cyrilzakka/clinical-trials huggingface dataset:
The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction

This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction with respect to the barrierpressure in the esophagogastric junction.

The secondary aim was to investigate whether the effect of cricoid pressure influences the barrierpressure.

During anesthesia induction and tracheal intubation one major concern is to avoid passive regurgitation of gastric content and aspiration.

The lower esophageal sphincter is a muscle located at the distal end of the esophagus. It plays an important role in creating a barrier between the stomach and the esophagus. The term "barrierpressure" is defined as the pressure difference between the lower esophageal sphincter pressure and the pressure in the stomach (intragastric pressure).

There are studies showing that opioids given iv/im, in the vein or in the muscle, may decrease the pressure in the lower esophageal sphincter and hereby increase the risk of aspiration.

Nevertheless,other studies shows that opioids are still frequently given to patients during anesthesia induction. This is done in order to prevent the cardiovascular response to (the painful) intubation which can often be seen as an equally high risk for the patient as the risk of aspiration.

In light of the above description, the investigators are planning a study in volunteers with the primary aim of investigating the effects of an opioid (alfentanil) on the pressures in the lower esophageal sphincter.

Another safety measure taken during anesthesia induction is the so called "cricoid pressure". This is based on the theory that passive regurgitation of gastric content may be prevented by occluding the esophagus by pressing on the cricoid cartilage. However, there are studies indicating that the application of cricoid pressure also may decrease the tonus of the lower esophageal sphincter.

The secondary aim of the study is to investigate the effect of cricoid pressure application on the pressure in the lower esophageal sphincter.

Measurements are being done using high-resolution solid-state manometry.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer 18-40 years old
* Informed,signed and dated consent

Exclusion Criteria:

* Pharyngoesophageal dysfunction
* Gastro/intestinal-,cardiovascular-,lung- or neurologic disease
* Ongoing medication
* Allergy to alfentanil, propofol, soya or peanuts
* Pregnancy or breast-feeding
* BMI\>30
* Participation in other clinical trial -ongoing or during last 30 days.
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.
* Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
* Must agree to comply with the visit schedule and other requirements of the study.
* Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Sub-epithelial infiltrates at the Day 1 visit in either eye.
* Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
* Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
* Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
* Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.
* Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
* History of active uveitis or iritis in either eye.
* History of corneal transplant in either eye.
* Presence of nasolacrimal duct obstruction at Day 1.
* Use of specified prohibited medications.
* Other protocol-defined exclusion criteria may apply.
Hypertension in Primary Health Care: Lifestyle Change and Blood Pressure Goals

The purpose of this study is to determine whether a program that includes 1) group seminars and 2) follow-up visits with blood pressure measurement and motivational interviewing (MI) that is focused on lifestyle change affect blood pressure.

High blood pressure is common in the population. In an earlier study conducted in our local geographical area, "How is health in Jordbro?" 46% of participants had a systolic blood pressure of \>140 millimeters of mercury (mm Hg) and 22% had a diastolic blood pressure \>90 mm Hg. 84% of those with known hypertension had a systolic blood pressure of \>140. We thus found that many people in our area have heightened blood pressure, and hypothesized that many of these people, particularly those with mild hypertension, probably could be helped with lifestyle-related intervention.

All persons who came to Jordbro Primary Health Care Center during a 6-month period were invited to participate in the current study, and local press announcements were used to recruit additional participants. A total of 301 persons volunteered to participate. A total of 141 of the volunteers had a systolic blood pressure =\>140 and/or a diastolic blood pressure of =\>90, and these people became the study population. The 141 persons in the study population filled in a questionnaire with general background and lifestyle questions.

Of the 141 persons in the study population, 75 had previously known hypertension and 66 had hypertension that was previously unknown. Participants were then randomized such that an equal number of persons with previously known and previously unknown hypertension were included in a) a treatment group and b) a control group. Background information such as height, weight, pulse, smoking habits, other diseases, and prescription drugs was gathered. Blood sugar and lipid tests were conducted. Participants' family physician were contacted as necessary (e.g., if blood pressure was dangerously high).

