cyrilzakka/clinical-trials huggingface dataset:
Validity and Reliability of a Depth Camera-based Automated Physical Function and Fall Risk Assessments

Falls significantly reduce physical function as well as quality of life which leads to failure of successful aging among elders. There is a great need for automated assessing physical functions that can be address fall risks for those elderly living alone. The study aims to test validity and reliability of a depth camera-based physical function and fall risk assessment among healthy young and elderly adults with and without fall histories.

The present study explores the concurrent, convergent, and discriminative validity of Azure Kinect-based physical function assessments, along with the intra-rater and inter-rater reliability of these measurements. The diagnostic accuracy and the optimal cut-off values of the Azure Kinect-based tests in differentiating fall risks will be provided.

The enrolled participants will complete the following evaluations during a single session: Tandem Stance Test (TST), Five Times Sit to Stand Test (FTSS), Turn Up and Go Test (TUG), Berg Balance Scale (BBS), Functional Reach Test (FRT), Four Square Step Test (FSST), Grip Strength (GS), and Short Physical Performance Battery (SPPB). Each of the AK-based evaluation will be measured three times with simultaneous measurements of the same physical therapist directed tests: two trials will be measured by one physical therapist, while one trial will be measured by the another physical therapist.


Eligibility Criteria:
Inclusion Criteria:

* those who: (1) are adults (≥18 years); (2) are able to follow instructions during physical examinations; (3) can walk independently for at least six meters; and (4) agrees to participate and provide written consent.

Exclusion Criteria:

* those who have: (1) orthopedic injuries; (2) neurological disease; (3) pain or inflammation; (4) visual or hearing problems; (5) a previous history of surgery; (6) serious medical concerns; or (7) refuses to participate
National Survey on Asthma

To evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms, according to the patient's level of asthma control.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of persistent asthma treated with an inhaled corticosteroid based maintenance treatment for more than 3 months
* Given his/her consent to participate to the study and who is able to answer the questionnaire in french by him/her-self.

Exclusion Criteria:

* Patient with a cardiac disease (congestive heart failure, coronary artery disease)
* Patient with a respiratory disease other than asthma (COPD, sleep apnea syndrome).
Diet and Exercise Solutions to Postprandial Hypotension

The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
* AIS A or B
* \>1-year post-injury

Exclusion Criteria:

* Currently pregnant of breast-feeding
* Type 1 or 2 diabetes
* Previous gut augmentation bariatric surgery
* Neurological impairment other than SCI
* History of uncontrolled autonomic dysreflexia
* History of bone fractures
* Use of abdominal binder or anti-hypotensive drugs
* Fitted with pacemaker or defibrillator
* Currently receiving electrical stimulation training or in the previous year
Sacrospinous Ligament Fixation and Lateral Suspension Operations

Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is transvaginal sacrospinous ligament fixation and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.

Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had previously undergone hysterectomy for benign causes
* Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up
* And for this, patients scheduled for operation

Exclusion Criteria:

* Patients with chronic diseases or medications that interfere with the operation
* Patients with oncology operated for malignant cause
* Non-localized patients with vaginal cuff prolapse
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)

The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.

Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.

In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Known allergy against hydroxyethyl starch
* Pre-treatment with \> 1000ml hydroxyethyl starch within 24 hours before inclusion
* Pre-existing kidney failure requiring dialysis or serum creatinine value \> 320 mmol/l (3,6 mg/dl)
* Intracerebral hemorrhage
* Severe head trauma with edema
* FiO2 at time of study inclusion \> 0,7
* Heart failure (New York Heart Association \[NYHA\] IV)
* Enrolment in another interventional study
* Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)
* Do not resuscitate (DNR) order
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom

The aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.


Eligibility Criteria:
Inclusion criteria:

For COPD:

* Over 20 years of age and below 85 years of age
* Smoking history
* Brinkman index 200 or more
* Diagnosis of COPD
* Forced expiratory volume in 1 second (FEV1) of \<80% of the predicted value
* Ratio of FEV1 to forced vital capacity (FVC) of \<70%
* symptom of expectorated sputum

For Asthma

* Over 20 years of age and below 85 years of age
* Scored between 20 to 24 by ACT (Asthma Control Test)
* Symptom of expectorated sputum
* Diagnosed partly controlled by global initiative for asthma

Exclusion criteria:

* Egg allergy
* Domiciliary oxygen therapy
* Pneumonia or pulmonary tuberculosis
* Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder
* Cancer
Clinical Evaluation of the Needleless® Sling

Urinary incontinence which is a major health issue in women affects 30-40% of older women.

Surgical treatments for SUI have undergone many modifications in the last century.

The Needleless Sling System is a one incision, minimally invasive, surgical procedure that has had great acceptance in Europe and has recently received FDA Clearance for use in the United States.

