During capsule endoscopy, a patient will swallow a pill-sized video-capsule, the wireless images of the gastrointestinal tract are transmitted to a computer. Findings of the PillCam Eso will be then compared to findings during conventional upper endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 80 years
* negative cardiac evaluation in the emergency department
* pre-established access to a primary care provider
* ability to give informed consent

Exclusion Criteria:

* known history of ischemic heart disease
* proton pump inhibitor therapy
* known or suspected obstructions or strictures in the gastrointestinal tract, including a history of Crohn's disease, gastrointestinal surgery other than cholecystectomy or appendectomy.
* permanent pacemakers/defibrillators or other implantable wireless devices
* known pregnancy
* unstable medical conditions
* inability to follow instructions
* active psychiatric conditions that preclude participation in the study