cyrilzakka/clinical-trials huggingface dataset:
Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis

The purpose of this research is to examine the effects of diastasis rectus abdominis on the overall function of postpartum women and to determine test-retest reliability and construct validity of a self-assessment palpation of inter-rectus distance for DRA using telehealth.

Step 1: Recruitment

* The investigators will place recruitment fliers in local obstetrician offices, labor and delivery units in local hospitals, retail and daycare establishments, and on social media outlets such as Facebook, Instagram and Twitter.
* The recruitment fliers will ask interested women to email a student investigator to enroll in the research project.

Step 2: Collection of functional outcome data using a Qualtrics version of the Inventory of Functional Status After Childbirth (IFSAC), a demographic survey, a numeric pain reporting scale, Oswestry Low Back Pain Disability Questionnaire, and the Pelvic Floor Distress Index.

Step 3: A meeting time will be set up with every participant to conduct a telehealth visit with a research assistant. During this virtual visit on a private, password protected Zoom call the participant will be instructed on self-assessment palpation of the abdominal wall in order to determine the presence or absence of diastasis rectus abdominis (DRA) along the inter-rectus distance (IRD).

Step 4: The first 18 participants with self-assessed DRA and the first 18 participants without self-assessed DRA, who live in Wichita or surrounding areas, will be scheduled for a one-time in-person confirmation appointment. The appointment will last a maximum of 15 minutes and occur at the WSU Old Town campus room A106. During this confirmation appointment research assistants will screen the participant with the COVID Pre-screening Questions Tool, obtain written informed consent, check the participant in, collect height and weight, and the principal investigator will measure the participants abdominal wall using real-time ultrasound, measure the IRD using the PI's palpation method, and ask the participant to demonstrate and measure IRD using the same palpation method used on the telehealth visit. See the virus protection plan for details of which all participants and investigators will follow in order to minimize risks related to COVID-19).

Step 5: The data will be entered into SPSS and analyzed with appropriate statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-40 years
* Postpartum (within 6-10 weeks of vaginal delivery)

Exclusion Criteria:

* Women who are currently being treated by a physical therapist for their diastasis rectus abdominis
* Women who had high-risk pregnancies (bedrest, gestational diabetes, pregnancy-induced hypertension)
* Women with a history of abdominal or back surgery
* Women with history of connective tissue disease such as Ehlers-Danlos Syndrome
Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury

Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.

Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.

Main goal is to test safety of Rimonabant in a specific population (incomplete spinal cord injury).

Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury
* Incomplete lesion (AIS D)
* Neurological level between C4 and L1
* Chronic stage (\>1 year since injury)
* Preserved walking ability for at least 5 m (aid allowed)
* Psychiatric assessment to exclude individuals with high suicide risk
* Capability to provide informed consent
* For fertile women, possibility to use anti conceptive methods

Exclusion Criteria:

* Non traumatic spinal cord injury
* AIS A, B, C or E
* Neurological level above C4 or below L1
* Subacute stage (\<1 year since injury)
* Preserved walking ability for less than 5 m (aid allowed)
* Pregnancy or breast feeding
* For fertile women, impossibility to use anti conceptive methods
* Anticoagulant treatment
* Hypothyroidism
* Severe kidney or liver dysfunction
* Severe depression
* Fatigue treatment in the last 6 months
* Impossibility to reach the Hospital
* Impossibility to provide informed consent
Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

assess the clinical and laboratory effects of the local and sub gingival application of a 0.8% hyaluronic acid gel (GENGIGEL®) as an adjunct to scaling and root planning (SRP) in chronic moderate to severe periodontitis patients as indicated by expression of Human Beta Definsin-2 (HBD2) in gingival crevicular fluid (GCF).

Patients who fulfilled the selection criteria will be included in the study. One quadrant will be treated with HA gel (test) and the other without to serve as control. Clinical examination will be done in a dental chair under standard conditions of light, using mouth mirror and graduated Williams Periodontal Probe.

All patients will receive full mouth scaling and root planing with hand instruments and ultrasonic scalers at baseline. Thereafter, in the test quadrant, 1 ml of 0.8% hyaluronic acid gel will be administered subgingivally in all selected test sites at baseline and 1 week later. The following clinical parameters will be recorded at baseline, after 6 weeks and 12 weeks post treatment. Oral hygiene instructions will be given to all patients. The clinical measurements and treatment will be performed by a single examiner.For every patient and control subject, GCF samples will be collected at baseline, 6 weeks and 12 weeks post treatment. The samples will be pooled from two periodontal sites with clinical attachment level of 3 mm or more (in the two different quadrants). The sampling area will be isolated with cotton rolls and carefully will be cleaned supragingivally with sterile cotton pellets. A sterile absorbent paper point will be inserted into the gingival crevice or pocket until resistance will be felt. The paper point will be held in place for 30 s and then will be transferred to a vial containing 100 μL of distilled water and vigorously will be mixed. The paper points will be removed, and the samples will be centrifuged and will be washed twice with distilled water. The resultant pellets will be resuspended in 0.4 mL of distilled water. The samples will be coded and stored at -70 °C until use for ELISA test for identification of Human beta Defensin-2.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be systemically healthy with moderate to severe chronic periodontitis of more than 4 mm probing depth in at least two sites in different quadrants.
* Patient should exhibit no known allergies
* Participants should have the ability to attend the hospital regular intervals.

