cyrilzakka/clinical-trials huggingface dataset:
Autonomic Control of the Circulation and VDR

The study objective of this project is to examine the mechanisms of the venous distension reflex (VDR) in humans. We hypothesize that COX blockade with ketorolac tromethamine, an intravenous NSAID, will attenuate the muscle sympathetic nerve activity (MSNA) response to limb venous distension. To gain further insight into whether the COX byproducts directly stimulate chemically-sensitive afferents, or enable venodilation and indirectly evoke afferent stimulation, we will measure vein size using 3T MRI during venous distention with and without ketorolac infusions.

We will use a prospective observational design to examine if a COX blockade will inhibit the MSNA response to venous distension (Aim1), and if a COX blockade will alter vein sizes during venous distension (Aim2). Each subject will serve as their own control.

Aim 1:

An IV will be inserted in the antecubital fossa of one arm, and the wrist-to-elbow occlusion will be performed.

To block the COX system, 6 mg ketorolac tromethamine in 10 ml saline will be infused into the forearm over 1 minute (Infusion 1). After 10 minutes, a second infusion of ketorolac tromethamine (up to 3 mg) in 5% of the forearm volume of saline,( \~40-60 ml) will be infused into the occluded forearm at a rate of \~ 30 ml/min (Infusion 2). Five minutes of data will then be collected before releasing the upper arm cuff. Infusion 1 is to block the COX pathway, while infusion 2 is to induce venous distension.

In the saline control trial, saline (without ketorolac) in identical volumes as those in the COX blockade trial will be performed on a separate day.

Aim 2:

The subject will lie supine inside the MRI scanner. The subject will be instrumented with cuffs for the wrist-to-elbow occlusion procedure on one arm, and cuffs for automated BP and HR measurements from the other arm, The images will be obtained before and during the wrist-to-elbow occlusion procedure. The sizes of veins (i.e. cross sectional area) will be measured offline.

Eligibility Criteria:
Inclusion Criteria

* Are capable of giving informed consent
* Are any race or ethnicity
* Are fluent in written and spoken English
* Have a satisfactory history and physical exam to meet inclusion/exclusion criteria
* Are free of acute or chronic medical conditions
* Are 21 - 35 years of age (inclusive)
* Weigh over 50 kg

Exclusion Criteria

* Are less than 21 or over 35 years of age
* Are Pregnant or nursing women
* Are prisoners or institutionalized individuals or unable to consent
* Any chronic diseases (hypertension, heart, lung, neuromuscular disease, kidney disease, diabetes or cancer).
* Are taking medications that may affect their cardiovascular or nervous system
* Has taken an NSAID within 48 hours of any visit (visit will need to be rescheduled)
* Has never taken NSAIDs and therefore would not know if they are allergic to it
* Have a supine BP \>140/90 mmHg
* Have known allergy to ibuprofen-like drugs (NSAIDS) or aspirin
* Have history of asthma or nasal polyps
* Have history of GI bleeding or ulcers
* Subjects with ferromagnetic metal implants
* Subjects who are claustrophobic
Lymphatic Osteopathic Manipulative Medicine to Enhance Coronavirus (COVID-19) Vaccination Efficacy

The purpose of this project is to study the impact of Osteopathic Manipulative Medicine (OMM) treatments, such as lymphatic myofascial release and thoracic pump techniques severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels in patients who receive the mRNA-1273 (Moderna) COVID-19 vaccine and to consider if these OMM strategies allow a stronger more robust immune response.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will include age greater than 18 years old and having safely received the COVID-19 vaccine.

Exclusion Criteria:

* Exclusion criteria will include age under 18 years old, malignancy/cancer, ongoing infection, coagulopathy history, use of anticoagulant medications, and fracture or acute injury of the torso neck or upper extremities. Lymphatic OMM is safe during pregnancy and this does not need to be an exclusion criteria.
Additional Manual Therapy Over Inspiratory Muscle Training in COPD

The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be limited.There is need for further research in new and complementary modalities to improve IMT efficiency in severe COPD patients.Manual therapy(MT) additional over IMT may be such a new approach that has not yet been investigated in COPD.

Aims: To investigate effects of MT additional over IMT on functional capacity,respiratory muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe COPD patients.

