cyrilzakka/clinical-trials huggingface dataset:
Occupational Therapy Intervention in Patients With Complex Needs to Improve Social Reintegration

A previous study that involved the intervention of the occupational therapist (OT) on complex patients both in hospital and at home showed the effectiveness of OT during hospitalization. The effectiveness was not demonstrated in the post-discharge phase. Now, the investigators presented a RCT to compare the levels of social reintegration between the intervention group and control group. The hypothesis is that the intervention group obtains a higher and clinically relevant level of social reintegration compared to the group treated with the usual care.

In the previous study, the intervention group achieved higher gains in the return to normal life than in the control group, but this difference did not reach statistical significance. Because of this, a new study was implemented with the correct sample size, defined through the previous study. In addition, the post-discharge phase the COPM was administered to define new objectives relating mainly to productivity and leisure time areas. Finally, the investigators have indentified some territorial services with the aim to create tailored paths/interventions for patients to promote social reintegration.

Eligibility Criteria:
Inclusion Criteria:

* Complex impatient
* Admitted to AUSL-IRCCS/UO MFR

Exclusion Criteria:

* Language barriers
* Severe cognitive impairment
* Psychiatric disorders
* Domiciled in a protected facility at the time of admission
Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-82 years
* Males or non-pregnant, non-lactating females
* Body mass index (BMI): ≥18.5 kg/m2 and ≤40.0 kg/m2
* Laboratory values meeting defined entry criteria

Subjects with normal renal function (Group 1) must also meet the following criteria:

• Match to one or more participants with renal impairment by gender, age, and BMI

Subjects with renal impairment (Groups 2-5) must also meet the following criteria:

• Stable, pre-existing renal impairment

Exclusion Criteria:

* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
* Congenital or acquired immunodeficiency syndrome
* Major adverse cardiovascular event within one year of dosing
* Positive alcohol, drug, or tobacco use/test
Study Evaluating SKI-606 in Subject With Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This study will also obtain preliminary information on the pharmacokinetics and antitumor activity of orally administered SKI-606 in subjects with advanced malignant solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
2. Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
4. Adequate hepatic, renal, and bone marrow function
5. Age 20 to 74 years
6. Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control for the duration of the study and for 6 months and 30 days after the last dose of test article for male and female, respectively
7. Life expectancy of at least 12 weeks

Exclusion Criteria:

1. Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
2. Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
3. Prior exposure to SKI-606 or any other Src-kinase inhibitor
4. Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
5. Subjects unable or unwilling to swallow SKI-606 capsules
6. Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
7. Recent or ongoing clinically-significant gastrointestinal disorder
8. Pregnant or breastfeeding women
9. Subjects who meet the following criteria:

   * Evidence of serious active infection, significant medical or psychiatric illness
   * History of unexplained syncope or known ventricular arrythmia
   * Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis hepatitis C
   * Hypokalemia
   * Unstable concurrent medical conditions
   * Any other condition that, in the investigator's judgment, make the subject inappropriate for this study the subject inappropriate for this study
Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study

Understanding the Impact of Critical Illness on Falls Risk - a 12 Month Observational Study

This observational study aims to investigate the incidence and risk factors for falls in the first 12 months post hospital discharge in patients following an ICU admission. It also aims to determine factors at hospital discharge which may predict future falls risk at 12 months and examine the physical activity levels of ICU survivors. Furthermore, it also will investigate the relationship between falls, fear of falling and activity limitations and participation restriction. All adult patients in intensive care that have been mechanically ventilated for over 48 hours, and remain in the ICU at least 4 days will be considered for inclusion. The primary outcome measure is a 12 month falls diary which commences on hospital discharge. There will also be Physiotherapy assessments just prior to hospital discharge, 3, 6, and 12 months post hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* hospitalised adults aged 18 years
* with an ICU admission requiring invasive mechanical ventilation for at least 48 hours and remain in ICU \> 4 days

Exclusion Criteria:

* Pregnant
* Insufficient English language skills to read and understand questionnaires and patient information consent form
* Pre-existing documented cognitive impairment
* Spinal cord injury or other primary neuromuscular disease or new brain injury
* Patient unable to be followed up due to geographic location
* New lower limb fracture on this admission
* Liver failure with abdominal distension due to ascites requiring fortnightly drainage
* Recent history of stroke or major surgery affecting lower limb e.g. Total knee or hip replacement in the past 12 weeks
* Neurological disorders such as Parkinson disease or multiple sclerosis
* Poor premorbid function defined as \<10 metres ambulation +/- gait aid independently
* Frequent falls history defined as 3 or more falls over 2 months
* incarcerated or safety concerns for follow up
* discharged to palliative hospice facility
* not expected to survive to 3 months post hospital discharge
* unable to provide informed consent before hospital discharge due to current cognitive state (e.g. delirium, psychosis)
Laparoscopic Access in General Surgery: the Closed (Veress Needle) Technique Versus the Open (Hasson) Technique

A randomised controlled trial (RCT) comparing the closed (Veress needle) with the open (Hasson) laparoscopic entry technique in haemodynamically stable patients undergoing either emergency or elective surgical procedures was conducted over a 13-month period. The success rate and complications related to the technique were recorded and analysed.

A randomised controlled trial (RCT) was conducted at the single academic tertiary institution (Dr George Mukhari Academic Hospital (DGMAH), South Africa). Patients were recruited over a 13-month period (from 1st November 2014 to 30th November 2015). All haemodynamically stable patients undergoing either emergency or elective laparoscopic procedures were offered to participate in the study. General surgical patients 18 years or older who were eligible to provide an informed written consent were included in the study. Patients younger than 18 years old and haemodynamically unstable patients were excluded from the study. The success rate and complications related to the technique were recorded and analysed.

All included patients were randomised by computer program into one of two arms of the study: the arm A (Veress needle) or the arm B (Hasson). Participating surgeons were fully proficient with both techniques. The periumbilical area and the left hypochondrium (Palmer's point) were the recommended sites of entry, however, depending on clinical situation a surgeon could opt the other areas. In the A arm, a standard reusable Veress needle was used guided by tactile clicks feeling and water drop test. After pneumoperitoneum was established, the trocar was introduced in the same area. In the B arm, the standard open Hasson technique was used by dissecting tissues and dividing peritoneum between two forceps and introducing the port (a sleeve) without a trocar under direct visualization. Failed entry was defined as an inability to access the peritoneal cavity by a surgeon using the access technique initially selected.

An anonymized data collection form was completed by the general surgeon responsible for the procedure. Patients' age, gender, height, weight, diagnosis, type of surgery, previous abdominal surgery, previous abdominal tuberculosis (TB), primary port site placement, a surgeon, intraabdominal findings, complications and their type were recorded. Body Mass Index (BMI) was calculated and patients were categorised into weight groups: BMI above 30 and below 30.

All patients were followed up in 24 hours to detect the early entry-site complications. The complication after 24 hours, including surgical site infection and port-site hernia were not included in the design of this study.

Eligibility Criteria:
Inclusion Criteria:

* haemodynamically stable patients, undergoing either emergency or elective laparoscopic general surgical procedures

Exclusion Criteria:

* haemodynamically unstable patients, invalid consent
Protein and Phospholipid Analysis of HDL in Patients With Very High Serum Levels of HDL-C

Coronary heart disease (CHD) is the single leading cause of death in the United States . Serum Cholesterol is known to have a direct impact on a number of human diseases through a variety of mechanisms. This is particularly true of cardiovascular disease. Measurement and manipulation of serum cholesterol has become a primary focus of primary care physicians and cardiologists when attempting to reduce risk of heart disease.

Clinical investigations have shown that lowering the "total serum cholesterol" levels result in a significant reduction of coronary artery disease and myocardial infarctions . Thus, interventions to lower the "total serum cholesterol" are commonly employed by medical professionals - this includes behavioral modifications (exercise, dieting, and weight loss) and pharmacological interventions.

Investigation has shown that clinical outcomes do not only rely on "total serum cholesterol". "Total serum cholesterol" is comprised of multiple subtypes - most notable are "HDL Cholesterol" and "LDL cholesterol". Analysis of the data has shown that high levels of LDL cholesterol predict higher rates of cardiovascular events, while high levels of HDL cholesterol are actually predictive of significantly less cardiovascular events. These effects are independent of other cardiovascular risk factors .

The mechanism by which LDL cholesterol results in heart disease has been intensely investigated and elucidated. Numerous drugs are now approved and utilized by physicians to lower the LDL cholesterol of patients to prevent primary and secondary cardiovascular disease.

Epidemiological data show that low levels of HDL-C place individuals at higher risk for coronary artery disease while high levels of HDL-C actually decrease an individual's risk . The mechanism behind this risk reduction remains unclear and is likely multi-factorial. Furthermore, some data suggests that while HDL-C is important in risk reduction, it is not necessarily the measured serum level of HDL-C, but also the composition, oxidation state, metabolism of the HDL-C that determines an individual's cardiac risk . Understanding of this mechanism could lead to potential therapeutic targets as well as clinically relevant diagnostic testing.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Serum HDL-C \> 100 mg/dL.

Exclusion Criteria:

* Significant history of smoking.
* Diabetes Mellitus.
* Severe hypertension.
* Age \> 65 years
Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites

Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level.

Our study aim to increase the level f knowledge of the parents of premature infants that stayed in the NICU,to better manage their stress and to provide them with informations to support the motor and social-communication development of their infants.

Eligibility Criteria:
Inclusion Criteria:

* infants Stayed in the neonatal intensive care unit for some time after premature birth for the purpose of care and treatment.
* Being a premature baby born at or under 32 weeks
* infant corrected age between 0-8 months
* To agree to participate in the study.

Exclusion Criteria:

* Having a concomitant major anomaly and genetic disease
* The fact that the family did not accept the evaluation of their baby in motor and social-communication area at sixth month of the study.
Taste Perception Pre and Post Bariatric Surgery

The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass lap banding, and sleeve gastrectomy. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight-loss on taste perception.

Bariatric surgery is the most effective weight loss therapy for obesity. However, the mechanisms responsible for decreased food intake are incompletely understood. One possible mechanism that could account for decreased food intake is changes in taste perception. Therefore, the primary goal of this proposal is to provide a better understanding of the effects of bariatric surgery-induced weight-loss on taste perception.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>=35 kg/m²
* on stable dose of medication for at least 4 weeks before the pre-surgery studies
* women

Exclusion Criteria:

* smokes \> 7 cigarettes per day
* previous malabsorptive or restrictive intestinal surgery
* pregnant or breastfeeding
* recent history of neoplasia (\< 5 years ago)
* have malabsorptive syndromes and inflammatory intestinal disease
* diabetes mellitus
* show signs of oral disease or xerostomia (i.e. dry mouth)
* history of chronic rhinitis
* on medication that might affect taste
* severe organ disfunction
Decisional Aid Intervention for Women Considering Breast Reconstruction

This is an intervention development and pilot study whose purpose is to determine the feasibility and acceptability of the breast reconstruction decisional aid (BRDA) and provide preliminary data on its impact on decisional outcomes.

The primary aim of this study is: "Is the intervention trial feasible?" The purpose is to develop a feasible web-based decisional aid (DA) for a larger scale trial. Thus it is important that this trial provide evidence of feasibility. The investigators will define feasibility as the rate of study acceptance and participation.

The secondary aim of this study is: " Is the BRDA acceptable and used?" The team will evaluate BRDA acceptability, use, difficulty with internet use, and what factors predict uptake and use. The investigators anticipate that, due to interest in the topic, the majority of women will access the website.

An additional secondary aim of this study is: "What is the impact of BRDA on BR knowledge, attitudes about BR, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with oncologist?" The purpose is to calculate effect sizes for a larger randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for a surgical consult with a breast surgeon
* Primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
* Patient speaks and reads English
* Patient is considering mastectomy

Exclusion Criteria:

* Patient who selects lumpectomy and not mastectomy
Study of an Investigational Product, QLS-111, Provided As an Eyedrop, for Treatment of Normal Tension Glaucoma (NTG)

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.

A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol).

Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM dosing.

Eligibility Criteria:
Inclusion Criteria:

* 30 years or older
* Able to provide written acknowledgement of giving informed consent
* Best corrected visual acuity (BCVA) 20/200 or better
* NTG in one or both eyes with untreated IOP \<21 mmHg at Visit 2 and morning assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2 mmHg; has open iridocorneal angles, historic IOP \<22 mmHg in either eye

Exclusion Criteria:

* History of angle closure glaucoma, narrow or occludable angle on gonioscope
* All secondary glaucomas
* Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
* Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1.5 years from study)
* Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
* Use of other ophthalmic concomitant medications during the study
* Refractive surgery
* Uncontrolled hypertension or hypotension
* Significant systemic or psychiatric disease
* Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
* Pregnant or lactating
Effect of a Natural Health Product on Urinary Estrogen Metabolites

The purpose of this study is to determine if a supplemental formula can beneficially alter the ratio of urinary estrogen metabolites.

The active botanical constituents in femMED Breast Health Formula contain lignans, compounds with anti-estrogenic activity, that have been shown to exert an estrogenic effect during the follicular phase \[i.e. when estrogen is low\] and an antiestrogenic effect in the luteal phase of a female menstrual cycle. These are plant-derived chemicals that can act as weak mimics of estrogen in the body. Overall these compounds have been found to be helpful in stabilizing the natural cyclical fluctuation of estrogen levels.

The trial will be a double-blind, placebo-controlled parallel study in which 100 subjects will be recruited to one of two arms of the study: one arm will consist of pre-menopausal women; another will consist of post-menopausal women. Each arm of the study will be carried out concurrently and in one phase, with no washout period. The placebo assignment will be randomized within each arm of the study.

Subjects in each arm of the study will follow the same protocol. Urine and blood samples will be collected from each group at both the first and last visit, and subjects will receive a month's supply of treatment or placebo at the first visit, which they will consume on a daily basis until their second lab visit 28 days later. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. Blood samples would be collected and assessed for levels of enterolactone. Pre and post-supplementation results will be assesses for any differences by statistical comparison.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Healthy
* Willing to collect urine samples and to have blood drawn
* Post-menopausal and have not taken hormone replacement therapy (HRT) in the past year (48 subjects)
* Pre-menopausal (48 subjects)

Exclusion Criteria:

* Diagnosed with any major illness(e.g. cancer)
* Diabetes, thyroid disease, atypical hyperplasia, fibrocystic breast disease, family history of ovarian cancer, a history of "migraines with aura"
* Women taking blood thinner or thyroid medication (including warfarin)
* Known allergy to any of the any of the study ingredients
* Pregnancy or lactation
* Regular consumption in the previous 3 months of any other natural health products (NHPs) or pharmaceutical containing ingredients with a similar effect on estrogen metabolism as those included in the femMED Breast Health treatment
* Family history of breast cancer risk
* Post-menopausal women on HRT
* Pre-menopausal women taking hormonal contraceptives (oral contraceptives, the patch etc.)
* All other forms of estrogen, progesterone and/or androgens (i.e. testosterone therapy)