cyrilzakka/clinical-trials huggingface dataset:
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors

This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion.

This study has 2 parts. Part 1a will evaluate the safety and tolerability and activity of escalating doses of ACTM-838 to estimate the maximum tolerated dose (MTD) and/or the optimum biological dose (OBD) for ACTM-838 as a monotherapy and determine the dose recommended for Part 1b.

Part 1b will further evaluate ACTM-838 in patients with advanced specific tumor types (defined pathologically, clinically and/or molecularly) based on data emerging from the Phase 1a and the pre-clinical program. The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit, or they must be ineligible to receive or refuse to receive such therapy
2. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST ) v1.1; amenable for biopsy, and radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI )
3. Eastern Cooperative Oncology Group (ECOG) 0-1
4. Adequate hematologic, hepatic, pulmonary, and cardiac function
5. CD4 count \>500/mL at screening
6. Additional protocol defined inclusion criteria may apply

Exclusion Criteria:

1. Active autoimmune disease requiring systemic treatment (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drug) within the past 6 months prior to dosing of investigational product.
2. History of permanent artificial implants (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopaedic screw\[s\], metal plate\[s\], bone graft\[s\], or other exogenous implant\[s\]
3. Known history of cholelithiasis or urolithiasis
4. History of valvular disease, arterial aneurisms or arterial or venous malformation
5. Known active brain metastases
6. Documented active Salmonella infection or vaccination with Salmonella typhi within 6 months prior to investigational product dosing
7. Additional protocol defined inclusion/exclusion criteria may apply
Medico-economic Evaluation of Therapeutic Adaptation Guided by the Soluble Suppression of Tumorigenicity 2 (sST-2) Biomarker in the Management of Patients With Acute Heart Failure

Management of patients with heart Failure remains a major health concern because of the high rate of rehospitalization, mortality and induced-cost. Biomarkers could help to guide the management of patients with heart failure (HF). Soluble suppression of tumorigenicity 2 (sST2) appears as a promising biomarker. As a working hypothesis, we postulate that sST2 values monitoring could be an helpful guide for medical management in an attempt to reduce hospital readmission.

Methods : ICAME is a multicentric, blinded prospective randomized controlled trial. 710 patients originated from 10 centers will be included over a period of 12 months and follow-up for 24 months. All patients have an external evaluation at 6, 12, 18 and 24 months. They were randomized into the usual treatment group (unknown sST2 level) or the interventional treatment group, for whom sST2 level was known at all external consultation and used to guide the treatment. The primary endpoint was the QALY (Quality Adjusted Life Years). The secondary endpoints were the Cost-efficacy ratio, Cost to avoid an hospitalization for heart failure, the readmission rate for any cause at 1 month and at two years, and the evolution of cardiac remodelling determined by the collagene biomarkers.

Eligibility Criteria:
Inclusion criteria:

* 18 years or older
* Hospitalization for heart failure (NTproBNP(N-terminal pro-Brain Natriuretic Peptid) ≥450 pg/ml (ou BNP ≥400 pg/ml)

Exclusion criteria:

* Waiting for heart transplantation
* Scheduled valve surgery
* No fluent french
* Not able to provide informed consent
* Hemodynamic instability
* Poor outcome during the first week.
* Pregnancy
* Participating to other study
Predictivity of Hemogasanalysis and Lung UltraSound in Determining COVID-19 Severity

This retrospective-prospective longitudinal observational study was designed to evaluate the role of bedside lung ultrasound per se and in association with hemogasanalysis parameters in predicting the severity of COVID-19 patients in the Emergency Departement (ED).

Retrospective data regarding patients who presented at the ED of IRCCS San Raffaele Hospital from 10/11/2020, together with those acquired by the observation of patients who will access to the ED until 10/05/2021 will be collected, configuring a total enrollment period of 6 months.

Clinical informations about patients' medical history will be recorded, with particular focus on the type and date of onset of the symptoms. The diagnostic and therapeutic strategy will be chosen according to the current standard of care. Results of bedside lung ultrasound, together with vital parameters, blood gas analysis, laboratory and other findings will be recorded.

The primary outcome will be defined as patients' outcome at time of discharge from the ED, in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death). Secondary outcomes will be patients' prognosis 30 days after access to ED and the required intensity of care (eg need for non-invasive ventilation, oro-tracheal intubation).The follow-up 30 days after access to the ED will be evaluated by telephone survey or by consulting medical records.


Eligibility Criteria:
Inclusion Criteria:

* SARS - CoV 2 infection confirmed by positive RT-PCR on nasopharyngeal swab

Exclusion Criteria:

* impossibility to perform lung ultrasound due to technical limitations.
Lean Body Mass Response to Higher-protein Diets During Winter Military Training

The objectives of this study are to: 1) determine effects of a prototype recovery food product providing supplemental energy on whole-body protein balance, skeletal muscle mass, and biomarkers of physiological status and strain during winter military training, and 2) determine the extent to which varying macronutrient composition (protein-based \[PRO\] versus carbohydrate-based \[CHO\]) of the food product modulates the physiological consequences to strenuous military training.