We will evaluate effectiveness and patient reported outcomes for Needleless® sling system (Neomedic International).

This is a prospective, multicenter, registry. Up to 150 women will be enrolled from up to 3 registry sites.

Patients will be evaluated at baseline, peri-operatively, and post-operatively up to 2 months, up to 6 months and at 12 months.

Effectiveness evaluations will include a standing stress test (objective cure), SANDVIK questions (subjective cure) \& I-QOL (quality of life measure).

Other evaluations will include type of anesthesia, concurrent surgery, operative time, post-operative pain, length of hospital stay, returning to usual activities, change of lower urinary tract symptoms (BFLUTSSF, voiding diaries), goal achievement and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

A patient must satisfy the following criteria before entering the study:

1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
2. Patient is age 18 or older.
3. Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing.
4. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.

Exclusion Criteria:

* A patient who meets any of the following criteria will be excluded from participating in the study:

  1. Patient has an associated or suspected neurological disease.
  2. Patient is on anti-coagulation therapy.
  3. Patient has received an investigational drug or device in the past 60 days.
  4. Patient has an active lesion or present injury to perineum or urethra.
  5. Patient has a urethral obstruction.
  6. Patient has a significant cystocele \> ICS Stage 2.
  7. The subject has active infection upon urine dipstick analysis, defined as ≥ +1 leukocytes or ≥ +1 nitrates (Must reschedule appointment after UTI resolves.)
  8. Patients with combined POP surgery.
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults with Alopecia Areata

The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Exclusion Criteria:

* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
* Donation of blood at any point throughout the study and for 30 days after last dose of study medication
Phase III Insulin Add-On Asia Regional Program - ST

The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
* Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment

Inclusion criteria for randomization:

HbA1c ≥ 7.5 and ≤ 10.5% at Day -14

Exclusion Criteria:

* Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
* History of diabetic ketoacidosis of hyperosmolar nonketotic coma
* Clinically diagnosed Type 1 diabetes mellitus
* Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
* Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
* History of unstable or rapidly progressing renal disease
* History of severe hepatobiliary disease
* Mallingancy within 5 years of the screening/enrollment visit
Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test

The SARS-CoV-2 Antigen Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the SARS-CoV-2 Antigen Rapid Test assay will be assessed by comparison to a reference method.

The clinical performance of the SARS-CoV-2 Antigen Rapid test was evaluated in a prospective clinical study conducted at a single (1) CLIA waiver investigational site in Miami, Florida, U.S. Consenting patients of any age, gender, or race/ethnicity who presented at the test site with COVID-19 like symptoms during the 2021 COVID-19 season were sequentially enrolled and tested. Five (5) minimally trained operators with little laboratory experience and who received no training on use of the SARS-CoV-2 Antigen Rapid test and were, therefore, representative of the intended users performed the study test evaluations.

A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.

Eligibility Criteria:
Inclusion Criteria:

1. Up to 200 subjects will be screened, consented, and enrolled to obtain a minimum of 60 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of informed consent
2. Subject is a suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) AND with no other etiology that fully explains the clinical presentation, with or without a history of close contact with a confirmed or probable COVID-19 case in the 14 days prior to onset of symptoms.
3. Subject is an appropriate candidate for Nasopharyngeal sample collection. d/. Subject is willing to provide nasopharyngeal swab samples.

Exclusion Criteria:An individual who meets the following criterion will be excluded from participation in this study:

1. Individuals who present with 10 or greater days of COVID-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post-defervescence and/or convalescence.
The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.

The aim of the present study was to assess the influence of different volumes of Pilates training exercises on metabolic, blood pressure (BP), functional physical fitness (PF) and quality of life (QL) outcomes in postmenopausal dyslipidemic women. In total, 26 women participated in the controlled clinical trial, being allocated into three groups: high volume group (HVG; n=9), low volume group (LVG; n=11) and control group (CG, n=6). HVG performed four weekly sessions and LVG performed only twice a week, during 10 weeks with 45 to 55 minutes per session. Before and after the intervention period, metabolic, BP, PF, QL and cardiovascular risk score (CRS) outcomes were measured. The results were described by mean values with lower and upper limits (95% confidence interval). Comparisons between groups and intra-groups were performed adopting Generalized Estimating Equations (GEE) method, with post hoc of Bonferroni and significance level of ɑ=0,05.


Eligibility Criteria:
Inclusion Criteria:

* Dyslipidemic, postmenopausal and sedentary.