The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits with each participant in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet. After 6 months, a follow-up was done that included blood pressure measurement and completion of the same questionnaire that was filled in at baseline.

Eligibility Criteria:
Inclusion Criteria:

* =\> 30 years
* ability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing

Exclusion Criteria:

* \< 30 years
* inability to speak Swedish well enough to fill the baseline and follow-up questionnaires, participate in the seminars, and participate in the motivational interviewing
Telerehabilitation in Individuals Over 65 Years of Age Having Social Isolation Due to Coronavirus (Covid-19)

In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. This virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared it as "pandemic". Staying home and social isolation are at the top of these precautions. For this purpose, in Turkey on March 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. However, not leaving the house and social isolation brings with it the limitation of physical activity. Physical activity (PA) is defined by WHO as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. Recommended PA levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. Studies investigating the relationship between social isolation and health behavior report consistent findings. Individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. Practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. When today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. The purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the COVID-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Being 65 years old and over
* Being in social isolation due to the coronavirus epidemic.
* Spending at least 1 week at home different from routine life.
* Not to be obstructed from doing physical activities.
* To have access to online exercise training.

Exclusion Criteria:

* Having a serious cognitive impairment
* Having serious hearing and vision problems
* Having vestibular disorders that can cause loss of balance
* Having diabetes, hypertension or a neurological disease
Trial of Pegasys® in Patients With Chronic Hepatitis C

The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL).

In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.


Eligibility Criteria:
Inclusion Criteria:

* Quantitative serum HCV-RNA is positive except for high viral load of genotype 1b (≥ 100 KIU/mL)
* Observation of serum ALT elevation above upper limit of normal
* Chronic hepatitis is evaluated as the negative result (\< 0) calculated by the method of "formula for discrimination between chronic hepatitis and liver cirrhosis."

Exclusion Criteria:

* Observation of white blood cells ≦ 3000/mm3; neutrophils ≦ 1500/mm3; platelets ≦ 90,000/mm3; or hemoglobin ≦ 10 g/dL.
* Observation of the following situations and disease: severe renal disease, hepatitis B co-infection, de-compensated liver disease, liver cirrhosis, hepatocellular carcinoma, poorly controlled psychiatric disease, seizure disorders, immunologically mediated disease, severe cardiac disease, poorly uncontrolled hypertension, poorly controlled diabetes, chronic pulmonary disease, retinopathy, malignant tumor, and organ transplant
Effects of Core Exercise in Low Back Pain

Non-specific low back pain in one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?

Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity in electromyography.

Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.

Therefore, the purpose of this study was to investigate the effects of core stability exercise alone or in combination with manual therapy or kinesiotape on pain, dysfunction, psychosocial factors and pressure pain threshold (PPTs) in patients with low back pain in ODI stage 2. The investigators hypothesized that exercise combined with manual therapy would provide greater changes and benefits than exercise alone.

This study's population will be composed by at least 15 individuals per group, both the male and female, with ages among 20 and 60.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: Exercise group or ET (realize therapeutic exercise alone), manual therapy group o ETmanualtherapy (realize manual therapy prior therapeutic exercise), and kinesiotape group or ETkinesiotape (realize therapeutic exercise plus kinesiotape).

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of CLBP confirmed by an orthopaedic specialist Classification at Stage 2 by ODI Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids.

Exclusion Criteria:

* Previous or scheduled surgeries in the low back and abdominal area
* Presence of severe fractures or pathologies.
* Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
* Structural deformity in the spinal column.
* Neurological or psychiatric disorder.
* Presence or suspicion of pregnancy.
Impact of Parathyroidectomy on Renal Function

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

Criteria are detailled in "Outcomes measures"

Eligibility Criteria:
Inclusion Criteria:

- patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia

Exclusion Criteria:

* patients on dialysis
* GFR \< 15 ml/min
* renal graft
The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 - \< 60 years
* Patients underwent elective spine surgery
* ASA classification 1-3

Exclusion Criteria:

* Patients who have the concomitant condition
* Cancer
* History of heart disease including, heart failure, coronary artery disease, hypertension treated with more than one medicament.
* Serum creatinine \> 1.5 mg/dL
* Stroke, neurologic and mental deficits, epilepsy
* General or local infection (site of surgery),
* Coagulation disorders.
* Intraoperative massive bleeding
* Infection of the spine
* Rheumatoid arthritis
* Patients who had either of the following drug (aspirin, methotrexate, cyclosporine, qualaquin)
Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology

The main objective is to evaluate the diagnostic accuracy of the MUSA terms and definitions, as defined in the paper by Van den Bosch T, Dueholm M, ea. in 2015, to differentiate between different types of myometrial lesions of more than 1 cm. The primary aim is the diagnostic accuracy of the MUSA terms and definitions and the secondary aim the development of a prediction model.

Primary aim: Diagnostic accuracy of the MUSA terms and definitions

Every patient planned for hysterectomy for myometrial pathology (e.g. benign fibroid, benign adenomyoma or malignant uterine sarcoma) will undergo a systematic preoperative ultrasound scan. Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions). The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an incidence of 4.9% for uterine sarcomas amongst women with a myometrial lesion referred to their tertiary center (Antonia Testa, personal communication).

Secondary aim: Development of prediction model

The Secondary aim is to build predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma). Because of the small number of cases with malignant myometrial lesion (expected to be 5% of the study population or around 75 women), we will limit the number of variables to be tested in order to avoid overfitting. Based on current literature, we preselected following characteristics for development of a prediction model:

* Outer contour: regular of irregular
* Echogenicity of uterine lesion: uniform (homogeneous) or non-uniform (mixed)
* Colour score: 1 to 4
* Presence of central necrosis
* Maximal diameter of the lesion (in mm)
* Presence of acoustic shadows

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients planned to undergo hysterectomy for myometrial pathology of more then 1cm (e.g. fibroid, focal adenomyosis, uterine sarcoma).

Exclusion Criteria:

* Patient's refusal
* Age \< 18 years
* Polymyomatous uterus
* Myometrial lesion with a diameter less then 10mm
* Patients currently treated for another cancer
* Patients with ovarian pathology, endometrial pathology of cervical pathology
* Power morcellation
Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

This clinical trial will test a combined group therapy plus mobile cognitive behavioral therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order to change motivational negative symptoms linked to defeatist attitudes.

The primary purpose of this project is to test whether a psychosocial intervention, Cognitive Behavioral Social Skills Training (CBSST) combined with a smartphone-based cognitive-behavioral therapy for negative symptoms called, Mobile-assisted Cognitive Behavioral Therapy for Negative Symptoms (mCBTn) can reduce defeatist performance attitudes in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms.The project will also identify the optimal dose to engage the defeatist attitude target. Pupillary responses, an objective psychophysiological biomarker of effort, will be recorded during a cognitive task as a secondary outcome to determine its potential as an end point in clinical trials of motivation and effort.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnosis of schizophrenia or schizoaffective disorder.
* Meets prospective criteria for persistent moderate-to-severe experiential negative symptoms in at least two of the three CAINS Motivation and Pleasure domains (mean of 2 -moderate- or greater for items averaged within the Social, Work or Recreational domains) at the beginning and end of a 2-week evaluation phase.
* Moderate-to-severe defeatist attitudes (DPAS \> 50).
* ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual consumer workbook).
* Clinically stable and stable on current medications (no changes within 3 months prior to enrollment and meeting all inclusion/exclusion criteria during longitudinal baseline evaluation at both week -2 and 0).

Exclusion Criteria:

* Prior CBT in the past 2 years.
* Greater than moderate PANSS positive symptoms (P1-Delusions, P2- Disorganization, P3-Hallucinations, or P6-Suspiciousness - any item \>5).
* Severe depression on the Calgary Depression Scale for Schizophrenia (CDS \>8).
* Extrapyramidal symptoms (Simpson-Angus Scale \>7).
* Ocular damage, disease, surgery or medications that affect pupil dilation.
* DSM-5 alcohol or substance use disorder in past 3 months.
* Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness).
* Unable to adequately see or manually manipulate the mobile device.