cyrilzakka/clinical-trials huggingface dataset:
Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting

This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD).

This is a randomized (participants will be assigned by chance to study treatments), double-blind (participants and study personnel will not know the identity of the study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in patients who receive maintenance hemodialysis. Three participants will receive PINTA 745 for every participant that receives placebo. PINTA 745 or placebo will be taken intravenously once per week following dialysis.

The study period will consist of screening, treatment for 12 weeks, and follow up for 8 weeks. Evaluations will be performed to assess the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body) and effectiveness in treating protein energy wasting (such as increasing muscle size and muscle function) throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patient and on outpatient maintenance hemodialysis for ≥ 6 months
* Adequate dialysis with Kt/V ≥ 1.2 on two occasions within 12 weeks of enrollment
* Undergoing dialysis at least 3 times per week, on average
* Serum albumin ≤ 3.8g/dL within 60 days of enrollment
* Able and willing to provide Informed consent

Exclusion Criteria:

* Presence of an indwelling central vascular catheter
* Current medical condition that would interfere with ability to perform physical function tests
* Active infection requiring hospitalization or antibiotics within the past month
* Major surgery within past 3 months, minor surgery within the past 4 months
* Dialysis access revision/angioplasty/replacement within the past 2 weeks
* History of renal transplant, whether or not functional, within 2 years (however, if graft has been removed, patient will be considered eligible) or plans to undergo renal transplantation within 6 months
* History of neoplasia, except non-melanoma skin cancers, with a 30% probability of recurrence within 12 months
* Current treatment with appetite stimulants, anabolic steroids or growth hormone
* Clinically significant heart disease
* Difficulty swallowing food or liquid
* If female, currently breast feeding
* If female, pregnant
* If female or male, unwilling to use a highly effective method of contraception
SHIFT Hospital in Motion (Pilot Study)

The goal of this monocentric observational study involving acute hospitalised patients is to develop a classification algorithm for the detection of various movements parameters.

Patients in hospitals spend the majority of their time inactive, sitting or lying down. Not being active is a common problem for patients in hospitals, often causing complications and impairing recovery, as it can lead to issues such as reduced blood volume, unsteady blood pressure when standing, weaker muscles, and a higher risk of infections, blood clots, and other health issues. The inactivity-related changes in the body in combination with the natural ageing process, the stress of being in the hospital, a poor nutritional status, and possibly troubles with thinking, memory, and understanding or depression diminish the ability to regenerate with overall compromised physiological resilience.

In order to quantify the amount of physical activity of hospitalised patients, the ability of activity sensors to distinguish between lying, sitting, standing and walking is an important requirement.

The primary objective of this observational, single center study is to develop an algorithm for the detection of various movements parameters. Therefore, enrolled patients, wearing a sensor on either ankle, wrist, or upper thigh, perform a fixed set of movements to generate acceleration and movement data.

The secondary objective is the evaluation of the best suited position of wearing the sensor.

The results of this pilot study will provide information about the feasibility and effectiveness of using activity sensors in clinical settings and will advance healthcare by developing an algorithm that accurately determines the activity patterns of hospitalized patients, thereby enhancing monitoring and understanding of patient mobility in hospital settings.

Eligibility Criteria:
Inclusion Criteria:

* patient must have been able to walk before hospitalisation (with or without aids)
* patient must be cognitively able to follow instructions (if a cognitive assessment has been carried out, this cut-off value counts, if no assessment is available, no cognitive impairment is assumed)
* ≥ 18 years
* signed informed consent

Exclusion Criteria:

* patient unable to move prior to hospital admission
* prior inclusion in the study
* discharge on the same day
* inability or contraindications to participate in the study or to follow the study procedures, e.g. due to certain neurological disorders (such as Parkinsonism, hemiplegia, severe Multiple Sclerosis), speech problems, mental disorders, or cognitive impairments isolated patient (unable to complete the test battery completely)
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)

This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.


Eligibility Criteria:
Inclusion Criteria:

* Have documented or anticipated neutropenia expected to last for at least 7 days, following treatment in at least one of the following clinical situations: acute leukemia, myelodysplasia, severe aplastic anemia, recipients of Autologous Hematopoietic Stem Cell Transplant (HSCT), high risk neuroblastoma, advanced stage non-Hodgkin's lymphoma, hemophagocytic lymphohistiocytosis
* Have a central line in place prior to IV study therapy
* Participants of reproductive potential agree to remain abstinent, or use a medically accepted method of birth control

Exclusion Criteria:

* Has a proven or probable invasive fungal infection
* Has received any formulation of POS within prior 10 days
* Is receiving any prohibited drugs
* Has laboratory results that are outside of normal limits at screening, as follows: a) Moderate or severe liver dysfunction, as defined as: Aspartate Aminotransferase (AST) \> 5 times the upper limit of normal (ULN), OR Alanine Aminotransferase (ALT) \> 5 times the ULN, OR Serum total bilirubin \>2.5 times the ULN, OR AST or ALT \> 3 times ULN with total bilirubin \> 2 times ULN; b) Calculated creatinine clearance \<30 mL/min.
* Has QTc (QT interval corrected for rate) prolongation defined as: a) Symptomatic QTc prolongation \>450 msec (males) or \>470 msec (females) OR b) Any QTc prolongation of \>500 msec
* Is pregnant, intends to become pregnant during study, or is breastfeeding
* Has a history of anaphylaxis attributed to the azole class of antifungal agents
* Is not expected to receive a minimum of 10 days of POS IV solution
* Has participated in any Phase 1 Investigational New Drug (IND) study within prior 30 days or expects to do so within the following 60 days
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
Pirfenidone for Progressive Fibrotic Sarcoidosis

Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis

Patients who meet the inclusion and exclusion criteria will be randomized to be treated with either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be titrated using the following schedule:

One 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed to take all doses of medication with food. Dosage will be titrated on an individual basis depending on patient tolerance of medication.

Those randomized to placebo will receive the same schedule using placebo tablets.

Block randomization will be done at each site. Liver function tests will be evaluated as listed above. If the patient has an abnormal liver function test, then the dose will be adjusted per the company's protocol for commercial drug.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis
* Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater than 40
* Patient must have evidence of \>20% fibrosis on high resolution cat scan
* Patients must be on a stable prednisone therapy for sarcoidosis for at least two months and no change in other immunosuppressives in the two months prior to entry into study
* Age greater than 18 and less than 90.
* Able to provide written informed consent for participation in the study

Exclusion Criteria:

* Patients receiving therapy for precapillary pulmonary hypertension.
* Patients with liver disease Childs class 3 or 4
* Patients with a left ventricular ejection fraction of less than 40%
* Patients receiving more than 20 mg prednisone daily or its equivalent
* Patients with massive hemoptysis within prior three months. Patients with mycetomas are eligible as long as no massive hemoptysis in prior three months.
* Patients with clinically important co-existing disease which in the opinion of the investigator is likely to affect patient's chance for survival during the course of the study
* Patient who is pregnant, lactating, intending to become pregnant during the study, or child bearing capacity who is not willing to use appropriate birth control methods approved by investigator
Evaluation of a New Female Urinary Intermittent Catheter

A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent.
* Females aged 18 years and over.
* Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
* Practice intermittent catheterization at least 2 times daily.
* Use catheter size available in the study
* Experienced practitioners of intermittent catheterization defined as a minimum of three months on therapy, but not more than approximately 5 years on therapy.
* Adults able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

* Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥10\^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
* Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
* Involvement in the planning and conduct of the study (applies to both Wellspect staff and staff at the study site).
* Previous enrolment in the present study.
* Simultaneous participation in another clinical study that may impact the primary endpoint
* Expected or severe non-compliance to protocol as judged by the investigator and/or Wellspect.
Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

The goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.

The main questions it aims to answer are:

* Does the intervention alleviate participants' financial toxicity?
* Does the intervention enhance participants' cost-related health literacy?
* Does the intervention improve participants' shared decision-making?
* Does the intervention reduce participants' perceived stress?

Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness.

Participants will receive the comprehensive financial navigation, including:

* Needs assessment;
* Cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
* Resource and service referral;
* Personalized counseling.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with breast cancer and undergoing surgery during this admission;
* Female, age 18 years or older;
* Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
* Eastern Cooperative Oncology Group Performance Status 0-2;
* Provided informed consent to participate in this study.

Exclusion Criteria:

* Diagnosed with ductal carcinoma in situ (DCIS)
* Presence of any serious psychiatric disorders;
* Cognitive impairments;
* Difficulty in reading, writing, or communicating in Chinese.
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers

The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
* Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Systolic BP \> 140mmHG or Diastolic BP \> 90mmHg)
* AST or ALT \> X 2 UNL
* History of drug abuse or positive drug screening.
* Participation in other drug studies within 3 months prior to the drug administration.
* Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
ACS Community Access to Resources Education and Support

The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization.

In 2023, the American Cancer Society (ACS) created a new program, ACS Cares, based on the Take the Fight experience and existing literature on non-clinical navigation. The goal of ACS Cares is to supplement existing navigation infrastructure to extend navigation services to a broader population of patients. This is accomplished through designating lower level, timely tasks to volunteers and allowing paid navigators to practice at the highest level of their license (e.g nurses proving symptom management, higher level coordination). The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization.

Eligibility Criteria:
Inclusion Criteria:

* patients of health system's healthcare physician champions with a confirmed cancer diagnosis
* patients with a confirmed cancer diagnosis
* families of patients with a confirmed cancer diagnosis
* Caregivers of patients with a confirmed cancer diagnosis

Exclusion Criteria:

* patients, families and/or caregivers without a confirmed cancer diagnosis
* patients not receiving care from healthcare physician champions
Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques

The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 24 months of follow-up
* The patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by MRI

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient require a single bundle, "KJ-type" surgical technique
* Contra-indication for MRI scans
The Strontium Chloride Associated With Photobiomodulation in the Control of Post-bleaching Sensitivity

This study investigated the effects of the association of strontium chloride with photobiomodulation on the dental bleaching process, testing the hypothesis that they may control dental sensitivity post-bleaching teeth.

The objective of this double-blind, randomized, controlled clinical study was to evaluate the effect of 10% strontium chloride associated with photobiomodulation (FBM) on teeth exposed to 35% hydrogen peroxide during 3 weeks of whitening treatment. Methods: 50 volunteers were evaluated by the split mouth model, where the hemiarchy patients were randomized and subsequently allocated to one of the experimental groups: PLACEBO (negative control) - group with no desensitizing treatment, only bleached; FBM (positive control) - group treated with placebo gel and application of the LLLT (Low Level Laser Therapy); ESTRÔNCIO (positive control) - group treated with 10% strontium chloride and simulation of LLLT application (without light emission); and FBM + ESTRÔNCIO - group treated with LLLT + 10% strontium chloride.

Eligibility Criteria:
Inclusion Criteria:

* good oral hygiene
* absence of active caries lesions
* never having undergone previous whitening therapy
* not present dental hypersensitivity
* don't be a smoker
* not be pregnant
* present at least 28 teeth in the oral cavity.

Exclusion Criteria:

* volunteers who were under orthodontic treatment,
* presence of periodontal disease
* dental cracks or fractures
* restorations and prostheses on anterior teeth
* extensive molar restorations
* gastroesophageal disorders
* severe internal dental darkening
* presence of dentinal exposure in anterior and / or posterior teeth.
Dementia Caregivers and Contemplative Practice: A Pilot Study

The goal of this study is to test the contemplative practice is feasible and acceptable among informal dementia caregivers population at all stages.

It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).

Eligibility Criteria:
Inclusion Criteria:

* Dementia Family Caregivers
* At least cared for dementia care receipient more than 6 months

Exclusion Criteria:

* If they have meditated less than 2 months ago
* Cognitive or language barrier that would make it difficult to understand and sign the informed consent
Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.

Stroke is defined as a sudden vascular accident that causes brain damage and neurological impairment. Literature shows that a stroke has a negative effect on participation. Self-Management (SM) is defined as health promotion and education programs used mostly for people with chronic diseases, which aim at helping patients to maintain a feeling of wellness. The primary aim of this study is to assess the effectiveness of a group-based SM program for post-stroke patients in a community setting, and its contribution to improving participation, compared to standard care.

At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). The group-intervention (SM program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. The intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known SM interventions that were found effective for stroke patients in the U.S. Standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). Follow-up measures will be performed within a week after the end of the intervention, and 6 months thereafter, in order to examine long term effectiveness. Outcome measures are questionnaires; change will be assessed by the difference in total score between T1 \|(pre-intervention), T2 (post-intervention) and T3 (after 6 months)

Eligibility Criteria:
Inclusion Criteria:

Cerebrovascular accident diagnosed 3-18 months before enrollment. Treated at th Neurologic Rehabilitation Center of Clalit Health Services in Kiryat Byalik, Israel.

Living in the community (in their homes). Are capable of basic communication in Hebrew.

Exclusion Criteria:

Moderate-severe stroke (National Institutes of Health Stroke Scale (NIHSS) score ≤ 16).

Moderate-Severe Cognitive impairment (Montreal Cognitive Assessment (MOCA) - total score ≤ 16). Inability to provide informed consent.
Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients

The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery.

Pediatric Type 1 Diabetes Mellitus patients and their parents will complete the forms before and 12 months after the diabetes clinic at Children's Mercy Hospital in Kansas City, MO transitions to a team model of care delivery.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus six years of age and older who are receiving care in the diabetic clinic at Children's Mercy Hospital

Exclusion Criteria:

* T1 Diabetes Mellitus patients not receiving care in the diabetes clinic at Children's Mercy Hospital or not meeting the age requirements