cyrilzakka/clinical-trials huggingface dataset:
Development and Validation of an Actimetric Protocol to Quantify Physical Activity and Sedentary Behaviour in Post-stroke Subjects

The aim of this project is to develop an actimetry protocol based on a system of motion sensors, such as accelerometers and pressure insoles.

These sensors will be used to analyze arm and leg movements in individuals who have experienced a stroke. Throughout the study, we will adjust certain parameters-such as sensor placement and measurement frequency-to optimize data quality.

We will also refine data analysis methods to better identify the types of movements performed (upper and lower limbs), estimate energy expenditure, and recognize different postures adopted by the participant (sitting, standing, etc.).

The goal of this protocol is to provide accurate measurements of physical activity and inactivity, both in controlled environments (such as a laboratory) and in real-life settings (outdoors or at home).

This study will allow us to validate the reliability of the actimetry protocol and assess how easy it is to use at home.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Stroke diagnosed by a neurologist and confirmed by medical imaging
* More than 14 days post-stroke
* Medically stable condition
* Hemiparesis with impaired locomotion: Functional Ambulation Classification (FAC) between 1 and 5
* Montreal Cognitive Assessment (MoCA) score \> 18/30

Exclusion Criteria:

* Inability to understand simple instructions
* Other neurological or musculoskeletal disorders limiting functional mobility
Feasibility of a Social Media-based Weight Loss Program for Low Socioeconomic Status Individuals

The purpose of this study is to see if it is practical to use social media-based and traditional online weight loss intervention components among low socioeconomic status participants using the Facebook social media (SM) and Fitbit self-monitoring platforms. Also, the study will test the effectiveness of recruiting participants via social media and at community events and locations. The results of this study will be used to inform future research studies.

The primary objectives of the proposed research are to:

1. assess the feasibility of social media-based (social support, social competition, and social rewards) and traditional online weight loss (education and goal setting) intervention components delivered to low-Socioeconomic Status (SES) participants using the Facebook SM and Fitbit self-monitoring platforms and
2. develop and assess methods for recruiting and retaining adequate numbers of low-SES participants for a future randomized controlled trial to assess the efficacy of an SM-based weight loss intervention. The study team will assess feasibility by conducting a 12-week pilot test of traditional and social media-based weight loss intervention components followed by qualitative and quantitative assessment with pilot participants.

The specific aims are:

Aim 1- Assess trial feasibility: The study team will assess intervention processes critical to the success of a larger efficacy trial during the 12-week pilot including: (1) participant recruitment and retention, (2) participant use of intervention components, (3) use of data collection strategies and instruments.

Aim 2 - Assess intervention acceptability: The study team will conduct structured interviews and surveys among participants to assess participants' experience during the intervention. This study focuses on: (1) intervention design and content, (2) participant use of intervention technologies (Facebook and Fitbit), (3) participant concerns about privacy, and (4) barriers and facilitators to recruitment, retention, and participation. Findings will be used to improve the design of a larger efficacy trial.

Study Design: This study will employ a one group pre-post design.

Eligibility Criteria:
Inclusion Criteria:

* able to speak English
* regular access to an internet-enabled device that can be synched with the Fitbit wristband
* Body mass index (BMI) 25-40 kg/m\^2
* \< 30 minutes per day of self-reported moderate or vigorous physical activity
* Considered eligible for Ohio Expanded Food and Nutrition Education Program (EFNEP) income guidelines
* located in the greater Cleveland metropolitan area
* not pregnant or planning on becoming pregnant
* answers 'no' to all questions on the PA Readiness Questionnaire (PAR-Q) or is cleared in writing by a physician
* does not have a recent history of alcohol or drug abuse or is in treatment
* does not have schizophrenia

Exclusion Criteria:

* Does not meet all inclusion criteria
Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine

Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of any race between the ages of 18 and 75 years with weight within 30% of normal for gender, height and frame as specified by the Metropolitan Life Insurance Table
* For patients in the renal group: stable creatinine clearance based on two estimations taken at least 3 days apart, corresponding to one of four groups:

  * Group 1 (mild dysfunction) = 50 ml/min \<= Creatinine Clearance (CLcr) \< 80 ml/min
  * Group 2 (moderate dysfunction) = 30 ml/min \<= CLcr \< 50 ml/min
  * Group 3 (severe dysfunction) = CLcr \< 30 ml/min and
  * Group 4 = end-stage renal disease (ESRD) requiring dialysis
* For patients in the hepatic group

  * Two baseline creatinine clearances (taken at least 3 days apart) \> 80 ml/min
  * clinically diagnosed with hepatic insufficiency and Class A or B liver disease according to Child-Pugh's Classification; subjects must have a Child-Pugh score of 5-9 points
* For patients in the normal group, i.e. normal with respect to hepatic and renal function

  * matched with hepatic group regarding gender, age (+- 10 years), weight (+- 30 pounds) and smoking history
  * Two baseline creatinine clearances (taken at least 3 days apart) \> 80 ml/min
  * No abnormalities on clinical or laboratory evaluations
* Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved form of barrier contraception
* Patients who are able to provide written consent and comply with study requirements

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Seated systolic blood pressure either \< 100 mmHg or \> 150 mmHg and/or heart rate either \< 50 beats/min or \> 90 beats/min
* History of any illness or drug allergy that in the opinion of the investigator might confound the results of the study or pose additional risk in administering nevirapine to the subject
* Patients who have had an acute illness or hospitalization other than for routine dialysis within 2 weeks prior to study initiation
* Patients who are currently taking any over-the-counter drug within 3 days prior to study initiation, or who are currently taking any prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor and pharmacokineticist might interfere with the absorption, distribution or metabolism on the test drug
* Significant electrocardiogram (ECG) abnormalities
NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock

The purpose of this study is to determine the course of NT-proBNP plasma concentrations in the context of confounding parameters in postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock.

In the recent sepsis-definitions, myocardial depression is included in the definition of severe sepsis, indicated as lowered cardiac index or echocardiographically documented cardiac dysfunction. Myocardial dysfunction occurs in greater than 50% of patients with severe sepsis and septic shock. In this context, B-type natriuretic peptid (BNP) from ventricular myocytes may serve as a surrogate biomarker for the evaluation and quantification of myocardial dysfunction. Biologically active BNP is cleaved into inactive NT-proBNP, which is supposed to be a better marker of myocardial dysfunction and prognosis in patients with severe sepsis and septic shock. However, severity of illness dependent association of myocardial dysfunction, especially left ventricular diastolic function, dosage of norepinephrine, NT-proBNP and biomarker plasma concentrations has not been systematically investigated in postoperative/posttraumatic patients in septic shock or volume-deficiency/hemorrhagic shock. Moreover, data regarding NT-proBNP plasma concentrations and renal function in postoperative/posttraumatic patients are sparse. Therefore, this prospective observational study will enroll n= 200 postoperative/posttraumatic patients to monitor longitudinally NT-proBNP, biomarkers, and cell surface markers on leukocytes to find out whether there is a discriminating pattern of myocardial dysfunction, NT-proBNP and biomarkers in patients with non-septic or septic shock, respectively, and with beneficial or harmful outcome.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill, postoperative/posttraumatic patients with severe systemic inflammatory response syndrome (SIRS) or severe sepsis

Exclusion Criteria:

* Life expectancy \< 24 hours
* Participation in other trials
* Known or suspected pregnancy
* Contraindications for transesophageal echocardiography (TEE): severe disease of the esophagus (hernia, strictures, esophageal resection, severe bleeding disorders)
Measurements of Water in Breath and Saliva

This study proposes to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva and breath by comparing the natural abundances of 2H:1H and 18O:16O in saliva and urine of un-dosed humans.

The scientific premises for this line of research are 1) challenges related to costs, the complexity of sample collection and preparation, and the level of technical skills required for Isotope-ratio mass spectrometry (IRMS) analysis have limited the adoption of the doubly labeled water (DLW) method; and 2) the investigators preliminary data demonstrates that Off-Axis Integrated Cavity Output Spectroscopy (OA-ICOS) provides a valid, more rapid, and less technically challenging approach to isotopic analysis of human samples.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women, aged 18-45 yrs

Exclusion Criteria:

* Obesity (body mass index (BMI) \> 30 kg/m2)
* Pregnant or lactating women
* Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers

This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

SUBJECTS WITH TYPE 2 DIABETES

* Subjects with type 2 diabetes mellitus
* Current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use \[maximum of one week in total\] of rapid-acting human insulin will be allowed)
* Age between 20-69 years, both inclusive
* HbA1c (glycosylated haemoglobin A1c) below 9.0%
* Body Mass Index (BMI) 18.5-25.0 kg/m\^2
* Total daily insulin dose (per day) above 0.2 U or IU/kg body weight and below 1.0 U or IU/kg body weight HEALTHY VOLUNTEERS
* Japanese subjects with considered generally healthy based on medical history and physical examination
* Age between 20-29 years, both inclusive
* Body Mass Index (BMI) 18.5-25.0 kg/m\^2
* Subjects with normal glucose tolerance (NGT); defined as fasting plasma glucose below 110 mg/dL and 2-hour post OGTT (oral glucose tolerance test) plasma glucose below 140 mg/dL

Exclusion Criteria:

SUBJECTS WITH TYPE 2 DIABETES

* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic function
* Impaired renal function
* Serious cardiac diseases
* Uncontrolled hypertension
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Current treatment or expected at the screening to start treatment with systemic corticosteroids HEALTHY VOLUNTEERS
* Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) at the screening
* History or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Subjects with a first-degree relative with diabetes mellitus
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets

A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is \<100mg/dl for patients with high risk and \<70mg/dl for patients at very high risk) are screened (hospital-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.


Eligibility Criteria:
Inclusion Criteria:

* Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy

Exclusion Criteria:

* Patients who do not receive cholesterol-lowering therapy
Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure

In this trial the measurement of whole body water will be compared to the standard method of measuring the body weight as treatment guidance in patients with decompensated heart failure. The Seca mBCA 515 \[medical Body Composition Analyser\] will be used to quantify the whole body water by using bioelectrical impedance analysis.

Investigators will include 153 participants hospitalized in the University Hospital in Basel. Daily measurements of whole body water and body weight will be performed in each person until diuretic treatment is stopped or the patient is discharged from hospital, respectively.

Primary endpoint is the correlation between reduction of whole body water (in kg) and reduction of body weight (in kg) in patients with decompensated heart failure receiving forced diuretic treatment (max. deviation +/- 1kg).

Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* hospitalization because of decompensated heart failure treated with forced diuresis
* able to stand on the scale without help from others and able to hold handrails with both hands

Exclusion Criteria:

* refusal to share personal data
* implantable electronic device (e.g. Pacemaker, etc.)
* condition that does not allow skin contact of soles of feet and scale or hands with handrail (leg prosthesis, wounds, bandage, etc.)
Using Rheological Methods to Characterize Cystic Fibrosis (CF) Sputum and the Effects of Mucoactive Agents

The purpose of this study is to characterize the rheological properties of cystic fibrosis (CF) and healthy sputum and to examine the effects of mucoactive agents on the rheology of CF and healthy sputum. By collaborating with Genentech, the investigators (scientists at UCSF) plan to incorporate the latest scientific findings into our work to discover and develop new treatments for CF.

There are two major mechanisms for mucus clearance in the airway, both of which are dependent upon optimal mucus viscosity and elasticity. These mechanisms are severely impaired in cystic fibrosis. The physical properties of sputum can be measured using rheological methods, enabling comparison between mucus in health and in disease. Therapies which enhance mucus clearance from the airway and decrease the volume of airway secretions are collectively called "mucoactive agents." Therapies which specifically disrupt innate mucus architecture by breaking intermolecular entanglements and bonds are called mucolytic agents. Mucolytic drugs can be considered in three general categories: classic mucolytics (n-acetylcysteine), peptide mucolytics (Pulmozyme®), and non-destructive mucolytics (hypertonic saline). Using state-of-the-art rheological methods, we can characterize the physical properties of CF mucus and measure the rheologic effects of mucoactive drugs more accurately and reproducibly than what has been previously done in the literature. In this way, we will determine which of the current mucoactive agents are most effective in normalizing sputum rheology in CF, and we will gain important insights about the limitations of current mucoactive drugs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy control subjects:

  * Age 18-65
  * No history of lung disease or cardiac disease
* Cystic fibrosis subjects:

  * Age 18-65
  * Diagnosis of CF - sweat chloride values \> 60 mM on pilocarpine iontophoresis sweat tests and/or 2 allelic CF-producing mutations by genetic analysis

Exclusion Criteria:

* Use of recreational drugs within 1 year prior to enrollment
* Use of tobacco within 1 year prior to enrollment, or \> 10 pack-year tobacco history
* Upper respiratory tract infection in the 4 weeks prior to enrollment in the study
* Current use of antihistamines to treat allergies
Study of Brain Circuitry in Anxiety Disorders

A diverse body of research has implicated the amygdalo-cortical circuitry in the pathophysiology of anxiety disorders. For example, one model of PTSD posits exaggerated amygdala responsivity to threat-related stimuli as well as deficient top-down modulation of amygdala responses by specific cortical regions, including the pregenual anterior cingulate cortex, subcallosal cortex, and hippocampus.

The investigators propose to investigate the pathophysiology of several specific anxiety disorders, Posttraumatic Stress Disorder (PTSD), Panic Disorder (PD), and Specific Phobia(SP), by using cognitive activation paradigms and magnetic resonance imaging (MRI) to probe the function and structure of implicated amygdalo-cortical circuitry.

All candidates for this project will undergo a comprehensive clinical assessment by an investigator trained to administer these instruments. At the MGH fMRI Center in Charlestown or at the Neuroimaging Center at McLean Hospital in Belmont, MA; each subject will undergo a single MRI session lasting approximately 2 hours. After the scanning session, subjects may be asked to make judgments about the facial expressions or the words that were presented.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years of age
* Right-handed (Edinburgh Inventory - Oldfield 1971)
* SCID diagnosis consistent with group designation:

Current PTSD (PTSD group; none current or past (NC and TENC group); Current SP (must be to small animal phobia, SP group); Current PD (PD group)

* To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.
* For female subjects, stage of menstrual cycle will be ascertained by history (see appendix), and dates of fMRI acquisition will be scheduled to prevent systematic differences between groups with respect to this variable.

Exclusion Criteria:

* Neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.
* History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion)
* History of exclusionary Axis I psychiatric diagnosis (other than as specified); i.e., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder. Note that comorbid current major depressive disorder will be allowed in up to one half of each study group. This will enable inclusion of this common comorbidity, but also enable a definitive assessment of whether or not the presence of this comorbid diagnosis is driving any observed significant between group differences.
* Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
* Pregnancy (to be ruled out by urine ß-HCG).
* Metallic implants or devices contraindicating magnetic resonance imaging.
VISIONAIRE™ Value Study

This is a single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIRE™ Patient Matched Technology. This study does not involve treatment or investigational products, as all components are FDA approved and are commercially available.

The objective of the current observational study is to assess value of surgical instrumentation following analysis of health economic data. It is hypothesized that patient matched cutting block technology VISIONAIRE™ may reduce TKA operative time, blood loss, surgical error and adverse event risk as well as providing improved mechanical alignment. In order to test this hypothesis, subjects will be randomized to either VISIONAIRE™ or standard TKA instrumentation groups. One site will enroll a total of 38 patients; 19 patients per group. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith \& Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the inclusion criteria.

1. Patient is diagnosed with degenerative joint disease of the knee requiring a unilateral TKA.
2. Patient is of legal age to consent, and is skeletally mature.
3. Patient is willing to sign and date an IRB/IEC approved consent form.

Exclusion Criteria:

Patients must not meet any of the exclusion criteria.

1. Patient has poor bone stock making a TKA unjustifiable.
2. Patient has active, local infection or previous intra-articular infections.
3. Patient has neuropathic (Charcot) joint.
4. Patient is pregnant or may become pregnant during the course of the study.
5. Patient is severely overweight (BMI \>40).
6. Patient is a prisoner.
Association With Low Compliance Bladder in Women With LUTS

Hypothesis / aims of study The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association.

Study design, materials and methods Between January 1996 and December 2021, the medical records of all consecutive women who underwent urodynamic studies for their lower urinary tract symptoms were reviewed to elucidate the clinical significance of low bladder compliance.


Eligibility Criteria:
Inclusion Criteria:

* Urodynamic finding with low bladder compliance

Exclusion Criteria:

* Nil.