Methods: It was a prospective single-blind randomized trial. 40 patients with COPD in Global Initiative for Chronic Obstructive Lung Disease(GOLD) stage III-IV were included. Patients were randomly assigned to receive either MT additional over IMT at 40% of maximal inspiratory pressure(MIP)(n= 20) or only IMT(n= 20) for 12 weeks. MT group received MT during 12 weeks for 40 minutes additional to IMT. Pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, functional capacity using six minute walk test, dyspnea using Modified Medical Research Council(MMRC) dyspnea scale, fatigue using fatigue severity scale and quality of life using St. George's Respiratory Questionnaire(SGRQ) were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease
* Being clinically stable
* Having FEV1/FVC ratio of ≤ 50% of the predicted value after bronchodilator drugs.

Exclusion Criteria:

* Having an acute bronchitis,
* Having a pneumonia,
* Having an exacerbation of COPD,
* Having thoracic spinal scoliosis,
* Having substantial chest wall deformity, or acute rib or vertebral fracture.
* Unable to perform the pulmonary function test because of cognitive or physical impairments.
Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment

The overarching goal of this pilot study is to explore the feasibility, acceptability, and patient/provider satisfaction of pharmacy-based administration and dispensing of methadone for opioid use disorder. The results gained will inform the development of a future multisite randomized clinical trial.

The study will use a non-randomized, prospective, single group design. Twenty long-term, clinically-stable methadone maintenance treatment (MMT) patients who receive between 6- and 13-days methadone take-home doses will be enrolled in the study where their methadone take-home administration and dispensing will be transferred to a community pharmacy for 3 months. Participants will also complete three follow-up assessments at 1-month, 2-months, and 3-months after the baseline visit to collect clinical and safety information since the previous assessment. Primary outcomes will be focused on feasibility measures (recruitment, accessibility to methadone treatment, substance use, medication call back success, and retention in treatment). Secondary outcomes will be focused on self-reported satisfaction measures from MMT providers (e.g., physician, physician assistant, nurse, and counselor) pharmacists, and patient participants.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or older receiving methadone treatment at Morse Clinic in Raleigh or Zebulon, NC.
* Able to provide informed written consent to participate in the pilot study.
* Receiving a stable methadone dose between 5 mg and 160 mg.
* Having all negative drug tests (except for prescribed methadone and ethanol) at the OTP for the past 12 months.
* No missed call-backs in the past 12 months.
* No signs/symptoms of a co-occurring major mental illness (i.e., thought disorder, thoughts of harm to self or others, delusions or hallucinations, cognitive impairment compromising informed consent to study procedures and requirements).
* Meeting the federal and state regulations for eligibility to receive between 6- and 13-days of take-home methadone and receiving this level of take-home doses at the time of study enrollment.
* If female, using adequate birth control methods.

Exclusion Criteria:

* Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
* Have chronic pain requiring ongoing pain management with opioid analgesics.
* Prisoner status or pending legal action that could prevent participation in study activities
* Legal order for treatment (e.g., parole, probation, or pre-trial)
* Pregnant or breastfeeding at the time of screening.
Theory Based SMS Reminders - Text's Impact on Patient Attendance

The project will be done at the ear, nose and throat outpatient department at Lovisenberg Diakonale Hospital (LDS) in 2015-2016. About 12% of patients with appointments at the surgical outpatient clinic at LDS do not attend their appointment even after receiving both letters and shot message service (SMS) reminders. Persuasion theory suggests that the SMS reminders may be more effective if the text appeals more to the patient's feelings. The project is designed as a randomized controlled trial in which the control group receives the standard text that has neutral content and the intervention group receives a more emotion-based SMS reminder. The aim is to determine whether the more emotional text reduces the proportion of patients who do not show up for their scheduled appointment at the surgical outpatient clinic.

Studies from Norway's Health South East (HSØ) show that the number of patients who do not attend their scheduled appointments account for 200 000 to 250 000 outpatient consultations each year. For comparison, there are 270,000 patients waiting for treatment. It has thus been recommended that regional health authorities take measures to reduce the number of patients who do not attend their scheduled appointment.