Exclusion Criteria:

* Women taking statins and smokers.
The Role of NLRP Gene Family (NLRP1~14) in Recurrent Miscarriage and Infertility

Development of mole was not associated with segregation of mutated NLRP7 allele in the haploid oocyte. We hypothesize NLRP7 is a maternal factor involved in regulating early embryo development or embryo-uterine interaction. In the proposed study, we seek to identify novel genetic variants and mutations of NLRP7 in women who experienced RM/HM. Genetic association study and haplotype analysis are performed to test assocation between NLRP7 gene and female reproductive performance. Immunohistochemical staining, RT-PCR, and Western blot analysis are used to investigate expression pattern of NLRP7 in endometrium and placenta. Two approaches are used to characterize functional significance of genetic variants/mutations. The first approach will be based on mutagenesis and the second approach will be based on induced pluripotent stem cells (iPSCs). Results obtained from the proposed study will provide novel insight into mechanism of embryo development and implantation.

Recurrent miscarriage (RM), defined as at least two consecutive fetal death or spontaneous abortions before the 20th week gestational age, occurred in about 1% to 5% couples. The causes of RM include uterine factors, endocrine factors, thromobophilic factors, immunologic factors and genetic factors. The hydatidiform mole (HM) can be divided into two separate syndromes: complete mole (CHM) and partial mole (PHM). In the West, CHMs occur in approximately 1 in every 1500 pregnancies. The incidence is higher in Latin America, Southeast Asia and the Middle East. The cause of RM and HM are not known for the vast majority of cases. The NLRP (Nucleotide-binding oligomerization domain, Leucine rich Repeat and Pyrin domain containing) family, also referred to as NALP family, is well known for its roles in apoptosis and inflammation. Expression studies showed that twelve of the fourteen members of NLRP family express differentially in human oocytes and preimplantation embryonic cells, especially NLRP7, indicating important role of NLRP family in female reproduction. Since 2006, mutations of NLRP7 have been found in women with repeated occurrence of molar pregnancy, repeated stillbirth or early spontaneous abortion. In women who experienced RM/HM, we also found some novel mutations/genetic variants of NLRP7. Taken together, these finding suggest RM and HM may share the same genetic etiology in some cases. In addition, NLRP7 is a strong candidate gene for RM/HM. A recent report showed chaotic cleavage abnormalities of embryos in patients with NLRP7 variants.

Eligibility Criteria:
Inclusion Criteria:

Recurrent abortions and infertility treatments but combined with repetitive (more than two consecutive) implantation failure couples, rather than general infertility couples.

Exclusion Criteria:

Women who do not have recurrent miscarriage and infertility problems.
An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.

To provide an alternative therapy to HIV-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* CD4 counts \>= 550 cells/ml.

NOTE:

* If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days for Study 806 or wait 6 months before entering the expanded access program.
* Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies.
* Patient must not meet inclusion criteria for other Remune trials.
* Patient must have laboratory tests within specified limits.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Clinically significant cardiac, hepatic, renal or gastrointestinal dysfunction.
* Current participation in a Remune study.

Concurrent Medication:

Excluded:

* Use of any immune-modulating drugs.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition.
* Current participation in a Remune study.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

* Previous participation in a Remune study.

Excluded within 30 days of study entry:

* Use of any immune-modulating drugs.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.
Comparison of Epidemiology and Clinical Outcomes of Influenza A & B Cases in Manitoba, Canada

This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza type A to type B following clinical diagnosis of influenza. Multivariate models are used to assess the effects of influenza type on clinical outcomes while accounting for potential confounders.

Annual epidemics of influenza are an important public health problem globally and in Canada. Each year, 10-25% of the Canadian population become infected with influenza. Most of these infections are typically asymptomatic or associated with a mild self-limiting illness. However, influenza can cause severe illness leading to hospitalization and death, especially among the very young, the elderly and among those with underlying chronic conditions. It has been estimated that on average about 4,000 influenza-related deaths occur in Canada each year. In addition, the economic burden of influenza is significant because of the high direct costs associated with increased utilization of services and the indirect costs caused by school and work absenteeism.

This project compares laboratory-confirmed cases of influenza A and B in terms of their epidemiology, and the overall and cause-specific incidence rates of important clinical outcomes including physician visits, hospitalization and death following clinical diagnosis of influenza cases in Manitoba over the period from 1993 to 2008.

The study assesses secular and seasonal trends in the incidence rates of influenza A and B cases in Manitoba during the period of 1993-2008, to determine whether these rates vary for different subsets of the population defined by demographic (e.g., age group, gender), socioeconomic, geographic (neighborhood of residence) and clinical (e.g., vaccination, presence of chronic conditions, immune status) characteristics.

The analysis by influenza type then compares the overall and cause-specific incidence rates of physician visits, hospitalization and death following the diagnosis of a laboratory-confirmed influenza. The effects of influenza type on clinical outcomes (e.g., hospitalization) are assessed with multivariate models while accounting for potential confounding by demographic, socioeconomic, geographic and clinical (e.g., co-morbidity, immune status) characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Any person who normally resides in Manitoba and who has been continuously covered by Manitoba Health during the study period will be eligible for inclusion in the study.

Exclusion Criteria: