cyrilzakka/clinical-trials huggingface dataset:
Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs

The POSITIVE platform offers the possibility of unsupervised monitoring of pre-frailty and frailty status in a community setting, to detect the onset of frailty and to assess its evolution.

The primary objective of the study is to evaluate whether the POSITIVE system improves frailty in at least 1 point in the Fried's Criteria and 5 points in the FTS-5.

This is a multi-centre, non-inferiority, randomized, simple blind and prospective pilot study with a 12-month follow up duration. The study will be carried out in Spain, Sweden and Poland. 150 participants will be randomized into two groups. The control group will receive usual medical care. The intervention group will receive, in addition, the POSITIVE frailty home monitoring and intervention system.

The primary endpoints is to evaluate whether a multimodal intervention supported by the POSITIVE technological ecosystem improves frailty in at least 1 point in Fried's Criteria and 5 points in FTS-5 during a 6-month follow-up period.

This objective will be investigated through a multi-centre, non-inferiority, randomized, simple blind and prospective pilot study with an intervention lasting for 6 months. The study will be carried out in Spain, Sweden and Poland. 150 participants (50 per site) will be randomized into two groups. The control group will receive usual medical care. The intervention group will receive, in addition, the POSITIVE frailty home monitoring and intervention system.

Both groups will be assessed with the same instruments. This assessment will be conducted at baseline (in the beginning of the trial period), at the middle (month 3) and at the end of the intervention (month 6).

A stratified randomization technique will be applied in each of the study groups based on: age group (70-85,\> 85), history of cognitive impairment, history of stroke to guarantee the existence of comparable groups. These factors have been significantly associated with frailty and pre-frailty status (stroke OR =3.11 (1.05-9.18), age, per 1-year OR = 1.14 (1.08-1.21); cognitive impairment OR = 8.37 (4.43-15.83)).

Eligibility Criteria:
Inclusion criteria:

* Age ≥ 70.
* Living at home.
* Having a caregiver/relative and/or supervision at home.
* Barthel ≥ 90.
* Meet at least 1 criterion from Fried's Criteria.

Exclusion criteria:

* Inadequate home infrastructure to host the required technology.
* Inability to understand on how to use the POSITIVE system by the participant.
* Diseases that may affect prescription therapy:
* History of alcohol/drugs abuse.
* Living with another participant.
* Participating in other clinical studies.
* Three or more hospitalizations in the last year.
Developing Models for Fatigue Monitoring in Obstetrics and Gyne- Cology Residents Using Wearables

This study is set out to observe heart-rate and related bio-metric indicators in Obstetrics and Gynecology residents during their duty hours, together with self-reporting of fatigue and tasks performances, in order to model possible relationships between the two.

There are vast evidences of the harmful consequences of fatigue in medical residents, consequently, leading to poor task performances and in some cases may cause injury to the patients. Medically, fatigue is a non-specific symptom, which means that it has many possible causes and accompanies many different conditions. Elevated fatigue is an indication that a person may not be fit-to-task (i.e., task efficacy).The investigators main goal is to use readily available body-worn sensors, such as an activity wrist-band, to continuously monitor for fatigue as a possible antecedent to predictions of task-efficacy in the area of Obstetrics and Gynecology. This study is anchored in prior research which established basic models that correlate between heart-rate variability (HRV) and fatigue. Specific to this study, the investigators would like to further establish the validity of such models at the individual level, also with the perspective of fatigue as an early predictor of task performance related to practices in Obstetrics and Gynecology. The investigators aim is to extend HRV based models with additional personal measures (e.g., age, weight, activity level), possibly with the extraction of additional data-driven features, to improve model accuracy at the individual level. The investigators will also try to find relationships between such measurements and task effectiveness via the gathering of self-reports regarding on-the-job task performances.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be chosen from the obstetrics and gynecology department in the Hillel Yaffe medical center.

Exclusion Criteria:

* Chronic fatigue syndrome
* Pregnancy
Contingency Management for Problematic Behavior Reduction in the Community

This study aims to determine the feasibility and effectiveness of implementing a contingency management program in a small group of mentally ill, unhoused individuals with schizophrenia or bipolar disorder and anosognosia (a lack of insight into their mental health) in the City of Tulsa. The primary objective of the study is to decrease disruptive or problematic behaviors (e.g. interactions with police, emergency services, hospitals, shelter staff, 911 calls) by unhoused individuals in the community through monetary incentives. Up to 15 participants will meet weekly for 30 minutes with their case manager to discuss progress on life goals ($10) and for having seven days with no disruptive behaviors (or "trouble-free days") per week at each visit, they will receive an additional baseline payment of $20, increasing with continued success in subsequent weeks by $1 per week.

This study aims to determine the feasibility and effectiveness of implementing a contingency management program in a small group of mentally ill, unhoused individuals with schizophrenia or bipolar disorder and anosognosia (a lack of insight into their mental health) in the City of Tulsa. Tulsa's unhoused population grew nearly 7% last year to the highest numbers since the beginning of the COVID-19 pandemic according to Housing Solutions data, an organization that oversees many of the city's efforts to address homelessness. The primary objective of the study is to decrease disruptive or problematic behaviors by unhoused individuals in the community through monetary incentives.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old
2. Diagnosis of Schizophrenia Spectrum, Bipolar, or Related Disorders
3. Presence of Anosognosia (SUMD: Minimum combined score of 4 on questions 1) and 2); Recent (at least \<6 months) history of disruptive behaviors (at least 1 disruptive behavior per week in \>50% of weeks in the 6-month period prior to enrollment)
4. Receive case management services through TDC
5. Ability to comply with study procedures
6. Willingness to participate in contingency management intervention

Exclusion Criteria:

1. Inability to provide informed consent
2. Unstable medical conditions that would interfere with participation
3. Cognitive impairment that would interfere with participation in the study
4. History of severe aggression or violent behavior posing a risk to study staff or other participants
5. Active suicidal ideation or a history of suicide attempts within the past 12 months
Pre-mapping Networks for Brain Stimulation 2

The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based on participants' brain networks) vs conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18 and 60 years
* Diagnosis of major depressive disorder according to DSM 5 (F32.x according to ICD-10) or bipolar disorder (bipolar I or bipolar II) according to DSM 5 (F31.x according to ICD-10) and an acute depressive condition at the time of the initial examination in outpatient or inpatient treatment (e.g. Department of Psychiatry and Psychotherapy, UMG)
* Availability of informed consent to participate in the study, including the examinations and interventions

Exclusion Criteria:

* Neurological diseases, current or previous
* Other Axis I diagnoses that mimic the affective disorder, current or previous
* Physical illnesses that could be related to the affective symptoms (so-called organic causes)
* Illicit drug use in the past month
* Substance dependence, current or previous
* Physical illnesses which, depending on their type and severity, could interfere with the planned examinations, influence the parameters to be examined or endanger the test participant during the course of the examination
* Medical contraindications against performing an MRT examination / rTMS application (such as metal parts in the body, e.g. implants, pacemakers, infusion pumps, metal splinters, etc.)
* Pregnancy
* Previously known cerebral-morphological abnormalities (e.g. tumor, lesion, etc.)
* Evidence or history of epilepsy
* Head trauma with a history of loss of consciousness
* Unwillingness to be informed of incidental findings
* Participation in an rTMS / EKT application within the last 8 weeks
* Lack of the ability to provide informed consent
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve \> 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.

This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms of the local marketing authorization. Follow up visits will occur 1, 3, 6, 9, and 12 months after screening.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT)
* Patients with Intact Parathyroid Hormone (iPTH) \> 70 pg/mL and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) \> 110 pg/mL and with chronic kidney disease (CKD) stage 4
* Patients clinically indicated for treatment with Zemplar capsules
* Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements are to be followed

Exclusion Criteria:

* Patients with clinically important hypercalcemia = Calcium \> 2.6 mmol/L (10.5 mg/dL)
* Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product
Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) in Breast Cancer Patients

The goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. The main question it aims to answer is:

1. Can perioperative nutrition interventions improve phase angle in relation to other bioimpedance parameters, handgrip strength and surgical outcomes in breast cancer population?

Researchers will compare oral nutritional supplement to a placebo to see if oral nutritional supplement can improve phase angle.

Participants will:

1. Be randomized into either arm
2. Take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively
3. Have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative


Eligibility Criteria:
Inclusion Criteria:

* Female
* Histopathologically confirmed operable breast cancer
* Aged 18 of years and above
* Consented and scheduled for mastectomy

Exclusion Criteria:

* On enteral supplementation prior to the study
* Lactose intolerance
* Pregnant or lactating
* Previous history of gastrectomy or small bowel resection surgery
* Advanced breast cancer staging, presence of pacemaker, decompensated liver disease, end stage renal failure, uncontrolled diabetes, on steroid therapy or complementary traditional medications
Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section

Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section.

Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy.

With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy

Eligibility Criteria:
Inclusion Criteria:

* women with a multiple term pregnancy undergoing elective cesarean section

Exclusion Criteria:

* single gestation
* placenta praevia and placental abruption
* undergoing cesarean section with general anesthesia
* women undergoing cesarean section at less than 37 weeks of gestation
* with a severe medical disorder
* allergy to tranexamic acid or misoprostol
A Study of Abemaciclib in Healthy Participants

The purposes of this study are to determine:

* The effect of single increasing doses of the study drug, abemaciclib, on healthy participants.
* The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given.
* How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it.

Information about any side effects that occur will be collected. The study will enroll two groups (cohorts) of participants. Each group will complete 4 study periods. This study is expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All participants will undergo a follow-up assessment approximately 21 days after administration of their final dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females, as determined by medical history and physical examination

  * Male participants will be sterile
  * Female participants must not be of childbearing potential

Exclusion Criteria:

* Have known allergies to abemaciclib, related compounds, or any components of the formulation
* Have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater than 470 ms (females)
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes, or constipation

Additional Exclusion Criterion for Participants Enrolled in Cohort 2:

* Have a known hypersensitivity to loperamide hydrochloride or to any of the excipients
Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions

A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Any condition possibly affecting drug absorption.
AN INTELLIGENT MODEL FOR THE OPERATIVE BLOCK

Perioperative medicine is characterized by a very delicate path; it is composed, in fact, of a series of highly specialized clinical measures managed by various professionals (surgeons, anesthetists, intensivists, nurses, etc.), who work together to ensure the best quality of all phases of the path (preoperative , intra and postoperative). On the other hand, it is necessary to underline the huge resources needed to provide surgical services. Organizational optimization, based on specific analyzes, could lead to a more careful management of resources in this area, avoiding waste due to early closure of the operating room or unexpected extension of the same. In recent years, precisely to respond to the need to analyze large quantities of information, the use of artificial intelligence techniques, and in particular of machine learning, is becoming increasingly popular, a branch of artificial intelligence that aims, through the use of algorithms and statistical model, to infer new knowledge in a way automatic. Such technologies appear to possess excellent analytical skills both in the clinical and, above all, organizational fields. The data that are emerging in the literature on this issue, although still the first in this regard, seem to confirm this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

all patients undergoing surgery who sign the informed consent form will be included.

Exclusion Criteria:

refusal of the patient to the study in question.
Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Any gender.
* ASA (American Society of Anesthesiologists) Classification( Class I-II)
* Patients undergoing major elective hepatobiliary surgery.

Exclusion Criteria:

* Preoperative renal failure (GFR \< 50 ml/min).
* Severe liver dysfunction (Child- turcotte -Pugh grade C).
* Hyponatremia (\<132 mmol/l).
* Severe aortic regurgitation, severe mitral regurgitation, heart failure.
* Symptomatic coronary heart disease.
* Bradycardic arrhythmia (heart rate \< 60/min).
* Peripheral artery occlusive disease (clinical stadium II-IV).
* Uncontrolled arterial hypertension (Blood pressure \>160/100 mmHg despite intensive treatment).
* Pregnancy.
a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

laparoscopic hernia sac high-ligation

* has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral umbilicus ligament covering the hernia opening
* The investigators developed a method of laparoscopic hernia repair by applying a new concept in hernia repair. The hernia opening was tightened, and hernia opening region repaired with a lateral umbilicus ligament in a tension-free manner. This method combines the advantages of a secure repair achieved by the open method with the minimal invasiveness of the laparoscopic method. The investigators hypothesized that the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot would result in lower recurrence and the same operation relative complication.

The primary outcome measure was the recurrence rate after surgery, and the secondary outcome measures included degree of postoperative pain, the amount of postoperative analgesia, procedural duration, number of days to recovery normal activity, surgical complications, cosmetic results, and patient satisfaction. The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery. The cosmetic result was scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or parents, the attending nurse, and the surgeon (maximum points = 9). The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The long axis of the testes was measured.

Eligibility Criteria:
Inclusion Criteria:

* unilateral inguinal hernia age between 2 and 17 years the absence of a history of abdominal or inguinal operations. Of the male patients, only those with completely descended testes were included.

Exclusion Criteria:

* the bilateral cases
Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers

This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Ability to give informed consent
3. Current Acuvue® Oasys® spherical lens wearer.
4. Distance visual acuity of 20/25 or better with current contact lenses in each eye.
5. Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
6. Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.

Exclusion Criteria:

1. Current or active ocular inflammation or infection as determined by the Investigator.
2. Currently pregnant or lactating. (Participants will be asked to self-report these conditions).
3. Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the investigator.