This study will evaluate whether short message service (SMS) appointment reminders that appeal to the patient's emotions are more effective for reducing non-attendance to scheduled outpatient appointments at the ear, nose, and throat outpatient clinic at Lovisenberg Diakonale Hospital in Oslo, Norway. The study will be designed as randomized controlled trial in which 2000 patients are randomly assigned to either the intervention group (emotional SMS text) or the control group (standard SMS text with neutral content). Because theory suggests that emotion-based text messages will be more effective reminders, it is hypothesized that they will result in a 50% reduction in the number of patients who do not show for their appointment compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients (any diagnosis) with a scheduled clinic appointment at the LDS Ear, Nose and Throat Surgical Clinic or scheduled for polysomnography during the inclusion period.
* Date of birth on or after 01.01.1935

Exclusion Criteria:

* Patients with 2 appointments on the same day, only the first appointment will be included.
* Patients without a phone number
* Patients born before 01.01.1935
* Included patients will not be included again if they get a new appointment in the inclusion period.
Raloxifene on Coagulation System in the Postmenopausal Women

Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation parameters in healthy postmenopausal women.

Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical University Hospital at gynecology out-patient clinic from December 2005 to December 2006. Local institutional ethics committee approved our study protocol and written informed consent was obtained from all participants before enrollment. All patients received daily 600 milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor modulator (SERM), was added to treatment protocol if patients required hormonal therapy. Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the study group(n=50). Control group (n=30) was made up of the patients only receiving calcium and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and fibrinogen levels were measured in all patients before treatment. These measurements were repeated at three and twelve months after treatment. Comparisons were performed with Student t test or Mann Whitney test between the two groups and two-way ANOVA within the groups. Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p\<0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* In the study planned on patients who have not had menstruation for at least one year, or who have been in menopause naturally or surgically,
* the presence of menopause was accepted if the patients' FSH level was\> 40 IU / L. Verbal and written consent was obtained from all patients included in the study.

Exclusion Criteria:

* . Hypertension,
* diabetes mellitus,
* hypercholesterolemia,
* presence of hepatic-renal-thyroid-parathyroid-adrenal diseases,
* cardiovascular,
* cerebrovascular and thromboembolic diseases,
* undiagnosed vaginal bleeding,
* presence of hormone-dependent malignancy or anamnesis,
* presence of varicose veins,
* chronic drug use that disrupts sex steroid metabolism
* cases with smoking
* alcohol use
Exploring the Clinical Efficacy of Remote Management Applications Through Comprehensive Physical Therapy for Patients With Moderate to Severe Sleep Apnea

To observe comprehensive physical therapy program for OSAHS patients

This study proposes to conduct a randomized controlled trial ，using an APP and wearable devices to provide comprehensive physical therapy and monitoring for people with moderate to severe OSAHS,to assess the effectiveness and adherence of different physiotherapy programs for patients with moderate-to-severe OSAHS by observing the improvement of sleep apnea hypoventilation index (AHI), nocturnal minimum oxygen saturation (Low SpO2), mean oxygen saturation (Mean SpO2), and other health outcomes in the study population. It is expected to explore a clinical treatment pathway suitable for patients with moderate-to-severe OSAHS through mobile app and comprehensive physical therapy, improve the treatment adherence of OSAHS patients, enhance the level of health management services in hospitals, and obtain more physical health and health economic benefits.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 60 years;
2. Those who have been recently diagnosed with moderate-to- severe OSAHS (AHI ≥ 15 beats/h) and who refuse or cannot tolerate the counter-adverse effects and refuse CPAP therapy after conventional medical advice;
3. Those who have not undergone any physical therapy;
4. Have some communication and comprehension skills and can use a smart phone;
5. Signed informed consent.

Exclusion Criteria:

1. BMI \> 35kg/m2;
2. Patients with central and mixed sleep apnea;
3. Those who use sleep aids (including benzodiazepines and non-benzodiazepine sedative-hypnotics, anxiolytics with sleep-aiding effects, antidepressants, antipsychotics) and/or nutritional supplements;
4. Those suffering from acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other acute cardiovascular diseases;
5. Those with severe respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung volume limitation (due to obesity, pregnancy, or spinal deformity), or cystic fibrosis, pneumothorax, or alveoli;
6. Those with hypothyroidism;
7. Those with severe ENT disorders such as severe upper airway obstruction (complete nasal congestion, tonsil grade III/IV), tongue-tie (Marchesani's protocol), motor symptoms limiting the tongue, antecedent or presence of temporomandibular joint disorders, and severe craniofacial injuries;
8. Those with inflammation-related systemic diseases (e.g., arthritis, tuberculosis, vasculitis, lupus);
9. Those who suffer from neuromuscular diseases (e.g., Duchenne muscular dystrophy) or diseases of the skeleton that prevent them from performing parallel movements due to exercise;
10. Those who smoke and drink alcohol;
11. Those who have had other sleep apnea treatments within 6 months (e.g., surgical procedures, MAD or CPAP treatments) that may affect the study results;
12. Ongoing clinical trials of drugs or devices in which they are participating;
13. Refusal to sign the informed consent form.
Treatment of Asymptomatic Toxocariasis With Albendazole in Children

The purpose of this study is to evaluate effectiveness of albendazole in the treatment of the asymptomatic infection with the parasite Toxocara in children. Treatment response is defined as a reduction in the number of eosinophils in blood. The study drug will be compared to placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50 children (25 per group) will be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric ambulatory patients with asymptomatic toxocariasis
* Children 2 - 15 years old
* Absolute eosinophil count \> 1100 / mm3
* Normal ophthalmoscopy

Exclusion Criteria:

* Treatment with a benzimidazole in the previous year
* Infection by other nematodes (Ascaris lumbricoides, strongyloides stercoralis, uncinarias, Trichuris trichuria)
* Symptomatic patients (prolonged fever, acute pneumonitis, hepatomegaly, splenomegaly, ocular compromise due to toxocara)
* Concomitant diseases
* Immunocompromised patients
* Altered liver or kidney function
* Pregnancy
Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients

This is a randomized, prospective, double-blind pilot study designed to evaluate the potential effectiveness of pregabalin in post-operative pain management for patients who have sustained a fracture.

On admission, all patients who have sustained orthopaedic injuries of any type, including pelvis, will be screened. However, only those patients who will undergo a single episode of surgery during this hospitalization to surgically repair only one of their orthopaedic fractures will be interviewed by a clinical research nurse. If the patient meets all criteria for inclusion/exclusion in the study, the attending physician will consent the patient for inclusion in the study. Upon enrollment into the study, the clinical research nurse will obtain a thorough history from the patient concerning prior narcotic use, response to painful events in the past and will record details of the injury. Prior to surgery, the patient will be treated with narcotic pain medication as required in the judgment of the attending physician. The patient will then be randomized before surgery into a placebo group or pregabalin group. The attending physician will be blinded as to which study arm the patient is in.

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive either pregabalin 75mg orally (PO) BID, pregabalin 150mg PO BID or placebo beginning on the day of surgery until discharge.

The clinical research nurse will complete a form which records the daily use of each of the post-operative pain medications. She will also ask the patient to complete a Visual Analog Scale (VAS) to assess pain each day while in the hospital.

Upon discharge, the patient will be given study medication (pregabalin, 75mg PO BID, 150mg PO BID or placebo). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/acetamenophen (APAP) 7.5mg PO every sic hours (Q6H) as needed (PRN). Patients will be followed for three months as an outpatient.

Eligibility Criteria:
Inclusion Criteria:

* fractures requiring operative treatment during a single operative episode
* Adult patients between the ages of 19 and 70

Exclusion Criteria:

* prior medical history of narcotic abuse or narcotic use within 2 weeks of injury (except those given in hospital)
* contraindications to pregabalin or narcotic analgesics
* significant closed head injury
* psychiatric illness requiring medical treatment
* surgery for other injuries (splenectomy, etc)
* history of seizures requiring current anticonvulsant therapy
* inability or unwillingness to give informed consent
The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children

This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.

Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling.

Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling.

A pain-free life is the right of every child. Eliminating pain and improving the quality of life of children is one of the main goals of nursing care. Pediatric nurses should choose the appropriate assessment tool for the child's age and developmental characteristics and diagnose pain correctly. For this purpose, nurses can use appropriate distraction methods. Since the nurse is the healthcare worker who is with the child and family the most throughout the day, s/he should closely monitor and evaluate the child's pain and inform the child and family about the principles of pain control. Many hospitals in Türkiye generally do not use any non-pharmacologic methods to reduce procedural pain. Given that distraction techniques are inexpensive and easy to use, and that reducing children's pain may reduce negative feelings towards future procedures, it is important to examine the effectiveness of such methods. In our study, a kaleidoscope, one of the methods of distraction to reduce pain during blood sampling in children, was used. A kaleidoscope is a game tool that helps distract the child's attention from procedural pain and shows the external image by reproducing it when viewed through it. This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.

Eligibility Criteria:
Inclusion Criteria:

* were being 7-12 years of age
* not having an auditory or visual disability
* not taking analgesics in the last eight hours
* not having any pain caused by other reasons before the procedure
* having vascular access and blood sampling interventions

Exclusion Criteria:

* having physical or mental disability
* having any nerve damage