cyrilzakka/clinical-trials huggingface dataset:
Breathing and Relaxation Exercises for Asthma: a Randomised Controlled Trial

All patients on the GP asthma database in one practice were invited for an asthma physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie - aged between 16 and 70, able to understand, read and write English, give informed consent, willing to attend the surgery to take part in the trial and with no other serious conditions - were invited to participate in the study. Patients were randomised either to a control group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises (known as the Papworth Method (PM)). The two groups would then be compared at 6 and 12 months.

Hypotheses:

1. The PM of breathing and relaxation training would improve the quality of life for adult patients with asthma in primary care, compared with patients only receiving usual medical care.
2. Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared with the control group.
3. Respiratory function measurements would improve compared with the control group.


Eligibility Criteria:
Inclusion Criteria:

* doctor diagnosed asthma, volunteers from the practice asthma database
* 16-70 years of age
* able to understand, speak and write English
* willing to give informed consent
* willing and able to attend the surgery for assessments and treatments

Exclusion Criteria:

* serious co-morbid conditions
T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition

T-mult is an experimental study using low-frequency (1Hz) single-sesson rTMS to the DLPFC (versus sham rTMS) to explore the effect of virtual lesions on the brain network and cognition in 100 healthy adults (20-65 years old).


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years old
* Native Dutch speaker
* Able to provide written informed consent

Exclusion Criteria:

* History of diagnosed neurological or psychiatric disease (including traumatic head injury)
* Current and regular use of centrally acting drugs (recreational or prescribed, including analgesics), including the use of alcohol \~8 hours prior to an appointment
* Presence of any contraindications for MRI, MEG, or TMS (including resting motor threshold \>75% of maximum stimulator output or no useful motor-evoked potential elicitable)
* Previous rTMS treatment
Effectiveness of Dry Needling and STM on Pain Management for ACLR

The purpose of this study is to determine if dry needling (DN) and soft tissue mobilization (STM) is superior to standard treatment protocol for affecting pain, pain medication usage and measurements of range of motion (ROM) after ACL reconstruction surgery compared to a standard treatment protocol. Measurements of pain, pain medication usage, lower extremity functional scale (LEFS) and ROM will be taken day 2 post op and 1 week, 2 weeks, 3 weeks, and 4 weeks post op. It is hypothesized that the inclusion of DN and STM will acutely decrease the demand for pain medication and improve objective measurements when compared to a standard treatment protocol. Findings will potentially lead to insights as to the benefit of applying these interventions to help decrease the demand for pain medication post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 Department of Defense( DOD) beneficiaries (17 if Cadet)
* Scheduled for ACL Reconstruction Surgery

Exclusion Criteria:

* Self-Reported Pregnancy
* History of blood borne pathogens/infectious disease/active infection/metal allergy
* Bleeding disorders or currently taking anti-coagulant medications
* Participants who are not fluent in English
Assessing Student Learning of Spinal Mobilization With Real-time Objective Feedback

This is a research project on physical therapy education. Subjects will be recruited using convenience sampling from second-year physical therapy students on the campus of Youngstown State University. There are currently 28 students in the class. All students will be recruited to participate in the study. The objective of the study is to assess student learning of grades of spinal mobilization with real-time objective feedback.

Sampling: Subjects will be recruited using convenience sampling from second-year physical therapy students on the campus of Youngstown State University.

Research Design: Randomized controlled trial (RCT). Subjects will be randomly assigned to the experimental group or control group. Subjects will attend a spinal mobilization lecture followed by a practice lab.

Randomization: Once enrolled in the study, each student will be randomly assigned to experimental or control groups. Randomization will occur via a random number generator and allocation will be concealed in opaque envelopes.

Intervention:

The experimental group will use a force sensor (Active5) while learning spinal mobilization during the practice lab portion of the class. The force sensor will provide objective feedback to the students. Each student will be instructed on how to use the Active 5 device prior to utilizing it in the classroom setting. The device can display the amount of force generated by the student on a smartphone or a tablet in real-time so the students would be able to adjust the amount of force.

The Control group will participate in the same classroom lecture and activity. However, during the practice lab portion of the class, the control group will only receive traditional subjective feedback from the class instructor and/or student peers.

A perceived competence scale survey (score between 0-10 with 10 being confident and 0 being not confident) with demographic information will be administered immediately after the intervention. An independent blinded instructor will serve as the assessor of student skill level to avoid bias immediately after the intervention/procedure. Student t-test will be used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Second year Physical Therapy students; males or females; age between 20 and 60 years of age.

Exclusion Criteria:

* Student who is not a second year Physical Therapy student or unwilling to participate in the study.
Diaphragm Dysfunction in ARDS Patients With V-V ECMO

Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS).

Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. The present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with VV-ECMO.

Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). It allows to provide a protective lung ventilation by reducing the level of airway pressures generated by the ventilator. The objective is to minimize the harmful effects of mechanical ventilation in the lungs and to provide adequate gases exchanges. This strategy requires a deep sedation to allow a perfect synchrony between the patient and the ventilator. Such a synchrony puts the respiratory muscles - in particular the diaphragm - completely at rest.

Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. Such a dysfunction has been associated with prolonged duration of mechanical ventilation and poor outcomes but its effect in patients with veno-venous extracorporeal oxygenation membrane has never been evaluated so far.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* ARDS according to the Berlin definition
* V-V ECMO
* patient or next of kin agrees to participate
* patient with health insurance

Exclusion Criteria:

* pregnancy
* Opposition to participate
* Contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"
Continuing Medical Education to Improve Knowledge of Viral Hepatitis B-C in Primary Healthcare Workers

The purpose of study is identifying the effectiveness of 'continuing medical education' (CME) to primary healthcare worker to improve knowledge about viral hepatitis B-C


Eligibility Criteria:
Inclusion Criteria:

* Currently working at Outpatient department, Primary-level hospitals
* Having Practicing Certificate
* Not attending any long-term education
* Accepting ICF

Exclusion Criteria:

* Not attending the full number of lessons
* Not answering the questionnaire
Comparison of Affect-based, Self-selected, and Traditional Exercise Prescriptions

This study will evaluate adherence to four types of walking programs. Participants will be randomized to walking programs that included either (1) affect-based exercise intensity, (2) self-selected (or "choice-based") exercise intensity, (3) heart-rate based exercise intensity, or (4) heart-rate guided exercise intensity with the emphasis on affective benefits.

The purpose of this study is to determine if an "affect-based" or "choice-based" exercise prescription is more effective for behavior change than a traditional, "moderate-intensity" exercise prescription. Prior research suggests that "choice-based" or "self-selected" exercise intensity is more pleasant and adhered to than "moderate-intensity exercise" (Williams et al., 2014). Similarly, affect-based exercise prescriptions (i.e., an exercise prescription where intensity is regulated based on the pleasure-displeasure one feels while exercising) appear to have merit (Baldwin, Kangas, Denman, Smits, Yamada, \& Otto, 2016).

However, choice-based and affect-based exercise prescriptions have not been compared to each other. Further, it is unknown if it is the intensity regulation that matters (e.g., "choose an intensity that feels good" or the focus on affect (e.g., "focus on feeling good). Third, prior research has not objectively measured physical activity behavior.

Eligibility Criteria:
Inclusion Criteria:

* Must be fluent in English
* Must be able to walk
* Exercise less than 90 minutes per week at a moderate-intensity
* Must be able to attend laboratory visits
* Must have mobile internet accent and a personal smartphone (iPhone iOS 9+ or Android OS 4.3+)
* Can safely exercise at an intensity that is at least "moderate"

Exclusion Criteria:

* People who are recommended to have medical clearance prior to exercising, according to the American College of Sports Medicine's preparticipation screening criteria, will be excluded
CV004-007 Thrombosis Chamber Study

The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
* Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive
* Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Any condition that could affect drug absorption
* Other protocol-defined exclusion criteria could apply
Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device

This randomized trial is determining the role of antibiotic prophylaxis in the prevention of the infectious complications in patients carrying out totally implantable venous access device.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* Have solid tumor
* White cells \>4000
* Platelets \>100.000
* Prothrombin time in normal range

Exclusion Criteria:

* Drug allergy
* Diabetes mellitus
Lace Up and Move: Structured After School Intervention for Hispanic and African American Youth

The purpose of this study is to test the efficacy of Lace Up and Move (LUAM), a structured after-school exercise intervention, designed to increase moderate-to-vigorous physical activity (MVPA) and enhance sleep quality among Hispanic and African American (AA) boys and girls.

This study uses a randomized comparison-group pre-post-test design. Overall objectives of LUAM are to: (1) to increase the percentage of youth who meet 60 minutes of daily MVPA per week; (2) to improve the quality of sleep patterns (i.e., sleep efficiency and duration); and (3) to reduce percent body fat (%BF). It is hypothesized that compared to the control group (CG) participants, the experimental group (EG) participants will exhibit: (a) greater increase in percentage of children who meet 60 minutes of daily MVPA per week; (b) greater increase of sleep efficiency and duration; and (c) greater decrease in sleep latency and (d) greater decrease in %BF.

Eligibility Criteria:
Inclusion Criteria:

* child and at least their mother \[or one member of the family\] must be of Hispanic or African American descent
* child must have no physical disability or medical conditions that interfere with their participation in the exercise program

Exclusion Criteria:

* neither child nor parental guardians is of Hispanic or African American descent
* child is not between the ages of 9-14 years
* child is pregnant or physically unable to participate in the exercise program.
Deep Neural Networks on the Accuracy of Skin Disease Diagnosis in Non-Dermatologists

Background: Deep neural networks (DNN) has been applied to many kinds of skin diseases in experimental settings.

Objective: The objective of this study is to confirm the augmentation of deep neural networks for the diagnosis of skin diseases in non-dermatologist physicians in a real-world setting.

Methods: A total of 40 non-dermatologist physicians in a single tertiary care hospital will be enrolled. They will be randomized to a DNN group and control group. By comparing two groups, the investigators will estimate the effect of using deep neural networks on the diagnosis of skin disease in terms of accuracy.

In the DNN group and control group, these steps are the same process.