Exclusion Criteria:

* pregnancy
* nursing
* hypertension
* patient with chronic diseases such as diabetes mellitus or rheumatoid arthritis. -Participants should not be under antibiotics and\\or had receive any periodontal therapy for the last 6 months.
* Participants should not taking drugs that could affect the state of the gingival tissues.
* Participants must not be undergoing orthodontic therapy, caries free
* Participants must not be using any other supplemental plaque control measures like mouthwashes.
* Participants should not have the habit of taking alcohol, smoking or chewing tobacco and do not suffer from any systemic disease.
Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation

A retrospective cohort study of Thai octogenarians with nonvalvular atrial fibrillation (NVAF) initiating apixaban, dabigatran, rivaroxaban or warfarin was conducted in medical school hospital in Thailand. Patients were recruited from January 1, 2013, to December 31, 2018. The efficacy outcome was early recurrence of stroke or transient ischemic attack (TIA) in 90 days after initiation of oral anticoagulants (OACs). The safety outcome were major bleeding and clinically relevant non-major bleeding complications in 180 days. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test. Furthermore, hazard ratios and P values were calculated by the use of multivariable Cox's regression analysis.

This is a retrospective cohort study of Thai octogenarians with NVAF. Patients who were prescribed with apixaban, dabigatran, edoxaban, rivaroxaban or warfarin from January 1, 2013, to December 31, 2018 were recruited. The primary efficacy was recurrent ischemic stroke or TIA in 90 days after initiating OACs. The secondary efficacy were recurrent ischemic stroke or TIA in 180 days after initiating OACs. While any bleeding complications were defied as primary safety outcomes. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 80 years old
* Patients who were diagnosed with I48, I63 or G45 from International Classification of Diseases 10th version (ICD-10). Patients who were diagnosed atrial fibrillation and flutter, cerebral infarction or transient cerebral ischemic attacks (TIA) and related syndromes)
* Patients were prescribed apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin

Exclusion Criteria:

* Patients were prescribed oral anticoagulants for other indications

  1. Prophylaxis thromboembolic events in valvular atrial fibrillation
  2. Treatment of venous thromboembolism
  3. Prophylaxis thromboembolic events in hip or knee replacement
* Patients who had contraindication to oral anticoagulants

  1. Creatinine clearance calculated from Cockcroft-Gault equation 1.1 Creatinine clearance less than 30 mL/min (for patients who receiving Dabigatran) 1.2 Creatinine clearance less than 15 (mL/min (for patients who receiving Apixaban, Edoxaban, Rivaroxaban)
  2. Patients were diagnosed acute hepatitis, chronic active hepatitis
Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio (CAREER) Study

To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.

This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Coronary CT angiography indicates that \>= 1 stenosis with percent diameter stenosis between 30%-90% in a vessel \>= 2mm.
2. The invasive coronary angiography should be less than 30 days after the coronary CT angiography.

Exclusion Criteria:

1. The target lesion has received coronary stent implantation or coronary artery bypass graft.
2. Target lesion involves myocardial bridge.
3. Severe heart failure (NYHA ≥III).
4. Renal function is seriously damaged (eGFR\<30 ml/min/1.73m2).
5. Those who are contraindicated to use contrast agents, beta blockers, nitrates or adenosine drugs.
6. Acute myocardial infarction within 1 month.
7. The image quality of CTA or coronary angiography cannot be assessed.
8. Any factors that affect the image quality of coronary CTA and coronary angiography, such as frequent premature contractions, atrial fibrillation, etc.
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Adverse event data will be covered in Adverse events section.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.

Exclusion Criteria:

* All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.
Effects of Sedation on Transpulmonary Pressure and Lung Homogenous

The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near diaphram during mechanical ventilation, however, strong respiratory drive could generate more transpulmonary pressure in ARDS patients, which increase the stress and strain in injured lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of ARDS patients.The purpose of this study is to investigate the effects of sedation on transpulmonary pressure of ARDS patients.

Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast University

Eligibility Criteria:
Inclusion Criteria:

1. ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:

   1. Requires positive pressure ventilation through an endotracheal tube
   2. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
   3. PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days
   4. No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine \<10ug/kg•min or norepinephrine \<10ug/kg)
2. Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine \<10ug/kg•min or norepinephrine \<10ug/kg)

Exclusion Criteria:

* Age younger than 18 years or older than 85 years
* Cardiac failure
* Known pregnancy
* Increased intracranial pressure
* Severe neuromuscular disease
* Recent injury or other pathologic condition of the esophagus
* Pneumothorax
* Pleural effusion
* Diaphragmatic hernia
* Severe chronic respiratory disease
* End-stage chronic organ failure
* Expected survival of less than 24 hours
* Participation in another interventional study
* Attending physician declines to give consent for participant to enroll
* Patient or surrogate declines or is unable to give consent
Partners in School: Promoting Continuity Across Home and School

Partners in School is a collection of implementation strategies (e.g., communication training, problem-solving consultation) to help parents/primary caregivers and teachers of children with autism spectrum disorder implement the same practices across home and school.

We recruited a total of 48 participants (N=22 parent-teacher dyads) from urban and suburban public schools in New York, New Jersey, and Connecticut. Teachers were matched on years of teaching experience (0-2 years, 3-5 years, 5-10 years, or 11+ years), and then randomized to the experimental condition or the control condition. The experimental condition had 13 parent-teacher dyads (N=26 participants) and the control condition had 11 parent-teacher dyads (N=22 participants). The experimental condition included the five steps of Partners in School including the pre-consultation phone interview, web-based communication skills training for the parent or teacher through School Talk, in-person parent-teacher conference, three weeks of implementing the same intervention with the student at home (by parents) and school (by the teacher), and a post-consultation phone interview. Parents and teachers also completed surveys at the beginning and end of Partners in School. The control condition had the same experiences but the parents/teachers in that condition did not receive communication skills training through School Talk. One of the key outcomes is that recruitment, randomization, condition protocols, retention, and assessment of Partners in School with School Talk is feasible and acceptable. These findings are significant to the scientific field because they suggest that researchers can partner with public schools and train parents and teachers to communicate and collaborate effectively in order to double the dosage, intensity, and impact of evidenced-based practices for young children on the autism spectrum disorder (ASD).

Eligibility Criteria:
Inclusion Criteria:

1. Must be parent/primary caregiver or full-time, lead teacher
2. Must have or teach preschool, pre- kindergarten, kindergarten, or 1st grade child with ASD
3. Must have or teach child with ASD that can see and hear
4. Access to internet via wifi-enabled phone, tablet, or computer
5. Must be English or Spanish speaking
6. An active email -

Exclusion Criteria:

1. Parents with younger (less than preschool) or older children (in 2nd grade or above)
2. Teachers who teach older than 1st grade.
3. Teaching assistants
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged more than 18 years
* Strongly suspected of having carotid or vertebral arterial disease
* Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination

Exclusion Criteria:

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²)
* Contraindication to MRI
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.

The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.

Inpatient patients in Raymond Poincaré hospital are informed of the utilization of their data retrospectively by the hospital's welcome booklet and reports of patients' hospitalization.

Period of date collected: November 2015 to June 2018.

The reference standard was the diagnosis established during a multidisciplinary meeting held during patient management involving a neurologist, an electrophysiologist, a pulmonologist, and a respiratory physiologist. The medical history, physical findings, and all available investigations including imaging studies, ENMG, lung function tests, and Pdi measurement were considered during the meeting.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years;
* Available data of Pdi and PNC;
* Suspected unilateral diaphragmatic paralysis.

Exclusion Criteria:

* Abnormalities in thoracic wall which susceptible to modify the investigation's results;
* Scoliosis;
* Pleural effusion.
A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones

Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan
* stone radiopaque on KUB, distal to the sacro-iliac joint
* patient suitable for discharge from ER
* patient willing to return for follow-up on a weekly basis for maximum 4 visits

Exclusion Criteria:

* more than one ureteral calculi
* radiolucent stones or cystine stones
* prior ipsilateral calculus or ureteral surgery
* congenital anomalies of the ureter
* patients presents with an absolute indication for intervention
* allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP \<90 mmHg)
* patient currently taking an alpha-blocker
* hepatic insufficiency
* pregnancy
A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in lung function and increased symptoms such as breathlessness/dyspnoea, cough and expectoration.

Even though subjective in nature, the symptomatology of COPD and mainly that of breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking into consideration that the symptoms experienced by the patient who suffers from a progressive disease such as COPD can only be perceived and interpreted by the patient him- or herself, and thus difficult to be quantified, COPD remains a challenge in clinical research.

Therefore, there is a need to carry out qualitative studies that will provide insight into the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a further mapping of the impact that COPD symptoms' perception has on a patient's life is required, as well as of the different pathways through which symptoms' perception is interpreted regarding the limitations of daily living activities, and the subsequent impact on disease management. The more the physician learns on the embodied experience of COPD, the better he/she may assist the patient in achieving optimal COPD management.

Thus this cross-sectional observational study was designed aiming to obtain these data. Specifically, the study aims to evaluate the most frequently used words by the patients and the physicians to express the symptoms of COPD as well as the limitation of activities that it causes.


Eligibility Criteria:
Inclusion Criteria:

* Aged 45-75 years
* Current or former smokers
* Known history of COPD for at least 6 months before enrolment into the study documented by spirometry (FEV1 /FVC \<70%)
* Patients with stable COPD (no exacerbation within the last month before enrolment into the study) under treatment with a long-acting inhaled bronchodilator (LABA and/or LAMA) alone or in combination with an inhaled corticosteroid
* Written consent for participation in the study
* Patients who are able to complete by themselves in Greek a questionnaire on COPD.

Exclusion Criteria:

* Patients with diagnosed Asthma
* Patients with any psychiatric, neurological or other disorder render them unable to complete the COPD questionnaire by themselves
* The patient participates in another study.