cyrilzakka/clinical-trials huggingface dataset:
Bioimpedance Spectroscopy for the Evaluation of Heart Failure

Despite impressive improvements in treatment strategies, heart failure (HF) morbidity and mortality remains substantially high worldwide. Pulmonary congestion is considered the leading cause for hospital admissions and death among patients with HF. Physical examination is crucial for titrating medical treatment in these patients, but despite a good specificity it is not sensitive enough to detect early elevated cardiac filling pressures.

The N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a recognized powerful predictor for HF prognosis. Recently, cardiotrophin-1 and galectin-3 have been proposed as new relevant biomarkers for HF evaluation.

Echocardiography can be also used to noninvasively measure left ventricular filling pressures. Lung ultrasound (LUS) through interstitial B-line evaluation has been recently proposed as a bed-side, noninvasive tool to assess interstitial lung water. B-lines correlate with NT-proBNP and E/e' levels in patients with acute dyspnea, chronic HF or after a stress test. LUS can also identify clinically silent pulmonary edema, suggesting that it may complement clinical evaluation to improve hemodynamic profiling and treatment optimization.

Biompedance is a bedside method for total body fluid status assessment. It defines individual fluid status/compartments/overload on the basis of an individual's normal extracellular volume and body composition. Recent studies indicate that bioimpedance-derived fluid overload indices are independent predictors of mortality in renal failure patients.

To date, no study has evaluated bioimpedance performance for fluid assessment in HF patients. The investigators aim to cross-sectionally compare bioimpedance parameters with clinical evaluation, LUS, cardiac biomarkers, and echocardiographic characteristics, in a cohort of incident consecutive patients with HF. Two years patients' survival will be evaluated to propose the best evaluative algorithm and rank the various methods for prognostic significance.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years;
2. HF diagnosis regardless of cause as defined by the Framingham criteria and satisfying the European Society of Cardiology guidelines;

Exclusion Criteria:

1. metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
2. no prior diagnosis of pulmonary fibrosis (due to lung ultrasonography limitations);
3. absence of congenital heart disease
Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding

All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.

full history, general and local examination were done. Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces.the level of HE4 was measured. All women underwent hystrospopic guided endometrial biopsy. Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.

All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.

Full history was taken , the number of episodes of postmenopausal bleeding, and previous investigations and current medications), general examination was performed and local examination was performed for all patients.

Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces by using electronic calipers. If there was fluid in the uterine cavity it was recorded. Suspected polyp was also recorded.

For the level of HE4: 5 ml of venous blood were withdrawn from all patients. The samples were left to clot. The separated sera were stored at -20˚ until all samples were obtained. Frozen samples were allowed to reach room temperature prior to use. Samples were then mixed thoroughly by gently inverting multiple times before analysis. HE4 was quantitatively assayed using the enzyme immunoassay (EIA) method (Fujirebio Diagnostics, Inc. Göteborg, Sweden). The functional sensitivity of the HE4 EIA is ≤ 25pM. The analytical specificity is 100 ± 15%.

All patients were then submitted to hysteroscopy under general anesthesia and endometrial biopsy.

After hysteroscopy and biopsy, 2 patient proved to have cervical malignancy, 2 patients were unfit for open surgery, and another 6 patients did not show up after. These 10 patients were excluded from the study leaving 90 patients eligible for final analysis .

Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with single or multiple episodes of postmenopausal bleeding Endometrial Thickness ≥ 5mm

Exclusion Criteria:

* • History of other Malignancies

  * Patients on chemo and/or radiotherapy
  * Patients on tamoxifen
  * Patients unfit for surgical intervention
  * Patients on HRT or other hormonal treatment
CoV-ICU Score, Intensive Care Unit, SARS-CoV-2

In the course of COVID disease, some patients need intensive care treatment. We aim to find an answer to the question of whether the patient's CRP, ferritin, D-dimer, Oxygen Saturation, lymphocyte count, and body mass index can be used as a criterion for admitting patients with COVID to the intensive see unit.

It is aimed to determine the patients who are above the threshold value to be determined according to this scoring result. Identifying patients who may need intensive care and following them closely will positively affect patient prognosis.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the intensive care unit with the diagnosis of COVID

Exclusion Criteria:

\<18 years patients
Cryoablation vs Lumpectomy in T1 Breast Cancers

This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of invasive ductal carcinoma of the breast of Luminal type A (ER/PR positive, Her-2 negative) that is grade 1 or 2 with intraductal component \<25%. Must be T1N0M0 (2 cm or less).
* Oncotyping will be performed on T1b+Allred\<6/8 and T1c tumors. Oncotype score in this subset of patients must be \<26 to be included in the trial.
* At least 50 years of age.
* Mass must be visible on ultrasound and \>5 mm from skin and chest wall muscles.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Indication for neoadjuvant chemotherapy.
* Prior history of breast cancer.
* Breast augmentation.
* Allergy to local anesthetics.
* Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* DCIS present beyond the proposed ablation zone on MRI, mammography, or ultrasound.
* Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.
A Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation

This is a research study to compare the well-being (caregiver strain index) of caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.


Eligibility Criteria:
Patient Inclusion Criteria:

* Scheduled to undergo an autologous hematopoietic stem cell transplant for any cancer or non-cancer illness
* Age 18-80 years
* Karnofsky Performance Scale KPS\> 80
* Able to read/write English
* A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke

Patient Exclusion Criteria:

* Lack of a caregiver
* Pregnant women
* Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
* Use of homeopathic medications, prebiotics, or probiotics that may impact gut microbiota

Caregiver Inclusion Criteria:

* Identified by patient as their primary caregiver
* Meet standard clinical criteria for being a caregiver (able to drive and take care of patient)
* Age 18-80 years

Caregiver Exclusion Criteria:

None
Evaluating UTI Outcomes in at Risk Populations

This is a multicenter, observational comparative cohort, study to evaluate the UTI related adverse event rates between Guidance® UTI clinical pathway versus the current traditional clinical pathways for urine testing.

Clinical sites will be identified by an internal database, prepared by the sponsor, based on previous experience with the sites. Study allocation will based on their current usage of Guidance® UTI and the reporting pathway (described above) will be implemented. Those who currently routinely use Guidance® UTI testing procedures will be over sampled 2:1 over those who do not routinely use Guidance® UTI. Larger clinical care systems with multiple care sites may have locations allocated to different cohort. The basis for cohort allocation will be based on the availability and willingness of providers in these markets to implement infrastructure for collecting and reporting of Guidance® UTI clinical pathway. The comparative cluster cohort will be selected from select geographies within the U.S. based on size of general population served matching to those enrolled in the Guidance® UTI clinical pathway.

The method of patient care and management (e.g., test ordering and antimicrobial initiation) is at the discretion of the treating physicians. Specimens collected for suspected UTI may be sent to Pathnostics for standard bacterial identification and sensitivities. Guidance® UTI can only be performed at Pathnostics, whereas urine cultures may be performed at any lab. Trained and experienced clinical lab scientists at Pathnostics are always available to assist the ordering provider with results interpretation or any other questions on the report they may have.

Eligibility Criteria:
Inclusion

* Male or female participants ≥ 65 years of age, no predetermined quotas or ratios for gender participation.
* High suspicion of active UTI
* Ability to provide/obtain a clean catch or sterile urine specimen
* Willing to adhere to follow-up schedule as stated in schedule of events
* Permanent residence in the same state in which they were consented for the study
* Able to provide informed consent

Exclusion

* Participation in another UTI trial during the study period
* Patients in hospice-care or limited life expectancy of ≤1 month)
* Inability to provide informed consent and/or respond independently to follow up surveys
* If the provider deems that a urine culture or Guidance UTI is not necessary in clinical management
Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive

This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.

The women will be recruited at the time of removal of a copper or hormonal intrauterine device (IUD) or removal of a contraceptive implant at the barnmorskemottagningar (midwife clinics) in Stockholm's county in Sweden. A total of 500 women will be included in the study and will be followed until conception or up to the end of 1 year, whichever comes first. If conception occurs, the woman will be followed throughout pregnancy. Participant recruitment will take place over a period of two years.

Eligibility Criteria:
Inclusion Criteria:

* Women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner.
* 18-40 years of age
* Swedish personal identity number and a Swedish address (to send a sampling self-kit)
* Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.

Exclusion Criteria:

* Women who do not have a child yet and plan to cease their contraception.
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
* Presence of active psoriatic skin lesion or a personal history of plaque psoriasis (Ps)
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Current or prior use of biologic agents for treatment of Ps or PsA
* Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
* Current use of more than one conventional DMARD
* Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Ability of Patients With Low Vision to Properly Instill Eye Drops

The investigators are interested in seeing how people with low vision (decreased visual acuity or restricted visual fields) instill eye drops into their own eyes. The investigators hypothesis is that this population will have more difficulty with self-instillation of drops than a better-seeing population. The investigators aim to explore whatever factors may be involved in preventing this population from getting prescribed eyedrops into their eyes, whether it is more related to visual field or visual acuity.

This is a study that involves a questionnaire that a study participant fills out, detailing their experience with eyedrops (if any), followed by a video recording of them instilling artificial tears into their worse-seeing eye, with their dominant hand. Patients must have visual acuity worse than 20/60 in at least one eye, and/or have a recent visual field that demonstrated Hodapp criteria for Moderate or Severe visual field damage. This is an observational study of how patients with low vision due to either glaucoma or retinal disease instill eyedrops. Each video will be "graded" by the principal investigator for "success" at instilling eyedrops, and patients will be stratified by their visual acuity or visual field, and whether they have a primary diagnosis of glaucoma or retinal disease.

Eligibility Criteria:
Inclusion Criteria:

* ETDRS visual acuity 20/60 or worse

Exclusion Criteria:

* Unwilling to participate
* Light perception vision
* No light perception vision
TIKeasy TAblet satisfaCtion (TikTac)

In the last ten years, gerontechnology is becoming an increasing topic in geriatric medicine. Nevertheless, there are still few studies assessing the usability of technologies in old patients, especially when they are hospitalized. Moreover, it has been shown that new technologies could be a source of ageism, thence the importance of involving the old people in the development of these technologies.

Tik easy is a subsidiary of La Poste Company. Tik easy as designed a new tablet PC for old people. Research tends to show that the use of tablet PC can promote health and well-aging, and delay cognitive decline. In this study, we want to give a free access to "Ardoiz", the tablet PC designed by Tik easy, for old patients hospitalized in a geriatric acute care unit. The "Ardoiz" tablet PC allows to:

* Maintain the family and social bond (send and receive messages, share photos and videos, call remotely between the patient and his family)
* Discovering the Internet at his own pace (browse the Internet with daily updated contents such as news, content on cooking, music, etc.).
* Prevent cognitive aging (stimulate cognitive abilities with the DYNSEO games).
* Facilitate online administrative procedures.

The "Ardoiz" tablet PC will be given to old patients hospitalized in the acute care geriatric unit of the university hospital of Angers. Patients and their relatives will have a free access to "Ardoiz" during their hospitalisation. The maximum duration of use will be 9 days. After the using period, a survey will be proposed to the patients and their relatives. This survey include questions concerning usability (using the validated SUS questionnaire), ergonomics (using non validated specific questionnaire with closed questions oriented on "Ardoiz" device), satisfaction (general and specific questions using non validated questionnaire with forced choice Likert scale in 4 points and closed questions). After recruiting all expected patients and relatives; the survey will also be submitted to the professional caregivers of the unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients :

  * Aged 65 years old and over
  * To be hospitalised in geriatric medicine department of Angers University Hospital
* Caregivers:

  * Family members or relatives
  * Aged 18 years old and over
* Healthcare team :

  * geriatric medicine department's staff of Angers University Hospital
  * Aged 18 years old and over

Exclusion Criteria:

* Patients :

  * Existence of a delirium revealed by the Confusion Assessment Method
  * To be under legal protection
* Refusal of participating
Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder

To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using medications available in the Brazilian Public Healthcare System (SUS), and assessment of the quality of life of these patients.

A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of unipolar depression episodes.

The study design was that of a pragmatic randomized clinical trial to evaluate the effectiveness of treatments for mood disorders in a public healthcare context in the city of Porto Alegre, in southern Brazil. The algorithm was originally developed for the treatment of major depression by a Delphi panel of experts from psychiatric associations in Brazil. All subjects provided an informed consent form, in writing, in order to participate in the study protocol, which was approved by the institutional ethics committee.

Procedures and measurements of the study

The subjects under evaluation were selected and they followed the stages defined by the treatment protocol:

1. Sample selection by being referred from the primary healthcare clinics in the municipality;
2. Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;
3. Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);
4. Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;
5. Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;
6. In each clinic visit, the severity of the symptoms were evealuated using the Clinical Global Impression Scale (CGI), Hamilton Rating Scale for Depression (HRSD), and Young Manic Rating Scale (YMRS);
7. Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. ages between 18 and 65;
2. current acute unipolar depression episode;
3. total capacity to understand and respond to self-applied instruments;
4. the presence of symptoms in the last 30 days;
5. abstinence for at least 30 days for drug addicts

Exclusion Criteria:

1. presence of Organic Brain Syndrome (OBS);
2. pregnancy or lactation;
3. criteria for psychiatric hospitalization.
Effects of Hippotherapy on Functionality in Children With Cerebral Palsy

The purpose of this clinical review is to investigate the effect of hippotherapy in improving upper limb functionality in children with cerebral palsy. The main question it aims to answer is The questions are as follows:

1. Does hippotherapy improve gross motor function of the upper extremity in children with cerebral palsy?
2. Is the development of trunk control in children with cerebral palsy who receive hippotherapy different from the development of trunk control in children who receive conventional physiotherapy?

Participants will:

Hippotherapy and routine physiotherapy in 2 different groups for 2 They will carry out the necessary evaluations before the implementation and at the end of 2 months.

Cerebral palsy (CP) is a permanent developmental disorder that occurs as a result of a lesion in the developing baby's brain. Due to the symptoms seen in CP, the individual's participation in daily living activities (ADL) is restricted and functional mobility is affected. Hippotherapy is preferred in children with CP because it includes fun activities and is effective in terms of the child's participation and motivation. The aim of this study is to examine the effect of hippotherapy on upper extremity function. In this study planned as a multicenter study, children with CP are divided into 2 groups as the study and control groups. After a 2-month application, children with CP will be evaluated in terms of upper extremity functionality and postural control. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. The change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". The "Chi-Square Test" will be used to examine the relationship between categorical variables. The relationship between numerical variables will be examined with the "Spearman rho correlation coefficient". The probability of error will be accepted as (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with SP
* Being between the ages of 4-16
* Being at GMFCS (Gross Motor Function Classification System) level 1,2 or 3
* Being at MACS (The Manual Ability Classification System) level 1,2,3 or 4
* Having a stable clinical condition
* Having the cognitive level to follow the instructions in the test and treatment protocol

Exclusion Criteria:

* Families who do not sign the consent form
* Presence of active seizures
* Presence of developmental hip dysplasia
* Presence of allergy to horses
* Having undergone surgical intervention or Botulinum Toxin A (BTX-A) application in the last 6 months