1. Routine exam and capture photographs of skin lesions for all eligible consecutive series patient.
2. Make a clinical diagnosis (BEFORE-DX)
3. Make a clinical diagnosis (AFTER-DX)
4. consult to dermatologist

In the DNN group, after making the BEFORE-DX, physicians use deep neural networks and make an AFTER-DX considering the results of the deep neural networks (Model Dermatology, build 2020).

In the control group, after making the BEFORE-DX, physicians make an AFTER-DX after reviewing the pictures of skin lesions once more.

Ground truth will be based on the biopsy if available, or the consensus diagnosis of the dermatologists.

The investigators will compare the accuracy between the DNN group and control group after 6 consecutive months study.

Eligibility Criteria:
Inclusion Criteria:

* non-dermatologist physician (residents) who agree to participate in this study

Exclusion Criteria:

* dermatology residents
* non-dermatology residents who use other deep neural networks for skin lesion diagnosis
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).

Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or higher
* documented recurrence of Clostridium difficile

Exclusion Criteria:

* none
Integrative Medicine of IgA Nephropathy

The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.

The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.

Eligibility Criteria:
Inclusion Criteria:

1. The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
2. TCM is liver kidney yin deficiency syndrome;
3. age 18-70 years old, sex, nationality is not limited;
4. CKD phase 2-4 （89 ml/min\>eGFR（EPI Formula）\>15ml/min/1.73m2）;
5. 24 hour urinary protein≥1g.

Exclusion Criteria:

1. It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
2. It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
3. Acute or progressive glomerulonephritis patients;
4. Severe complications threat to life, such as severe infection;
5. Active hepatitis B and liver function test sustained abnormal;
6. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;
7. Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
8. Gravid or lactation woman;
9. Other clinical trials are being studied;
10. Merger with other serious disease and dysfunction of the organ.
Diabetic Foot Ulcer Imaging- Study 2

All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

The research procedures consist of a) a research assistant measuring the size of the foot ulcer (for ulcer patients), b) patients having pictures of their feet taken with a smart phone under 4 conditions- 1) photos taken by researchers, 2) photos taken by the patient by hand, 3) photos taken by the patient with a selfie stick, and 4) photos taken by a 3rd party (e.g., friend/family member of patient). If the patient is not able to take photographs under any of the conditions, that condition will be excluded. In addition to photos being taken with a smart phone, additional photos will be taken with a thermal camera by the research team to determine if there is a difference in ulcer size depending on type of camera used. It is anticipated that procedures will last between 15 and 45 minutes. There is no long-term follow-up. If a patient returns to the clinic they will be asked if they wish to complete all study procedures again. Once the patient has left the clinic, the research team will check the medical record for: age, sex, race, ethnicity, BMI, co-morbidities, and zip code (to determine if patient lives in an urban or rural location).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 1 or Type 2 Diabetes
* Has a current foot lesion
* Receiving care through University of Iowa Hospitals and Clinics (UIHC) Iowa River Landing Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic.

Exclusion Criteria:

* Cognitive impairment that prevents consent
* Lack of fluency in speaking or understanding English
* Known aversion to research studies
Safety and Efficacy of Liposomal Latanoprost in Ocular Hypertension

Aim: Evaluation of a single subconjunctival injection of liposomal EggPC formulation of latanoprost in treating glaucoma.

Hypothesis: The investigators have already evaluated carrier stability, drug partitioning, in vitro drug release, tolerance, and efficacy of latanoprost-incorporated EggPC liposomes upon subconjunctival administration in both rabbit and monkey eyes. Therefore, the investigators hypothesize that this would be safe and efficacious in humans as well.

Methodology: A pilot study to assess a liposome formulation containing latanoprost. The investigators will recruit 6 study subjects with eyes that have raised IOP, for subconjunctival injection of this liposome formulation. The recruited eye will be injected and monitored for inflammation, toxicity and pain as primary end-points. Monitoring of the eye will be for the first 24 hours post-injection, week 2, months 1, 2 and 3 thereafter.

Importance: If proven safe, this method of drug delivery could potentially be used for treatment of raised intraocular pressures in blinding conditions such as glaucoma.

The number of recorded adverse events and intolerance to the subconjunctival injection procedure by the participants during the study period was used as a measure of safety.

Eligibility Criteria:
Inclusion Criteria:

Glaucoma patients who have eyes with raised IOP (baseline IOP \>21 mmHg) due to end-stage glaucoma with a poor visual prognosis.

Exclusion criteria:

1. Active or recent eye infection, endophthalmitis
2. Known hypersensitivity to latanoprost
3. Only eye
4. Previous glaucoma filtration surgeries or trabeculectomy
5. Intraocular pressure less than 12mmHg.
6. Inability to give informed consent.
7. Inability to safely administer a subconjunctival injection
8. Uncontrolled systemic hypertension, CVA or TIA within the previous month.
9. Pregnancy -
Quantra QStat Sample Type Comparison

This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.

In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \>=18 years
* Subject is scheduled for liver transplant surgery
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject is pregnant
* Subject is incarcerated at the time of the study
* Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks
* Subject, or subject's LAR, is unable or unwilling to provide informed consent