Up to 120 Norwegian Soldiers from the 2nd Battalion, Brigade North, Norwegian Army stationed at Skjold Garrison will be enrolled in a 9-day, randomized controlled study. Using dietary analysis, body composition assessments, stable isotope methodologies, basic biochemical techniques, and measures of physiological strain, the effects of supplemental energy in the form of carbohydrate and protein on indices of muscle mass and physiological status will be assessed.

We hypothesize that consuming supplemental energy will attenuate the effects of severe energy deficit on inflammation, androgenic hormones, and whole-body protein retention, thereby protecting skeletal muscle mass. We expect that consuming PRO will promote a more favorable recovery than consuming CHO, as indicated by measures of increased whole-body protein synthesis and greater conservation of skeletal muscle mass.

Eligibility Criteria:
Inclusion Criteria:

* Male and female Norwegian Soldiers aged 18 years or older participating in the 4-day training program.

Exclusion Criteria:

* History of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing large pills, and allergies to dairy products
Macronutrients and Satiety in Older and Younger Adults

This study aims to compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake, perceived appetite and gastric emptying in younger (\<40 years) and older (\> 65 years) people living in the United Kingdom (UK).

To assess if increasing protein intake in older adults will have a compensatory decrease in energy intake due to protein's satiating effects.

To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on energy intake and perceived appetite in younger (\<40 years) and older adults (\>65 years).

To compare the effect of meals high in protein, fat and carbohydrate but equal in energy and volume on gastric emptying in younger (\<40 years) and older adults (\>65 years).

Eligibility Criteria:
Inclusion Criteria:

* either aged \>65 years or \<40 years
* healthy

Exclusion Criteria:

* having a disease and/or using a medication that can impact on appetite in the past three months;
* having an allergy to any of the test foods;
* disliking or cannot eat any of the test foods;
* being pregnant or breastfeeding;
* being obese (BMI \> 30 kg/m2);
* being on a weight loss diet;
* smoking more than 10 cigarettes a day.
Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment

Different cognitive rehabilitation intervention methods have been developed for the treatment of cognitive dysfunctions seen in mild cognitive impairment (MCI). The aim of this study was to examine the effectiveness of cognitive rehabilitation intervention applied with the telerehabilitation method in elderly patients with amnestic-MCI.

Participants included in the study according to inclusion and exclusion criteria were randomly assigned to the telerehabilitation and face-to-face groups. A 12-week cognitive rehabilitation intervention was applied to both groups. Pre- and post-intervention cognitive skills of the participants were evaluated using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G).

A single-blinded, feasibility randomized controlled trial (RCT) investigated changes in the cognitive functions of older adults with amnestic-MCI after CR interventions applied face-to-face and with telerehabilitation. The study was designed according to the CONSORT statement. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study.

The demographic characteristics of the participants were recorded, including age, sex, education level, and marital status. All participants underwent a cognitive function assessment using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric twice, once before the intervention and again after the 12-week intervention. All participants were assessed in occupational therapy clinical practice units.

Participants were randomized to either the Face-to-Face group (FF) or the Tele-rehabilitation group (TR) using a computer-generated randomization technique.

After the randomization, cognitive rehabilitation intervention for both methods consist of 45-minute twice a week for 12 weeks. All participants received the intervention individually.

Eligibility Criteria:
Inclusion Criteria:

* Age between 65 and 75 years
* Diagnosed with amnestic-MCI by medical doctors
* Access to technological equipment; and
* Ability to understand and follow verbal instructions.

Exclusion Criteria:

* Secondary chronic disease that may affect cognitive functioning;
* Auditory and visual problems that may affect rehabilitation implementation and communication; and
* Attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period.
Indonesian Registry on Atrial Fibrillation

Our rationale of creation of this registry stems from the fact that the use of VKA in patients with AF is a double-edged sword, physicians face tremendous burden in assigning patients with VKA, due to risk of Bleeding complications despite its potential benefit. We intend to seek a safe and beneficial range of INR on Indonesian patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Diagnosis of valvular or nonvalvular AF

Exclusion Criteria:

* Reversible AF
* Patients who have been enrolled as a respondent on other clinical studies
Moral Reasoning Intervention on Moral Justification Abilities

The primary aim of this study is to evaluate the short (immediate) and mid-term (one month) impact of moral (vs non-moral) reasoning interventions on the moral justification abilities in non-expert subjects. Such an impact will be assessed by observing quantitative changes (on 1 to 4 points scale) of qualitative variables in the moral justification expressed by the subjects.

The aim of this study is to test wether a single intervention on moral reasoning can have short and/or mid-term effects on the justification of moral judgements about a problematic moral case. Focusing on justification allows to assess reasonable improvement by referring to a procedural standard, that is, without assuming any substantive normative view; namely, without evaluating a "betterment" on the basis of the content of moral judgements, but rather on the satisfaction of formal, procedural conditions in their justification. Our standard for a good moral justification consists in a set of procedural features, such as logical, empirical, and conceptual competence, openness to revision, sympathetic imagination, and bias avoidance.

Once enrolled, participants will be randomized through random.org software in the two experimental groups: 1) the moral and 2) the non-moral condition. Allocation concealment will be carried out through closed and opaque mails by a blind operator. Subjects will undergo a neuropsychological assessment and a (optional) task-based fMRI at study entry. Furthermore, during the day of the intervention (seminar: moral or logical reasoning), participants will undergo a pre-test (before the intervention) and a post-test (after the intervention) on a morally problematic case. The same test will be repeated by all participants one month after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* University students (other than Philosophy) within the first 3 years
* Aged between 18 and 26 years old
* Italian speakers
* Oral and written informed consent to study participation

Exclusion Criteria:

* A current psychiatric condition
* Contraindications to MRI study (cardiac pacemakers; metal splinters or fragments; metal protheses not compatible with the magnetic field; claustrophobia; women who are pregnant or intending to become pregnant during the study; breastfeeding women).
Comparison Between Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight by Ultrasound

We are going to do 2d ultrasound to compare between hadlock's formula and thigh soft tissue formula in expecting the after birth fetal weight and to find which of these formulas to be more accurate

We are going to do 2d ultrasound to 200 pregnant women between 38 weeks to 40 weeks singleton pregnancy in Ain Shams University Maternity Hospital to measure the expected fetal weight by hadlock's formula and thigh soft tissue formula and then we are going to measure the actual fetal weight after birth of these 200 fetuses and to find out which formula to be more accurate in estimation of fetal weight

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age 38 - 40 wks
2. Singleton uncomplicated pregnancies
3. Normal amniotic fluid volume

Exclusion Criteria:

Women with one of the following conditions:

1. Fetuses with congenital anomalies,
2. The biometric measurements of those, which were unable to ascertain due to reasons like deeply engaged head, very thick abdominal wall etc.
The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists

The question this study is designed to answer is whether or not the use of a MUSE Meditation Device lowers student registered nurse anesthetist's perception of stress, anxiety, and burnout within the Mayo Clinic Doctorate of Nurse Anesthesia Practice Program.


Eligibility Criteria:
Inclusion Criteria:

* Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.

Exclusion Criteria:

* Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021 and 2022.
Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial

Randomized Clinical Trial to evaluate which is the best infusion system of heparin solution for Keeping the mean invasive blood pressure whether the continuous system and the intermittent one.


Eligibility Criteria:
Inclusion Criteria:

* patients in post-operative in congenital heart disease under 15 kg

Exclusion Criteria:

* no consent of parents or responses
Glucagon-like Peptide (GLP) Utilization and Safety

This study will assess the utilization patterns (adherence, source of the index antidiabetic agent (ADA) and treatment modification) of the marketed glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide and liraglutide), dipeptidyl-peptidase-4 (DPP-4) inhibitors (sitagliptin, saxagliptin, and linagliptin) and other ADAs and the incidence rate of acute pancreatitis among the users of these GLP-1 receptor agonists and users of DPP-4 inhibitors, separately, in comparison to other ADAs.

The proposed study will help in understanding the treatment utilization patterns and the incidence rate of acute pancreatitis among users of the marketed GLP-1 receptor agonists. This study differs from previous observational studies by including both exenatide and liraglutide and follow-up time is expected to be longer in the current study (2005 - 2011).

This study will be a retrospective cohort study conducted in the Truven (Thomson Reuters) commercial health insurance database from 2005-2011.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged ≥ 18 and ≤ 64 years as of index date and those who have continuous enrolment for at least 12 months in Truven
* Subjects should have complete medical and pharmacy benefits and continuous enrolment in the health plan for at least 12 months before the index date (pre-index period).
* Subjects should also have at least 1 claim of T2D diagnosis identified using ICD-9 codes 250.x0 or 250.x2 (excluding 250.x1 and/or 250.x3 - Type 1 diabetes and 648.0x - gestational diabetes)

Exclusion Criteria:

* For the objective of evaluating the association between GLP-1 receptor agonists, DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and the use of other ADAs, subjects having evidence of pancreatic disease (ICD 9 code of 577.xx) in the pre-index period (12 months before the index date) will be excluded.
New Mechatronic Device for Epidural Space Detection

This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.


Eligibility Criteria:
Inclusion Criteria:

* patients whose pathology requires specific treatment such as epidural infiltration

Exclusion Criteria:

* coagulation abnormalities or assumption of anticoagulant drugs
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed study CN012-0023 or CN012-0024 per protocol.
* Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).

Exclusion Criteria:

* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
* Other protocol-defined Inclusion/Exclusion criteria apply.
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital

This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 1 year

Exclusion Criteria:

Autoimmune hepatitis Primary sclerosing cholangitis
Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial

Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta.

Methods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided randomly to two groups: (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3. In cases of allergy to Penicillin the antibiotic regimen will be: Gentamycin 240 mg\*1, Clindamycin 600 mg\*3.

Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent hospitalization in the first 2 weeks after discharge.


Eligibility Criteria:
Inclusion Criteria:

* suspected retained placenta

Exclusion Criteria:

* Intrapartum fever